Novo Nordisk Is In Trouble For Misleading Advertising - Again
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I’ve had a bunch of requests to write about this so here y’all go! Novo Nordisk has a long and sordid history of misdeeds, many of which I’ve written about previously (though please note this is not even close to a full list):
Marketing their drug through Grand Rounds presentations
Getting caught in unethical practices by investigative journalists
Now they have a new one to add to the list. The FDA sent Novo Nordisk a letter on February 5 about misleading advertising around their new Wegovy pill. Many of those who asked me to dig into this had found an article in a publication that didn’t link to the original FDA letter, so I started by digging that up. Let’s take it bit by bit. (As always, I’ve indented the text of the letter which includes weight stigma by quoting the ad):
Dear Angela Muñoz:
The articles that people sent gave Ms. Muñoz all kinds of titles. Per her LinkedIn she is “Director, Regulatory Advertising & Promotion” since June, 2023 (the latest in a number of positions in her nearly 20 years with the company.)
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer television broadcast advertisement “January 2026 Pill Spot” (US25SEMO01839) (TV ad) for WEGOVY® (semaglutide) tablets, for oral use (Wegovy) submitted by Novo Nordisk Inc. (Novo Nordisk) under cover of Form FDA 2253.
I believe that this is the ad they are talking about (it includes all of the quotes that are included in the FDA letter, but there might be multiple ads that do and I wasn’t able to verify it with the details given.) Trigger warning for weight stigma, weight loss talk, painfully ironic use of the song “This is Me” from The Greatest Showman to advertise a diet drug, and misleading claims (and if you don’t want to take my word for it, take the FDA’s!)
The FDA has determined that the TV ad is false or misleading. Thus, the TV ad misbrands Wegovy and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The problem here, of course, is that the ad was not reviewed and pushed back BEFORE it was aired. And the ad, or an ad that includes all of the individual claims we are about to read, is still available on YouTube as of 2/9/26.
The TV ad includes the following claims and presentations (in pertinent part, emphasis original).
Voiceover (VO): “Mеet Wegovy pill.”
ON-SCREEN TEXT: “Meet Wegovy® pill”
VO: “The first and only FDA approved GLP-1 weight loss pill.”
ON-SCREEN TEXT: “Only GLP-1 weight-loss pill”
VO: “Weight loss has never looked like this.”
VO: “Now you can live lighter by losing weight.”
ON-SCREEN TEXT: “LIVE LIGHTER™M by losing weight”
VO: “The power of Wegovy, now in the palm of your hand.”
VO: “Weight loss with Wegovy isn’t a shortcut. It’s a way forward.”
VO: “Live lighter by losing weight and keeping it off.”
ON-SCREEN TEXT: “LIVE LIGHTER™M by losing weight and keeping it off
The totality of these claims and presentations misleadingly suggest that because of its dosage form (i.e., pill), Wegovy offers an advancement or improvement (i.e., superior efficacy and/or safety) over other currently approved glucagon-like peptide-1 (GLP-1) treatments for weight loss. Specifically, these claims and presentations misleadingly imply that Wegovy in pill form uniquely enables patients to achieve outcomes that were not previously possible with other GLP-1 treatments for weight loss. For example, the claims “live lighter” and “a way forward” misleadingly imply additional weight loss compared to other currently approved GLP-1 treatments, when this has not been demonstrated.
I know that Novo Nordisk knows better than this because I know better than this and I learned it by analyzing trials that they funded and that were conducted by their employees and researchers who take money from them.
In fact, the average weight loss for the Wegovy pill was 13.6% of body weight over 64 weeks. The average weight loss for the injection was 14.9%. Now the injection trial was 68 weeks rather than 64, but in the pill trial average weight loss actually went up from weeks 56-64 so even if the pill trial went an extra 4 weeks it’s not at all certain that it would have even shown the same weight loss. (Also note that while 13.6% was the average weight loss in the pill trial, 20.8% of people who took the drug failed to lose 5% of body weight, 37% failed to lose 10%, 50% failed to lose 15%, and 70.3% failed to lose 20% of body weight.)
Additionally, they misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition, when this has also not been demonstrated.
Thank you! The Wegovy pill trial tested for weight loss these ads are always loaded up with claims (both stated and implied) about general “life improvement.” The weight loss industry wants to get their low-calorie cake and eat it too by claiming that these drugs are a “treatment” for the (made up by them) “disease” of “ob*sity” but then they market it as a cure for all the psychological harms that weight stigma (that they perpetuate) causes. In truth what most people will get is losing weight (and muscle mass) short-term and gaining back weight (but not as much muscle mass) long-term.
According to the FDA-approved Wegovy Prescribing Information (PI), the CLINICAL STUDIES section states (in pertinent part), “The efficacy of WEGOVY 25 mg oral once daily tablet was . . . evaluated in a . . . placebo-controlled trial.” FDA is not aware of data to support the implication that Wegovy, in pill form, is superior to other currently approved GLP1 treatments for weight loss in terms of efficacy and/or safety. Therefore, claims and presentations suggesting such are misleading. If you have data to support these claims and presentations, please submit them to the FDA for review.
I wouldn’t hold my breath were I the FDA.
In addition, the major statement includes presentations where there is information in the SUPERs that is not from the corresponding audio. Therefore, the TV ad is misleading because it fails to present the major statement concurrently using both audio and text (dual modality).
Here “SUPERs” refers to text that is superimposed over the ad. What they are saying is that to be appropriate, major statement in the ad has to be in both the superimposed text and the voiceover.
I believe what they are referring to it:
Standard 3 (21 CFR 202.1(e)(1)(ii)(C)): “In advertisements in television format, the major statement is presented concurrently using both audio and text (dual modality). To achieve dual modality: - Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and - The text is displayed for a sufficient duration to allow it to be read easily. For purposes of the standard in the paragraph (e)(1)(ii)(C)(2), the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.”
Conclusion and Requested Action
For the reasons described above, the TV ad misbrands Wegovy and makes the distribution of the drug in violation of the FD&C Act. This letter notifies you of our concerns and provides you with an opportunity to address them. FDA requests that Novo Nordisk take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).
Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Novo Nordisk that contain representations like those described above, and explaining your plan for the discontinuation of such communications, or for ceasing distribution of Wegovy.
If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.
If you don’t think I’ve marked it in my calendar to check up on this then you must not be a regular reader. (Welcome!)
The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.
I feel you on that FDA, it’s almost impossible to keep track of all of Novo’s misdeeds.
I’ll update this story as it unfolds/
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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.
Wow, finally some good news from the FDA LOL.
And maybe this is my wishful thinking, but I think it was brave of them to call this out when the current administration is promoting glp1’s as a cure-all alongside raw milk and trans fats. I think this might be an act of malicious compliance for the people’s benefit.
Keep it up, FDA!
It’s super frustrating (but not that surprising) that the US even allows direct to consumer marketing of prescription drugs on television. Most countries in the world recognize the harms that can be caused by this practice, I wish we did as well.