Hims & Hers runs the first Super Bowl ad for GLP-1 weight loss

Telehealth company Hims & Hers became the first advertiser to promote GLP-1 weight-loss offerings during a Super Bowl, airing a 60-second spot called "Sick of the System" in the third quarter of Super Bowl LIX on Feb. 9 ^[1]. The ad drew a 650% spike in site traffic and an immediate backlash from Novo Nordisk, a pharmaceutical trade group and two U.S. senators ^[1].

The game drew 127.7 million viewers, the most-watched Super Bowl ever, according to FOX Sports ^[1]. The ad showed a montage of junk food and abdominal fat, cited statistics about obesity risks and drug prices, and pitched Hims & Hers' weight-loss products \u2014 including compounded GLP-1 medications \u2014 as an alternative to branded drugs like Ozempic and Wegovy ^[1]. A narrator says, "Welcome to weight loss in America\u2014a $160 billion industry that feeds on our failure. There are medications that work\u2014but they are priced for profits, not patients" ^[3]. The spot claims 74% of U.S. citizens are overweight and that more than 500,000 people die each year from obesity-related causes ^[3].

The company told Fierce Healthcare that traffic jumped more than 650% in the hours after the ad aired, that new customer registrations hit record highs, and that the Hers app climbed to #2 in the Apple Store's Health & Wellness category after not being in the top 10 before the game ^[1]. TV measurement firm EDO ranked the spot #5 in engagement among all ads in the game ^[1]. Hims & Hers shares rose 10% that week and were up 83% for the year at the time of the report ^[1].

The fight over compounded semaglutide

Hims & Hers offers subscriptions for Wegovy and Ozempic starting around $1,800 a month, while its compounded GLP-1 subscription is priced at $165 a month, according to Fierce Healthcare ^[1]. Adweek reported a different figure, saying the company began offering compounded semaglutide injections in May for $199 per month, versus almost $1,000 for Ozempic and $1,349 for Wegovy ^[3]. The sources disagree on the exact price.

Compounded semaglutide has the same active ingredient as the branded drugs but does not go through the FDA's approval process ^[1]. Because of that, compounded products do not carry FDA-required labeling such as side-effect warnings, boxed warnings or risk evaluation and mitigation strategies, though they remain subject to state pharmacy board oversight and USP standards under Sections 503A and 503B of the federal drug law, according to the Alliance for Pharmacy Compounding ^[1]. The FDA warned in June 2023 that unapproved GLP-1 versions "can be risky for patients" because they are not reviewed for safety, effectiveness and quality ^[1]. The agency has also said patients should not use a compounded GLP-1 drug if an approved drug like Wegovy is available ^[1].

Novo Nordisk responded the next day with print ads in The New York Times and USA Today headlined "Check Before You Inject" ^[1]. The ad reads: "Some compounded semaglutide vials have been found to contain dangerous impurities, banned substances, or incorrect doses. Bottom line: If the label doesn't say Wegovy (semaglutide) or Ozempic (semaglutide), it's not FDA approved and you have no idea what's inside" ^[1]. Hims & Hers said it makes Certificates of Analysis available to every GLP-1 customer showing ingredients from FDA-regulated suppliers ^[1].

Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) sent a bipartisan letter to the FDA saying the ad "risks misleading patients" and that "nowhere in this promotion is there any side-effect disclosure, risk, or safety information, as would be typically required in a pharmaceutical advertisement" ^[3]. PhRMA said the ad runs afoul of federal law requiring prescription drug ads not be false or misleading ^[1]. The Obesity Society said on Feb. 7 the ad "will mislead viewers by excluding any information about the overall risks and side effects of compounded drugs" ^[1]. The Alliance of Pharmacy Compounders defended the spot, arguing it does not promote a specific drug and so is not required to disclose side effects, and that compounded drug advertising falls under FTC jurisdiction ^[1]. Hims & Hers said it complies with existing law and discloses that compounded medications are not FDA-approved \u2014 though Fierce Healthcare noted that disclaimer appeared briefly and in very small font ^[1].

Why it matters for patients

The fight highlights a real gap in what consumers see. FDA-approved drug ads must include risk and side-effect information; ads for compounded products, at least as Hims & Hers and its trade group read the law, do not ^[1]. That means a mass-market ad can pitch a much cheaper option without the safety language people are used to hearing.

Price differences are large \u2014 hundreds of dollars a month versus roughly $1,000 to $1,800 ^[1][3] \u2014 but so are the regulatory differences. Compounded versions skip FDA review for safety, effectiveness and quality, and Novo Nordisk says some vials have contained impurities, banned substances or wrong doses ^[1]. Independent verification of those specific claims is not detailed in the sources.

Doctors are watching too. In a survey of 2,000 primary care physicians on Sermo, 67% said getting GLP-1 prescriptions through a third-party telehealth provider may put a patient's health at risk ^[1].

What happens next

Durbin and Marshall said they plan to introduce legislation to close gaps in prescription drug advertising rules; no timeline was given ^[1]. Novo Nordisk and Eli Lilly have filed petitions asking the FDA to add their GLP-1 medications to a list of drugs deemed too complex to compound safely ^[3]. Whether the FDA takes enforcement action on the ad is not yet known.