Compounding

FDA warns 30 telehealth companies over compounded GLP-1 marketing claims

The letters say compounded semaglutide and tirzepatide have not been through FDA review, so ads comparing them to approved brand-name drugs are misleading.

By the Semaglutides news desk·
Signage is seen outside of FDA headquarters in White Oak, Maryland
Image: reuters.com

The Food and Drug Administration announced on March 3, 2026 that it had issued warning letters to 30 telehealth companies, saying the firms used their websites to make false or misleading claims about compounded GLP-1 products [1][2]. The agency's announcement did not name the companies [1].

Reuters reported that the letters covered compounded semaglutide and tirzepatide, and that a few also cited liraglutide [2]. Semaglutide is the active ingredient in Novo Nordisk's Ozempic and Wegovy. Tirzepatide is the ingredient in Eli Lilly's Mounjaro and Zepbound. Liraglutide is sold by Novo Nordisk under the brand name Saxenda [2].

Two problems appeared most often, according to the FDA. One was marketing that suggested a compounded product was the same as an FDA-approved one. The other was advertising that hid where a product came from by putting the telehealth company's own name or trademark on it without qualification, making the company appear to be the compounder [1]. Reuters described the same two kinds of violations [2].

"It's a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action," FDA Commissioner Marty Makary said in the announcement [1]. He said compounded drugs "can be important for overcoming shortages or meeting unique patient needs," but that compounders should not "circumvent FDA's approval process" [1]. Reuters quoted him saying companies should not "circumvent FDA's approval process by mass-marketing compounded drugs" [2].

The 30 letters are the second batch directed at telehealth firms since the FDA began a campaign in September against misleading direct-to-consumer drug advertising [1][2]. That earlier round went to makers and sellers of weight-loss drugs, among them Eli Lilly, Novo Nordisk and the telehealth company Hims & Hers, as part of President Donald Trump's order to crack down on drug advertising [2]. Over six months, the agency says it has told pharmaceutical and telehealth companies to remove misleading ads in thousands of letters — more than it sent in the entire decade before [1].

Hims & Hers had already drawn scrutiny. The FDA warned in February 2026 that it could act over the company's $49 compounded weight-loss pill, and Novo Nordisk sued the company that same month [2].

The FDA's position on compounded medicines is that they are not FDA-approved, so their safety, effectiveness and quality are not reviewed before they are marketed. A compounded drug is also not a generic drug, which does go through FDA approval [1].

Why it matters for patients

These letters concern advertising claims, not a finding that any particular compounded product is unsafe or ineffective [1][2]. Even so, they touch on details that can matter when someone is comparing a compounded GLP-1 with a brand-name one.

First, approval status differs. Ozempic, Wegovy, Mounjaro and Zepbound have been through FDA review. Compounded semaglutide and tirzepatide have not, and the agency does not check their safety, effectiveness or quality before they are sold [1].

Second, the name on the label is not proof of who made the drug. The FDA says some companies obscured sourcing by branding products with their own name or trademark [1][2]. A product marketed under a telehealth company's name may have been made by a compounding pharmacy the company does not identify.

Third, compounded drugs and generics are not the same category. Generics are FDA-approved; compounded drugs are not [1].

Which companies received the 30 letters, and what they sell, has not been disclosed in the FDA announcement or in Reuters' reporting [1][2]. Whether any of the 30 also received a letter in September has not been reported [1][2].

What happens next

Each company has 15 working days to reply in writing and describe how it will fix the violations [2].

The FDA has not said what it will do if a company fails to respond or does not change its marketing, and no further enforcement steps have been announced [1][2]. The agency has also not said whether additional warning letters are coming [1][2].

Sources

  1. https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
  2. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-30-telehealth-firms-over-misleading-marketing-compounded-glp1-drugs-2026-03-03/

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