Written by: James Doar
Hims & Hers, a telehealth startup known for offering virtual healthcare services, aired a commercial during Super Bowl LIX which has sparked controversy among regulators, lobbyists, and U.S. Senators. The ad led to allegations that it violated the Federal Food, Drug, and Cosmetic Act (FDCA) and the Food and Drug Administration’s (FDA) regulations governing drug advertising.
Hims & Hers, founded in 2017, has made waves in the telehealth industry by offering accessible and discreet solutions for various health issues such as erectile dysfunction, hair loss, mental health conditions, and weight loss. Through their platform, users can consult licensed professionals, receive prescriptions, and have medications delivered directly to their homes. However, the recent ad, which focused heavily on promoting the company’s compounded versions of popular weight loss drugs, has raised questions about whether it adequately complied with FDA rules governing direct-to-consumer pharmaceutical advertising.
The Ad and the Reaction
The commercial, which aired during the Super Bowl, attacked the weight loss industry and promoted Hims & Hers’ compounded versions of drugs like Ozempic and Wegovy, which are prescribed for weight loss. “There are medications that work, but they’re priced for profits, not patients,” the narrator says in the ad. The ad positioned the company as an affordable, accessible alternative to these brand-name medications, providing versions that cost a fraction of the price. However, the commercial raised eyebrows because of its omission of important safety and regulatory information.
The ad glossed over the fact that Hims & Hers offers compounded versions of these popular weight loss drugs, meaning they are not subject to the same rigorous FDA approval process as their brand-name equivalents. While Ozempic and Wegovy have undergone extensive clinical trials and received approval from the FDA, the compounded versions sold by Hims & Hers have not been subjected to the same scrutiny. This distinction was buried in small font at the bottom of the screen for just three seconds during the minute-long commercial—an approach that many, including industry experts and U.S. Senators, viewed as misleading.
Before it aired during the Super Bowl, the advertisement was posted online, where it quickly attracted attention. Shortly after its release, U.S. Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) expressed concerns about the ad’s compliance with FDA regulations. The Senators sent a joint letter to the Acting Commissioner of the FDA, Sarah Brenner, urging the agency to investigate the commercial’s potential violation of advertising laws. The letter stated in part, “we believe FDA may already have the authority to take enforcement action against marketing that may mislead patients about this company’s products.”
Legal Implications and FDA Oversight
The FDCA and the FDA’s advertising regulations are designed to protect consumers from misleading or incomplete information about the drugs they use. Section 502(a) of the FDCA (21 U.S.C. § 352) requires that drug advertising must not be false or misleading in any way. More specifically, FDA regulations at 21 CFR 202.1 mandate that advertisements for prescription drugs must include a fair and balanced presentation of both the benefits and risks of the drug, as well as any relevant contraindications.
When an advertisement omits important safety information or presents an unbalanced view of a drug’s benefits, it can be deemed misleading. In this case, critics argue that the omission of key regulatory information regarding the compounded drugs—specifically their lack of FDA approval—was a clear violation of the requirement for “fair balance.” Critics say the small disclaimer that briefly appeared on the screen was inadequate in communicating the full extent of the risks involved with using drugs that are not subject to the traditional FDA approval process.
The absence of information about FDA approval and possible side effects could lead to potential violations of FDA advertising rules, such as 12 CFR 202.1(e)(7)(viii). That section says that an ad lacks fair balance and violates the FDCA if it “[f]ails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.”
Hims & Hers Responds
In the wake of the controversy, spokespeople for Hims & Hers have said that the company is complying with existing laws and that they 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 health care.” They maintain that “the ad aims to raise awareness to a critical issue—the obesity public health crisis—by showcasing the impact of obesity and the realities of the lack of access to life-saving weight loss treatments.”
As of now, the FDA has not issued any formal statement or enforcement action against Hims & Hers. However, the company’s ad has undoubtedly raised important questions about how the telehealth industry markets prescription drugs, particularly when it comes to compliance with FDA regulations.
Conclusion
The controversy surrounding Hims & Hers’ ad highlights the challenges of regulating digital health and pharmaceutical marketing in an era of rapid technological change. As telehealth continues to grow, the need for clear and effective regulation of drug advertisements is becoming more urgent. The FDA’s response to this issue will likely have significant implications not only for Hims & Hers but for the entire telehealth industry, which relies on consumer trust in the safety and efficacy of its offerings.
Sources:
Dani Blum, Millions Will See This Super Bowl Ad. Health Experts (and Two Senators) Aren’t Pleased, N.Y. Times, Feb. 7, 2025.
David Wainer, Hims Super Bowl Ad Spotlights Weight-Loss Drug Copycats as Clock Ticks on Their Business, Wall Street Journal, Feb. 10, 2025
Federal Food, Drug, and Cosmetic Act § 502, 21 U.S.C.S. § 352
Jennifer Leong, Super Bowl ad for Hims & Hers’ weight loss drug sparks backlash, Good Morning America, Feb. 11, 2025.
Lindsey Leake, Ozempic, Wegovy maker calls out Hims & Hers Super Bowl ad: ‘Check before you inject’, Fortune, Feb. 11, 2025.
Press Release, Sen. Dick Durbin, Durbin, Marshall Draw FDA Attention To Misleading Drug Commercial Set To Run During Super Bowl (Feb. 7, 2025)
21 C.F.R. 202.1 (2025)