The U.S. Food and Drug Administration (FDA) on Wednesday sent warning letters to 18 cosmetic websites for allegedly illegally marketing counterfeit or unapproved botulinum toxin products. The agency is acting after reports of adverse events associated with these products, including botulism symptoms.

Botulinum toxin injectable products come with a boxed warning, the FDA’s most serious warning that indicates a particular drug carries significant risk of serious or life-threatening side effects. Botulism in these cases—iatrogenic botulism, from injected medicines—happens when too much of the Clostridium botulinum toxin is injected. In approved products, the number of units that need to be injected to be effective vary between brands. With these counterfeit products, the lack of these established and studied protocols makes the risk to patients much higher.

The FDA approval process is in place to keep patients safe. New drugs must go through extensive clinical trials and testing before they get introduced to the public. Even drugs that are widely used in other countries must be evaluated and cleared by the FDA before they can be legally sold and marketed in the U.S. to treat patients. 

Providers who buy from these sites and use unapproved or misbranded drugs on patients are violating FDA regulations. They open themselves up to state & FDA enforcement, and it goes against the ethos of responsible practice.

Commit to safe, ethical operations alongside a community of like-minded med spa professionals. Become an AmSpa Member to access the education, networking and brand partnerships you need to run an aesthetic practice the right way.

Further Reading:

• What Are the Rules for Who Can Inject Neurotoxins?
• Injectables Safety: What Patients Should Know About Dermal Filler and Neurotoxin
• Shady at Best, Dangerous to Patients at Worst | Parallel Importation