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AceCosm was cited for introducing unapproved new drugs and misbranded injectable botulinum toxin 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 prior to offering these injectable drug products for sale to U.S. consumers, creating serious public health risks including potential contamination, counterfeit formulations, inconsistent active ingredient amounts, and life-threatening conditions such as septicemia or sepsis. The FDA demanded that AceCosm cease offering all unapproved and misbranded drugs for sale immediately.