

#### [108] maxlife-technologies-inc-dba-maxlife-721453-02202026 | issued 02/20/2026 | MaxLife Technologies Inc. dba Maxlife | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Maxlife: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://maxlife.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Maxlife” on the pictured label, suggesting Maxlife is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Maxlife is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “generic compounded medication” “With the same active ingredient as Wegovy® and Ozempic®, this treatment has been clinically tested and FDA-approved for effective weight management.” “With the same active ingredient as Mounjaro® and Zepbound®, this treatment has been clinically tested and FDA-approved for effective weight management.” “FDA Approved” “Active ingredients in Ozempic® & Wegovy®” “Active ingredients in Mounjaro® & Zepbound®” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ____________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [109] newself-limited-dba-newself-721472-02202026 | issued 02/20/2026 | NewSelf Limited dba NewSelf | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 NewSelf: 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.newself.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “NewSelf” on the pictured label, suggesting NewSelf is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that NewSelf is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same active ingredient as Ozempic® & Wegovy®” “Same active ingredient as Mounjaro® & Zepbound®” “What is the FDA-approved use of Wegovy?” “What is the FDA-approved use of Zepbound?” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B285] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [110] newman-clinic-pllc-dba-newman-clinic-721470-02202026 | issued 02/20/2026 | Newman Clinic, PLLC dba Newman Clinic | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Dr. Newman: 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.newmanclinic.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Newman Clinic” on the pictured label, suggesting Newman Clinic is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Newman Clinic is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same Ingredient as Ozempic® and Wegovy®” “Same Ingredient as Mounjaro® and Zepbound®” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ________________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [111] peaks-curative-llc-dba-peaks-721817-02202026 | issued 02/20/2026 | Peaks Curative, LLC dba Peaks | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Peaks: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://peakscurative.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide drug products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide products 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)], result 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 compounded semaglutide products displayed on your website identify “Peak Now” on the pictured label, suggesting Peak Now is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Peak Now is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claims concerning compounded semaglutide products appear on your website: “This FDA-approved treatment promotes safe, effective weight loss, helping you reduce up to 20% of your body weight and maintain long-term results.” “Clinically proven to aid in significant weight loss in overweight adults.” “Safe, affordable, and effective.” “The compounded products offered on PeaksCurative.com use FDA approved active pharmaceutical ingredients (API).” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] For the reasons discussed above, your compounded semaglutide 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] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [112] pharmazee-721473-02202026 | issued 02/20/2026 | PharmaZee | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 PharmaZee: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://pharmazee.co, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “PharmaZee” on the pictured label, suggesting PharmaZee is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that PharmaZee is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “clinically proven medications” “proven prescription medications” “Same active ingredient as Ozempic® and Wegovy®” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B285] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [113] premium-health-management-inc-dba-premium-health-721474-02202026 | issued 02/20/2026 | Premium Health Management Inc. dba Premium Health | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Premium 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://premiumhealth.us, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Premium Health” on the pictured label, suggesting Premium Health is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Premium Health is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “generic compounded medication” “Semaglutide (the active ingredient used in Ozempic® and Wegovy®)” “Tirzepatide (active ingredient used in Mounjaro®)” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B284] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/05/2026 Regulated Product(s)

#### [114] refills-health-llc-dba-refills-health-721475-02202026 | issued 02/20/2026 | Refills Health, LLC dba Refills Health | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Refills 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://www.refills.