FDA Chief Says Hims’ Weight-Loss Drug Ad Breached Agency’s Rules

FDA Commissioner Marty Makary on Friday cited a widely watched TV commercial aired earlier this year by telehealth company Hims & Hers promoting its copycat obesity drug as an example of the industry’s misleading advertisements.

“Online pharmacies are advertising drugs with only upsides mentioned, contributing to America’s culture of overreliance on pharmaceuticals for health,” Makary wrote in a JAMA Network Open article focused on how the agency is overdue for a “crackdown on misleading pharmaceutical advertisements.”

“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,” Makary wrote.

The ad promoted the use of its compounded version of Novo Nordisk A/S‘s obesity drug, Wegovy.

Hims & Hers Health Inc. didn’t immediately respond to request for comment about Makary’s remarks.

The paper follows President Donald Trump’s executive order signed earlier this week that called for agency action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising. The Food and Drug Administration sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products.

The letters signal the agency’s aim to increase control over the promotion of copycat drugs, staking a position in a regulatory gray area that overlaps with the Federal Trade Commission.

Telehealth companies that market compounded drugs have argued their advertisements are purview of the Federal Trade Commission, which oversees ads for over-the-counter drugs, and not the stricter advertising rules for FDA-reviewed prescription medications. Opponents, however, have argued the FDA should have oversight of the ads since they can omit discussion of potential side effects.

Compounders defended the Hims commercial earlier this year and said it’s a help-seeking ad that encourages viewers to consult with a health-care provider. The ad, therefore, isn’t under the FDA’s purview and doesn’t need to mention side effects of the drug, they said.

Makary’s article also addressed the need to crack down on pharmaceutical advertising on social media, which has been criticized for avoiding FDA enforcement.

“Drug advertisements on social media are often presented as entertainment, blurring the boundaries between editorial content, user-generated media, and pharmaceutical advertising,” he wrote. “Consumers are encountering medical claims in casual, immersive formats that lack clear promotional identification, making it difficult to distinguish between evidence-based information and promotional material.”

A 2023 Bloomberg Law investigation found that the FDA’s prescription drug office had sent just a handful of warning letters to pharmaceutical companies about ad violations or questionable promotional activities on social media platforms including Facebook, Instagram and YouTube.