Hims & Hers falls after FDA commissioner says its Super Bowl ad breached regulations

Hims & Hers slipped in early trading after its Super Bowl ad from February was singled out as the “most overt” example of “brazen” marketing tactics among online pharmacies by FDA Commissioner Marty Makary.

The claim, made in an opinion piece written by Makary and published in the JAMA Network on Friday, highlighted the agency’s stricter enforcement policies on pharmaceutical advertisements. It was also one of the first indications that the FDA may potentially view telehealth advertisements as under its purview. Cracking down on direct-to-consumer advertising could have big implications for Hims, which spends about 40% of its revenue on marketing.

“Equally brazen, online pharmacies are advertising drugs with only upsides mentioned, contributing to America’s culture of overreliance on pharmaceuticals for health,” Makary wrote. “This breach of FDA regulation was most overt earlier this year when Hims & Hers ran a Super Bowl ad highlighting the benefits of glucagon-like peptide-1 drugs without any mention of side effects or disclaimers.”

Hims’ Super Bowl ad touted its direct-to-consumer weight-loss medications as “life-changing,” “affordable,” and “doctor-trusted,” billing its approach as “the future of healthcare.” Google searches for the company spiked after the ad appeared during the big game.

The ad did not specifically name any drug but did include an image of a vial identical to those it uses for its compounded GLP-1 drugs, which have the same active ingredients as Novo Nordisk’s Ozempic and Wegovy but are not approved by the FDA.

Hims also received a cease and desist letter from the FDA last week over its compounded GLP-1s, according to a copy seen by The New York Times. “Your claims imply that your product is the same as an FDA-approved product when it is not,” the letter reportedly said.

“As we’ve previously stated, our Super Bowl ad did not advertise any one treatment or solution,” a Hims spokesperson said. “Rather, it aimed to raise awareness to a critical issue — the obesity public health crisis — by showcasing the impact of obesity and the realities of the lack of access to life-saving holistic weight loss care.”

Last week, President Donald Trump issued an executive order directing the Secretary of Health and Human Services to crack down on TV drug ads. It was initially unclear whether that order applied to telehealth companies.

Compounded drugs have not been subject to the same regulatory burdens over their advertisements as branded, FDA-approved drugs made by pharmaceutical companies. This is because the FDA’s advertisement rules regulate drug manufactures, not healthcare providers, but companies like Hims — which sell compounded drugs and also prescribe them — don’t fall squarely in either bucket.

This has historically given them more wiggle room when it comes to ads than a drugmaker. For example, Hims can advertise generic Prozac for climax control (an off-label use) while the company that makes the drug, Eli Lilly, cannot.

Darshan Kulkarni, a regulatory and compliance attorney who represents FDA-regulated companies, said he sees the recent developments as reiteration of preexisting expectations rather than the addition of new requirements.

“It has raised the level of caution, but I tended to tell my clients to be more careful in all scenarios,” Kulkarni said. “So it’s one more arrow in the quiver of caution.”