FDA WARNING_LETTER - Nexlife Inc. dba Nexlife - March 01, 2026

On June 8, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nexlife Inc., doing business as Nexlife, following a March 2026 review of the company"s website. The FDA identified significant violations regarding the marketing of compounded drug products, specifically semaglutide and tirzepatide. The primary issue involves misbranding; the agency found that Nexlife"s website and product labeling contained false or misleading claims. Specifically, the labels prominently featured the "Nexlife" name, which incorrectly suggested the company was the actual compounder or manufacturer of the drugs when it was not. These actions violate the Federal Food, Drug, and Cosmetic Act, which prohibits the sale of misbranded drug products in interstate commerce to protect public health. To address these violations, Nexlife must submit a written response within 15 business days. This response should detail the corrective measures taken, identify the actual entities producing the drugs, provide updated labeling samples, and confirm the removal of misleading claims from their website. Failure to rectify these issues could result in legal actions, including product seizures or injunctions.