FDA ramps up its pushback against compounded GLP-1s

In a move that will delight Novo Nordisk and Eli Lilly, the FDA has sent warning letters to 30 telehealth companies, accusing them of illegally marketing compounded GLP-1 agonist formulations.

The barrage of letters continues a crackdown on companies selling compounded versions of in-patent drugs that started last year, and has already resulted in warnings for prominent telehealth companies offering GLP-1s for weight loss, including Hims & Hers.

The latest block includes a swathe of smaller companies – such as Strut Health, PharmaZee, Lean Rx, and influencer and TV personality Savannah Chrisley's GoodGirlRx – that are operating weight-loss programmes based on providing compounded versions of Novo Nordisk's GLP-1 agonists semaglutide and liraglutide and Lilly's dual GIP/GLP-1 agonist tirzepatide.

Various transgressions are detailed in the letters, including implying that medicines were FDA-evaluated for safety or FDA-approved, using phrases like "clinically proven" in promotions, claiming to be the manufacturer when in fact another organisation is making the drugs, and misleading advertising.

The FDA announced a concerted action against direct-to-consumer (DTC) advertising of pharma products last September, and has since sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads for a range of medicines, maintaining that the tally is more than were issued "over the entire preceding decade."

The earlier letters also rapped Novo Nordisk and Lilly over advertising for their branded weight-loss medicines, Wegovy and Zepbound, which have been affected by low-cost competition from compounded versions. Novo Nordisk has been particularly hard-hit, with US sales of Wegovy shrank 2% in the final three months of 2025.

"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.

"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 [the] FDA's approval process."

Under US regulations, compounding pharmacies can make and sell medicines - even if they are still under patent - if supplies are limited in the marketplace.

Semaglutide, liraglutide, and tirzepatide are no longer on the shortage list, but some companies have continued to provide the drugs to patients under exceptions for 'personalised' treatments under a framework known as Section 503A, which allows compounders to make compounds in small quantities for patients whose needs - they claim - are not met by a standard formulation.

Photo by Kate Macate on Unsplash