FDA intends to ‘take action’ against non-FDA-approved GLP-1 drugs

The U.S. Food and Drug Administration announced its intent to take decisive 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 (HIMS) and other compounding pharmacies – as similar alternatives to FDA-approved drugs. These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy, the FDA said. The FDA is also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025. In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient. The FDA will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns. Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Publicly traded companies that make GLP-1s include Eli Lilly (LLY) and Novo Nordisk (NVO).