In brief
In a significant move, the U.S. Food and Drug Administration (FDA) has begun to address misleading advertising practices from telehealth companies selling unapproved versions of popular medications, including weight-loss drugs. This follows a directive for more accurate pharmaceutical advertising, targeting firms like Hims & Hers that have faced criticism for not disclosing side effects in their promotional materials.
WASHINGTON – In a groundbreaking regulatory effort, the Food and Drug Administration (FDA) has taken direct action aiming at telehealth companies that promote unofficial versions of widely-used prescription drugs, including popular weight-loss medications. This initiative aligns with the Trump administration’s broader effort to enhance pharmaceutical advertising regulations.
On Tuesday, the FDA dispatched more than 100 warning letters to various telehealth companies, prominently featuring Hims & Hers, a company that has amassed significant profits by offering cheaper alternatives to well-known drugs like Wegovy and Ozempic.
The agency criticized Hims for fabricating claims about their products containing the same active ingredient as FDA-sanctioned medications, pointing out that these formulations, produced by compound pharmacies, lack FDA review.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” stated the FDA's warning letter, dated September 9.
This marks the first substantial effort by the FDA to regulate advertising from online platforms that have claimed exemption from existing drug promotion rules.
The FDA letters come as part of a wider administrative push from President Trump’s recent memo instructing Health Secretary Robert F. Kennedy Jr. to ensure pharmaceutical advertisements across various media platforms are “truthful and non-misleading.”
Health advocates have long criticized companies like Hims for creating a culture reliant on pharmaceuticals by not adequately representing drug risks and benefits, as displayed in a recent Super Bowl advertisement that omitted serious side effects.
The FDA's approach marks a shift in how they communicate with companies about misleading advertising, now using “cease and desist” directives instead of the typically bureaucratic language.
Following public scrutiny and the rapid growth in demand for obesity drugs, the FDA clarified its stance regarding the compounding of medications, affirming that while such practices are permitted, they must not mislead the public about the products’ nature and efficacy.
As the FDA continues to monitor advertising practices closely, there are growing calls for comprehensive reform in pharmaceutical marketing to better protect consumers.
