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WARNING LETTER

September 9, 2025

Dear Maziar Mike Doustdar:

The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding WEGOVY (semaglutide) injection, for subcutaneous use (Wegovy), OZEMPIC ® (semaglutide) injection, for subcutaneous use (Ozempic), and VICTOZA® (liraglutide) injection, for subcutaneous use (Victoza). The video features Dr. W. Scott Butsch¹ and Dr. Amanda Velazquez², paid consultants (representatives) who “receive research funding from companies making GLP-1³ drugs.”⁴ The video also features Negelle Morris,⁵ Senior Vice President of Cardiometabolic Sales for Novo Nordisk Inc. (Novo Nordisk). The video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024 and can also be accessed through ABC’s website.⁶ The video subsequently appeared on Hulu on March 19, 2024. FDA has determined that the video is false or misleading. Thus, the video misbrands Wegovy, Ozempic, and Victoza within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5); (e)(7)(viii). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Wegovy, Ozempic, and Victoza, which are drugs with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors. Obesity and excessive weight and type 2 diabetes mellitus are significant public health concerns that affect vulnerable populations (e.g., children) and millions of adults in the United States and are associated with numerous co-morbidities. Consumers and patients who seek medical treatment for managing obesity and excessive weight or their type 2 diabetes mellitus should receive truthful and nonmisleading information regarding the serious risks associated with the use of a weight management prescription drug product, such as Wegovy, and with the use of type 2 diabetes prescription drug products, such as Ozempic and Victoza.

Background

Below are the indication and summary of the most serious and most common risks associated with the use of Wegovy, Ozempic, and Victoza.⁷ According to the INDICATIONS AND USAGE section of the respective FDA-approved prescribing information (PI)⁸,⁹,¹⁰ (in pertinent part):

WEGOVY is indicated in combination with a reduced calorie diet and increased physical
activity:
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
• to reduce excess body weight and maintain weight reduction long term in:
• Adults and pediatric patients aged 12 years and older with obesity
• Adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use:
• WEGOVY contains semaglutide. Coadministration with other semaglutidecontaining products or with any other GLP-1 receptor agonist is not recommended.

The PI for Wegovy contains a boxed warning regarding the risk of thyroid C-cell tumors. Wegovy is 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); and in patients with a prior serious hypersensitivity reaction to semaglutide or any of the excipients in Wegovy. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Wegovy. In addition, the PI for Wegovy includes warnings and precautions regarding acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, heart rate increase, and suicidal behavior and ideation. The most common adverse reactions observed with Wegovy were nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

OZEMPIC is indicated:
• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:
• OZEMPIC has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• OZEMPIC is not indicated for use in patients with type 1 diabetes mellitus.

The PI for Ozempic contains a boxed warning regarding the risk of thyroid C-cell tumors. Ozempic is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2; and in patients with a serious hypersensitivity reaction to semaglutide or any of the excipients in Ozempic. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Ozempic. In addition, the PI for Ozempic includes warnings and precautions regarding pancreatitis, diabetic retinopathy complications, never sharing an Ozempic pen between patients, hypoglycemia with concomitant use of insulin secretagogues or insulin, acute kidney injury, hypersensitivity reactions, and acute gallbladder disease. The most common adverse reactions observed with Ozempic were nausea, vomiting, diarrhea, abdominal pain, and constipation.

VICTOZA is indicated:
• as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:
• VICTOZA should not be used in patients with type 1 diabetes mellitus.
• VICTOZA contains liraglutide and should not be coadministered with other liraglutide-containing products.

The PI for Victoza contains a boxed warning regarding the risk of thyroid C-cell tumors. Victoza is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2; and in patients with a serious hypersensitivity reaction to liraglutide or any of the excipients in Victoza. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Victoza. In addition, the PI for Victoza includes warnings and precautions regarding pancreatitis, never sharing a Victoza pen between patients, hypoglycemia, acute kidney injury, hypersensitivity reactions, and acute gallbladder disease. The most common adverse reactions observed with Victoza were nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.

