{"id":279365,"date":"2026-02-11T21:57:15","date_gmt":"2026-02-11T21:57:15","guid":{"rendered":"https:\/\/www.newsbeep.com\/nz\/279365\/"},"modified":"2026-02-11T21:57:15","modified_gmt":"2026-02-11T21:57:15","slug":"fda-blocks-hims-hers-49-compounded-wegovy-pill-what-to-know","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/nz\/279365\/","title":{"rendered":"FDA Blocks Hims & Hers $49 Compounded Wegovy Pill: What to Know"},"content":{"rendered":"

\"BottleShare on Pinterest<\/a>Hims & Hers has withdrawn its low cost compounded weight loss pill after pressure from top U.S. health officials and a major lawsuit. Image courtesy of Novo NordiskHims & 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compounded semaglutide pill, offering a low cost alternative to the new Wegovy pill.However, the compounded version was withdrawn from the market after pressure from the HHS and FDA.Hims & Hers now faces a lawsuit from Novo Nordisk for patent infringement.Experts say it\u2019s unclear whether Hims & Hers\u2019 pills perform as well as Wegovy, and while access and affordability matter, consumer safety comes first.<\/p>\n

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

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.<\/p>\n

On February 6, the Department of Health and Human Services\u2019 (HHS) General Counsel Mike Stuart announced via X<\/a> that he would refer the compounded drug to the Department of Justice (DOJ) for potential violations of the Federal Food, Drug, and Cosmetic Act<\/a>, as well as possible offenses under Title 18 of the U.S. Code.<\/p>\n

Hims & Hers swiftly responded on X<\/a>, stating that after conversations with industry stakeholders, they\u2019d decided to stop offering the compounded semaglutide<\/a> pill.<\/p>\n

\u201cWe remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care,\u201d the company wrote.<\/p>\n

This came after an X<\/a> 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 \u201cillegal copycat drugs.\u201d<\/p>\n

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.<\/p>\n

\u201cHims 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,\u201d the company said in a news release<\/a>.<\/p>\n

The drug manufacturing giant is seeking to halt Hims & Hers\u2019 sales of compounded semaglutide products and recover damages. Healthline reached out to Hims & Hers for comment, but did not receive a response.<\/p>\n

James J. Chao<\/a>, 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.<\/p>\n

\u201cThe active ingredient may be the same, yes, but everything else about the pill\u2019s behavior in the body can change dramatically,\u201d he told Healthline.<\/p>\n

Chao explained that compounded pills might be mixed by hand in small batches without stringent bioequivalence standards.<\/p>\n

\u201cSo a 2 milligram (mg) compounded semaglutide pill may not act anything like its brand-name counterpart,\u201d he said. \u201cAbsorption 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.\u201d<\/p>\n

Novo Nordisk expressed similar sentiments, telling Fierce Pharma<\/a> that Hims & Hers is using an \u201cuntested delivery mechanism that lacks supporting evidence and has never been reviewed by the FDA.\u201d<\/p>\n

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.<\/p>\n

Chao added that compounded products like Hims & Hers\u2019 semaglutide pills also lack the post-market surveillance documenting adverse events across large numbers of patients that FDA-approved drugs have.<\/p>\n

\u201cThat generates data we, as clinicians, can use to identify when something doesn\u2019t seem right,\u201d he said.<\/p>\n

According to Chao, compounders instead rely on the quality assurance of individual pharmacies, which may lack a rigid safety net.<\/p>\n

\u201cSo whisper-soft signals, such as a 5% incidence of nausea<\/a> that persists beyond three weeks in your treated population, could go unnoticed until much, much later,\u201d he explained.<\/p>\n

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

\u201cMany 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,\u201d he noted, explaining that this amounts to experimental medicine being sold directly to consumers without clear dosing standards, safety data, or oversight.<\/p>\n

\u201cIt\u2019s a wild west!\u201d said Zucchi.<\/p>\n

Additionally, more and more companies are marketing these drugs for vanity weight loss<\/a>, he said, rather than chronic disease management.<\/p>\n

\u201cWhen powerful metabolic medications are treated like cosmetic products and sold through aggressive marketing, patient safety becomes secondary to sales,\u201d he said.<\/p>\n

Zucchi said he does feel that compounding has a role to play, however, when a patient truly needs a customized medication.<\/p>\n

However, it was never intended to be a mass-market substitute for FDA-approved, patented medications.<\/p>\n

\u201cWhen compounding becomes a business model designed to mimic brand-name medications at scale, quality, transparency, and patient protection suffer,\u201d he said.<\/p>\n

Chao acknowledged that with branded GLP-1 medications<\/a> 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.<\/p>\n

\u201cBut what most patients don\u2019t consider are the tradeoffs that come with that pricing difference,\u201d he said. <\/p>\n

Pharmacies may not be as diligent in their testing for stability or uniformity, said Chao.<\/p>\n

\u201cCombine 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,\u201d he said.<\/p>\n

Zucchi agreed. \u201cI want lower prices for patients, too, and I genuinely hope FDA-approved obesity medications<\/a> continue to come down in cost. But affordability alone cannot be the standard we use in medicine.\u201d<\/p>\n

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.<\/p>\n

\u201cIn healthcare, cheaper should never mean unverified,\u201d he said. \u201cPatients deserve treatments that are tested, regulated, and supported by real evidence, not shortcuts driven by marketing.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Share on PinterestHims & Hers has withdrawn its low cost compounded weight loss pill after pressure from top…\n","protected":false},"author":2,"featured_media":279366,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[134,524,111,139,69],"class_list":{"0":"post-279365","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-medication","10":"tag-new-zealand","11":"tag-newzealand","12":"tag-nz"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/279365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/comments?post=279365"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/279365\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/279366"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=279365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=279365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=279365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}