Functional Medicine

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.

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.

Zaappaaz LLC

The FTC filed suit against Zaappaaz LLC, operators of wrist-band.com and other online storefronts, for failing to deliver PPE products (face masks, sanitizer, etc.) as promised during the COVID-19 pandemic. The company allegedly violated the FTC's Mail, Internet and Telephone Order Rule by not notifying consumers of shipping delays and failing to offer timely cancellations and refunds. This case is primarily a shipping/fulfillment enforcement action rather than a health-marketing claim case.

American Screening, LLC

The FTC filed suit against American Screening, LLC for failing to fulfill shipping promises on PPE products including face masks and sanitizer during the COVID-19 pandemic. The company allegedly violated the FTC's Mail, Internet and Telephone Order Rule by not notifying consumers of shipping delays in a timely manner and failing to offer cancellations and prompt refunds. This is a consumer protection enforcement action related to order fulfillment practices rather than health marketing claims.

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.

Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC

FDA issued a warning letter to Dr. Maggie Jeffries of Avanti Anesthesiology, LLC in Houston, TX, following a 2021 inspection of two clinical investigations involving investigational drugs including MKO Melt®, diazepam, tramadol, ondansetron, and midazolam/ketamine. The agency found that Dr. Jeffries conducted Protocol ANES001 without a required IND, as the study did not qualify for an exemption under 21 CFR 312.2(b)(1) due to significantly increased patient risks from drug combinations and dosing in a cataract surgery population. Additionally, Dr. Jeffries failed to provide subjects with copies of informed consent forms and failed to identify experimental procedures or foreseeable risks in the consent documents. FDA required a written response within 15 business days detailing corrective actions, warning that failure to respond adequately could lead to further regulatory action.

QYK Brands LLC d/b/a Glowwy

The FTC filed suit against QYK Brands LLC d/b/a Glowyy, an online retailer, for failing to ship face masks, sanitizer, and other PPE in a timely manner during the COVID-19 pandemic. The company allegedly violated the FTC's Mail, Internet and Telephone Order Rule by not notifying consumers of shipping delays and failing to offer cancellations and prompt refunds. This case concerns e-commerce fulfillment practices rather than health marketing claims specifically.

ALG-Health LLC, et al., U.S. v.

The FTC, via DOJ referral, charged Adam J. Harmon and ALG-Health LLC with falsely claiming that PPE products and light fixtures were made in the United States during the COVID-19 pandemic. The complaint alleged the products were wholly imported or incorporated significant imported materials, and that defendants falsely represented their respirators as NIOSH-certified U.S.-origin products. Under the proposed consent order, defendants must cease deceptive Made-in-USA claims, provide substantiation for all such claims and COVID-19-related claims, and pay a civil penalty of $157,683.37. This case does not involve physician-led health clinic marketing and has no direct relevance to the sub-verticals in scope.

Gravity Defyer, FTC v.

The FTC filed a federal complaint against Gravity Defyer Medical Technology Corporation and its owner Alexander Elnekaveh for allegedly deceptive pain-relief marketing claims for their footwear products. The FTC alleged Elnekaveh violated a prior 2001 order by making scientifically unsupported efficacy claims and using misleading consumer testimonials. A final order was entered in February 2025 permanently barring the defendants from the deceptive advertising practices and requiring payment of a $175,000 civil penalty.

R360, FTC v.

The FTC took action against R360 LLC and its owner Steven Doumar for deceiving consumers seeking addiction treatment about the evaluation and selection criteria used to recommend treatment centers in their network. This was the FTC's first enforcement action under the Opioid Addiction Recovery Fraud Prevention Act of 2018. The agency secured a $3.8 million civil penalty judgment and an order prohibiting the defendants from continuing to make the same misrepresentations.

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.

Physician's Technology, LLC

Physician's Technology, LLC, marketers of the Willow Curve low-level light therapy (LLLT) device, settled FTC charges in June 2020 after being accused of deceptively claiming the device treats chronic, severe pain and associated inflammation without adequate scientific evidence. The FTC alleged the device was promoted as 'smart' and 'clinically proven' since 2014 despite lacking substantiation. Two defendants were each required to pay $200,000 to the Commission. In August 2021, the FTC distributed more than $350,000 in refunds to defrauded consumers.

Neurometrix, Inc.

Neurometrix, Inc., marketer of the Quell electrical nerve stimulation device, settled with the FTC in March 2020 over deceptive claims that the device treats pain throughout the body when worn below the knee. The FTC found the company falsely claimed clinical proof of efficacy and misrepresented FDA clearance as covering full-body pain treatment. As part of the settlement, Neurometrix agreed to pay $4 million and cease the challenged claims; nearly $3.9 million was subsequently returned to defrauded consumers in September 2020.

Lawrence L. Duskin

The FTC brought a civil penalty action in the Northern District of California against Lawrence L. Duskin, individually and doing business as HollywoodColorContacts.com, WorldColorContacts.com, and TopModelContacts.com. The case involves consumer protection violations related to contact lens advertising and marketing, including health claims. The enforcement type is civil penalties, indicating serious regulatory violations. No specific dollar penalty amount is stated in the available document text.