FDA posts more than 100 warning and untitled letters in ad crackdown

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like peptide-1 (GLP-1) agonist drugs for weight loss. The agency also posted dozens of untitled letters to major drugmakers for advertisements of their prescription drugs, including multiple letters to AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, and Novartis.

The letters, published on Tuesday, were sent as part of FDA’s crackdown on drug advertising announced last week, in which the agency promised to end a longstanding practice that enables drugmakers to provide a major risk statement in ads and point the audience to more complete risk information contained elsewhere. (RELATED: FDA cracks down on drugs ads, promises to end adequate provision ‘loophole’, Regulatory Focus 10 September 2025)

Warning letters

Over the past year, FDA has warned numerous compounding pharmacies for selling GLP-1 since the GLP-1 drug shortage was declared over. However, several compounders have continued marketing the massively popular drugs, arguing that they are custom-made for their clientele.

Most of the warning letters posted on Tuesday were to companies for marketing GLP-1 agonist drugs, including a warning letter to several telemedicine companies, such as Hims & Hers Health, which received two warning letters. One of the warning letters was for its website www.hims.com, while the other was for www.forhers.com.

The warning letters are nearly identical and state that the companies’ marketing of compounded semaglutide is illegal.

“Compounded drug products are not FDA-approved,” said FDA. “Your claims imply that your products are the same as an FDA-approved product when they are not.

“As a result, these claims are false or misleading and your products are therefore misbranded…” the agency added.

FDA sent warning letters to several other telemedicine companies for identical violations, including Amazing Meds, ybycmeds, and GenLabMeds. The agency also sent warning letters to more recognizable companies, such as Eli Lilly, which received three warning letters for different versions of the GLP-1 agonist tirzepatide.

FDA said that the company promoted the weight loss drugs on different news websites featuring interviews with Eli Lily executives and paid consultants. The agency also noted in a warning letter that the company featured its drug on ABC as a Primetime Oprah Special. In every case, regulators said the company failed to divulge risks associated with the drugs adequately.

More specifically, FDA noted that the drugs include boxed warnings about the risk of thyroid C-cell tumors and are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). During the interview with Oprah, the agency says the company significantly downplayed the risks.

“The video not only omits several serious and significant risks, it also understates the safety profile of these drugs,” said FDA. “By essentially suggesting that safety or tolerability issues have been ‘overhyped,’ and by implying that these products are not associated with the serious and significant risks outlined above, the video grossly misrepresents the safety profile of Zepbound and Mounjaro.

“This implication is false or misleading and raises significant public health and safety concerns,” the agency added.

FDA also sent Novo Nordisk a warning letter for promoting its GLP-1 agonists during the same Oprah special. The agency listed the same paid consultants named in the Eli Lily warning letter as Novo Nordisk consultants. It also cited statements from a Novo Nordisk executive featured in the program. Ultimately, it cited Novo Nordisk for the same violations as Eli Lily, stating that it had downplayed the risks of its drugs.

FDA published several warning letters to other companies for non-GLP-1 drugs, including two warning letters to Aytu Biopharma. One letter was for marketing COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII (Cotempla XR-ODT), and another for ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII (Adzenys XR-ODT).

FDA said the Aytu failed to adequately present the risks associated with the attention-deficit hyperactivity disorder (ADHD) drugs and, in one case, misled the public on the efficacy of the drug. The agency also cited the company for failing to use the required established drug names.

“Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk,” said FDA. “The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.

“The established name of a prescription drug must be presented prominently, in direct conjunction with the proprietary name,” the agency added.

Untitled letters

In addition to the stack of warning letters published by FDA, the agency also published 40 untitled letters citing companies for advertising practices that go afoul of regulations. In some instances, the agency issued multiple untitled letters to the same company, often for the same drug. For example, AstraZeneca received five letters, Novartis received four letters, UCB received three, Phathom received three, and Boehringer Ingelheim received three. Takeda, Bristol-Myers Squibb, AbbVie, Teva Neuroscience, and Supernus Pharmaceuticals all received two letters each.

In an untitled letter to BridgeBio Pharma, the FDA notes that the company used a voiceover of actor Morgan Freeman for an advertisement of its cardiomyopathy drug Attruby (acoramidis), in which an older man seems to be living a happy life. The agency said the ad misleads patients about the quality of life they can live while on the drug.

"The totality of these claims and presentations misleadingly suggests that patients treated with Attruby can be carefree regarding the effects of cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) and the burdens commonly associated with the disease or will be able to live as they did prior to their ATTR-CM diagnosis, when this has not been demonstrated in the clinical trial for Attruby," said FDA. "The totality of these claims and presentations also misleadingly suggests that treatment with Attruby will broadly improve a patient’s overall quality of life when this has not been demonstrated."

The FDA took similar umbrage with other companies that did not faithfully portray patient experience with the promoted drugs to the agency’s liking.

As an example, FDA sent a warning letter to Teva for its television advertisements for Austedo XR (deutetrabenazine) to treat tardive dyskinesia (TD) in which actors don't show obvious uncontrollable movements after treatment.

"These presentations misleadingly suggest that Austedo XR provides a greater magnitude of benefit in the treatment of TD than has been demonstrated," said FDA.

"FDA acknowledges that both TV ads include the SUPER, 'Individual results may vary,'" added the agency. "Furthermore, we acknowledge that the TV ads also include the SUPER, 'In one study, patients taking AUSTEDO 36 mg saw a 33% movement improvement vs 14% for placebo at 12 weeks. However, neither presentation mitigates the misleading impression that patients can expect a near-complete resolution of TD symptoms when taking Austedo XR."

Warning letters, Untitled letter

FDA posts more than 100 warning and untitled letters in ad crackdown

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