By Katherine Hamilton


The Food and Drug Administration is initiating a crack-down on Hims & Hers and other sellers of non-FDA-approved weight-loss drugs.

The FDA said Friday it would take "decisive steps" to restrict non-approved drugs that use GLP-1 active pharmaceutical ingredients. The FDA also said it will aim to combat advertising from drug companies, including Hims & Hers.

"The FDA will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns," the FDA said, adding that failure to address any violations could result in legal action.

Mike Stuart, general counsel for the U.S. Health Department, said in a post on X that his office had referred Hims & Hers to the Justice Department for potential violations of the federal Food, Drug, and Cosmetic Act.

"Hims & Hers has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law," a spokesperson for the company said in response to the FDA's actions.

The FDA sent warning letters last fall telling companies they cannot claim products not approved by the FDA are generic versions of, or the same as, drugs approved by the agency.

Shares of Hims & Hers slid 14% to $19.81 in after-hours trading Friday.

Hims & Hers sells compounded versions of GLP-1s which generally include the same active ingredients as drugs like Wegovy or Ozempic, but are produced by compounding pharmacies instead of the original manufacturer. They aren't FDA-approved.

On Thursday, Hims & Hers said it would start offering copies of Wegovy for a starting price of $49 a month. The copycat version uses the same ingredient, semaglutide, as Wegovy.

Novo Nordisk, the maker of Wegovy, responded by accusing the telehealth company of "illegal mass compounding." It said it would take legal and regulatory action against Hims & Hers, arguing that the move posed a risk to patient safety.

Hims & Hers said Novo Nordisk's claims were false.


Write to Katherine Hamilton at katherine.hamilton@wsj.com


(END) Dow Jones Newswires

02-06-26 1838ET