FDA WARNING_LETTER - FWD Care, Inc. dba FWD - August 31, 2025

The FDA issued a warning letter to FWD regarding their website content, reviewed in August 2025, which promotes compounded drug products, including semaglutide and tirzepatide. The FDA identified that claims on the website suggest these compounds are equivalent to FDA-approved drugs like Wegovy, Ozempic, Zepbound, and Mounjaro. Such claims are deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded. This misbranding violates section 301(a) of the FDCA, which prohibits introducing misbranded products into interstate commerce.

The FDA requires FWD to take immediate corrective action, including ceasing the use of misleading language. The company must respond within 15 working days, detailing steps taken to rectify the violations and prevent recurrence. Failure to comply may lead to legal actions, including product seizure and injunctions. FWD is also advised to provide reasoning and supporting information if they believe their products do not violate the FDCA. Correspondence should be directed to the Office of Compounding Quality and Compliance, with a clear subject line indicating a response to the warning letter.