A telehealth company that sells a compounded version of medications used for weight loss has found itself at the center of an escalating controversy over an advertisement that aired during the 2025 Super Bowl.
The minute-long ad from telehealth company Hims & Hers shows imagery including a scale, food including pies and cheeseburgers, and a refrigerator full of vials of Hims & Hers-labeled medications alongside narration about the state of America's obesity crisis.
"Something's broken, and it's not our bodies," the narrator says in the ad, adding, "There are medications that work, but they're priced for profits, not patients."
The ad goes on to tout Hims & Hers' weight loss drugs as less expensive alternatives to medications like Ozempic and Wegovy, which both contain the active ingredient semaglutide and are approved by the U.S. Food and Drug Administration to treat Type 2 diabetes and obesity, respectively.
Unlike Ozempic and Wegovy, Hims & Hers' weight loss drug is compounded and is not required to go through the FDA's rigorous approval process.
Compound versions of drugs are made for individual patients using raw ingredients.
The FDA has previously warned consumers about using compounded versions of FDA-approved medications.
"Compounded drugs pose a higher risk to patient than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality," the agency said in a statement to ABC News in 2023. "The FDA's compounding program aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients."
Before Hims & Hers' commercial even aired, Democratic Sen. Dick Durbin of Illinois and Republican Sen. Roger Marshall of Kansas sent a letter to the FDA asking the agency to take action for what the senators described as the ad's failure to include "any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement."
"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. However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities," Durbin and Marshall wrote in the letter, dated Feb. 7. "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. But, we believe FDA may already have the authority to take enforcement action against marketing that may mislead patients about this company's products."
The same day the senators sent a letter to the FDA, the Alliance for Pharmacy Compounding released a statement by CEO Scott Bruner, who said that this type of advertisement does not fall under FDA regulation. Instead, advertisements by non-FDA approved products are regulated by the Federal Trade Commission.
“This distinction is important because compounded drug advertisements fall under FTC jurisdiction, not the FDA's typical prescription drug advertising rules,” Brunner said in the statement.
“Hims’ Super Bowl ad does not promote a specific drug or medication and therefore is not required to provide information about side effects or risks," he added. "Instead, it encouraged viewers to consult with a healthcare provider, which aligns with the FTC's guidelines for non-specific, "help-seeking" advertisements."
The day after the ad for Hims & Hers' aired during the Super Bowl, on Feb. 10, Novo Nordisk, the maker of Ozempic and Wegovy, published a full-page ad in the New York Times and USA Today that included the copy, "Do you really know what you're injecting into your body?"
FDA warns about safety of 'off-brand' versions of Ozempic, WegovyIn response to Novo Nordisk's ad, Hims & Hers told ABC News in a statement it takes, “safety, quality, and transparency steps for every customer on our platform.”
“That includes making Certificates of Analysis – a report card on quality standards for USP benchmarks – available to every GLP-1 customer, so they know the exact ingredients from FDA-regulated suppliers that are in the medications they receive,” the company said. “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 also said in its statement that the company is “complying with existing law,” in response to Sens. Durbin and Marshall’s letter to the FDA.
“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,” the company said. “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 popularity of compounded versions of weight loss medications like Ozempic has skyrocketed in recent years due to the popularity of the medications themselves, which has led to shortages.
Some people are overdosing on semaglutide, FDA warnsThe high price of the medications has also helped propel interest in compounded versions of the drugs.
Without insurance coverage, the cost of medications like Ozempic and Wegovy can run more than $1,000 a month. Insurance coverage for the medications varies, depending on everything from a person's medical diagnosis to where they live and their insurance plan.
According to Novo Nordisk, over 55 million Americans have commercial insurance coverage for Wegovy, with around 90% of those people paying $0 to $25 per month for the medication. The company says it also offers a savings program that brings the cost of a 28-day supply of Wegovy to $650 for those without insurance coverage.
On its website, Hims & Hers advertises a price of $165 per month for weekly injections of compounded semaglutide.
