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GenLabMeds sold unapproved and misbranded compounded drug products, including retatrutide, semaglutide, and tirzepatide, directly to U.S. consumers via their website in violation of Federal Food, Drug, and Cosmetic Act sections 505(a), 502(f)(1), 301(a), and 301(d). The company made false or misleading claims regarding these compounded products' safety and efficacy without FDA approval or proper labeling with adequate directions for use. The violations included offering retatrutide as an unapproved new drug and failing to comply with requirements for compounded drug products under sections 503A and 503B of the FDCA.