FDA WARNING_LETTER - JulyMD - August 31, 2025

**FDA Warning Letter Summary**

**Company:** JulyMD **Inspection Dates:** August 2025 **Main Violations/Issues:** The FDA identified that JulyMD"s website offers compounded drug products, including semaglutide, with claims that are false or misleading. These claims suggest that the compounded products are equivalent to FDA-approved drugs, which they are not. This misbranding violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the unlawful introduction of these products into interstate commerce, violating section 301(a) of the FDCA.

**Regulatory Framework:** The violations fall under the FDCA, specifically sections 502(a), 502(bb), and 301(a), which address misbranding and the illegal distribution of unapproved drugs.

**Required Actions:** JulyMD must immediately cease using misleading language that misbrands their products. They are required to provide a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing corrective actions taken and measures to prevent future violations. The response should include documentation of these actions. Failure to comply may result in legal actions, including product seizure and injunctions. If JulyMD believes their products are not in violation, they must provide supporting information. Delays in response must be justified with a timeline for compliance.

**Contact:** Questions should be directed to compoundinginspections@fda.hhs.gov.