Prior Communications

FDA notes that several advisory comments dated March 24, 2010, March 29, 2010, January 14, 2011, May 22, 2013, and April 22, 2016, to Novo Nordisk addressed draft promotional communications for Victoza with certain similarities to the video in this letter. Specifically, in the March 24, 2010 advisory comments, FDA recommended revising the draft promotional communication to avoid minimizing material risk information regarding the risk associated with Victoza. In the March 29, 2010 advisory comments, FDA recommended revising the draft promotional communication to avoid omitting material risk information regarding the risk of MTC and thyroid tumors, and warnings and precautions associated with gastrointestinal side effects and hypoglycemia. In the January 14, 2011 advisory comments, FDA recommended revising the draft promotional communications to avoid minimizing the warning and precaution of pancreatitis. In the May 22, 2013, advisory comments, FDA recommended revising the draft promotional communication to include important risk information regarding injection site reactions, symptoms of a serious allergic reaction associated with the use of Victoza, pancreatitis, and dehydration, or otherwise misrepresenting important risk information. In the April 22, 2016, advisory comments FDA recommended revising the draft promotional communication to avoid omitting material information regarding the risk of Victoza in patients with a personal or family history of MTC and warnings and precautions associated with gastrointestinal side effects and common side effects associated with Victoza, or otherwise misrepresenting important risk information.

Additionally, FDA notes that our advisory comments dated May 7, 2018, to Novo Nordisk addressed a draft promotional communication for Ozempic with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising the draft promotional communication to avoid minimizing the boxed warning, or otherwise misrepresenting important risk information. FDA also notes that our advisory comments dated September 23, 2021, to Novo Nordisk addressed draft promotional communications for Wegovy with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising draft promotional communications to avoid minimizing the risk of increased risk of acute gallbladder disease and gastrointestinal adverse reactions associated with Wegovy, or otherwise misrepresenting important risk information.

We are concerned that Novo Nordisk is promoting Wegovy, Ozempic, and Victoza in a manner that fails to present the serious risks of these drug products in a truthful and nonmisleading manner, despite FDA’s prior comments.

False or Misleading Risk Presentation

Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. 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 video is a 42-minute special program, hosted by Oprah Winfrey, concerning “the new drugs sparking... a weight loss revolution...that have captured the world’s attention”¹¹ due to “so-called miracle medications like Ozempic, Wegovy, Mounjaro, and Zepbound.” The video features patient testimonials from those who struggle with obesity and excessive weight, including those who have used these drug products to help lose weight. One such patient testimonial, at approximately 21 minutes and 14 seconds, includes a mother and her teenage daughter who share their story of the daughter’s weight loss journey and experience with the use of GLP-1s in adolescence, specifically the use of Victoza.

The video also prominently features two paid consultants of Novo Nordisk, Drs. Butsch and Velazquez,¹² who are asked about their experiences with treating patients who are obese or have excess weight, and the use of these medications. The Novo Nordisk Vice President of Cardiometabolic Sales, Negelle Morris, is also featured at the end of the video to discuss access to Novo Nordisk drug products: Wegovy, Ozempic, and Victoza. At approximately 12 minutes and 30 seconds into the video, Ms. Winfrey introduces Dr. Butsch using a prerecorded cut-away where he provides information to the audience about some of the causes for the high rates of obesity in the United States and the complexity of obesity as a medical condition. Ms. Winfrey then introduces Dr. Velazquez at approximately 16 minutes and 40 seconds using another pre-recorded cut-away with the preface that they will now ask “how these medications actually work.” Dr. Velazquez describes in the cut-away how the “newer agents like GLP-1s” are a “new era for the treatment of obesity.” While Dr. Velazquez is speaking, a photo of an Ozempic pen is displayed on screen. Dr. Velazquez continues by describing how our naturally occurring GLP-1 hormone works in the body and how drugs, like Wegovy, Ozempic, and Victoza are “essentially copying what our normal GLP-1 hormone does in our body, but doing it a little bit better.” Throughout the remainder of the cut-away, Dr. Velazquez provides more details about the clinical and metabolic processes associated with GLP-1s and how these medications, compared to previous obesity and excessive weight treatments, have achieved “double the amount of weight loss.” Ms. Winfrey then continues the conversation with both Drs. Butsch and Velazquez on-stage about the benefits of the medications, and then concludes this segment of the video (20:05) by asking “You are both consultants for the drug companies, what does that mean?” Dr. Velazquez answers that “…they are looking for our expert opinion to be able to deliver high quality care to patients” and Dr. Butsch further states “I’ve been involved with some of these companies in developing educational programs and modules for medical students and medical trainees to learn more about the disease of obesity. I’m also running clinical trials with future medications.”

