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- Hims & Hers on Saturday halted its $49 compounded weight loss pill after the Food and Drug administration issued a crackdown warning.
- The FDA plans to restrict GLP-1 ingredients in compounded drugs due to safety concerns.
- Novo Nordisk's shares fell but recovered; Hims' compounded drug also lacks FDA approval.
NEW YORK — Online telehealth company Hims & Hers on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight loss pill after the Food and Drug Administration said it would take action against it.
"Since launching the compounded semaglutide pill on our platform, we've had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said.
The FDA said on Friday that it plans to restrict GLP-1 ingredients used in compounded drugs that companies such as Hims and compounding pharmacies have marketed, citing concerns over quality, safety and potential violations of federal law.
The Department of Health and Human Services said it would refer the company to the Department of Justice, but did not make clear whether it could quickly halt the sale of the Hims' product, the cheapest GLP-1 therapy on the market.
Reuters reported on Thursday that Hims 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.
The news caused a selloff in shares of Novo and rival Eli Lilly, whose own pill is expected to launch in April. The shares recovered some of the losses on Friday after FDA Commissioner Dr. Marty Makary tweeted his concern after the market's close on Thursday.
Hims & Hers did not respond to a Reuters query about whether it would continue selling the compounded semaglutide injection.
Federal action to limit the production of any compounded weight loss drug would be a win for Novo Nordisk, which has been losing share in the weight loss market to rival Eli Lilly and telehealth firms like Hims.
Novo and Hims had a partnership in 2025, allowing Hims to sell injectable Wegovy, but the two companies walked away with Novo saying Hims had wrongfully marketed copycats of Wegovy. Hims' CEO Andrew Dudum accused Novo of attempting to control how clinicians at Hims make decisions.
Novo Nordisk and Eli Lilly did not immediately respond to a Reuters request for comment.
Compounding, in which pharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, has flourished as Americans chase lower prices for drugs. The practice is legal under the Federal Food, Drug and Cosmetic Act in certain circumstances.
Hims' compounded drug is not FDA-approved and has not gone through clinical trials to prove efficacy.
Makary said in a statement on Friday that the agency will "use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns."
