FDA Targets 30 Telehealth Firms Over Compounded GLP-1 Marketing

The U.S. Food and Drug Administration (FDA) has intensified its enforcement against compounded GLP-1 agonist formulations by sending warning letters to 30 telehealth companies. This action comes as a significant development for major pharmaceutical firms such as Novo Nordisk and Eli Lilly, which produce popular weight-loss medications. The FDA’s crackdown targets companies that are accused of illegally marketing compounded versions of these in-patent drugs.

This wave of enforcement continues a campaign that began in 2022, which has already resulted in warnings to several prominent telehealth firms, including Hims & Hers. The recent letters also encompass a range of smaller companies, such as Strut Health, PharmaZee, and Lean Rx. These businesses, along with influencer Savannah Chrisley’s GoodGirlRx, have been providing compounded versions of GLP-1 agonists like semaglutide, liraglutide, and tirzepatide for weight-loss programs.

The FDA letters outline various violations, including misleading claims that the compounded drugs were evaluated for safety or approved by the FDA. Phrases like “clinically proven” have been criticized for misrepresentation, as have claims from companies asserting they are the manufacturers of the drugs while another organization produces them. The FDA has been proactive in addressing misleading advertising practices since September 2022, when it initiated a substantial campaign against direct-to-consumer (DTC) advertising of pharmaceutical products. Since then, the agency has dispatched thousands of letters to pharmaceutical and telehealth firms, significantly more than in the previous decade combined.

The earlier warnings also targeted Novo Nordisk and Eli Lilly for their advertising of branded weight-loss medicines, Wegovy and Zepbound. These products have faced increased competition from lower-cost compounded versions, which has impacted sales. Notably, Wegovy‘s U.S. sales declined by 2% in the last quarter of 2025.

FDA Commissioner Marty Makary emphasized the agency’s vigilance regarding misleading claims. “We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” he stated. He acknowledged the importance of compounded drugs in addressing shortages or unique patient needs but stressed that compounding should not bypass the FDA’s approval process.

Under U.S. regulations, compounding pharmacies are permitted to create and sell medications, even those still under patent, when market supplies are limited. Although semaglutide, liraglutide, and tirzepatide are no longer classified as shortage medications, some companies continue to provide these drugs under exceptions for personalized treatments. This is allowed under a provision known as Section 503A, which permits compounding in small quantities for patients whose needs are not adequately met by standard formulations.

As the FDA’s efforts to regulate compounded drugs intensify, the landscape for telehealth companies and pharmaceutical giants may shift significantly, raising questions about the future of compounded GLP-1 formulations in the weight-loss sector.