FDA warning letters on drug ads name Lilly, Novo Nordisk and Hims & Hers
Warning letters about drug advertising single out three companies that sell or compound weight-loss treatments, putting the pitches patients see under closer FDA scrutiny.
On September 9, 2025, President Donald Trump signed an executive order on disclosure in direct-to-consumer prescription drug advertising, and the FDA published dozens of letters that day — many aimed at companies that make or sell weight-loss drugs [1]. The order directed the agency to tighten enforcement of laws against misleading advertising [1].
FDA Commissioner Marty Makary said the agency intended to issue about 100 cease-and-desist notices along with thousands of letters, and that companies must give a balanced view of their drugs, including a full list of side effects [1]. Warning letters went to Eli Lilly, Novo Nordisk and telehealth company Hims & Hers Health [1].
By September 16, the FDA's website showed 40 untitled letters and 35 warning letters, each dated September 9, according to attorneys Dara Katcher Levy and Sarah Wicks of the firm Hyman, Phelps & McNamara, writing on the FDA Law Blog [2]. The untitled letters covered promotion of 29 different drugs, and the blog said they appeared to have been signed and posted within about 15 minutes, shortly after 5 p.m. [2].
The Lilly and Novo Nordisk letters
The FDA's letters to Lilly cite three media interviews, among them a 2024 Oprah Winfrey special, in which company representatives discussed Zepbound and Mounjaro; regulators say boxed warnings and other serious risks were omitted or downplayed [1]. A Lilly spokesperson said the interviews came from independent media outlets, that the company had no editorial control over them, and that Lilly does not consider them advertisements [1].
Novo Nordisk received a similar letter about the same broadcast. The agency said the program highlighted benefits of Wegovy and Ozempic while minimizing their risks, and that the material was never submitted for review [1]. Novo did not immediately respond to a Reuters request for comment [1].
The FDA Law Blog noted that the letters identify two doctors as representatives who receive research funding from companies that make GLP-1 drugs, and that the letters do not allege Lilly or Novo sponsored the special or further distributed the videos [2].
The Hims & Hers letter
For Hims & Hers, the FDA said it reviewed the company's website in August 2025 and found false or misleading claims about its compounded semaglutide products, the active ingredient in Ozempic and Wegovy [1]. CEO Andrew Dudum posted on X that the FDA's focus on informed patient choices aligns with the company's mission and that it will keep working with regulators [1].
Hims & Hers shares fell more than 7% in afternoon trading on the day Reuters reported the letters, while Lilly shares rose 2.6% [1].
What the letters cover
Many of the warning letters concern the compounded GLP-1 market. The FDA objected to website language describing compounded products as "the same as" or "similar to" approved brand-name drugs, which the agency calls misleading because compounded drugs are not reviewed for safety, effectiveness or quality before they reach patients [2].
Regulators also treated third-party programs featuring company representatives as promotional communications that should have been filed on Form 2253, and asked for corrective messages sent to the same audiences, generally with the same media, duration and frequency [2].
The untitled letters raised objections to lifestyle imagery, the use of individual items pulled from validated quality-of-life scales, oversimplified treatment timelines, and music or rapid scene changes that compete with the required risk statement, the blog said [2]. Most were brief and did not cite specific sections of the law [2].
Why it matters for patients
These letters are addressed to companies about their promotional materials. They do not change which drugs are approved, what is in a prescription, or how a medication is dispensed [1][2].
The FDA's stated worry is that advertising for semaglutide and tirzepatide products can leave viewers with an overstated sense of benefit and an incomplete picture of risk [1][2]. For compounded semaglutide, the agency's position is that these products have not been reviewed for safety, effectiveness or quality, so claims of equivalence to brand-name drugs are misleading [2]. Companies may be required to run corrective messages reaching the same audiences [2].
It has not been reported whether any of the letters have led to further penalties, or whether any company has disputed a letter beyond Lilly's public statement [1][2].
What happens next
The firms were told to respond within 15 working days, and the FDA said it could pursue legal action, including seizure or injunction, if violations are not corrected [1]. As of September 16, the posted total of 40 untitled letters and 35 warning letters was below the roughly 100 cease-and-desist notices Makary described [1][2]. No deadline for companies to air corrective communications has been reported [2].
Sources
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