Telehealth company Hims & Hers stirred up controversy by debuting a 2025 Super Bowl ad touting the benefits of its weight loss program, which offers access to compounded semaglutide. Now, semaglutide maker Novo Nordisk is chiming in.
The commercial takes aim at the broader U.S. weight loss industry as well as makers of GLP-1 drugs for obesity, which are “priced for profits, not patients,” it claims.
Following its late January release, trade and advocacy groups including the Pharmaceutical Research and Manufacturers of America and the Partnership for Safe Medicines criticized the ad, while several legislators called on the FDA to step in, pledging to introduce new legislation to bring compounded drugs under the agency’s marketing rules.
Of primary concern, according to its critics, is the ad’s lack of information about potential adverse effects of GLP-1 medicines and about how compounded versions of drugs are not subject to FDA oversight.
After the ad made its big game debut Sunday, Novo added its voice to the conversation. The Big Pharma ran an ad in The New York Times and USA Today on Monday calling out the potential risks of compounded drugs.
“Do you really know what you’re injecting into your body?” the Novo ad asks, adding, “They may call it ‘semaglutide,’ but it’s not real FDA-approved medicine, and it’s not proven safe or effective.”
The “Check Before You Inject” ad goes on to note that some vials of compounded semaglutide “have been found to contain dangerous impurities, banned substances, or incorrect doses.” Toward the bottom, the ad urges readers to “get the facts” from Novo's own web page about semaglutide.
“The recent explosion in irresponsible and misleading advertising about compounded GLP-1 drugs, like the Hims & Hers Super Bowl commercial, puts patients’ safety at risk and we cannot stay silent,” the drugmaker said in a statement sent to Fierce Pharma Marketing.
“When it comes to fake, illegitimate Ozempic or Wegovy, consumers don’t know what’s in the vials—but whatever it is, it’s not FDA-approved,” the statement continued. “As makers of the only real FDA-approved semaglutide medicines (Wegovy, Ozempic and Rybelsus), patient safety remains our top priority. We are committed to confronting the stigma linked with chronic diseases, like obesity, and expanding access to our authentic, prescription-only medicines.”
For its part, Hims & Hers began last year making Certificates of Analysis available to each of its compounded GLP-1 customers, detailing ingredients and test results showing that its products comply with certain quality and safety standards.
A Feb. 7 statement (PDF) from Scott Brunner, CEO of the Alliance for Pharmacy Compounding, further explained that because the commercial “does not promote a specific drug or medication, it is not required to provide information about side effects or risks.” Brunner also noted that ads for compounded drugs fall under the jurisdiction of the Federal Trade Commission rather than the FDA.
“While the focus of Hims’ Super Bowl ad on drug pricing may push the envelope in terms of the role of compounded drugs in our healthcare system—a debate worth having—it’s also perfectly consistent with laws and regulations that allow companies to promote healthcare services without promoting specific drug or needing to make certain disclosures about certain drugs,” Brunner concluded.
Both sides of the debate do, of course, have a financial incentive to promote the legitimacy of their respective GLP-1 offerings. And this is far from the first battle between compounders and Big Pharma in the space. Compounders were able to begin making their copycat versions of semaglutide and tirzepatide in 2022, when both drugs were added to the FDA's shortage list. When the FDA removed tirzepatide—which Eli Lilly sells as Zepbound for obesity—from the list last fall, compounders sued the agency.
Meanwhile, Novo has nominated semaglutide for inclusion on the FDA’s Demonstrable Difficulties for Compounding list, which would bar compounders from being able to make their own versions of the drug despite its still being on the shortage list.
Following the proposal last fall, Brunner said it looked “more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument.”