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www.bigpharmausa.com was cited for unlawfully selling unapproved and misbranded opioid drugs, including tramadol products, over the internet in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's unapproved drugs lacked FDA oversight assurances and posed risks of contamination, counterfeit products, and inconsistent active ingredients. The FDA emphasized the enforcement action was critical given the severity of the opioid epidemic and the significant public health danger posed by easy internet availability of these products.