Experts say the product lacked the appropriate absorption technology<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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MONDAY, Feb. 9, 2026 (HealthDay News) \u2014 Hims & Hers<\/a> says it will stop selling a low-cost copy of a new weight-loss pill made by Novo Nordisk<\/a>, after federal officials raised concerns that the product may violate drug laws.<\/p>\n The online health company announced the move Saturday, just two days after introducing the pill.<\/p>\n The decision followed warnings from federal regulators, including a referral to the Justice Department for possible legal violations.<\/p>\n In a social media post<\/a>, Hims said it pulled the product after \u201cconstructive conversations with stakeholders across the industry.\u201d<\/p>\n The withdrawn pill was a knockoff version of a new oral form of Wegovy<\/a>, a popular weight-loss drug that had previously been available mainly as an injection.<\/p>\n Since the pill\u2019s launch in early January, about 170,000 people have purchased the Wegovy pill.<\/p>\n Novo\u2019s 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.<\/p>\n That same evening, the U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary<\/a> said the agency would \u201ctake swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.\u201d<\/p>\n The FDA later confirmed that Hims was among the companies reviewed.<\/p>\n Hims is one of the largest sellers of compounded weight-loss drugs, products mixed by pharmacies that are not approved through large clinical trials.<\/p>\n 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.<\/p>\n But some people said Hims went too far by offering a pill version that copied a product protected by patents.<\/p>\n \u201cIt\u2019s so far beyond what compounding was meant to solve that it\u2019s hard to understand how Hims thought that this could be a legitimate practice,\u201d Dr. David Kessler, a former FDA commissioner, told The New York Times<\/em>.<\/p>\n \u201cThis was not a copy,\u201d Kessler said. \u201cThis was a different technology that was being used.\u201d<\/p>\n He added that there is no public data showing that the Hims pill works as intended. Novo Nordisk\u2019s pill uses a special absorption method called SNAC, which helps the drug work in pill form.<\/p>\n Without that technology, \u201cit just simply doesn\u2019t work,\u201d Novo Nordisk CEO Mike Doustdar<\/a> said. He warned that customers buying the cheaper pill would be \u201cwasting $49.\u201d<\/p>\n 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.<\/p>\n Experts also warned that allowing copycat pills could deter drug companies from investing in new treatments.<\/p>\n Compounding was originally meant to help patients during shortages or when custom medicines are needed. But as demand for weight-loss drugs surged, companies like Hims expanded rapidly.<\/p>\n 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.<\/p>\n Hims has faced these types of regulatory issues before. Last year, the FDA warned the company about misleading marketing, including a Super Bowl ad that promoted weight-loss drugs without clearly listing side effects.<\/p>\n That same scrutiny continued in this year’s Super Bowl between the Seattle Seahawks<\/a> and New England Patriots<\/a>.<\/p>\n In rankings published after last night’s game, The New York Times<\/em> placed the company\u2019s ad last (No. 59) on its list of 2026 Super Bowl commercials<\/a>.<\/p>\n The Times<\/em> criticized the spot as \u201cthe same formula as last year,\u201d describing it as \u201ca nightmare vision of the current American health-care system followed by a vague and unconvincing pitch for the company\u2019s telehealth services.\u201d<\/p>\n More information<\/strong><\/p>\n Brown University Health has more on compounded weight loss medications<\/a>.<\/p>\n