FDA warns semaglutide and tirzepatide compounders and telehealth firms over marketing claims
The FDA's September 2025 warning letters target ads that call compounded semaglutide or tirzepatide equal to approved drugs, a claim regulators say misleads patients.
The Food and Drug Administration, working with the Department of Health and Human Services, issued dozens of warning letters in September 2025 to compounding pharmacies, telehealth platforms and manufacturers that market GLP-1 drugs, with the focus on advertising claims suggesting compounded products are equivalent to FDA-approved medicines [1].
More than 50 of the letters went to U.S. and international companies that compound or manufacture semaglutide and tirzepatide — the active ingredients in Ozempic and Wegovy, and in Mounjaro and Zepbound — according to the law firm Wilson Sonsini [3]. Most were issued on September 9, 2025, and the FDA has continued to publish new ones [3].
The letters single out statements the agency considers false or misleading, including claims that a compounded product is a "generic version" of an approved drug or contains the "same active ingredient" [3]. The FDA also flagged weight-loss claims such as "real results" or "proven effectiveness," and repeated that it does not evaluate compounded drugs for safety, effectiveness or quality [3].
Not all of the letters went to compounders. Eli Lilly received three letters and Novo Nordisk one, all dated September 9, 2025, about a prime-time television special hosted by Oprah Winfrey that first aired on ABC on March 18, 2024 [4][5]. The FDA said the program created "a misleading impression regarding the safety" of Zepbound and Mounjaro and omitted or minimized risks listed on the drugs' labels, including a boxed warning for thyroid C-cell tumors and the risks of pancreatitis and hypoglycemia [4][5].
The agency also said the program did not specifically mention that tirzepatide should not be used in patients with a personal or family history of multiple endocrine neoplasia type 2, a rare genetic condition that causes tumors [4]. In its letter to Novo Nordisk, the FDA objected to a doctor describing GLP-1 side effects as "overhyped" and "mild to moderate," writing that such phrases "misleadingly undermine the risk's importance and severity" [4].
Hims & Hers Health also received a warning about its compounded semaglutide products after the FDA reviewed the company's website in August 2025 [5].
Companies that receive a warning letter have 15 working days to respond with a corrective action plan or a justification, according to Wilson Sonsini. Failure to address the violations can lead to further enforcement, including product seizure or an injunction [3].
The size of the September action is described differently in different accounts. Wilson Sonsini counts more than 50 warning letters [3], while FDA Commissioner Marty Makary said the agency intended to distribute approximately 100 cease-and-desist notices, a figure echoed in another account of the campaign [5][2]. Whether the roughly 100 refers to the same batch of letters or a wider set of communications has not been disclosed.
The letters follow the end of the shortage period that had allowed much of the compounding. The FDA placed tirzepatide on the national drug-shortage list in 2022, which under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act permitted compounding pharmacies to prepare the medicine to help meet patient demand [2]. In late 2024 the agency lifted the shortage designation for tirzepatide and directed compounders to stop; semaglutide had already come off the list [2]. Once the shortage basis disappeared, the legal room for routine compounding narrowed [1][2].
Why it matters for patients
Compounded GLP-1 drugs are not FDA-approved and have not gone through the clinical testing required for approval [2]. The September letters rest on the position that patients can be misled by advertising that implies otherwise [3].
If an ad, website or social media post says a compounded semaglutide or tirzepatide product is the "same" as Ozempic, Wegovy, Mounjaro or Zepbound, or has been "tested in clinical trials," that is the kind of claim regulators are now targeting [3][2]. Compounded versions have often been sold at a fraction of the branded price [2], and branded prices have exceeded $1,000 a month [1], so the wording matters to people comparing costs.
Compounding still has a recognized role for shortages or individual patient needs [2]. Whether these letters change prices, availability or which sellers stay in business has not been reported.
What happens next
The letters dated September 9, 2025 gave recipients 15 working days to reply with corrective steps, putting responses due around the end of September 2025 [3]. Companies that fail to answer face the possibility of seizure or an injunction [3]. The FDA has said it continues to publish new warning letters [3].
Sources
- https://www.bipc.com/oral-semaglutide-and-the-glp-1-compounding-reckoning-from-regulatory-ambiguity-to-fda-enforcement,-doj-referrals,-and-novo-nordisk%E2%80%99s-case-against-hims-and-hers
- https://www.frierlevitt.com/articles/fda-warning-letters-hims-novo-nordisk-compounded-glp1/
- https://www.wsgr.com/en/insights/fda-sends-warning-letters-to-more-than-50-glp-1-compounders-and-manufacturers.html
- https://www.biospace.com/policy/fdas-ad-crackdown-targets-novo-lillys-oprah-special-on-glp-1s
- https://www.pharmtech.com/view/lilly-novo-hims-get-fda-warnings-about-misleading-drug-communications
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