Executive order targets direct-to-consumer prescription drug advertising

President Donald Trump signed an executive order on Sept. 9, 2025 covering disclosure in direct-to-consumer prescription drug advertising, and the FDA moved the same day, posting dozens of enforcement letters — many of them to companies that make or sell weight-loss drugs ^[1]. The order instructed the FDA to step up enforcement of laws against misleading ads ^[1].

FDA Commissioner Marty Makary said companies need to present a balanced view of drugs and comply with advertising rules, including listing all side effects, and that the agency would send roughly 100 cease-and-desist notices and thousands of letters ^[1].

What the letters say

As of Sept. 16, the FDA had publicly posted 40 untitled letters and 35 warning letters, all dated Sept. 9 ^[2]. According to an analysis by attorneys at Hyman, Phelps & McNamara, the 40 untitled letters actually covered promotional issues for 29 unique drugs, because the agency split complaints about the same product into separate letters rather than grouping them as it has in the past ^[2]. All of them appeared to have been signed and released within about a 15-minute window shortly after 5 p.m. on Sept. 9 ^[2].

Three recipients matter most to GLP-1 patients. The FDA's letters to Eli Lilly cite three media interviews, including a 2024 Oprah Winfrey special, in which company representatives discussed Zepbound and Mounjaro — both tirzepatide — but, regulators said, omitted or downplayed boxed warnings and other serious safety risks ^[1]. Novo Nordisk received a similar letter over the same Oprah broadcast, with the agency saying the program presented the benefits of Wegovy and Ozempic — both semaglutide — while minimizing their risks ^[1]. In both cases the FDA also cited a failure to submit the material to the agency for review on Form 2253 ^[1][2]. The letters identified two doctors as representatives who receive research funding from companies making GLP-1 drugs, and did not allege that either company sponsored or further distributed the special ^[2].

For the telehealth company 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 ^[1]. More broadly, many of the warning letters focused on the compounded GLP-1 market, flagging website claims that compounded products were "the same as" or "similar to" approved brand-name drugs ^[2]. The FDA alleges that framing is false or misleading because compounded drugs are not reviewed by the agency for safety, effectiveness or quality before reaching patients ^[2].

The FDA told the firms to respond within 15 working days and said it could seek legal action, including seizure or injunction, if violations are not corrected ^[1]. The agency also asked recipients to submit a plan to distribute corrective communications to the same audiences that saw the original material, using the same media and generally for the same duration and frequency ^[2].

Companies pushed back in part. A Lilly spokesperson said the letter referred to interviews conducted by independent media, over which the company had no editorial control, and that Lilly did not consider them advertisements ^[1]. Novo Nordisk did not immediately respond to a Reuters request for comment ^[1]. Hims & Hers CEO Andrew Dudum said on X that the FDA's effort on informed patient choices aligns with the company's mission and that it will keep working with regulators on customer safety ^[1]. Hims shares fell more than 7% in afternoon trading on Sept. 16; Lilly shares rose 2.6% ^[1].

Why it matters for patients

Most people first hear about semaglutide and tirzepatide through television commercials, social media, celebrity interviews and telehealth websites. The FDA's letters argue that several of those channels left out or softened information about serious risks, including boxed warnings ^[1]. If the agency's requested corrective communications go out, patients may see follow-up messages that describe what was wrong with earlier promotions ^[2].

The compounded-drug letters speak to a specific point of confusion: marketing that implies a compounded semaglutide product is equivalent to Ozempic or Wegovy. The FDA's position is that compounded versions have not gone through its review for safety, effectiveness or quality ^[2].

The letters also show what regulators now consider promotion. Untitled letters criticized lifestyle montages of happy people exercising or with family, the use of subscales from larger quality-of-life measures, oversimplified treatment timelines, and rapid scene changes or music that compete with the risk narration ^[2].

What happens next

Recipients had 15 working days from Sept. 9 to respond to the FDA ^[1]. Makary's figures suggest more letters are coming, since about 100 cease-and-desist notices and thousands of letters were promised versus the 75 posted as of Sept. 16 ^[1][2]. Whether the FDA pursues seizures or injunctions, and how companies revise their ads, is not yet known.