

#### [33] eli-lilly-and-company-716462-09092025 | issued 09/09/2025 | Eli Lilly and Company | SUBJ: False & Misleading Claims/Misbranded
WARNING LETTER Dear David A. Ricks: The U.S. Food and Drug Administration (FDA) has reviewed a promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) posted on the website okcfox.com 1 . The video features Dr. Clare Lee 2 , Associate Vice President of Medical Affairs for Eli Lilly and Company (Eli Lilly) and Rhonda Pacheco 3 , Group Vice President of Diabetes and Obesity for Eli Lilly. The video starts with the disclaimer that “this segment is sponsored by Eli Lilly and Company.” The video originally appeared on Fox25’s “Living Oklahoma” website on July 11, 2025. [B274] Thus, the video misbrands Zepbound 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)(3)(i); (e)(5). [B271] These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Zepbound, which is a drug with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors. Background Below are the indication and summary of the most serious and most common risks associated with the use of Zepbound 4 . According to the INDICATIONS AND USAGE section of the Zepbound FDA-approved prescribing information (PI) (in pertinent part): ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use: ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound 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). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal adverse reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease. Prior Communications FDA notes that advisory comments dated May 3, 2024, to Eli Lilly addressed draft promotional communications for Zepbound with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising draft promotional communications regarding gastrointestinal adverse reactions associated with Zepbound, or otherwise misrepresenting important risk information. Additionally, FDA notes that our advisory comments dated November 6, 2024, included recommendations to revise draft promotional communications to avoid omitting information regarding the limitations of use of Zepbound. FDA also recommended revising draft promotional communications to avoid omitting information regarding the risks of hypoglycemia and depression associated with Zepbound, thus creating a misleading impression about the safety and approved use of the drug. [B273] [B269] The video, which features a reporter introducing Dr. Lee and Ms. Pacheco as representatives from Eli Lilly, contains claims and representations about obesity and the benefits of Zepbound but fails to communicate any risk information. For example, Dr. Lee talks about obesity and how adults with obesity should “look out for FDA-approved safe and authentic medicines if they are already on treatment for obesity and to avoid those unapproved ones. . . .” The reporter then asks Ms. Pacheco (in pertinent part), “. . . what are people’s options to access safe and effective obesity medicines” and Ms. Pacheco responds making claims such as (in pertinent part), “We at Lilly are providing options. One of the options for treatment is Zepbound, which is now available at LillyDirect which is our self-pay pharmacy solution. This provides an option to patients to get access to safe and effective authentic medicine. . . .” The video, however, entirely omits risk information. By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety. This omission is especially concerning from a public health perspective given the boxed warning and serious risks associated with Zepbound. Omission of Material Facts The video is misleading because it fails to provide material information regarding Zepbound’s limitations of use. Specifically, the INDICATIONS AND USAGE section of the PI states the following (underlined emphasis added): ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use: ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound. [B265] [B270] A copy of the video was not submitted to OPDP 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 Zepbound within the meaning of the 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). [B271] [B83] [B268] [B1] 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 Zepbound that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound. [B266] [B276] [B278] We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). [B275] [B272] [B277] [B260] Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. [B267] Please refer to MA 824 in addition to the NDA number in all future correspondence relating to this particular matter. [B7] [B261] [B264] Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov. [B263] [B262] Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ CARTER M BEACH 09/09/2025 05:09:22 PM On behalf of George Tidmarsh, M.D., Ph.D _____________________________ 1 This video is available on the internet at https://okcfox.com/features/living-oklahoma/experts-share-tips-onfinding-safe-authentic-obesity-meds-amid-rising-online-scams (last accessed September 8, 2025). 2 Dr. Clare Lee is Associate Vice President of Global Medical Affairs for Eli Lilly and Company (LLY). https://www.linkedin.com/in/clarejlee/. 3 Rhonda Pacheco is Group Vice President of US Cardiometabolic Health for Eli Lilly and Company. https://www.linkedin.com/in/rhonda-janice-pacheco-1176666/. 4 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication cited in this letter. Promotional Material Content current as of: 09/16/2025 Regulated Product(s)

