Hims & Hers Super Bowl Ad for Semaglutide "Nothing Short of Reckless," Says Partnership for Safe Medicines
In letters to the FDA and Fox Broadcasting, PSM enumerated the laws abrogated and the potential harms of the ad being viewed by 200 million people on February 9, 2025.
“Nothing short of reckless,” is how the Partnership for Safe Medicines (PSM) describes an advertising campaign for compounded semaglutide produced by the telehealth company Hims & Hers and scheduled to appear in a prime slot during the Super Bowl LIX coverage this Sunday.
PSM Executive Director
Shabbir Imber Safdar
Shabbir Imber Safdar
PSM, a consortium of 45 nonprofit organizations that takes on drug counterfeiters, supply chain security, and regulation of online medicine sellers, has sent letters to the Fox Corporation1 and to the FDA’s Office of Prescription Drug Promotion2 underscoring the specific prescription drug advertising laws and guidelines being abrogated in the full 1-minute spot for the “knock off copy of a prescription drug.”1,2 PSM said the commercial has already been posted on YouTube.
“We strongly urge FDA to take action and stop Hims & Hers from misleading the 200 million people who will see this commercial if it runs during Super Bowl LIX,” PSM said in its letter to the FDA.2
To the Fox Corporation the partnership wrote: “It is a prescription drug advertisement, and as such, we believe that [it] is non-compliant with both Fox Broadcasting Company’s (FBC) Advertising Guidelines and the FDA and FTC regulations governing commercial advertisements.”1
Semaglutide History
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is marketed by Novo Nordisk as Wegovy for weight management in persons with overweight and obesity and as Ozempic for treatment of type 2 diabetes. The drug’s meteoric rise in popularity after FDA approval, fueled by online celebrity endorsements and other ad-hoc promotions, led to dwindling supplies and manufacturing lapses that landed the drug on the FDA’s shortage list. It is legal in the US for compounding pharmacies to produce and sell drugs protected by a manufacturer’s patent, in limited quantities.
Although the company’s efforts were not successful, Novo Nordisk last year petitioned the FDA to block compounded versions of semaglutide, arguing that the active drug is too complex to be made safely by compounders.3
According to the PSM and noted specifically in the letter to FOX,1 the ad fails to sufficiently convey that the semaglutide offered is a compounded product and not FDA-approved and omits the typically lengthy risk and side effect information that is required in promotion of a prescription medicine in all media. The information left out is “necessary for patient protection,” PSM said.
The organization in both letters quotes public health experts calling the commercial “incredibly irresponsible,” and cites coverage of the plan for the ad from The Wall Street Journal and STAT News.1,2
Signed by PSM Executive Director Shabbir Imber Safdar, the letter to the FDA asks the CDER director to act immediately to prevent the ad from appearing on the Super Bowl broadcast. In a gesture toward disclosure, PSM said, the ad does include a disclaimer that compounded products are not FDA-approved, but this appears "only briefly in tiny grey font at the bottom of the screen that is nearly imperceptible to an average viewer, without any accompanying audio disclosure." It also discloses no risks, omitting the "fair balance" requirements of medicine promotion in the US.2
Nor does the ad clearly indicate to the viewer that the product is available by prescription only and that it should be discussed in consultation with a physician. “There is a brief disclaimer at the bottom of the screen that reads ‘Prescription required,’ but it is displayed in miniature font for three seconds and does not communicate clearly to the viewer,” PSM chided in the letter to Fox.1
"Compounded drugs have a role to play in medicine, but they can present significant health risks – particularly with complex injectable products like Hims & Hers is advertising," Safdar added. Compounded drugs are considered a “last resort” for those who need them while there is a shortage but should never be “the first choice in therapy,” he said. “…the many millions of people who tune into the Super Bowl won't learn that from this ad."4
From Hims & Hers
The 'Sick of the System' ad, Hims & Hers first for a Super Bowl, aims “to raise awareness to a critical issue – the obesity public health crisis – with a bold and direct spot showcasing the impact of obesity and the realities of the lack of access to life-saving weight loss treatments," according to a spokesperson.5 The 60-second commercial will air during the game’s third quarter and showcases that the company “is committed to being part of easing the strain the weight loss drug shortage is placing on the millions of Americans who have obesity and are looking for help.”5
Hims & Hers accuses the pharma industry of selling weight-loss drugs at unreasonably high prices and claims that its semaglutide products are "accessible, affordable, doctor-trusted, and formulated in the USA." The company says its semaglutide injections are fulfilled and shipped from Hims & Hers' affiliated pharmacies.4
