FDA WARNING_LETTER - Fitish Holdings, LLC - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to FITISH following a March 2026 review of the company’s website. The investigation revealed significant violations concerning the marketing of compounded drug products, specifically those containing semaglutide and tirzepatide. The FDA identified that FITISH was operating in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act by making false or misleading claims that resulted in the misbranding of their products. A primary issue identified was that FITISH"s labeling suggested the company was the actual manufacturer of the drugs, which was found to be untrue. Additionally, the company made claims linking their products to brand-name drugs such as Ozempic, Mounjaro, and Zepbound. These representations misleadingly implied that the compounded drugs were FDA-approved or had been evaluated for safety and effectiveness, when compounded drugs actually bypass the standard FDA drug approval process. To comply with the regulatory framework, FITISH is required to investigate the root causes of these violations and implement corrective measures to prevent recurrence. The FDA has mandated a written response within 15 business days, which must include identification of the actual drug manufacturers, representative samples of product labeling, and evidence that misleading website claims have been corrected or removed. Failure to address these concerns promptly may result in legal action, including product seizures or injunctions.