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide drug products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide products 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)], result 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 compounded semaglutide products displayed on your website identify “Refills Health” on the pictured label, suggesting Refills Health is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Refills Health is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claims concerning compounded semaglutide products appear on your website: “clinically proven” “the same active ingredient found in certain FDA approved treatments” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] For the reasons discussed above, your compounded semaglutide 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] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [115] strut-health-llc-dba-strut-721448-02202026 | issued 02/20/2026 | Strut Health, LLC dba Strut | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Dr. Patel: 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.struthealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Strut” on the pictured label, suggesting Strut is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Strut is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Generic Zepbound, Mounjaro” “Semaglutide is the active ingredient in the brand medications.” “Tirzepatide is the active ingredient in the brand medications Zepbound® and Mounjaro®.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research __________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [116] viv-health-inc-dba-viv-rx-721818-02202026 | issued 02/20/2026 | Viv Health, Inc. dba VIV RX | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 VIV 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://www.vivrx.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “VIV RX” on the pictured label, suggesting VIV RX is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that VIV RX is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _________________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [117] weightless-medical-llc-dba-weightcare-721478-02202026 | issued 02/20/2026 | Weightless Medical LLC dba WeightCare | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 WeightCare: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://joinweightcare.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “WeightCare” on the pictured label, suggesting WeightCare is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that WeightCare is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _________________ 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain arepresentation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [118] zeuss-llc-dba-zeuss-717985-02202026 | issued 02/20/2026 | Zeuss LLC dba Zeuss | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Zeuss: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://getzeuss.com/, in December 2025, and has observed that your website offers compounded drug products, including tirzepatide drug products. 1 As described below, your website’s false or misleading claims concerning compounded tirzepatide products 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)], result 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 compounded tirzepatide products displayed on your website identify “Zeuss” on the pictured label, suggesting Zeuss is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Zeuss is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claims concerning compounded tirzepatide products appear on your website: “GLP-1 is a class of medication that mimic naturally produced hormone in a body. It is FDA approved and clinically proven to work treatment for weight loss.” “Proven Weight Loss” “each batch rigorously tested for efficacy and safety” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] 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] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 1 The 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii)[21 U.S.C. § 353b(a)(10)(A)(ii)]. [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [119] novo-nordisk-inc-717576-03052026 | issued 03/05/2026 | Novo Nordisk Inc. | SUBJ: Postmarketing Adverse Drug Experience Reporting Requirements
WARNING LETTER Mr. David S. Moore FDA Ref. No.: 26-HFD-45-03-01 President Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536 Dear Mr. Moore: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your firm, Novo Nordisk Inc. (hereinafter referred to as NNI), between January 13 and February 7, 2025. The investigators representing FDA reviewed your compliance with postmarketing adverse drug experience (PADE) regulations. The inspection revealed serious violations of PADE reporting requirements found in section 505(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 355(k)] and Title 21, Code of Federal