https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs * Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links U.S. flag An official website of the United States government Here's how you know Dot gov The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. SSL The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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Press Announcements FDA Statement FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs More Press Announcements * For Immediate Release: February 06, 2026 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies -- including Hims & Hers 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. We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act. 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. Related Information Related Information * FDA's concerns with unapproved GLP-1 drugs used for weight loss * Compounding when drugs are on FDA's drug shortages list * FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize * Compounding and the FDA: Questions and answers * Understanding the risks of compounded drugs * FDA guidance on Section 503A of the Federal Food, Drug, and Cosmetic Act --------------------------------------------------------------------- Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 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