Hims & Hers, a major online provider of obesity medications, said on Saturday that it would stop selling a cheap knockoff version of Novo Nordisk’s new pill version of its popular weight loss drug Wegovy, bowing to pressure from federal regulators who suggested the product might be illegal.
Hims had just introduced the offering on Thursday and was immediately met with sharp backlash. On Friday, the top lawyer for the Department of Health and Human Services, Mike Stuart, wrote on X that his office had referred Hims to the Justice Department for potential violations of a federal law that regulates the sale of medications.
In a statement, Hims said its decision to cancel the pill offering was made after “constructive conversations with stakeholders across the industry.”
The company was attempting to capitalize on consumers’ stunning desire for Novo’s new Wegovy pill, The tablet version is expected to usher in even more demand for the drugs, which until now were generally only available as injections. About 170,000 people have purchased the Wegovy pill since it was introduced in early January. People can use their own money to buy it for $149 for the first month and $199 for each month after that.
Novo’s pill is prominently featured on TrumpRx, a new government website that is intended to help patients pay the lowest prices for certain medicines.
But just hours before President Trump unveiled the TrumpRx site on Thursday night, Hims upstaged him. The company announced that its knockoff of Novo’s pill would cost $49 for the first month and $99 for each subsequent month — cheaper than the president’s price.
That same evening, the F.D.A. commissioner, Dr. Marty Makary, alluded to the uproar, saying that the agency would “take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The agency said in a news release that Hims would be among the companies scrutinized.
Hims is widely believed to be the largest provider of copycat versions of weight-loss drugs produced through a process known as compounding. The company does not invent drugs, nor does it perform the large, expensive clinical trials necessary to demonstrate that a medication is safe and effective. Compounded weight loss products were banned by the Food and Drug Administration last year, though some sales have continued.
Critics said that Hims’s new pill represented a brazen attempt to steal customers from Novo Nordisk, which has patents protecting both its injectable and pill versions of Wegovy. The F.D.A. has approved both products.
“It’s so far beyond what compounding was meant to solve that it’s hard to understand how Hims thought that this could be a legitimate practice,” Dr. David Kessler, a former F.D.A. commissioner who last year published a book about weight-loss drugs, said in an interview.
Dr. Kessler said the decision by Hims to sell a pill version was especially egregious because Hims relied on a technology that was different than what Novo used to help the body properly absorb the drug.
“This was not a copy,” Dr. Kessler said. “This was a different technology that was being used.”
“I’m not aware of any clinical trial data that suggests that the product that they wanted to sell actually worked using the technology that they used,” he added.
In a call with analysts on Thursday, Novo Nordisk’s chief executive, Mike Doustdar, said that consumers would be “wasting $49” if they bought Hims’s version because it lacked special technology, known as SNAC, that Novo Nordisk had developed to help the body properly absorb the pill.
Without Novo Nordisk’s technology, “it just simply doesn’t work,” Mr. Doustdar said.
Hims said its knockoff version used “liposomal technology that is intended to support absorption.” The company did not respond to questions about whether it had conducted clinical trials to test its version of the Wegovy pill with that technology. Hims has not published or announced any such results.
Critics also accused Hims of undermining the F.D.A.’s role as a gatekeeper and of creating a dangerous precedent that could discourage drugmakers from investing in inventing and testing new treatments. If the knockoff pill were allowed, they said, what would stop Hims or other companies from immediately producing and selling their own versions of other patent-protected medications?
Novo Nordisk has struggled mightily in recent months as it has lost market share to Eli Lilly, the maker of the rival weight-loss drug Zepbound, as well as to providers like Hims.
Novo Nordisk’s stock price has plummeted since its peak in mid-2024, erasing hundreds of billions of dollars in market value. The company’s stock has now fallen to below where it was when the weight-loss drug craze began around 2022.
Compounding, which was meant to be a backstop during shortages and to allow pharmacists to customize medicines for patients with allergies, has been around at a small scale for decades. As the interest in weight-loss drugs soared a few years ago, far outpacing the demand Novo Nordisk and Eli Lilly had anticipated, the F.D.A. allowed compounding of those weight-loss drug injections because of the shortages.
Hims and Hers seized on the opportunity and extensively expanded its business. The company said in November that it was on pace to bring in $725 million in revenue last year from a category of weight-loss drugs that included both brand-name and compounded products. The company spent $681 million on marketing in the first nine months of 2025.
But supply of the brand-name drugs improved as Novo Nordisk and Eli Lilly ramped up production, and last spring, the F.D.A. ordered the compounders to stop producing and selling their products. But sales of the compounded versions have continued, with companies like Hims and Hers adding vitamins or tweaking dosages of the drugs, asserting that would still be allowed. The strategy to circumvent the ban on compounding falls in a legal gray area.
Hims has run afoul of regulators before. Last September, the F.D.A. sent the company a warning letter ordering it to stop “false or misleading” marketing. And in an opinion article published in the medical journal JAMA, Dr. Makary accused the company of engaging in a “breach of F.D.A. regulation” with its Super Bowl ad last year.
That ad touted Hims’ weight-loss drugs, but it did not detail their side effects as a traditional pharmaceutical ad would. Instead, fine print at the end of the ad directed patients to the company website “for details and important safety information.”
Hims is expected to air another advertisement during the Super Bowl on Sunday. The ad promotes its weight-loss drug offerings, though it does not feature the now-withdrawn version of the Wegovy pill.
Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.
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