FDA cites Hims & Hers over claims about compounded semaglutide

The FDA issued a warning letter dated September 9, 2025, to Hims & Hers Health, Inc., which operates as Hers, saying the company's website misdescribes its compounded semaglutide and that the products are therefore misbranded ^[1].

The letter is addressed to chief executive Andrew Dudum and signed by George Tidmarsh, M.D., Ph.D., who directs the agency's Center for Drug Evaluation and Research ^[1]. It follows an FDA review of forhers.com in August 2025, when the site was offering compounded drug products, semaglutide among them ^[1]. Two lines of copy drew the objection: "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients" ^[1].

Compounded medicines do not pass through FDA's approval process, the letter states, so wording that suggests a compounded product matches a brand-name medicine is false or misleading ^[1]. FDA called the semaglutide products misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act and said moving them in interstate commerce breaks section 301(a) ^[1]. Ozempic and Wegovy are FDA-approved products. In the agency's words, the compounded items are "new drugs" that are not generally recognized as safe and effective for their labeled uses ^[1].

The two quoted statements are not the full extent of FDA's concern, the letter says, and a footnote singles out overstated benefits or downplayed risks as particularly troubling ^[1]. Hims & Hers was told to answer in writing within 15 working days to the Office of Compounding Quality and Compliance, part of CDER's Office of Compliance, describing what it has corrected and how it would keep the problem from happening again ^[1]. The letter warns that violations left unaddressed could bring legal action without further notice, including seizure or an injunction ^[1].

The warning was part of a wider enforcement push that continued into 2026. On March 3, 2026, FDA announced 30 warning letters to telehealth companies selling compounded GLP-1s, according to the law firm Venable ^[2]. That round targeted promotions implying an approved drug's equivalent, plus private-label packaging that leaves the actual compounder unclear ^[2]. Commissioner Marty Makary said the agency is "paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action" ^[2].

Venable notes that FDA has not settled whether compounded GLP-1s are "essentially a copy" of the approved drugs, a finding that would bar compounding them under section 503B ^[2]. The firm also points to roughly two years of agency concerns about dosing errors, questionable sourcing of active ingredients and serious adverse events tied to compounded semaglutide and tirzepatide, and to FDA's position that salt forms of semaglutide, along with investigational substances such as retatrutide and cagrilintide, cannot lawfully be used in compounding ^[2].

More letters followed on August 24, 2026, to five online peptide sellers — Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, Peptide Partners LLC and TXP Innovations LLC, which trades as Tex Peptides — whose sites listed semaglutide, tirzepatide and retatrutide behind "for research purposes only" labels ^[3]. FDA also added a section about multi-dose vials to its consumer fact sheet on unapproved GLP-1 drugs ^[3].

Why it matters for patients

A compounded semaglutide product is not an FDA-approved medicine, and sharing an active ingredient with Ozempic or Wegovy does not, in the agency's view, make the two interchangeable ^[1]. The dispute here centers on wording posted on a consumer site, the kind of claim someone might read while comparing prices online — and FDA's position is that such wording can mislead about what is actually being prescribed.

The agency's worries reach past advertising. It has flagged dosing errors, ingredient sourcing and serious adverse events involving compounded semaglutide and tirzepatide ^[2], and its consumer materials now address concerns about vials that hold more than one dose ^[3]. What the letter does not do is approve compounded semaglutide or resolve whether these products count as "essentially a copy" of the brand-name drugs ^[2].

What happens next

Hims & Hers had 15 working days from receiving the letter to file a written response ^[1]. Whether the company replied, and what it told the agency, has not been reported.

If FDA decides the problems were not fixed, the letter says the agency can seek seizure or an injunction ^[1]. Separately, HHS Secretary Robert F. Kennedy Jr. has said FDA is weighing reclassifying about 14 previously restricted peptides so they could be compounded under a prescription; no decision has been reported ^[2].