FDA targets telehealth firms over ads for compounded weight-loss drugs

The Food and Drug Administration on Tuesday posted more than 100 warning letters to telehealth and drug-related companies, saying some online platforms have promoted compounded or customized versions of prescription weight‑loss injections in ways that falsely imply they are the same as FDA‑approved products.

Among the companies singled out was Hims & Hers, which the FDA warned to remove language asserting that its customized formulations contain “the same active ingredient” as approved drugs such as Wegovy and Ozempic. The agency said the formulations cited by regulators are produced by specialty compounding pharmacies and are not reviewed or approved by the FDA, and a warning letter dated Sept. 9 told the company its claims “imply that your products are the same as an FDA‑approved product when they are not.” Hims said it “looks forward to engaging with the FDA” and noted its customer materials state that compounded treatments are not approved or evaluated by the agency.

The letters were posted as part of a broader White House initiative directing the Health and Human Services secretary and the FDA to ensure drug advertising on television, social media and other websites is “truthful and non‑misleading.” A memo signed last week by President Donald Trump charged the FDA with increasing enforcement efforts; the agency said the newly posted letters include stronger “cease and desist” language than the more technical regulatory notices it has typically issued.

Federal officials have been closely watching telehealth platforms that have expanded beyond early offerings such as generics for hair loss and erectile dysfunction to sell lower‑cost alternatives to popular injectable GLP‑1 obesity drugs. The FDA allows compounding — customized production of medications by pharmacies — in limited circumstances, including when there is an approved product shortage. The agency recently determined that the GLP‑1 drugs no longer met shortage criteria, but compounding can still be allowed when prescriptions are individually customized for patients, an exception companies have cited to justify personalized dosages and formulations.

FDA officials said the online statements at issue go beyond describing compounding options and instead create the impression that compounded products are identical to specific FDA‑approved brands. The agency’s drug center drafted the majority of the letters posted Tuesday; a separate letter last week from the FDA’s vaccine division criticized a television spot for AstraZeneca’s FluMist vaccine, saying the spot’s background music and visual distractions detracted from required information about side effects. That letter was signed by Dr. Vinay Prasad, the vaccine division chief who recently returned to the agency after briefly stepping aside.

The scrutiny reflects growing concern among regulators, researchers and some clinicians that upbeat consumer advertising can obscure information about risks and drive demand for medications. Critics flagged a Hims Super Bowl advertisement earlier this year that promoted the benefits of weight‑loss medications without listing side effects, and a commentary in the Journal of the American Medical Association called the spot a “brazen” example of advertising that contributes to reliance on pharmaceuticals.

Studies have found that exposure to direct‑to‑consumer drug advertising increases patient requests for advertised medicines, sometimes irrespective of whether patients meet prescribing criteria. The American Medical Association has in the past supported a ban or tighter limits on such advertising, citing its role in inflating demand for newer and often more expensive therapies.

The FDA’s action marks its most direct effort to regulate the public faces of online prescribing platforms, which long have argued they are not subject to the same advertising rules as traditional drug manufacturers. Agency officials have emphasized that compounded formulations are not evaluated for safety, efficacy or manufacturing quality in the way approved drugs are, and that promoting them as equivalent could mislead patients and clinicians.

The posted letters instruct companies to remove or correct promotional statements that the FDA deems false or misleading and to provide written responses describing corrective actions. The agency did not release details about further enforcement steps.

Industry and consumer advocates say the move may intensify debates over access and affordability of GLP‑1 therapies, which have seen surging demand for weight‑loss treatment. Telehealth companies have argued that personalized compounding can meet patient needs and potentially reduce costs, while regulators say clarity is required so patients understand when they are receiving an FDA‑approved product versus a compounded alternative.

The FDA has said it will continue reviewing promotional materials and advertising across media platforms to ensure that information presented to consumers accurately reflects the status of products and their risks. The agency’s letters to telehealth firms come as federal authorities refine how to apply longstanding advertising standards to new online health marketplaces and as public demand for obesity treatments remains high.