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Estaderma, a South Korea-based company, was cited for introducing unapproved and misbranded injectable botulinum toxin (Botox) products into U.S. interstate commerce through its website in violation of the Federal Food, Drug, and Cosmetic Act sections 301(a), 301(d), 503(b), and 505(a). The company failed to obtain FDA approval for these new drug products prior to marketing them and did not maintain proper drug labeling and safety documentation. The FDA emphasized that injectable unapproved drugs pose serious risks including contamination, counterfeit formulations, variable ingredient amounts, and potentially life-threatening conditions such as sepsis, and requested immediate cessation of all sales to U.S. consumers.