U.S. Food and Drug Administration Commissioner Martin Makary said on Friday that Hims & Hers’ (HIMS.N), opens new tab Super Bowl advertisement breached federal law as it highlighted the benefits of weight-loss drugs without mentioning side effects.
Under federal law, advertisements for prescription drugs must present a “fair balance” of risks and benefits, Makary said in JAMA, opens new tab, a peer-reviewed medical journal published by the American Medical Association.
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He also highlighted a sharp drop in FDA enforcement, saying the agency used to issue hundreds of warning letters annually in the late 1990s compared with just one in 2023 and none in 2024.
A Hims & Hers spokesperson said the company’s “Super Bowl ad did not advertise any one treatment or solution.”
“Rather, it aimed to raise awareness to a critical issue – the obesity public health crisis – by showcasing the impact of obesity and the realities of the lack of access to life-saving holistic weight loss care,” the spokesperson said in an emailed statement.
The FDA’s latest move follows a presidential memorandum signed by Donald Trump on Tuesday, urging his administration to step up enforcement of direct-to-consumer (DTC) pharmaceutical ad regulations to ensure transparency and accuracy.
On the same day, the FDA said it would issue around 100 cease-and-desist enforcement notices and thousands of warning letters to pharmaceutical companies, reminding them to adhere to DTC advertising rules.
Makary noted that the U.S. is one of only two countries globally that allow DTC pharmaceutical advertising.
Hims & Hers had aired an ad during the Super Bowl in February showcasing its compounded versions of Novo Nordisk’s (NOVOb.CO), opens new tab Wegovy.
U.S. regulations permit compounding pharmacies to replicate brand-name drugs during periods of shortage. Wegovy had seen significant supply constraints in the country last year.
Americans unable to afford Wegovy or facing difficulties obtaining it have turned to lower-cost options offered by pharmacies and telehealth providers such as Hims & Hers and WeightWatchers (WW.O), opens new tab.
“Online pharmacies are advertising drugs with only upsides mentioned, contributing to America’s culture of over-reliance on pharmaceuticals for health,” Makary said, adding that the Hims & Hers ad was the most overt breach of FDA’s regulations on advertising.