Regulations (21 CFR) 314.80. Failure to comply with section 505(k) is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to ensure that accurate, reliable, and timely safety data are submitted to FDA for the monitoring of product safety, and to ensure compliance with PADE regulations. At the conclusion of the inspection, the investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your written response to the Form FDA 483 dated March 3, 2025, and your subsequent correspondence dated April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response and correspondence dated March 3, 2025; April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026, it appears that you did not adhere to the applicable statutory requirements in the FD&C Act and applicable regulations contained in 21 CFR part 314. We wish to emphasize the following: Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA as required by 21 CFR 314.80(b). As an application holder of products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, NNI is required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA. You developed written procedures that failed to ensure that you, and your contractor acting on your behalf, complied with all applicable PADE regulations for the surveillance, receipt, evaluation, and reporting of ADEs. Examples of this failure include but are not limited to the following: 1. You failed to develop written procedures, as required under 21 CFR 314.80(b), that ensured that you, and your contractor acting on your behalf, reported all serious and unexpected ADEs to FDA within 15 calendar days, in accordance with 21 CFR 314.80(c)(1)(i). PADE regulations require the applicant to report each ADE that is both serious and unexpected, whether foreign or domestic, no later than 15 calendar days from the initial receipt of the information by the applicant (21 CFR 314.80(c)(1)(i)). Specifically: a. Your written procedure Q014048, “Handling of Adverse Events and Other Safety Information” (Ver: 28.0, Effective Date: 03 Oct 2024), allowed ADEs reported to NNI to be rejected or cancelled (and therefore not to be reported to FDA) if the ADE was considered by the reporter to be unrelated to the product. Specifically, Q014048 excludes reports from the definition of “adverse reaction” if “the reporters specifically state that they believe the events to be unrelated or that a causal relationship can be excluded.” This definition is inconsistent with FDA regulations, which define an ADE as “[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug-related.” FDA’s regulations require applicants to develop written procedures for, among other things, the reporting of ADEs regardless of whether the event is considered causally related to the product. An ADE that is determined to be both serious and unexpected must be reported to FDA no later than 15 days from the date of initial receipt. Based on your written procedure, your staff or contractor cancelled or rejected serious and unexpected ADEs that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product. For example, Argus 1 Case #1331385 involves a consumer who was disabled after experiencing a stroke, which is a serious and unexpected ADE, while receiving liraglutide. The consumer reported that the stroke was not related to liraglutide; therefore, you rejected this case. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations. During the inspection, you stated that you opened deviation DV0166369 in April 2024 after discovering that not all reportable serious and unexpected ADEs were submitted to FDA because the ADEs were cancelled or rejected by your staff or contractor and were documented as being “incidental” or “incidental and unrelated.” You identified your written procedures, including Q014048 (both the current and prior versions), as a root cause for this deviation, because both the current and prior versions allowed ADEs reported to NNI to be rejected or cancelled based on the reporter’s assessment of a lack of causality of the event to the product. The root-cause analysis noted that while the exclusion of certain ADEs from reporting as described in the written procedures was consistent with foreign regulatory authority regulations, it was not consistent with U.S. regulations. Although you closed deviation DV0166369 in December 2024, you did not ensure that your corrective and preventive actions were effectively implemented to resolve the existing issues and to prevent recurrence of the noncompliance. Specifically, while you ensured that prior versions of Q014048 were no longer in use, you did not update the definition of “adverse reactions” to remove references to relatedness and causality in the current version of Q014048. Additionally, you closed deviation DV0166369 without confirming the completion of your corrective action to submit all reportable serious and unexpected ADEs to FDA. Although you stated in your written response that you submitted these ADEs to FDA after the investigators discussed them with you during this inspection, you did not provide the case numbers and dates submitted to FDA for all cases with serious and unexpected ADEs that were identified as part of deviation DV0166369. As a result, FDA cannot verify that all serious and unexpected