The Controversy Surrounding Hims & Hers’ Super Bowl Ad: A Debate on Healthcare Access and Safety

A Telehealth Company at the Center of a Growing Debate

The 2025 Super Bowl became more than just a platform for sports and entertainment when telehealth company Hims & Hers aired a controversial advertisement for its compounded weight loss medications. The ad, which lasted a minute, aimed to highlight America’s obesity crisis while positioning the company’s products as affordable alternatives to FDA-approved medications like Ozempic and Wegovy. These medications, which contain the active ingredient semaglutide, are used to treat Type 2 diabetes and obesity. However, Hims & Hers’ version of the drug is compounded, meaning it is not subject to the FDA’s rigorous approval process. This distinction has sparked a heated debate over the safety, transparency, and regulation of compounded drugs in the telehealth industry.

The Ad and Its Message: A Call for Affordable Healthcare

The advertisement featured imagery of a scale, tempting foods like pies and cheeseburgers, and a refrigerator stocked with Hims & Hers medication vials. The narrator delivered a powerful message, stating, "Something’s broken, and it’s not our bodies," and criticized the high pricing of medications like Ozempic and Wegovy, which are often out of reach for many Americans without insurance. Hims & Hers positioned itself as a solution, offering a compounded version of semaglutide at a lower cost. The ad encouraged viewers to consult with healthcare providers, aligning with telehealth’s mission of expanding access to care. However, the ad’s lack of side effect disclosures and safety information raised red flags among regulators and competitors.

Regulatory Scrutiny and the Role of Compounded Drugs

Compounded drugs, such as those offered by Hims & Hers, are made for individual patients using raw ingredients and do not undergo the FDA’s premarket review for safety, effectiveness, or quality. The FDA has long warned that these drugs pose a higher risk to patients compared to FDA-approved medications. Despite this, compounded drugs are not regulated by the FDA but instead fall under the jurisdiction of the Federal Trade Commission (FTC). The FTC regulates advertisements for non-specific, "help-seeking" content, which is why Hims & Hers’ ad did not include detailed safety information. However, this regulatory distinction has led to criticism from lawmakers and competitors alike.

Senators Call for Action: Closing the Regulatory Loophole

In response to the ad, Democratic Sen. Dick Durbin of Illinois and Republican Sen. Roger Marshall of Kansas sent a joint letter to the FDA, expressing concerns about the lack of transparency and safety disclosures in the advertisement. The senators argued that patients should not be misled by advertisements that omit critical information, regardless of whether the product is FDA-approved or compounded. They called on the FDA to take enforcement action or, if necessary, for Congress to introduce bipartisan legislation to close the regulatory gap. This bipartisan effort reflects growing concerns about the balance between expanding access to affordable care and ensuring patient safety.

Industry Backlash: Competitors Question Safety and Transparency

The day after the Super Bowl, Novo Nordisk, the manufacturer of Ozempic and Wegovy, published a full-page ad in major newspapers, questioning the safety of compounded drugs. The ad asked, "Do you really know what you’re injecting into your body?" Hims & Hers responded by emphasizing its commitment to safety, quality, and transparency. The company highlighted its provision of Certificates of Analysis, which detail the quality standards of its compounded medications. Hims & Hers also defended its pricing, stating that it offers a more affordable alternative to expensive FDA-approved drugs, with a monthly cost of $165 for compounded semaglutide compared to over $1,000 for name-brand medications without insurance.

The Broader Implications: Access, Affordability, and the Future of Telehealth

The controversy surrounding Hims & Hers’ Super Bowl ad highlights a larger issue in the healthcare industry: the tension between expanding access to affordable medications and ensuring patient safety. While compounded drugs provide a cheaper alternative for many Americans struggling with obesity and diabetes, their lack of FDA oversight raises legitimate concerns. Telehealth companies like Hims & Hers argue that they are filling a critical gap in the healthcare system by offering personalized and affordable treatments. However, this approach must be balanced with robust regulatory oversight to protect patients. As the telehealth industry continues to grow, the debate over compounded drugs and their role in the healthcare system is likely to intensify, shaping the future of how medications are prescribed, regulated, and advertised.

Summary: Hims & Hers’ Super Bowl ad for its compounded weight loss medications has sparked a contentious debate about affordability, safety, and regulatory oversight in the telehealth industry. While the company argues that its products provide much-needed access to affordable care, critics raise concerns about the lack of FDA approval and transparency in advertising. This controversy underscores the broader challenges of balancing patient access with safety in an increasingly complex healthcare landscape.