FDA WARNING_LETTER - Momentum Health 360 dba Momentum Health

On June 8, 2026, the FDA issued a warning letter to Momentum Health 360 (dba Momentum Health) following a March 2026 review of the company"s website. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the marketing of compounded versions of popular medications, including semaglutide, tirzepatide, and liraglutide. The FDA determined that the company’s products are misbranded due to false and misleading claims. Specifically, the website incorrectly suggested that Momentum Health was the actual manufacturer of the drugs. Furthermore, the company falsely represented its compounded products as having the same status as FDA-approved brand-name drugs like Ozempic and Mounjaro. The agency also clarified that it does not "license" or "approve" compounding facilities, making the company"s claims of using "FDA-licensed" facilities misleading to consumers. Under the FD&C Act, these violations constitute the prohibited introduction of misbranded drugs into interstate commerce. Momentum Health is required to submit a written response within 15 business days detailing its plan to correct these issues. Required actions include identifying the actual entities producing the drugs, providing updated product labels, and removing misleading advertising from their website. Failure to address these violations promptly may result in legal action, such as product seizures or court-ordered injunctions.