The video includes numerous representations about the benefits of Wegovy, Ozempic, and Victoza made by representatives of Novo Nordisk, but omits important risk information and otherwise minimizes the risks of these drug products. We acknowledge that the video includes a segment on “the side effects” of GLP-1s, generally (beginning at 33:35 and ending at 37:47). However, this segment begins with comments from a non-Novo Nordisk affiliated health care provider about how patients should be weighing the risks and benefits of taking any drug and, as explained below, concludes after several misleading statements and omissions by representatives of Novo Nordisk about the risks of Wegovy, Ozempic, and Victoza.¹³

First, the video omits an important concept from the boxed warning for these drugs; specifically the contraindication in patients with a personal or family history of MEN 2 due to the risk of thyroid c-cell tumors. While Dr. Velazquez does provide a limited discussion of the thyroid cancer risk to “anybody [who] has a history specifically of medullary thyroid cancer,” the risk to patients with a history of MEN 2 is omitted. The boxed warning in the Wegovy, Ozempic, and Victoza PIs states the following (in pertinent part; bolded emphasis original, underlined emphasis added):

WEGOVY [and OZEMPIC and VICTOZA] is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) . . . . Counsel patients regarding the potential risk for MTC with the use of WEGOVY [and OZEMPIC and VICTOZA] and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Additionally, several warnings and precautions associated with Wegovy, Ozempic, and Victoza are completely omitted from the video. Specifically, serious risks pertaining to hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, heart rate increase, and suicidal behavior and ideation, which are described in the “What are the possible side effects of WEGOVY?” section of the Wegovy Medication Guide, are omitted from the video. Similarly, the serious risks to patients treated with Ozempic pertaining to diabetic retinopathy complications, shar[ing] an Ozempic pen between patients, hypoglycemia, acute kidney injury, and hypersensitivity reactions are also omitted from the video. Furthermore, similar warnings and precautions for Victoza, as described in the “What are the possible side effects of VICTOZA?” section of the Medication Guide, are also omitted from the video.

These omissions are further exacerbated by statements from Dr. Velazquez in the video that misleadingly minimize and downplay the drugs’ boxed warning, contraindications, warnings and precautions and other common adverse events. For example, when Ms. Winfrey asks about the “serious health effects down the road” from treatment with GLP-1 medications, like Wegovy, Ozempic, and Victoza (36:56), Dr. Velazquez responds with the following (emphasis added):

• “There’s been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%.” (37:00)
• “If anybody has a history specifically of MTC... is very, very rare. So if they do have that, we are not prescribing that medication. So, we have to be able to keep up with knowing the data, and recognizing that it’s rare, but it’s there and we have to always screen.” (37:19)

Dr. Velazquez’s description of the incidence of MTC in patients treated with GLP-1 drugs is misleading when she states, “this has really not been shown in human studies” and is “very, very rare.” According to the WARNINGS AND PRECAUTIONS, Risk of Thyroid C-cell Tumors, section of the Victoza PI “cases of MTC have been reported in the postmarketing period in patients treated with Victoza”. While we acknowledge that current data is insufficient to establish or exclude a causal relationship between MTC and GLP-1s, it is misleading to describe this risk as having “…not been shown in human studies” and as “very, very rare” since the risk of thyroid C-cell tumors, including MTC and MEN 2, is a boxed warning across the entire GLP-1 pharmacological class.

These statements are also concerning because they misleadingly minimize the serious risks associated with Wegovy, Ozempic, and Victoza by suggesting that a patient does not need to be worried about the potential for developing “pancreatitis,” “gallbladder complications,” and “thyroid cancer” from treatment with Wegovy, Ozempic, and Victoza. Specifically, the statements that “there’s been a lot of hype” about the risks and they are “rare, but…there” are especially egregious, given the nature of the risks to patients from GLP-1 treatment, including pancreatitis, which has led to serious complications, such as organ failure and death. According to the WARNINGS AND PRECAUTIONS, Acute Pancreatitis, section of the Wegovy PI, “acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide.” Moreover, the “gallbladder complications” documented in clinical trials for Wegovy, Ozempic, and Victoza also led to serious complications in some patients and required hospitalization or cholecystectomy (gallbladder removal).