#### [34] eli-lilly-and-company-716475-09092025 | issued 09/09/2025 | Eli Lilly and Company | SUBJ: False & Misleading Claims/Misbranded
WARNING LETTER Dear David A. Ricks: The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) posted on the website dayton247now.com. 1 The video features Dr. Clare Lee 2 , Associate Vice President of Medical Affairs for Eli Lilly and Company (Eli Lilly) and Rhonda Pacheco 3 , Group Vice President of Diabetes and Obesity for Eli Lilly. The video originally appeared on Dayton247 Now’s “Your Day” website on July 9, 2025. [B274] Thus, the video misbrands Zepbound 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)(3)(i); (e)(5). [B271] These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Zepbound, which is a drug with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors. Background Below are the indication and summary of the most serious and most common risks associated with the use of Zepbound4. According to the INDICATIONS AND USAGE section of the Zepbound FDA-approved prescribing information (PI) (in pertinent part): ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use: ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound 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). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal adverse reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease. Prior Communications FDA notes that advisory comments dated May 3, 2024, to Eli Lilly addressed draft promotional communications for Zepbound with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising draft promotional communications regarding gastrointestinal adverse reactions associated with Zepbound, or otherwise misrepresenting important risk information. Additionally, FDA notes that our advisory comments dated November 6, 2024, included recommendations to revise draft promotional communications to avoid omitting information regarding the limitations of use of Zepbound. FDA also recommended revising draft promotional communications to avoid omitting information regarding the risks of hypoglycemia and depression associated with Zepbound, thus creating a misleading impression about the safety and approved use of the drug. [B273] [B269] The video, which features a reporter introducing Dr. Lee and Ms. Pacheco as representatives from Eli Lilly, contains claims and representations about obesity and the benefits of Zepbound but fails to communicate any risk information. For example, Dr. Lee talks about obesity and how “if pharmacotherapy is indicated, . . . make sure they have access to the FDA-approved, authentic and safe medicines . . . . ” The reporter then asks Ms. Pacheco (in pertinent part), “what are the options for people who want to access the safe and effective obesity medicines?” Ms. Pacheco responds making claims such as (in pertinent part), “We at Lilly are providing options. We know different patients have different needs and we have access to Zepbound on Lilly Direct. You can go to Lilly Direct, it’s our self-pay option. . . . This is the option for patients living with obesity that have a way to get that access to that safe and authentic medication . . . . ” The video, however, entirely omits risk information. By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety. This omission is especially concerning from a public health perspective given the boxed warning and serious risks associated with Zepbound. Omission of Material Facts The video is misleading because it fails to provide material information regarding Zepbound’s limitations of use. Specifically, the INDICATIONS AND USAGE section of the PI states the following (underlined emphasis added): ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use: ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound. [B265] [B270] 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 Zepbound 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). [B271] [B83] [B268] [B1] 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 Zepbound that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound. [B266] [B276] [B278] We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). [B275] [B272] [B277] [B260] 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. [B267] Please refer to MA 831 in addition to the NDA number in all future correspondence relating to this particular matter. [B7] [B261] [B264] Questions related to the submission of your response letter should be emailed to CDER-OPDP-RPM@fda.hhs.gov. [B263] [B262] Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ CARTER M BEACH 09/09/2025 05:09:35 PM On behalf of George Tidmarsh, M.D., Ph.D ___________________________ 1 This video is available on the internet at https://dayton247now.com/news/local/experts-discuss-obesitymedications-and-warn-against-online-scams# (last accessed September 8, 2025). 2 Dr. Clare Lee is Associate Vice President of Global Medical Affairs for Eli Lilly and Company (LLY). https://www.linkedin.com/in/clarejlee/. 3 Rhonda Pacheco is Group Vice President of US Cardiometabolic Health for Eli Lilly and Company. https://www.linkedin.com/in/rhonda-janice-pacheco-1176666/. 4 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication cited in this letter. Promotional Material Content current as of: 09/16/2025 Regulated Product(s)

