FDA to restrict GLP-1 ingredients used in non‑approved compounded drugs

Feb 6 (Reuters) – The U.S. Food and Drug Administration said on Friday it plans to restrict GLP-1 ingredients used in non-approved compounded drugs that companies such as Hims & Hers and other compounding pharmacies have been marketing as alternatives to authorized treatments, citing concerns over quality, safety and potential violations of federal law.

Shares of online telehealth company Hims and Hers Health fell nearly 12% in after-hours trade.

The FDA said it 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 U.S. Department of Health and Human Services’ General Counsel, Mike Stuart, also said on Friday he has referred Hims & Hers to the Department of Justice for investigation over potential violations, following a review of the applicable facts.

Hims and Hers did not immediately respond to a Reuters request for comment.

The company had said earlier on Thursday that it would begin offering copies of Novo Nordisk’s new Wegovy pill at an introductory price of $49 per month, about $100 less than the brand name.

Novo Nordisk later said it would take legal action against the telehealth company over its plan to sell compounded copies of the drug.

The health regulator said that, in promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA.

It added that “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.”

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona)