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Glam Derma was cited for introducing unapproved and misbranded injectable botulinum toxin (Botox) products into interstate commerce through its 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 prior to marketing and distribution, and the products lacked proper labeling and regulatory oversight required for injectable pharmaceutical products. The FDA emphasized that unapproved injectable drugs pose serious health risks including contamination, variable active ingredient concentrations, and life-threatening conditions such as sepsis, and demanded the company cease offering these products to U.S. consumers.