Additional statements in the video, with respect to the common adverse reactions for Wegovy, Ozempic, and Victoza, are similarly misleading since they suggest that Wegovy, Ozempic, and Victoza are safer because the adverse events are less common and less severe than have been demonstrated. For example, when asked to respond to the concerns of a guest patient that experienced side effects from using GLP-1s and subsequently had to discontinue treatment, the following conversation occurs (emphasis added):

• Ms. Winfrey: (after speaking to the guest patient “Rolanda” about her need to discontinue treatment with a GLP-1 medication due to side effects such as becoming “very nauseous” and vomiting blood) “So Dr. Velazquez, what do you have to say about that?” (36:37)
• Dr. Velazquez: “Yeah, I think that’s about education of the side effects. It’s about effective management of the side effects.” (36:42)
• Ms. Winfrey: “But they do have side effects?” (36:46)
• Dr. Velazquez: “I think that they’ve gotten overhyped. Medicines have side effects, but the important part is that they’re mild to moderate in the research studies.” (36:48)
• Dr. Butsch: “Yeah.” while nodding affirmatively in response to Dr. Velazquez (36:53)

These statements further compound the misleading minimization of the risks for Wegovy, Ozempic, and Victoza (particularly the common adverse events), by suggesting such risks are “overhyped.” The use of phrases such as “a lot of hype” and “overhyped” when referring to risk information misleadingly undermines the risk’s importance and severity.¹⁴ These statements also minimize the risks by describing them as “mild to moderate,” when this has not been demonstrated. Similar to the guest patient who was the subject of the above conversation, a number of patients in clinical trials taking GLP-1s, such as Wegovy, Ozempic, and Victoza, experienced adverse events, some of which were so severe that patients discontinued use of the drug. For example, according to the ADVERSE REACTIONS, Gastrointestinal Adverse Reactions section of the Wegovy PI (in pertinent part, emphasis added):

In clinical trials in adults, 73% of WEGOVY-treated patients and 47% of patients receiving placebo reported gastrointestinal adverse reactions, including severe reactions that were reported more frequently among patients receiving WEGOVY (4.1%) than placebo (0.9%). The most frequently reported reactions were nausea (44% vs. 16%), vomiting (25% vs. 6%) and diarrhea (30% vs. 16%).
. . . .
In the pediatric clinical trial, 62% of WEGOVY-treated patients and 42% of placebotreated patients reported gastrointestinal disorders. The most frequently reported reactions were nausea (42% vs. 18%), vomiting (36% vs. 10%), and diarrhea (22% vs. 19%). Other gastrointestinal-related reactions that occurred at a higher incidence than placebo among WEGOVY-treated patients included abdominal pain, constipation, eructation, gastroesophageal reflux disease, and flatulence.
. . . .
Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of WEGOVY-treated adult patients versus 0.7% of placebo-treated patients.

In addition, according to the ADVERSE REACTIONS, Gastrointestinal Adverse Reactions section of the Ozempic PI (in pertinent part, emphasis added):

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC than placebo (placebo 15.3%, OZEMPIC 0.5 mg 32.7%, OZEMPIC 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation. More patients receiving Ozempic 0.5 mg (3.1%) and Ozempic 1 mg (3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).

Similarly, according to the ADVERSE REACTIONS, Gastrointestinal Adverse Reactions section of the Victoza PI (in pertinent part, emphasis added):

In the pool of 5 glycemic control, placebo-controlled adult clinical trials, withdrawals due to gastrointestinal adverse reactions, occurred in 4.3% of VICTOZA-treated patients and 0.5% of placebo-treated patients. Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials.

Moreover, the statement that “medicines have side effects,” coupled with the statement that GLP-1 side effects are “mild to moderate,” further downplays the serious nature of the risks associated with GLP-1s, like Wegovy, Ozempic, and Victoza, by suggesting that because all drugs generally have side effects, that the individual risks of GLP-1s are no more than other drugs and are therefore of little concern. There are several additional common adverse reactions, some of which were severe in nature (i.e., hypoglycemia), that were observed with Wegovy, Ozempic, and Victoza; but, as noted above, were omitted entirely from the video. Therefore, it is misleading to represent that the side effects of GLP-1s, like Wegovy, Ozempic, and Victoza, are generally “mild to moderate.”

The video not only omits several serious and significant risks; it also understates the minimal safety information that is disclosed, thus misrepresenting the safety profile of these drugs. By suggesting that safety or tolerability issues are “overhyped,” and by implying that these products are not associated with the serious and significant risks outlined above, the video misrepresents the safety profile of Wegovy, Ozempic, and Victoza. This implication is false or misleading and raises significant public health and safety concerns.

