FDA WARNING_LETTER - Lovely Meds, Inc. dba Lovely Meds - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Lovely Meds, Inc. (dba Lovely Meds) following a review of the company’s website conducted in August 2025. The regulatory action centers on the promotion and sale of compounded drug products containing semaglutide and tirzepatide. The FDA determined that Lovely Meds engaged in misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections 502(a) and 502(bb). The violations involve false or misleading claims on the company"s website, such as stating their products contain the "same active ingredient" as FDA-approved medications like Wegovy, Ozempic, Zepbound, and Mounjaro. Because compounded drugs are not FDA-approved, the agency asserts that implying they are identical to approved brand-name drugs is deceptive. Furthermore, introducing these misbranded products into interstate commerce violates section 301(a) of the FDCA. The FDA has ordered Lovely Meds to take immediate corrective action, including ceasing the use of the cited misleading language. The company must provide a written response within 15 working days outlining the specific measures taken to resolve the violations and prevent future occurrences. Failure to comply may lead to legal enforcement, such as product seizure or injunctions. This letter highlights the company"s responsibility to ensure its marketing and operations comply with all federal regulations.