FDA WARNING_LETTER - Thrivelab Co. dba Thrivelab - March 01, 2026
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On June 8, 2026, the FDA issued a warning letter to Thrivelab Co. (dba Thrivelab) following a review of the company"s website conducted in March 2026. The review identified significant violations regarding the marketing and promotion of compounded semaglutide drug products. The FDA determined that Thrivelab engaged in misbranding by making false or misleading claims that suggest their products are equivalent to FDA-approved medications. Specifically, the website claimed their drugs contained the "same active ingredient" as Ozempic and Wegovy and were "clinically proven to work." However, compounded drugs do not undergo FDA approval for safety or effectiveness. Additionally, the FDA noted that Thrivelab’s labeling improperly suggested the company was the actual manufacturer of the drugs. These actions violate the Federal Food, Drug, and Cosmetic Act, which prohibits the sale of misbranded drugs and misleading advertising. Thrivelab is required to submit a written response within 15 business days detailing their corrective actions. This must include identifying the actual producers of the drugs, providing updated labeling, and removing all misleading claims from their website to ensure future compliance with federal law.
ID · 2771edd4-7945-4539-bc05-6c1383083f02
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