FDA cracks down on online advertising of compounded GLP-1 drugs

As part of HHS's effort to combat deceptive advertising, the FDA has launched its first nationwide enforcement action against digital health providers that promote illegally compounded versions of popular GLP-1 weight-loss drugs online.

On Tuesday, the agency posted more than 50 warning letters sent to various wellness clinics and telehealth platforms, including Hims & Hers Health, citing the "unlawful sale of unapproved and misbranded drugs to United States consumers over the internet."

The letters were issued by the Center for Drug Evaluation and Research and signed by the division's director, George Tidmarsh, M.D., Ph.D., on Sept. 9, 2025.

This move, a first for the agency, signals it is prepared to directly regulate online telehealth platforms that have previously claimed exemption from standard FDA drug advertising requirements.

The warning letters flag companies' claims that compounded versions of GLP-1 drugs like semaglutide and tirzepatide are comparable to FDA-approved brands (Wegovy, Ozempic, Mounjaro, Zepbound), despite lacking FDA review or approval.

Drugs are considered misbranded under section 502(a) of the Federal Food, Drug and Cosmetic Act (FDCA) [21 U.S.C. § 352(a)] if "their labeling is false or misleading in any particular," and compounded drugs similarly fall under section 502(bb) [21 U.S.C. § 352(bb)] when "their advertising or promotion is false or misleading in any particular," the letters say.

Current FDA policy allows compounding only for patient-specific prescriptions or drugs on the national shortage list, in accordance with Sections 503A and 503B of the FDCA [21 U.S.C. §§ 353a, 353b].

While tirzepatide and semaglutide were added to the shortage list in 2022, compounders were instructed to wind down the temporary compounding allowances earlier this year.

However, many telehealth providers that have developed new revenue streams due to the rising demand for GLP-1 drugs have continued to sell mass-produced compounded formulations under the guise of personalization.

To comply, the companies under scrutiny must immediately stop suggesting that their compounded GLP-1 products are FDA-approved or have the same level of review as the branded versions.

All promotional materials must also accurately reflect the unapproved status of these products.

The FDA requires a written response within 15 working days that details the steps taken to remedy violations and prevent recurrence, including all relevant supporting documents.

"Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction," the letters warn.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.