Hims & Hers, a telehealth company known for its personalized healthcare offerings, aired a minute-long advertisement during the 2025 Super Bowl, promoting its compounded weight loss medications. The ad drew controversy by comparing the cost of its medication to FDA-approved drugs like Ozempic and Wegovy, which are used to treat Type 2 diabetes and obesity. Unlike these medications, Hims & Hers' compounded version does not require FDA approval, raising concerns among lawmakers and health officials.
“Something's broken, and it's not our bodies” – Hims & Hers narrator
The advertisement highlighted the high costs associated with FDA-approved weight loss drugs and suggested that Hims & Hers' compounded solutions offer a more affordable alternative. The company advertises a monthly price of $165 for weekly injections of compounded semaglutide, in contrast to the over $1,000 monthly cost for medications like Ozempic and Wegovy without insurance. However, the FDA has previously warned consumers about using compounded versions of approved medications due to potential safety risks.
In response to the ad, Democratic Senator Dick Durbin and Republican Senator Roger Marshall sent a letter to the FDA, urging the agency to take action against what they considered misleading advertising. They argued that the ad omitted critical safety and side effect information necessary for consumer protection.
“We recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments” – Sen. Dick Durbin and Sen. Roger Marshall
“However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities” – Sen. Dick Durbin and Sen. Roger Marshall
Hims & Hers defended its advertisement, stating that it complies with existing laws and is prepared to collaborate with Congress and the new Administration to address issues within the healthcare system. The company's response emphasized its commitment to providing consumers with affordable healthcare options while adhering to legal standards.
“By offering access to personalized treatments, we’re able to help customers feel healthier, better manage side effects, and stay on treatment up to 3 times longer than the industry standard” – Hims & Hers
The Alliance for Pharmacy Compounding also weighed in on the matter. CEO Scott Bruner noted that compounded drug advertisements fall under the jurisdiction of the Federal Trade Commission (FTC) rather than the FDA's typical prescription drug advertising rules. Bruner clarified that Hims & Hers’ Super Bowl ad did not promote a specific drug or medication, thus exempting it from the requirement to provide information about side effects or risks.
“This distinction is important because compounded drug advertisements fall under FTC jurisdiction, not the FDA's typical prescription drug advertising rules” – Scott Bruner, CEO of Alliance for Pharmacy Compounding
“Instead, it encouraged viewers to consult with a healthcare provider, which aligns with the FTC's guidelines for non-specific, "help-seeking" advertisements” – Scott Bruner, CEO of Alliance for Pharmacy Compounding
Despite these clarifications, Senators Durbin and Marshall expressed their intent to propose bipartisan legislation aimed at closing regulatory loopholes in pharmaceutical advertising. They emphasized the need for transparency and consumer protection in advertisements that promote health-related products.
“To the extent this falls within a regulatory loophole for the FDA's authorities, we plan to soon introduce bipartisan legislation to close this gap, so that patients are not deceived by advertisements that glaringly omit critical safety and side effect information” – Sen. Dick Durbin and Sen. Roger Marshall
While Hims & Hers offers a savings program that reduces the cost of a 28-day supply of Wegovy to $650 for uninsured individuals, over 55 million Americans with commercial insurance coverage for Wegovy pay significantly less—often between $0 and $25 monthly. The company's strategy aims to make weight loss treatments more accessible but has raised questions about consumer awareness and safety.
