FDA Warns Companies Against False and Misleading Drug Ads

Regulators sent dozens of letters to companies such as Eli Lilly and Hims and Hers.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023.Madalina Vasiliu/The Epoch Times

Federal regulators sent dozens of letters to companies in September warning them that their advertisements for drugs are misleading and could lead to repercussions unless fixed.

The Food and Drug Administration on Sept. 16 released 65 letters it sent on Sept. 9 to companies, including Eli Lilly and Novo Nordisk. President Donald Trump signed a memorandum that day directing officials to enforce existing rules surrounding direct-to-consumer advertising for drugs.

In letters to Eli Lilly, FDA officials said that advertisements for weight loss products, including one that originally appeared in a special held by Oprah Winfrey, did not present people with accurate information about possible side effects.

The ad that aired during the Oprah special “creates a misleading impression regarding the safety of Zepbound and Mounjaro, which are drugs with multiple serious, potentially life threatening risks,” officials with the FDA’s Center for Drug Evaluation and Research said in one of the letters. They said that people who seek medical treatment for obesity or Type 2 diabetes “should receive truthful and non-misleading information.”

An Eli Lilly spokesperson told The Epoch Times in an email: “FDA’s correspondence to Lilly addresses three interviews conducted by independent media outlets. These interviews were not advertisements, and Lilly had no editorial control over them.

“We remain committed to providing patients with accurate, reliable information that empowers them to make informed healthcare decisions in partnership with their physicians.”

Novo Nordisk was accused—in a video that featured paid consultants and aired during the Oprah special—of creating a misleading impression of the safety of Wegovy, Ozempic, and Victoza, which are injections used to lose weight.

“You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above),” officials said.

“Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.”

Liz Skrbkova, a spokeswoman for Novo Nordisk, told The Epoch Times via email that the company has received the letter and will respond.

“Importantly, this program was not placed, requested, sponsored, or controlled by Novo Nordisk. Instead, the program was developed, produced and broadcast by ABC. Novo Nordisk did not control the content and was not a sponsor or a funder of this independent news program. In our limited role as an invited guest, a Novo Nordisk employee responded to questions,” Skrbkova said.

“We remain focused on responsible communication to help drive change for the millions of people in the U.S. who are living with this chronic, progressive disease.”

A telehealth company called Hims and Hers also received a warning over an ad that aired during the Super Bowl and promoted weight loss products it claimed contained “clinically proven ingredients” and the “same active ingredient as Ozempic and Wegovy.”

While Ozempic and Wegovy are approved by the FDA, Him and Hers has no FDA-approved products.

“As a result, these claims are false or misleading,” Dr. George Tidmarsh, director of the Center for Drug Evaluation and Research, said.

Andrew Dudum, CEO of Hims and Hers, said on X that the FDA effort “is demonstrating its commitment to ensuring individuals can make informed choices about their care—a commitment we share and something Hims & Hers was built to do.”

He added, “We have a long history of working with regulators to keep customers safe, and I’m looking forward to continuing that work with the FDA.”