Global Healthy Living Foundation Says Hims & Hers Health Super Bowl Ad Omits Risks of Weight Loss Drug

GHLF Urges Greater Transparency and Patient Protections

UPPER NYACK, N.Y.--(BUSINESS WIRE)--The Global Healthy Living Foundation (GHLF), a leading worldwide patient advocacy organization, is raising concerns about the lack of full disclosure in the Hims & Hers Health Super Bowl ad to be aired tomorrow night. The ad promotes, without identifying, semaglutide, the compounded versions of the weight-loss drugs Ozempic and Wegovy, and tirzepatide, the compounded version of Zepbound.

While the ad describes the unnamed product’s benefits, it does not provide the viewer with the full safety information because technically it doesn’t have to. It is compounded, not an FDA-approved brand-name drug, so it only directs viewers to its website -- which is not identified -- in a three-second, light gray, small-type message at the end of the two $7 million commercials scheduled to air.

“A brief, hard-to-read disclaimer flashes on-screen for a few seconds with no accompanying audio. It fails to ensure patients understand the critical differences between compounded and FDA-approved medications and fails to provide safety information in the commercial itself,” said Steven Newmark, GHLF’s Chief Policy and Legal Officer.

Two Senators, Dick Durbin (D-Illinois) and Roger Marshall (R-Kansas) sent a letter Friday morning to FDA acting Commissioner Sara Brenner pointing out this patient safety loophole. They wrote that they worry that the Hims & Hers Health ad, which will be seen by millions of people during the big game on Sunday, “risks misleading patients by omitting any safety or side effect information” about the compounded weight loss drugs that it promotes.

“We applaud these Senators' actions,” Mr. Newmark said. “And their plan to ‘introduce bipartisan legislation to close this regulatory loophole for the FDA’s authorities … so that patients are not deceived by advertisements that glaringly omit critical safety and side effect information.’” (The Durbin/Marshall letter is here.)

Companies such as Hims & Hers Health, Ro and Noom use loopholes in the law that allow FDA-approved drugs to be compounded to meet market demand. But this loophole does not require the same safety and side effects disclosures.

“When a medication is being marketed for widespread use, particularly one that involves weight loss and serious health implications, whether it is compounded or not, a full and transparent safety and side-effects disclosure must be prominent and accessible,” GHLF’s Chief Science Policy Officer, Robert Popovian, PharmD, said.

“Viewers should not have to hunt for critical safety information in fine print that they may never see,” Popovian added.