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Dermax Co., Ltd was cited for introducing unapproved and misbranded injectable botulinum toxin products into interstate commerce through its website (www.dermaxshop.com) 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 drugs prior to marketing them to U.S. consumers, and the products lacked required labeling and safety assurances. The FDA emphasized that unapproved injectable drugs pose serious risks of contamination, counterfeit formulations, inconsistent active ingredient concentrations, and life-threatening conditions such as sepsis, and demanded immediate cessation of sales to American consumers.