FDA Blocks Hims & Hers $49 Compounded Wegovy Pill: What to Know

• Hims & Hers recently announced a $49 compounded semaglutide pill, offering a low cost alternative to the new Wegovy pill.
• However, the compounded version was withdrawn from the market after pressure from the HHS and FDA.
• Hims & Hers now faces a lawsuit from Novo Nordisk for patent infringement.
• Experts say it’s unclear whether Hims & Hers’ pills perform as well as Wegovy, and while access and affordability matter, consumer safety comes first.

Telehealth provider Hims & Hers announced its plans for a compounded semaglutide pill on February 5, priced at $49 per month.

However, Hims & Hers has put the brakes on sales of its compounded version amid potential legal action from top health officials who said the drug violates U.S. regulatory laws.

On February 6, the Department of Health and Human Services’ (HHS) General Counsel Mike Stuart announced via X that he would refer the compounded drug to the Department of Justice (DOJ) for potential violations of the Federal Food, Drug, and Cosmetic Act, as well as possible offenses under Title 18 of the U.S. Code.

Hims & Hers swiftly responded on X, stating that after conversations with industry stakeholders, they’d decided to stop offering the compounded semaglutide pill.

“We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care,” the company wrote.

This came after an X post from Marty Makary, MD, Commissioner of the Food and Drug Administration (FDA), who stated that the agency would take action against any companies marketing what he called “illegal copycat drugs.”

Novo Nordisk itself announced on February 9 that it was suing Hims & Hers for patent infringement for both its compounded pill and its injectable semaglutide.

“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs,” the company said in a news release.

The drug manufacturing giant is seeking to halt Hims & Hers’ sales of compounded semaglutide products and recover damages. Healthline reached out to Hims & Hers for comment, but did not receive a response.

James J. Chao, MD, FACS, co-founder and chief medical officer of VedaNu Wellness in San Diego, CA, said the concerns about safety stem from differences in how the pills are formulated compared to brand-name Wegovy.

“The active ingredient may be the same, yes, but everything else about the pill’s behavior in the body can change dramatically,” he told Healthline.

Chao explained that compounded pills might be mixed by hand in small batches without stringent bioequivalence standards.

“So a 2 milligram (mg) compounded semaglutide pill may not act anything like its brand-name counterpart,” he said. “Absorption can be off by upward of 30%, meaning one pill will have little effect while another will overdo it. You literally cannot know ahead of time.”

Novo Nordisk expressed similar sentiments, telling Fierce Pharma that Hims & Hers is using an “untested delivery mechanism that lacks supporting evidence and has never been reviewed by the FDA.”

According to Fierce Pharma, Wegovy pills contain salcaprozate sodium (SNAC) technology to ensure absorption, while Hims & Hers uses liposomal technology, which the FDA has proposed restricting for compounding due to concerns about over- or under-dosing.

Chao added that compounded products like Hims & Hers’ semaglutide pills also lack the post-market surveillance documenting adverse events across large numbers of patients that FDA-approved drugs have.

“That generates data we, as clinicians, can use to identify when something doesn’t seem right,” he said.

According to Chao, compounders instead rely on the quality assurance of individual pharmacies, which may lack a rigid safety net.

“So whisper-soft signals, such as a 5% incidence of nausea that persists beyond three weeks in your treated population, could go unnoticed until much, much later,” he explained.

Joseph Zucchi, PA-C, clinical supervisor and physician associate at Transition Medical Weight Loss in Salem, NH, pointed out several red flags in the compounding industry.

“Many pharmacies and clinics are now selling peptides like retatrutide, cagrilintide, and other investigational compounds that are not FDA-approved and are still in clinical trials,” he noted, explaining that this amounts to experimental medicine being sold directly to consumers without clear dosing standards, safety data, or oversight.

“It’s a wild west!” said Zucchi.

Additionally, more and more companies are marketing these drugs for vanity weight loss, he said, rather than chronic disease management.

“When powerful metabolic medications are treated like cosmetic products and sold through aggressive marketing, patient safety becomes secondary to sales,” he said.

Zucchi said he does feel that compounding has a role to play, however, when a patient truly needs a customized medication.

However, it was never intended to be a mass-market substitute for FDA-approved, patented medications.

“When compounding becomes a business model designed to mimic brand-name medications at scale, quality, transparency, and patient protection suffer,” he said.

Chao acknowledged that with branded GLP-1 medications costing as much as $1,300 out of pocket, it can be tempting when compounding pharmacies offer to sell the same drug for much less.

“But what most patients don’t consider are the tradeoffs that come with that pricing difference,” he said.

Pharmacies may not be as diligent in their testing for stability or uniformity, said Chao.

“Combine that with the fact that most compounded GLP-1 pills are and will NOT be FDA-approved, and you have a gray market that patients may not even realize they are entering,” he said.

Zucchi agreed. “I want lower prices for patients, too, and I genuinely hope FDA-approved obesity medications continue to come down in cost. But affordability alone cannot be the standard we use in medicine.”

Zucchi said that the concerns with compounded GLP-1s go far beyond price. Products that are not FDA-approved may not be reviewed for ingredient identity, purity, potency, sterility, dose consistency, or clinical outcomes.

“In healthcare, cheaper should never mean unverified,” he said. “Patients deserve treatments that are tested, regulated, and supported by real evidence, not shortcuts driven by marketing.”