FDA updates its guidance page for telehealth companies promoting compounded drugs

The Food and Drug Administration has updated its guidance page aimed at telehealth companies that promote compounded drugs, listing the specific marketing claims the agency considers false or misleading. The page singles out compounded glucagon-like peptide-1 receptor agonists (GLP-1s) among the products it is concerned about. ^[1]

The agency says false or misleading promotion "puts patients at risk as they cannot make an informed decision about their health based on false or misleading claims," and that it "also violates federal law." ^[1]

What the FDA says companies cannot claim

The page lists five practices the agency is warning against when telehealth companies market compounded GLP-1 drugs to consumers. ^[1]

First, companies should not use website branding that "falsely or misleadingly implies the telehealth company is the compounder." In other words, a site that sells the product should not blur the line between itself and the pharmacy or outsourcing facility that actually makes it. ^[1]

Second, companies should not describe a compounded drug as a generic version of an FDA-approved drug, or as the same as an FDA-approved drug. The FDA's reasoning is a regulatory one: generic drugs are reviewed and approved by the agency before they are marketed, while compounded drugs are not. ^[1]

Third, companies should not claim that a compounded drug has been FDA-approved or otherwise "evaluated for safety and effectiveness." The agency states plainly that compounded drugs "are not reviewed by the agency for safety, effectiveness or quality prior to marketing." ^[1]

Fourth, companies should not describe a compounded drug as "clinically proven to produce the same result as the FDA-approved drug." ^[1]

Fifth, companies should not claim a compounded drug is sourced from an "FDA-approved" or "FDA-licensed" pharmacy or outsourcing facility, because, as the page states, "FDA does not approve or license any facility." ^[1]

The page also notes that the FDA has already issued warning letters to telehealth companies over false or misleading claims, and directs readers to search the term "telehealth" in the agency's public warning letter database to find them. The number of letters, which companies received them, and when they were sent are not listed on the page itself. ^[1]

Why it matters for patients

Compounded semaglutide and tirzepatide have been widely sold online, often through telehealth platforms, and the marketing language on those sites is frequently the main information a buyer sees before paying. This page is essentially the FDA telling sellers which phrases it views as unlawful — and, by extension, telling consumers which phrases are not reliable signals of quality. ^[1]

The practical takeaway is about labels, not medicine. Phrases such as "generic Ozempic," "FDA-approved pharmacy," "FDA-licensed facility," or "clinically proven to work the same" are, according to the agency, either inaccurate or describe something that does not exist. The FDA is explicit that it does not approve or license pharmacies or outsourcing facilities at all. ^[1]

It also matters that the FDA distinguishes compounded drugs from generics. A generic semaglutide or tirzepatide would have to clear FDA review before sale; a compounded version does not go through that review for safety, effectiveness, or quality. ^[1]

The page does not say the compounded products are unsafe, does not name specific sellers, and does not announce any new rule or enforcement deadline. It describes the agency's position on promotion and says the FDA "remains vigilant in its oversight of promotional materials" and "will continue to take actions" against false or misleading claims by telehealth companies. ^[1]

What happens next

The FDA has not published a timetable, comment period, or planned rulemaking tied to this page, so no dated milestones are known from the source. The agency's stated next step is continued oversight of promotional materials and further enforcement actions, without specifying targets or timing. Patients tracking this can watch the FDA warning letter database, which the agency points to as the public record of actions already taken. ^[1]