FDA issues 25 more warning letters to telehealth companies over compounded GLP-1 claims

The U.S. Food and Drug Administration issued 25 warning letters to telehealth companies during the week of June 15, 2026, alleging false or misleading promotional claims about compounded GLP-1 products. The agency says the marketing violates the misbranding provisions of the Federal Food, Drug, and Cosmetic Act, including Sections 502(a) and 502(n) ^[1].

Alongside the letters, the FDA launched a dedicated webpage for telehealth companies outlining common compliance problems when promoting compounded drugs, plus a separate page laying out its specific concerns with compounded GLP-1 products ^[1].

This is the third large batch of letters in less than a year, most of them aimed at telehealth marketing of compounded GLP-1s. In September 2025, the agency issued roughly 80 warning letters and 40 untitled letters; in March 2026, 30 warning letters; and now 25 in June 2026 ^[1]. Last year's broader push against direct-to-consumer drug advertising, run through the Office of Prescription Drug Promotion within the Center for Drug Evaluation and Research, included 58 letters about claims for compounded GLP-1s such as semaglutide and tirzepatide and other compounded products like sildenafil and tadalafil ^[1].

What the FDA says the ads got wrong

The June letters follow a standardized template built around "net impression" — whether marketing, taken as a whole, could lead a consumer to believe a compounded product is FDA-approved, FDA-reviewed, or equivalent to an approved drug. Under that framework, even individually accurate statements can make a product misbranded if the overall presentation misleads ^[1].

Specific problems the agency flagged include calling a compounded product a "generic" version of an approved GLP-1; stating or implying that the FDA approved, evaluated or reviewed the product; claiming it is "clinically proven" to deliver the same results as the brand drug; and saying the product came from an "FDA-approved" or "FDA-licensed" pharmacy or facility. The FDA stresses that it does not approve or license compounding pharmacies or outsourcing facilities in that way ^[1].

The agency also objected to branding, proprietary labeling or label-like displays that make it look like the telehealth company itself compounds or manufactures the drug when it does not, and to "exact same active ingredient" phrasing used to imply sameness with the brand-name product ^[1].

On its GLP-1 page, the FDA details other risk areas: import alerts meant to keep GLP-1 active pharmaceutical ingredients with quality concerns out of the U.S.; its position that retatrutide and cagrilintide may not be used in compounding; dosing concerns; counterfeit versions of brand-name GLP-1s circulating in the market; and adverse event reports. As of May 21, 2026, the FDA said it had received more than 1,700 adverse events associated with compounded semaglutide and tirzepatide ^[1].

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

Why it matters for patients

Many people buy compounded semaglutide or tirzepatide through telehealth sites, often at lower prices than Ozempic, Wegovy, Mounjaro or Zepbound. The FDA's action is about what those sites say, not about whether compounding under FDCA Section 503A or 503B is legal — the agency's focus stays on promotional claims that blur the line between compounded and approved drugs ^[1].

Practically, that means some of the reassuring language a shopper may have seen online — "generic," "FDA-approved pharmacy," "clinically proven," "same active ingredient" — is language the FDA considers misleading ^[1]. Compounded drugs are not FDA-approved. They have not gone through the review for safety, effectiveness and manufacturing quality required under the new drug application or abbreviated new drug application pathways, and exemptions from approval requirements are conditioned on meeting specific statutory rules ^[1].

The letters do not name which companies received them, according to the available reporting, and the source does not say whether any products were recalled or whether patients should expect supply changes. Those details are not yet known from this account.

What happens next

The legal analysis describes the FDA's approach as ongoing monitoring released in coordinated batches rather than a steady trickle, so quiet stretches should not be read as lower priority ^[1]. A lull after March 2026 had raised questions about whether the agency had moved on, including after the May dismissal of Commissioner Dr. Marty Makary — but the June wave suggests the course has not changed ^[1].

More waves of enforcement are expected, with the same focus on net impression in website copy, branding and promotional content ^[1]. No specific date for the next round was given.