FDA sends 25 warning letters to telehealth companies over compounded GLP-1 marketing

During the week of June 15, 2026, the FDA issued 25 warning letters to telehealth companies over allegedly false or misleading promotional claims about compounded GLP-1 products ^[1]. The agency said the marketing violated the misbranding provisions of the Federal Food, Drug, and Cosmetic Act, including Sections 502(a) and 502(n) ^[1].

It is the third large batch in less than a year. FDA sent roughly 80 warning letters and 40 untitled letters in September 2025, then 30 warning letters in March 2026, and now 25 in June 2026 ^[1]. In 2025, the agency issued 58 letters about claims for compounded GLP-1s such as semaglutide and tirzepatide, alongside letters about other compounded products ^[1]. FDA also launched a dedicated webpage for telehealth companies on promoting compounded drugs, and a separate page on its concerns about compounded GLP-1 products ^[1].

What FDA says the marketing got wrong

The June letters are highly standardized and turn on the "net impression" of an ad — whether the presentation as a whole, not just isolated phrases, could lead consumers to believe a compounded product is FDA-approved or otherwise equivalent to an approved drug ^[1]. FDA flagged several recurring claims:

• Calling a compounded product a "generic" version of an FDA-approved GLP-1 drug ^[1].
• Suggesting FDA approved, reviewed or evaluated the compounded product for safety, effectiveness or quality ^[1].
• Saying the compounded product is "clinically proven" to achieve the same results as an approved product ^[1].
• Describing the supplier as an "FDA-approved" or "FDA-licensed" pharmacy or facility; FDA says it does not approve or license compounding pharmacies or outsourcing facilities that way ^[1].
• Branding or label-style displays that make the telehealth company look like the compounder or manufacturer of the drug when it is not ^[1].
• Using "exact same active ingredient" language in a way that implies the compounded product is the same as the brand-name drug ^[1].

CDER Acting Director Michael Davis made a similar point publicly, writing that compounded GLP-1 products "have not been proven safe, effective, or of consistent quality like FDA-approved drugs" ^[1].

Safety concerns the agency lists

FDA's GLP-1 page also covers import alerts meant to keep GLP-1 active ingredients with quality problems out of the United States, the agency's position that retatrutide and cagrilintide may not be used in compounding, dosing concerns, and counterfeit versions of brand-name GLP-1s on the market ^[1]. As of May 21, 2026, FDA had received more than 1,700 adverse event reports associated with compounded semaglutide and tirzepatide, according to the agency ^[1].

The telehealth companies that received the June letters have not been disclosed.

Why it matters for patients

Compounded semaglutide and tirzepatide are not FDA-approved drugs, even though approved versions of those molecules are sold as Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound. FDA says compounded products have not gone through the review for safety, effectiveness and manufacturing quality required for approved drugs ^[1].

That means phrases patients see in ads — "generic Ozempic," "FDA-approved pharmacy," "clinically proven same results" — are the exact language the agency now treats as a misbranding problem ^[1]. Patients comparing sellers can weigh whether a company's claims match the wording FDA has flagged, and can ask who actually compounds the drug and where it comes from, since the letters also target branding that makes a telehealth company look like the manufacturer ^[1].

FDA's enforcement is aimed at promotion, not at the legality of compounding itself, which can continue under Sections 503A and 503B of the law if statutory conditions are met ^[1]. The agency's stated concern is that patients cannot tell compounded and approved products apart ^[1].

What happens next

No further waves have been announced, and FDA has not said when it will issue more letters. The analysis published by the law firm Sheppard, Mullin, Richter & Hampton says the agency tends to monitor continuously and then release warning letters in coordinated batches, so quiet stretches should not be read as a drop in priority ^[1]. The firm also noted that recent leadership changes at FDA, including the May 2026 dismissal of Commissioner Dr. Marty Makary, do not appear to have changed the agency's course on this issue ^[1]. Whether any of the 25 letters lead to further action has not been reported.