Every regulatory action against hormone, peptide, and weight-loss marketers since 2015.

Wholesale Peptide

FDA's Center for Drug Evaluation and Research issued a warning letter to Wholesale Peptide (Brooksville, FL) in June 2026 after reviewing their website and finding that two injectable products — 'Prostamax' and 'Gonadorelin' — are being marketed as unapproved new drugs under section 505(a) of the FD&C Act. The products' labeling included claims about treating benign prostatic hyperplasia, prostatitis, spermatogenesis, and cancer, establishing intended human drug use despite 'research use only' disclaimers. FDA warned that continued interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, and that failure to correct violations may result in seizure or injunction.

Indiangoods.shop

FDA issued a warning letter to Indiangoods.shop, an India-based online retailer, for selling three unapproved new drugs — 'Moon Herbal Josh Awar Khas,' 'Kapiva Him Foods Testo Capsules,' and 'Patanjali Youvan Gold Plus Capsule' — into U.S. interstate commerce without FDA-approved applications. The products were marketed with claims related to testosterone boosting, sexual performance, stamina, and libido, qualifying them as drugs under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct could result in seizure or injunction. The recipient was required to respond within 15 business days with corrective steps.

WPATH, FTC v.

The FTC, joined by Alaska, Iowa, Nebraska, and Texas, filed a lawsuit against the World Professional Association for Transgender Health (WPATH), alleging the organization provided medical providers with the means to make false and unsubstantiated claims to parents in order to sell pediatric medical transition services. The complaint centers on WPATH's role in enabling downstream marketing of these services through claims the FTC characterizes as unsupported by adequate scientific evidence. This is a multi-state enforcement action seeking to hold a professional standards body liable for facilitating deceptive health claims. No specific penalty amount or corrective deadline is stated in the available document text.

Altru Telehealth, LLC dba Altru Telehealth

FDA issued a warning letter to Altru Telehealth, LLC (dba Altru Telehealth) on June 8, 2026, following a March 2026 review of its website, which marketed compounded semaglutide and tirzepatide products. The agency found that Altru's website made false or misleading claims by implying the compounded products were FDA-approved and that its compounding pharmacies held FDA approval or licensure — designations that do not legally exist for compounding facilities. These representations caused the compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act, constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.

Nova Vascular LLC dba NOVARX

FDA issued a warning letter to Nova Vascular LLC dba NOVARX (New York, NY) following a March 2026 review of its website, which markets compounded semaglutide and tirzepatide products. The agency found the website made false or misleading claims, including implying FDA approval of compounded drugs by referencing the same active ingredient as Ozempic and describing sourcing from 'FDA Approved Pharmacies,' a designation that does not legally exist for compounding facilities. The product labels also falsely identified 'NOVA RX' as the compounder when it is not. FDA cited misbranding violations under FD&C Act sections 502(a) and 502(bb) and warned that failure to correct violations may result in seizure or injunction.

Medica Weight Loss

FDA issued a warning letter to Medica Weight Loss (Aventura, FL) following a March 2026 review of its website, finding that the company made false or misleading claims about compounded semaglutide and tirzepatide products in violation of FD&C Act sections 502(a) and 502(bb). Specific violations included falsely implying FDA approval of compounded drugs, misrepresenting the compounder's identity on product labels, and describing the sourcing pharmacy as 'FDA-approved' — a designation FDA does not grant to compounding facilities. The misbranding violations constitute prohibited acts under section 301(a) of the FD&C Act, and FDA warned that failure to correct them may result in seizure or injunction.

Momentum Health 360 dba Momentum Health

FDA issued a warning letter to Momentum Health 360 dba Momentum Health (Newport Beach, CA) following a March 2026 review of their website, which markets compounded semaglutide, tirzepatide, and liraglutide products. The agency found the website made false or misleading claims by implying the compounded drugs share FDA-approved status with branded GLP-1 products (Ozempic®, Wegovy®, Mounjaro®, Zepbound™), falsely labeled Momentum Health as the compounder, and misrepresented the compounding facility as 'FDA-licensed.' These representations caused the products to be misbranded under FD&C Act §§ 502(a) and 502(bb), and FDA warned that failure to correct violations may result in seizure or injunction.

Maximus Health, Inc. dba Maximus

FDA issued a warning letter to Maximus Health, Inc. dba Maximus (Santa Monica, CA) in June 2026 after reviewing their website and finding false or misleading promotional claims about compounded semaglutide and tirzepatide products. The company falsely implied these unapproved compounded drugs had been clinically studied or proven effective, and misrepresented their sourcing pharmacies as 'FDA approved' — a designation FDA does not grant to compounding facilities. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a), with FDA warning that failure to correct violations may result in seizure or injunction.

Clover Meds LLC dba Clover Meds

FDA issued a warning letter to Clover Meds LLC dba Clover Meds (Sarasota, FL) in June 2026 following a review of their website, which markets compounded semaglutide and tirzepatide products. The agency found two false or misleading representations: product labels bearing the 'Clover Meds' name implied the company was the compounder when it was not, and the website falsely described sourcing facilities as 'FDA-licensed,' a designation FDA does not grant to compounding pharmacies or outsourcing facilities. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), and FDA warned that failure to correct violations could result in seizure or injunction.

Joi and Blokes dba Joi + Blokes

FDA issued a warning letter to Joi and Blokes dba Joi + Blokes (Denver, CO), a telehealth company offering compounded semaglutide and tirzepatide products, for false or misleading marketing claims on their website. The company falsely implied their compounded products were FDA-approved by describing them as 'bioidentical' to brand-name drugs like Ozempic and Wegovy, and also misbranded products by displaying the 'Joi + Blokes' name on product labels when the company is not the actual compounder. FDA cited violations of FD&C Act sections 502(a) and 502(bb) for misbranding, and warned that failure to correct violations could result in seizure or injunction.

Roen Health, Inc. dba RoenRx

FDA issued a warning letter to Roen Health, Inc. dba RoenRx (New York, NY) after a March 2026 review of its website found false or misleading claims about compounded semaglutide products. The website falsely implied FDA approval by associating compounded semaglutide with FDA-approved brand names Wegovy and Ozempic, and also misidentified RoenRx as the compounder on product labels. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.

OrderlyMeds LLC dba OrderlyMeds

FDA issued a warning letter to OrderlyMeds LLC (dba OrderlyMeds) in Decatur, GA, citing misbranding violations related to compounded semaglutide and tirzepatide products marketed on its website. The agency found two specific false or misleading representations: (1) the company's logo appeared on product labels implying OrderlyMeds was the compounder when it was not, and (2) the website falsely described the compounding source as an 'FDA-licensed pharmacy,' a designation that does not legally exist. These representations rendered the products misbranded under FD&C Act sections 502(a) and 502(bb), and FDA warned that failure to correct violations could result in seizure or injunction.

FITISH

FDA issued a warning letter to FITISH (Fort Worth, TX) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The agency found that FITISH's labeling falsely implied it was the compounder of the drugs, and that website claims associating the compounded products with FDA-approved brand-name drugs (Ozempic, Mounjaro, Zepbound) misrepresented the products as FDA-approved or evaluated for safety and effectiveness. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.

Ready Med

FDA issued a warning letter to Ready Med (Clearwater, FL) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The violations included falsely implying Ready Med was the compounder of the drugs, misrepresenting compounded products as equivalent to FDA-approved branded drugs (Mounjaro, Zepbound, Ozempic, Rybelsus), and falsely describing the compounding facility as 'FDA licensed.' These representations caused the products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act, and FDA warned that failure to correct violations could result in seizure and injunction.

Ezra Holdco LLC dba Ezra

FDA issued a warning letter to Ezra Holdco LLC dba Ezra (joinezra.com) in June 2026 for false or misleading representations on its website concerning compounded semaglutide and tirzepatide products. The core violation is that product labels displayed on the website identify 'Ezra' as the compounder when Ezra is not actually the manufacturer, constituting misbranding under FD&C Act sections 502(a) and 502(bb). FDA found these practices result in misbranded drug products being introduced into interstate commerce in violation of section 301(a). Ezra was required to respond within 15 business days with corrective steps, including identifying actual compounders, providing sample labeling, and removing or modifying false or misleading website claims.

Public Health Solution LLC dba DrMedHealth

FDA issued a warning letter to Public Health Solution LLC dba DrMedHealth (Fredericksburg, VA) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The company's website stated these compounded products contained the 'Same active ingredient as Ozempic®' and 'Same active ingredient as Mounjaro®,' which FDA determined falsely implied FDA approval or evaluation for safety and effectiveness. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.

Trinity HealthCare Supply, LLC dba altRx

FDA issued a warning letter to Trinity HealthCare Supply, LLC dba altRx (Miami, FL) for false or misleading marketing of compounded semaglutide and tirzepatide products on its website. The agency found that altRx's labeling falsely identified itself as the compounder of the drugs and that website claims describing GLP-1s as 'clinically proven' implied FDA approval for unapproved compounded products, violating FD&C Act sections 502(a) and 502(bb). FDA warned that failure to correct these violations could result in seizure and injunction, and required a written corrective response within 15 business days.

Amare Global Holdings, FTC v.

The FTC sued multilevel marketer Amare Global Holdings Inc. and three of its principals for falsely claiming that its dietary supplements — marketed for both children and adults — could treat or cure health conditions including depression, anxiety, and ADHD. The company also allegedly misled prospective 'brand partner' recruits about their potential earnings. The case represents a critical enforcement action combining unsubstantiated disease-treatment claims for supplements with deceptive income representations in an MLM structure.

Blue Horizon International, LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Blue Horizon International, LLC (Dr. Brian Mehling, CMO/Founder) in Hackensack, NJ, citing the company's marketing of unapproved umbilical cord blood-derived Stem Cell Therapy and WJ-MSC-derived Exosome Therapy for allogeneic use without a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website made extensive disease-treatment claims spanning neurological, cardiovascular, musculoskeletal, metabolic, and other conditions, rendering the products unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. Both products were also found to be misbranded under section 502(f)(1) for failing to bear adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.

Meta Labs Pharmaceuticals, LLC

FDA issued a warning letter to Meta Labs Pharmaceuticals, LLC (Roswell, GA) following a December 2025 facility inspection and April 2026 website review, finding that six products — Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response — bore disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The products were also found misbranded for lacking adequate directions for use, and two products (Diabetic Advantage and Respiratory Response) were adulterated due to serious CGMP violations including absent finished-product specifications, missing component identity testing, and incomplete master manufacturing and batch production records. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Fagron BV

FDA issued a warning letter to Fagron BV (operating as Fresenius Kabi Compounding, LLC / Fagron Sterile Services in Canton, MA), a registered 503B outsourcing facility, following an October–November 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile drug products. Investigators found that operators blocked first-air to sterile vials, smoke studies were inadequate, environmental monitoring was insufficient, and the quality unit failed to act on known adverse trends involving defective IV bags — all causing drug products to be adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). The facility had already initiated a voluntary recall in February 2026 of affected lots, but FDA found multiple corrective action responses inadequate or unsupported by documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.

Harbin Jixianglong Biotech Co., Ltd.

FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd., a Chinese manufacturer of peptide APIs including semaglutide and tirzepatide, following a November 2025 inspection. The agency found the firm purchased semaglutide API from unapproved suppliers, repackaged and relabeled it under its own name with falsified manufacturing and retest dates, and distributed it to the U.S. market — conduct FDA characterized as potentially circumventing Import Alert 66-80 safeguards. Additional violations included lack of process and cleaning validation, inadequate analytical method validation, insufficient water quality controls, and drug listing/misbranding violations. The firm was placed on Import Alert 66-40 (detention without physical examination), removed from the GLP-1 Green List, and initiated a voluntary recall of two semaglutide API batches.

OptiHealth Products, Inc.

FDA issued a warning letter to OptiHealth Products, Inc. (President Russell Dickson) regarding their dietary supplement Super Antioxidant (OPCXtra), finding that disease-treatment claims on the company's website and Facebook page caused the product to be regulated as an unapproved new drug under the FD&C Act. The flagged claims included assertions that the product could help manage diabetes, reduce heart disease risk, combat Alzheimer's and Parkinson's disease, and treat macular degeneration. FDA determined the product is both an unapproved new drug under section 505(a) and a misbranded drug under section 502(f)(1) for lacking adequate directions for use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

ibeautistore.com

FDA issued a warning letter to ibeautistore.com (Dover Plains, NY) regarding its product 'Umary' (sold as 'New Hyaluronic Acid 850 mg Sealed 30 Caps'), which laboratory analysis confirmed contained undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and omeprazole. The product was marketed as a dietary supplement but constitutes an unapproved new drug under FD&C Act section 505(a) and is misbranded under section 502(a) due to failure to disclose these dangerous hidden drug ingredients. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within fifteen working days.

Ray’s Vitamins

FDA issued a warning letter to Rene Gonzalez, owner of Ray's Vitamins (Whittier, CA), regarding the sale of 'Yeicob Ácido Hialurónico,' a product marketed as a dietary supplement for joint and arthritis support. Laboratory analysis confirmed the product contained undeclared active pharmaceutical ingredients diclofenac (an NSAID) and dexamethasone (a corticosteroid), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made drug-intended-use claims without FDA approval, and the failure to disclose the undeclared ingredients poses serious consumer health risks. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Foshan Miwei Cosmetics Co., Ltd.

FDA issued a warning letter to Foshan Miwei Cosmetics Co., Ltd. (China) for manufacturing OTC sunscreen drug products — Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer — that are unapproved new drugs and misbranded under the FD&C Act, in addition to multiple CGMP violations. The products' labeling made pharmacological claims for ingredients such as plant-based stem cells, sodium hyaluronate, vitamins B/C, and vitamin B3 (e.g., collagen promotion, cell repair, reducing hyperpigmentation/inflammation) that rendered them unapproved drugs not conforming to the OTC sunscreen monograph M020. FDA had already placed the firm on Import Alert 66-40 as of February 13, 2026, and the letter demands corrective action within 15 working days or continued refusal of admission of the firm's products into the United States.

New Life Pharma LLC

FDA issued a warning letter to New Life Pharma LLC (Northvale, NJ) after a February 2026 inspection found the company was manufacturing and distributing unapproved semaglutide and tirzepatide sterile multi-dose vials — GLP-1 drugs shipped primarily to weight loss clinics and med spas — without FDA approval, proper registration, or adequate sterility controls. The products were deemed unapproved new drugs, misbranded, and adulterated due to pervasive CGMP failures including no aseptic process validation, no environmental monitoring, and no sterility testing. The company also denied FDA investigators access to portions of its manufacturing suite, further adulterating the drugs under FD&C Act section 501(j). A voluntary recall of all distributed batches was issued on February 25, 2026, and FDA demanded the firm confirm it will permanently cease drug manufacturing.

TruHeight (Vanilla Chip LLC)

Nevada-based Vanilla Chip LLC (d/b/a TruHeight) and its two principals, Eden Stelmach and Justin Rapoport, agreed to settle FTC charges that they deceptively marketed supplements as supporting height growth in children and teenagers without adequate substantiation. The FTC also charged the company with relying on fake or incentivized reviews — written by employees or consumers offered free products or discounts in exchange for 5-star ratings — to bolster product credibility. The matter resulted in a consent order requiring corrective action.

ProRx LLC

ProRx LLC, a 503B outsourcing facility in Exton, PA, received an FDA Warning Letter following a September 2025 inspection that found the company compounding tirzepatide and semaglutide injectable products under insanitary conditions with serious sterility assurance failures. The facility violated section 503B by using tirzepatide bulk drug substance not on the 503B bulks list, omitting required label statements, and failing to maintain adequate adverse event reporting procedures. Multiple CGMP violations were cited including inadequate contamination investigations, blocked first air during aseptic operations, and use of non-sterilized equipment in ISO 5 areas. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure or injunction.

Nature’s Elements, Inc.

FDA issued a warning letter to Nature's Elements, Inc. (Bohemia, NY) following an October 2025 facility inspection and website review, finding that five dietary supplement products — He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps — bore disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The DHT Blocker and Schizandra Berry extract were additionally cited as misbranded drugs for lacking adequate directions for use. Multiple products were also found adulterated due to serious CGMP violations including absent product specifications, missing master manufacturing records, and no batch production records. FDA warned that failure to correct these violations may result in seizure or injunction.

Purolea Cosmetics Lab

FDA issued a warning letter to Purolea Cosmetics Lab (Livonia, MI) after a October 2025 inspection found the facility manufacturing adulterated homeopathic drug products under insanitary conditions, with multiple CGMP violations including failure to conduct microbiological testing, component identity testing, and adequate quality unit oversight. Two products — 'Dermveda Extra Strength Shingles Relief' and 'Dermveda Extra Strength Ultra Genital Herpes Relief' — were identified as unapproved new drugs marketed for serious conditions (shingles and genital herpes) without FDA approval. The firm also improperly relied on AI-generated compliance documents without human QU review. FDA warned that failure to address violations may result in seizure, injunction, and withholding of approvals, and required a written response within 15 working days.

Beauty of Aztlan LLC

FDA issued a warning letter to Beauty of Aztlan LLC for selling unapproved and misbranded injectable botulinum toxin products ('Botulax 100units' and 'Innotox 50units') via their website without requiring a prescription. The products were marketed with drug-intent claims such as 'Correction of blepharospasm' and 'Hyperhidrosis (increased sweating),' triggering violations of the FD&C Act for introducing unapproved new drugs and misbranded prescription drugs into interstate commerce. FDA demanded cessation of sales, a written corrective action response within 15 working days, and warned that failure to comply could result in seizure or injunction.

Pure Indulgence Aesthetics

FDA issued a warning letter to Pure Indulgence Aesthetics, a medical spa in Southlake, TX, following a December 2025 inspection that revealed the facility dispensed significantly more Botox units to patients than it had purchased from the authorized manufacturer (AbbVie), indicating procurement from unauthorized trading partners in violation of the Drug Supply Chain Security Act (DSCSA). Investigators also found an unlabeled vial containing botulinum neurotoxin type A in the facility's trash that lacked required product identifiers and did not match authentic AbbVie Botox packaging. The facility's December 2025 response to the FDA 483 was deemed inadequate for failing to address the purchase-dispensing discrepancy, provide supporting documentation, or establish forward-looking compliance procedures. FDA warned that failure to correct violations may result in seizure and injunction.

FormPour

FDA issued a warning letter to FormPour (Shuja Arshad, Canton, MI) regarding the sale of 'SMGT-GLT-1 Nano Microneedle Patch' on eBay, which FDA determined is an unapproved new drug under section 505(a) of the FD&C Act. The product's labeling made explicit disease-treatment claims for Type 2 Diabetes, weight loss, and cardiovascular protection, establishing its intended use as a drug. Because no approved NDA is in effect for this product, its interstate sale violates sections 301(d) and 505(a) of the FD&C Act. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.

Prime Sciences

FDA issued a warning letter to Prime Sciences (Scottsdale, AZ) on March 31, 2026, after reviewing their website and finding that they were selling unapproved new drugs — including Cagrilintide, Retatrutide, Semaglutide, Tirzepatide, Mazdutide, and BAC water — in violation of sections 301(d) and 505(a) of the FD&C Act. Despite labeling the products as 'for laboratory research purposes only,' the website's marketing copy made clear the products were intended for human use in weight loss and diabetes management. FDA warned that failure to correct these violations could result in seizure and injunction, and required a written response within fifteen working days.

Guangzhou Huli Technology Co., Ltd. dba Fantasy Face

FDA issued a warning letter to Guangzhou Huli Technology Co., Ltd. dba Fantasy Face (operating an eBay store) for selling 'Googeer GLP-1 Weight Control Oral Solution' in the United States without an approved new drug application. The product's labeling made drug-intended-use claims including weight management, blood sugar balance, and body shaping, qualifying it as an unapproved new drug under FD&C Act sections 301(d) and 505(a). FDA requires written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

PekCura Labs

FDA issued a warning letter to PekCura Labs (Jonathan Snider and Jonathan Speck, Pensacola, FL) on March 31, 2026, after reviewing their website in January 2026. The agency found that PekCura Labs was selling injectable peptide products marketed as 'GLP-1-S,' 'GLP-2-T,' 'GLP-3-R,' and 'Bacteriostatic Water' — all unapproved new drugs under section 505(a) of the FD&C Act — with product pages making explicit disease-treatment and body-weight-reduction claims referencing clinical studies. Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on the marketing language, and warned that failure to correct violations could result in seizure and injunction.

Mile High Compounds LLC

FDA issued a warning letter to Mile High Compounds LLC (Clifton, CO) on March 31, 2026, after reviewing the company's website and affiliated community forum from January to March 2026. The company was found to be selling unapproved new drugs — including products containing semaglutide ('GLP-1 SM'), tirzepatide ('GLP-2 TRZ'), retatrutide ('GLP-3 RT'), and bacteriostatic water ('BAC Water') — marketed under research-only labels but with clear human-use dosing and therapeutic claims. FDA determined these products are intended for human use to treat obesity and metabolic conditions, making them unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure and injunction.

Gram Peptides

FDA issued a warning letter to Gram Peptides (Bernard Gramlich, Rancho Santa Fe, CA) on March 31, 2026, after reviewing the company's website and finding it offered Retatrutide, Tirzepatide, and Bacteriostatic Water for Injection for sale as unapproved new drugs. Despite 'Research Use Only' disclaimers, the website's marketing claims—describing appetite suppression, weight loss, glucose regulation, and metabolic benefits—established intended human drug use under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct may result in seizure or injunction.

Lovega LLC dba Pink Pony Peptides

FDA issued a warning letter to Lovega LLC dba Pink Pony Peptides (Susan Vega, Wellington, FL) after reviewing the company's website in December 2025 and finding that three products — 'GLP-2 TZ' (tirzepatide), 'GLP-3 RT' (retatrutide), and 'Bacteriostatic Water' — were being sold as unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. Despite 'research purposes only' disclaimers, the website's marketing copy made explicit human-use drug claims including appetite suppression, fat loss, insulin sensitivity, and glucose control. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Nupack Inc.

FDA issued a warning letter to Nupack Inc. (Elgin, IL) following a facility inspection and website review, finding that six dietary supplement products — Cardiag, Diabetech, Cleanse-CAMP, MACA, Kidney Cleanse, and Pure Psyllium Husk — bore disease-treatment and prevention claims that rendered them unapproved new drugs under the Act. Three products (Cardiag, Diabetech, MACA) were also deemed misbranded drugs for lacking adequate directions for use. Additionally, Cardiag, Cleanse-CAMP, and MACA 1000 mg were found adulterated due to serious CGMP violations including absent product specifications, master manufacturing records, and batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.

Novo Nordisk Inc.

FDA issued a Warning Letter to Novo Nordisk Inc. (NNI) following a January–February 2025 inspection that revealed serious violations of postmarketing adverse drug experience (PADE) reporting regulations under 21 CFR 314.80, affecting products including semaglutide and liraglutide. NNI failed to develop adequate written procedures ensuring timely 15-day Alert reporting of serious and unexpected ADEs, improperly rejected reportable cases based on reporter-assessed causality, and failed to promptly investigate ADEs subject to expedited reporting. FDA found systemic failures in NNI's pharmacovigilance program—including inadequate vendor oversight and corrective actions—and requires a written response within 15 business days detailing remediation steps, with the warning that failure to adequately address these issues may lead to further regulatory action.

Belle Health LLC dba Belle

FDA issued a warning letter to Belle Health LLC dba Belle (Draper, UT) on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labeling that falsely identified 'Belle' as the compounder when it is not. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Dripgym Mobile Parent, LLC dba Amp Health

FDA issued a warning letter to Dripgym Mobile Parent, LLC dba Amp Health (Los Angeles, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely identified 'Amp Health' as the compounder on product labels, and made claims implying FDA approval by referencing the same active ingredients as FDA-approved brand-name drugs (Wegovy, Ozempic, Saxenda, Mounjaro, Zepbound). These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Alan Health Technologies Inc. dba Alan

FDA issued a warning letter to Alan Health Technologies Inc. dba Alan (Brooklyn, NY) on February 20, 2026, after reviewing the company's website alanmeds.com in December 2025. The agency found that Alan's website displayed compounded semaglutide and tirzepatide products with the 'Alan' brand name on the pictured labels, falsely implying Alan was the compounder of those drugs when it was not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these products into interstate commerce violates section 301(a). Alan was given 15 working days to respond with corrective steps, and failure to comply could result in seizure or injunction.

24HrDoc, Inc. dba 24HrDoc

FDA issued a warning letter to 24HrDoc, Inc. (Houston, TX) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely implied 24HrDoc was the compounder of the drugs by displaying its name on product labels, and made claims that the compounded products contained the 'same ingredients' as FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound), which FDA found misleadingly implied FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce introduction constituting a prohibited act under section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to comply may result in seizure or injunction.

NewSelf Limited dba NewSelf

FDA issued a warning letter to NewSelf Limited dba NewSelf on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found the website made false or misleading claims by displaying the 'NewSelf' label on drug products it does not compound, and by using language implying FDA approval for compounded drugs that have not been approved. These representations render the products misbranded under FDCA sections 502(a) and 502(bb), and their interstate commerce introduction violates section 301(a). NewSelf was given 15 working days to respond with corrective steps, and was warned that failure to act may result in seizure or injunction.

Newman Clinic, PLLC dba Newman Clinic

FDA issued a warning letter to Newman Clinic, PLLC (operated by Donna Newman, DMSc, PA-C) on February 20, 2026, after reviewing the clinic's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The clinic's website falsely implied Newman Clinic was the compounder of these drugs by displaying its name on product labels, and made claims suggesting the compounded products were FDA-approved by stating they contained the 'Same Ingredient as Ozempic® and Wegovy®' and 'Same Ingredient as Mounjaro® and Zepbound®.' FDA found these representations misbranded the products under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

MEDVi, LLC dba MEDVi

FDA issued a warning letter to MEDVi, LLC dba MEDVi on February 20, 2026, after reviewing its website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The agency found that MEDVi's website falsely implied the company was the compounder of these drugs (when it was not) and that claims comparing its products to FDA-approved brand-name drugs (Wegovy, Ozempic, Mounjaro, Zepbound) misleadingly implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to act could result in seizure or injunction.

Kin Meds

FDA issued a warning letter to Kin Meds (Manhattan Beach, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely identified 'Kin Meds' as the compounder on product labels when it is not, and made claims implying FDA approval or evaluation of compounded products that have not been approved. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Ivim Services LLC dba Ivim

FDA issued a warning letter to Ivim Services LLC dba Ivim, a telehealth company based in Columbus, OH, after reviewing its website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labeling that falsely identified 'Ivim' as the compounder when it is not. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.

Peaks Curative, LLC dba Peaks

FDA issued a warning letter to Peaks Curative, LLC dba Peaks on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide products. The website falsely implied FDA approval of compounded drug products and misidentified 'Peak Now' as the compounder on product labels. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Viv Health, Inc. dba VIV RX

FDA issued a warning letter to Viv Health, Inc. dba VIV RX, a telehealth company based in Austin, TX, for misbranding compounded semaglutide and tirzepatide products on its website. The core violation is that the product labels depicted on the website identify 'VIV RX' as the compounder when VIV RX is not actually the compounder, constituting false or misleading labeling under FDCA sections 502(a) and 502(bb). FDA found these products to be misbranded drugs introduced into interstate commerce in violation of section 301(a) of the FDCA. The company was given 15 working days to respond with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

Refills Health, LLC dba Refills Health

FDA issued a warning letter to Refills Health, LLC (dba Refills Health) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide products. The website falsely identified Refills Health as the compounder of the drugs on product labels, and made claims implying FDA approval or clinical validation for products that have not been FDA-approved. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Strut Health, LLC dba Strut

FDA issued a warning letter to Strut Health, LLC dba Strut (CEO Simal Patel, MD) on February 20, 2026, concerning false or misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that Strut's website falsely implied the company itself was the compounder of these drugs (by displaying 'Strut' on product labels) and that claims such as 'Generic Zepbound, Mounjaro' falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Premium Health Management Inc. dba Premium Health

FDA issued a warning letter to Premium Health Management Inc. dba Premium Health (Santa Ana, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The FDA found that the website falsely implied Premium Health was the compounder of the products and that the products had received FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce constituting a prohibited act under section 301(a). The company was given 15 working days to respond with corrective steps, and was warned that failure to comply may result in seizure or injunction.

Weightless Medical LLC dba WeightCare

FDA issued a warning letter to Weightless Medical LLC dba WeightCare on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labels identifying 'WeightCare' as the compounder when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Aspen Aesthetics dba Fifty 410

FDA issued a warning letter to Aspen Aesthetics dba Fifty 410 (Prosper, TX) on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found two categories of misbranding violations: (1) the product labels displayed on the website identified 'Fifty 410' as the compounder when it is not, constituting a false or misleading representation under FDCA §§ 502(a) and 502(bb); and (2) the claim 'clinically proven ingredients' falsely implied FDA approval or evaluation for safety and effectiveness for unapproved compounded drugs. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Join Josie

FDA issued a warning letter to Join Josie, a website offering compounded semaglutide and tirzepatide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The site falsely displayed the 'Join Josie' label on compounded drug products, implying the company was the compounder when it was not, and made misleading claims linking its compounded products to FDA-approved brands Wegovy® and Zepbound®, implying FDA approval or evaluation that does not exist. FDA found these representations false or misleading, constituting misbranding and prohibited interstate commerce under section 301(a). Join Josie was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.

Kare Solutions, LLC dba Zappy

FDA issued a warning letter to Kare Solutions, LLC dba Zappy (La Jolla, CA), a telehealth platform offering compounded semaglutide, tirzepatide, and liraglutide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The website falsely displayed 'Zappy' on product labels implying it was the compounder, and made claims linking its compounded products to FDA-approved branded drugs (Wegovy®, Saxenda®, Zepbound®) and describing them as 'a proven medication' and 'clinically studied,' implying FDA approval that compounded drugs do not have. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Better Health Labs, Inc. dba Measured

FDA issued a warning letter to Better Health Labs, Inc. dba Measured (New York, NY) on February 20, 2026, after reviewing the company's website trymeasured.com in December 2025. The agency found that Measured's website falsely implied the company itself was the compounder of semaglutide and tirzepatide products by displaying the 'Measured' brand name on product labels, and that marketing claims comparing compounded products to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to adequately address violations may result in seizure and injunction.

MaxLife Technologies Inc. dba Maxlife

FDA issued a warning letter to MaxLife Technologies Inc. dba Maxlife (Irvine, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The company falsely labeled products with the 'Maxlife' brand as if it were the compounder, and made multiple claims that the compounded drugs were 'FDA-approved' or equivalent to FDA-approved branded products, when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Levity Inc. dba Levity

FDA issued a warning letter to Levity Inc. dba Levity (Delray Beach, FL) on February 20, 2026, after reviewing their website in December 2025 and finding that compounded semaglutide and liraglutide products were marketed with false or misleading claims. The company's website displayed the 'Levity' brand name on product labels despite Levity not being the actual compounder, and used claims implying FDA approval by referencing brand-name drugs Ozempic, Wegovy, and Saxenda. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb), with interstate commerce violations under section 301(a), and warned that failure to respond could result in seizure or injunction.

PharmaZee

FDA issued a warning letter to PharmaZee (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified PharmaZee as the compounder of the drugs and made claims implying FDA approval or clinical validation for unapproved compounded products. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Genesis Health International Inc. dba Genesis

FDA issued a warning letter to Genesis Health International Inc. dba Genesis (Boynton Beach, FL) on February 20, 2026, after reviewing their website trygenesis.com in December 2025. The agency found that Genesis falsely represented itself as the compounder of semaglutide and tirzepatide products by displaying the 'Genesis' name on product labels, and made misleading claims implying FDA approval by stating their products contain 'the same active ingredient as Ozempic® and Wegovy®' and 'Same active ingredient as Mounjaro®.' These practices rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to address violations may result in seizure and injunction.

FitRX, LLC dba FitRx

FDA issued a warning letter to FitRX, LLC dba FitRx (New York, NY) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the FitRx label appearing on product images implies FitRx is the compounder when it is not, and (2) website claims linking their compounded products to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely imply FDA approval or evaluation for safety and effectiveness. Both violations constitute misbranding under FDCA sections 502(a) and 502(bb), and FitRx was given 15 working days to respond with corrective steps or face potential seizure and injunction.

