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www.thesafepills.org was cited for unlawfully selling unapproved and misbranded opioid drugs to U.S. consumers via the internet, specifically tapentadol products marketed under names like "Aspadol 100mg" and "Generic Nucynta," in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA found that the website introduced these drugs into interstate commerce without required FDA approval and without proper labeling safeguards. The agency emphasized that unapproved drugs pose significant public health risks because they lack assured safety and effectiveness, may be contaminated or counterfeit, and could contain varying or incorrect active ingredients. The enforcement action reflected FDA's concern about the opioid epidemic and the heightened dangers of unregulated opioid availability through internet sales.