The U.S. Food and Drug Administration on Tuesday formally notified 30 telehealth companies with warning letters after finding false or misleading statements on their websites about compounded GLP-1 products.
FDA Commissioner Marty Makary said the agency is tracking misleading claims across media platforms made by both telehealth and pharmaceutical companies and is taking enforcement actions to address them. He acknowledged that compounded drugs can play a role in alleviating shortages or meeting specific patient needs, but warned that compounders must not try to compound drugs in ways that sidestep the FDA approval process.
This set of letters represents the second tranche sent to telehealth firms since the FDA launched a crackdown in September aimed at direct-to-consumer pharmaceutical advertising deemed misleading. According to the agency, over the last six months it has dispatched thousands of letters to pharmaceutical and telehealth companies ordering removal of misleading advertisements - a volume that exceeds the total number of such notices issued in the prior decade.
Among the firms previously called out, the agency issued action in February involving Hims & Hers; in that instance, Hims & Hers received a start warning from the FDA concerning its mass-marketing of compounded GLP-1 drugs.
In the new letters the FDA identified primary violations including claims that implied equivalence between compounded products and FDA-approved medicines, and practices that obscured product sourcing. The agency cited examples where telehealth companies advertised drug products bearing the telehealth firm's name or trademark without qualification, creating the impression that the telehealth company itself was the compounder.
The FDA reiterated a key regulatory distinction: compounded drugs are not FDA-approved, and therefore the agency does not review their safety, effectiveness or quality prior to marketing. The agency also noted that compounded products are not the same as generic drugs, which have undergone FDA review and approval.
The agency further noted that currently FDA-approved GLP-1 drugs are developed by Novo Nordisk and Eli Lilly.
Context and implications
The agency's continued outreach to telehealth and pharmaceutical firms signals heightened scrutiny of how compounded formulations are presented to consumers online. The letters focus on advertising language and branding practices that could mislead patients about a product's regulatory status or its relationship to FDA-approved therapies.
While the FDA framed the enforcement as corrective - emphasizing both the legitimate medical uses of compounding and the limits of the practice - the agency's notices stress that mischaracterizing compounded products as equivalent to approved medicines is a regulatory violation.
What the letters cite as problematic
- Claims suggesting compounded products are equivalent to FDA-approved drugs.
- Advertising that brands compounded products with the telehealth company’s name or trademark without qualification, implying the firm manufactured the compound.
Regulatory note
Compounded drugs are not reviewed by FDA for safety, effectiveness, or quality before they are marketed, and they are distinct from FDA-approved generics. The FDA named Novo Nordisk and Eli Lilly as developers of currently approved GLP-1 drugs.
This article is presented as a standalone news analysis of the FDA's recent enforcement actions and does not include additional commentary from affected firms beyond the agency's statements.