Good Girl LLC dba GoodGirlRX

FDA issued a warning letter to Good Girl LLC dba GoodGirlRX (CEO Savannah Chrisley) in February 2026 after reviewing the company's website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely labeled products as if GoodGirlRX were the compounder, and made claims that compounded drugs were 'FDA-approved' or 'clinically proven,' when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and warned that failure to address violations may result in seizure or injunction.

Lean Rx, Inc. dba SkinnyRx

FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx (Sacramento, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the website's product images display the 'SkinnyRx' label, falsely implying SkinnyRx is the compounder of the drugs, and (2) marketing claims imply FDA approval or equivalence to FDA-approved medications, which is false for compounded products. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Zeuss LLC dba Zeuss

FDA issued a warning letter to Zeuss LLC dba Zeuss on February 20, 2026, regarding its website marketing of compounded tirzepatide products. The agency found the products misbranded under FDCA sections 502(a) and 502(bb) because the website falsely implied Zeuss was the compounder of the drugs, and made claims suggesting the compounded products were FDA-approved or clinically proven when they are not. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics

FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The company's website falsely implied it was the compounder of these drugs by displaying its name on product labels, and made claims linking its compounded products to FDA-approved brand-name drugs (Ozempic®, Mounjaro®, Wegovy®, Rybelsus®, Zepbound®), thereby misleadingly implying FDA approval or evaluation for safety and effectiveness. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

BluefitMD

FDA issued a warning letter to BluefitMD (Lakewood Ranch, FL) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified BluefitMD as the compounder of these drugs when it was not, and marketing language implied the compounded products shared FDA-approved status with brand-name drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. FDA determined the products were misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). BluefitMD was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Bliv Wellness LLC dba Bliv

FDA issued a warning letter to Bliv Wellness LLC dba Bliv (Ogden, UT) on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with the 'Bliv' name on the pictured product labels, falsely implying Bliv is the compounder of those drugs when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.

A. Nelson & Co. Ltd.

FDA issued a warning letter to A. Nelson & Co. Ltd., a London-based homeopathic drug manufacturer, following an unannounced inspection in September 2025. The agency found significant CGMP violations including failure to conduct adequate microbial testing on each batch before release (including products for children as young as two), extending expiration dates without adequate stability data, and serious data integrity failures involving improper disposal of quality records and uninvestigated out-of-trend results. FDA warned that continued non-compliance could result in refusal of admission of the firm's products into the United States and withholding of approval for new applications.

Dynamic Stem Cell Therapy

FDA's Center for Biologics Evaluation and Research issued a warning letter to Dynamic Stem Cell Therapy (Henderson, NV), directed to Medical Director Dale Carrison, D.O., for marketing an unapproved, unlicensed umbilical cord-derived stem cell product and exosomes via stemcellpowernow.com. The products were found to be unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act, and the stem cell product was deemed misbranded because it lacked adequate directions for use. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Thrive Health and Wellness, LLC dba Thrive Health Solutions

Thrive Health and Wellness, LLC dba Thrive Health Solutions (Englewood, CO), owned by Doug Hatch, received an FDA Warning Letter following a March–April 2025 inspection that found serious sterility deficiencies in the repackaging of drug products including NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections. The firm conducted aseptic operations outside certified ISO 5 areas, used non-sterile gloves and wipes, had carpeted flooring in processing areas, and never performed media fills, rendering products adulterated under FDCA section 501(a)(2)(A). The products were also cited as unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1); the firm voluntarily ceased repackaging and initiated a recall of all affected products dispensed between January 2 and April 18, 2025. FDA warned that failure to adequately address violations may result in seizure and injunction.

Bio-Medical Pharmaceutical Manufacturing Corporation

FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation (Houston, TX) following a August 2025 inspection that found significant CGMP violations in the manufacture of OTC sterile drug products. The facility lacked classified cleanrooms, ISO 5 aseptic filling conditions, validated sterilization and cleaning processes, and adequate release testing including sterility testing, rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act. FDA also cited failure to list the drug product '(b)(4) Solution' in eDRLS and recommended removal of distributed batches from the U.S. market, which led to a voluntary recall by the distributor. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Apollo Care, LLC

FDA issued a warning letter to Apollo Care, LLC, a 503B outsourcing facility in Columbia, MO, following a March 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile compounded drug products. The facility was found to have produced adulterated drugs under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), including insanitary conditions, inadequate microbial contamination controls, and multiple CGMP violations. Apollo Care had already initiated a voluntary recall of a fentanyl/ropivacaine lot due to lack of sterility assurance, but FDA found several corrective action responses inadequate or insufficiently documented. FDA demands a written response within 15 working days and warns that failure to adequately address violations may result in seizure or injunction.

Diamond-Herpanacine of PA, Inc.

FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. (President Leslie A. Diamond) on January 22, 2026, after reviewing the company's website and Facebook page in September 2025. The agency determined that marketing claims for two dietary supplements — Diamond Eye Health and Herpanacine Skin Support — characterized the products as intended to cure, mitigate, treat, or prevent diseases (including macular degeneration, herpes, eczema, and bacterial/viral skin conditions), rendering them unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Supersmart USA, LLC

FDA issued a warning letter to Supersmart USA, LLC (Miami, FL) in January 2026 after reviewing their website and finding that eleven dietary supplement products — including Berberine, Aminoguanidine HCL, Glucofit, Super DHA, Celadrin, and others — bore disease-treatment and drug-effect claims that caused them to be regulated as unapproved new drugs under the FD&C Act. The claims covered blood sugar regulation, anti-inflammatory effects, cardiovascular disease prevention, joint pain relief, and treatment of depression, among others. Super DHA was additionally cited as a misbranded drug for lacking adequate directions for use for conditions requiring licensed-practitioner supervision. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Golden Sunrise Nutraceutical, Inc.

The FTC filed a federal court complaint in July 2020 against Golden Sunrise Nutraceutical, Inc., its affiliated corporation, and two executives (CEO Huu Tieu and Medical Director Stephen Meis) for marketing fraudulent 'plans of care' priced between $23,000 and $200,000 that falsely claimed to treat or cure COVID-19, cancer, Parkinson's disease, and other serious conditions. A proposed order barring the defendants from making bogus health claims was announced in June 2021. The FTC subsequently established a consumer refund process in January 2024 and began distributing refund checks to defrauded consumers in February 2026.

GenoGenix LLC

GenoGenix LLC, a compounding outsourcing facility in Boca Raton, FL, received an FDA Warning Letter following a July 2025 inspection that uncovered pervasive CGMP violations, sterility failures, and use of ineligible bulk drug substances including 5-Amino-1MQ, NAD+, and Thymosin Beta-4. The facility also repackaged unapproved new drugs including Semaglutide, Tirzepatide, and Retatrutide without FDA-approved applications, and released products with sub-labeled potency and excessive bacterial endotoxins that sent three patients to the emergency room. FDA required a written response within 15 working days and warned that failure to adequately address violations may result in seizure and injunction; the firm had already voluntarily ceased production and initiated a recall.

Boothwyn Pharmacy, LLC

FDA issued a warning letter to Boothwyn Pharmacy, LLC (Kennett Square, PA) following a May–June 2025 inspection that revealed serious deficiencies in sterile compounding practices. The pharmacy distributed GLP-1 injectable products (Semaglutide, Tirzepatide) and other sterile preparations that failed sterility testing and were subpotent relative to their labeled strengths, rendering them adulterated and misbranded under the FDCA. The firm had already initiated a voluntary recall and ceased GLP-1 sterile production, but FDA found corrective action responses inadequate due to missing documentation and contradictory SOPs for at-risk product release. FDA demands a written response within 15 working days and warns that failure to correct violations may result in seizure or injunction.

Center For Immunology Science, LLC

FDA issued a warning letter to Center For Immunology Science, LLC (CEO Bruce S. Gillis, M.D.) following an inspection revealing that the company conducted a clinical investigation of heat-killed Mycobacteria smegmatis on 200 human subjects without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company had marketed the substance as a dietary supplement/biotic to boost immune system and microbiome health, but FDA determined the investigation's intent was to treat or mitigate immune-deficiency diseases, qualifying it as a drug under the FD&C Act. The company's response claiming IND exemption under DSHEA was deemed inadequate because it lacked a corrective and preventive action plan. FDA warned that failure to adequately address the violations may lead to further regulatory action.

CC Pollen Company

FDA issued a warning letter to CC Pollen Company (Glendale, AZ) following an April 2025 inspection of its dietary supplement manufacturing facility. The agency found multiple serious CGMP violations related to its Bee Pollen Granules and Royal Jelly capsules, including failure to establish finished product specifications, failure to reject out-of-spec components, missing master manufacturing records, and inadequate identity testing of dietary ingredients. The products were also deemed misbranded due to an incorrect serving size declaration on the Royal Jelly capsules label. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Prodrome Sciences USA, LLC

FDA issued a warning letter to Prodrome Sciences USA, LLC (CEO Dayan B. Goodenowe, Ph.D.) following an inspection that found the company conducted a clinical investigation of ProdromeNeuro™ Oil on 29 human subjects with mild to moderate dementia without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company claimed the product was a dietary supplement exempt from IND requirements, but FDA determined the study design — including neurocognitive outcome assessments and enrollment of dementia patients — established the product was being investigated as a drug. FDA found the company's corrective action plan inadequate because it lacked sufficient detail on how future IND compliance would be ensured, and warned that failure to adequately address the deficiencies may lead to further regulatory action.

NextMed

NextMed (Southern Health Solutions, Inc.), a telemedicine company offering weight-loss membership programs, was charged by the FTC with using deceptive claims about costs and weight-loss outcomes, fake reviews, and fake testimonials to attract consumers. The company also concealed material terms and conditions of its membership programs. Under the proposed consent order, NextMed and its principals agreed to pay $150,000, which is expected to be used to provide refunds to affected consumers.

LXR Biotech, LLC

FDA issued a warning letter to LXR Biotech, LLC (Rochester Hills, MI) following a February–March 2025 facility inspection, citing serious Current Good Manufacturing Practice (CGMP) violations related to their dietary supplement products Eternal Energy Grape and Eternal Energy Tropical Punch. The violations include failure to establish complete finished product specifications, failure to establish identity specifications for components, and use of testing methods that are not scientifically valid to confirm ingredient identity. FDA found the products adulterated under 21 U.S.C. 342(g)(1) and warned that failure to correct these violations may result in seizure or injunction.

Agebox Inc.

FDA issued a warning letter to Agebox Inc. (Wang Zheng) regarding its 'iKids-Growth IGF-1 Support Day Formula' and 'iKids-Growth IGF-1 Support Night Formula' products, which were found through laboratory analysis to contain the undeclared and unapproved ingredient ibutamoren mesylate (MK-677), a growth hormone secretagogue. The products were marketed as dietary supplements for children's height growth but are classified as unapproved new drugs because ibutamoren is excluded from the dietary supplement definition and lacks FDA approval. The products are also misbranded because their labels fail to disclose the presence of ibutamoren mesylate, which can cause serious side effects. FDA warned that failure to correct violations may result in seizure and injunction.

Private Label Skin Care, Inc.

FDA issued a warning letter to Private Label Skin Care, Inc. (Canoga Park, CA) following a June 2025 inspection that found significant CGMP violations and drug listing failures. The company, which uses a contract manufacturer, continued distributing OTC drug products with elevated impurities after being notified of the problem, and ultimately issued a voluntary recall. Additionally, the firm failed to provide required drug listings for at least 21 OTC drug products, rendering them misbranded under the FD&C Act. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure, injunction, or withholding of export certificates and new application approvals.

TITAN SARMS LLC

FDA issued a warning letter to Titan SARMs LLC of Denver, CO in December 2025 after reviewing their website and finding they were selling unapproved new drugs — specifically SARMs including LGD-4033 (Ligandrol), RAD-140 (Testolone), S-4 (Andarine), and YK-11 — marketed with claims about muscle growth, strength, fat loss, and recovery intended for human use. Despite labeling the products as 'research-only,' FDA determined the website copy established clear intended human drug use, violating sections 301(d) and 505(a) of the FD&C Act. The agency demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure and injunction.

MedisourceRx

FDA issued a warning letter to MedisourceRx, a 503B outsourcing facility in Los Alamitos, CA, following a May–June 2025 inspection that found the facility failed to meet section 503B conditions, primarily by not submitting required adverse event reports and maintaining inadequate adverse event reporting procedures. Because these conditions were not met, MedisourceRx's compounded drug products lost eligibility for exemptions from FDA approval requirements, rendering them unapproved new drugs and misbranded products under the FDCA. FDA found the facility's corrective responses partially deficient, noting that submitted procedures still did not adequately define 'serious' adverse events consistent with 21 CFR 310.305(b). The letter warns that continued non-compliance may result in seizure or injunction, and requires a written response within 15 working days.

Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS

FDA issued a warning letter to Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS (Madison, WI) for marketing SARMs products — 'GE Labs Ykarine' and 'GE Labs MK 677' — as dietary supplements on their websites. The products were found to be unapproved new drugs under the FD&C Act, and lab analysis confirmed 'GE Labs Ykarine' contained undeclared trendione, a Schedule III controlled anabolic steroid, rendering it misbranded. FDA cited serious safety concerns including liver toxicity, heart attack, stroke, and kidney damage associated with SARMs and anabolic steroids. The firm was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.

Dynamic Health Group dba SARMS AMERICA

FDA issued a warning letter to Dynamic Health Group dba SARMS AMERICA (Cheyenne, WY) in December 2025 for marketing unapproved new drugs — specifically SARMs including Ostarine MK-2866, MK-677 Ibutamoren, Cardarine GW501516, and LGD-4033 Ligandrol — via their website sarmsamerica.co. Despite labeling the products 'for research use only,' the website's health and body-composition claims established intended human drug use, violating FD&C Act sections 301(d) and 505(a). FDA cited safety concerns including liver toxicity, increased risk of heart attack, and stroke. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Pinnacle Professional Research dba Pinnacle Peptides

FDA issued a warning letter to Pinnacle Professional Research dba Pinnacle Peptides (Greensboro, NC) in December 2025 after reviewing their website and finding three SARM products — S4 Andarine, LGD-4033, and MK-2866 — marketed with drug-intended-use claims including treatment of cancer, osteoporosis, muscle wasting, and diabetes. Despite 'FOR RESEARCH ONLY / NOT FOR HUMAN USE' disclaimers, FDA determined the website copy established human drug intent, rendering the products unapproved new drugs in violation of FD&C Act sections 301(d) and 505(a). The letter demands a written corrective-action response within 15 working days and warns that failure to comply may result in seizure or injunction.

Prime Sports Nutrition

FDA issued a warning letter to Prime Sports Nutrition (Fernando Arias, Bakersfield, CA) in December 2025 after reviewing the company's website and finding it was selling unapproved new drugs marketed as SARMs — specifically LGD-4033, RAD-140, MK-677, and S-23 — with claims about muscle building, fat loss, testosterone boosting, and treatment of conditions like Alzheimer's disease and androgenic deficiencies. Despite labeling some products as 'research compounds not for human consumption,' FDA determined the marketing copy established clear intent for human drug use. The firm was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Atomix LLC

FDA issued a warning letter to Atomix LLC (Sheridan, WY) in December 2025 after reviewing the company's website, Instagram, and Facebook accounts and finding that it was selling unapproved new drugs marketed as selective androgen receptor modulators (SARMs), specifically MK-2866 (Ostarine/Enobosarm) and RAD-140 (Testolone). Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on marketing claims about muscle growth, bone health, and treatment of conditions like sarcopenia, cachexia, and osteoporosis. The products lack FDA-approved applications under section 505 of the FD&C Act, making their interstate sale a violation of sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure and injunction.

Medinatura New Mexico, Inc.

FDA issued a warning letter to Medinatura New Mexico, Inc. (Albuquerque, NM) following a May 2025 inspection of their homeopathic drug manufacturing facility. The agency found significant CGMP violations including failure to adequately test incoming components for identity and purity (including hazardous ingredients linked to lethal poisoning incidents), an inadequate cleaning validation program that risked cross-contamination across multiple drug products, and a process validation program that had not been updated since 2007. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Darmerica, LLC

FDA issued a warning letter to Darmerica, LLC (Davie, FL), an API distributor and repackager, following a March 2025 inspection that revealed serious CGMP violations, misbranding, and adulteration of APIs including GLP-1 peptides and other compounding-related APIs. The firm distributed APIs ineligible for 503A compounding (including retatrutide, cagrilintide acetate, and multiple peptides), received shipments mislabeled as 'custom peptide' to obscure drug identity, sourced from unregistered or non-compliant foreign manufacturers, and failed to maintain adequate quality unit oversight, supplier qualification, complaint investigation, and pre-release testing. FDA characterized the APIs as adulterated and misbranded under multiple FD&C Act provisions and required a written response within 15 working days along with extensive corrective actions.

BioXtek LLC

FDA issued a warning letter to BioXtek LLC (CEO Bruce R. Werber, DPM) in Pompano Beach, FL, after a February 2025 facility inspection found that its human amniotic membrane-derived products, Sanoplast ECM and Sanoplast Duo, are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The products' website claims—including accelerating wound healing, tendon repair, nerve regrowth, and anti-fibrotic/anti-inflammatory effects—establish drug/biologic intent without an approved BLA. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Apothecary Pharma, LLC

FDA issued a warning letter to Apothecary Pharma, LLC (Cary, NC), a 503B outsourcing facility, following a May 2025 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility compounded GLP-1 products including Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL with inadequate labeling, deficient adverse event reporting procedures, and multiple insanitary aseptic processing practices that rendered drug products adulterated and misbranded. Because the 503B conditions were not met, the compounded drugs are also unapproved new drugs subject to FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Lux Therapeutics LLC dba Ponya Therapeutics LLC

FDA issued a warning letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC (Brookhaven, GA) following a June 2025 inspection that found significant violations of 21 CFR Part 1271 governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to validate its manufacturing process for its dehydrated dual-layer amniotic membrane patch (TheraMend) and failed to include required communicable disease test summaries with distributed products. FDA found the firm's corrective responses inadequate, particularly its plan to continue distributing TheraMend without a validated process, and demanded a written response within 15 working days outlining corrective actions or face further regulatory action.

Mahita LLC dba PushMyCart

FDA issued a warning letter to Mahita LLC dba PushMyCart (Richmond, TX), an online retailer selling homeopathic and Ayurvedic products, after reviewing its website and Facebook account in September 2025. The agency found eleven products — including homeopathic dilutions and herbal formulations — marketed with claims to cure, treat, or prevent serious conditions such as measles, hepatitis, diabetes, Parkinson's disease, cancer, and glaucoma, without FDA-approved applications. FDA determined these products are unapproved new drugs under sections 301(d) and 505(a) of the FD&C Act, and warned that failure to correct violations could result in seizure or injunction.

Handelnine Global, LLC dba Navafresh

FDA issued a warning letter to Handelnine Global, LLC dba Navafresh (South Plainfield, NJ) after reviewing its website in September 2025 and finding ten products — including Ayurvedic, homeopathic, and herbal preparations — marketed as unapproved new drugs for serious conditions such as cancer, diabetes, measles, Parkinson's disease, and arthritis. Laboratory testing of 'Rheumacare Capsules' revealed lead contamination at approximately 7,000 times the permitted daily exposure limit, plus preliminary findings of mercury, strychnine, brucine, and arsenic, rendering the product adulterated and misbranded. FDA cited violations of FD&C Act sections 301(a), 301(d), 502, and 505(a) and warned that failure to respond may result in seizure or injunction. The company was directed to notify FDA in writing within fifteen working days of corrective steps taken.

Swift Digital Group LLC dba Swadesii

FDA issued a warning letter to Swift Digital Group LLC dba Swadesii (Raleigh, NC) in November 2025 after reviewing their website and finding ten products — including Ayurvedic, homeopathic, and herbal preparations — marketed with claims to treat, cure, or prevent serious conditions such as measles, cancer, diabetes, stroke, Alzheimer's, and hepatitis. These products are classified as unapproved new drugs under section 505(a) of the FD&C Act because no FDA-approved applications are in effect for them, and their sale in interstate commerce violates sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Distacart Inc.

FDA issued a warning letter to Distacart Inc. (Mountain View, CA) after reviewing its website in September 2025 and finding nine products — including homeopathic, Ayurvedic, and ophthalmic preparations — marketed as treatments for serious conditions such as malaria, depression, asthma, measles, and various eye diseases without FDA approval. The products are classified as unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective for the claimed uses. FDA expressed particular concern that consumers may forgo proven medical treatments and that ophthalmic products bypass natural bodily defenses. Distacart was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

VarunKart Group LLC dba Organic Wellnesses

FDA issued a warning letter to VarunKart Group LLC dba Organic Wellnesses (Albuquerque, NM) after reviewing its website in September 2025 and finding nine products — including homeopathic drops, Ayurvedic preparations, herbal supplements, and ophthalmic eye drops — marketed with claims to cure or treat serious conditions such as measles, cancer, diabetes, tuberculosis, syphilis, HIV, and hepatitis. All nine products are classified as unapproved new drugs under FD&C Act section 505(a) because no FDA-approved applications are in effect for them, and their sale in interstate commerce violates sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Wells Pharma of Houston, LLC

Wells Pharma of Houston, LLC, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter following a March 2025 inspection that identified serious CGMP deficiencies and failures to meet section 503B conditions. The facility produced sterile drug products (including Fentanyl and Phenylephrine formulations) under insanitary conditions—including cracked laminar airflow hood plexiglass, inadequate smoke studies, and deficient media fills—rendering them adulterated. Drug products also lacked required 'This is a compounded drug' labeling and the facility had inadequate adverse event reporting procedures, causing products to be ineligible for 503B exemptions and thus constitute unapproved new drugs and misbranded products. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Glowface

FDA issued a warning letter to Glowface (www.glowface.store) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Botulax 200U set' and 'Botulax 200U,' to U.S. consumers without FDA approval under section 505 of the FD&C Act. The products were marketed with drug-intent claims and lack adequate directions for use required for prescription drugs, constituting misbranding under section 502(f)(1). FDA warned that unapproved injectables pose serious risks including contamination, counterfeit ingredients, and life-threatening conditions such as sepsis. Glowface was directed to cease sales of these products immediately and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Derma Solution

FDA issued a warning letter to Derma Solution (www.derma-solution.com) on November 3, 2025, for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Botulax 300 Units' and 'Botulax 300' — to U.S. consumers without FDA approval. The site made therapeutic claims positioning these products as treatments for hyperhidrosis, blepharospasm, migraines, and overactive bladder, which established drug intent under the FD&C Act. Because no approved NDA exists for these products and they lack adequate directions for use by laypersons, they constitute both unapproved new drugs and misbranded drugs under sections 505(a) and 502(f)(1) of the FD&C Act. FDA demanded cessation of sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

MJS Medicals

FDA issued a warning letter to MJS Medicals, a South Korea-based company, for selling unapproved and misbranded injectable botulinum toxin products ('Innotox 100ui' and 'Innotox 100u') to U.S. consumers via its website. The products were marketed with specific clinical efficacy claims but lack FDA-approved drug applications under section 505 of the FD&C Act, and their labeling fails to bear adequate directions for use as required for prescription drugs. FDA demands cessation of sales to U.S. consumers and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Meamo

FDA issued a warning letter to Meamo (operating via meamoshop.com, based in South Korea) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'X4 Wondertox 100U Set' and 'Wondertox' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with drug-intent claims and lack adequate directions for use required for prescription drugs, constituting misbranding under section 502(f)(1). FDA demands cessation of sales to U.S. consumers, a written corrective-action response within 15 working days, and warns that failure to comply may result in seizure or injunction.

Glam Derma

FDA issued a warning letter to Glam Derma (Netherlands), operator of glamderma.com, for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'NABOTA 100 Type A' and 'Nabota 100' — to U.S. consumers without FDA approval under FD&C Act sections 301(a), 301(d), 503(b), and 505(a). The products were marketed with therapeutic claims (e.g., treating hyperhidrosis and blepharospasm) that establish drug intent, yet no approved NDA exists for these products in the U.S. FDA demands cessation of sales to U.S. consumers, a written corrective-action response within 15 working days, and warns that failure to comply may result in seizure or injunction.

COSMO KOREA

FDA issued a warning letter to COSMO KOREA, a South Korea-based website (www.cosmo-korea.com), for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Nabota 200ui' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The product was marketed with therapeutic claims such as 'blepharospasm elimination' and 'hyperhidrosis elimination,' establishing drug intent, yet lacks FDA approval and adequate directions for use required for prescription drugs. FDA demands cessation of sales to U.S. consumers and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Elle Pharm

FDA issued a warning letter to Elle Pharm (www.ellepharm.com) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Hutox 100ui' and 'Hutox 100,' to U.S. consumers. The products were marketed with drug-intent claims such as 'blepharospasm correction' and 'hyperhidrosis' but lack FDA-approved applications under section 505 of the FD&C Act. The products also lack adequate directions for use required for prescription drugs, constituting misbranding under section 502(f)(1). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Aesthetic Essentials Limited

FDA issued a warning letter to Aesthetic Essentials Limited (Hong Kong), operator of aesthetic-essentials.com, for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Rentox 200U' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with therapeutic indications (blepharospasm, hyperhidrosis, cervical dystonia) that establish drug intent, yet lack FDA approval and required prescription labeling. FDA demands cessation of U.S. sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Glow Nest Beauty

FDA issued a warning letter to Glow Nest Beauty (glownestbeauty.com) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Rentox 200U – Botulinum Toxin Type A,' to U.S. consumers without FDA approval or a prescription requirement. The site's product listing included drug-intent claims such as 'Excessive sweating (hyperhidrosis)' under 'Indications,' establishing the products as drugs under the FD&C Act. FDA cited violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act and demanded corrective action within 15 working days, warning that failure to comply may result in seizure or injunction.

Dermax Co., Ltd

FDA issued a warning letter to Dermax Co., Ltd. (operating dermaxshop.com, based in China) for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Botulax 100U' — to U.S. consumers without an approved NDA under FD&C Act section 505. The products were marketed with claims such as 'reducing sweating' for underarms, palms, and feet, constituting drug-intended use without FDA approval. FDA demands cessation of sales to U.S. consumers, a written corrective action response within 15 working days, and warns that failure to comply may result in seizure or injunction.

AceCosm

FDA issued a warning letter to AceCosm (Hong Kong), operator of acecosm.com, for selling unapproved and misbranded injectable botulinum toxin products — specifically 'Nabota 200U Botulinum Toxin Type A' — to U.S. consumers without an approved NDA under FD&C Act section 505. The products bore therapeutic claims (chronic migraine prevention, urinary incontinence treatment, hyperhidrosis management) that established drug intent, yet lacked FDA approval, adequate directions for use, and required prescription-drug safeguards. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

CelestaPro

FDA issued a warning letter to CelestaPro (www.celestapro.com) for selling unapproved and misbranded injectable botulinum toxin drug products, specifically 'Nabota 200 Unit,' to U.S. consumers without an FDA-approved new drug application under section 505 of the FD&C Act. The product was identified as a drug intended for human use based on the claim 'Hyperhidrosis' listed under 'Application area' on the website. FDA found the product misbranded because its labeling lacks adequate directions for use as required for prescription drugs. CelestaPro was directed to cease sales of unapproved and misbranded drugs and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Korean Aesthetic dba Korean Fillers

FDA issued a warning letter to Korean Aesthetic dba Korean Fillers (www.koreanfillers.com) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'MEDITOXIN BOTULINUM TOXIN,' 'Cosmetics Medi 2,' and 'Meditoxin Botulinum Toxin 200U' — to U.S. consumers without FDA approval under section 505 of the FD&C Act. The products were marketed with therapeutic disease claims and lacked adequate directions for use, constituting misbranding under section 502(f)(1). FDA warned that unapproved injectable drugs pose serious risks including contamination, counterfeit ingredients, sepsis, and death. The company was directed to cease sales of these products and respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Estaderma

FDA issued a warning letter to Estaderma, a South Korea-based company operating www.estaderma.com, for selling unapproved and misbranded injectable botulinum toxin products ('Liztox 100u' and 'Liztox') to U.S. consumers without FDA approval under section 505 of the FD&C Act. The products were marketed with treatment claims for hyperhidrosis and were found to lack adequate directions for use as required for prescription drugs. FDA warned that failure to cease distribution may result in seizure or injunction, and required a written response within 15 working days.

Maypharm

FDA issued a warning letter to Maypharm, a South Korea-based company, for selling unapproved and misbranded injectable botulinum toxin products (marketed as 'BOTULAX 200 units' and 'Botulax 200ui') to U.S. consumers via www.maypharm.net. The products lack FDA-approved drug applications under section 505 of the FD&C Act and are misbranded because their labeling fails to bear adequate directions for use as required for prescription drugs. FDA warned that unapproved injectable drugs pose serious risks including contamination, counterfeit ingredients, sepsis, and life-threatening adverse effects. The agency demanded corrective action within 15 working days and cautioned that failure to comply may result in seizure or injunction.

Dermacare dba Filler Outlet

FDA issued a warning letter to Dermacare dba Filler Outlet (operating at filleroutlet.com, based in South Korea) for selling unapproved and misbranded injectable botulinum toxin drug products — specifically 'Innotox 50u' — to U.S. consumers without an approved NDA under section 505 of the FD&C Act. The products were marketed with therapeutic claims (e.g., treating hyperhidrosis and blepharospasm) that establish drug intent, yet lack FDA approval and adequate directions for use required for prescription drugs. FDA demands cessation of sales to U.S. consumers and a written corrective-action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Cosmenic

FDA issued a warning letter to Cosmenic (Panama), operator of www.cosmenic.net, for selling unapproved and misbranded injectable botulinum toxin products to U.S. consumers. The site marketed 'NABOTA® (JEUVEAU®) 100u' as an FDA-approved equivalent while it lacks any approved NDA, and made drug-indication claims such as prevention of chronic migraine headaches. FDA cited violations of FD&C Act sections 301(a), 301(d), 503(b), and 505(a), and warned that failure to comply may result in seizure or injunction.

Miers Laboratories, Ltd

FDA issued a warning letter to Miers Laboratories, Ltd (New Zealand) following a May 2025 inspection that found significant CGMP violations in the manufacture of homeopathic drug products intended for the U.S. market. Key violations included failure to perform identity testing on incoming components — including a solvent with potentially lethal contamination — and use of an active pharmaceutical ingredient more than 14 years past expiration, as well as inadequate quality unit oversight. These are repeat violations from 2014 and 2019 inspections; FDA has placed all drugs from this firm on Import Alert 66-40, effectively blocking U.S. importation.

Uriel Pharmacy, Inc.

FDA issued a warning letter to Uriel Pharmacy, Inc. (East Troy, WI) following a February–March 2025 inspection that found significant CGMP violations including inadequate in-process testing, component identity testing failures, and deficient quality control unit oversight. In addition, FDA determined that seven homeopathic ampule drug products sold on shopuriel.com are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, with serious public health concerns because the glass ampule packaging mimics sterile injectable containers and the products have been documented being injected by clinicians despite oral-use labeling. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications, and required a written response within 15 working days.

PQ Pharmacy, LLC

FDA issued a warning letter to PQ Pharmacy, LLC (Brooksville, FL), a 503B outsourcing facility, following a March–April 2025 inspection that found serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility produced adulterated drug products due to insanitary conditions and CGMP violations, including poor aseptic practices, inadequate smoke studies, and failure to investigate batch discrepancies. Drug products — including semaglutide vials and ophthalmic solutions — were found to be unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

New Life Medical Services, LLC

FDA issued a warning letter to New Life Medical Services, LLC (Lutz, FL) following a May 2024 facility inspection, finding that its umbilical cord-derived products (Restor+, Regain, Renyte), amniotic fluid-derived product (ReCyte/Cytosomes), and exosome product (Rexo) are unapproved new drugs and unlicensed biological products marketed for treating pain, inflammation, neuropathy, orthopedic conditions, and tissue regeneration without an approved BLA. The products also fail HCT/P regulatory criteria under 21 CFR 1271.10(a) because they are more than minimally manipulated and are not intended for homologous use only. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Revive Rx LLC dba Revive Rx Pharmacy

FDA issued a warning letter to Revive Rx LLC dba Revive Rx Pharmacy (Houston, TX) following a January–February 2025 inspection that identified serious insanitary conditions in sterile drug compounding operations. The facility exposed sterile drug products to worse than ISO-classified air quality, failed to perform adequate media fills and smoke studies under dynamic conditions, and did not conduct sufficient environmental monitoring in aseptic processing areas. FDA found these practices caused drug products to be adulterated under section 501(a)(2)(A) of the FDCA, and the firm's corrective action responses were deemed deficient or insufficiently documented. The agency warned that failure to adequately address violations may result in seizure or injunction.

