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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. The agency said the actions are intended to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy. The agency also emphasized ongoing concerns around promotional claims and direct-to-consumer messaging, building on the 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, the agency said

The fact that you can see benefits within 3 to 6 months points to other mechanisms that may be involved more rapidly than what we would typically look at in terms of weight change, said Plutzky