Hims Withdraws Compounded Wegovy Pill After FDA Referral to Justice Department

Hims and Hers Health last week said it would offer a much cheaper $49 version of Novo Nordisk's Wegovy weight-loss pill, before backing off the plan after the Food and Drug Administration said it would take steps against the company. The online health company announced the move Saturday, just two days after introducing the pill.

The FDA has since referred Hims to the Department of Justice for potential legal violations, according to the Department of Health and Human Services general counsel. The Justice Department could seek a court injunction or civil or criminal fines against Hims for violating the Food, Drug and Cosmetic Act by marketing an unapproved drug, said three attorneys.

The general counsel told CNBC on Monday that the agency's actions were in part motivated by protecting the investment that pharmaceutical companies have made in pursuing traditional FDA approval, and in ensuring the products are safe. "When you look at compounders versus the pharmaceutical industry generally, these compounders haven't spent that inordinate amount of money making sure that they're safe and effective," he said.

The withdrawn pill was a knockoff version of a new oral form of Wegovy, a popular weight-loss drug that had previously been available mainly as an injection. Since the pill's launch in early January, about 170,000 people have purchased the Wegovy pill. Novo's pill costs $149 out of pocket for the first month and $199 for each month after. Hims had announced it would sell its version for $49 the first month and $99 after that, drawing immediate criticism.

Weight-loss drug manufacturers including Novo and rival Eli Lilly have scrambled to meet skyrocketing demand for their blockbuster products. Drugmakers have argued that some compounders, which mix drug ingredients to create customized pharmaceuticals, are illegally marketing unapproved copies of their products.

Compounded pharmaceuticals are legal in the U.S. under narrow provisions of the Food, Drug, and Cosmetic Act, meant to allow production of drugs during a shortage or when a patient requires personalization due to medical concerns. Without those conditions, the FDA can take enforcement actions against drug compounders when they essentially sidestep the federal drug approval process by manufacturing products already available for commercial sale, three attorneys told Reuters. Hims has argued its products are legal because they are tailored to patients' medical needs.

At question is whether Hims' products are sufficiently personalized to be allowable under federal law, which is difficult to ascertain due to a lack of public information about the company's manufacturing and prescription practices, said two attorneys with expertise in FDA regulations. As a next enforcement step, the FDA could inspect Hims' records to evaluate whether their prescriptions are properly documented, alone or in coordination with state regulators that license compounding pharmacies.

Because Hims said on Saturday that it will no longer offer the compounded weight-loss pill, the Department of Justice could decide not to take action against the company after all. "If Hims has already stepped back and is saying we're not going to do this, it's not clear there's a case or controversy here," said an attorney at Epstein, Becker & Green, P.C.

The administration could turn its attention to Hims' compounded injectable weight-loss drugs, which are also based on the active ingredient semaglutide found in Novo's Wegovy. It would face a more complex case due to the varied dosages and inactive ingredients in injectables that compounders can more easily argue are permitted under the law.

To pursue legal action, the FDA needs the assistance of the Justice Department because the agency lacks independent litigating authority. The agencies typically work closely together, with the FDA's counsel's office providing interpretation of the Food, Drug and Cosmetic Act while the Justice Department leads litigation. "If the FDA refers something, then Justice typically acts on it," said the chair of the FDA regulatory practice at Lowenstein Sandler and former general counsel for Novo Nordisk.

Novo Nordisk's pill uses a special absorption method called SNAC, which helps the drug work in pill form. Without that technology, "it just simply doesn't work," the CEO stated. He warned that customers buying the cheaper pill would be "wasting $49." Hims said its pill used a different method, called liposomal technology, to help with absorption. The company did not say whether it had conducted clinical trials to test whether the approach was effective.

Hims is one of the largest sellers of compounded weight-loss drugs, products mixed by pharmacies that are not approved through large clinical trials. While compounding is sometimes allowed during drug shortages, the FDA ordered companies last year to stop selling compounded versions of popular weight-loss drugs once supplies improved. The company reported it was on track to earn $725 million last year from weight-loss products and spent $681 million on marketing in the first nine months of 2025.

HHS sent warning letters last September to Novo, Hims and other companies warning them about misleading advertising. The FDA on February 5 told Novo that a television advertisement for its weight-loss pill misleadingly suggested that Wegovy offers an advancement or improvement over other GLP-1 drugs.