ADEs identified in this deviation were submitted to FDA. Furthermore, you did not provide sufficient information regarding how you will implement the corrective and preventive actions identified in this deviation to ensure that all serious and unexpected ADEs are reported to FDA. In your written response dated March 3, 2025, and in subsequent correspondence, you described corrective actions including but not limited to: (1) revising procedures and other documents to remove certain terminology that created ambiguity and led to serious and unexpected ADEs not being reported to FDA; (2) updating definitions and documentation of the term “spontaneous cases”; and (3) performing a retrospective review of cases to ensure that all valid cases were submitted to FDA. Further, you stated that all cases that were identified as 15-day Alert reports as part of deviation DV0166369 had been submitted to FDA as of February 6, 2025. While we acknowledge the corrective and preventive actions you have taken or plan to take, your written response and subsequent correspondence are inadequate because you did not provide sufficient details for the Agency to determine whether your actions effectively resolved the existing issues and will prevent similar violations in the future. Specifically, you did not provide sufficient details about how your updated procedures, guidance, and training materials will ensure future compliance with reporting serious and unexpected ADEs to FDA in a timely manner. b. Your written procedure Q014048, “Handling of Adverse Events and Other Safety Information” (Ver: 28.0, Effective Date: 03 Oct 2024), states that the minimum criteria for Individual Case Safety Reports (ICSRs) to qualify for submission in an expedited manner are: (1) one or more identifiable reporters; (2) a single identifiable patient; (3) a suspected NNI product; and (4) a suspected adverse reaction. However, your written procedure did not ensure that you, and the call-center contractors acting on your behalf, correctly received, reviewed, and processed ADE information, which resulted in the failure to submit serious and unexpected ADEs that were required to be reported to FDA within 15 calendar days. Specifically, you and your contractors inappropriately invalidated 15-day Alert reports because of a lack of patient identifiers; however, during the inspection, FDA identified valid patient identifiers in source documents for these reports. These reports were not submitted to FDA until they were discussed with you during the inspection. For example, Argus Case #1342548 includes a consumer reporting a death for a male patient who received semaglutide; however, you invalidated the case because you failed to capture the patient identifier. During the inspection, FDA found the patient identifier in the source documents for this case. As a result of this erroneous invalidation, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required. We note that you identified this issue when (b)(4) served as your call-center contractor between May 12 and October 12, 2023. You later terminated your contract with (b)(4) ⁽ᵇ⁾ ⁽⁴⁾ and switched your call-center contractor to (b)(4) , starting on October 13, 2023. You also opened deviation DV0155511 in December 2023 in response to issues observed with (b)(4) . Although you switched your call-center contractor to (b)(4) and completed corrective and preventive actions as part of deviation DV0155511, you continued to invalidate cases of ADEs for lack of a patient identifier, despite the patient identifiers’ being available in accordance with written procedure Q014048 and the cases’ otherwise qualifying as reportable. Therefore, you did not ensure that your corrective and preventive actions (for example, review and creation of training resources and content for vendors) were effectively implemented to resolve the existing issues and to prevent recurrence of the noncompliance. In your March 3, 2025, written response and in subsequent correspondence, you stated proposed corrective actions, including but not limited to: (1) conducting retrospective reviews of cases to ensure that all valid cases were submitted to FDA; (2) drafting work instructions related to ICSR quality checks and verification, including source data verification; (3) planning a phased approach to transition safety case intake from the contracted call-center agents to dedicated insourced patient safety agents, who are health care professionals; (4) performing an assessment of the vendor management program; and (5) creating a Vendor Management team, a Vendor Quality team, and a Training team dedicated to your U.S. Patient Safety team, to ensure adequate vendor training and oversight. While we acknowledge the corrective and preventive actions you have taken or plan to take, your written response is inadequate because you did not provide information about whether your proposed actions will prevent similar violations in the future. For example, you did not provide specific information about how you will ensure that vendors acting on your behalf correctly receive, review, and process ADE information, including how you will maintain oversight related to delegated functions. Specifically, you did not provide sufficient details about how