Dr. Gater’s Weight Loss & Wellness

Warning LetterOpen

United StatesIssued Sep 9, 2025Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateSep 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dr. Gater’s Weight Loss & Wellness
Location: United States
FEI Number: N/A
Country: United States
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Dr. Gater's Weight Loss & Wellness was cited for unlawfully selling unapproved and misbranded compounded drugs (semaglutide and tirzepatide) via their website. The company made false or misleading claims including labeling compounded products as "FDA Approved," falsely describing semaglutide as a "generic version" of Ozempic/Wegovy, and claiming compounded semaglutide was the "generic equivalent" of brand-name products, all in violation of the Federal Food, Drug, and Cosmetic Act sections 502(a) and 502(bb). These marketing practices resulted in unapproved drug products being introduced into interstate commerce without proper regulatory authorization.

Dr. Gater’s Weight Loss & Wellness FDA Warning Letter, September 9, 2025