#### [35] elite-health-center-715869-09092025 | issued 09/09/2025 | Elite Health Center | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Elite Health Center: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://eliterapidfatloss.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B229] [B14] [B12] The following claim concerning compounded semaglutide products appears on your website: “Compounded semaglutide was first introduced and patented in 2016, and FDA approved as a type 2 diabetes treatment in 2017. It wasn’t until 2021 that compounded semaglutide was approved as a treatment for obesity!” Compounded drug products are not FDA-approved. [B111] [B112] [B11] [B127] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration _______________________ 1 The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [36] evolife-wellness-715507-09092025 | issued 09/09/2025 | EvoLife Wellness | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 EvoLife Wellness: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://evolifewellness.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “FDA-Approved” “Clinically Proven: Semaglutide is FDA-approved for chronic weight management….” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration ________________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [37] expert-aesthetics-715796-09092025 | issued 09/09/2025 | Expert Aesthetics | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Ms. Burr: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://erasingage.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “At home weight loss with the popular Ozempic generic Semaglutide.” • “At home weight loss with the popular Mounjaro generic Tirzepatide.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [38] fwd-care-inc-dba-fwd-716696-09092025 | issued 09/09/2025 | FWD Care, Inc. dba FWD | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 FWD: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://fwd.care in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Manage weight affordably with compounded GLP-1, the same active ingredients as Wegovy, Ozempic, Zepbound & Mounjaro” • “Same active ingredient in Mounjaro and Zepbound” • “Same active ingredient as Ozempic and Wegovy” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [39] fancy-meds-llc-dba-fancy-meds-716487-09092025 | issued 09/09/2025 | Fancy Meds, LLC dba Fancy Meds | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Fancy Meds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://fancymeds.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Same active ingredient as Ozempic and Wegovy” • “Same active ingredient as Mounjaro and Zepbound” • “Compounding semaglutide involves creating small, customized batches of the medication in an FDA-monitored, state-licensed pharmacy, using FDA-approved ingredients….” • “Compounding tirzepatide involves creating small, customized batches of the medication in an FDA-monitored, state-licensed pharmacy, using FDA-approved ingredients….” • “Though they contain the same active ingredient as branded Mounjaro and Zepbound, compounded versions are much more affordable, so you win!” • “Though they contain the same active ingredient as branded Ozempic and Wegovy, compounded versions are much more affordable, so you win!” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [40] fitrx-llc-dba-zealthy-716501-09092025 | issued 09/09/2025 | FitRX, LLC dba Zealthy | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Zealthy: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.getzealthy.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B207] [B14] [B12] The following claims concerning compounded semaglutide products appear on your website: • “Is Semaglutide the same as Wegovy and Ozempic? Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective...” • “Your healthcare provider will help you find the right dose of GLP-1 Medication including Semaglutide (same active ingredient as Wegovy, and Ozempic), to achieve healthy weight loss.” • “Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective for Zealthy members whose insurance deny coverage of brand name medication like Wegovy or who are uninsured.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [41] glp-1-solution-715883-09092025 | issued 09/09/2025 | GLP-1 Solution | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 GLP-1 Solution: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://glp1solution.store in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide. [B192] In addition, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. A. [B141] [B188] [B106] [B227] [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. [B228] [B201] [B105] [B225] [B200] [B170] [B198] [B12] The following claims concerning your compounded semaglutide and tirzepatide products appear on your website: • “MOUNJARO” • “Semaglutide is the generic drug delivered in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 7 D. [B186] In addition, your claims concerning compounded semaglutide, and tirzepatide drug products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)] resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B259] [B5] [B187] [B149] [B195] [B199] [B258] [B226] [B224] [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [42] genlabmeds-713650-09092025 | issued 09/09/2025 | GenLabMeds | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 GenLabMeds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://genlabmeds.