FDA WARNING_LETTER - Sprout Health Partners LLC dba Sprout Health - August 31, 2025

The FDA issued a warning letter to Sprout Health on September 9, 2025, following a review of their website in August 2025. The review identified that Sprout Health"s website offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading under the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the claims imply that these compounded products are equivalent to FDA-approved products, which they are not, leading to their classification as misbranded under sections 502(a) and 502(bb) of the FDCA.

The FDA highlighted that the introduction or delivery of these misbranded products into interstate commerce violates section 301(a) of the FDCA. The letter emphasizes that the violations noted are not exhaustive, and Sprout Health is responsible for identifying and correcting all violations to ensure compliance with federal law. Immediate corrective actions are required, including ceasing misleading claims.

Sprout Health must respond within 15 working days, detailing steps taken to address the violations and prevent recurrence. Failure to comply may result in legal actions, including seizure or injunction. The letter also notes that if Sprout Health operates outside the U.S., their products may be detained or refused entry into the U.S. The FDA encourages Sprout Health to provide reasoning and supporting information if they believe their products are not in violation. Correspondence should be directed to the Office of Compounding Quality and Compliance.