FDA WARNING_LETTER - Lovely Meds, Inc. dba Lovely Meds - August 31, 2025

**FDA Warning Letter Summary**

**Company:** Lovely Meds **Inspection Dates:** August 2025 **Main Violations/Issues:** The FDA reviewed Lovely Meds" website and found that it offers compounded drug products, specifically semaglutide and tirzepatide, with claims that are false or misleading. The website suggests these compounded products have the same active ingredients as FDA-approved drugs like Wegovy, Ozempic, Zepbound, and Mounjaro. Such claims misbrand the products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), as they imply equivalence to FDA-approved drugs, which compounded products are not. This misbranding results in the illegal introduction of these products into interstate commerce, violating section 301(a) of the FDCA.

**Regulatory Framework:** The violations are assessed under sections 502(a), 502(bb), and 301(a) of the FDCA [21 U.S.C. §§ 352(a), 352(bb), and 331(a)]. Misbranding is defined as false or misleading labeling or advertising of drug products.

**Required Actions:** Lovely Meds must immediately address these violations by ceasing the use of misleading language on their website. They are required to provide a written response within 15 working days to the Office of Compounding Quality and Compliance (OCQC) detailing the corrective actions taken. This response should include documentation of steps to prevent future violations. Failure to comply may result in legal actions, including product seizure and injunctions. If Lovely Meds believes their products are not in violation, they must provide supporting information. Correspondence should clearly reference the Warning Letter.