FDA WARNING_LETTER - Dr. Gater’s Weight Loss & Wellness

On September 9, 2025, the FDA issued a warning letter to Dr. Jameelah Gater of Dr. Gater’s Weight Loss & Wellness after reviewing the company’s website earlier that month. The investigation revealed that the business was marketing compounded versions of semaglutide and tirzepatide—medications commonly used for weight loss—using false and misleading information. Specifically, the website incorrectly claimed these compounded products were "FDA Approved" and referred to them as "generic" versions of brand-name drugs such as Ozempic, Wegovy, and Mounjaro. The FDA emphasized that compounded drugs do not undergo the same rigorous approval process as brand-name or generic drugs and therefore cannot be marketed as FDA-approved or generic equivalents. These actions violate the Federal Food, Drug, and Cosmetic Act, which classifies products with deceptive labeling or advertising as misbranded and prohibits their sale. The FDA requested that the company immediately stop using the misleading language and address the identified violations. Dr. Gater is required to provide a written response within 15 working days detailing the corrective actions taken to resolve these issues and prevent them from happening again. Failure to comply could lead to legal consequences, including product seizure or an injunction.