Time Challenger Labs International, Inc.

FDA issued a warning letter to Time Challenger Labs International, Inc. (Round Rock, TX) following a December 2024 facility inspection and May 2025 website review, finding that five herbal tincture products — Adrenal Boost, Chaga, Brain & Vein, Thyroid Support, and UTI — were marketed with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The company also committed multiple repeat CGMP violations (no product specifications, no master manufacturing records, no batch production records, no quality control procedures) causing its dietary supplements to be adulterated. Additionally, its Resveratrol product label was misbranded for failing to identify the product as a dietary supplement and omitting plant-part sourcing information. FDA warned that failure to correct these violations may result in seizure or injunction.

Ralph A. DeFronzo, M.D.

FDA issued a warning letter to Dr. Ralph A. DeFronzo, a clinical investigator at the University of Texas Health Science Center in San Antonio, following a December 2024 inspection of two clinical investigations involving investigational drugs, one of which involved GLP-1 receptor agonist-related eligibility criteria. The letter cites two primary violations: (1) failure to ensure subjects met protocol eligibility criteria before enrollment — all seven enrolled subjects had disqualifying blood pressure readings, eGFR values, or were on excluded medications (SGLT2 inhibitors and GLP-1 receptor agonists) — and (2) failure to promptly report a material change in study design (from a double-blind placebo-controlled trial to a pilot feasibility study) to the IRB before enrolling and treating all seven subjects. FDA found Dr. DeFronzo's corrective responses inadequate and required a written response within 15 business days detailing actions taken to prevent future violations, warning that failure to adequately respond may lead to regulatory action.

Stellalife, Inc.

FDA issued a warning letter to Stellalife, Inc. (Northbrook, IL) on September 16, 2025, after reviewing the company's website and social media accounts and finding that five homeopathic oral care products — including the VEGA Oral Care Recovery Kit, gels, and rinses — were being marketed as unapproved new drugs. The products' labeling and online claims described intended uses to treat, mitigate, or cure disease conditions (e.g., mucositis, periodontal disease, post-surgical wound healing, xerostomia from radiation therapy) without an approved FDA application, violating sections 505(a) and 301(d) of the FD&C Act. FDA also flagged heightened public health concern because the products target vulnerable populations including children and post-surgical patients, and because prior lots were recalled for microbial contamination. The agency demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.

Turbare Manufacturing

FDA issued a warning letter to Turbare Manufacturing, a 503B outsourcing facility in Conway, Arkansas, following a January 2025 inspection that found serious sterile manufacturing deficiencies. The facility failed to conduct adequate process simulation (media fill) studies, investigate batch discrepancies, establish proper acceptance criteria for quality control, and maintain adequate environmental monitoring in aseptic processing areas. FDA found the drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), and the firm had already initiated a voluntary recall of Bevacizumab lots due to lack of sterility assurance; FDA warned that failure to adequately address violations may result in seizure and injunction.

Cellebration LLC

FDA issued a warning letter to Cellebration LLC (San Juan, Puerto Rico) after the company failed to provide records requested under section 704(a)(4) of the FD&C Act regarding its cord blood-derived cellular products marketed for treating conditions including autism, cerebral palsy, multiple sclerosis, and Parkinson's disease. The company repeatedly delayed and ultimately never submitted the requested records despite multiple extensions and follow-up communications spanning October 2024 through May 2025. FDA determined the products constitute unapproved drugs and biological products under the FD&C Act and PHS Act, and that the refusal to provide records violates section 301(e) of the FD&C Act. FDA warned that failure to adequately address the matter may result in seizure and/or injunction without further notice.

Chengdu Brilliant Biopharmaceutical Co., Ltd.

FDA issued a warning letter to Chengdu Brilliant Biopharmaceutical Co., Ltd., a Chinese API manufacturer, for significant CGMP deviations related to its Semaglutide (GLP-1 receptor agonist) API. The agency found the firm failed to conduct process validation for Semaglutide and failed to perform identity testing on incoming raw materials used in API manufacturing. FDA placed all drugs from this facility on Import Alert 66-40 as of July 9, 2025, and warned that continued non-compliance could result in refused admission of articles into the United States under the FD&C Act.

motionpharmacy.com

FDA issued a warning letter to motionpharmacy.com on September 10, 2025, for selling unapproved and misbranded prescription drugs to U.S. consumers over the internet without requiring a prescription. The site was found to be offering unapproved opioids (hydrocodone, oxycodone, hydromorphone, oxymorphone, promethazine/codeine), benzodiazepines (clonazepam, diazepam, lorazepam, alprazolam, bromazepam, bromazolam), Schedule II stimulants (lisdexamfetamine, methylphenidate, amphetamine, dextroamphetamine), and semaglutide (marketed as Ozempic) without valid FDA-approved drug applications. FDA demanded cessation of all such sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Eniva USA, Inc.

FDA issued a warning letter to Eniva USA, Inc. (Plymouth, MN) following a November 2024–January 2025 facility inspection, citing serious CGMP violations under 21 CFR Part 111 for its Immune Support (formerly Cold Buster) and Ashwagandha Gummies dietary supplements. The violations include failure to establish adequate finished product specifications for identity, purity, strength, and composition, and failure to document material review and disposition decisions. FDA found the company's February 2025 corrective-action responses inadequate and lacking supporting evidence. The letter warns that failure to address these violations may result in seizure or injunction.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) regarding a direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that was posted on dayton247now.com on July 9, 2025. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting all risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. FDA determined the video misbrands Zepbound in violation of the FD&C Act and also cited Eli Lilly for failing to submit the promotional material under Form FDA-2253 at the time of initial dissemination; Lilly was directed to respond within 15 working days, cease misleading communications, and disseminate corrective communications to the same audience.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) on September 9, 2025, regarding a sponsored direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that aired on okcfox.com. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting required risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. The video was also never submitted to FDA under Form FDA-2253 at the time of initial publication as required by regulation. FDA determined the video misbrands Zepbound in violation of the FD&C Act and demanded a written response within 15 working days, a corrective communication plan, and cessation of the misleading promotional materials, warning that failure to comply may result in seizure or injunction.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company regarding a direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Eli Lilly consultants making false or misleading claims about the safety profile of Zepbound (tirzepatide) and Mounjaro (tirzepatide). The video omitted critical risk information—including contraindications related to MEN 2, acute kidney injury, suicidal behavior, and severe gastrointestinal disease—while paid consultants actively minimized boxed warning risks as 'overhyped' and described side effects as 'mild to moderate,' contrary to clinical trial data. FDA determined the video misbrands both drugs under the FD&C Act and that Eli Lilly failed to submit the promotional material under Form FDA-2253 at the time of initial dissemination, demanding a written response within 15 working days and a corrective communications plan, with threats of seizure and injunction for non-compliance.

Novo Nordisk Inc.

FDA issued a warning letter to Novo Nordisk Inc. regarding a 42-minute direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Novo Nordisk consultants making false or misleading claims about the safety profile of Wegovy, Ozempic, and Victoza. The video omitted critical boxed-warning risk information (including MEN 2 contraindication), downplayed serious adverse events such as pancreatitis and thyroid cancer as 'overhyped,' and characterized side effects as 'mild to moderate' contrary to clinical trial data. FDA determined the video misbrands all three drugs under the FD&C Act and demanded immediate cessation of the misleading communications, a written response within 15 working days, and a corrective advertising campaign directed at the same audience.

Healthon Inc. dba Healthon

FDA issued a warning letter to Healthon Inc. dba Healthon (Irvine, CA), a telehealth company, after reviewing its website in August 2025 and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims falsely implied that compounded products are equivalent to FDA-approved drugs such as Wegovy, Ozempic, Mounjaro, and Zepbound, and misrepresented the FDA-approval status of the active ingredients. FDA found the products misbranded and introduced into interstate commerce in violation of section 301(a), and warned that failure to correct violations may result in seizure or injunction.

Curex

FDA issued a warning letter to Curex, a Miami-based telehealth company, in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied that Curex's compounded products were equivalent to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound, when compounded drugs are not FDA-approved. FDA cited these claims as misbranding violations and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Elite Health Center

FDA issued a warning letter to Elite Health Center (Washington Township, NJ) on September 9, 2025, after reviewing the website eliterapidfatloss.com and finding a false or misleading claim about compounded semaglutide implying FDA approval of the compounded product. The claim falsely stated that compounded semaglutide received FDA approval as a diabetes treatment in 2017 and an obesity treatment in 2021, when in fact compounded drugs are never FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and directed Elite Health Center to cease the misleading language and respond within 15 working days, warning that failure to comply could result in seizure or injunction.

Matthew Stern, CEO MyStart Health LLC.

FDA issued a warning letter to Matthew Stern, CEO of MyStart Health LLC, in September 2025 after reviewing the company's website and finding that it marketed compounded semaglutide using claims that falsely implied equivalence to FDA-approved products such as Ozempic. The specific claims 'Generic Ozempic' and 'Save with generics that offer the same active ingredients and results' were found to be false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Fancy Meds, LLC dba Fancy Meds

FDA issued a warning letter to Fancy Meds, LLC dba Fancy Meds (Sunnyvale, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved branded drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded cessation of the offending language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

EA WORKS Limited Liability Company dba Trust Labs

FDA issued a warning letter to EA WORKS LLC dba Trust Labs (operating as coretrustlabs.com) in September 2025 for unlawfully selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via the internet. Compounded retatrutide products were cited as unapproved new drugs and misbranded because retatrutide does not appear on the 503A or 503B bulk drug substances lists and is not a component of any FDA-approved drug. Additionally, website claims implying that compounded semaglutide and tirzepatide are FDA-approved were found to be false or misleading. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Remedy Meds

FDA issued a warning letter to Remedy Meds (Summit, NJ) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Dr. Gater’s Weight Loss & Wellness

FDA issued a warning letter to Dr. Jameelah Gater, MD, of Dr. Gater's Weight Loss & Wellness (Eatonton, GA) in September 2025 after reviewing her website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely described compounded drugs as 'FDA Approved,' as 'generic' equivalents of brand-name GLP-1 drugs (Ozempic, Wegovy, Mounjaro), and as 'pharmacologically similar' to FDA-approved products, when compounded drugs are not FDA-approved. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and warned that failure to correct violations may result in seizure or injunction.

Invigorate Med Spa

FDA issued a warning letter to Invigorate Med Spa (Pittsburgh, PA) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using the brand names of FDA-approved drugs (Wegovy and Mounjaro), falsely implying equivalence with those approved products. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), constituting prohibited introduction of misbranded drugs into interstate commerce under section 301(a). The FDA demanded immediate cessation of the misleading language and required a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Intimate Rose

FDA issued a warning letter to Intimate Rose (Kansas City, MO) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded cessation of the offending language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Healthy Male

FDA issued a warning letter to Healthy Male (Tempe, AZ) in September 2025 after reviewing their website and finding that marketing claims for compounded tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied the compounded products were equivalent to FDA-approved drugs, which they are not, constituting misbranding. FDA directed Healthy Male to immediately cease using the offending language and to provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

All American Wellness

FDA issued a warning letter to All American Wellness on September 9, 2025, after reviewing their website in August 2025 and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs Ozempic and Mounjaro. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Canada Med Stop

FDA issued a warning letter to Canada Med Stop, a Vancouver-based online pharmacy, after reviewing its website in August 2025 and finding false or misleading claims about compounded semaglutide products offered to U.S. consumers. The site claimed its products contained the 'same active ingredient in branded weight loss medications,' were 'FDA-Approved,' and were 'GENERIC' — all of which are false or misleading because compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and warned that failure to correct violations may result in seizure or injunction.

Body Good Studio

FDA issued a warning letter to Body Good Studio (Miami, FL) in September 2025 after reviewing their website and finding a false or misleading claim about compounded semaglutide products implying equivalence to FDA-approved drugs Ozempic and Wegovy. The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded, and their interstate commerce distribution violates section 301(a). FDA demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

ASN-LABS

FDA issued a warning letter to ASN-LABS (Honolulu, HI) in September 2025 after reviewing their website and finding they were selling compounded retatrutide and semaglutide products unlawfully. The compounded retatrutide products were cited as unapproved new drugs and misbranded drugs because retatrutide does not appear on the 503A or 503B bulks lists and is not an FDA-approved drug component. Additionally, ASN-LABS' website claims about compounded semaglutide were found to be false or misleading because they implied equivalence to FDA-approved products (Wegovy, Ozempic, Rybelsus). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

GLP-1 Solution

FDA issued a warning letter to GLP-1 Solution, a Germany-based online retailer, for selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via its website glp1solution.store. Retatrutide products were cited as unapproved new drugs because retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component. Claims on the site implied compounded semaglutide and tirzepatide were equivalent to FDA-approved branded products (Ozempic, Wegovy, Mounjaro), rendering those products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.

Lumimeds

FDA issued a warning letter to Lumimeds (Las Vegas, NV) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name GLP-1 medications. Specifically, Lumimeds claimed these compounded products contain 'the same active ingredient as the brand name medications' and that 'GLP-1 was FDA-approved in 2017,' misleading consumers into believing the compounded products share FDA-approved status. FDA determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb), and directed Lumimeds to immediately cease the offending language and respond within 15 working days, warning that failure to comply could result in seizure or injunction.

Mane & Steel, LLC. dba Mane & Steel

FDA issued a warning letter to Mane & Steel, LLC (Sacramento, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the company's claims implied their compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products misbranded and their interstate commerce introduction a prohibited act under section 301(a). The company was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.

MedClub by Dr. Jenn

FDA issued a warning letter to MedClub by Dr. Jenn (Dr. Jenn Guthrie, MD) in West Palm Beach, FL, after reviewing the website drjennpb.com in June 2025 and finding it offered compounded retatrutide and semaglutide products. Compounded retatrutide was cited as an unapproved new drug and misbranded drug because retatrutide does not appear on the 503A or 503B bulks lists and is not a component of any FDA-approved drug. Compounded semaglutide products were cited as misbranded due to false or misleading claims including 'FDA Approved,' 'Generic Ozempic,' and 'USA Compounded'/'Custom Compounded,' which falsely implied equivalence to FDA-approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Hims & Hers Health, Inc. dba Hims

FDA issued a warning letter to Hims & Hers Health, Inc. dba Hims (CEO Andrew Dudum) on September 9, 2025, after reviewing the hims.com website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims 'Same active ingredient as Ozempic and Wegovy' and 'Clinically proven ingredients' were found to falsely imply equivalence to FDA-approved products, which compounded drugs are not. FDA determined the products are misbranded and introduced into interstate commerce in violation of section 301(a), and warned that failure to correct violations may result in seizure or injunction.

directmeds.com, Inc. dba DirectMeds

FDA issued a warning letter to directmeds.com, Inc. dba DirectMeds (Bluffdale, UT) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied these products are equivalent to FDA-approved brand-name drugs. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

SemaBio

FDA issued a warning letter to SemaBio on September 9, 2025, after reviewing the company's website (sema.bio) and finding that it marketed compounded semaglutide products using the term 'generic semaglutide,' a claim FDA determined to be false or misleading because compounded drugs are not FDA-approved and the label implies equivalence to an approved product. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of such misbranded products violates section 301(a). FDA demanded immediate corrective action, including cessation of the misleading language, and warned that failure to comply may result in seizure or injunction.

Nuvo Life Health Inc. dba Nuvo Life Health

FDA issued a warning letter to Nuvo Life Health Inc. (Santa Monica, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs (Ozempic, Wegovy, and Mounjaro). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

eDrugstore

FDA issued a warning letter to eDrugstore (Tempe, AZ) in September 2025 after reviewing its website and finding that marketing claims for compounded tirzepatide falsely implied the products were FDA-approved, in violation of FDCA sections 502(a) and 502(bb). Specific claims included labeling the active ingredient as 'FDA-Approved Active,' guaranteeing products are 'genuine, FDA-approved formulations,' and equating the compounded product with the brand-name drug Zepbound. FDA found these claims misbranded the products and directed eDrugstore to immediately cease using the offending language, with a written corrective response required within 15 working days, and warned that failure to comply could result in seizure or injunction.

EvoLife Wellness

FDA issued a warning letter to EvoLife Wellness (Boca Raton, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied FDA approval. The claims 'FDA-Approved' and 'Clinically Proven: Semaglutide is FDA-approved for chronic weight management…' were deemed false or misleading under FDCA sections 502(a) and 502(bb) because compounded drug products are not FDA-approved. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Cosmo Medical Spa dba Cosmo Med Spa

FDA issued a warning letter to Cosmo Medical Spa dba Cosmo Med Spa, a Canadian-based telehealth/med spa operator, for selling compounded semaglutide products to U.S. consumers via its website while labeling them as 'Ozempic (semaglutide)' — falsely implying equivalence to an FDA-approved drug. The claims were found to constitute misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of these products violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure, injunction, or product detention at the U.S. border.

Elevate Your Wellness LLC, dba Elevated

FDA issued a warning letter to Elevate Your Wellness LLC (dba Elevated) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

SimpleRx

FDA issued a warning letter to SimpleRx (Bellevue, KY) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using brand names (Ozempic, Zepbound) in a manner that falsely implied equivalence to FDA-approved drugs. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Bioverse, Inc. dba Bioverse

FDA issued a warning letter to Bioverse, Inc. dba Bioverse (New York, NY) in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded Bioverse cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

inspire.clinic

FDA issued a warning letter to inspire.clinic (Grand Prairie, TX) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs Ozempic and Mounjaro. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the clinic cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

FitRX, LLC dba Zealthy

FDA issued a warning letter to FitRX, LLC dba Zealthy on September 9, 2025, citing that the company's website (getzealthy.com) made false or misleading claims implying its compounded semaglutide products are equivalent to FDA-approved brand-name drugs Wegovy and Ozempic. The claims violate FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded Zealthy cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Las Villas Health Care LLC dba Villas Health

FDA issued a warning letter to Las Villas Health Care LLC dba Villas Health (Coral Gables, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and sildenafil falsely implied equivalence to FDA-approved drugs (Ozempic/Wegovy and Viagra). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Tuyo Health, Inc. dba Tuyo Health

FDA issued a warning letter to Tuyo Health, Inc. (Miami, FL) in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro). Because compounded drugs are not FDA-approved, these claims rendered the products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Lyfe Rx

FDA issued a warning letter to Lyfe Rx (Bee Cave, TX) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims implied the compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products to be misbranded and introduced into interstate commerce in violation of section 301(a). Lyfe Rx was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Try Nova

FDA issued a warning letter to Try Nova (trynovamd.com) in September 2025 after reviewing the company's website and finding that its marketing of compounded semaglutide products contained a false or misleading claim implying equivalence to FDA-approved drugs Wegovy and Ozempic. The claim 'Same active ingredient as Wegovy & Ozempic' was found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), because compounded drugs are not FDA-approved and cannot be represented as equivalent to approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Lean Dreams LLC dba LeanDreams

FDA issued a warning letter to Lean Dreams LLC dba LeanDreams in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

GenLabMeds

FDA issued a warning letter to GenLabMeds, a telehealth/online pharmacy, in September 2025 after reviewing its website and finding it was selling compounded retatrutide, semaglutide, and tirzepatide products in violation of the FDCA. Retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component, making GenLabMeds' compounded retatrutide products unapproved new drugs and misbranded drugs. Additionally, website claims falsely implied that compounded products were equivalent to or the same as FDA-approved branded drugs (e.g., Mounjaro, Zepbound, Ozempic, Wegovy). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

ybycmeds

FDA issued a warning letter to ybycmeds (Sanborn, NY) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound. The claims were found to misbrand the products under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Amazing Meds

FDA issued a warning letter to Amazing Meds (Colorado Springs, CO) in September 2025 after reviewing their website and finding they were selling compounded retatrutide and semaglutide products unlawfully. The compounded retatrutide products were cited as unapproved new drugs and misbranded drugs because retatrutide does not appear on the 503A or 503B bulks lists and is not a component of any FDA-approved drug. Additionally, Amazing Meds' claim that their compounded semaglutide is the 'same as Ozempic/Wegovy' was found to be false or misleading, rendering those products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Vitals RX

FDA issued a warning letter to Vitals RX in September 2025 after reviewing their website and finding that the company marketed compounded semaglutide and tirzepatide products under a page title that referenced the FDA-approved brand name Ozempic, falsely implying equivalence with FDA-approved drugs. The FDA determined this claim misbranded the compounded products under FDCA sections 502(a) and 502(bb), constituting a prohibited act under section 301(a). The company was directed to immediately cease using the misleading language and to provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.

Healthy Living Clinic

FDA issued a warning letter to Healthy Living Clinic (Edgewater, CO) in September 2025 after reviewing its website and finding a false or misleading claim implying that its compounded semaglutide products are equivalent to FDA-approved brand-name drugs (Wegovy, Ozempic, Rybelsus). The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

The HCG Institute

FDA issued a warning letter to The HCG Institute (Medford, NJ) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims falsely implied that compounded semaglutide is equivalent to FDA-approved products, constituting misbranding. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Lovely Meds, Inc. dba Lovely Meds

FDA issued a warning letter to Lovely Meds, Inc. dba Lovely Meds (Clarksville, MD) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Dermacare LLC dba BlueChew

FDA's Center for Drug Evaluation and Research issued a warning letter to Dermacare LLC dba BlueChew in September 2025 after reviewing the bluechew.com website and finding that marketing claims for compounded sildenafil and tadalafil products falsely implied equivalence to FDA-approved drugs such as Viagra and Cialis. The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be promoted as equivalent to approved products. FDA directed BlueChew to immediately cease using the offending language and to provide a written corrective response within 15 working days. Failure to comply could result in seizure or injunction without further notice.

Expert Aesthetics

FDA issued a warning letter to Expert Aesthetics (owner Brenda Burr RN, MSN) in Mansfield, TX, after reviewing the website erasingage.com in August 2025. The agency found that marketing claims describing compounded semaglutide and tirzepatide as generics of Ozempic and Mounjaro falsely implied equivalence to FDA-approved products, constituting misbranding under FDCA sections 502(a) and 502(bb). FDA demanded cessation of the misleading language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

FWD Care, Inc. dba FWD

FDA issued a warning letter to FWD Care, Inc. dba FWD on September 9, 2025, after reviewing the company's website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro). The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be represented as the same as approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Get.Fit.Medical, LLC dba Get.Fit.Medical

FDA issued a warning letter to Get.Fit.Medical, LLC on September 9, 2025, after reviewing its website and finding that the telehealth company marketed compounded sildenafil, tadalafil, semaglutide, and tirzepatide using brand-name equivalency claims such as 'GENERIC VIAGRA,' 'GENERIC OZEMPIC/WEGOVY,' and 'GENERIC MOUNJARO.' These claims falsely implied the compounded products were the same as FDA-approved drugs, constituting misbranding under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

NuVida Medical LLC

FDA issued a warning letter to NuVida Medical LLC (Phoenix, AZ) after a February 2025 inspection found the company distributing four unapproved biological products — Procenta, XCELLERATE, completeFT, and Coll-e-Derm — derived from human amniotic, placental, and dermal tissue without an approved Biologics License Application (BLA). The products were marketed for wound care and revascularization applications that FDA determined constitute non-homologous use under 21 CFR 1271.10(a)(2), disqualifying them from the HCT/P exemption and making them unlicensed biological products and unapproved new drugs. FDA found NuVida's voluntary website corrections insufficient because the products' intended non-homologous uses remained unchanged. Failure to adequately respond may result in seizure and/or injunction.

Life Enthusiast Co-op

FDA issued a warning letter to Life Enthusiast Co-op (President Martin Pytela) on August 25, 2025, after reviewing the company's website and finding three ophthalmic products — 'Amazing Colyrio,' 'Fulvic Eyes,' and 'MSM Gold Drops' — marketed with drug claims (treating eye irritation, restoring vision, fighting infections) without FDA approval. The products are classified as unapproved new drugs under section 505(a) of the FD&C Act because they are intended to diagnose, cure, mitigate, treat, or prevent disease and are not generally recognized as safe and effective for their labeled uses. FDA noted particular public health concern because ophthalmic products bypass natural bodily defenses. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Supply Center USA

FDA issued a warning letter to Supply Center USA (Sheridan, WY) on August 25, 2025, after reviewing their website and finding they were selling multiple Similasan and Boiron homeopathic ophthalmic drug products that lack FDA approval. The products — including various Similasan eye relief drops and Boiron Optique 1 — are marketed with therapeutic claims (e.g., relieving allergy symptoms, pink eye, redness, burning) that qualify them as unapproved new drugs under section 505(a) of the FD&C Act. FDA determined these products are not generally recognized as safe and effective (GRASE) for their labeled uses, making their interstate sale a violation of sections 301(d) and 505(a). The agency demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Homeopathic Educational Services dba Homeopathic Family Medicine

FDA issued a warning letter to Homeopathic Educational Services dba Homeopathic Family Medicine (owner Dana Ullman, Berkeley, CA) after reviewing their website in May 2025 and finding that 'Cineraria Maritima Eye Drops' was being sold as an unapproved new drug. The product's website claimed it was indicated for cataracts, establishing drug-intended-use without FDA approval under FD&C Act sections 301(d) and 505(a). FDA flagged ophthalmic products as posing heightened public health risk due to the eye-administration route bypassing natural defenses, and warned that failure to correct violations could result in seizure, injunction, or import detention.

Chromatography Institute of America dba Compounder’s International Analytical Laboratory

FDA issued a warning letter to Chromatography Institute of America dba Compounder's International Analytical Laboratory (Castle Rock, CO), a contract testing laboratory serving 503B outsourcing facilities and other drug manufacturers, citing significant CGMP violations including inadequate laboratory controls, invalid sterility test investigations, and insufficient Quality Unit oversight. The firm was found to have adulterated drugs within the meaning of section 501(a)(2)(B) of the FD&C Act due to failures in microbiological testing, data integrity, and document control. FDA expressed concern about the validity and integrity of data provided to 503B outsourcing facilities and noted the firm communicated intent to shut down operations during the inspection. The letter warns that failure to remediate may result in seizure, injunction, withholding of export certificates, and blocking of new drug application approvals.

Platinum Biologics LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Platinum Biologics LLC (Orlando, FL) on August 15, 2025, citing four products — Nano PRP Jelly, Nano Flex, NanoEx, and Nano Xsomes — as unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. The products, derived from umbilical cord tissue and exosomes, were marketed for allogeneic use to treat conditions including autoimmune disease, pain, depression, connective tissue repair, shoulder injuries, and heart failure without an approved Biologics License Application. FDA warned that failure to address violations may result in seizure and/or injunction, and required a written response within 15 working days.

Innate Healthcare Institute

FDA's Center for Biologics Evaluation and Research issued a warning letter to Innate Healthcare Institute (Scottsdale, AZ) and its founder Travis Whitney, NMD, for marketing unapproved umbilical cord mesenchymal stem cells (UC-MSCs) and exosomes as treatments for autism, osteoarthritis, COPD, heart disease, and numerous other conditions without a valid Biologics License Application (BLA). The agency found the UC-MSC product fails the minimal manipulation and homologous-use criteria under 21 CFR 1271.10(a), making it an unapproved biological drug subject to premarket review. The product was also deemed misbranded under FD&C Act section 502(f)(1) for lacking adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.

cheaptrustedpharmacy.com

FDA issued a warning letter to cheaptrustedpharmacy.com, an online pharmacy based in the Turks & Caicos Islands, for selling unapproved and misbranded drugs to U.S. consumers, including unapproved semaglutide products (marketed as 'Semaglutide 0.5mg,' 'Semaglutide 1mg,' 'Semanize 4 Mg,' and 'Semanize 8 Mg'), unapproved lenalidomide, HIV combination therapy, and opioid tapentadol products. The products lack FDA-approved applications under section 505 of the FD&C Act and bear inadequate directions for use, constituting misbranding under section 502(f)(1). FDA demanded the site cease offering these products to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure or injunction.

Mericon Industries, Inc.

FDA issued a warning letter to Mericon Industries, Inc. (Peoria, IL) following a facility inspection and website review, finding that its Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules were marketed with disease-treatment claims (notably osteoporosis prevention and remediation) that rendered them unapproved new drugs under the FD&C Act. The products were also found to be misbranded drugs (lacking adequate directions for use), adulterated dietary supplements (due to serious CGMP violations including absent finished-product identity specifications and inadequate batch records), and misbranded dietary supplements (non-compliant nutrition labeling). FDA warned that failure to correct these violations may result in seizure or injunction, and required a written response within 15 working days.

Vidaslim Co.

FDA issued a warning letter to Vidaslim Co. (San Antonio, TX) following a December 2024 facility inspection that uncovered serious CGMP violations and labeling deficiencies across multiple dietary supplement product lines. The company failed to establish written procedures for quality control, distribution, reserve samples, complaint handling, returned products, and packaging/labeling operations. Multiple products — including Vidaslim Total Control Fat Burning Capsules, Vidaslim Gut Check Probiotic Super Greens, and others — were found misbranded due to missing adverse-event contact information, undeclared ingredients, improper Supplement Facts formatting, absent structure/function claim disclaimers, and inaccurate net quantity declarations. FDA warned that failure to adequately address these violations may result in seizure or injunction.

Valentine Enterprises, Inc.

FDA issued a warning letter to Valentine Enterprises, Inc. (Lawrenceville, GA) following an October 2024 facility inspection, citing serious CGMP violations and misbranding of multiple dietary supplement products including Vibrant Health Green Vibrance, MuscleTech EuphoriQ Pre-Workout, Vibrant Health Joint Vibrance, and Premium Green Superfood Cytogreens. CGMP violations included failure to establish adequate finished-product identity specifications, failure to verify laboratory testing method suitability, and incomplete batch production records. Misbranding violations included failure to declare common or usual names of all ingredients and incorrect serving size declarations. FDA warned that failure to adequately address these violations may result in seizure or injunction.

Evoke Wellness, LLC., FTC v.

The FTC sued Florida-based Evoke Wellness, LLC, Evoke Health Care Management, and their officers Jonathan Mosley and James Hull in January 2025 for using deceptive Google search ads and telemarketing to impersonate other substance use disorder treatment providers. The defendants misled consumers seeking addiction treatment by masquerading as competing or well-known providers. A settlement was reached in June 2025 in which the defendants were barred from the deceptive conduct and agreed to pay a $1.9 million civil penalty.

EyeTech One, LLC

FDA issued a warning letter to EyeTech One, LLC (doing business as EYELIVIO) on July 9, 2025, citing its EYELIVIO lubricant eye ointment as an unapproved new drug and misbranded drug sold via its website and Instagram. The product's formulation includes botanical active ingredients (Aloe vera, Arnica montana, Calendula officinalis) not permitted under OTC Monograph M018 for ophthalmic emollients, and its labeling makes claims for anti-inflammatory benefits and ocular surface protection that exceed permitted OTC indications. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within 15 working days.

Revitalize Energy, Inc.

FDA issued a warning letter to Revitalize Energy, Inc. (Pittsburgh, PA) regarding its Revitalize Energizing Eye Drops, finding the product to be an unapproved new drug and misbranded under the FD&C Act. The product's website and Facebook marketing made drug claims — including relieving eye strain, boosting focus, fighting screen fatigue, and protecting against cataracts — using active ingredients (menthol, camphor, caffeine, taurine) not permitted under the applicable OTC monograph M018. The product's labeling also falsely displayed FDA logos with claims of 'FDA COMPLIANT,' 'MADE IN A FDA REGISTERED FACILITY,' and 'FDA GRAS APPROVED,' creating a misleading impression of FDA approval. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.

Roca Labs, Inc.

The FTC took action against Roca Labs, Inc., a Florida-based marketer of weight-loss supplements, for making allegedly baseless efficacy claims and using 'gag clause' contract provisions to suppress negative consumer reviews and testimonials online. A federal district court issued summary judgment in the FTC's favor in September 2018. In July 2025, the Commission announced it was returning more than $409,000 to defrauded consumers as consumer redress.

