Hims & Hers withdraws imitation weight loss pill after official review

Hims & Hers, a major online supplier of obesity medications, said Saturday it would stop selling a cheap knockoff of Novo Nordisk’s new pill version of its popular weight-loss drug Wegovy, bowing to pressure from federal regulators who suspected the product might be illegal.

Hims only presented the offer on Thursday and was immediately met with sharp backlash. On Friday, the Health Department’s top lawyer, Mike Stuart, wrote on

In a statement, Hims said the decision to stop offering the pills was made after “constructive discussions with stakeholders across the industry.”

The company sought to capitalize on overwhelming consumer desire for Novo’s new Wegovy pill. The tablet version is expected to increase demand for the drugs, which were previously generally only available as injections. About 170,000 people have bought the Wegovy pill since its launch in early January. People can buy it with their own money for $149 for the first month and $199 for each additional month.

Novo’s pill is featured prominently on TrumpRx, a new government website designed to help patients pay the lowest prices for certain medications.

But just hours before President Trump unveiled the TrumpRx website on Thursday evening, he was eclipsed by Hims. The company said the Novo pill copycat would cost $49 the first month and $99 each subsequent month – less than the president’s price.

That same evening, FDA Commissioner Dr. Marty Makary responded to the uproar, saying the agency would “take swift action against companies that mass-market 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 under investigation.

Hims is widely believed to be the largest supplier of copycat versions of weight-loss drugs made through a process known as compounding. The company does not invent drugs or conduct the large, expensive clinical trials required to prove that a drug is safe and effective. Compound weight-loss products were banned by the Food and Drug Administration last year, but some sales have continued.

Critics said Hims’ new pill was a brazen attempt to steal customers from Novo Nordisk, which has patents protecting both its injectable and pill versions of Wegovy. The FDA has approved both products.

“It goes so far beyond what compounding was intended to solve that it’s hard to understand how Hims thought this could be a legitimate practice,” Dr. David Kessler, a former FDA commissioner who published a book about weight-loss drugs last year, in an interview.

Dr. Kessler said Hims’ decision to sell a pill version was particularly egregious because Hims relies on technology different from Novo’s to help the body properly absorb the drug.

“It wasn’t a copy,” said Dr. Kessler. “That was a different technology that was used.”

“I’m not aware of any clinical trial data that suggests the product they were trying to sell actually worked with the technology they were using,” he added.

In a call with analysts Thursday, Novo Nordisk CEO Mike Doustdar said consumers would “waste $49” if they bought the Hims version because it lacked a 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 doesn’t work,” Doustdar said.

Hims said his imitation uses “liposomal technology designed to aid absorption.” The company did not respond to questions about whether it has conducted clinical trials to test its version of the Wegovy pill using this technology. Hims has not published or disclosed any such results.

Critics also accused Hims of undermining the FDA’s role as a gatekeeper and setting a dangerous precedent that could discourage drugmakers from investing in inventing and testing new treatments. If the copycat pill were allowed, they said, what would stop Hims or other companies from immediately making and selling their own versions of other patent-protected drugs?

Novo Nordisk has struggled in recent months as it has lost market share to Eli Lilly, maker of rival weight-loss drug Zepbound, as well as players like Hims.

Novo Nordisk’s share price has plummeted since peaking in mid-2024, losing hundreds of billions of dollars in market value. The company’s shares have now fallen below the level they were when the hype about weight loss drugs began around 2022.

Compounding, intended to provide a backstop during shortages and allow pharmacists to customize medications for patients with allergies, has been around on a small scale for decades. A few years ago, when interest in weight-loss drugs surged, far exceeding the demand that Novo Nordisk and Eli Lilly had anticipated, the FDA allowed the combination of these injections with weight-loss drugs due to shortages.

Hims and Hers seized the opportunity and expanded its business extensively. The company said in November that it was on track to generate $725 million in sales last year from a category of weight-loss drugs that included both branded and compounded products. The company spent $681 million on marketing in the first nine months of 2025.

But supplies of brand-name drugs improved as Novo Nordisk and Eli Lilly increased production, and last spring the FDA ordered compounders to stop producing and selling their products. However, sales of the compounded versions continued, and companies such as Hims and Hers added vitamins or adjusted the dosage of the drugs, claiming this was still permitted. The strategy for circumventing the ban on compound interest operates in a legal gray area.

Hims has run afoul of regulators before. Last September, the FDA sent the company a warning letter asking it to stop “false or misleading” marketing. And in an opinion article published in the medical journal JAMA, Dr. Makary accused the company of “violating FDA regulations” with its Super Bowl ad last year.

This advertisement promoted Hims’ weight loss medications, but did not describe their side effects in detail, as would be the case in a conventional pharmaceutical advertisement. Instead, the fine print at the bottom of the ad directed patients to the company’s website “for details and important safety information.”

Hims is expected to air another commercial during Sunday’s Super Bowl. The ad promotes the range of weight loss medications but does not introduce the now withdrawn version of the Wegovy pill.