your Vendor Management, Quality, and Training teams will operate, what their activities will be, or how these teams will ensure that contractors acting on your behalf will accurately and completely capture ADEs, perform quality check activities, and comply with all applicable PADE requirements. In addition, you did not describe how the “insourced” call center will operate, nor did you provide adequate information to ensure that your insourced call center will comply with PADE requirements in the future. c. Your written procedure Q040018, “Handling Individual Safety Cases in the Global Safety Database” (Ver 43.0, Effective Date: 17 May 2024), states that most serious adverse reactions should enter medical review by calendar day 9 following the awareness date, and they should complete medical review by calendar day 10 following the awareness date. However, your written procedure failed to ensure that cases completed “medical review” within the timelines specified in your written procedure. Rather, cases remained in “medical review” status longer than specified in your written procedure, resulting in your failure to submit 15-day Alert reports to FDA within the required time frame. During the inspection, FDA identified and made you aware of serious and unexpected ADEs that were not submitted to FDA because they remained in “medical review” status beyond the timeline specified in your written procedures. For example, in Argus Case #1334278, you received information on December 9, 2024, from a consumer who reported suicidal ideation while taking semaglutide. This case entered “medical review” status on December 16, 2024; however, medical review was not performed until February 3, 2025, after being identified during FDA’s inspection, and the case was submitted to FDA on February 5, 2025. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations. In your March 3, 2025, written response and your April 11, 2025, correspondence, you stated that your corrective actions included but were not limited to a requirement for daily review of patient safety cases across each workflow state. However, your written response is inadequate because you did not provide any information about whether your proposed actions will prevent similar violations in the future. For example, you did not provide sufficient details regarding the root cause of this violation, including why these cases remained in “medical review” status beyond the time frames specified in your written procedure. You also have not provided an assessment of whether, and to what extent, this issue implicates the timely reporting of other cases in your product portfolio. 2. You failed to develop written procedures that ensured all ADEs that are the subject of 15-day Alert reports were promptly investigated in accordance with 21 CFR 314.80(c)(1)(ii). PADE regulations require that the applicant must promptly investigate all ADEs that are the subject of postmarketing 15-day Alert reports (21 CFR 314.80(c)(1)(ii)). Your written procedure Q0360683, “Case Management Workflow at Novo Nordisk Inc. Patient Safety” (Ver: 7.0, Approved Date: 04 Nov 2024), stated that you did not require follow-up on reported ADEs if consent was not obtained from the reporter and if the reporter was a non-health care professional. Based on this written procedure, you, and your contractor acting on your behalf, failed to promptly investigate ADEs that were subject to 15-day Alert reporting because you did not follow up with reporters to request additional information unless you explicitly obtained consent from the reporter. PADE regulations do not require the obtaining of consent to acquire additional information. As a result, you failed to investigate serious and unexpected ADEs as required by PADE regulations. For example, Argus Case #1171264 includes a non-health care professional reporting the death of a patient receiving semaglutide; however, you failed to promptly investigate because consent was not obtained from the reporter and the reporter was a non-health care professional, as stated in your written procedure. This case was closed without your reporting it to FDA. Procedure Q0360683 also required that NNI perform two follow-up attempts for serious cases in which a death is reported, to obtain relevant safety information for reporting to FDA. However, you failed to promptly investigate Argus Case #1079792, in which a physician reported to your company representative that a patient taking semaglutide was depressed and committed suicide. You failed to document any attempt to obtain additional information from the reporter, including patient identifiers. As of the date of issuance of this letter, this case has not been submitted to FDA. In your written response dated March 3, 2025, you attributed the failure to promptly investigate serious and unexpected ADEs to a procedural gap that required unnecessary consent from the reporter. In your written response and in subsequent correspondence, you described corrective actions including but not limited to: (1) revising local and global SOPs and trainings to remove the requirement to obtain consent from reporters for follow-up; (2) removing fields requiring reporters’ consent from local IT platforms; (3) sending a communication to