WASHINGTON (AP) — For the first time, U.S. health officials are targeting telemedicine companies that promote unofficial versions of prescription medications, including popular weight‑loss drugs, as part of the Trump administration’s push against pharmaceutical advertising.
The FDA published on Tuesday more than 100 letters directed at various online prescription drug outfits, including Hims & Hers, which has built a multi‑billion‑dollar business around lower‑cost versions of obesity injections.
The FDA warned the company to remove from its site promotional statements that are “false and misleading,” including language that claims its customized products contain “the same active ingredient” as Wegovy and Ozempic, which are FDA‑approved medications. The drugs cited are produced by specialized compounding pharmacies and are not reviewed by the FDA.
“Their claims imply that their products are the same as an FDA‑approved product when they are not,” the warning letter states, dated September 9.
Hims, based in San Francisco, said on Tuesday that it “looks forward to cooperating with the FDA.”
“Our website and consumer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the company said in a statement.
It marks the FDA’s first direct attempt to oversee online platforms like Hims, which have long argued they are not subject to the traditional rules governing prescription drug advertising.
A memo signed by President Donald Trump last week directed Health Secretary Robert F. Kennedy Jr. and the FDA to ensure that pharmaceutical ads on television, social media, and other websites are “truthful and not misleading.” As part of the initiative, the FDA pledged to issue 100 letters to companies with deceptive advertisements.
The new letters include the wording “cease and desist,” a language departure for the agency, which typically drafts letters in highly bureaucratic language citing specific FDA regulations.
Hims has been under Washington scrutiny for months.
Earlier this year, the company ran a Super Bowl ad touting the benefits of its weight‑loss medications, but failed to list side effects or potential harms. FDA rules require ads to present a balanced picture of the risks and benefits of medications.
Makary highlighted the ad in last week’s Journal of the American Medical Association, calling it a “brazen” example of how advertising is “contributing to America’s culture of overreliance on pharmaceutical products for health.”
Hims and similar firms initially sold inexpensive generic versions of hair‑loss, erectile dysfunction, and other health products. But growing demand for obesity drugs opened the door to cheaper copies.
The FDA permits the so‑called compounding, or custom manufacturing, when there is a shortage of official FDA‑approved versions of medications.
Recently, the FDA determined that GLP‑1 medications no longer met the criteria for shortage status. That should have ended compounding, but there is an exception: the practice remains allowed when a prescription is tailored to the patient.
Hims and other firms have begun offering “personalized” doses and formulations for certain patients, arguing that they provide additional benefits.
The letters published on Tuesday come from the FDA’s Center for Drug Evaluation and Research.
A letter issued last week by the FDA’s vaccines division questioned a TV ad for AstraZeneca’s FluMist vaccine, saying the “background music and visual distractions” of the spot downplayed information about side effects. The letter was signed by the FDA’s vaccine chief, Dr. Vinay Prasad, an ally of Kennedy who recently returned to agency work after briefly being sidelined.
Researchers and consumer advocates have long argued that imagery of patients enjoying life with family and friends in drug ads often overshadows warnings about side effects.
Additionally, studies have shown that patients exposed to drug ads are more likely to ask their doctors about the medication, even if they do not meet prescription criteria. The American Medical Association, the country’s largest doctors’ group, backed a ban in 2015, citing television advertising’s role in “inflating demand for new and more expensive drugs.”
