(Washington, D.C.) September 2, 2026 – Americans for Safe and Effective Medicines’ (ASEM) Chief Policy Officer, Fred Mills, PharmD, released the below statement following the U.S. Food and Drug Administration (FDA) updating its guidance on unapproved GLP-1 drugs used for weight loss:
“As the compounded and counterfeit weight-loss drug market continues to boom and put patients at increasing risk, the FDA is once again updating its guidance around illegally marketed and distributed compounded GLP-1 medications. While a step in the right direction, this update must be backed by aggressive enforcement action to have any meaningful impact on patient safety.
The FDA’s own public database chronicling recalled products reports that more than 230,000 compounded GLP-1 products have been recalled due to a lack of sterility since 2022. The lack of guardrails and enforcement around this parallel industry has already resulted in hospitalizations, acute liver failure, and in some cases, death.
Of equal concern is the rapidly expanding black market for retatrutide, an investigational drug for weight loss that has not yet received FDA approval and cannot be lawfully distributed outside of an authorized clinical trial or the FDA’s Expanded Access program. Online sellers and medical spas are peddling their illegal products directly to consumers who are misled into believing they are receiving a clinically validated drug—when in reality the product is subject to no oversight and sourced from unregistered foreign facilities.
ASEM recognizes that FDA has taken initial steps through warning letters; however, they carry little weight without arrests, seizures, and injunctions to back them up. ASEM urges the FDA to leverage an all-of-government response working with the U.S. Department of Justice, U.S. Customs and Border Patrol and the Federal Trade Commission to shut down this black market and protect Americans from fraudulent and illegal medicines.”