all vendors and revising safety data exchange agreement (SDEA) templates to clarify that consent is not a predicate requirement to collecting information from a reporter; and (4) conducting a retrospective review of cases to assess that appropriately timed and documented follow-up attempts with reporters were conducted. However, your written response is inadequate because you did not provide information about how your proposed or completed corrective actions would prevent similar violations in the future. For example, you did not provide sufficient details about your quality-control activities, including how you will maintain oversight of vendors with whom you contract to fulfill any of your ADE responsibilities. Additionally, your written response did not specifically address how you will conduct appropriate follow-up, as required by 21 CFR 314.80(c)(1)(ii), for 15-day Alert reports that were not submitted at the time of the inspection. In your March 3, 2025, written response, and in subsequent correspondence, you described corrective actions including but not limited to your engagement with a consultant to perform reviews of your pharmacovigilance processes and associated interfaces, as well as your deviation system and your corrective and preventive action system, to ensure that all cases have been reported to FDA and all deviations have been handled adequately. You also stated that your consultant is engaged in a retrospective review of all closed pharmacovigilance-related deviations dating back to June 2017, and that you have created a deviation review board. We acknowledge that your retrospective review of deviations is complete and that you have received the final report. For each major deviation that may affect compliance with PADE regulations and that has a Quality Assurance approval date after 01 Jan 2021, including those listed on the Deviations Handling request provided to the investigators during the inspection, you should submit a description of the deviation, date of identification, current status, the root-cause analysis, an assessment of the impact, the status of all corrective and preventive actions, and the timeline and results for effectiveness checks. While we acknowledge the corrective and preventive actions your firm has taken since our inspection, your response is inadequate because you did not provide sufficient details to determine whether your actions will effectively prevent similar violations in the future. Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA. In addition, your failure to identify and assess the root cause(s) of deficiencies discussed in this letter raises concerns about your firm’s ability to monitor the safety of your products, including through oversight of vendors with whom you contract to fulfill any of your ADE responsibilities. While this inspection focused on NNI’s compliance with PADE regulations for a sample of NNI’s products, including semaglutide, liraglutide, nedosiran sodium, and estradiol, based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio. FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health. Reporting ADEs to FDA within the required time frames is necessary for the ongoing monitoring of drug safety profiles. Failure to report and investigate ADEs may limit the safety information that FDA may need when monitoring potential safety signals. We emphasize that as an application holder, it is your responsibility to ensure that you comply with all applicable PADE requirements, including when you contract with a vendor to fulfill any of your ADE responsibilities. Your failure to develop procedures that ensure the submission of 15-day Alert reports and the prompt investigation of ADEs that were the subject of 15-day Alert reports raises significant concerns about your ability to accurately and completely report product safety information to the FDA in accordance with PADE requirements. This letter is not intended to be an all-inclusive list of deficiencies that exist at NNI. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that you comply with FDA regulations. If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration. Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-ADE@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to: Dipti Kalra R.Ph., M.S., MBA Branch Chief Postmarketing Safety Branch Division of Enforcement and Postmarketing Safety Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Building 51, Room 5343 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Sincerely, {See appended electronic signature page} David C. Burrow, Pharm.D., J.D. Director Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration -------------------------------------------------------------------------------------------- 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. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ DAVID C BURROW 03/05/2026 08:24:50 AM ______________________ 1 Argus is NNI’s drug safety database. Content current as of: 03/10/2026 Regulated Product(s)

