The U.S. Food and Drug Administration (FDA) has issued warning letters to 30 telehealth companies for making false or misleading claims about compounded versions of widely used GLP-1 weight-loss medications, the agency announced Tuesday.
According to the FDA, several companies promoted their compounded products as equivalent to FDA-approved GLP-1 drugs. The agency also alleged that some firms obscured the origin of these medications by marketing them under proprietary brand names, creating the impression that they were the original manufacturers.
The latest enforcement action marks the second round of warning letters related to compounded weight-loss drugs. In September, the FDA sent similar notices to companies involved in manufacturing or selling weight-loss treatments, including pharmaceutical giants Eli Lilly and Novo Nordisk, as well as telehealth provider Hims & Hers Health. The crackdown aligns with President Donald Trump’s directive to tighten oversight of drug advertising.
“It’s a new era of enforcement,” FDA Commissioner Marty Makary said in a statement, cautioning companies against attempting to “circumvent FDA’s approval process by mass-marketing compounded drugs.”
In the current batch of letters, the FDA said telehealth firms made deceptive claims on their websites regarding compounded versions of semaglutide and tirzepatide. A smaller number of companies were also cited for claims involving liraglutide.
Semaglutide is the active ingredient in Novo Nordisk’s blockbuster drugs Wegovy and Ozempic, while tirzepatide is used in Eli Lilly’s Zepbound and Mounjaro. Liraglutide is marketed by Novo Nordisk under the brand name Saxenda.
The FDA has given the companies 15 working days to respond in writing and detail corrective actions to address the alleged violations.
Hims & Hers Health has drawn particular attention in recent months. In February, the FDA warned it could take action over the company’s $49 compounded weight-loss pill. That same month, Novo Nordisk escalated the dispute by filing a lawsuit against the telehealth firm.
Compounded drugs are customized medications prepared by licensed pharmacists or physicians who combine, mix or alter ingredients to meet specific patient needs, according to the FDA. While compounding can serve important medical purposes, the agency has repeatedly stressed that such products are not FDA-approved and must not be marketed as equivalent to approved therapies.
The agency’s latest move underscores growing regulatory scrutiny of the booming market for GLP-1 weight-loss treatments, particularly as telehealth platforms expand their role in distributing these medications.