Exela Pharma Sciences, LLC

FDA issued a warning letter to Exela Pharma Sciences, LLC (Lenoir, NC) following a November 2024 inspection of its drug manufacturing and outsourcing facility, citing significant CGMP violations under 21 CFR parts 210 and 211. Key violations included inadequate investigation of out-of-specification and failing sterility/growth-promotion test results, inaccurate documentation of microbiology test results, and multiple deficiencies in sterility testing, stability programs, personnel training, and visual inspection programs for sterile compounded drug products. The facility had already deregistered as a 503B outsourcing facility in December 2024, but FDA warned that violations would apply if operations resume. FDA demanded written corrective actions within 15 working days and cautioned that failure to comply could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

My Smoke Wholesale

FDA issued a warning letter to My Smoke Wholesale (Houston, TX), owned by Laila Dawoodani, regarding their '777 Jackpot Alkaloids, 18 mg tablets' product containing 7-hydroxymitragynine (7-OH), a new dietary ingredient with opioid-like effects. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because there is inadequate information to provide reasonable assurance that 7-OH does not present a significant or unreasonable risk of illness or injury. The agency cited adverse event reports and the absence of any pre-October 1994 marketing history for 7-OH as a dietary ingredient. The recipient was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Shaman Botanicals, LLC

FDA issued a warning letter to Shaman Botanicals, LLC (CEO Stephen Vincent Sanders II) regarding two chewable tablet products containing 7-hydroxymitragynine (7-OH) marketed as dietary supplements. FDA determined that 7-OH is a new dietary ingredient with inadequate safety information to provide reasonable assurance it does not present a significant or unreasonable risk of illness or injury, rendering the products adulterated under section 402(f)(1)(B) of the Act. The agency cited opioid-like effects, adverse event reports, and lack of pre-market safety evaluation as serious concerns. FDA warned that failure to address the violations may result in seizure and injunction, and required a written response within 15 working days.

Healwell Homeo Private Limited

FDA issued a warning letter to Healwell Homeo Private Limited, an Indian manufacturer of homeopathic and OTC drug products, following a December 2024 inspection that found pervasive insanitary conditions including live rodents, birds, rodent and avian excreta, mold, insects, and stray dogs in manufacturing and storage areas. The firm also failed to conduct identity testing on incoming components and lacked adequate quality unit oversight, written procedures, and process validation. FDA placed the firm on Import Alert 66-40, a distributor-initiated recall of U.S.-distributed products was executed in April 2025, and the firm is required to respond with corrective actions within 15 working days.

www.buynetmeds.com

FDA issued a warning letter to www.buynetmeds.com, an India-based online pharmacy, for unlawfully selling unapproved and misbranded drugs to U.S. consumers, including tapentadol opioid products and semaglutide (GLP-1) products such as counterfeit Rybelsus tablets and injectable semaglutide under the brand 'Fitaro.' The products were sold without valid FDA approval and without requiring a prescription, violating multiple provisions of the FD&C Act. FDA demanded the site cease all sales of unapproved and misbranded drugs to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure or injunction.

www.peacefulmeds.com

FDA issued a warning letter to www.peacefulmeds.com for unlawfully selling unapproved and misbranded prescription drugs to U.S. consumers via the internet, including opioids (tramadol), benzodiazepines (diazepam/Valium), and injectable semaglutide (marketed under the Ozempic brand name) without requiring a prescription. The site's product descriptions made therapeutic claims establishing intended drug use while bypassing FDA approval and prescription requirements, violating multiple provisions of the FD&C Act. FDA demanded the site cease all sales of unapproved and misbranded drugs and respond within 15 working days with corrective steps. Failure to comply may result in seizure or injunction.

Staska Pharmaceuticals, Inc.

FDA issued a warning letter to Staska Pharmaceuticals, Inc. (Bennet, NE), a 503B outsourcing facility, following a September 2024 inspection that revealed serious CGMP deficiencies in sterile drug manufacturing, including insanitary aseptic conditions, inadequate media fills, and failed smoke studies. The facility also failed to meet 503B conditions by using bulk drug substances from an unregistered supplier and omitting required labeling elements (adverse event reporting info, directions for use) on products such as Glutathione Solution and Ascorbic Acid Solution. As a result, the compounded drug products are deemed adulterated, misbranded, and unapproved new drugs under the FDCA. FDA required a written response within 15 working days and strongly recommended a comprehensive third-party assessment of aseptic processing operations.

Supreme Rejuvenation, LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Supreme Rejuvenation, LLC (Houston, TX) in May 2025 for marketing human umbilical cord mesenchymal stem cell-derived exosome products without an approved biologics license application or investigational new drug application. The company's website and Instagram page made numerous disease-treatment and structure/function claims for conditions including traumatic brain injury, arthritis, fibromyalgia, COVID-19 long-haulers, dementia, and androgenetic alopecia. FDA characterized the products as unapproved new drugs under FD&C Act § 505(a) and unlicensed biological products under PHS Act § 351(a)(1), warning that failure to respond adequately may result in seizure and/or injunction.

American Behavioral Research Institute, LLC

American Behavioral Research Institute, LLC (ABRI), the maker and sponsor of the dietary supplement Relaxium® Sleep, received an FDA Warning Letter dated April 30, 2025, for conducting a clinical investigation (Protocol ABRI-002) on human subjects to evaluate Relaxium's effects on insomnia without first submitting a required Investigational New Drug (IND) application. FDA determined that because the study was designed to assess Relaxium's efficacy in treating insomnia — a disease — the product was being used as a drug under the FD&C Act, regardless of its commercial marketing as a dietary supplement. ABRI's response, which argued Relaxium was a dietary supplement and that no future studies were planned, was deemed inadequate because it lacked a corrective and preventive action plan for IND compliance. FDA required ABRI to respond within 15 business days with actions taken to prevent future violations, warning that failure to do so may lead to regulatory action.

OSRX, Inc.

FDA issued a warning letter to OSRX, Inc., a registered 503B outsourcing facility in Missoula, Montana, following an October 2024 inspection that revealed sterile drug products were produced under insanitary conditions and failed to meet 503B labeling requirements. The facility's compounded sterile ophthalmic products were found adulterated due to inadequate smoke studies, unresolved microbial contamination in ISO 5 areas, and multiple CGMP violations including failures in aseptic process validation and environmental monitoring. The products were also deemed unapproved new drugs and misbranded due to missing adequate directions for use and incomplete labeling. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

www.24hreup.biz

FDA issued a warning letter to www.24hreup.biz, a Germany-based website, for selling unapproved and misbranded semaglutide drug products — marketed as 'Ozempic 0.5mg,' 'Ozempic 1mg,' and 'Rybelsus Semaglutide 14mg' — to U.S. consumers without a prescription and without FDA approval. The products violate the FD&C Act as unapproved new drugs and misbranded prescription drugs lacking adequate directions for use. FDA demands the site cease sales to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure and injunction.

M.O.M. Enterprises, LLC

FDA issued a warning letter to M.O.M. Enterprises, LLC (Mommy's Bliss) following a 2024 inspection of its Richmond, CA dietary supplement facility, citing serious cGMP violations, failure to submit required Serious Adverse Event Reports for infant injuries, misbranding of supplement labels, and unapproved new drug status for Gripe Water Original. The company's website blog posts made disease-treatment claims linking Gripe Water Original to relief of acid reflux, GERD, asthma, and colic, causing the product to be regulated as an unapproved new drug. FDA warned that failure to address these violations may result in seizure or injunction, and required a written response within 15 working days.

Anti L’Age

FDA issued a warning letter to Anti L'Age (owner Dr. Arash Mohrdar, Riverside, CA) following a September–October 2024 facility inspection, citing extensive CGMP violations for three dietary supplement products — ESR Amino, Transfer Factor C, and Heart Amino — including failure to establish product specifications, maintain batch records, or implement quality control procedures. The products were also found misbranded for missing required labeling elements such as the 'dietary supplement' statement of identity, adverse event reporting contact, manufacturer information, correct serving size declarations, and required FDA structure/function claim disclaimers. FDA warned that failure to adequately address these violations may result in seizure or injunction. The recipient had not responded to the FDA 483 issued at the close of inspection prior to this letter.

Gluten Free Remedies LLC

FDA issued a warning letter to Gluten Free Remedies LLC (CEO Alex Shikhman, San Diego, CA) regarding its product 'Sulbutiamine Plus Brain Support,' labeled as a dietary supplement. The agency found that sulbutiamine — declared on the label as a dietary ingredient — does not qualify as a dietary ingredient under section 201(ff)(1) of the Act, making the product misbranded under section 403(a)(1). FDA warned that failure to address the violation could result in seizure or injunction, and required a written response within 15 working days.

Tailstorm Health Inc. dba Medivant Health

FDA issued a warning letter to Tailstorm Health Inc. dba Medivant Health (Phoenix, AZ), an outsourcing facility registered under section 503B, following a September–October 2024 inspection that found serious sterility and CGMP deficiencies. The facility's compounded drug products — including Semaglutide Injection, Tirzepatide Injection, and Bevacizumab — were found adulterated due to insanitary conditions, inadequate microbial contamination response, and deficient smoke studies, and were also deemed unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure or injunction.

PMS4PMS, LLC

FDA issued a warning letter to PMS4PMS, LLC (Clarence, NY) after a November 2024 inspection found significant CGMP violations and determined that their 'Comforté® Menstrual Cramp RELIEF CREAM' is an unapproved new drug and misbranded product. The product's labeling includes menstrual cramp relief indications not covered under OTC monograph M017 for external analgesics, making it a new drug marketed without an approved application. FDA also cited failures in release testing, stability programs, and quality unit oversight. The company is required to respond within 15 working days, and failure to comply may result in seizure, injunction, or withholding of export certificates and new application approvals.

Empower Clinic Services, LLC dba Empower Pharmacy

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX) following a September–October 2024 inspection that identified serious insanitary conditions in the production of sterile injectable drug products. Investigators found failures in environmental monitoring, inadequate media fills, and unsterilized equipment components contacting injectable drug product stoppers, rendering the compounded products adulterated under FDCA section 501(a)(2)(A). FDA found the firm's corrective action responses insufficient and lacking supporting documentation. The letter warns that failure to adequately address violations may result in seizure and injunction.

Empower Clinic Services, LLC dba Empower Pharma

Empower Clinic Services, LLC dba Empower Pharma, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter citing adulterated and misbranded sterile drug products — including Testosterone Cypionate, Glutathione, Pyridoxine HCl, and Lipo-B injections — due to serious CGMP deficiencies in aseptic processing, inadequate environmental monitoring, and failure to meet 503B labeling conditions. The facility released batches despite positive microbial contamination findings, failed to conduct adequate smoke studies, and had repeat violations previously discussed at a May 2023 regulatory meeting. Because the compounded products did not meet all 503B conditions, they are subject to unapproved new drug and misbranding violations under the FDCA. FDA warned that failure to adequately address violations may result in seizure and injunction.

Mother Earth Minerals, Inc.

FDA issued a warning letter to Mother Earth Minerals, Inc. (Ogden, UT) after inspecting their facility and reviewing their website, finding that their Calcium, Magnesium, and Silver products were marketed with disease-treatment and prevention claims—including for cancer, multiple sclerosis, diabetes, AIDS, and other conditions—rendering them unapproved new drugs and misbranded drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to widespread CGMP violations including absent identity specifications, missing master manufacturing records, incomplete batch production records, no written quality control procedures, and failure to retain reserve samples. FDA warned that failure to adequately address these violations may result in seizure and injunction.

Naturista Store LLC

FDA issued a warning letter to Naturista Store LLC (Downey, CA) for selling 'ADVANCE KING,' a product marketed as a dietary supplement but found via laboratory analysis to contain undeclared pharmaceutical ingredients dexamethasone, diclofenac, and methocarbamol. The product was marketed with disease-treatment claims for conditions such as sciatica, osteoarthritis, gout, and joint pain, making it an unapproved new drug under the FD&C Act. FDA also flagged eight additional similarly named products sold on the website as posing serious safety concerns based on prior analyses of comparable products. The agency demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

Xlear, Inc., U.S. v.

The FTC, acting through DOJ, sued Xlear, Inc. in October 2021 under the COVID-19 Consumer Protection Act, alleging the Utah-based company falsely marketed its saline nasal sprays as effective for preventing and treating COVID-19. The core violation was unsubstantiated efficacy claims tied to a serious infectious disease. In March 2025, DOJ agreed to dismiss the case with prejudice, resulting in no final judgment or penalty against Xlear.

B4B Corp.

The FTC, DOJ, and FDA jointly sued B4B Corp., a New York-based herbal tea marketer, seeking a permanent injunction to halt deceptive advertising for its 'Earth Tea' product. The company claimed its tea was clinically proven to treat, cure, and prevent COVID-19, which constitutes unsubstantiated and forbidden health claims under FTC and FDA standards. The enforcement action seeks to permanently block these deceptive advertisements.

Advanced Pharmaceutical Technology

FDA issued a warning letter to Advanced Pharmaceutical Technology (Elmsford, NY) following a July–August 2024 inspection that found significant repeat CGMP violations at their combination product drug manufacturing facility. Key violations included failure to prevent microbiological contamination of purportedly sterile drug products, lack of adequate dissolution/release testing for controlled-release dosage forms, insufficient process validation, and an inadequate quality control unit that failed to oversee contract testing and manufacturing organizations. FDA warned that failure to correct these violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals, and required a written response within 15 working days.

Annovex Pharma, Inc.

FDA issued a warning letter to Annovex Pharma, Inc. (Lorton, VA), a 503B outsourcing facility, following an August–September 2024 inspection that revealed serious CGMP violations and failure to meet section 503B conditions. The facility produced sterile drug products under insanitary conditions — including failing to investigate positive microbial growth in 10% of media fill units — and failed to submit required biannual drug product reports and adequate adverse event reporting procedures. As a result, the compounded drug products were deemed adulterated, misbranded, and unapproved new drugs, with FDA warning that failure to remediate may result in seizure or injunction.

ProRx, LLC

FDA issued an amended warning letter to ProRx, LLC, a 503B outsourcing facility in Exton, PA, following a July–August 2024 inspection that uncovered serious sterility assurance failures and CGMP violations in the production of sterile drug products including Semaglutide and Tirzepatide. The facility's compounded drugs were found to be adulterated due to insanitary conditions (e.g., insects in cleanrooms, improper gowning, no environmental monitoring in ISO 5 areas) and misbranded due to inadequate labeling and failure to meet 503B conditions. ProRx voluntarily recalled all sterile products within expiry on August 22, 2024, and ceased sterile production, but FDA found multiple corrective action responses deficient. FDA warned that failure to adequately address violations may result in seizure and injunction.

C & A Naturistics

FDA issued a warning letter to C & A Naturistics (National City, CA) for selling multiple products — including AK Forte, TE DE MORONEL, Jengibre en Polvo, Té Uva Ursi, RenaLimp, and two ophthalmic products — as unapproved new drugs and misbranded drugs. Lab analysis confirmed AK Forte contained undeclared acetaminophen and diclofenac, posing serious risks of liver damage, cardiovascular events, and dangerous drug interactions. The products bore disease-treatment claims (cancer, arthritis, kidney stones, conjunctivitis) without FDA approval, and labeling failed to disclose active pharmaceutical ingredients or provide adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and/or injunction.

Vivid-Scientific LLC

FDA issued a warning letter to Vivid-Scientific LLC (Jamestown, NC) in March 2025 after reviewing their website and finding they were selling unapproved injectable lipolytic products — 'LemonBottle Ampoule Solution,' 'Lipo Lab PPC Solution,' 'Neobella Extreme,' and 'Deoxycholic Acid Booster' — without FDA-approved applications. The products were marketed with drug claims such as permanently dissolving fat cells, tightening skin, and boosting metabolism, establishing their intended use as drugs under the FD&C Act. FDA determined these products are unapproved new drugs introduced into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

USApeptide.com

FDA issued a warning letter to USApeptide.com (based in Germany) for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these GLP-1 receptor agonists with claims referencing FDA-approved brand names (Ozempic, Wegovy, Rybelsus, Mounjaro) and human therapeutic uses, despite labeling them 'research use only' and 'not for human consumption.' FDA found the products to be unapproved new drugs lacking valid section 505 applications and misbranded because they lacked adequate directions for use and were dispensed without a prescription. FDA demanded cessation of sales to U.S. consumers and a written corrective response within 15 working days, warning that failure to comply may result in seizure and injunction.

TKTX USA

FDA issued a warning letter to TKTX USA on February 25, 2025, concerning five topical numbing cream products (Blue, Green, Black, Gold, and Yellow TKTX Numbing Creams 40%) marketed for use before cosmetic procedures such as tattooing, microblading, and laser treatments. The products were found to be unapproved new drugs because they contain lidocaine at concentrations (20–40%) far exceeding the 0.5–4% permitted under OTC Monograph M017, and include non-permitted active ingredients (prilocaine, epinephrine) in non-permitted combinations. FDA also cited misbranding violations and raised safety concerns about increased systemic absorption through broken or irritated skin during cosmetic procedures. TKTX USA was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

ISOThrive, Inc.

FDA issued this warning letter to ISOThrive, Inc. (CEO Jack Oswald) following a June 2023 inspection under the Bioresearch Monitoring Program. The agency found that ISOThrive conducted two clinical investigations of an investigational drug — marketed commercially as a dietary supplement — on a combined 288 human subjects without first submitting or having in effect an Investigational New Drug (IND) application, as required by 21 CFR 312. FDA determined the studies were designed to assess treatment of disease (not merely tolerability), making the product a drug under FD&C Act §201(g)(1) and disqualifying it from IND exemption. ISOThrive was directed to respond within 15 business days with corrective actions, with failure to do so potentially triggering further regulatory action.

Strukmyer LLC dba Strukmyer Medical

FDA issued a warning letter to Strukmyer LLC dba Strukmyer Medical (Mesquite, TX) following a July–August 2024 inspection that found significant CGMP violations at their OTC drug manufacturing facility. The firm repeatedly isolated objectionable microorganisms (including Burkholderia and Pseudomonas) from their water system used to manufacture wound and burn products on over 60 occasions, failed to adequately investigate contamination incidents, and did not perform proper identity testing on high-risk components such as glycerin for DEG/EG contamination. FDA warned that failure to promptly correct these violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals, and required a written response within 15 working days.

Nubratori, Inc. dba Nubratori Rx

FDA issued a warning letter to Nubratori, Inc. dba Nubratori Rx, a 503B outsourcing facility in Torrance, CA, following a July 2024 inspection that revealed serious CGMP deficiencies in sterile drug compounding operations. The violations included insanitary conditions (improper glove fingertip sampling), failure to establish adequate acceptance criteria for batch release, inadequate environmental monitoring, and failure to validate component supplier test analyses. FDA found the facility's corrective action responses insufficient due to missing supporting documentation, and warned that failure to adequately address violations may result in seizure or injunction.

Chara Biologics, Inc.

FDA issued a warning letter to Chara Biologics, Inc. (CEO Joy Kong, M.D.) following a July–August 2024 facility inspection, finding that its three products—CharaExo (amniotic fluid), CharaCore, and CharaOmni (umbilical cord-derived)—are unapproved new drugs and unlicensed biological products marketed for a wide range of serious diseases including Parkinson's, ALS, autism, and diabetes without an approved BLA or active IND. The products were also found to violate CGMP and CGTP requirements, and CharaExo was misbranded due to unsupported expiration date extensions. FDA warned that failure to adequately respond may result in seizure and/or injunction.

BioStem Life Sciences

FDA issued a warning letter to BioStem Life Sciences (Pompano Beach, FL) on January 17, 2025, citing that its umbilical cord-derived and amniotic membrane products (OROPRO®, PROVISCUS®, NEOFYL®, and RHEO®) are unapproved biological drugs lacking a valid Biologics License Application (BLA), and that the products fail HCT/P criteria for minimal manipulation and homologous use. The letter also documents five significant CGMP violations covering environmental monitoring, cleaning validation, process validation, laboratory controls, and stability testing. FDA warned that failure to adequately respond may result in seizure and/or injunction.

Mihon Corp. d/b/a VitalityVita and Boulla, LLC

FDA issued a warning letter to Mihon Corp. d/b/a VitalityVita and Boulla, LLC for marketing four products — VitalityXtra, PeakMax, ZapMax, and ZoomMax — as dietary supplements while laboratory analysis confirmed they contained undeclared active pharmaceutical ingredients sildenafil (a PDE-5 inhibitor, the active ingredient in Viagra) and, in three products, diclofenac (an NSAID). The products are classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and as misbranded drugs under section 502 for failing to disclose prescription drug ingredients, lacking adequate directions for use, and omitting required safety warnings. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.

www.weightcrunchshop.com

FDA issued a warning letter to www.weightcrunchshop.com, a Hong Kong-based website, for selling unapproved and misbranded drugs to U.S. consumers, including counterfeit/unapproved semaglutide products ('Orsema 0.25 mg,' 'Orsema 0.50 mg'), genuine brand-name Ozempic offered without a prescription, and oxycodone tablets sold without a prescription. The site violated the FD&C Act by introducing unapproved new drugs into interstate commerce, failing to bear adequate directions for use, and dispensing prescription drugs without valid prescriptions. FDA demanded cessation of all such sales and a written corrective-action response within 15 working days, warning that failure to comply may result in seizure and injunction.

Stem Cell Institute of America, LLC

The FTC and Georgia Attorney General's Office sued the co-founders of Stem Cell Institute of America, LLC in August 2021 for marketing stem cell therapy to seniors using unsubstantiated claims that the treatment is effective for arthritis, joint pain, and other orthopedic conditions. In January 2025, two court orders were entered settling the complaint and barring the company from the allegedly illegal conduct. The case represents a coordinated federal-state enforcement action targeting deceptive health marketing directed at a vulnerable population.

Evolutionary Biologics Inc.

FDA's Center for Biologics Evaluation and Research issued a warning letter to Evolutionary Biologics Inc. (CEO Jim Morrison) on December 30, 2024, finding that three products — EXO RNA™ (exosome), EVO JEL™ (umbilical cord-derived), and EVO HYBRID™ (umbilical cord/placental/amniotic membrane) — are unapproved new drugs and unlicensed biological products marketed with disease-treatment and structure/function claims. The products lack approved BLAs or NDA approvals and fail HCT/P minimal-manipulation and homologous-use criteria under 21 CFR 1271.10(a). FDA also flagged three additional products (EXO RX™, EXO ELIXIR™, EXO PERIO™) for similar concerns and warned that failure to respond adequately may result in seizure and/or injunction.

Fagron Compounding Services, LLC dba Fagron Sterile Service

FDA issued a warning letter to Fagron Compounding Services, LLC dba Fagron Sterile Service, a 503B outsourcing facility in Wichita, KS, following a June 2024 inspection that found sterile drug products produced under insanitary conditions, CGMP violations, and labeling deficiencies that disqualified products from 503B exemptions. The facility's drug products were deemed adulterated (due to microbial contamination risks including a Chaetomium globosum recovery in an ISO 5 area and construction without adequate contamination controls), misbranded (lacking adequate directions for use), and unapproved new drugs. FDA acknowledged a voluntary recall of four lots of Lidocaine HCl Injection 2% for lack of sterility assurance and warned that failure to adequately address violations may result in seizure and injunction.

Brands International Corporation

FDA issued a warning letter to Brands International Corporation (Lakewood, NJ / Newmarket, Ontario) after a June 2024 inspection found the firm obstructed investigators, failed to adequately investigate mold contamination complaints, released drug products without proper active-ingredient testing, and stored APIs outdoors without climate control. The firm's drugs were deemed adulterated under multiple provisions of the FD&C Act, FDA placed the firm on Import Alert 66-40, and two voluntary recalls were initiated for mold-contaminated products. FDA demanded comprehensive corrective action plans, CGMP consultant engagement, and a written response within 15 working days.

Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals

FDA issued a warning letter to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, a 503B outsourcing facility in Irving, TX, following a May–June 2024 inspection that revealed adulterated sterile drug products, CGMP violations, and labeling deficiencies. The facility's compounded products—including Testosterone Cypionate injections and Ketoconazole cream—were found to be adulterated due to insanitary conditions and inadequate aseptic processing controls, and misbranded due to missing inactive ingredient information on labels. FDA determined the products do not qualify for 503B exemptions and are being marketed as unapproved new drugs, warning that failure to correct violations may result in seizure or injunction.

Skye Biologics Holdings LLC

FDA issued a warning letter to Skye Biologics Holdings LLC (El Segundo, CA) following a November–December 2022 inspection, finding that its umbilical cord-derived 'placental connective tissue matrix allograft' products (BioECM™ line) are unapproved new drugs and unlicensed biological products marketed without a valid Biologics License Application (BLA). The products were found to exceed minimal manipulation thresholds and were not intended for homologous use, disqualifying them from regulation solely under PHS Act section 361. FDA also documented seven categories of significant CGMP violations, including lack of process validation, inadequate environmental monitoring, missing endotoxin testing, and unsupported five-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

XO Biologix, LLC

FDA issued a warning letter to XO Biologix, LLC (Austin, TX) on December 12, 2024, regarding its amniotic fluid-derived product MaviX™. The agency found MaviX™ to be an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act, marketed with claims that it reduces pain, inflammation, and regenerates tissue without an approved Biologics License Application. The product was also found adulterated due to CGMP violations at its manufacturer and misbranded due to false or misleading labeling, including inconsistent and unsupported shelf-life claims. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

INCELL Corporation LLC

FDA's Center for Biologics Evaluation and Research issued a Warning Letter to INCELL Corporation LLC (San Antonio, TX) on December 12, 2024, finding that its amniotic fluid-derived product is an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The company also committed multiple CGMP violations including failure to validate aseptic processes, lack of identity testing specifications, and unsupported expiration dating. The product's Instructions for Use were found to contain false or misleading labeling, rendering it misbranded, and FDA warned that failure to remediate may result in seizure and/or injunction.

Summit Research Peptides

FDA issued a warning letter to Summit Research Peptides (Hoover, AL) on December 10, 2024, after reviewing the company's website and Facebook page and finding that products marketed as Semaglutide, Retatrutide, Cagrilintide, Tirzepatide, and Mazdutide were being sold as unapproved new drugs for human use despite 'Research Use Only' labeling. The agency found that product descriptions and social media posts established intended human therapeutic use — including claims about weight loss, glucose control, and cardiovascular health — in violation of FD&C Act sections 505(a) and 301(d). No FDA-approved applications are in effect for these products. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Swisschems

FDA issued a warning letter to Swisschems (New York, NY) on December 10, 2024, after reviewing their website and social media accounts and finding that they were selling unapproved Semaglutide and Retatrutide products in the United States. Despite labeling the products as 'research chemicals only,' FDA determined the marketing claims established intended human drug use, making them unapproved new drugs in violation of FD&C Act sections 505(a) and 301(d). FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure and injunction.

Prime Vitality, Inc. dba Prime Peptides

FDA issued a warning letter to Prime Vitality, Inc. dba Prime Peptides (Santa Barbara, CA) on December 10, 2024, after reviewing the company's website and social media accounts and finding that its Semaglutide and Retatrutide products were being marketed as drugs for human use despite 'research purposes only' disclaimers. The company's website, blog posts, Facebook, Instagram, and YouTube content made explicit disease-treatment and weight-loss efficacy claims, establishing intended human use and rendering the products unapproved new drugs under the FD&C Act. FDA found violations of sections 505(a) and 301(d) of the FD&C Act and warned that failure to correct may result in seizure or injunction. The company was required to respond within fifteen working days with corrective steps.

Veronvy

FDA issued a warning letter to Veronvy (Rancho Dominguez, CA) on December 10, 2024, regarding its 'Elily Veronvy' and 'Elily Veronvy 40+' products marketed as GLP-1-mimicking weight loss drops. The products were found to be unapproved new drugs making drug-intent claims (appetite suppression, gastric emptying, fat burning, and weight loss up to 52 lbs) and were misbranded because the labeling falsely claimed FDA approval via an 'FDA APPROVED' badge and explicit written statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Xcel Research LLC

FDA issued a warning letter to Xcel Research LLC (xcelpeptides.com) in December 2024 for selling unapproved new drugs — including Retatrutide, Cagrilintide/Semaglutide blends, Mazdutide, Semaglutide, Survodutide, and Sermorelin — marketed under the guise of 'research use only' products. The website's own claims established intended human use by describing therapeutic effects such as weight loss, blood sugar regulation, cardiovascular protection, and neuroprotection. The products violate FD&C Act sections 505(a) and 301(d) as unapproved new drugs lacking any FDA-approved application. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Centura Pharmaceuticals Inc

FDA issued a warning letter to Centura Pharmaceuticals Inc. (Lutz, FL) regarding its 'BLT 1-2-3 Cream,' a triple-combination topical anesthetic (benzocaine 20%, lidocaine HCl 4%, tetracaine 2%) marketed OTC for cosmetic procedures such as laser hair removal, microneedling, and dermal fillers. The product was found to be an unapproved new drug because it does not conform to OTC Monograph M017, which prohibits combining more than one '-caine' active ingredient, and its labeling includes indications beyond those permitted by the monograph. FDA also cited misbranding violations and raised safety concerns about increased systemic absorption when used in cosmetic settings without professional supervision. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Western Innovations, Inc.

FDA issued a warning letter to Western Innovations, Inc. (Denver, CO) following a January–February 2024 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failures to establish component specifications, written quality control procedures, proper master manufacturing records, and complete batch production records for their Acetyl-glutathione product. These violations render the dietary supplements adulterated under section 402(g)(1) of the FD&C Act, and FDA warned that failure to correct them may result in seizure or injunction.

Frontier Biologics, LLC

FDA issued a warning letter to Frontier Biologics, LLC (Waco, TX) after a February–March 2024 inspection found that its human amniotic fluid and amniotic membrane allograft products are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The company's marketing materials made therapeutic claims for wound healing, inflammation reduction, and orthopedic use without an approved BLA or active IND. FDA also cited six significant CGMP violations including failure to validate aseptic processes, inadequate environmental monitoring, and two uninvestigated sterility failures. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Choice All Natural, Inc. dba Om Botanical

FDA issued a warning letter to Choice All Natural, Inc. dba Om Botanical (Apex, NC) following a January–February 2024 inspection that found multiple CGMP violations including pest activity in raw material storage, inadequate finished-product release testing, lack of stability testing, and use of the QC laboratory for meal preparation. The company's 'Om Botanical Rash & Itch Cream' was cited as an unapproved new drug because its combination of Zinc Oxide, Witch Hazel, and Colloidal Oatmeal is not permitted under OTC Monograph M016, and the product was also found misbranded. Additionally, the firm's FDA establishment registration had lapsed since December 31, 2021, and five drug products were not listed with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.

Amnio Technology, LLC

FDA issued a warning letter to Amnio Technology, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen® Flow® and PalinGen® InovōFlo®, finding them to be unapproved new drugs and biological products marketed without a valid Biologics License Application (BLA) or approved NDA. The company's promotional materials made wound healing, tissue regeneration, anti-inflammatory, and anti-microbial claims that triggered drug/biologic classification under the FD&C Act and PHS Act. FDA also documented significant CGMP deviations including lack of process validation, inadequate stability testing, and failure to report adverse events. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Pinnacle Transplant Technologies, LLC

FDA issued a warning letter to Pinnacle Transplant Technologies, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen®, which FDA determined are unapproved new drugs and biological products lacking required BLA or IND authorization. Promotional materials claimed the products support wound healing and tissue regeneration, triggering classification as drugs under the FD&C Act and biological products under the PHS Act. FDA also documented six significant CGMP deviations including failures in aseptic process validation, sterility failure investigations, and environmental monitoring. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Supercore Products Group, Inc.

