The FDA is taking no prisoners as it continues its efforts to combat widespread GLP-1 drug compounding. In its latest offensive, the agency has unleashed a fresh set of 30 warning letters targeting telehealth companies it says make “false or misleading” claims about compounded versions of popular obesity drugs.
The new warning letters, which were sent Feb. 20 and made public March 3, are an extension of the FDA’s September crackdown of misleading direct-to-consumer (DTC) drug advertising, the agency said in a press release. They also follow last month’s promise by FDA Commissioner Marty Makary, M.D., to take “swift action” against companies that mass-market copycat drugs.
Makary’s pledge came in response to Hims & Hers’ attempt to market a compounded version of Novo Nordisk’s Wegovy (semaglutide) pill. While the health and wellness company eventually backed down in the face of legal threats, the FDA still has its eye on several others that continue to sell compounded copies of Eli Lilly’s tirzepatide-based meds and Novo’s semaglutide.
“It’s a new era,” Makary said in a statement. “We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action. 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.”
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.
The FDA scoured each website in December 2025, according to the letters, picking out instances of advertising that claimed compounded products contained the same ingredients as Novo and Lilly’s branded products or have been tested in clinical trials.
“Compounded drug products are not FDA-approved,” the letters say. “Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
Telehealth companies targeted in the warning letters have 15 days to address the FDA’s concerns. If the firms don’t respond, the agency threatened “legal action without further notice, including, without limitation, seizure and injunction,” the agency said.
For companies located outside of the U.S., the FDA may alert the relevant regulatory authorities that the compounded products “appear to be misbranded products that cannot be legally sold to consumers in the U.S.,” it added.
Compounded GLP-1 drugs for weight loss hit the market en masse when high demand and supply constraints of Lilly and Novo’s branded drugs landed the meds on the FDA’s shortage list, giving compounders the green light to help fill patient needs in the meantime. Now that regular supplies of the drugs are up and running, companies are no longer legally allowed to sell mass-marketed compounded versions of semaglutide and tirzepatide.
Nonetheless, many industry players have turned to the “personalization” argument to skirt the GLP-1 compounding crackdown, maintaining that personally tailored doses can make their compounded versions legal.
This is the route that Hims & Hers initially took with its semaglutide pill before Novo and the FDA stepped in. The debacle ultimately led the FDA to bare its teeth against GLP-1 drug compounders specifically, warning that it will “use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns” related to GLP-1 compounding, the agency said in a Feb. 6 release.