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Meamo was cited for introducing unapproved and misbranded injectable botulinum toxin (Botox) products into U.S. interstate commerce through its website www.meamoshop.com, violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The products lacked FDA approval and proper labeling, posing serious safety risks to consumers including contamination, counterfeit formulations, inconsistent active ingredient concentrations, and potential life-threatening infections from injectable administration. The FDA emphasized that unapproved injectable drugs bypass critical regulatory safeguards and the body's natural defenses, potentially leading to septicemia or sepsis, and requested immediate cessation of sales to U.S. consumers.