FDA WARNING_LETTER - Bliv Wellness LLC dba Bliv - December 31, 2025

The FDA issued a Warning Letter to Bliv Wellness LLC dba Bliv on February 20, 2026, following a December 2025 review of their website, joinbliv.com. The agency found that Bliv Wellness was offering compounded semaglutide and tirzepatide drug products. A key violation identified was that the company"s website falsely suggested Bliv was the compounder of these drugs when it was not. This misrepresentation causes the products to be "misbranded" under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), which address false or misleading labeling and advertising for compounded drugs. Introducing these misbranded products into interstate commerce is a prohibited act under FDCA section 301(a).

The FDA requires Bliv Wellness to take immediate action. The company must provide a written response within fifteen working days, detailing the specific steps taken to correct the violations and prevent their recurrence. This response should include identifying the actual producers of the compounded products, supplying representative labeling samples, and addressing or modifying all false or misleading claims on their website. Failure to adequately address these violations may lead to further legal actions, including seizure or injunctions.