The FDA is taking no prisoners as it continues its efforts to combat widespread GLP-1 drug compounding. In its latest offensive, the agency announced 30 new warning letters targeting telemedicine companies it says are making “false or misleading” claims about combinations of popular obesity drugs.
The new warning letter, sent on February 20 and published on March 3, is an extension of the FDA’s crackdown on misleading direct-to-consumer (DTC) drug advertising in September, the agency said in a press release. It also followed FDA Commissioner Marty McCulley, M.D.’s promise last month to take “swift action” against companies that sell large quantities of counterfeit drugs.
Mr McCurry’s pledge was made in response to Hims & Hers’ attempt to sell a combination version of Novo Nordisk’s Wigovy (semaglutide) tablets. Although the company ultimately withdrew in the face of legal threats, the FDA is still eyeing several other companies that continue to sell combination copies of Eli Lilly’s tirzepatide-based drugs and Novo’s semaglutide.
“It’s a new era,” McCurry said in a statement. “We are paying close attention to misleading claims made by telemedicine and pharmaceutical companies across all media platforms and are taking swift action. Compounded drugs can be important to overcome shortages or meet patients’ unique needs, but compounders should not attempt to compound drugs in a way that circumvents the FDA approval process.”
In a letter, the FDA criticized a series of online health clinics for promoting combination versions of semaglutide, tirzepatide, or both drugs on their websites, alleging that they are misleading consumers about the source of the combination products.
According to the letter, FDA investigated each website in December 2025 and identified instances of advertisements claiming that the combination products contained the same ingredients as Novo and Lilly branded products or had been tested in clinical trials.
“Combined medicines are not FDA approved,” the letter states. “Your claims imply that your product is FDA approved or has been evaluated for safety and effectiveness even if it is not.”
Telemedicine companies targeted by warning letters have 15 days to address the FDA’s concerns. If the companies did not comply, the agency said it threatened to take “legal action without further notice, including but not limited to seizure and injunction.”
For companies based outside the United States, the FDA added that it may alert relevant regulatory authorities that a compounded product “appears to be a misbranded product that cannot be legally sold to U.S. consumers.”
Due to high demand and supply constraints for Lilly and Novo’s branded drugs, combination GLP-1 drugs for weight loss hit the market en masse, and the drugs were placed on the FDA’s shortage list, giving compounders the green light to meet patients’ needs in the meantime. Now that the drug is in regular supply, companies are no longer legally allowed to sell the combination of semaglutide and tirzepatide in large quantities.
Nevertheless, many industry players have turned to the “personalization” argument to avoid a crackdown on GLP-1 formulations, arguing that personally tailored doses can make the formulation version legal.
This is the route Hims & Hers first took with its semaglutide tablets before Novo and the FDA intervened. This debacle finally led the FDA to specifically target formulators of GLP-1 products, warning that it would “use all compliance and enforcement tools available within the agency to address unsubstantiated claims and related public health concerns” related to GLP-1 formulas, the agency said in a Feb. 6 release.
