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COSMO KOREA's website (www.cosmo-korea.com) was found to be introducing unapproved and misbranded injectable botulinum toxin drug products into interstate commerce 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 before offering them for sale to U.S. consumers, and the products lacked proper labeling and regulatory oversight. The FDA emphasized that unapproved injectable drugs pose serious risks including contamination, counterfeit formulations, variable active ingredient concentrations, and life-threatening conditions such as septicemia or sepsis due to the injectable route of administration bypassing natural body defenses. The FDA requested that the company cease offering these unapproved and misbranded drugs immediately.