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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

Other peptide medications are intended to treat conditions like: Certain cancers Osteoporosis Irritable bowel syndrome (IBS) and other gastrointestinal issues Severe chronic pain Heres something especially important to know: that many of the peptide products teens hear about online are very different from those medical treatments

In coordinated proceedings overseen through a judicial panel process and managed by the MDL court (including matters before District Judge Karen Marston), consistent documentation is often the difference between a claim that can be evaluated and one that cannot

doi: 10.1159/000485089 187 McNeilEMAstellKRRitchieA-MShaveSHoustonDRBakraniaPet al