Hims & Hers is under scrutiny from U.S. lawmakers over its upcoming Super Bowl advertisement promoting weight loss treatments. Senators Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) have raised concerns with the FDA, arguing that the ad may mislead consumers by omitting critical safety and side effect information.
Lawmakers Raise Concerns Over ‘Misleading’ Marketing
The ad, titled “Sick of the System,” criticizes the $160 billion weight loss industry and features imagery of injection pens resembling Novo Nordisk’s Ozempic, a popular GLP-1 diabetes and weight loss drug. It claims that existing treatments are “priced for profits, not patients,” while positioning Hims & Hers’ weight loss medications as more affordable alternatives.
The senators’ letter does not explicitly name Hims & Hers but references visuals from the ad, including the injection pen. They argue that the commercial lacks the typical risk disclosures required in pharmaceutical ads. The only disclaimer, stating that the medications are not FDA-approved, appears briefly in small font for just three seconds.
Hims & Hers Defends Compliance
A company spokesperson stated that Hims & Hers is complying with existing regulations and is open to working with lawmakers to improve healthcare access. Meanwhile, Scott Brunner, CEO of the Alliance for Pharmacy Compounding, defended the ad, calling it a “help-seeking” pharmaceutical advertisement. He emphasized that since it does not promote a specific drug, it is not required to disclose side effects.
Hims & Hers began offering compounded semaglutide—an alternative to Ozempic and Wegovy—through its platform in May 2023. While brand-name GLP-1 drugs can cost around $1,000 per month without insurance, the company offers compounded semaglutide for under $200.
Regulatory and Market Implications
Compounded GLP-1s, which are custom-made alternatives to brand-name drugs, are often used when brand-name medications are in shortage. The FDA does not review their safety or efficacy, a concern highlighted by lawmakers.
Senators Durbin and Marshall argue that ads for FDA-approved GLP-1 drugs contain necessary warnings about side effects, including risks to the gallbladder and pancreas, as well as nausea and diarrhea. They believe the FDA has the authority to take enforcement action against misleading marketing and are considering new legislation to close regulatory loopholes.
Despite the controversy, investor confidence in Hims & Hers remains strong. The company’s stock soared 170% in 2023 due to rising demand for GLP-1 treatments and closed up 5% on Friday, pushing its market cap to approximately $9.5 billion.