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide, and tirzepatide. [B192] In addition, your claims concerning compounded retatrutide, semaglutide, and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)] resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. A. [B141] [B188] [B106] [B227] [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. [B228] [B201] [B105] [B225] [B200] [B170] [B198] [B12] The following claims concerning your compounded retatrutide, semaglutide, and tirzepatide products appear on your website: • “Compounded Retatrutide [--] Active Ingredient in Mounjaro and Zepbound” • “Compounded Retatrutide [--] Active Ingredient in Ozempic and Wegovy” • “What does the treatment plan generally look like? The standard, FDA-approved dosing schedule for Retatrutide is: Month 1: 0.25 mg per week…” • “Doctors frequently recommend Compounded Tirzepatide (Mounjaro/Zepbound) or Compounded Semaglutide (Wegovy, Ozempic), which are both GLP-1 agonists.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 7 D. [B186] In addition, your claims concerning compounded retatrutide, semaglutide, and tirzepatide drug products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)] resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B259] [B5] [B187] [B149] [B195] [B199] Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. [B226] [B224] [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [43] getfitmedical-llc-dba-getfitmedical-715801-09092025 | issued 09/09/2025 | Get.Fit.Medical, LLC dba Get.Fit.Medical | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Get.Fit.Medical: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.getfitmedical.com in August 2025 and has observed that your website offers various compounded drug products, including sildenafil, tadalafil, semaglutide, and tirzepatide. 1 As described below, your claims concerning compounded sildenafil, tadalafil, semaglutide, and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claims concerning compounded sildenafil, tadalafil, semaglutide, and tirzepatide products appear on webpages that offer only compounded products: • “SILDENAFIL (GENERIC VIAGRA)” • “TADALAFIL (GENERIC CIALIS)” • “SEMAGLUTIDE (GENERIC OZEMPIC/WEGOVY)” • “TIRZEPATIDE (GENERIC MOUNJARO)” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 2 For the reasons discussed above, your compounded sildenafil, tadalafil, semaglutide, and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration 1 The sildenafil, tadalafil, semaglutide, and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [44] healberry-719809-09092025 | issued 09/09/2025 | HealBerry | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 HealBerry: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healberry.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. 1 As described below, your claim concerning compounded semaglutide products is false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in your products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claim concerning compounded semaglutide products appears on your website: “Same active ingredient as Ozempic and Wegovy” Compounded drug products are not FDA-approved. [B111] [B112] [B11] [B127] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration ______________________ 1 The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [45] healthon-inc-dba-healthon-719809-09092025 | issued 09/09/2025 | Healthon Inc. dba Healthon | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Dr. Montazeri: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthon.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “Same active ingredient as Wegovy and Ozempic.” “Same active ingredient as Mounjaro pens and Zepbound.” “Clinically proven weight loss” “The active ingredient in our formula is FDA-approved….” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration __________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [46] healthy-living-clinic-09092025 | issued 09/09/2025 | Healthy Living Clinic | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Healthy Living Clinic: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthyliving.clinic in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B229] [B14] [B12] The following claim concerning compounded semaglutide products appears on your website: • “It is also available under brand names like Wegovy, Ozempic, and Rybelsus.” Compounded drug products are not FDA-approved. [B111] [B112] [B11] The claim identified in this letter put you on notice of our concerns but does not represent an exhaustive list of misbranding violations. [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [47] healthy-male-716506-09092025 | issued 09/09/2025 | Healthy Male | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Healthy Male: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthymale.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide. 1 As described below, your claims concerning compounded tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claims concerning compounded tirzepatide products appear on your website: • “Clinically shown to support 15-22% average body weight reduction.” • “Clinically proven medications and compounds for sustainable weight management” • “Clinically proven to deliver sustainable results….” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 2 For the reasons discussed above, your compounded tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [48] hims-hers-health-inc-dba-hers-716825-09092025 | issued 09/09/2025 | Hims & Hers Health, Inc. dba Hers | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Mr. Dudum: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.forhers.