Hims and Hers Superbowl Ad Draws Controversy Over Safety

Telehealth company Hims and Hers plans to run a controversial ad promoting their compounded semaglutide medication during Super Bowl LIX this weekend.

Ad critics cite that the company does not list potential side effects or risks or safety information and therefore misleads customers, which violates the Federal Food, Drug, and Cosmetic Act (FDCA).

Today, two United States senators, Sen. Roger Marshall, M.D., a Kansas Republican and Sen. Dick Durbin, an Illinois Democrat, sent out a bipartisan letter to the FDA about the ad.

"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," the letter reads. "However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities."

In an email to Managed Healthcare Executive, a Hims and Hers spokesperson said the following:

"We agree with the Senators Durbin and Marshall on the value of compounding and telehealth when it comes to expanding much-needed access to personalized care. We are complying with existing law and 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 healthcare."

The Partnership for Safe Medicines (PSM), an association of 45 advocacy nonprofits, has also issued letters to the FDA and FOX, the network airing the commercial, to prevent the ad from airing, citing potential harm to buyers because there have been no major safety or efficacy studies for this product.

GLP-1 is the active ingredient in expensive weight loss drugs like Wegovy and the type 2 diabetes drug, Ozempic, which can cost up to $1,050 and $1,417 respectively. There is currently no FDA-approved lower cost generic for either drug. The Hims and Hers ad, already on YouTube, relies on this information, the voiceover in the ad stating the company provides a cost-effective alternative when faced with “$160 billion industry that feeds on our failure.” They started selling semaglutide injections in May 2024 and it’s currently listed for $165 a month. Both Wegovy and Ozempic can lead to serious side effects such as pancreatitis.

This Hims and Hers product is considered a compounded drug. Drugs are compounded when a licensed pharmacist, licensed physician or outsourcing facility combines drug ingredients to create a medication tailored to the individual needs of a patient, according to the FDA website. Although they are not approved by the FDA, they are sometimes the only viable option if a patient has a dye allergy to the approved version or if an elderly or pediatric patient cannot swallow the pill form.

The Super Bowl has long been a prime time for commercials, providing an audience for millions of potential buyers. In 2024, more than 123 million viewers tuned in to watch. This spotlight creates a high price tag, with some advertisers spending up to $8 million for a 30-second slot, CNBC reports.

Hims and Hers Inc. is a member of the Alliance for Pharmacy Compounding, which recently released guidelines on compounding drug manufacturing, stating specifically that compounded drugs “cannot be promoted as safe and effective for treating that condition. This holds true for compounded medications…”

Pharmaceutical Research and Manufacturers of America (PhRMA), another advocacy group, released the following statement about compounders:

“We urge federal and state regulators to conduct real oversight over compounders, including by ensuring that their advertising and promotion does not mislead patients or put them at increased risk,” the news release reads.