FDA Crackdown: 18 Warning Letters Issued Over Illegal Marketing of Unapproved Botox and Neurotoxin Injectable

In early November 2025, the FDA took decisive enforcement action against 18 online entities marketing unapproved or misbranded Botox (botulinum toxin type A) and similar cosmetic injectable products. Notable named companies/websites include glowface.store, glownestbeauty.com, koreafillerexperts.com, maypharm.net, and mjsmedicals.com, all found to be operating outside legal pharmaceutical and consumer safety regulations. These businesses were ordered to cease operations, remove unapproved products, and correct regulatory breaches under threat of prosecution and shutdown.

Dangers of Unapproved and Counterfeit Botox

Unapproved and counterfeit Botox products represent a serious threat to public health, primarily because they sidestep the strict regulatory standards established by the FDA for safety, efficacy, and labeling. These illicit products may be produced in unsanitary conditions, contain dangerous concentrations of botulinum toxin, or lack information on proper dosage, ingredients, or origins. Contamination, adulteration, and improper compounding methods increase the risk of severe allergic reactions, paralysis, botulism, and even death. Furthermore, the use of these products by unlicensed practitioners or through direct-to-consumer online marketplaces further magnifies these risks, as patients are often unaware of the product’s authenticity, safety profile, or legal status. Investigations have revealed hospitalizations, lasting neurological damage, and fatalities caused by such improperly sourced, misbranded cosmetic injectables. Vigilance, and acquiring Botox only from licensed healthcare professionals, remains essential to avoid these dangers.

FDA and Press Statements

FDA Commissioner Marty Makary emphasized, “Unapproved and misbranded Botox products carry serious health risks. Today we’re taking action to protect US consumers and prevent online entities from selling these dangerous products.”​

All FDA-approved neurotoxin products in the U.S. carry a boxed warning: the agency’s most serious caution, due to potential for toxin spread causing life-threatening injury.

Industry and Global Impact

The rise of cosmetic e-commerce and social media “medical” marketplaces enables sellers to reach large audiences with illegitimate products, frequently hidden behind professional marketing or fake reviews. Global health authorities in the UK, Canada, and Australia have reported Botox-linked scandals, some resulting in cross-border investigations, regulatory action, and legal penalties for both companies and practitioners.

Guidance for Consumers and Providers

Only obtain Botox and related injectables from licensed, medically qualified professionals

Never purchase or accept cosmetic injectables from online discounters, unlicensed clinics, or unverifiable sources

Be suspicious of ambiguous product origin, low pricing, or websites with poor transparency

Report suspected counterfeit or adverse events immediately to the FDA MedWatch program

Guidance on Botulism

If a consumer experiences symptoms of botulism such as double or blurred vision, difficulty swallowing or speaking, muscle weakness that descends through the body, or trouble breathing immediate action is needed. Botulism is a medical emergency, and prompt intervention can be life-saving. The affected individual should seek urgent medical care.

Reporting the case to public health authorities or the FDA can assist with rapid public health response and prevent further cases.

Legal and Ethical Dimensions

Marketing and selling unapproved cosmetic injectables violates the U.S. Food, Drug, and Cosmetics Act, with serious consequences including fines, shutdowns, prosecution, and industry bans. Ethical responsibilities lie with manufacturers, prescribers, and outlets to ensure rigorous sourcing and patient safety first.