FDA WARNING_LETTER - Amie Health, Inc. dba Amie - March 01, 2026

On June 8, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Amie Health, Inc. (dba Amie) following a March 2026 review of the company’s website. The FDA identified significant violations concerning the promotion and labeling of compounded drug products, specifically semaglutide and tirzepatide.

The investigation revealed that Amie Health’s website featured false or misleading claims about their products. One primary concern was that product labels displayed the company’s name, "Amie," incorrectly implying they were the actual manufacturer. Additionally, the company claimed their compounded treatments used "FDA-approved active ingredients" and were equivalent to brand-name medications like Ozempic, Mounjaro, and Wegovy. The FDA emphasized that compounded drugs are not FDA-approved, and such claims misleadingly suggest the agency has evaluated these specific products for safety and effectiveness.

These actions violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the sale of misbranded drugs in interstate commerce. Specifically, the violations fall under sections of the Act regarding misleading labeling and advertising.

To resolve these issues, the FDA requires Amie Health to respond within 15 business days. The response must include a plan to correct current violations and prevent future ones. Specifically, the company must identify the actual manufacturers of the drugs, provide sample labels, and modify or remove misleading website claims. Failure to comply may result in legal consequences, such as the seizure of products or court-ordered injunctions.