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PowerAll Pharma was cited for introducing unapproved and misbranded opioid and benzodiazepine drugs into interstate commerce through its websites, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's products lacked FDA approval and proper labeling, posing significant public health risks given the ongoing opioid epidemic and the known potential for benzodiazepine abuse and polysubstance overdose deaths. The FDA emphasized that unapproved drugs do not carry the same safety and effectiveness assurances as FDA-regulated products, and the internet distribution channel made these controlled substances easily accessible to U.S. consumers.