#### [120] gram-peptides-721806-03312026 | issued 03/31/2026 | Gram Peptides | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 721806 Bernard Gramlich: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://grampeptides.com from January to March 2026. The FDA has observed that your website offers “Retatrutide” (also referred to by your firm as “GLP-1-R peptide”) and “Tirzepatide” (also referred to by your firm as “GLP-2 peptide”) and “Bacteriostatic Water for Injection” (hereinafter Gram Peptides products) for sale in the United States. [B230] 355(a). [B120] 331(d) and 355(a). [B121] [B122] Despite statements on your product labeling marketing your products for “Research Use Only,” and “not intended for human consumption, medical use, or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. [B231] Retatrutide (also referred to as “GLP-1-R Peptide”) On the webpage https://grampeptides.com/product/retatrutide/: “[I]nfluences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models.” “[D]emonstrated significant potential for reducing body weight, improving glucose handling, and enhancing lipid metabolism.” “GLP-1-R peptide acts through coordinated activation of: GLP-1 receptors – improving glucose response, slowing gastric emptying, and reducing appetite.” Tirzepatide (also referred to as “GLP-2 Peptide”) On the webpage https://grampeptides.com/product/tirzepatide/: “Benefits of GLP-2 Peptide . . . o Metabolic Regulation – Studied for its ability to lower glucose and support balanced insulin levels. o Weight Management – Associated with significant decreases in body weight in both animal and human studies. o Improved Lipid Profiles – Research shows reductions in triglycerides and improved cholesterol ratios.” Bacteriostatic Water for Injection Your firm offers “Bacteriostatic Water for Injection” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water for Injection” to be used in combination for injection. Therefore, your “Bacteriostatic Water for Injection” is a drug. Your Gram Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B232] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “721806” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 04/07/2026 Regulated Product(s)

#### [121] guangzhou-huli-technology-co-ltd-dba-fantasy-face-722228-03312026 | issued 03/31/2026 | Guangzhou Huli Technology Co., Ltd. dba Fantasy Face | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 722228 Haijie Long: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your eBay store at https://www.ebay.com/str/fantasyface in December 2025. The FDA has observed that your eBay store offers “Googeer GLP-1 Weight Control Oral Solution” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Based on a review of your eBay store, your “Googeer GLP-1 Weight Control Oral Solution” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your eBay store, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: Googeer GLP-1 Weight Control Oral Solution On the your eBay store webpage https://www.ebay.com/itm/357972658414?itmmeta=01KBR20V0X11QS0M7FX9DMNAJ9&hash=item5358d548ee:g:XG0AAeSwfq5osANH: “Metabolism Support . . . Weight management Blood Sugar Balance” “Ideal Body Shaping helps to shape a slim body.” Your “Googeer GLP-1 Weight Control Oral Solution” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling. [B107] 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “722228” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration cc: Mike Carson Regulatory Policy Group eBay, Inc. 2025 Hamilton Avenue San Jose, California 95125 Content current as of: 04/07/2026 Regulated Product(s)

#### [122] lovega-llc-dba-pink-pony-peptides-721088-03312026 | issued 03/31/2026 | Lovega LLC dba Pink Pony Peptides | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 721088 Susan Vega: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pinkponypeptides.com/ in December 2025. The FDA has observed that your website offers “GLP-2 TZ,” “GLP-3 RT,” and “Bacteriostatic Water” (hereinafter Pink Pony Peptides products) for sale in the United States. [B230] 355(a). [B120] 331(d) and 355(a). [B121] [B122] Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “[n]ot for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. [B231] GLP-2 TZ On the webpage https://pinkponypeptides.com/product/glp2/: “As a dual GIP and GLP-1 receptor agonist, Tirzepatide helps: o . . . Reduce appetite and increase satiety o . . . Enhance insulin sensitivity and glucose control o . . . Curb cravings without harsh stimulants o . . . Support fat loss over time with clinical precision Originally developed for type 2 diabetes, Tirzepatide has rapidly become a favorite among physicians and wellness experts for its dramatic body recomposition results and long-lasting appetite regulation.” GLP-3 RT On the webpage https://pinkponypeptides.com/product/glp3/: “As a GIP, GLP-1, and glucagon receptor agonist, Retatrutide offers three times the fat-fighting horsepower in one clean, clinical ride. This cutting-edge peptide has shown jaw-dropping results in clinical trials — helping the body torch fat, suppress appetite, regulate blood sugar, and even improve metabolic function better than its single-pathway competitors.” Bacteriostatic Water Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug. Your Pink Pony Peptides products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B232] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “721088” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 04/07/2026 