FDA issued a warning letter to Supercore Products Group, Inc. (Atlanta, GA) regarding its 'Hard Steel' and 'Gold Hard Steel Plus' products, which were marketed as dietary supplements but found via laboratory analysis to contain undeclared pharmaceutical ingredients sildenafil and acetaminophen. The products were cited as unapproved new drugs and misbranded drugs under the FD&C Act due to erectile dysfunction treatment claims and failure to disclose active drug ingredients that pose serious health risks. The company had already issued a voluntary recall in July 2024, but FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Far East Summit LLC

FDA issued a warning letter to Far East Summit LLC (Dexter, OR) following a January–February 2024 inspection of their facility and review of their website and product catalog. The agency found that multiple traditional Chinese herbal products—including Si Ni San, Gan Mao Ling, Tong Jing Tang, and others—bore drug claims (e.g., 'Relieves pain,' 'Arrests diarrhea,' 'Suppresses cough') that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed significant dietary supplement CGMP violations (inadequate specifications, failure to investigate an adverse event involving hallucinations, lack of contamination limits) and misbranded several dietary supplement products through improper labeling. FDA warned that failure to correct these violations may result in seizure or injunction.

Nomida.biz

FDA issued a warning letter to Nomida.biz on September 12, 2024, for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet without requiring a prescription. The site marketed these GLP-1 injectable products with claims of safety, effectiveness, and weight loss innovation, despite lacking FDA-approved drug applications for the specific formulations offered. FDA cited violations of the FD&C Act including introduction of unapproved new drugs and misbranding, and demanded corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

SoloVital

FDA issued a warning letter to SoloVital (Chula Vista, CA) on August 27, 2024, regarding their product 'Umary Hyaluronic Acid,' which laboratory analysis confirmed contained undeclared drug ingredients diclofenac (an NSAID) and omeprazole (a PPI). The product was marketed as a dietary supplement but is classified as an unapproved new drug under the FD&C Act because it contains approved drug substances not disclosed on the label, rendering it both an unapproved new drug and a misbranded drug. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

MexHealth LLC d/b/a Al Natural E-Shop

FDA issued a warning letter to MexHealth LLC d/b/a Al Natural E-Shop (Travis Bunch, La Mesa, CA) regarding their product 'Ossos-Sans,' marketed as a dietary supplement. Laboratory analysis confirmed the product contained undeclared diclofenac (an NSAID) and methocarbamol (a muscle relaxant), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made numerous disease-treatment claims (arthritis, osteoporosis, fractures, etc.) without FDA approval, and failed to disclose the presence of active pharmaceutical ingredients. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Mother Stem Institute, Corp.

FDA's Center for Biologics Evaluation and Research issued a warning letter to Mother Stem Institute, Corp. (Coral Gables, FL), founded by Dr. Alvaro Skupin, after reviewing the firm's website and records related to its stromal vascular fraction (SVF) product derived from enzymatic digestion of adipose tissue. The firm's website marketed the SVF product for treatment of Alzheimer's disease, Type I/II Diabetes, Lupus, Rheumatoid Arthritis, Parkinson's, and other conditions, establishing drug and biological product intended uses without an approved Biologics License Application or active IND. FDA found the SVF product constitutes more than minimal manipulation of a structural tissue, does not qualify for the same-surgical-procedure exception, and is both an unapproved biological drug and a misbranded drug, warning that failure to correct violations may result in seizure and/or injunction.

AnuMed International, LLC

AnuMed International, LLC, a Phoenix-based drug manufacturer, received an FDA Warning Letter on August 20, 2024, citing multiple unapproved new drugs sold without FDA approval, including a 'Semaglutide Homeopathic Formula,' bio-identical hormone creams, and various supplement products making disease treatment claims. The company's products were also found to be misbranded—falsely implying FDA approval by labeling products as made in an 'FDA Approved Facility' or 'FDA registered facility'—and adulterated due to serious CGMP violations including failure to perform identity testing on components such as glycerin and ethanol. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Regenerative Processing Plant, LLC

FDA issued a Warning Letter to Regenerative Processing Plant, LLC (owner Dr. Carl R. Harrell) in Palm Harbor, FL, citing multiple serious violations related to their Regener-Eyes® PRO and Regener-Eyes® LITE ophthalmic solutions. The products were found to be unapproved new drugs, misbranded, and adulterated due to significant CGMP failures including inadequate aseptic process validation, insufficient environmental monitoring, and unsupported stability claims. FDA also raised serious concerns that products marketed after June 2021 may still contain amniotic fluid — a biologic requiring a valid BLA — despite the company's claims of discontinuation. Failure to adequately address these violations may result in seizure and/or injunction.

Restorative Botanicals, LLC

FDA issued a warning letter to Restorative Botanicals, LLC (Longmont, CO) following a November–December 2023 facility inspection that found significant Current Good Manufacturing Practice (CGMP) violations in the production of two dietary supplement products: My GUT Shrooms Gummies 60 ct. and My IMMUNE Shrooms Capsules 60 ct. The violations included failure to establish adequate component identity and contamination-limit specifications (including toxic element testing for mushroom ingredients), discrepancies between batch production records and product labels, and incomplete master manufacturing and batch production records. FDA declared the products adulterated under 21 U.S.C. § 342(g)(1) and warned that failure to correct violations may result in seizure or injunction.

ISIS.GOLD

FDA issued a warning letter to ISIS.GOLD (Michelle Golde, Elmhurst, IL) on July 25, 2024, concerning two chemical peel products — 'TCA 100% Trichloroacetic Acid' and 'Whitening SA Peels' — sold on the company's website. The products were found to be unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act due to drug-intent claims such as removing warts, treating melasma, and anti-aging effects, without any FDA-approved application in effect. FDA flagged public health risks including burns, scarring, and injuries requiring emergency care. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Txsyn Int. LLC

FDA issued a warning letter to Txsyn Int. LLC (San Antonio, TX) following an October–November 2023 inspection of their dietary supplement repackaging and labeling facility. The agency identified five significant CGMP violations under 21 CFR Part 111, including failure to retain reserve samples for required periods, lack of written procedures for received products, packaging/labeling operations, and returned dietary supplements, as well as releasing product for distribution without quality control approval. No marketing claims were flagged; the violations are entirely operational/manufacturing in nature, and FDA warned that failure to correct may result in seizure or injunction.

Central Admixture Pharmacy Services, Inc.

Central Admixture Pharmacy Services, Inc. (CAPS), a 503B outsourcing facility in San Diego, CA, received an FDA Warning Letter following a July–August 2023 inspection that uncovered serious sterility assurance failures, CGMP violations, and failure to meet 503B conditions. The facility produced adulterated and misbranded sterile drug products (including Ephedrine Sulfate, Fentanyl Citrate, Ketamine Hydrochloride, and others) without adequate aseptic controls, proper labeling, or adverse event reporting. CAPS initiated voluntary recalls and subsequently permanently ceased operations at the San Diego location. FDA warned that failure to adequately address violations may result in seizure and injunction.

Formulation Technology, Inc.

FDA issued a warning letter to Formulation Technology, Inc. (Oakdale, CA) following a facility inspection in October–November 2023, citing violations across three categories: marketing a product as an unapproved new drug (with disease-treatment claims implying migraine cure/mitigation), adulterated dietary supplements due to cGMP failures (missing heavy metal and strength specifications), and misbranded dietary supplements due to incorrect serving size declarations and non-compliant Supplement Facts labeling. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Natural Ginger, Corp/Jonaus Corp

FDA issued a warning letter to Natural Ginger, Corp/Jonaus Corp (owner Jose Ramirez, Medley, FL) after reviewing the company's website and Facebook page in June 2024. The agency found that marketing claims for six products — including ginger/honey/aloe syrups, AFA Blue Green Algae, Magnesium Complex, and Vitamin C capsules — characterized them as intended to cure, mitigate, treat, or prevent diseases such as flu, coughs, sore throats, and inflammation, rendering them unapproved new drugs under the FD&C Act. Two of the syrup products were also found misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Ozempen.com

FDA issued a warning letter to Ozempen.com on June 24, 2024, for selling unapproved and misbranded semaglutide drug products ('4mg Semaglutide Pen' and '8mg Semaglutide Pen') to U.S. consumers over the internet without valid FDA-approved drug applications under section 505 of the FD&C Act. The site marketed these products as containing the 'same active ingredient as Ozempic, Rybelsus and Wegovy' while bypassing prescription requirements and omitting required safety warnings, including the black box warning for thyroid C-cell tumor risk. FDA demanded cessation of sales and a written corrective action response within 15 working days, warning that failure to comply could result in seizure and injunction.

Optikem International Inc.

FDA issued a warning letter to Optikem International Inc., a contract manufacturer of sterile OTC and homeopathic ophthalmic drug products in Denver, CO, citing significant CGMP violations found during a January 2024 inspection. Violations included inadequate aseptic processing facility design, insufficient environmental and personnel monitoring, lack of process simulation (media fills), failure to validate manufacturing and water systems, inadequate laboratory controls, and data integrity deficiencies. FDA also noted that certain ophthalmic drug products manufactured by Optikem are considered unapproved new drugs, and warned that failure to remediate could result in seizure, injunction, and withholding of export certificates or new application approvals.

West Coast Laboratories, Inc.

FDA issued a warning letter to West Coast Laboratories, Inc. (Gardena, CA) following an October 2023 facility inspection, citing serious CGMP violations in the manufacture of Calcium Pyruvate, Chromium Picolinate, and CalComplex dietary supplements. Violations included failure to conduct identity testing on dietary ingredients, inadequate component specifications, releasing products before quality control approval, and deficient batch production records. The products were also found misbranded due to missing adverse event reporting contact information and non-compliant Supplement Facts label formatting. FDA warned that failure to adequately address these issues may result in seizure or injunction.

Aqualex Co., Ltd.

FDA issued a warning letter to Aqualex Co., Ltd., a South Korean OTC sunscreen drug manufacturer, citing multiple CGMP violations (process validation, water system design, quality unit failures, inadequate release and stability testing) and declaring their 'DBH Beverly Hills, EGF FGF DNA, UV Shield' product an unapproved new drug. The product's website marketing claims for EGF, FGF, and DNA ingredients as anti-aging and cell-repair actives rendered them unapproved active ingredients outside the OTC sunscreen monograph. The product was also found misbranded for contradictory labeling (claiming 'OCTINOXATE FREE' while listing octinoxate as an active ingredient), missing manufacturer identity, and use of non-established ingredient names. FDA placed the firm on Import Alert 66-40 and required a written response within 15 working days.

Monument, Inc., U.S. v.

The FTC took action against Monument, Inc., an online alcohol addiction treatment service, for allegedly disclosing users' sensitive personal health data — including information about their alcohol use and treatment — to third-party advertising platforms such as Meta and Google without consumer consent. This occurred despite Monument's promises to keep such information confidential. The case represents a critical enforcement action targeting unauthorized sharing of health data for advertising purposes.

Neobiosis, LLC

FDA issued a warning letter to Neobiosis, LLC (Gainesville, FL), a manufacturer of amniotic fluid and umbilical cord-derived products, following a January–February 2023 inspection. The agency found that Neobiosis's products (Purified Amniotic Fluid, Wharton's Jelly Cellular, and Wharton's Jelly Acellular) are unapproved drugs and biological products marketed for wound healing and orthopedic uses without approved Biologics License Applications or active INDs, in violation of the FD&C Act and PHS Act. The firm also had significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported expiration dating. FDA warned that failure to adequately address these violations may result in seizure and/or injunction.

Top Health Manufacturing, LLC

FDA issued a warning letter to Top Health Manufacturing, LLC (Spanish Fork, UT) following a October 2023 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations — including failures in quality control procedures, missing component and finished-product specifications, incomplete master manufacturing records, and deficient batch production records — causing products 'Grandma's Herbs Kidney' and a redacted product to be adulterated under 21 U.S.C. § 342(g)(1). Additionally, both products were found misbranded for labeling deficiencies including failure to identify plant parts for botanical ingredients, a false ingredient declaration (candelilla wax listed but not used), and non-compliant nutrition information formatting. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Cerebral, Inc. and Kyle Robertson, U.S. v.

Cerebral, Inc. and its CEO Kyle Robertson agreed to an FTC consent order resolving charges that the telehealth company failed to adequately secure and protect sensitive consumer health data. The order restricts how Cerebral may use or disclose sensitive consumer data and requires the company to provide consumers with a simple cancellation mechanism. The FTC's action targeted data security and privacy practices rather than specific marketing claims. This is a critical enforcement action given the consent order and mandatory operational restrictions imposed.

Nerium International, LLC

The FTC sued Nerium International (later Neora, LLC) and its CEO Jeffrey Olson, alleging the company operated as an illegal pyramid scheme and made deceptive health claims about its 'EHT' supplements, specifically that they could treat or prevent concussions, chronic traumatic encephalopathy (CTE), Alzheimer's disease, and Parkinson's disease. The FTC sought a permanent injunction to stop the deceptive practices. In September 2023, the district court ruled against the FTC on its claims, and in May 2024 the court further ruled that Neora could not recover its fees and expenses because the FTC's litigation position was 'substantially justified.'

Simple Health Plans LLC

The FTC filed a federal court complaint against Simple Health Plans LLC, Steven J. Dorfman, and related entities in October 2018, alleging that defendants deceived consumers into believing they were purchasing comprehensive health insurance covering preexisting conditions, prescription drugs, specialist care, hospital services, surgeries, and lab testing. An amended complaint was filed in November 2019 adding Candida Girouard as a defendant. The case centers on fraudulent misrepresentation of health plan coverage rather than specific therapeutic marketing claims. This is a critical enforcement action involving federal court litigation.

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA issued a warning letter to Biomic Sciences, LLC dba ION Intelligence of Nature (owner Dr. Zachary Bush) following a June–August 2023 inspection of their Charlottesville, VA facility. The agency found the ION Intelligence of Nature Sinus Support Nasal Spray to be adulterated due to gross microbial contamination (up to 1,100,000 CFU/mL), prompting a voluntary recall of all nasal spray lots. Additional violations included multiple drug CGMP failures, dietary supplement CGMP failures for Ion Gut Support, low-acid canned food registration and process-filing violations, and misbranding of dietary supplement labels. FDA warned that failure to adequately address these matters may result in seizure and injunction.

Akan Biosciences, Inc.

FDA issued a warning letter to Akan Biosciences, Inc. (Gaithersburg, MD) following a September 2022 inspection of their manufacture and distribution of Ayama™, an allogeneic adipose-derived stromal vascular fraction (SVF) cellular product. The product was found to be an unapproved biological drug lacking a valid biologics license application or IND, and failed to meet HCT/P minimal manipulation and homologous use criteria under 21 CFR 1271. FDA documented multiple serious violations including inadequate donor communicable disease screening and testing, distribution of quarantine-status product, and failure to validate manufacturing processes, affecting 585 vials from three donors. FDA warned that failure to adequately address these violations may result in seizure and/or injunction.

www.dashpct.com

FDA issued a warning letter to www.dashpct.com, a Malaysia-based website, for selling unapproved and misbranded semaglutide drug products — specifically 'Rybelsus 14mg' and 'Rybelsus 7mg' — to U.S. consumers over the internet without valid FDA-approved drug applications. The site falsely represented these products as FDA-approved while selling them without a prescription or licensed practitioner oversight, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act. FDA demanded the site cease sales of unapproved and misbranded drugs and respond within 15 working days. Failure to comply may result in seizure and injunction.

APG SEVEN, INC

FDA issued a warning letter to APG SEVEN, INC (Miami, FL) regarding 14 dietary supplement products sold under the Alpagi brand, including BioMoringa, BioDiabetin, HongoTrap, and BioCell. The products' labels and social media marketing made disease treatment, cure, and prevention claims — including claims to destroy cancer cells, eliminate fungal infections from the blood, increase insulin production, and treat fibromyalgia — rendering them unapproved new drugs under the FD&C Act. FDA also found five products (BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba, BioCell) to be misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days or face potential seizure and injunction.

Northern VA Compounders PLLC, dba Akina Pharmacy

FDA issued a warning letter to Northern VA Compounders PLLC dba Akina Pharmacy (Sterling, VA) following a November–December 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including use of non-pharmaceutical-grade sterilization materials, inadequate water quality controls, dirty aseptic processing equipment, and insufficient smoke studies for airflow validation. These deficiencies caused compounded drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The pharmacy had already initiated a voluntary recall of all sterile lots produced using materials labeled 'research use only,' but FDA found the firm's corrective action responses lacked adequate supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.

Stokes Healthcare Inc. dba Epicur Pharma

FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma, a 503B outsourcing facility in Mount Laurel, NJ, following a September–October 2023 inspection that revealed sterile drug products were produced under insanitary conditions and failed to meet CGMP requirements, rendering them adulterated under section 501(a)(2)(A) and (B) of the FDCA. Specific violations included inadequate sterilization testing, deficient media fills and smoke studies, insufficient sporicidal dwell times, and failure to investigate an adverse trend of Mucor circinelloides fungal contamination in ISO 8 cleanrooms while continuing to distribute affected drug products. The facility also failed to meet section 503B labeling conditions (missing inactive ingredient quantities and adverse event reporting information) and did not submit adverse event reports per 21 CFR 310.305, causing products to be misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Central Admixture Pharmacy Services, Inc.

FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Allentown), a 503B outsourcing facility, following a February–March 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug compounding operations. The agency cited failures to adequately investigate microbial contamination in ISO 5 aseptic processing areas and deficient laboratory controls, rendering drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). CAPS had already initiated a voluntary recall of all sterile drug products within expiry on April 28, 2023, due to lack of sterility assurance. FDA warned that failure to adequately address violations may result in seizure and injunction, and noted similar CGMP deficiencies at sister facilities CAPS Phoenix and CAPS San Diego.

SeeNext Venture, Ltd.

FDA issued a warning letter to SeeNext Venture, Ltd. (doing business as NumbSkin) for distributing three lidocaine numbing cream products — NumbSkin 5% Lidocaine Numbing Cream (15g and 30g) and NumbSkin 10.56% Lidocaine Numbing Cream — as unapproved new drugs and misbranded drugs. The products were marketed for use before cosmetic procedures such as tattooing, piercing, laser hair removal, and microblading, with lidocaine concentrations (5% and 10.56%) exceeding the 0.5%–4% range permitted under OTC Monograph M017, and with indications not covered by any applicable final administrative order. FDA cited serious safety concerns about increased systemic absorption when applied under plastic wrap to large or broken skin areas without professional supervision, and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Sky Bank Media, LLC dba Painless Tattoo Cream Co.

FDA issued a warning letter to Sky Bank Media, LLC dba Painless Tattoo Cream Co. for distributing PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY as unapproved new drugs and misbranded products. The products contain lidocaine at 5% concentration and combinations with prilocaine and epinephrine that exceed or fall outside OTC monograph M017 permissible conditions, and are marketed for cosmetic procedures (tattooing, piercing, laser treatments) not covered by any FDA final administrative order. FDA cited safety concerns about increased dermal absorption during cosmetic procedures and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Central Admixture Pharmacy Services, Inc.

FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Phoenix), a 503B outsourcing facility in Phoenix, AZ, following a June–July 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug production. Investigators observed visibly dirty production areas, inadequate microbial contamination responses, failures in quality control, batch release testing, stability programs, and unauthorized electronic record access. The facility had already voluntarily recalled products and ceased production, but FDA found corrective action responses inadequate and lacking supporting documentation. FDA warned that failure to address violations may result in seizure or injunction, and required a written response within 15 working days.

The Bountiful Company

The Bountiful Company, a marketer of vitamins and dietary supplements, was charged by the FTC for 'review hijacking' — abusing an Amazon.com feature to make newly introduced supplements appear to have more ratings, higher average scores, and prestigious badges like '#1 Best Seller' and 'Amazon's Choice' by misappropriating reviews from other products. This was the FTC's first law enforcement action challenging review hijacking as a deceptive practice. The company agreed to pay $600,000 in consumer redress to settle the complaint, with over $527,000 subsequently distributed to affected consumers in March 2024.

Carbon Fire, LLC

FDA issued a warning letter to Carbon Fire, LLC (Saint Louis, MO) regarding its dietary supplement product '213° Metabolism Boosting Complex,' which contains N-Methyltyramine, a new dietary ingredient (NDI) not marketed in the U.S. before October 15, 1994. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because no NDI notification was submitted to FDA as required under section 413(a)(2) and 21 CFR 190.6. The agency warned that failure to address the violations may result in seizure or injunction, and required a written response within fifteen working days.

Native Salts LLC

FDA issued a warning letter to Native Salts LLC (Chicago, IL) on February 28, 2024, concerning its 'N, Native Salts' smelling salts product marketed as an OTC stimulant. The agency found the product to be an unapproved new drug under FD&C Act section 505(a) because it contains ammonium as a reflex stimulant ingredient — a use FDA determined not to be generally recognized as safe and effective in a 2008 proposed rule — and does not conform to OTC Monograph M011, which permits only caffeine as an active stimulant ingredient. The product was also found to be misbranded under section 502(ee). FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Precision Patient Outcomes

The FTC filed a complaint in November 2022 against California-based Precision Patient Outcomes, Inc. and its CEO Margrett Priest Lewis for marketing an OTC dietary supplement — containing only vitamins, zinc, and a flavonoid — as an effective treatment to mitigate the effects of COVID-19. The FTC alleged the defendants engaged in deceptive practices by making unsupported disease-treatment claims for a product with no demonstrated efficacy against COVID-19. In February 2024, a settlement order was announced barring the defendants from the alleged deceptive practices.

LightEyez Limited

FDA issued a warning letter to LightEyez Limited (UK), the maker of MSM Eye Repair Drops and related ophthalmic products, after laboratory testing revealed gross microbial contamination (including Pseudomonas spp. and Mycobacterium spp.) in a batch of their eye drops. The products were also found to be unapproved new drugs under section 505(a) of the FD&C Act, with website claims asserting the drops could repair eyes, reduce glaucoma/cataracts, permanently change eye color by destroying melanin, and treat floaters and bloodshot eyes. FDA demanded a voluntary recall of all sterile products, full contamination investigations, and a written response within 15 working days, and warned that continued violations could result in refusal of admission of LightEyez products into the United States.

Amman Pharmaceutical Industries

FDA issued a warning letter to Amman Pharmaceutical Industries, a Jordanian contract manufacturer of sterile OTC and homeopathic drug products, following an August 2023 inspection that revealed serious CGMP violations including fundamental aseptic processing design flaws, inadequate environmental monitoring, pervasive data integrity breaches, and an ineffective quality control unit. The facility had shipped sterile drug products to the U.S. without completing required process simulations (media fills) or dynamic smoke studies, and laboratory records were found to be unreliable with over 50 microbial excursions contradicting the firm's claim of zero excursions over two years. FDA placed the firm on Import Alert 66-40, the firm committed to recalling all U.S.-bound drug products and suspending production, and FDA warned that failure to remediate could result in seizure, injunction, and continued refusal of admission of articles into the United States.

Synthetix Inc. DBA Helix Chemical Supply

FDA issued a warning letter to Synthetix Inc. DBA Helix Chemical Supply (Bronx, NY) in February 2024 after reviewing their website and finding unapproved Semaglutide and Tirzepatide products being sold for human use despite 'research use only' labeling. The products were deemed unapproved new drugs under FD&C Act sections 505(a) and 301(d), and misbranded under section 502(f)(1) for lacking adequate directions for use. FDA cited website claims referencing human dosing schedules, therapeutic effects, and explicit references to the branded drug Mounjaro as evidence of intended human use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

US Chem Labs

FDA issued a warning letter to US Chem Labs (Miami, FL) in February 2024 after reviewing their website and finding they were selling Semaglutide, Tirzepatide, and Thymalin as unapproved new drugs intended for human use, despite labeling them 'research chemicals only' and 'not for human consumption.' The products were found to violate the FD&C Act as unapproved new drugs and misbranded drugs lacking adequate directions for use. FDA expressed particular concern about marketing Thymalin for use in children. The letter demands a written response within 15 working days and warns that failure to comply may result in seizure or injunction.

Madhu Instruments Private Limited

FDA issued a warning letter to Madhu Instruments Private Limited (New Delhi, India) following a 2022 inspection that found sterile drug products manufactured under insanitary conditions, including peeling paint, blocked HEPA filters, broken tiles with residue, visibly dirty equipment, and improvised patching materials in ISO 7 manufacturing rooms. The firm's corrective response was deemed inadequate for failing to conduct a retrospective risk assessment or develop a sufficient cleaning and sanitization regimen. FDA had already placed the firm on Import Alert 66-40 as of May 31, 2023, subjecting its products to detention or refusal of admission into the United States. The letter requires a written response within 15 working days with documented corrective actions.

Les Importations Herbasanté Inc.

FDA issued a warning letter to Les Importations Herbasanté Inc., a Canadian contract manufacturer of homeopathic drug products (including pediatric formulations), following an August 2023 inspection that revealed significant CGMP violations. The firm failed to perform adequate identity testing of high-risk components such as glycerin (which carries risk of lethal diethylene glycol/ethylene glycol contamination), failed to validate its manufacturing processes, and had an inadequate quality control unit. As a result, FDA placed the firm on Import Alert 66-40, making its products subject to detention or refusal of admission into the United States, and required corrective action within 15 working days.

Inmar Supply Chain Solutions, LLC

FDA issued a warning letter to Inmar Supply Chain Solutions, LLC (Winston-Salem, NC) following a June–July 2023 inspection of its Arlington, TX warehouse that revealed a severe rodent infestation affecting human foods, dietary supplements, OTC drugs, and medical devices. Investigators documented live and dead rodents, rodent excreta pellets too numerous to count, gnawed food and drug packaging, and putrid spilled product throughout the facility, constituting adulteration under multiple provisions of the FD&C Act. The company had initiated a voluntary recall of affected products and taken some corrective actions, but FDA found the responses inadequate for devices and warned that failure to fully remediate could result in seizure or injunction.

QuVa Pharma, Inc.

FDA issued a warning letter to QuVa Pharma, Inc., a 503B outsourcing facility in Bloomsbury, NJ, following an August–October 2022 inspection that revealed serious sterility and CGMP deficiencies in the production of sterile drug products. Investigators observed mold recovery on operator glove finger plate samples in ISO 5 areas, improper aseptic technique by operators, and multiple CGMP violations including inadequate environmental monitoring, failure to investigate batch discrepancies, and inadequate computer system controls. The facility had already initiated a voluntary recall of oxytocin product due to incorrect formulation, and FDA warned that failure to adequately address violations may result in seizure and injunction.

Botanical Be

FDA issued a warning letter to Botanical Be (Edgar H. Felix, El Paso, TX) regarding three products — 'Kuka Flex Forte,' 'Reumo Flex,' and 'Artri King Reforzado con Ortiga y Omega 3' — sold via botanical-be.com. Laboratory analysis confirmed the products contained undeclared diclofenac, a prescription NSAID, making them unapproved new drugs and misbranded under the FD&C Act. The products were marketed with disease-treatment claims for arthritis, rheumatism, sciatica, and pain relief without FDA approval. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Curtis Jacquot dba Pacific BioLogic Co.

FDA issued a warning letter to Curtis Jacquot dba Pacific BioLogic Co. (Concord, CA) following a June 2023 inspection and July 2023 website review, finding that multiple dietary supplement products (ArteClear Circulation 2, Headache Release, Natura-Mune-2, Pain Release, and Attack 2) bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed numerous CGMP violations including failure to establish component/finished-product specifications, missing master manufacturing records and batch production records, inadequate complaint handling, and failure to collect reserve samples. FDA noted these are repeat violations from a 2014 warning letter and a 2015 regulatory meeting, and warned that failure to correct may result in seizure or injunction.

Amazon.com, Inc.

FDA issued a warning letter to Amazon.com, Inc. (CEO Andy Jassy) regarding its distribution via Fulfillment by Amazon of seven products — marketed as energy supplements or food — that laboratory analysis confirmed contained undeclared active pharmaceutical ingredients sildenafil or tadalafil (PDE-5 inhibitors). The products were deemed unapproved new drugs and misbranded under the FD&C Act because their labeling failed to disclose the presence of prescription drug ingredients that can cause dangerous interactions with nitrates. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Hua Da Trading, Inc.

FDA issued a warning letter to Hua Da Trading, Inc. (Brooklyn, NY) regarding its 'WeFun' product, which was marketed as a dietary supplement but found via laboratory analysis to contain undeclared sildenafil, a prescription PDE-5 inhibitor. The product was deemed an unapproved new drug and misbranded under the FD&C Act because its labeling lacked adequate directions for use, failed to disclose the active pharmaceutical ingredient, and bore false or misleading claims. FDA warned that failure to address violations could result in seizure and/or injunction, and required a written response within fifteen working days.

Colonial Dames Company, Ltd

FDA issued a warning letter to Colonial Dames Company, Ltd (Commerce, CA) following a April 2023 inspection that found significant CGMP violations and unapproved new drug marketing for its 'oxygenetix® Oxygenating Foundation Acne Control' and a redacted companion product. The products were marketed with drug claims—including acne treatment, anti-inflammatory, antimicrobial, and time-release salicylic acid efficacy claims—without FDA approval and in non-conformance with the OTC Topical Acne Monograph M006. The facility also had repeat CGMP deficiencies (unclean equipment, unvalidated processes, inadequate quality unit oversight) dating back to 2015 inspections, and failed to properly list the drug products with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.

Lone Star Botanicals Inc.

FDA issued a warning letter to Lone Star Botanicals Inc. (doing business as Dr. Botanical Health) in Tyler, TX, citing serious CGMP violations at their food manufacturing facility, unapproved new drug claims across 11 botanical supplement products, and extensive food misbranding violations. The company's website, product labels, and brochures made disease treatment and prevention claims — including curing colds/flu, reducing anxiety and depression, fighting cancer, stabilizing blood sugar, and lowering cholesterol — that caused the products to be classified as unapproved new drugs under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

K W Technology Inc., et al. (1 Invisible Mask), FTC v.

The FTC sued K W Technology Inc. and three related defendants for deceptively marketing the '1 Virus Buster Invisible Mask,' a product claimed to create a three-foot protective barrier against 99.9% of all viruses and bacteria, including COVID-19. The agency alleged these efficacy claims lacked any scientific substantiation. The lawsuit sought to halt the deceptive marketing practices.

Abbott Laboratories

FDA issued a warning letter to Abbott Laboratories (CEO Robert B. Ford) regarding its Similac® Probiotic Tri-Blend dietary supplement marketed for use in preterm infants. FDA found that marketing claims on Abbott's websites and sales handouts — stating the product reduces necrotizing enterocolitis (NEC), mortality, and sepsis — rendered the product an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The product was also found adulterated because it contains B. infantis (Bb-02), an unsafe food additive for preterm infant use, and S. thermophilus (TH-4®), a new dietary ingredient lacking adequate safety assurance for this population. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Natural Relief Inc.

FDA issued a warning letter to Natural Relief Inc. (owner Omar Ashraf, Coshocton, OH) following a March–April 2023 facility inspection and June 2023 website review, finding that two products — Edema NatRelief 6 and BP NatRelief 11 — were marketed with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to extensive CGMP violations including absent specifications, inadequate quality control procedures, and deficient manufacturing records. FDA warned that failure to adequately address these violations may result in seizure and injunction, and required a written response within 15 working days.

Sun Pharmaceutical Industries Ltd.

FDA issued an amended warning letter to Sun Pharmaceutical Industries Ltd. (Halol, India) following a May 2022 inspection that found significant CGMP violations including inadequate media fills, poor aseptic technique, contaminated and damaged filling equipment, and insufficient contamination investigations. The violations affected sterile injectable products including medroxyprogesterone acetate injectable suspension and testosterone cypionate injection, with multiple voluntary recalls initiated. FDA placed the firm on Import Alert 66-40 and warned that continued non-compliance could result in refusal of admission of articles into the United States.

www.gorillahealing.com

FDA issued a warning letter to www.gorillahealing.com for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these prescription GLP-1 drugs without FDA-approved applications, without adequate directions for use, and without required safety warnings such as the black box warning for thyroid C-cell tumor risk. FDA demanded the company cease sales of these products and respond within 15 working days, warning that failure to comply could result in seizure and injunction.

www.semaspace.com

FDA issued a warning letter to www.semaspace.com for selling unapproved and misbranded semaglutide drug products ('Semaglutide 2mg' and 'Semaglutide 5mg') directly to U.S. consumers over the internet without requiring a prescription. The site marketed these injectable products as weight-loss medicines for obesity and excessive hunger, despite no approved NDA being in effect for these specific products. FDA found violations of FD&C Act sections 301(a), 301(d), 301(k), 503(b), and 505(a), and demanded corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

Southern Tier Home Infusion, Inc. dba Pharmacy Innovations

Southern Tier Home Infusion, Inc. dba Pharmacy Innovations, a compounding pharmacy in Erie, PA, received an FDA Warning Letter following a November 2022 inspection that found sterile drug products produced under insanitary conditions, including rust, microbial contamination, inadequate HEPA filtration, and poor aseptic operator practices. The firm also compounded drug products — including Lidocaine/Tetracaine/Phenylephrine 20/4/2% Gel and Dutasteride 0.1% Injectable — without valid patient-specific prescriptions, disqualifying them from section 503A exemptions and rendering them unapproved new drugs and misbranded products. FDA acknowledged the firm's voluntary recall of all sterile compounded products and cessation of sterile compounding in the affected area, but found several corrective action responses insufficient. The letter warns that failure to adequately address violations may result in seizure or injunction.

