FDA WARNING_LETTER - Belle Health LLC dba Belle - December 31, 2025

The FDA issued a Warning Letter to Belle Health LLC dba Belle on February 20, 2026, after reviewing their website, joinbelle.com, in December 2025. The agency found that Belle's website offers compounded semaglutide and tirzepatide drug products, which are misbranded. The main violation stems from false or misleading claims on the product labels displayed online, where "Belle" is identified as the compounder, despite Belle not being the actual compounding entity.

This misrepresentation violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), which stipulate that drug labeling and compounded drug advertising must not be false or misleading. Introducing these misbranded products into interstate commerce is a prohibited act under section 301(a) of the FDCA.

Belle Health LLC is required to provide a written response to the FDA within fifteen working days, detailing immediate actions taken to address these violations and prevent recurrence. This includes identifying the actual compounders of the products, providing representative labeling samples, and modifying or removing any other false or misleading claims on their website. Failure to comply could result in further legal action, including product seizure and injunction.