The news: Hims & Hers’ weight loss drug advertising is under watch by the FDA amid a broader government crackdown on direct-to-consumer (D2C) pharma ads.

• The regulator recently warned Hims to stop making “false or misleading” claims about its compounded GLP-1 offering. The FDA is sending cease-and-desist and warning letters to numerous other healthcare and pharma companies for allegedly making misleading claims in drug ads.
• Separately, FDA commissioner Marty Makary, MD, called out Hims in a medical journal opinion piece for the company’s Super Bowl ad that mentioned the benefits of GLP-1 drugs, but left out side effect or disclaimer information.

Unpacking the news: The FDA’s letter targets how Hims is marketing compounded Wegovy. For context, companies like Hims produce and sell low-cost “copycat” forms of brand-name GLP-1s by modifying formulations or customizing doses.

The letter takes issue with Hims’ marketing language on its website that says its compounded GLP-1 has the “same active ingredient as Ozempic and Wegovy” and “clinically proven ingredients.” For context, compounded medications are not FDA-approved, and Hims includes this language on its website. “Your claims imply that your product is the same as an FDA-approved product when it is not,” according to the letter.

Meanwhile, Makary’s piece noted that Hims’ Super Bowl ad was an overt “breach of FDA regulation.” The ad begins as a disease awareness campaign for obesity before promoting Hims’ weight loss medications. But a specific product is not mentioned.

Zooming out: Telehealth companies are not bound to the same drug advertisement laws as pharma manufacturers. But government officials and lawmakers have been pushing for a policy change amid the surge of online healthcare entities promoting access to weight loss drugs without disclosing information on side effects or risks.

US senators introduced a bill earlier this year that calls on the FDA to take enforcement against influencers and telehealth companies for omitting key facts regarding a medication, or failing to include traditional risk and side effect disclaimers.

Our take: Hims would likely be in compliance with the FDA by marketing its GLP-1 as “compounded Wegovy,” while removing language that it’s the same active ingredient as the branded version (which is technically true, but could be seen as misleading since there are different inactive ingredients). This seems like a relatively easy, low-stakes fix.

The far more impactful piece is whether telehealth companies like Hims may soon be on an equal playing field with drugmakers when it comes to full product disclosures in ads. We don’t think that healthcare brands and marketers in this space (e.g., ones that promote online access to GLP-1s but are not drug manufacturers) should rush to overhaul their D2C ad campaigns just yet—as long as they avoid mentioning specific pharmaceutical products in commercials.

However, companies like Hims, Ro, and WeightWatchers should lean more into ads that highlight the services and capabilities not offered by traditional drugmakers, such as easy access to virtual care, ongoing clinical support, and digital tools to manage one’s health.

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