Signature Biologics, LLC

FDA issued a warning letter to Signature Biologics, LLC (Irving, TX) regarding its Signature Cord™ product, derived from human umbilical cord tissue and distributed to healthcare professionals for allogeneic injection use. The agency found the product constitutes an unapproved biological drug requiring a valid Biologics License Application (BLA) or active IND, neither of which was in place, and that it fails the minimal manipulation and homologous use criteria under 21 CFR 1271.10(a). FDA also documented seven significant CGMP deviations including inadequate aseptic process validation, insufficient environmental monitoring, missing endotoxin testing, unvalidated manufacturing processes, and unsupported expiration dating. Failure to adequately respond may result in seizure and/or injunction.

Curexa – East, LLC dba Curexa

FDA issued a warning letter to Curexa – East, LLC dba Curexa (Egg Harbor Township, NJ) following an August–September 2022 inspection that found serious insanitary conditions in the compounding pharmacy's production area, including non-microbial contamination, inadequate cleaning of utensils and equipment used for hazardous drugs, and residue buildup in air-handling equipment directly above production areas. These conditions rendered the firm's compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the firm's corrective-action responses to the Form FDA 483 either insufficiently documented or outright deficient, and warned that failure to adequately address violations may result in seizure or injunction.

Walgreens Boots Alliance, Inc.

FDA issued a warning letter to Walgreens Boots Alliance, Inc. on September 11, 2023, regarding three homeopathic ophthalmic products — 'Walgreens Allergy Eye Drops,' 'Walgreens Stye Eye Drops,' and 'Walgreens Pink Eye Drops' — sold on walgreens.com. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses, and their contract manufacturer was found to have significant CGMP violations rendering the products adulterated. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure, injunction, or detention of products at the U.S. border.

TRP Company, Inc

FDA issued a warning letter to TRP Company, Inc. (Reno, NV), owned by Thomas Pominville, regarding twelve ophthalmic homeopathic drug products sold at thereliefproducts.com, including 'Dryness Relief,' 'Pink Eye Relief,' 'Allergy Eyes Relief,' and others. The products were deemed unapproved new drugs under FD&C Act section 505(a) because they are not generally recognized as safe and effective for their labeled uses and lack FDA-approved applications. FDA also cited adulteration violations stemming from CGMP failures at the contract manufacturer. The letter warns that failure to correct violations may result in seizure, injunction, and import detention.

Similasan AG

FDA issued a warning letter to Similasan AG, a Swiss homeopathic ophthalmic drug manufacturer, citing that twelve named eye-drop and gel products sold in the U.S. are unapproved new drugs lacking FDA approval under FD&C Act section 505(a). The letter also identifies serious CGMP violations including inadequate aseptic process validation, failure to conduct 100% visual inspection for particulates, incomplete laboratory records, and insufficient quality unit oversight. FDA placed all Similasan AG products on Import Alert 66-40, and the agency warned that continued violations may result in seizure, injunction, and detention of products without physical examination. The company was directed to respond within fifteen working days with corrective actions.

CVS Health

FDA issued a warning letter to CVS Health (President & CEO Karen S. Lynch) on September 11, 2023, regarding its 'CVS Health Pink Eye Relief Drops,' a homeopathic ophthalmic product sold on cvs.com. FDA determined the product is an unapproved new drug under FD&C Act section 505(a) because it is not generally recognized as safe and effective for its labeled uses, and also deemed adulterated due to CGMP violations at its contract manufacturer. FDA further flagged safety concerns about the use of silver sulfate as a preservative. CVS was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.

DR Vitamins, LLC dba DR Vitamin Solutions

FDA issued a warning letter to DR Vitamins, LLC dba DR Vitamin Solutions (North Richland Hills, TX) on September 11, 2023, citing four ophthalmic eye drop products — 'Vision Clarity Eye Drops,' 'Life Extension Brite Eyes III,' 'Can-C Eye Drops,' and 'Longevity Science Visual Ocuity' — as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(o). The products were marketed with claims to treat or prevent cataracts, glaucoma, floaters, and dry eyes using N-Acetyl-Carnosine (NAC), an ingredient not permitted under OTC Monograph M018 for ophthalmic demulcents. FDA found no adequate clinical evidence supporting GRASE status and noted the drug listing for 'Vision Clarity Eye Drops' had been inactive since January 2020. The company was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Natural Ophthalmics, Inc.

FDA issued a warning letter to Natural Ophthalmics, Inc. (Lafayette, CO) on September 11, 2023, after reviewing the company's website and finding six homeopathic ophthalmic products — including 'Cataract Eye Drops with Cineraria' and 'Women's Tear Stimulation Dry Eye Drops' — marketed with disease-treatment claims that render them unapproved new drugs under section 505(a) of the FD&C Act. The products are not generally recognized as safe and effective for their intended uses and lack any FDA-approved application. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Boiron, Inc.

FDA issued a warning letter to Boiron, Inc. on September 11, 2023, regarding their homeopathic 'Optique 1 Eye Drops' product sold via their website and social media channels. FDA determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it is marketed with drug claims (treating eye irritation, dryness, allergies, and eyestrain) without an approved application, and is not generally recognized as safe and effective for those uses. The agency flagged the product as especially concerning due to the ophthalmic route of administration, which bypasses natural bodily defenses. Boiron was directed to respond within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.

InnoMark, Inc.

FDA issued a warning letter to InnoMark, Inc. (Saint George, UT) following a March 2023 facility inspection, citing multiple serious violations of dietary supplement cGMP regulations (21 CFR Part 111) and misbranding under the Federal Food, Drug, and Cosmetic Act. The company's products were found to be adulterated due to failures in establishing product and component specifications, identity testing, supplier COA qualification, and incomplete master manufacturing and batch production records. Product labels were also found to be false or misleading, declaring ingredients not present in the products, omitting ingredients that were present, and failing to comply with Supplement Facts labeling requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Kimera Labs, Inc.

FDA issued a Warning Letter to Kimera Labs, Inc. (Miramar, FL) regarding its exosome products XoGlo®, XoGlo®Pro, and amniotic fluid product Amnio2X®, which were manufactured and distributed without an approved Biologics License Application (BLA) or valid IND, constituting unapproved biological drug products under the FD&C Act and PHS Act. The inspection uncovered at least 10 significant CGMP violations affecting over 37,000 vials, including failures in aseptic process validation, sterility testing, environmental monitoring, and laboratory controls. FDA noted that Kimera continued distributing products after a prior 2020 Untitled Letter put them on notice, and that serious adverse events had been reported in patients treated with exosome products. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

Osmosis, LLC

FDA issued a warning letter to Osmosis, LLC (CEO Dr. Benjamin T. Johnson, MD) in Evergreen, CO following a January 2023 facility inspection and June 2023 website review. The agency determined that three products — Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate — were being marketed as unapproved new drugs due to disease-treatment claims (e.g., treating eczema, psoriasis, rosacea, diabetes, and high cholesterol) on product labels and the company website. FDA also cited multiple dietary supplement CGMP violations and misbranding violations across several products, warning that failure to correct these issues may result in seizure or injunction.

Amazon.com, Inc

FDA issued a warning letter to Amazon.com, Inc. (CEO Andrew Jassy) regarding the distribution of four unapproved new drug products — 'Naturasil Molluscum Treatment Kit,' 'Conzerol 2 Step Treatment for Molluscum Contagiosum,' 'ZymaDerm for Molluscum,' and 'HealthyDerm Molluscum Contagiosum Treatment' — sold via Amazon's Fulfillment by Amazon service. These products were marketed with drug claims to treat molluscum contagiosum, a condition with no legally marketed OTC drug products, without FDA approval. FDA flagged particular public health concern because the products were marketed for use in children and could cause consumers to forgo proper medical diagnosis. Amazon was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure and/or injunction.

Walmart, Inc

FDA issued a warning letter to Walmart, Inc. (CEO Doug McMillon) regarding its distribution of the 'Naturasil Molluscum Treatment Kit' through Walmart Fulfillment Services on walmart.com. The product was flagged as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act because it bears claims to treat molluscum contagiosum, a condition with no legally marketed OTC drug products, and is not FDA-approved. FDA expressed particular public health concern because the product is marketed for use in children and may cause consumers to forgo proper medical diagnosis of potentially serious conditions. Walmart was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure and/or injunction.

Thrasio, LLC D/B/A ZymaDerm

FDA issued a warning letter to Thrasio, LLC d/b/a ZymaDerm on August 18, 2023, regarding their 'ZymaDerm for Molluscum' product marketed on naturopathix.com and Facebook. The agency determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it makes drug-intended-use claims for treating molluscum contagiosum, a condition with no legally marketed OTC drug products. FDA flagged multiple efficacy, cure, and clinical-proof claims across the company's website and social media, and noted particular public health concern because the product is marketed for use in children. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Nature’s Innovation, Inc.

FDA issued a warning letter to Nature's Innovation, Inc. (CEO William Carlson) on August 18, 2023, after reviewing the company's website and social media pages and finding that its 'Naturasil Molluscum Treatment Kit' and 'Naturasil Shingles' products were being marketed as treatments for molluscum contagiosum and shingles without FDA approval. The products were deemed unapproved new drugs under section 505(a) of the FD&C Act because the marketing claims established drug intent, and neither product is generally recognized as safe and effective for the claimed uses. FDA expressed particular public health concern because the molluscum product is marketed for children and the shingles product could cause patients to forgo necessary antiviral treatment. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

ALVA-AMCO Pharmacal Companies, LLC

FDA issued a warning letter to ALVA-AMCO Pharmacal Companies, LLC regarding their 'Nauzene Kids' homeopathic product, finding it to be an unapproved new drug under section 505(a) of the FD&C Act. The product's label and website made drug claims (nausea and upset stomach relief) without an FDA-approved application, and the product is not generally recognized as safe and effective for its intended uses. Additional concern was raised because the product is directed at young children and was manufactured by a facility with known CGMP violations. FDA demanded written corrective action within fifteen working days, warning that failure to comply may result in seizure or injunction.

CalmCo LLC previously named Ketomi LLC

FDA issued a warning letter to CalmCo LLC (formerly Ketomi LLC) in August 2023 regarding its 'Colic Calm' and 'Colic Calm +' homeopathic products marketed for infant colic, gas, and reflux relief. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses and lack an approved NDA. The products are of heightened public health concern because they are directed at infants and were manufactured by a third party (Denison Pharmaceuticals) cited for significant CGMP violations. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Biorica International Corp.

FDA issued a warning letter to Biorica International Corp. (Hollywood, FL) regarding its Plaquex® Oral Dietary Supplement, finding that marketing claims on multiple websites and Facebook pages established the product was intended to treat, prevent, or mitigate diseases including cardiovascular disease, high cholesterol, liver and kidney disease, psoriasis, and potentially cancer. Because the product is not generally recognized as safe and effective for these uses, FDA determined it constitutes an unapproved new drug under section 201(p) of the Act and is also misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.

FDA issued a warning letter to Moor Herbs, Inc. (Detroit, MI) following a facility inspection and website review, finding that 19 herbal products were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. Products such as 'Full Body Antibiotic,' 'Tumor Release,' 'Un-Vax,' and 'Venereal Defense' bore explicit cure, treatment, and prevention claims for serious conditions including cancer, HIV, herpes, and sexually transmitted infections. The facility also violated dietary supplement CGMP regulations across eight categories (specifications, quality control, recordkeeping, cleaning, etc.) and multiple products were misbranded due to labeling deficiencies. FDA warned that failure to correct violations may result in seizure or injunction.

US Specialty Formulations, LLC

FDA issued a warning letter to US Specialty Formulations, LLC, a 503B outsourcing facility in Allentown, PA, following a March–April 2022 inspection that revealed serious sterility assurance failures, CGMP violations, and labeling deficiencies. The facility's compounded sterile drug products were found to be adulterated due to insanitary conditions (e.g., use of non-sterile wipes in ISO 5 areas, inadequate aseptic technique, insufficient environmental monitoring) and multiple CGMP regulatory violations. Because the products failed to meet 503B conditions, they are also deemed unapproved new drugs and misbranded, and FDA warned that failure to remediate could result in seizure or injunction.

Denison Pharmaceuticals, LLC

FDA issued a warning letter to Denison Pharmaceuticals, LLC (Lincoln, RI) following a January–February 2023 inspection that found significant CGMP violations including inadequate contamination investigations, failure to test for DEG/EG in high-risk components, and use of unvalidated microbiological test methods. Additionally, FDA determined that three homeopathic products — 'Colic Calm,' 'Colic Calm +,' and 'Nauzene Kids' — are unapproved new drugs based on disease-treatment claims on their labels and associated websites. The company issued a voluntary nationwide recall of four products in May 2023, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.

Gadget Island, Inc.

FDA issued a warning letter to Gadget Island, Inc. (President/CEO Naeem Azizian) regarding three male sexual enhancement products — 'NUX Male Enhancement,' 'DYNAMITE Male Sexual Enhancement,' and 'ProPower Knight Plus 2550mg' — sold on www.gearisle.com. Laboratory analysis confirmed each product contained undeclared pharmaceutical ingredients tadalafil and sildenafil (active ingredients in FDA-approved prescription drugs Cialis and Viagra), rendering them unapproved new drugs and misbranded under the FD&C Act. The products were marketed as dietary supplements but cannot qualify as such under federal law because tadalafil and sildenafil were approved as drugs before being marketed as supplements. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Rejuvica, LLC., FTC v.

The FTC took action against Rejuvica, LLC, the maker of Sobrenix, for deceptively marketing the product as able to reduce and even eliminate alcohol cravings and consumption. The FTC alleged violations of the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act (OARFPA). Defendants agreed to a court order permanently banning them from making unsubstantiated claims about health care products or services and were required to pay $650,000 in consumer refunds. In November 2024, the FTC distributed $536,000 in refunds to affected consumers.

Eden’s Answers, Inc.

FDA issued a warning letter to Eden's Answers, Inc. (Tampa, FL) following an August–November 2022 inspection of their Ohio manufacturing facility. The agency found serious CGMP violations related to inadequate identity and finished-product specifications, incomplete batch production records, and deficient master manufacturing records for dietary supplements including Dental Health, Honey Herbal Syrup, and Lil' Ones Sleepy Time. Additionally, the Honey Herbal Syrup and Sleepy Time product labels were found misbranded for failing to declare serving sizes, servings per container, and quantitative amounts per serving for each intended group. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Easy Healthcare Corporation, U.S. v.

The FTC reached a settlement with Easy Healthcare Corporation, developer of the fertility tracking app Premom, over allegations that it deceived users by sharing sensitive personal health information with unauthorized third parties, including two China-based firms, AppsFlyer, and Google. The company was also alleged to have violated the Health Breach Notification Rule (HBNR) by failing to notify consumers of these unauthorized disclosures. The case resulted in a settlement, representing a critical enforcement action involving deceptive data-sharing practices and health privacy violations.

Row1 Inc. dba Regenative Labs

FDA issued a warning letter to Row1 Inc. dba Regenative Labs (Pensacola, FL) regarding its umbilical cord-derived cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro), finding they constitute unapproved biological drugs requiring a Biologics License Application (BLA) or active IND, neither of which the company holds. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), meaning they cannot be regulated solely as HCT/Ps under section 361 of the PHS Act. FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, improper personnel practices, and unsupported five-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Healthtex Distributors, Inc.

FDA issued a warning letter to Healthtex Distributors, Inc. (Miami, FL) following a January–February 2023 inspection of their dietary supplement warehouse. The agency found serious CGMP violations — including no written quality control procedures, no identified QC personnel, and inadequate holding/distribution procedures — rendering their Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products adulterated. Additionally, both products were found misbranded due to incomplete ingredient declarations, missing bilingual label requirements, improper nutrition facts formatting, absent adverse event reporting contact information, missing dietary supplement identity statements, and structure/function claims lacking the required FDA disclaimer. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Warrior Labz SARMS

FDA issued a warning letter to Warrior Labz SARMS (Jeremy Brown, Simi Valley/Agoura Hills, CA) in June 2023 after reviewing the company's website and Instagram, finding that products including SARMs (RAD-140, MK-677, MK-2866, LGD-4033), peptides (BPC-157, TB-500), prohormones (19-Nor Andro, 4-Andro), and unapproved sildenafil/tadalafil formulations were being marketed with drug claims for human use despite 'research only' disclaimers. FDA determined these products are unapproved new drugs sold in violation of FD&C Act sections 505(a) and 301(d). The agency cited safety concerns including liver toxicity, increased heart attack and stroke risk, and dangers of injectable/intranasal administration. Warrior Labz was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure and injunction.

Pharmacy Plus, Inc., dba Vital Care Compounder

FDA issued a warning letter to Pharmacy Plus, Inc., dba Vital Care Compounder (Hattiesburg, MS) following an October 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including microbial contamination in ISO 5 aseptic processing areas, use of non-sterile materials, inadequate media fills, and insufficient smoke studies. The firm had already initiated a voluntary recall of sterile drug products within expiry on October 7, 2022, but FDA found the corrective action responses incomplete and lacking supporting documentation. FDA cited violations of FDCA section 501(a)(2)(A) (adulterated drugs under insanitary conditions) and warned that failure to adequately address violations may result in seizure or injunction. The firm was required to respond within 15 working days with specific corrective steps and supporting documentation.

Stratus Biosystems, LLC dba CellGenuity Regenerative Science

FDA issued a warning letter to Stratus Biosystems, LLC dba CellGenuity Regenerative Science for manufacturing and distributing unapproved biological products — AmnioAMP-WJ™ (umbilical cord/amniotic membrane-derived) and AmnioAllograft (amniotic fluid-derived) — without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application in effect. The products were marketed for broad non-homologous uses including orthopedics, neurology, cardiac, and oncology applications, disqualifying them from the 21 CFR 1271 section 361 exemption. FDA also documented extensive CGMP violations including unvalidated aseptic processes, inadequate environmental monitoring, sterility and endotoxin failures without investigation, and expiration dates assigned without stability testing. The letter demands a written response within 15 working days and warns that failure to comply may result in seizure and/or injunction.

Hekma Center, LLC

FDA issued a warning letter to Hekma Center, LLC (Wilmington, DE) in June 2023 after reviewing the company's website and social media pages, finding that its dietary supplement products — including packages marketed for anemia, cardiomyopathy, diabetes, hypertension, stroke, multiple sclerosis, and depression — bore disease-treatment claims that legally classified them as unapproved new drugs under the FD&C Act. The products were also found to be misbranded because adequate directions for use by a layperson could not be written for conditions requiring licensed practitioner supervision. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

A&Z Pharmaceutical, Inc.

FDA issued a warning letter to A&Z Pharmaceutical, Inc. (Hauppauge, NY) regarding its Chewable Calcium 600MG with Vitamin D for Kids product, finding that disease-treatment claims on the company's website and Facebook pages rendered the dietary supplement an unapproved new drug under the FD&C Act. Flagged claims included assertions that the product could prevent osteoporosis, treat hypocalcemia, lower blood pressure, reduce depression, and cut the risk of COVID-19. FDA also found the product misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days and warned that failure to act could result in seizure or injunction.

RenatiLabs Inc.

FDA issued a warning letter to RenatiLabs Inc. (Erlanger, KY) following an August 2022 inspection of their manufacture and distribution of WJMAX™, a Wharton's jelly/umbilical cord-derived product intended for allogeneic intra-articular injection and wound treatment. FDA determined WJMAX™ is an unapproved biological drug product lacking a valid biologics license application (BLA) or investigational new drug (IND) application, and that it fails the homologous use and minimal manipulation criteria under 21 CFR 1271.10(a). The agency also documented serious CGMP violations including release of a lot that failed sterility testing due to Staphylococcus epidermidis contamination, lack of aseptic process validation, and unsupported four-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

ImprimisRx NJ

FDA issued a warning letter to ImprimisRx NJ (President John Saharek) following a July–August 2022 inspection that revealed serious insanitary conditions in sterile drug compounding operations and repeated release of subpotent Timolol-Latanoprost ophthalmic drops. The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(c) due to insanitary cleanroom conditions and label-strength discrepancies, and misbranded under section 502(a) for false labeling. This was a repeat issue, as subpotency of the same product was also identified during a 2019 inspection. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Carolina Infusion

FDA issued a warning letter to Carolina Infusion (Ridgeland, SC), a compounding pharmacy owned by Melissa Etheridge, following a July–August 2022 inspection that found drug products produced without valid patient-specific prescriptions, insanitary sterile compounding conditions (including inadequate endotoxin testing, improper cleanroom pressure differentials, and uncertified ISO-5 hoods), and use of non-pharmaceutical-grade components. The firm's compounded products — including Tri-Mix 30/2/20 Injectable and topical anesthetics — were deemed adulterated, misbranded, and unapproved new drugs under the FDCA. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply could result in seizure or injunction.

Champaklal Maganlal Homeo Pharmacy Private Limited

FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) and its U.S. distributor Pharmadel, LLC/CAD Import, Inc. for manufacturing and distributing 'Bebelyn Diarrhea' and 'Bebelyn Colic' — homeopathic drug products marketed for infants and young children — without FDA approval. The products were found to be unapproved new drugs under section 505(a) of the FD&C Act, and the manufacturer had previously been cited for CGMP violations including failure to adequately test glycerin for diethylene glycol contamination, a known lethal hazard. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA issued a warning letter to New England Life Care, Inc. dba Advanced Compounding Solutions, a 503B outsourcing facility in Woburn, MA, following a March–April 2022 inspection that revealed serious CGMP violations and insanitary conditions in sterile drug production. The facility's compounded drug products — including Diltiazem HCl, Norepinephrine Bitartrate, Vancomycin HCl, and Phenylephrine HCl preparations — were found to be adulterated due to insanitary conditions (pest intrusion, blocked air returns, improper aseptic technique) and CGMP failures (inadequate investigations, complaint handling, sterilization validation, and cleaning procedures). Products also failed to meet 503B labeling conditions (missing dosage form on labels), rendering them ineligible for exemptions from FDA approval and adequate-directions-for-use requirements. FDA warned that failure to adequately address violations may result in seizure and injunction.

Cosmax NBT USA

FDA issued a warning letter to Cosmax NBT USA, a dietary supplement manufacturer in Garland, TX, following a 2021 facility inspection that revealed serious CGMP violations and labeling deficiencies. The company failed to establish adequate product and component specifications, verify component identity before use, and properly document pesticide testing, causing products to be adulterated under 21 CFR Part 111. Multiple finished products were also found misbranded due to non-compliant Supplement Facts labeling, including improper Daily Value declarations, missing ingredient common names, and erroneous calorie statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Pharmedica USA, LLC

FDA issued a warning letter to Pharmedica USA, LLC (Phoenix, AZ) following a November 2022 inspection that found the company manufactured preservative-free, multi-dose ophthalmic eye drops and nasal spray products under insanitary conditions without ISO-classified sterile manufacturing areas, no sterility testing, no process validation, and no adequate quality unit. The violations rendered the drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act. The company voluntarily ceased all drug manufacturing and distribution, and on March 3, 2023 issued a worldwide recall of Purely Soothing 15% MSM Drops due to non-sterility. FDA warned that failure to address violations could result in seizure, injunction, and withholding of export certificates or new application approvals.

Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club

FDA issued a warning letter to Tager Online, Inc. DBA Volt Candy regarding its 'PrimeZEN Black 6000' product, which was marketed as a dietary supplement but found through laboratory analysis to contain undeclared pharmaceutical ingredients tadalafil and sildenafil — the active ingredients in FDA-approved prescription drugs Cialis and Viagra. The product was deemed an unapproved new drug and misbranded drug under the FD&C Act due to its drug-intent marketing claims, failure to declare PDE-5 inhibitor ingredients, and lack of adequate directions for use or safety warnings. The company had already voluntarily recalled the product in February 2023, but FDA warned that failure to adequately address violations could result in seizure and/or injunction.

EarthLab, Inc., dba Wise Woman Herbals

FDA issued an amended warning letter to EarthLab, Inc. dba Wise Woman Herbals (Park City, UT) following a 2022 facility inspection and review of its website and Facebook page. The agency found that eight herbal supplement products — including Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Elderberry Plus Syrup, and others — were marketed with disease-treatment and prevention claims (stroke, cancer, influenza, joint pain, respiratory infections) that rendered them unapproved new drugs under the FD&C Act. FDA also cited serious CGMP violations, including failure to establish adequate specifications, use of components that failed microbial and heavy-metal (lead) limits, and failure to follow written laboratory procedures. The letter warns that failure to correct these violations may result in seizure or injunction.

Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.

FDA issued a warning letter to Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. (CEO Arthur Mikaelian) in April 2023 after reviewing their websites and finding that five 'Escozine' products — marketed as homeopathic remedies containing polarized blue scorpion venom — were being sold with claims to treat, cure, or mitigate serious conditions including cancer, HIV, and COVID-19. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, as no approved application is in effect for any of them. The agency warned that failure to correct violations could result in seizure and injunction, and required a written response within fifteen working days.

Champaklal Maganlal Homeo Pharmacy Private Limited

FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) for significant CGMP violations identified through a 704(a)(4) records request. The firm failed to conduct adequate identity testing on glycerin — a high-risk component used in OTC and homeopathic drug products — specifically to detect potentially lethal diethylene glycol (DEG) and ethylene glycol (EG) impurities. FDA placed all drugs manufactured by the firm on Import Alert 66-40 as of March 3, 2023, meaning products may be detained or refused admission at the U.S. border. The firm was directed to conduct risk assessments, test retain samples, and engage a CGMP consultant before resuming U.S. market manufacturing.

STPCA Inc. dba Sun Ten Laboratories

FDA issued a warning letter to STPCA Inc. dba Sun Ten Laboratories (Irvine, CA) following a facility inspection and website review, finding that eight products (Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2) were marketed with disease-treatment claims that rendered them unapproved new drugs under the Act. The agency also cited serious CGMP violations for dietary supplement products (Lycium Formula Huan Shao Dan, and two redacted products), including failures in identity specifications, quality control disposition decisions, and master manufacturing records. Additionally, multiple products were found misbranded due to labeling deficiencies including foreign-language label requirements, missing plant-part identification, and non-compliant Supplement Facts panels. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

SCS Direct, Inc.

FDA issued a warning letter to SCS Direct, Inc. (CEO Howard Greenspan) regarding its dietary supplement products Uplift Max and Shred Her Max, finding both adulterated under the FD&C Act because they contain hordenine HCl, which is not a recognized dietary ingredient and is not GRAS-approved as a food additive. FDA also flagged a misrepresentation on the company's website falsely implying affiliation with Optimum Nutrition, Inc. The agency demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

Chemical Services Group, Inc./Royal Chemical Company

FDA issued a warning letter to Chemical Services Group, Inc./Royal Chemical Company (Macedonia, OH / East Stroudsburg, PA) following a November 2022 inspection of their drug manufacturing facility. The agency found significant CGMP violations including manufacturing OTC hand sanitizer drug products on equipment shared with industrial chemicals, failure to validate ethanol supplier test analyses, inadequate batch release testing (missing methanol and benzene impurity checks), and a quality control unit that failed to exercise proper oversight. FDA warned that failure to correct these violations could result in seizure, injunction, or withholding of export certificates and new drug application approvals.

ByPro Nutrition LLC

FDA issued a warning letter to ByPro Nutrition LLC (owner Dr. Robert L. Bynum) regarding their product Dodecin, a nutraceutical supplement marketed for pain and inflammation relief. The agency determined that claims on the product label, website, YouTube video, and customer testimonials established Dodecin as an unapproved new drug intended to cure, mitigate, treat, or prevent diseases such as osteoarthritis, rheumatoid arthritis, fibromyalgia, neuropathy, and lupus. Because Dodecin lacks FDA approval and fails to bear adequate directions for use, it is both an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA warned that failure to address the violations may result in seizure or injunction.

Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy

FDA issued a warning letter to Belmar Pharma Solutions / Drug Depot, LLC dba APS Pharmacy (Palm Harbor, FL) following a June 2022 inspection, finding that the compounding pharmacy produced drug products using bulk drug substances ineligible under section 503A of the FDCA — specifically substances lacking USP/NF monographs, not components of FDA-approved drugs, and not on the 503A bulks list — and sourced from unregistered establishments. As a result, the compounded products were deemed unapproved new drugs and misbranded under sections 505 and 502(f)(1) of the FDCA. FDA warned that continued non-compliant compounding could result in seizure and injunction, and required a written corrective-action response within 15 working days.

Brand Packaging Group, Inc.

FDA issued a warning letter to Brand Packaging Group, Inc. (Farmingdale, NY) following a March–April 2022 inspection that revealed significant CGMP violations in their dietary supplement manufacturing operations. The company failed to properly verify finished batch specifications, test incoming dietary ingredients for identity, reject components that failed established specifications, maintain valid laboratory controls for reference standards, and follow calibration procedures for testing instruments. FDA found these violations caused their dietary supplement products to be adulterated under 21 U.S.C. § 342(g)(1), and warned that failure to correct the issues could result in seizure or injunction.

Dalal A. Akoury d/b/a AWAREmed, et al., U.S. v.

In March 2023, the FTC sued Dr. Dalal A. Akoury and her AWAREmed Health & Wellness Resource Center under the Opioid Addiction Recovery Fraud Prevention Act for making false or unsupported claims about addiction treatment, cancer treatment, and other serious conditions. The proposed consent order bars Dr. Akoury and AWAREmed from making such unsupported claims going forward. Dr. Akoury is also required to pay a $100,000 civil penalty to settle the Commission's complaint.

Spartan Enterprises Inc. dba Watershed Wellness Center

FDA issued a warning letter to Spartan Enterprises Inc. dba Watershed Wellness Center (Lansing, MI), a dietary supplement manufacturer, after inspecting its facility and reviewing its websites and YouTube channel. The company's products — including Dr. Bob's Naturals Yew VeggieCaps, Parasite Killer, Magtein, Ginkgo Magic, and others — bore claims that cancer treatment, Alzheimer's, kidney stone removal, parasite killing, and blood sugar regulation, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. The facility also had serious CGMP violations including missing specifications, inadequate batch records, and unsanitary conditions. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and injunction.

Herbal Vitality, Inc.

FDA issued a warning letter to Herbal Vitality, Inc. (Sedona, AZ) after a July 2022 facility inspection revealed that 21 herbal supplement products — including formulas named for Lyme disease, Hepatitis C, COPD, PCOS, asthma, and kidney stones — were being marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The products were also found misbranded due to inadequate labeling, missing allergen declarations, and improper supplement facts formatting. Additionally, the company had significant CGMP violations including absent component specifications, no finished-product specifications, and failure to collect reserve samples. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

doTERRA - Wong

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors — all healthcare practitioners — for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, with defendants leveraging their medical credentials to lend credibility to the product recommendations. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act. This case represents a critical enforcement action targeting unsubstantiated disease-cure claims tied to MLM health product marketing.

doTERRA - Busch

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors — all healthcare practitioners — for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, where the defendants leveraged their medical credentials to promote the products. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act.

doTERRA - Bacot

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors who were also healthcare practitioners for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, with the defendants leveraging their medical credentials to lend credibility to the product recommendations. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act. This enforcement action represents a critical regulatory outcome targeting unsubstantiated disease-cure claims tied to a multi-level marketing health product line.

GoodRx Holdings, Inc.

The FTC took its first-ever enforcement action under the Health Breach Notification Rule against GoodRx Holdings, Inc., a telehealth and prescription drug discount provider. GoodRx failed to notify consumers, the FTC, and media of its unauthorized disclosures of consumers' personal health information to third parties including Facebook and Google. This action marks a landmark use of the Health Breach Notification Rule in the telehealth space. The enforcement resulted in a consent order requiring GoodRx to remediate its data-sharing practices and pay civil penalties.

