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FDA Cracks Down on Telehealth Companies

March 12, 2026

The FDA is finally cracking down on telehealth companies marketing compounded weight loss drugs, warning them not to imply their products are FDA-approved or that they manufacture the medications.

Roughly 30% of the more than 70 telehealth companies warned in the past six months rely on just four nationwide “white-label” medical groups — Beluga Health, OpenLoop, MD Integrations, and Telegra — that provide the clinicians who actually prescribe the drugs.

The telehealth companies that have been warned — with names like Lovely Meds, Hello Cake, and MEDVi — don’t directly prescribe the medications, which are not approved by the FDA or evaluated for safety and efficacy. That falls to the clinicians in medical groups affiliated with the companies.

“It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”

This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.

In the letters, the FDA criticized an array of online wellness clinics for promoting compounded versions of semaglutide, tirzepatide or both drugs on their websites, arguing that they have misled consumers over the source of their compounded offerings

Furthermore, the FDA clarified that these compounded products are not the same as generic drugs, which do undergo a rigorous approval process. The misleading claims often involve branding the drugs with a telehealth firm’s name or trademark without qualification, which falsely implies the firm itself is the compounder.

The legal battle over GLP-1 marketing has also reached the courts, with Novo Nordisk filing a lawsuit against the telehealth company Hims & Hers. The manufacturer of semaglutide (Ozempic; Wegovy) alleges that Hims has engaged in promotional campaigns that dupe consumers and health care professionals regarding the safety and clinical benefits of unapproved and compounded semaglutide products. Novo Nordisk reported that their own testing of certain compounded injectable semaglutide drugs revealed impurities as high as 86%. Such impurities, even in small amounts, can lead to life-threatening immune responses, including anaphylactic shock, or result in hospitalizations due to incorrect active ingredient levels.3

Commentary

The FDA has warned these companies in the past, yet basically nothing was done and they ignored the warnings and continued to sell the compounded meds. Some significant fines need to be assessed. When their actions cost them money, that’s when they will comply.

 

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