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Cosmenic was cited for introducing unapproved and misbranded botulinum toxin injectable drug products into interstate commerce through its website in violation of 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 prior to marketing them to U.S. consumers, and the products lacked proper branding and regulatory oversight. FDA emphasized that unapproved injectable drugs pose serious risks including contamination, counterfeit formulations, variable active ingredient amounts, and potential life-threatening conditions such as sepsis. The agency requested that Cosmenic immediately cease offering these unapproved and misbranded drugs for sale to U.S. consumers.