American Chinese Natural Herbs, Inc.

FDA issued a warning letter to American Chinese Natural Herbs, Inc. (Garland, TX) following a February–March 2022 inspection, citing serious CGMP violations and widespread misbranding across approximately 13 dietary supplement products including Almond Plus, Stomach Miracle, King Kong, LIV-97, and others. CGMP violations included failure to establish component and finished-product specifications, inadequate master manufacturing records and batch production records, and absent quality control procedures. Misbranding violations included false or misleading quantity statements, missing allergen declarations (oyster), absent or improperly linked structure/function claim disclaimers, and failure to declare standardized common names and plant parts for botanical ingredients. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply could result in seizure or injunction.

ZyCal Bioceuticals Healthcare Company, Inc.

The FTC filed a federal complaint against ZyCal Bioceuticals Healthcare Company, Inc. and related party Excellent Marketing Results, Inc. (EMR) for making unsubstantiated health claims about Cyplexinol-based products marketed for joint pain, arthritis, bone tissue, and cartilage growth. EMR claimed its StimTein product was 'clinically proven' to stimulate bone and cartilage cell growth without adequate scientific support. EMR and its president settled, were barred from making unsupported health claims, and over $110,000 was returned to consumers; in February 2023, a proposed order was announced barring ZyCal defendants from the deceptive conduct alleged in the complaint.

Organic Heirloom Plants

FDA issued a warning letter to Organic Heirloom Plants (Wendy Wiegert, Hancock, MI) in January 2023 after reviewing the company's website and Facebook page, finding that six products — Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature's Ancer, Zeolite, and Chaga Mushroom — were marketed with disease-treatment and cure claims (including for mpox, cancer, HIV, diabetes, and COVID-19) that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The products lacked FDA approval and bore no adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Old Tiles Wallpaper, LLC DBA Old Tiles Decor

FDA issued a warning letter to Old Tiles Wallpaper, LLC DBA Old Tiles Decor (Payson, UT) for selling three products — 'Wind River Skin Comfort Blend,' 'Wind River Cayenne Tincture,' and 'Wind River Elderberry Tincture' — as unapproved new drugs in violation of the FD&C Act, with particular concern over mpox-related claims and marketing to children and infants. The products were found to make drug-intended-use claims (treating monkeypox sores, heart conditions, cold and flu) without FDA approval or authorization. Two of the products were also found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Adept Life Science, LLC

FDA issued a warning letter to Adept Life Science, LLC (Chandler, AZ) following an April 2022 facility inspection that uncovered serious CGMP violations and misbranding of dietary supplement products. The CGMP violations included failures to establish identity and purity specifications for raw materials, inadequate quality control release procedures, and incomplete master manufacturing records. The misbranding violations involved non-compliant Supplement Facts labeling — including incorrect serving sizes, missing consumer group declarations, wrong units of measurement, and failure to declare common ingredient names. FDA warned that failure to correct these violations could result in seizure or injunction.

Zing Brothers LLC

FDA issued a warning letter to Zing Brothers LLC (Salt Lake City, UT) following an August 2022 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish component and product specifications, lack of written quality control procedures, missing master manufacturing records, and incomplete batch production records. Additionally, two products were found misbranded because their labels falsely claimed ingredients not present in formulations, failed to declare actual ingredients, omitted artificial coloring disclosures, presented nutrition information incorrectly, and lacked a domestic contact address for adverse event reporting. FDA warned that failure to correct these violations may result in seizure or injunction.

Atlantic Management Resources LTD dba. Claire Ellen Products

FDA issued a warning letter to Atlantic Management Resources LTD dba Claire Ellen Products (Westborough, MA) following a July–August 2022 inspection that found significant CGMP violations in the manufacture of homeopathic drug products, including failure to establish a quality unit, inadequate storage conditions, and absence of batch production records. The firm also distributed 'Neuroquell Plus Cream' without proper FDA drug listing, rendering it misbranded. The company voluntarily ceased production and distribution and issued a nationwide recall in November 2022. FDA warned that failure to address violations could result in seizure, injunction, or withholding of approvals, and required a written response within 15 working days.

Buzzagogo, LLC

FDA issued a warning letter to Buzzagogo, LLC regarding their 'Allergy Bee Gone for Kids' nasal swab product, finding it to be an unapproved new drug under section 505 of the FD&C Act based on disease-treatment claims on its labeling and website. FDA laboratory analysis also found the product adulterated with objectionable microbial contamination including Bacillus cereus, posing serious risk to children as young as one year old. The company had already conducted a voluntary recall of lot 2006491 in June 2022. FDA demanded a written response within 15 working days detailing corrective actions, and warned that failure to comply could result in seizure and injunction.

HIS Enterprise Inc dba Adam’s Secret USA, LLC

FDA issued a warning letter to HIS Enterprise Inc dba Adam's Secret USA, LLC for marketing multiple 'Adam's Secret' sexual enhancement products and 'Dr. Reade Slim Sense' as dietary supplements while laboratory analysis confirmed they contained undeclared pharmaceutical ingredients — tadalafil, sildenafil, and lorcaserin. These products were deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and misbranded under section 502 for failing to declare active drug ingredients and lacking adequate directions for use. The undeclared PDE-5 inhibitors pose serious risks of dangerous drug interactions, particularly with nitrates, and lorcaserin (a withdrawn drug) carries cancer and psychiatric risks. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Distributor RFR, LLC

FDA issued a warning letter to Distributor RFR, LLC (owner Roger L. Flores, Doral, FL) regarding its product 'SANGTER Natural Male Energy Supplement,' which was found through laboratory analysis to contain undeclared sildenafil — the active ingredient in FDA-approved prescription drug Viagra. The product was marketed as a dietary supplement with drug-intent claims related to erectile dysfunction and sexual performance, making it an unapproved new drug and misbranded drug under the FD&C Act. FDA required a written response within 15 working days detailing corrective steps, and warned that failure to comply could result in seizure or injunction; the company had already initiated a voluntary nationwide recall in August 2022.

Green Pharmaceuticals Inc.

FDA issued a warning letter to Green Pharmaceuticals Inc. (Camarillo, CA) regarding its OTC homeopathic nasal spray product SnoreStop NasoSpray, which was found to be adulterated with gross microbial contamination (Providencia rettgeri, with counts up to 6,200 CFU/mL) and manufactured without adequate CGMP controls. The product was also found to be an unapproved new drug under section 505 of the FD&C Act, as its labeling made drug-use claims without an FDA-approved application. A voluntary recall of the contaminated lot was conducted in June 2022, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.

Quality Supplement Manufacturing, Inc.

FDA issued a warning letter to Quality Supplement Manufacturing, Inc. (Oklahoma City, OK) following a June 2022 facility inspection that revealed serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111, resulting in dietary supplement products being deemed adulterated. Violations included failures to establish finished product specifications, prepare and follow master manufacturing records, verify batch specifications for identity/purity/strength/composition, and document quality control approvals. Additionally, multiple products were found misbranded due to non-compliant supplement facts labeling, undeclared allergens, missing ingredient common names, and absence of a domestic adverse event reporting contact. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Optum Infusion Services 308 LLC

FDA issued a warning letter to Optum Infusion Services 308 LLC (Chandler, AZ) following a March 2022 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin in the production area, microbial contamination in the ISO 5 aseptic processing zone, and improper aseptic technique by operators. These conditions rendered the facility's sterile drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the facility's corrective action responses inadequate due to missing supporting documentation and directed the firm to respond within 15 working days, warning that failure to comply could result in seizure or injunction.

Aspire Pharmaceuticals, Inc.

FDA issued a warning letter to Aspire Pharmaceuticals, Inc. (Somerset, NJ) following a joint inspection of their dietary supplement and drug manufacturing facility in late 2021 and early 2022. The agency found significant cGMP violations including use of scientifically invalid testing methods, failure to conduct material reviews for out-of-specification results, data integrity breaches (including an analyst who falsified sample weights to pass release specifications), and inadequate OOS investigation practices for both dietary supplement and drug products. The letter also cited misbranding of a dietary supplement due to an incorrect serving size declaration. FDA warned that failure to adequately address these violations may result in seizure and injunction.

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

FDA issued a warning letter to North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding (Richardson, TX) following a March 2022 inspection that identified serious insanitary conditions in sterile drug compounding operations. Violations included inadequate sterilization equipment, insufficient disinfection procedures, improper handling of hazardous drugs, failed smoke studies, and inadequate media fills — all causing drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already initiated a voluntary recall of sterile drug products in April 2022. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Evimeria El Aztecano, Inc.

FDA issued a warning letter to Evimeria El Aztecano, Inc. (owner Michael A. Vizcarrondo, Gardena, CA) regarding their 'Yerbas Finas Leche de Alpiste con Guanabana y Omega-3' dietary supplement following a November 2021 facility inspection. The product was found to be misbranded on multiple grounds, including false or misleading nutrient content claims (declaring protein levels far below what 'high in protein' and 'as much protein as meat' claims require), inaccurate mineral content declarations, numerous Supplement Facts label formatting violations, missing structure/function claim disclaimers, and failure to repeat required label information in both languages. FDA required a written response within 15 working days detailing corrective actions, and warned that failure to comply may result in seizure or injunction.

Essential Elements

FDA issued a warning letter to Essential Elements (Lindon, UT) in November 2022 regarding their CholestAid dietary supplement, sold at essentialelementsnutrition.com and on Amazon. The agency determined that marketing claims about lowering LDL cholesterol, managing blood pressure, and improving heart health rendered the product an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacked adequate directions for use for conditions requiring licensed practitioner supervision. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Anabolic Laboratories Inc

FDA issued a warning letter to Anabolic Laboratories Inc. (Lake Forest, CA) in November 2022 after reviewing website claims for two products — CoQ10 Ubiquinol Prime and Policosanol Microtabs — that characterized them as intended for treatment of cardiovascular disease, heart failure, cholesterol management, and related conditions. These claims caused the products to be classified as unapproved new drugs under the FD&C Act, and CoQ10 Ubiquinol Prime was additionally found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

Calroy Health Sciences, LLC

FDA issued a warning letter to Calroy Health Sciences, LLC (Scottsdale, AZ) in November 2022 regarding their Arterosil dietary supplement product. The agency determined that website claims on arterosil.com — including assertions about plaque regression, blood pressure reduction, and diabetic neuropathy improvement — rendered Arterosil an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacks adequate directions for use for conditions requiring licensed practitioner supervision. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Chambers' Apothecary

FDA issued a warning letter to Chambers' Apothecary (Robert Norris, Chambersburg, PA) after reviewing their website in October 2022 and finding that marketing claims for their Blood Pressure Support and CoEnzyme Q10 products established drug-intended use under the FD&C Act. Specific claims about lowering blood pressure, reducing cholesterol, and improving heart disease outcomes rendered these products unapproved new drugs. FDA also found both products misbranded for lacking adequate directions for use. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Healthy Trends Worldwide, LLC

FDA issued a warning letter to Healthy Trends Worldwide, LLC (operating as GoldenAfter50.com) regarding their BPS-5 dietary supplement product. The company's website, Facebook, and YouTube marketing claimed the product could lower blood pressure, fight blood disorders, and address heart disease, causing FDA to classify BPS-5 as an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacked adequate directions for use for conditions requiring licensed practitioner supervision. The letter demands corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

BergaMet North America LLC

FDA issued a warning letter to BergaMet North America LLC in November 2022 regarding its 'Cholesterol Command' dietary supplement, finding that claims on its website, Facebook page, and Walmart product listing established the product as an unapproved new drug intended to treat or mitigate diseases such as high cholesterol, type 2 diabetes, inflammation, and heart disease. The agency cited both direct marketing claims and endorsed customer testimonials as evidence of drug-intended use. The product was also deemed misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

iwi

FDA issued a warning letter to iwi (Houston, TX) in November 2022 after reviewing the company's website, social media, Amazon, and Walmart pages for its 'iwi Cholesterol' dietary supplement. The agency determined that marketing claims — including that the product is 'clinically shown to decrease cholesterol' and can 'protect your heart by lowering bad cholesterol' — rendered the product an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA demanded written corrective action within fifteen working days, warning that failure to comply could result in seizure or injunction.

Invitrx Therapeutics, Inc.

FDA issued a Warning Letter to Invitrx Therapeutics, Inc. (Lake Forest, CA) following a March 2022 inspection documenting that the company manufactured and distributed unapproved biological products — including a human umbilical cord-derived mesenchymal stem cell product (Invitra UC-MSC™) and exosome products (Invitra EX™ and Invitra EV-OP™) — without an approved Biologics License Application or an active IND, in violation of the FD&C Act and PHS Act. The letter also cited extensive CGMP and CGTP deviations including unvalidated aseptic processes, deficient donor eligibility determinations, inadequate sterility testing, and failure to investigate adverse event complaints. This was a repeat action following a March 2020 Warning Letter for the same firm, and FDA warned that failure to adequately respond could result in seizure and/or injunction.

Conners Clinic

FDA issued a warning letter to Dr. Kevin Conners of Conners Clinic (Lake Elmo, MN) after reviewing the clinic's website and social media accounts (May–August 2022) and finding that ten products — including Fenbendazole Starter Pack #1, Panacur-C Fenbendazole, Breast Cancer Prevention Protocol Bundle, Curcu Clear, Black Cumin Seed Oil, Chronic LX, Cayenne, D3-Xym, Rapid Immune Boost, and Glucosamine Sulfate Chondroitin Sulfate MSM — were marketed with disease-treatment and cancer-cure claims that rendered them unapproved new drugs under the FD&C Act. The claims spanned the clinic's website, Facebook, Instagram, and Twitter, and included explicit anticancer, antiviral, and disease-prevention language. FDA determined the products were also misbranded because adequate directions for layperson use could not be written for conditions requiring licensed-practitioner supervision. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Todos Medical Ltd aka Todos Medical USA Inc

FDA issued a warning letter to Todos Medical Ltd (CEO Gerald Commissiong) on November 7, 2022, for marketing their dietary supplement Tollovid 3CL Protease Inhibitor Delayed Release as intended to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval or authorization. The agency cited website claims, social media posts, and customer testimonials as evidence of intended drug use, classifying Tollovid as an unapproved new drug and misbranded drug under the FD&C Act. FDA demanded the company cease sales immediately, respond within 48 hours with corrective steps, and warned that failure to comply could result in seizure or injunction.

Amazon.com, Inc.

FDA issued a warning letter to Amazon.com CEO Andy Jassy regarding Amazon's distribution of three products — 'Artri Ajo King,' 'Artri King Reforzado con Ortiga y Omega 3,' and 'Ortiga Mas Ajo Rey' — marketed as dietary supplements but found via laboratory analysis to contain undisclosed diclofenac, a prescription NSAID. The products bore disease-treatment claims (arthritis, osteoarthritis, joint deterioration) that caused them to be classified as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(a) due to failure to disclose the active pharmaceutical ingredient. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Walmart Inc.

FDA issued a warning letter to Walmart Inc. (CEO Doug McMillon) regarding its distribution of 'Artri King Reforzado con Ortiga y Omega 3,' a product sold via Walmart.com and fulfilled through Walmart Fulfillment Services. Laboratory analysis confirmed the product contained undeclared diclofenac, an NSAID not listed on the label, rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made multiple disease-treatment claims (arthritis, joint deterioration, cartilage restoration) that established drug intent without FDA approval. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC

FDA issued a warning letter to Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC, a registered 503B outsourcing facility in West Columbia, SC, following a March–April 2022 inspection that revealed serious sterility assurance failures, including approximately 1,686 microbial contamination excursions in ISO 5 aseptic processing areas and inadequate media fills. The facility also compounded drug products using glycopyrrolate, a bulk drug substance not on the 503B bulks list and not on the drug shortage list, rendering those products ineligible for 503B exemptions and subject to unapproved new drug and misbranding violations. FDA acknowledged two voluntary recalls initiated by the firm but found corrective action responses inadequate in several respects. The letter warns that failure to address violations may result in seizure and injunction.

Nephron SC Inc.

FDA issued a warning letter to Nephron SC Inc. (West Columbia, SC) following a March–April 2022 inspection that found significant CGMP violations at its drug manufacturing facility. The agency cited failures to adequately investigate cross-contamination of drug products (including Bupivacaine detected in other drug lots), inadequate response to microbial contamination (Pseudomonas aeruginosa) in aseptic processing, deficient environmental monitoring in ISO 5 critical areas, and a failure to submit required NDA Field Alert Reports within three working days of identifying contamination — waiting over a year to file. FDA warned that failure to remediate may result in seizure, injunction, withholding of export certificates, and denial of new application approvals.

Sterling Pharmaceutical Services, LLC

Sterling Pharmaceutical Services, LLC, a contract manufacturer of sterile ophthalmic drug products in Dupo, Illinois, received an FDA Warning Letter citing significant CGMP violations including inadequate investigation of microbiological contamination in aseptic processing areas, insufficient environmental monitoring, and poor aseptic practices by personnel. The FDA also found that multiple sterile eye drop and ointment products bearing therapeutic claims (including homeopathic ophthalmic products) were unapproved new drugs marketed without FDA-approved applications in violation of sections 301(d) and 505(a) of the FD&C Act. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Muscle Sports Products, LLC

FDA issued a warning letter to Muscle Sports Products, LLC (CEO Jason R. Mancuso) after reviewing multiple company websites and social media in May and September 2022. The agency found that numerous products — including CardioBurn For Her Powder, Rhino Rampage Capsules, Joint Revolution Capsules, IMMUNITY+ Powder, THERMX, HYPEX, RECOMP Capsules, and others — bore claims establishing drug intent (cure, mitigation, treatment, or prevention of disease) without FDA approval, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. Several products also made COVID-19 mitigation and prevention claims. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within 15 working days.

Vision Path, Inc., d/b/a Hubble Contacts, U.S. v.

Vision Path, Inc. (d/b/a Hubble Contacts), an online direct-to-consumer contact lens seller, settled FTC charges in January 2022 for violating the Contact Lens Rule by failing to obtain and properly verify prescriptions and substituting Hubble lenses for those actually prescribed. The FTC also alleged the company violated the FTC Act by failing to disclose that many consumer reviews were written by compensated reviewers, including at least one company executive. The settlement required Vision Path to pay $3.5 million in penalties and consumer redress.

Vita Pharmacy, LLC dba Talon Pharmacy of Boerne

FDA issued a warning letter to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne (co-owner Praful Patel) following an October–November 2021 inspection that revealed serious insanitary conditions in sterile drug compounding operations. Violations included inadequate air-quality separation between ISO-classified areas, failure to segregate hazardous drug production, visibly dirty equipment with unknown foreign substances on HEPA filters, inadequate disinfection protocols, missing smoke studies, and insufficient aseptic process simulations (media fills). FDA found the firm's corrective-action responses deficient in multiple respects and warned that failure to adequately address violations may result in seizure or injunction.

The Elderberry Fairy & Co., LLC

FDA issued a warning letter to The Elderberry Fairy & Co., LLC (owner Catie Fasano) in August 2022 after reviewing the company's website and Facebook page, finding that marketing claims for Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider established these products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease. Claims included fighting colds and flu, relieving allergies, suppressing coughs, and acting as a sinus decongestant, none of which have FDA approval. FDA determined the products were also misbranded for lacking adequate directions for use, and warned that failure to correct violations could result in seizure or injunction.

Oregon’s Wild Harvest, Inc.

FDA issued a warning letter to Oregon's Wild Harvest, Inc. following a September 2021 inspection of their Redmond, Oregon dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish adequate product specifications, use of scientifically invalid testing methods (e.g., relying on input calculations rather than validated analytical methods for strength), failure to reject components contaminated with allergens, rodent feces, glass, and other foreign materials, and failure to verify microbial testing methodology. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.

Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc.

FDA issued a warning letter to Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. (Missoula, MT) following a September 2021 facility inspection. The agency found serious CGMP violations — including failures to verify finished batch specifications, follow quality control procedures, validate testing methodologies, and establish proper reference standard criteria — rendering multiple dietary supplement products adulterated. Additionally, several products were found misbranded due to incorrect serving size declarations, improper nutrient naming conventions, and failure to declare ingredients by their common or usual names. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

Deggeh Foods, Inc.

FDA issued a warning letter to Deggeh Foods, Inc. (Bronx, NY) after inspecting their facility and reviewing their website and Facebook page, finding that four products — Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags — bore disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to multiple CGMP violations, and misbranded due to extensive labeling deficiencies. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Vitti Labs, LLC

FDA issued a warning letter to Vitti Labs, LLC, a Liberty, MO manufacturer of human umbilical cord- and amniotic membrane-derived products (EV-PURE+, WJ-PURE+, VITTI-PURE, NS-PURE, EV-OPTI DROPS), finding that these HCT/Ps are unapproved biological drug products marketed without a valid biologics license application (BLA) or investigational new drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), and the inspection documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported two-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

Sagent Pharmaceuticals, Inc.

FDA issued a warning letter to Sagent Pharmaceuticals, Inc. (SterRx, LLC) following a September–November 2021 inspection of its 503B outsourcing facility in Plattsburgh, NY, finding serious CGMP deficiencies in sterile drug manufacturing, including inadequate first-air protection, turbulent ISO 5 airflow, microbial contamination failures, dirty equipment, and improper sterilization practices. These deficiencies caused drug products to be adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. The firm had already voluntarily ceased aseptic production, initiated a voluntary recall of sterile lots, and destroyed in-process inventory, but FDA found corrective action responses inadequate due to missing supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction, and required a written response within 15 working days.

Muscle Feast, LLC

FDA issued a warning letter to Muscle Feast, LLC (Nashport, OH) following a December 2021–January 2022 inspection of their dietary supplement manufacturing facility. The agency identified seven serious CGMP violations under 21 CFR Part 111, including failures to establish identity and purity specifications for components and finished products, inadequate quality control review of batch records, and improper reserve sample storage. FDA found these violations caused the company's dietary supplement products to be adulterated under section 402(g)(1) of the FD&C Act, and warned that failure to correct the issues could result in seizure or injunction.

NatureLab Corp.

FDA issued a warning letter to NatureLab Corp. (Carrollton, TX) following inspections in April–May and October 2021 of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failure to establish required specifications, maintain adequate master manufacturing records and batch production records, and implement written complaint procedures, rendering multiple products adulterated. Additionally, numerous products were found misbranded due to incorrect serving size declarations, improper Supplement Facts label formatting, missing statement of identity, absent adverse event contact information, and non-compliant FDA disclaimers. FDA warned that failure to correct these violations may result in seizure or injunction.

Elite Supplement Center LLC and Elite Training Facility LLC

FDA issued a warning letter to Elite Supplement Center LLC and Elite Training Facility LLC (Wayne/Pompton Lakes, NJ) in July 2022 after reviewing their website and finding they were selling five SARM products — Ostarine MK-2866, Ligandrol LGD-4033, Ibutamoren MK-677, Testolone RAD140, and Cardarine GW501516 — with marketing claims establishing intended human use despite 'Research Only / Not for Human Consumption' labels. FDA determined these products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, citing safety concerns including liver toxicity, heart attack, and stroke risk. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

1am USA Incorporated dba Pleasure Products USA

FDA issued a warning letter to 1am USA Incorporated dba Pleasure Products USA regarding its product X RATED HONEY FOR MEN, sold at pleasureproductsusa.com. Laboratory analysis confirmed the product contained undeclared tadalafil (the active ingredient in FDA-approved prescription drug Cialis), making it an adulterated food under section 301(ll) of the FD&C Act and disqualifying it from being marketed as a dietary supplement. The product poses serious health risks due to potential dangerous interactions with nitrate-containing prescription drugs. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Thirsty Run LLC / US Royal Honey LLC

FDA issued a warning letter to Thirsty Run LLC / US Royal Honey LLC (Dearborn, MI) after laboratory analysis confirmed that their honey products Etumax Royal Honey for Him and Dose Vital Honey for Men contained undeclared tadalafil, and Secret Miracle Royal Honey for Her contained undeclared sildenafil — both prescription-only PDE-5 inhibitors. The products were marketed with disease-treatment claims on the company's websites, making them unapproved new drugs under the FD&C Act, and their introduction into interstate commerce was also a prohibited act under section 301(ll) for adding approved drug ingredients to food. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and injunction.

Imprimis Rx LLC

FDA issued a warning letter to Imprimis Rx LLC (Carlsbad, CA) regarding promotional materials for its compounded ophthalmic drug product Pred-Moxi-Brom (PMB), published in two professional periodicals in early 2021. The agency found the materials made false or misleading claims about FDA approval status (implying bulk drug substances were FDA-approved), unsubstantiated superiority claims over other drug products, and misleading safety presentations that omitted known risks of the active ingredients. FDA cited violations of 21 U.S.C. 352(bb), 321(n), and 331(a) and demanded written corrective action within 15 working days, warning that failure to comply may lead to further regulatory action.

Health Research Laboratories, LLC

Health Research Laboratories, LLC, a Texas-based dietary supplement company, and its owner were banned from advertising or selling dietary supplements under an FTC consent order finalized in June 2022. The enforcement action was triggered by claims that their products treat, cure, or reduce the risk of disease — classic disease-claim violations under FTC and FDA standards. The proposed settlement was announced in March 2022 and received final approval in June 2022, resulting in a permanent ban on supplement sales and disease-related marketing claims.

Fagron Group B.V.

FDA issued a warning letter to Fagron Group B.V. (via its Saint Paul, Minnesota facility) following a November 2021 inspection that found significant CGMP deviations in the repackaging and relabeling of active pharmaceutical ingredients, including testosterone, estradiol, and opioids. Key violations included failure to conduct adequate cleaning validation to prevent cross-contamination, failure to investigate out-of-specification results, and failure of the quality unit to exercise proper oversight including unrestricted data deletion on CGMP-related equipment. FDA warned that failure to correct these deviations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Hybrid Pharma, LLC

FDA issued a warning letter to Hybrid Pharma, LLC, a 503B outsourcing facility in Deerfield Beach, FL, following a July–September 2021 inspection that revealed CGMP violations, failure to submit complete drug product reports, and production of adulterated, misbranded, and unapproved new drug products. The facility failed to thoroughly investigate batch discrepancies, establish validated test methods, and maintain adequate environmental monitoring for aseptic processing. Drug products including Phosphatidyl choline 5% and deoxycholate 4.2% injectable were compounded without meeting 503B conditions, rendering them ineligible for exemptions from FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Re-Gen Active Lab, Inc.

FDA issued a warning letter to Re-Gen Active Lab, Inc. (Irving, TX) regarding three amniotic membrane and umbilical cord tissue-derived cellular products — ActiveFlow™, ActiveShot™, and ActivePro™ — distributed to physicians and medical clinics nationwide. The products were found to be unapproved biological drugs lacking a valid Biologics License Application (BLA) or Investigational New Drug (IND) application, and failed to meet HCT/P homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented nine significant CGMP deviations including failure to validate aseptic processes, inadequate sterility testing, and unsupported two-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Golden Lab LLC

FDA issued a warning letter to Golden Lab LLC (Jacksonville, FL), owned by Dr. Howard J. Loff, M.D., following a November 2021 facility inspection. The agency found that three ocular health supplement products — DoctoRx's Optimal Formula Ocular Pressure & Optic Nerve Support Formula, Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The letter also cited multiple cGMP violations including missing finished-product and component specifications and incomplete batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.

New Vitalis, LLC dba New Vitalis Pharmacy

FDA issued a warning letter to New Vitalis, LLC dba New Vitalis Pharmacy (Louisville, KY) following an August 2021 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin near production areas, dirty surfaces, improper aseptic technique, and unsealed HEPA filters. These deficiencies caused drug products — including Testosterone Cypionate/Testosterone Propionate — to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already voluntarily recalled the affected testosterone products and ceased all sterile compounding by September 7, 2021. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.

AdvoCare International, L.P.

AdvoCare International, L.P., a multi-level marketer of health and wellness products, and its former CEO agreed to pay $150 million and accept a permanent ban from the MLM business to resolve FTC charges that the company operated an illegal pyramid scheme. The FTC alleged AdvoCare deceived consumers into believing they could earn significant income as distributors of its health and wellness products. Two top promoters also settled related charges, agreeing to an MLM ban and a $4 million judgment (suspended upon surrender of substantial assets). The enforcement action targeted deceptive income opportunity claims tied to the distribution of nutrition and wellness products.

Complete Nutrition

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Complete Nutrition (Omaha, NE) regarding their dietary supplement product 'DR1,' which contains 5-alpha-hydroxy-laxogenin. The FDA determined that 5-alpha-hydroxy-laxogenin does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unsafe food additive that renders DR1 an adulterated dietary supplement. Introducing or delivering the product into interstate commerce constitutes a prohibited act under section 301(a) of the FD&C Act. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Max Muscle

FDA issued a warning letter to Max Muscle (Sioux Falls, SD) regarding two dietary supplement products, Lipo Red and StimoVEX XT, finding both adulterated under the FD&C Act. StimoVEX XT was found to contain hordenine HCl, which is not a dietary ingredient and is an unapproved food additive, rendering the product adulterated under section 402(a)(2)(C)(i). Lipo Red was found to contain octopamine, a new dietary ingredient for which no required premarket notification was submitted to FDA, making it adulterated under sections 402(f) and 413(a). FDA warned that failure to address these violations could result in seizure and injunction.

New York Nutrition Company

FDA issued a warning letter to New York Nutrition Company (American Metabolix) regarding its dietary supplement products 'Lean Muscle For Her' and 'Lean Muscle,' which were found to contain 5-alpha-hydroxy-laxogenin, a substance that does not qualify as a dietary ingredient under the FD&C Act. Because this substance is neither GRAS nor approved as a food additive, the products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

Assault Labs

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Assault Labs (Burbank, CA) regarding their dietary supplement product 'Wild Thing Tropical Tornado flavor.' The product was found to be adulterated because it contains hordenine HCl and higenamine HCl, which are not dietary ingredients under the FD&C Act and are not generally recognized as safe (GRAS), making them unapproved food additives. FDA determined that marketing this product violates section 402(a)(2)(C)(i) of the FD&C Act. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Performax Labs Inc

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Performax Labs Inc. (Torrance, CA) regarding two products — Brute BCAA and Predator Pro — labeled as dietary supplements. Both products declare 5-alpha-hydroxy-laxogenin as a dietary ingredient; however, FDA determined this substance does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unapproved food additive. As a result, both products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act, and FDA warned that failure to address the violations may result in seizure or injunction.

Complete Nutrition

FDA issued a warning letter to JW Nutritional LLC (McKinney, TX) following a September 2025 inspection of their OTC drug manufacturing facility. The agency cited significant CGMP violations including failure to perform adequate identity and contamination testing on incoming components, lack of process validation, inadequate water system validation, and use of food/dietary supplement microbiological standards instead of USP drug standards. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Nutritional Sales and Customer Service, LLC

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Nutritional Sales and Customer Service, LLC (metabolicnutrition.com) regarding their dietary supplement product Synedrex. The product was found to be adulterated because it contains three new dietary ingredients — octopamine, hordenine, and higenamine — for which no required premarket new dietary ingredient (NDI) notifications were submitted to FDA. Additionally, FDA determined that hordenine and higenamine lack adequate safety evidence and present a significant or unreasonable risk of illness or injury, making the product adulterated under the FD&C Act regardless of notification status. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Steel Supplements Inc

FDA issued a warning letter to Steel Supplements Inc. of Sarasota, FL regarding six dietary supplement products (Shredded-AF, Charged-AF, Alpha-AF, 3-EPI-Andro, Focused-AF, and Amped-AF) found to be adulterated under the FD&C Act. The products were found to contain ingredients — hordenine HCl, higenamine HCl, and 5-alpha-hydroxy-laxogenin — that either do not qualify as dietary ingredients and lack GRAS status, or are new dietary ingredients for which required premarket notifications were never submitted. FDA warned that continued interstate commerce of these adulterated products is prohibited and that failure to address the violations may result in seizure or injunction.

Exclusive Nutrition Products, LLC

FDA issued a warning letter to Exclusive Nutrition Products, LLC (operating as Black Dragon Labs) regarding two dietary supplement products, Thermo Burn and 5-Alpha. The agency found both products adulterated under the FD&C Act because they contain higenamine HCl and 5-alpha-hydroxy-laxogenin, respectively, which do not qualify as dietary ingredients and are not GRAS, making them unsafe food additives. FDA warned that continued interstate commerce of these adulterated products is a prohibited act and that failure to address the violations may result in seizure or injunction. The company was given 15 working days to respond with corrective steps.

