Hims' Super Bowl Ad: A Wake-Up Call for Weight-Loss Drug Copycats

The 2025 Super Bowl was more than just a football game; it served as a platform for Hims & Hers to spark a conversation about the weight loss industry. The telehealth company's ad, "Sick of the System," criticized the high costs of weight loss drugs and positioned its compounded version of Novo Nordisk's Wegovy as an affordable alternative. However, the ad has drawn criticism from industry watchers and lawmakers, raising questions about the long-term viability of Hims & Hers' business model and the broader market for compounded weight loss drugs.



The FDA's oversight of compounded drug ads is considered a "regulatory gray area," allowing companies like Hims & Hers to operate in a "Wild West" environment. The agency has historically not done much around this area, but statutory requirements for labeling and advertising promotion still apply. The FDCA states that a compounded drug is misbranded if its advertising or promotion is false or misleading. Hims & Hers' ad has been criticized for lacking information on safety, side effects, and efficacy, potentially violating these regulations.

The ad has prompted Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) to send a letter to the FDA, asking the agency to review the Hims ad for potential violations of the Federal Food, Drug, and Cosmetic Act. The Partnership for Safe Medicines, a pharmaceutical industry group, has also called on the FDA to investigate Hims & Hers for potential violations. If the FDA takes action against Hims & Hers, it could set a precedent for the industry and lead to stricter regulations for compounded drug advertising.

The FDA's response to the Hims & Hers ad could have far-reaching implications for the broader market for compounded weight loss drugs and the telehealth industry. Clarification of regulatory standards, impact on consumer trust, potential changes in legislation, market dynamics and competition, and investor sentiment are all factors that could be influenced by the agency's decision.

In conclusion, Hims & Hers' Super Bowl ad has spotlighted the growing market for compounded weight loss drugs and the regulatory gray area surrounding their advertising. As the clock ticks on their business model, the company and the broader telehealth industry await the FDA's response, which could shape the future of this market and the regulatory landscape.