Two senators ask the FDA to act on Hims & Hers' Super Bowl ad
Sens. Dick Durbin and Roger Marshall asked the FDA to look at a Hims & Hers Super Bowl ad for compounded weight-loss drugs, saying it left out side effect and risk information [1][2].
Two U.S. senators sent a bipartisan letter to the Food and Drug Administration on Feb. 7, 2025, flagging a weight-loss drug commercial scheduled to air during the Super Bowl, saying it "risks misleading patients by omitting any safety or side effect information" [1]. Sen. Dick Durbin (D-Ill.) and Sen. Roger Marshall (R-Kan.), a physician, addressed the letter to Acting Commissioner Brenner and noted the spot would reach more than 120 million Americans [1].
The senators did not name Hims & Hers in the letter, but they described details that match the telehealth company's ad, including "imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication" [1][2]. The ad, called "Sick of the System," was posted online in late January and criticizes the $160 billion weight loss industry, showing injection pens that resemble Novo Nordisk's Ozempic and claiming those drugs are "priced for profits, not patients" while presenting Hims & Hers' offerings as "affordable" and "doctor-trusted" [2].
What the senators said
Durbin and Marshall wrote that "nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement" [1]. They added that "for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved" [1].
By comparison, they wrote, FDA-approved labels and ads for brand-name GLP-1 medications carry "significant risk disclosures to patients about side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications" [1]. The letter cites Section 502 of the Federal Food, Drug, and Cosmetic Act and regulations at 21 CFR 202.1, which require prescription drug ads to be truthful, not misleading and balanced [1]. In the last six months of 2024, the FDA issued four untitled letters to manufacturers seeking corrections to false or misleading ads, the senators noted [1].
The senators argued the ad appears to exploit "a perceived loophole" in federal law covering promotions of compounded drugs by telehealth companies, said they believe the FDA may already have enforcement authority, and previewed bipartisan legislation to close any gap [1].
The company's response
"We are complying with existing law and are happy to continue working with Congress and the new Administration to fix the broken health system and ensure that patients have choices for quality, safe, and affordable healthcare," a Hims & Hers spokesperson told CNBC [2].
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said the ad is consistent with "help-seeking" pharmaceutical advertising: "Hims' Super Bowl ad does not promote a specific drug or medication and therefore is not required to provide information about side effects or risks," he said, adding that it encouraged viewers to consult a health care provider, which he said aligns with FTC guidelines for non-specific ads [2].
Why it matters for patients
The dispute is about what information an ad has to give you before you click. Hims & Hers began offering compounded semaglutide in May 2024 and sells it for under $200 a month, compared with roughly $1,000 a month without insurance for Ozempic and Wegovy, which both contain semaglutide [2]. The FDA does not review the safety and efficacy of compounded products, which are custom-made alternatives to brand-name drugs and can be produced when brand-name treatments are in shortage [2]. Semaglutide was listed as in shortage by the FDA at the time of the CNBC report [2].
That means a compounded version does not come with the same FDA-reviewed label and risk disclosures that accompany approved GLP-1 products [1][2]. The senators' complaint is that viewers seeing a fast-moving ad may not register that difference from a disclaimer shown for about three seconds in small type [1].
The letter also sets the ad against the broader backdrop of drug advertising: roughly $6 billion a year in U.S. direct-to-consumer prescription drug ads, with about one-third of evening news commercial time going to pharmaceutical promotions, and a JAMA study finding more than two-thirds of TV-advertised drugs were considered "low therapeutic value" [1].
What happens next
The letter was sent Friday, Feb. 7, 2025, with the ad set to air that Sunday [1][2]. Durbin and Marshall said they plan to introduce bipartisan legislation "soon" to close advertising gaps; no bill text, introduction date or FDA response is described in the sources [1][2]. Durbin has separately reintroduced the Drug-price Transparency for Consumers Act, which would require price disclosures in prescription drug ads [1]. Whether the FDA takes any enforcement action is not yet known [1][2]. Hims & Hers shares closed up 5% on Friday, giving the company a market value of about $9.5 billion [2].
Sources
Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.