Medical Spa / Aesthetics

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.

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.

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.

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.

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.

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.