Finally, the video is misleading because it fails to present information related to the side effects and contraindications for Wegovy, Ozempic, and Victoza with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Wegovy, Ozempic, and Victoza. As noted, the video contains numerous representations and suggestions about the benefits of Wegovy, Ozempic, and Victoza, while the risk information is relegated to the end of the video and briefly discussed. Of the 42-minute video, only four minutes in total are devoted to the important shared risks associated with GLP-1s, like Wegovy, Ozempic, and Victoza. Additionally, the video does not provide any signal to alert the viewer where they may be able to find additional risk information about the drugs. The overall effect of disclosing risk information in this limited manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Wegovy, Ozempic, and Victoza.

Failure to Submit Under Form FDA-2253

FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the video was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).

Conclusion and Requested Action

For the reasons discussed above, the video misbrands Wegovy, Ozempic, and Victoza and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).

This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. 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 other promotional communications (with the 2253 submission date) for Wegovy, Ozempic, and Victoza that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Wegovy, Ozempic, and Victoza.

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.

Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Wegovy, Ozempic, and Victoza; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.

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.

Please direct your response to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 774, MA 1352, and MA 2028 in addition to the NDA numbers in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDEROPDP-RPM@fda.hhs.gov.

Sincerely,
{See appended electronic signature page}
George Tidmarsh, M.D., Ph.D.
Director
Center for Drug Evaluation and Research
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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.
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/s/
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CARTER M BEACH
09/09/2025 05:18:24 PM
On behalf of George Tidmarsh, M.D., Ph.D

Promotional Material

1. 1Dr. W. Scott Butsch is a health care provider who serves as the Director of Obesity Medicine at the Bariatric Institute of Cleveland Clinic. Dr. Butsch has financial and consultancy connections to Novo Nordisk. Based on currently available data, from 2017-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Butsch has received (b)(4) in consulting fees, grants, and other payments from Novo Nordisk (https://openpaymentsdata.cms.gov/physician/1050529).
2. 2Dr. Amanda Velazquez is a health care provider who serves as the Director of Obesity Medicine at Cedars- Sinai Medical Center. Dr. Velazquez has financial and consultancy connections to Novo Nordisk. Based on currently available data, from 2019-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Velazquez has received (b)(4) in consulting fees, grants, and other payments from Novo Nordisk (https://openpaymentsdata.cms.gov/physician/439627).
3. 3GLP-1 = Glucagon-like Peptide-1
4. 4At approximately 20 minutes and 46 seconds, the video includes the following prominent on-screen text: “Dr. Butsch and Dr. Velazquez consult for and receive research funding from companies making GLP-1 drugs.”
5. 5Negelle Morris is Senior Vice President, Novo Nordisk Inc. (NNI) Cardiometabolic Sales. https://www.novonordisk-us.com/about/our-executive-team/negelle-morris.html
6. 6This video is available on the internet at https://abc.com/shows/an-oprah-special-shame-blame-and-theweight- loss-revolution/episode-guide/season-01/01-an-oprah-special-shame-blame-and-the-weight-lossrevolution (last accessed date September 8, 2025)
7. 7This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication(s) cited in this letter.
8. 8The version of the Wegovy PI referred to in this letter is dated March 2024.
9. 9The version of the Ozempic PI referred to in this letter is dated September 2023.
10. 10The version of the Victoza PI referred to in this letter is dated July 2023.
11. 11The entirety of this video is focused on weight loss and weight loss products, specifically GLP-1s. While diabetes is briefly mentioned, the majority of the program focuses on weight loss. Ozempic and Victoza are not FDA-approved for weight loss.
12. 12See supra footnotes 1, 2, and 3.
13. 13We note that shortly after the segment on side effects, Ms. Morris was introduced (38:19) as Vice President of Sales for Novo Nordisk. Although Ms. Morris appeared to be present during the filming of the side effects segment video, Ms. Morris made no additions to the limited risk presentation or interjected any corrections to the misleading representations made by the previous representatives of Novo Nordisk.
14. 14While these and other statements made by Dr. Velazquez may be a reflection of their experience as a health care provider treating patients with GLP-1s, like Wegovy, Ozempic and Victoza, their personal experience does not support the representation in a promotional communication regarding the benefits of these drugs that the serious risks associated with Wegovy, Ozempic, and Victoza have received “a lot of hype” or have been “overhyped.”