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B207] [B14] [B12] The following claims concerning your compounded semaglutide products appear on your website: • “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” • “Clinically proven ingredients” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [49] hims-hers-health-inc-dba-hims-716567-09092025 | issued 09/09/2025 | Hims & Hers Health, Inc. dba Hims | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Mr. Dudum: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.hims.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. 1 As described below, your claims concerning your compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claims concerning your compounded semaglutide products appear on your website: • “Same active ingredient as Ozempic and Wegovy” • “Clinically proven ingredients” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [50] intimate-rose-716458-09092025 | issued 09/09/2025 | Intimate Rose | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Intimate Rose: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.intimaterose.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Same active ingredient as Ozempic and Wegovy” • “Same active ingredient as Mounjaro and Zepbound” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [51] invigorate-med-spa-715872-09092025 | issued 09/09/2025 | Invigorate Med Spa | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Invigorate Med Spa: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://invigoratemedspa.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “Semaglutide (Wegovy)” “Tirzepatide/B12 (Mounjaro)” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration _______________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [52] julymd-716828-09092025 | issued 09/09/2025 | JulyMD | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 JulyMD: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://julymd.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B207] [B14] [B12] [B128] “Our Semaglutide injection, featuring the same active ingredient as Wegovy and Ozempic, offers a powerful solution.” “Yes, Semaglutide is the active ingredient in Ozempic and Wegovy, a medication commonly used to manage type 2 diabetes and support weight loss. If you’re looking for an affordable alternative, consider trying our compounded Semaglutide. It offers the same effective ingredient as Ozempic and Wegovy, but at a fraction of the price.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration _____________ 1 The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [53] las-villas-health-care-llc-dba-villas-health-716504-09092025 | issued 09/09/2025 | Las Villas Health Care LLC dba Villas Health | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Villas Health: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://villashealth.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and sildenafil. 1 As described below, your claims concerning compounded semaglutide and sildenafil products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claims concerning compounded semaglutide and sildenafil products appear on your website: • “Semaglutide GLP-1 is a once-a-week injection that contains the same active ingredient as Ozempic and Wegovy….” • “Sildenafil 2%: the active ingredient in Viagra. Clinically proven to improve outcomes in women with sexual arousal disorder by increasing blood flow to the genitals.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 2 For the reasons discussed above, your compounded semaglutide and sildenafil products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration 1 The semaglutide and sildenafil products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [54] lean-dreams-llc-dba-leandreams-716697-09092025 | issued 09/09/2025 | Lean Dreams LLC dba LeanDreams | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 LeanDreams: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.leandreamsweightloss.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide appear on your website: • “Compounded Semaglutide has the same active ingredient as Ozempic and Wegovy.” • “With compounded Tirzepatide, you get the same active ingredient found in Mounjaro and Zepbound.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [55] lovely-meds-inc-dba-lovely-meds-716829-09092025 | issued 09/09/2025 | Lovely Meds, Inc. dba Lovely Meds | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Lovely Meds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.lovelymeds.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Same active ingredient as Wegovy and Ozempic” • “Same active ingredient as Zepbound & Mounjaro” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [56] lumimeds-716510-09092025 | issued 09/09/2025 | Lumimeds | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Lumimeds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://lumimeds.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Doctors frequently recommend Compounded Tirzepatide or Compounded Semaglutide, both of which are GLP-1 agonists with the same active ingredient as the brand name medications.” • “GLP-1 Injections contain GLP-1, which mimics a naturally occurring hormone in the body. This is the same active ingredient used in brand name GLP-1 weight-loss medications. GLP-1 was FDA-approved in 2017 . . . . It was FDA-approved in 2021 for weight loss.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [57] lyfe-rx-09092025 | issued 09/09/2025 | Lyfe Rx | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Lyfe Rx: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://thelyferx.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Clinically Proven Weight Loss – Semaglutide has been shown to….” • “Clinically Proven Weight Loss – Tirzepatide has been shown to….” