U.S. FDA Signals Crackdown on Non-approved Compounded GLP-1 Weight-loss Drugs Marketed to Consumers

Silver Spring, Maryland — The Food and Drug Administration said Friday it plans to take “decisive steps” to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded drugs that are being mass-marketed as alternatives to brand-name weight-loss and diabetes medications—an expanding market that has reached many families through direct-to-consumer telehealth ads.

In a statement dated Feb. 6, 2026, FDA Commissioner Martin A. Makary said the agency is concerned about products for which it “cannot verify quality, safety, or efficacy,” and warned that potential violations of the Federal Food, Drug, and Cosmetic Act will be taken seriously.

The FDA also said it is stepping up efforts to combat misleading advertising after warning letters sent in fall 2025. The agency said promotions for compounded GLP-1 products cannot claim the products are “generic” versions of FDA-approved drugs, “the same as” approved drugs, or “clinically proven,” and cannot represent that compounded products use “the same active ingredient” as FDA-approved medications.

For parents, the message is practical: if a weight-loss or diabetes drug is being offered through an online subscription or promoted heavily on social media, ask the prescriber whether it is an FDA-approved product, and confirm exactly what you are being dispensed and by whom. Keep copies of labeling and receipts, and report suspected side effects through the FDA’s reporting channels.

The agency said it will use enforcement tools that can include seizure and injunction for firms that fail to address violations.