The Food and Drug Administration said Friday it intends to restrict access to GLP-1 drug ingredients used in unapproved compounded weight-loss products.
The company Hims & Hers Health Inc. could face federal enforcement, a move the agency said is aimed at curbing mass-marketed copycat weight-loss drugs.
In a statement dated Feb. 6, FDA Commissioner Martin A. Makary said the agency is taking steps to restrict GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs.
The drugs are being mass-marketed as alternatives to approved treatments, including by telehealth companies and compounding pharmacies.
Compounding allows pharmacies to make custom medications or alternative dosages, a practice that is growing as Americans seek cheaper drug options.
The FDA said it would take action against Hims & Hers over its $49 weight-loss pill, including restricting access to the drug's ingredients, and that the company was referred to the Department of Justice for potential violations of federal law.
Shares of Hims fell 14.1% in after-hours trading, Reuters reported.
The FDA said companies cannot market nonapproved compounded products as generic versions of, or the same as, FDA-approved drugs, and cannot claim that compounded products use the same active ingredient as an approved drug or are clinically proven to produce results.
The agency said it may pursue enforcement, including seizure and injunction, if violations are not addressed.
The dispute intensified this week after Hims said it would begin offering compounded copies of Novo Nordisk's new Wegovy pill at an introductory price of $49 per month, roughly $100 less than the brand-name price.
Novo Nordisk said it would take legal action over the plan.
Compounded drugs are not FDA-approved, and federal law allows compounding only under specific conditions, including certain patient-specific needs and some circumstances tied to shortages.
The FDA has recently warned consumers and providers about unapproved GLP-1 products and has emphasized that it cannot verify their quality, safety, or effectiveness.
The agency also pointed to warning letters sent this past fall as part of its effort to combat misleading direct-to-consumer marketing.
One warning letter dated Sept. 9, 2025, cited claims about compounded semaglutide on a Hims & Hers-affiliated site that regulators said were false or misleading.
A Lilly spokesperson expressed support for the FDA's decision: "For years, compounders have been putting patients at risk by unlawfully mass-producing knockoff drugs using substandard ingredients from illicit foreign suppliers and selling them without clinical evidence that they're safe or even work.
"Patients deserve better, and we look forward to decisive action by the FDA, other regulators, and law enforcement."
Reuters contributed to this report.
Jim Thomas ✉
Jim Thomas is a writer based in Indiana. He holds a bachelor's degree in Political Science, a law degree from U.I.C. Law School, and has practiced law for more than 20 years.
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