Hims & Hers is facing scrutiny from lawmakers over an advertisement for its weight loss offerings that’s slated to run during the Super Bowl on Sunday.
Sens. Dick Durbin, D-Ill., and Roger Marshall, R-Kan., wrote a letter to the U.S. Food and Drug Administration on Friday expressing concerns over an “upcoming advertisement” that “risks misleading patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.”
The Hims & Hers ad, which the company released online in late January, is called “Sick of the System” and sharply criticizes the $160 billion weight loss industry. It shows visuals of existing weight loss medications known as GLP-1s, including injection pens that look like Novo Nordisk’s blockbuster diabetes drug Ozempic.
The ad claims those drugs are “priced for profits, not patients” and points to Hims & Hers’ weight loss medications as “affordable” and “doctor-trusted” alternatives.
“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,” a Hims & Hers spokesperson told CNBC in a statement.
The senators do not mention Hims & Hers by name in their letter, but they do reference some of the visuals in the ad, including “imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication.”
“Nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement,” the senators wrote. “Further, for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved.”
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said Friday that Hims & Hers’ ad is consistent with “help-seeking” pharmaceutical advertising.
“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,” Brunner said in a statement. “Instead, it encouraged viewers to consult with a healthcare provider, which aligns with the FTC’s guidelines for non-specific, ‘help-seeking’ advertisements.”
Hims & Hers began offering compounded semaglutide through its platform in May after launching a new weight loss program in late 2023. Semaglutide is the active ingredient in Ozempic and Wegovy, which can each cost around $1,000 a month without insurance.
Shares of Hims & Hers jumped more than 170% last year, thanks to soaring demand for GLP-1s. They closed up 5% on Friday, lifting the company’s market cap to about $9.5 billion.
Compounded GLP-1s are typically much cheaper and can serve as an alternative for patients who are navigating complex supply hurdles and spotty insurance coverage. Hims & Hers sells compounded semaglutide for under $200 a month.
The FDA doesn’t review the safety and efficacy of compounded products, which are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs. Compounded products can also be produced when brand-name treatments are in shortage.
Semaglutide is currently in shortage, according to the FDA.
Durbin and Marshall said advertisements for brand-name GLP-1 medications include “significant risk disclosures to patients about side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications.”
A release on Durbin’s website says that the ad in question appears to exploit a loophole “regarding promotions of compounded drugs by telehealth companies.”
The senators said they believe the FDA may have the authority to take enforcement actions against marketing that could mislead patients, and they plan to introduce new legislation to address regulatory loopholes.
WATCH: New study reveals why patients stop taking GLP-1 obesity drugs