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [58] mane-steel-llc-dba-mane-steel-716455-09092025 | issued 09/09/2025 | Mane & Steel, LLC. dba Mane & Steel | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Mane & Steel: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://maneandsteel.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B207] [B14] [B12] The following claims concerning compounded semaglutide products appear on your website: • “Clinically Proven Weight Loss” • “Clinically proven GLP-1 therapy to suppress appetite, regulate blood sugar, and accelerate fat loss—trusted by medical professionals worldwide.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [59] master-pharmaceuticals-group-715800-09092025 | issued 09/09/2025 | Master Pharmaceuticals Group | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Master Pharmaceuticals Group: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.master-pharmaceuticals.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “Semaglutide (Ozempic/Wegovy)” “Tirzepatide (Mounjaro/Zepbound)” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration _________________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [60] matthew-stern-ceo-mystart-health-llc-714755-09092025 | issued 09/09/2025 | Matthew Stern, CEO MyStart Health LLC. | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Mr. Stern: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.mystarthealth.com in August 2025 and has observed that your website offers compounded semaglutide. 1 As described below, your claims concerning your compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The following claims concerning your compounded semaglutide products appear on your website: • “Generic Ozempic” • “Save with generics that offer the same active ingredients and results.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [61] medclub-dr-jenn-712126-09092025 | issued 09/09/2025 | MedClub by Dr. Jenn | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Dr. Guthrie: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://drjennpb.com in June 2025 and has observed that your website offers various compounded drug products, including retatrutide and semaglutide. [B192] In addition, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)] resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. A. [B141] [B188] [B106] 3 ³ Among the conditions of sections 503A and 503B are restrictions on the bulk drug substances (active pharmaceutical ingredients or APIs) that may be used to compound human drug products. [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. [B228] [B201] [B105] [B225] [B200] [B170] [B198] [B12] The following claims regarding compounded semaglutide products appear on your website: • “FDA Approved” • “USA Compounded” or “Custom Compounded” • “Generic Ozempic” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 7 D. [B186] In addition, your claims concerning compounded semaglutide drug products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)] resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration 1 The retatrutide and semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] [B187] [B149] [B195] [B199] [B258] [B226] [B224] [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [62] novo-nordisk-inc-716495-09092025 | issued 09/09/2025 | Novo Nordisk Inc. | SUBJ: False & Misleading Claims/Misbranded
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 Butsch 1 and Dr. Amanda Velazquez 2 , paid consultants (representatives) who “receive research funding from companies making GLP-1 3 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. [B274] 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). [B271] 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. [B273] [B269] 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. [B265] [B270] 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). [B271] [B83] [B268] [B1] 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. [B266] [B276] [B278] 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). [B275] [B272] [B277] [B260] 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 . [B267] 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. [B7] [B261] [B264] Questions related to the submission of your response letter should be emailed to CDEROPDP-RPM@fda.hhs.gov. [B263] [B262] Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ CARTER M BEACH 09/09/2025 05:18:24 PM On behalf of George Tidmarsh, M.D., Ph.D Promotional Material 1 Dr. 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 Dr. 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 GLP-1 = Glucagon-like Peptide-1 4 At 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 Negelle Morris is Senior Vice President, Novo Nordisk Inc. (NNI) Cardiometabolic Sales. https://www.novonordisk-us.com/about/our-executive-team/negelle-morris.html 6 This 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 This 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 The version of the Wegovy PI referred to in this letter is dated March 2024. 9 The version of the Ozempic PI referred to in this letter is dated September 2023. 10 The version of the Victoza PI referred to in this letter is dated July 2023. 11 The 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 See supra footnotes 1, 2, and 3. 13 We 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 While 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.” Content current as of: 09/16/2025 Regulated Product(s)