Federal health officials are stepping up scrutiny of how telehealth companies and drugmakers advertise weight-loss medications, warning that some promotions may mislead consumers.
The Food and Drug Administration (FDA) on Tuesday issued more than 100 warning letters to pharmaceutical companies and online prescribing platforms, including Hims & Hers, a telehealth startup that has grown rapidly by offering lower-cost versions of popular obesity drugs.
Concerns About Compounded Drugs
At the center of the dispute are compounded medications—customized formulations prepared by specialty pharmacies. These products are not reviewed by the FDA and are legally distinct from brand-name drugs like Wegovy and Ozempic.
Regulators said Hims & Hers made “false and misleading” claims on its website, suggesting its compounded treatments contained “the same active ingredient” as FDA-approved drugs.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” the FDA wrote in its Sept. 9 letter.
In a statement, Hims & Hers said it “looks forward to engaging with the FDA,” adding that its materials already note compounded drugs are not FDA-approved.
A New Approach to Drug Advertising
The warning marks the first time the FDA has targeted online platforms like Hims & Hers under drug advertising rules. Regulators also flagged other high-profile promotions, including a 2024 infomercial featuring Oprah Winfrey that highlighted GLP-1 drugs such as Wegovy and Zepbound.
The FDA said the segment downplayed serious risks associated with the medications, which include potential life-threatening side effects.
The agency’s tougher stance follows a White House directive last week requiring drug ads on TV, social media, and online platforms to be “truthful and non-misleading.”
Growing Scrutiny of Weight-Loss Marketing
This isn’t the first time Hims & Hers has faced questions about its advertising. Earlier this year, its Super Bowl commercial promoting weight-loss drugs failed to mention potential side effects—an omission that runs afoul of FDA rules requiring a balanced presentation of benefits and risks.
Hims built its business by selling lower-cost treatments for hair loss and sexual health before expanding into obesity medications. Demand for GLP-1 drugs has soared, opening a new market for compounded alternatives.
The FDA allows compounding only under certain conditions, such as during drug shortages. Regulators recently declared that GLP-1 drugs are no longer in shortage, although compounded versions remain permitted if prescribed for an individual patient.
Shares of Hims & Hers fell more than 6% on Tuesday following the FDA’s announcement.
A Broader Debate on Drug Ads
The FDA’s actions highlight a longstanding debate over direct-to-consumer pharmaceutical advertising. Critics, including the American Medical Association, argue that upbeat ads often overshadow risks and can drive unnecessary demand.
Research shows that patients exposed to drug commercials are more likely to request specific medications, even if they don’t meet the clinical criteria.
As federal regulators turn their attention to digital platforms, companies like Hims & Hers may face greater pressure to adjust how they market their treatments.
YOU MAY ALSO LIKE
