Dr. Gater’s Weight Loss & Wellness – FDA Warning Letter, Sep 30, 2025

The FDA issued a Warning Letter to Dr. Gater on September 9, 2025, following a review of the website https://drgatergetsresults.com. The inspection identified that the website offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These violations result in the products being misbranded and introduced into interstate commerce unlawfully under section 301(a) of the FDCA.

The FDA noted that the website"s claims suggest these compounded products are equivalent to FDA-approved drugs, which they are not. This misrepresentation constitutes misbranding under the FDCA. The letter emphasizes that the identified issues are not exhaustive and that Dr. Gater is responsible for ensuring compliance with all federal laws and FDA regulations.

The FDA requires Dr. Gater to take immediate corrective actions, including ceasing the misleading language and addressing all violations. A written response detailing the corrective measures and documentation must be submitted to the Office of Compounding Quality and Compliance within 15 working days. Failure to comply may result in legal actions, including product seizure and injunctions. The letter also advises that if the products are not in violation, Dr. Gater should provide supporting information for consideration.