Advanced Nutritional Supplements LLC

FDA issued a warning letter to Advanced Nutritional Supplements LLC (Harrisburg, PA) regarding six products — New God of Rage, God of War, New God of Fire, Legion: Extreme Fat Burner, Laxovar: Natural Recomposition, and Uprising: Natural Testosterone Support — labeled as dietary supplements. The agency found that the declared ingredients higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin do not qualify as dietary ingredients under the FD&C Act and are unapproved food additives, rendering all six products adulterated. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

National Urological Group, Inc., et al.

National Urological Group, Inc. and associated defendants, including repeat offender Jared Wheat, were found in contempt by a federal district judge in October 2017 for violating prior court orders related to the sale of weight-loss dietary supplements. The court imposed a judgment exceeding $40 million against the defendants. The FTC used a portion of those funds to mail refunds totaling more than $8.5 million to defrauded consumers in May 2020.

MCACO, LTD

FDA issued a warning letter to MCACO, LTD (Grand Prairie, TX) following a November–December 2021 inspection that revealed serious Current Good Manufacturing Practice (CGMP) violations in the production of dietary supplements. Violations included failure to establish finished product and component specifications, failure to qualify suppliers via confirmed certificates of analysis, inadequate laboratory testing methodologies, incomplete master manufacturing records, and backdated batch production records. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.

Age Management Institute Santa Barbara

FDA issued a warning letter to Age Management Institute Santa Barbara (owner Michael R. Repik, D.O.) following a March–April 2021 inspection that found serious sterile compounding deficiencies, including lack of a certified ISO 5 area, visibly dirty equipment and surfaces, and use of expired components in IV therapy drug products. These conditions rendered the compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. The facility had voluntarily ceased IV therapy drug production at the time of inspection. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.

NDAL Mfg Inc.

FDA issued a warning letter to NDAL Mfg Inc. (Monterey, CA) following a September 2021 inspection, citing significant CGMP violations and identifying three Manuka Honey nasal spray products as unapproved new drugs. The company's product labels and website made drug-intended-use claims — including treating sinus infections, supporting immune function, and clearing nasal passages — without FDA-approved applications. FDA also flagged inadequate quality control, failure to investigate microbial contamination, and lack of stability testing. The letter demands corrective actions within 15 working days and warns that failure to comply may result in seizure, injunction, or withholding of export certificates.

Jason Cardiff (Redwood Scientific Technologies, Inc.)

The FTC filed a complaint against Jason Cardiff and Redwood Scientific Technologies, Inc. in October 2018, alleging a scheme using illegal robocalls to deceptively market dissolvable oral film strips as effective smoking cessation, weight-loss, and sexual-performance aids. An initial 2019 settlement permanently banned co-defendant Danielle Cadiz from all robocall activities and imposed an $18.2 million judgment against her. In March 2022, the FTC announced final court orders against all remaining defendants, including Cardiff. The enforcement actions addressed both the deceptive health efficacy claims and the illegal robocall marketing methods used to promote the products.

Med Shop Total Care, Inc.

FDA issued a warning letter to Med Shop Total Care, Inc. (Longview, TX), a compounding pharmacy, following a July 2021 inspection that identified serious insanitary conditions in sterile drug production. Violations included microbial contamination in the ISO 5 aseptic processing area, improper glove sanitization, inadequate disinfectant contact times, and a brownish residue on a HEPA filter screen — all causing drug products to be adulterated under FDCA section 501(a)(2)(A). The firm's corrective action responses were deemed inadequate in key areas, and FDA warned that failure to remediate could result in seizure or injunction.

Health Research Laboratories, LLC

The FTC and State of Maine brought a complaint against Health Research Laboratories, LLC and its principal for deceptively marketing two dietary supplements, BioTherapex and NeuroPlus, with claims not supported by competent and reliable scientific evidence. A final Commission order was entered, and over $750,000 in consumer redress was distributed to approximately 16,596 affected consumers in November 2018. The defendants were subsequently alleged to have violated the final order by continuing to market supplements with unsupported claims, leading to a contempt motion and later an administrative complaint. A proposed settlement order was announced in March 2020.

Dr Retter Ec Wladyslaw Retter

FDA issued a CGMP warning letter to Dr Retter Ec Wladyslaw Retter, a Polish OTC drug manufacturer, citing four significant violations related to manufacturing a homeopathic cream distributed to the United States: lack of process validation (including a ~100,000,000-fold discrepancy in active ingredient concentration versus label claims), failure to conduct identity testing on incoming components, inadequate batch production records, and insufficient laboratory controls for microbiological testing. FDA placed all products from the firm on Import Alert 66-40 as of March 4, 2022, and warned that continued non-compliance may result in refusal of admission of all articles manufactured at the facility into the United States.

Weight Watchers/WW

The FTC reached a settlement with WW International, Inc. (formerly Weight Watchers) and its subsidiary Kurbo, Inc. over allegations that they marketed a weight-loss app targeting children as young as eight years old and collected their personal information without obtaining verifiable parental consent, in violation of the Children's Online Privacy Protection Act (COPPA). The case resulted in a settlement requiring corrective actions and financial penalties.

MYA International, Inc.

FDA issued a warning letter to MYA International, Inc. (Chula Vista, CA) after inspecting their facility and reviewing product labeling for nine dietary supplement products (Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea/Tea Cellular, Quiebra Piedras, Shark Cartilage, and Helper). The products' catalog claims established drug intent — including treating diabetes, cancer, bacterial infections, and psychiatric disorders — making them unapproved new drugs and misbranded drugs under the FD&C Act. FDA also cited serious cGMP violations and numerous dietary supplement labeling deficiencies, and warned that failure to correct violations may result in seizure or injunction.

Princess Lifestyles, LLC

FDA issued a warning letter to Princess Lifestyles, LLC (San Gabriel, CA) following a March 2021 facility inspection and February 2022 website review, finding that multiple dietary supplement products — including TMAXX and PS Brain — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The agency also cited extensive CGMP violations (no written QC procedures, missing component specifications, inadequate complaint and returns handling), an adulterated product containing ephedrine alkaloids (Stomaisu), and widespread labeling deficiencies across 13 product lines. FDA warned that failure to promptly correct violations may result in seizure or injunction.

Teami, LLC

The FTC sued Teami, LLC and its owners in March 2020 for making deceptive health claims about their tea products without reliable scientific evidence, and for paying social media influencers who failed to adequately disclose their paid relationships. Teami claimed its 30 Day Detox Pack would cause weight loss and that other teas could fight cancer, clear clogged arteries, decrease migraines, treat and prevent flu, and treat colds. The case resulted in the FTC returning more than $930,000 in consumer redress to buyers of the products.

BASF SE

BASF SE, along with DIEM Labs, agreed to pay over $416,000 to settle FTC charges that they deceptively marketed dietary fish oil supplements as clinically proven to reduce liver fat in adults and children with non-alcoholic fatty liver disease (NAFLD). The FTC found the efficacy claims were unsubstantiated. The settlement funds were used to provide consumer refunds, and both companies were barred from the allegedly illegal conduct under final consent orders approved in June 2021.

ECI Pharmaceuticals, LLC

FDA issued a warning letter to ECI Pharmaceuticals, LLC (Fort Lauderdale, FL) regarding drug registration and listing violations for two esterified estrogens and methyltestosterone products (NDC 51293-639 and NDC 51293-640). The firm submitted electronic listing files identifying 'conjugated estrogens' as the active ingredient, which does not match the 'esterified estrogens' stated on the product labeling — two distinct, non-equivalent ingredients. This constitutes a violation of FD&C Act sections 510(j) and 301(p), and renders the products misbranded under section 502(o). FDA previously notified the firm of these deficiencies in October and December 2021, resulting in removal from the Online NDC Directory, and now requires written corrective action within 15 working days.

ECI Pharmaceuticals, LLC

FDA issued a warning letter to ECI Pharmaceuticals, LLC (Fort Lauderdale, FL) regarding drug registration and listing violations for two esterified estrogens and methyltestosterone products (NDC 51293-639 and NDC 51293-640). The firm submitted electronic listing files naming 'conjugated estrogens' as the active ingredient, which does not match the 'esterified estrogens' stated on the product labeling — two distinct, non-equivalent ingredients. This constitutes a violation of FD&C Act sections 510(j) and 301(p), and renders the products misbranded under section 502(o). FDA previously notified the firm of these deficiencies in October and December 2021, resulting in removal from the Online NDC Directory, and now requires written corrective action within 15 working days.

Sunny Creek Farm, Inc.

FDA issued a warning letter to Sunny Creek Farm, Inc. (Tryon, NC) following an August 2021 inspection that found serious violations of the Produce Safety Rule, including distributing sprouts after pathogen-positive test results and inadequate sanitation of food contact surfaces. Additionally, FDA reviewed the company's website and determined that marketing claims for broccoli sprout products — including claims that they treat cancer, Alzheimer's, heart disease, autism, and schizophrenia — rendered those products unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. The company was directed to respond within 15 working days with corrective actions, and FDA warned that failure to comply could result in seizure or injunction.

Smart Surgical, Inc dba Burst Biologics

FDA issued a warning letter to Smart Surgical, Inc. dba Burst Biologics (Boise, ID) regarding its BioBurst Fluid and BioBurst Rejuv products derived from human umbilical cord blood, which FDA determined are unapproved biological drugs lacking a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website marketing indicated the products were intended to treat various diseases and conditions, and the products failed to meet the homologous-use and other criteria required for regulation solely under section 361 of the PHS Act. FDA also documented serious CGMP/CGTP deviations including deficient donor screening (Zika virus risk), unvalidated aseptic processes, inadequate environmental monitoring, and numerous uninvestigated sterility failures. FDA warned that failure to address these violations may result in seizure and/or injunction.

Innoveix Pharmaceuticals Inc

FDA issued a warning letter to Innoveix Pharmaceuticals Inc. (Addison, TX) following a May 2021 inspection that found serious sterility and insanitary-conditions violations in the compounding of injectable peptide products, including Sermorelin/Ipamorelin and AOD-9604. The firm had already voluntarily recalled both products due to lack of sterility assurance. FDA cited multiple CGMP failures — including use of an unsuitable sterilization unit, improper aseptic technique, and use of household dish detergent on sterile glassware — constituting adulteration under FDCA section 501(a)(2)(A). The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Varigard, LLC

FDA issued a warning letter to Varigard, LLC (Foley, AL) on December 29, 2021, citing its alcohol-based hand sanitizer products as unapproved new drugs marketed in violation of the FD&C Act. The company's product labels and websites made claims that the products kill and prevent COVID-19 (including specific variants), provide two hours of protection against deadly pathogens, and are flame retardant — claims that go beyond permitted OTC monograph conditions and are false or misleading. FDA also found misbranding violations including unauthorized use of the FDA logo suggesting agency approval. The letter demanded corrective action within 48 hours and warned that failure to comply could result in seizure and injunction.

Wholly Liquid Nutritional Supplements LLC

FDA issued a warning letter to Wholly Liquid Nutritional Supplements LLC (Hampton, NH) in December 2021 after reviewing their website and Facebook page and finding that seven products — SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver — were marketed with disease-treatment claims (including Lyme disease, cancer, diabetes, ADHD, Alzheimer's, and numerous bacterial/viral pathogens) that rendered them unapproved new drugs under the FD&C Act. Because the products lacked FDA approval and bore no adequate directions for use, they were also deemed misbranded. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Western Herb Products, Inc.

FDA issued a warning letter to Western Herb Products, Inc. (Index, WA) following a May 2021 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failures to establish adequate specifications, master manufacturing records, and batch production records for their Wormwood/Aloes dietary supplement capsules. Additionally, the product's labeling was found to be misbranded on multiple grounds, including incorrect plant part declarations, non-compliant Supplement Facts formatting, failure to declare common ingredient names, and use of 'approximately' in net quantity statements. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

Lifewatch Inc.

Lifewatch Inc., Evan Sirlin, and Mitchel May were found liable for conducting over one billion illegal robocalls targeting primarily elderly consumers to pitch supposedly 'free' medical alert systems. The FTC, acting jointly with the Florida Attorney General's Office, alleged the defendants misrepresented the terms of their medical alert product sales since 2012. A court order permanently bans the Lifewatch defendants from telemarketing and prohibits misrepresentation of product or service terms. A financial judgment of $25.3 million was imposed against Lifewatch and Sirlin.

NV Nutrition, LLC

FDA issued a warning letter to NV Nutrition, LLC (operating nutrovape.com and nutriair.com) in December 2021, finding that its inhaled 'vaporizer' and 'diffuser' products—marketed under the nutrovape and nutriair brands—were unapproved new drugs sold in violation of the FD&C Act. The agency cited numerous disease-treatment and structure/function claims on the company's websites, social media, and product packaging that established drug intent, including claims about treating insomnia, anxiety, hangovers, ADHD, and immune function. Because the products are intended for inhalation rather than ingestion, they also do not qualify as dietary supplements under the FD&C Act. FDA warned that failure to promptly correct violations could result in seizure and/or injunction.

VitaStik, Inc.

FDA issued a warning letter to VitaStik, Inc. (Beverly Hills, CA) in December 2021 after reviewing the company's website and social media, finding that its line of oral inhalation/aromatherapy sticks made disease-treatment claims for conditions including asthma, COPD, anxiety, PTSD, epilepsy, insomnia, and nasal congestion. These claims caused the products to be classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and FDA also noted the products do not qualify as dietary supplements because they are intended for inhalation, not ingestion. FDA warned that failure to promptly correct violations could result in seizure and/or injunction, and required a written response within fifteen working days.

Eagle Energy USA, Inc.

FDA issued a warning letter to Eagle Energy USA, Inc. in December 2021 regarding its inhalable 'Caffeine Pen' products (Lychee Ice and Guarana Berry), finding them to be unapproved new drugs under the FD&C Act. The company's website, Facebook page, and product packaging made drug-like claims about treating GERD, boosting immune function, reducing inflammation, improving memory, and preventing osteoporosis, among others. Because the products are intended for inhalation rather than ingestion, they do not qualify as dietary supplements, and no FDA-approved applications exist for them. FDA demanded a written response within 15 working days and warned that failure to act could result in seizure and/or injunction.

Sanitor Corporation

FDA issued a warning letter to Sanitor Corporation (Stanton, CA) following a May–June 2021 inspection that found multiple CGMP violations including inadequate quality control, microbial contamination in hand sanitizer batches, data integrity failures, and distribution of drug products before testing was complete. The company also marketed unapproved new drug products — hydroquinone-based skin bleaching/lightening products — without FDA approval, and one acne product was found to be misbranded for failing to bear a required statement of identity. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Saffron Health Sciences

FDA issued a warning letter to Saffron Health Sciences (Dr. Song Gao, E Brunswick, NJ) in November 2021 regarding three dietary supplement products — Crocin Rich, Crocin Rich II, and Crocin Rich Plus — marketed with disease-treatment claims covering Alzheimer's, COVID-19, multiple sclerosis, stroke, depression, macular degeneration, and other conditions. The agency determined these claims caused the products to be classified as unapproved new drugs under the FD&C Act, and also found them misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

GeroNova Research Inc.

FDA issued a warning letter to GeroNova Research Inc. (President Karyn Young) in November 2021 after reviewing the company's Amazon store, Facebook, Twitter, and website for products including CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg. The agency found that marketing claims on these platforms — including references to treating diabetes, cardiomyopathy, Parkinson's disease, depression, neuropathy, and liver disease — rendered the products unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. FDA demanded a written response within 15 working days detailing corrective steps, and warned that failure to comply could result in seizure or injunction.

Surgenex LLC

FDA issued a warning letter to Surgenex LLC (Scottsdale, AZ) regarding its manufacture and distribution of three allogeneic HCT/P products — SurCord®, SurForce®, and SurFactor® — derived from umbilical cord and amniotic membrane and marketed for orthopedic conditions. The products were found to be unapproved biological drugs lacking a valid biologics license application or IND, and failed to meet homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, uninvestigated sterility failures, and unsupported expiration dating, raising potential significant patient safety concerns. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure and/or injunction.

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine, operated by Dr. Leonard D. Guyer in Indianapolis, IN, received an FDA Warning Letter following a 2020 inspection that found the facility producing compounded sterile drug products under insanitary conditions and without meeting the conditions of section 503A of the FDCA. The facility used bulk drug substances including peptides such as BPC-157, thymosin alpha, thymosin beta, LL-37, Selank, and Semax that are ineligible for 503A exemptions, and produced drugs without valid patient-specific prescriptions. The violations encompass adulterated and misbranded drug products, unapproved new drug marketing, and serious CGMP deficiencies including unclassified sterile processing areas, lack of environmental monitoring, and improper aseptic technique. The firm was required to respond within 15 working days and must notify FDA 15 working days before resuming sterile production; failure to correct violations may result in seizure or injunction.

Synaptent, LLC

FDA issued a warning letter to Synaptent, LLC (operating liftmode.com) in November 2021 for marketing numerous dietary supplement products—including Phenibut, Berberine HCL, Curcumin, and others—with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The agency cited claims such as anti-inflammatory, anxiolytic, blood pressure reduction, and erectile dysfunction uses as evidence of drug intent without FDA approval. Several products were also cited as misbranded drugs for lacking adequate directions for use, and four products were cited as misbranded dietary supplements for incomplete labeling. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Agora Financial LLC

The FTC sued Agora Financial LLC and affiliates for deceptively marketing publications to seniors that falsely claimed to cure type 2 diabetes and promoted a fraudulent government check scheme. Key products included 'The Doctor's Guide to Reversing Diabetes in 28 Days' and pitches tied to a fabricated 'Congress' Secret $1.17 Trillion Giveaway.' The complaint alleged these claims were false and targeted older consumers nationwide. A proposed settlement order was announced in February 2021.

Dominant Nutrition LLC formerly 8 Weeks Out Labs

FDA issued a warning letter to Dominant Nutrition LLC (formerly 8 Weeks Out Labs) in October 2021 after reviewing their website and finding serious violations related to four products: ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX. LipogenX was found to be an adulterated dietary supplement due to the inclusion of Hordenine, a new dietary ingredient lacking the required FDA safety notification. ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA were deemed unapproved new drugs based on disease-treatment claims on the company's website, with OPTIMUM-CLA additionally cited as a misbranded drug. The company was given 15 working days to respond with corrective actions, with FDA warning that failure to comply could result in seizure or injunction.

Nordic Clinical, Inc. and Encore Plus Solutions, Inc.

Nordic Clinical, Inc. and Encore Plus Solutions, Inc., marketers of supplements Neurocet, Regenify, and Resetigen-D, settled FTC charges in April 2020 for deceptively promoting their products to older Americans with false claims that the supplements could stop pain and treat age-related ailments. The FTC found the health benefit claims were unsubstantiated and not supported by scientific evidence. The resulting order barred the defendants from making any health benefit claims unless true and backed by scientific evidence. In October 2021, the FTC announced it was returning $1.1 million to consumers who purchased the defendants' products.

Empower Clinic Services, LLC dba Empower Pharmacy

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX), an outsourcing facility registered under section 503B, following a February–March 2020 inspection. The facility failed to meet multiple 503B conditions, including omitting required adverse event reporting contact information from drug product labels (e.g., Testosterone Cypionate, HCG, FSH, Menotropins), failing to submit complete biannual drug compounding reports, maintaining inadequate adverse event reporting procedures, and wholesaling compounded drugs through a third-party entity in violation of the prohibition on wholesaling. Because these conditions were not met, the compounded products are deemed unapproved new drugs and misbranded under the FDCA, and FDA warned that failure to correct violations may result in seizure or injunction.

Organa International Corp.

FDA issued a warning letter to Organa International Corp. (Springville, UT) after reviewing its website and Facebook page in June 2021, finding that at least 19 products — including colloidal minerals, Silver Gel, Relieve Progesterone Cream, Essiac Tea, and MSM — were marketed with disease-treatment and cure claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The claims spanned cancer, HIV, diabetes, osteoporosis, Alzheimer's disease, arthritis, and numerous infections, none of which are supported by FDA-approved applications. FDA also cited extensive dietary-supplement labeling violations and demanded written corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

Quicksilver Scientific

FDA issued a warning letter to Quicksilver Scientific (Louisville, CO) on October 13, 2021, finding that website claims for four products — Nanoemulsified Milk Thistle, Cat's Claw Elite, Nanoemulsified CoQ10, and Liposomal GABA with L-Theanine — established drug intent by referencing disease treatment, prevention, and mitigation (e.g., heart failure mortality reduction, liver protection from alcohol, antimicrobial effects). FDA determined the products are unapproved new drugs under the FD&C Act and misbranded because they lack adequate directions for use. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.

FDA issued a warning letter to RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. (CEO Kieu Hoang) following a March 2021 inspection under the Bioresearch Monitoring Program. The agency found that RAAS conducted multiple clinical investigations of investigational drug products — including a COVID-19 study — without submitting required Investigational New Drug (IND) applications, in violation of 21 CFR 312. RAAS argued its products were dietary supplements not subject to IND requirements, but FDA determined the products were being studied as drugs because the investigations were designed to evaluate their ability to cure, mitigate, and treat disease. RAAS was directed to respond within 15 business days with a corrective action plan, with failure to comply potentially triggering further regulatory action.

ICA Health, LLC/Future Formulations, LLC

FDA issued a warning letter to ICA Health, LLC/Future Formulations, LLC (Dr. James L. Wilson) after reviewing three websites in July 2021 and finding that five dietary supplement products — Dr. Wilson's Good Sugar, Super Immune Space Sprinkles, Cortisol Stress Reset, BFF, and Nat-Stim — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The claims linked the products to conditions including diabetes, metabolic syndrome, cardiovascular disease, autoimmune disorders, herpes, fibromyalgia, and cancer-related adrenal fatigue, among others. Four of the five products were also found to be misbranded because adequate directions for layperson use could not be written for prescription-level intended uses. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop

FDA issued a warning letter to Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop, a 503B-registered outsourcing facility in Texas, following a 2019 inspection. The facility failed to meet section 503B conditions by omitting National Drug Code numbers from labels (including Estradiol and Testosterone pellets), failing to report all compounded drug products upon initial registration, and submitting an adverse event report 35 days late for a serious event involving testosterone pellets. As a result, the compounded drug products were deemed unapproved new drugs and misbranded, with FDA warning that continued non-compliance could result in seizure and injunction.

Walfer Corporation dba The Medicine Shoppe Pharmacy

FDA issued a warning letter to Walfer Corporation dba The Medicine Shoppe Pharmacy (Port Charlotte, FL) following a March 2020 inspection that found the compounding pharmacy producing drug products without valid patient-specific prescriptions, under insanitary conditions (vermin, stained equipment, unsealed ceiling tiles), and in violation of CGMP regulations. The facility also compounded what appeared to be essentially copies of commercially available drug products (e.g., Oxycodone HCl 30mg capsules). FDA found the drug products adulterated and misbranded under the FDCA, and the firm had already recalled all in-expiry products and ceased sterile compounding. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Holographic Health, Inc.

FDA issued a warning letter to Holographic Health, Inc. (President Theodore Baroody) regarding 14 products — including Glyco-Well, Pan-Gest, Heart-Line, Passionate Pursuit, Better Mood, and others — sold on holographichealth.com. The agency determined these products were unapproved new drugs because website claims established intent to cure, mitigate, treat, or prevent diseases such as diabetes, arthritis, erectile dysfunction, depression, and hemorrhoids. The products were also found to be misbranded for lacking adequate directions for use, and Pink Lady was found to be improperly labeled as a dietary supplement despite being a topical product. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Holistic Healer & Wellness Center, Inc.

FDA and FTC jointly issued a warning letter to Holistic Healer & Wellness Center, Inc. (Dearborn, MI) regarding its 'Diabalance Diabetes Supplement' product. The product's website claims established it as an unapproved new drug under the FD&C Act by asserting it could treat, mitigate, or aid diabetes and blood sugar conditions without FDA approval. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims. The company was required to respond within 15 working days and faces potential seizure, injunction, civil penalties up to $43,792 per violation, and consumer refunds.

Lysulin, Inc.

FDA and FTC jointly issued a warning letter to Lysulin, Inc. (San Diego, CA) in September 2021 regarding five dietary supplement products marketed for diabetes and prediabetes management. The regulators found that claims on the company's website, social media pages, and Amazon storefront established the products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease — specifically diabetes and prediabetes — without FDA approval. FDA cited violations for introducing unapproved new drugs and misbranded drugs into interstate commerce, while the FTC issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and consumer redress obligations.

Ar-Rahman Pharm LLC

FDA and FTC jointly issued a warning letter to Ar-Rahman Pharm LLC (Abdur-Rahmaan Felder) in September 2021 regarding its 'Diabetes Support' dietary supplement. The agencies found that website and social media claims—asserting the product balances blood sugar, supports insulin/glucagon, and manages diabetes—rendered the product an unapproved new drug under the FD&C Act and a misbranded drug lacking adequate directions for use. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress.

Aceva, LLC

FDA and FTC jointly issued a warning letter to Aceva, LLC (CEO Joseph Esposito) in September 2021 regarding their 'Sugar Balance' dietary supplement. The agencies found that website and social media claims — including assertions about improving insulin sensitivity, controlling blood glucose, and helping manage diabetes — caused the product to be classified as an unapproved new drug and a misbranded drug under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims could result in civil penalties of up to $43,792 per violation and consumer refund obligations. Aceva was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure, injunction, or FTC legal action.

Radhanite, LLC d/b/a Curalife Ltd

FDA and FTC jointly issued a warning letter to Radhanite, LLC d/b/a Curalife Ltd (CEO Ron Elul) regarding their CuraLin dietary supplement, marketed on their website and social media. The regulators found that claims on the company's website, Instagram, and Facebook pages — including references to managing blood sugar, treating Type 2 Diabetes, and ingredient-level claims about insulin sensitivity — rendered CuraLin an unapproved new drug and a misbranded drug under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure, injunction, or civil penalties.

Live Good Inc.

FDA and FTC jointly issued a warning letter to Live Good Inc. (Miami, FL) regarding its 'Berry Gen Sugar Control' dietary supplement marketed via website, Facebook, Instagram, and Amazon. The product's marketing claims — including treating diabetes, controlling blood sugar and insulin levels, and protecting the pancreas — caused FDA to classify it as an unapproved new drug and misbranded product under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress obligations.

Metamune Inc

FDA and FTC jointly issued a warning letter to Metamune Inc (doing business as Bodymune) in September 2021 regarding its 'DiabetesSupport' dietary supplement sold via its website, Facebook page, and Amazon storefront. The agencies determined that marketing claims positioning the product as a treatment, cure, or support for diabetes and pre-diabetes rendered it an unapproved new drug and a misbranded drug under the FD&C Act. The FTC separately issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims violate the FTC Act and could result in civil penalties of up to $43,792 per violation plus consumer refunds. Both agencies required written corrective action within fifteen working days.

Nuturna International LLC

FDA and FTC jointly issued a warning letter to Nuturna International LLC (Orlando, FL) regarding its 'Diabetic Support Formula' dietary supplement. The agencies found that website and Amazon product page claims — including customer testimonials and direct marketing language — positioned the product as intended to treat, cure, or mitigate diabetes and related conditions, making it an unapproved new drug under the FD&C Act and a misbranded drug for lacking adequate directions for use. The FTC separately demanded the company cease and desist from making unsubstantiated disease-treatment claims, warning that violations could result in civil penalties of up to $43,792 per violation, consumer refunds, injunctions, or administrative cease and desist orders.

Phytag Labs

FDA and FTC jointly issued a warning letter to Phytag Labs (George Rivera, Bee Cave, TX) regarding their 'GLUCOTYPE2' dietary supplement, which was marketed with claims that it could treat, prevent, or cure Type 2 diabetes and related conditions. The agencies determined the product constituted an unapproved new drug under the FD&C Act and was misbranded due to inadequate directions for use. The FTC simultaneously issued a cease-and-desist demand, warning that continued unsubstantiated disease claims could result in civil penalties of up to $43,792 per violation, injunctions, and consumer redress obligations.

Pharmaganics LLC

FDA and FTC jointly issued a warning letter to Pharmaganics LLC (CEO Tom Redmond III) regarding its 'Diabetes Doctor Pre-Diabetes' and 'Diabetes Doctor Blood Sugar 24 Hour' dietary supplement products sold via its website, Amazon, Walmart, Facebook, and Instagram. The products were found to bear disease-treatment claims — including preventing, treating, and mitigating Type 2 diabetes and insulin resistance — that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated efficacy claims, warning of civil penalties up to $43,792 per violation and potential consumer redress. Both agencies required written response within 15 working days.

McDaniel Water, LLC

FDA issued a warning letter to McDaniel Water, LLC (directors Gary McDaniel and Ruth Shields) regarding their product 'Black Indian Salve,' also marketed as 'Indian Herb,' 'X,' and 'Black Salve.' The product, which contains bloodroot and zinc chloride — known corrosive agents capable of causing tissue necrosis — was found to be an unapproved new drug marketed with disease-treatment and anti-cancer claims in violation of FD&C Act sections 505(a) and 301(d). FDA noted a prior 2019 warning letter to a related entity and a voluntary recall of a similar product, and warned that failure to address violations may result in seizure and injunction.

Fibromyalgia Treatment Group - FTG, LLC

FDA issued a warning letter to Fibromyalgia Treatment Group - FTG, LLC (James L. Sparling, Manager) in August 2021 for marketing four products—Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support—with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The websites made explicit claims about treating fibromyalgia, neuropathy, depression, cancer, diabetes, and other conditions without FDA approval, and falsely stated that their manufacturing facility was 'FDA approved.' FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and injunction.

Infusion Options, Inc.

FDA issued a warning letter to Infusion Options, Inc. (Brooklyn, NY), an outsourcing facility registered under section 503B, following a 2019 inspection that found sterile drug products produced under insanitary conditions, multiple CGMP violations, missing required labeling elements, and failure to submit mandatory biannual drug product reports to FDA. The compounded drug products were deemed adulterated under section 501(a)(2)(A) and (B) and misbranded under section 502(f)(1) of the FDCA. The facility had already voluntarily recalled all sterile products, permanently discontinued 503B compounding, and de-registered as an outsourcing facility prior to the letter. FDA required written acknowledgment within 15 working days and warned that failure to address violations could result in seizure or injunction.

AnazaoHealth Corporation

FDA issued a warning letter to AnazaoHealth Corporation, a Las Vegas-based 503B outsourcing facility, following a September 2019 inspection. The agency found that the facility's compounded drug products failed to meet section 503B conditions—specifically due to inadequate adverse event reporting procedures—rendering them ineligible for exemptions from FDA approval and labeling requirements. As a result, the products were deemed unapproved new drugs and misbranded under the FDCA. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Je Dois Lavoir LLC

FDA issued a warning letter to Je Dois Lavoir LLC (CEO Sandra Orozco) regarding its '365 Skinny High Intensity' weight-loss product, which laboratory analysis confirmed contained undeclared sibutramine — a withdrawn prescription drug linked to increased risk of heart attack and stroke. The product was marketed as a natural dietary supplement but was deemed an unapproved new drug and misbranded drug under the FD&C Act due to drug-intent claims on the company's website and social media. FDA warned that failure to address violations could result in seizure and/or injunction, and the firm had already voluntarily recalled the product prior to the letter's issuance.

Utah Cord Bank LLC dba Utah Cell Bank

FDA issued a Warning Letter to Utah Cord Bank LLC dba Utah Cell Bank (owner Eliott D. Spencer, PhD) following a February 2021 inspection of its Sandy, Utah facility, finding that its allogeneic cellular products—StemVive®, StemMaxx™, StemTru™, and StemCellect™—derived from umbilical cord blood, cord tissue, and amniotic membrane, are unapproved biological drugs marketed without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria required for regulation solely under section 361 of the PHS Act, and the inspection documented 14 significant CGMP/CGTP deviations including unvalidated aseptic processes, 16 uninvestigated sterility failures, and inadequate batch records. FDA warned that failure to adequately address these violations may result in seizure and/or injunction, and required a written response within 15 working days.