FDA cracks down on telehealth firms over weight-loss drug claims

Patients searching online for cheaper GLP-1 weight-loss drugs are running into a regulatory gray zone that the U.S. Food and Drug Administration says some telehealth companies crossed with false and misleading claims. The agency said it sent 25 warning letters to firms marketing compounded versions of tirzepatide and semaglutide, the active ingredients in drugs such as Zepbound, Mounjaro, Ozempic and Wegovy.

FDA said some companies suggested their products came from FDA-approved pharmacies, implied the ingredients had been clinically studied, or tried to make the compounded drugs sound identical to approved medications. That matters because compounded drugs are not FDA approved and are not reviewed by the agency for safety, effectiveness or quality before they are sold.

Michael Davis, the acting director of FDA’s Center for Drug Evaluation and Research, said patients deserve to know what they are getting. The agency’s concern is that consumers may be using telehealth sites to chase lower prices without understanding the gap in manufacturing oversight, evidence and consistency between a compounded product and an approved medicine.

The FDA also warned that some compounded GLP-1 products had arrived warm or with inadequate ice packs, raising another layer of risk in a market that already depends on careful handling. For patients, that means the danger is not only whether a drug works, but whether it was made, stored and shipped under conditions that protect its integrity.

The crackdown comes as FDA tightens the rules around how these drugs can be compounded. In an April 1 notice, the agency said tirzepatide’s national shortage had been resolved and reminded compounders that they must meet the conditions in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions. In a Federal Register notice published May 1, FDA proposed not including semaglutide, tirzepatide and liraglutide on the 503B Bulks List, with public comments due June 30, 2026.

Reuters reported that the warning letters were posted on the FDA website Tuesday and had been sent earlier in June to companies including Medica Weight Loss, Ready Med and Clover Meds. The agency had already sent warning letters this year to SkinnyRx, MEDVi and BluefitMD, and in 2025 it targeted other telehealth marketers, including Hims & Hers Health, Inc., over compounded semaglutide claims.

FDA Commissioner Marty Makary said the agency was paying close attention to misleading claims by telehealth and drug companies across media platforms and taking swift action. The message to the industry is clear: promotional language that blurs the line between compounded products and approved medicines is now a regulatory target, not a marketing gray area.