By Mrinalika Roy and Kamal Choudhury
(Reuters) – The U.S. Food and Drug Administration issued warning letters to Eli Lilly, Novo Nordisk and telehealth firm Hims & Hers Health last week as part of President Donald Trump’s order to crack down on drug advertising.
The FDA website shows dozens of letters issued on September 9, many to companies that make or sell weight-loss drugs, the day Trump signed an executive order on disclosure in direct-to-consumer prescription drug advertising. The order instructed the FDA to step up enforcement of laws against misleading ads.
The FDA’s letters to Lilly cite three media interviews, including a 2024 Oprah Winfrey special, where company representatives discussed Zepbound and Mounjaro but, according to regulators, omitted or downplayed boxed warnings and other serious safety risks.
Novo Nordisk received a similar letter over the same Oprah broadcast, with the agency saying the program presented Wegovy and Ozempic’s benefits while minimizing their risks. The agency also cited failures to submit the material for review.
A Lilly spokesperson said the FDA’s letter referred to interviews conducted by independent media, over which the company had no editorial control and did not consider them advertisements.
Novo did not respond immediately to a Reuters request for comment.
For Hims, the health regulator said it had reviewed the company’s website in August of this year and found false or misleading claims about its compounded semaglutide products, the active ingredient in Ozempic and Wegovy.
FDA Commissioner Marty Makary last week said that companies need to present a balanced view of drugs and comply with advertising rules, including listing all side effects. He said the FDA would send about 100 cease-and-desist notices and thousands of letters.
Shares of Hims fell over 7% in afternoon trading. Lilly shares were up 2.6%.
Hims & Hers CEO Andrew Dudum, in a post on X, said the FDA’s effort on informed patient choices aligns with the company’s mission, and they will continue to work with the regulators to ensure customer safety.
The agency instructed the firms to respond within 15 working days and said it could seek legal action, including seizure or injunction, if violations are not corrected.
(Reporting by Mrinalika Roy and Kamal Choudhury in Bengaluru; Editing by Krishna Chandra Eluri and Vijay Kishore)
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