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.<\/p>\n
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.<\/p>\n
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\nHe 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.<\/p>\n
A Hims & Hers spokesperson said the company’s “Super Bowl ad did not advertise any one treatment or solution.”
\n“Rather, it aimed to raise awareness to a critical issue \u2013 the obesity public health crisis \u2013 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
Makary noted that the U.S. is one of only two countries globally that allow DTC pharmaceutical advertising.
\nHims & 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“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.<\/p>\n","protected":false},"excerpt":{"rendered":"
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 […]<\/p>\n","protected":false},"author":2,"featured_media":1798,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[489],"class_list":{"0":"post-1797","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-food-and-drug","8":"tag-us-fda-chief-says-hims-hers-super-bowl-ad-violated-drug-promotion-rules"},"yoast_head":"\n