Two senators ask FDA to act on Hims & Hers Super Bowl ad for compounded semaglutide
The dispute centers on advertising for compounded semaglutide, which the FDA does not review for safety or effectiveness, and on whether telehealth ads must carry the same warnings as brand-name drug commercials.
Two U.S. senators asked the Food and Drug Administration on Feb. 7, 2025, to examine a Hims & Hers commercial booked for the Super Bowl, saying the spot pitches weight loss medication while leaving out side effect and safety information [1][2].
The letter went to FDA Acting Commissioner Brenner from Sen. Dick Durbin (D-Ill.) and Sen. Roger Marshall (R-Kan.), who noted the broadcast was expected to reach more than 120 million people [1].
What the commercial shows
According to CNBC, the ad is titled "Sick of the System," was posted online in late January, and takes aim at a weight loss market it values at $160 billion. It displays injection pens that look like Novo Nordisk's Ozempic, calls existing drugs "priced for profits, not patients," and offers Hims & Hers' own products as "affordable" and "doctor-trusted" alternatives [2].
Durbin and Marshall did not name the company in their letter. They cited "imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication" and wrote that no side effect, risk or safety disclosure appears anywhere in the promotion [1][2]. For three seconds of the minute-long spot, they said, the screen flashes in "small, barely legible font" that the products are not FDA-approved [1][2]. By contrast, the approved labels and ads for brand-name GLP-1 drugs carry warnings about the gallbladder, pancreas, vomiting, diarrhea and other effects, the letter states [1].
Section 502 of the Federal Food, Drug, and Cosmetic Act and rules at 21 CFR 202.1 require prescription drug advertising to be truthful, not misleading and balanced, and the senators said violations can bring enforcement action, including civil monetary penalties [1]. Their letter notes the FDA issued four untitled letters in the last six months of 2024 directing manufacturers to correct advertising that was false or misleading [1].
Two competing readings of the ad
Hims & Hers pushed back. A company spokesperson told CNBC: "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" [2].
Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, said the ad does not promote a particular medication and therefore is not required to list risks or side effects. In his account, it urged viewers to talk with a health care provider, which he said matches FTC guidance for non-specific, "help-seeking" advertising [2].
The senators take the opposite view, arguing the ad falls under the FDA's jurisdiction and that the agency may already hold the authority to act [1]. No FDA response to the letter has been reported.
The business behind the ad
Hims & Hers started selling compounded semaglutide through its platform in May 2024, after launching a weight loss program in late 2023 [2]. Semaglutide is the active ingredient in Ozempic and Wegovy, which can run around $1,000 a month without insurance; the compounded version from Hims & Hers sells for under $200 a month [2].
Compounded products are custom-made alternatives that the FDA does not review for safety and efficacy, and they can be made while a brand-name treatment is in shortage. Semaglutide was in shortage at the time, according to the FDA [2]. Hims & Hers shares closed up 5% on Feb. 7, putting its market value near $9.5 billion after a year in which the stock climbed more than 170% [2].
Why it matters for patients
A commercial featuring an injection pen can read like advertising for an approved medicine, while the product actually being sold may be compounded semaglutide that the FDA has not evaluated for safety or effectiveness [2]. That gap is the heart of the senators' complaint: in their telling, a viewer would not learn about side effects or approval status from the ad itself [1].
The price difference matters too. Compounded semaglutide is generally available only while the brand-name drug is in shortage, and the two sides disagree about whether this particular promotion needed risk disclosures, because advertising rules hinge on whether a specific drug is named [1][2].
What happens next
The senators said they will soon introduce bipartisan legislation to close any regulatory gap covering promotions of compounded drugs by telehealth companies, although they gave no date [1]. Durbin also recently reintroduced the Drug-price Transparency for Consumers Act, a separate bipartisan bill that would require price disclosures in prescription drug ads [1]. Whether the FDA opens a review, and what the planned legislation would require, has not been disclosed [1].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.