FDA takes aim at Hims & Hers, weight loss drugs in new advertising blitz
[September 17, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — For the first time, federal health officials are
taking aim at telehealth companies promoting unofficial versions of
prescription drugs — including popular weight loss medications — as part
of the Trump administration’s crackdown on pharmaceutical advertising.
The Food and Drug Administration on Tuesday posted more than 100 letters
to various drugmakers and online prescribing companies, including Hims &
Hers, which has built a multibillion-dollar business centered around
lower-cost versions of blockbuster obesity injections.
The FDA warned the company to remove “false and misleading” promotional
statements from its website, including language claiming that its
customized products contain “the same active ingredient” as FDA-approved
drugs Wegovy and Ozempic. The formulations cited by regulators are
produced by specialty compounding pharmacies and aren't reviewed by the
FDA.
“Your claims imply that your products are the same as an FDA-approved
product when they are not,” states the warning letter, dated Sept. 9.
Hims said Tuesday that it “looks forward to engaging with the FDA.”
“Our website and our customer-facing materials note that compounded
treatments are not approved or evaluated by the FDA,” the company said
in a statement.
It’s the first FDA attempt to directly police online platforms like Hims,
which have long argued they’re not subject to traditional drug
advertising rules.
The FDA also posted separate warning letters to manufacturers of the
so-called GLP-1 drugs, taking issue with a 2024 infomercial featuring
Oprah Winfrey. Regulators said the 42-minute TV segment from Eli Lilly
and Novo Nordisk gave a “misleading impression” about the safety of
Zepbound, Wegovy and similar “drugs with multiple serious, potentially
life-threatening risks.”
Health Secretary Robert F. Kennedy Jr. has long been a critic of the
pharmaceutical industry, including GLP-1 drugs, and previously suggested
Americans can reverse obesity with diet and exercise alone.
A memo signed by President Donald Trump last week directed Kennedy and
the FDA to ensure that pharmaceutical ads on TV, social media and other
websites are “truthful and non-misleading.”
The new FDA letters each contain “cease and desist” language. That’s a
different approach for the agency, which typically drafts its letters in
highly bureaucratic language citing specific FDA regulations.
Hims has been under scrutiny from Washington for some time.
Earlier this year, a Super Bowl ad from the company touted the benefits
of its weight-loss medications but didn't list any of their side effects
or potential harms. FDA rules require advertisements to present a
balanced picture of drug risks and benefits.
Makary singled out 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 pharmaceuticals
for health.”
[to top of second column]
|
The Food and Drug Administration seal is seen at the Hubert Humphrey
Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose
Luis Magana, File)
Hims and similar companies initially sold cheap generic versions of
drugs for hair loss, erectile dysfunction and other health issues. But
booming demand for obesity medications opened the door to selling
cheaper copies.
The FDA permits so-called compounding, or customized production, when
there is a shortage of the official versions of FDA-approved
medications.
FDA recently determined that GLP-1 drugs no longer met the criteria for
a shortage. That should have ended the compounding, but there is an
exception: The practice is still permitted when a prescription is
customized for the patient.
Hims and other companies have taken to offering “personalized” dosages
and formulations for certain patients, arguing they offer extra
benefits.
Shares of San Francisco-based Hims & Hers Health Inc. fell more than
6.47% in trading Tuesday.
The letters posted Tuesday come from FDA’s drug center.
A letter posted last week from FDA’s vaccine division took issue with a
TV ad for AstraZeneca’s FluMist vaccine, saying the spot’s “background
music and visual distractions” detract from information about side
effects. The letter was signed by FDA vaccine chief Dr. Vinay Prasad, an
ally of Kennedy who recently returned to his job at the agency after
briefly being forced to step aside.
Researchers and consumer advocates have long complained that the upbeat
TV images of patients enjoying life with family and friends often
overshadow discussions of 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
don’t fit the prescribing criteria. The American Medical Association,
the nation’s largest physician group, came out in support of a ban in
2015, citing TV advertising’s role in “inflating demand for new and more
expensive drugs.”
___
The Associated Press Health and Science Department receives support from
the Howard Hughes Medical Institute’s Science and Educational Media
Group and the Robert Wood Johnson Foundation. The AP is solely
responsible for all content.
All contents © copyright 2025 Associated Press. All rights reserved
 |
