Weight a minute. FDA moves to restrict copycat GLP-1 weight loss drugs

The U.S. Food and Drug Administration announced Friday it will take steps to restrict GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies including Hims & Hers and other compounding pharmacies.

The FDA said these compounded products are marketed as alternatives to FDA-approved drugs, but the agency cannot verify their quality, safety, or efficacy. The regulatory action targets companies that the FDA says are potentially violating the Federal Food, Drug, and Cosmetic Act.

The agency is also addressing misleading direct-to-consumer advertising following warning letters sent in fall 2025. Companies cannot claim that non-FDA-approved compounded products are generic versions or equivalent to FDA-approved drugs, according to the FDA. Marketing materials also cannot state that compounded drugs use the same active ingredient as FDA-approved drugs or that they are clinically proven to produce results.

The FDA stated it will use all available compliance and enforcement tools to address what it calls unsubstantiated claims and associated public health concerns. Companies involved in manufacturing, distributing, or marketing unapproved compounded GLP-1 products face potential legal action without further notice, including seizure and injunction, if they fail to address violations.