Loading…
Aesthetic Essentials Limited was cited for introducing unapproved and misbranded injectable botulinum toxin products into interstate commerce through their website, violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval for these new drugs and did not ensure proper labeling, creating significant safety risks to consumers including potential contamination, counterfeit products, inconsistent active ingredient concentrations, and serious injection-related complications such as sepsis. The FDA emphasized that unapproved injectable drugs pose inherent dangers by bypassing the body's natural defenses and lack the safety and effectiveness assurances provided through FDA regulatory oversight.