Regulated Product(s)

#### [123] mile-high-compounds-llc-721600-03312026 | issued 03/31/2026 | Mile High Compounds LLC | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 721600 Max Radovanic: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://milehighcompounds.is, which links to your community forum www.skool.com/milehighcompoundsofficial/, from January to March 2026. The FDA has observed that your website offers “GLP-1 SM,” “GLP-2 TRZ,” “GLP-3 RT” and “BAC Water” (hereinafter Mile High Compounds products) for sale in the United States. [B230] 355(a). [B120] 331(d) and 355(a). [B121] [B122] Despite statements on your product labeling marketing your products for “in vitro research and educational purposes only” and “not for human or veterinary consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. [B231] GLP-3 RT On the webpage https://milehighcompounds.is/product/glp-3-rt/: “GLP-3 RT is a triple-receptor agonist compound targeting GLP-1, GIP, and glucagon receptors.” From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “GLP-3 RT (Retatrutide) 􀂃 Uses: Weight Loss, Addiction Recovery 􀂃 Dosing: Start: 1mg - 2mg weekly. Titrate up to: 12mg weekly.” From the “Retatrutide (GLP- 3 RT) - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “2. Benefits & Effects Unprecedented Weight Loss & Metabolic Control Significant Weight Reduction. . . Improved Glycemic Control. . . Enhanced Lipid Profile. . . Liver Fat Reduction. . . Increased Energy Expenditure” GLP-2 TRZ On the webpage https://milehighcompounds.is/product/glp-2-trz/: “GLP-2 TRZ is a research-only compound designed for scientific investigation involving GLP-1 and GIP receptor pathways.” From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “GLP-2 TRZ (Tirzepatide) 􀂃 Uses: Weight Loss, Addiction Recovery 􀂃 Dosing: Start: 2.5mg weekly. Titrate up to: 15mg weekly.” From the “Tirzepatide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “2 Studied Research Areas Visceral Fat & Appetite Regulation. . . Lean Muscle Maintenance Research. . . Liver Health & Lipid Metabolism . . . Cognitive Function & Neuroprotection” GLP-1 SM On the webpage https://milehighcompounds.is/product/glp-1-sm/: “GLP-1 SM is a research-only compound designed for scientific investigation involving GLP-1 receptor pathways.” From “The Ultimate Mile High Compounds Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “GLP-1 SM (Semaglutide) 􀂃 Uses: Weight Loss 􀂃 Dosing: Start: 0.25mg weekly. Titrate up to: 2.5mg weekly.” From the “Semaglutide - Peptide Cheat Sheet” available through www.skool.com/milehighcompoundsofficial/: o “2 Studied Research Areas Visceral Fat & Appetite Regulation . . . Lean Muscle Maintenance Research. . . Liver Health & Metabolism . . . Cognitive Function & Neuroprotection” BAC Water Your firm offers “BAC Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “BAC Water” to be used in combination for injection. Therefore, your “BAC Water” is a drug. Your Mile High Compounds products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B232] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “721600” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 04/07/2026 Regulated Product(s)

#### [124] pekcura-labs-721709-03312026 | issued 03/31/2026 | PekCura Labs | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 721709 Jonathan Snider and Jonathan Speck: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pekcuralabs.com/ in January 2026. The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. [B230] 355(a). [B120] 331(d) and 355(a). [B121] [B122] Despite statements on your product labeling marketing your products for “Research, [sic] Development [sic] use only” and “are Not [sic] for Human [sic] consumption of any kind,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. [B231] GLP-1-S (all variations) On the webpages https://pekcuralabs.com/shop/pcl-glp-1-s-5mg/, https://pekcuralabs.com/shop/pcl-glp-1-s/, https://pekcuralabs.com/shop/gmp-pcl-glp-1-s/, and https://pekcuralabs.com/shop/gmp-pcl-glp-1-s-5mg/: “What is GLP-1-S? . . . In multiple studies utilizing once-weekly subcutaneous administration at a 2.4 mg dose, GLP-1-S consistently induced substantial reductions in body weight under experimental conditions. . . . GLP-1-S has also been associated with changes in cardiovascular endpoints in long duration studies. . . . GLP-1-S 2.4 mg administered weekly was associated with a reduced incidence of composite cardiovascular outcomes, including death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke (Lincoff et al., 2023). An earlier trial using 0.5 mg and 1.0 mg doses similarly reported a statistically significant reduction in the rate of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in subjects with type 2 diabetes treated with GLP-1-S relative to placebo (Marso et al., 2016).” GLP-2-T (all variations) On the webpages https://pekcuralabs.com/shop/pcl-glp-2-t-10mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-15mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-30mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-60mg/, https://pekcuralabs.com/shop/gmp-pclglp-2-t-15mg/, and https://pekcuralabs.com/shop/gmp-pcl-glp-2-t/: “What is GLP-2-T? . . . Across randomized controlled trials, GLP-2-T induced dose-dependent reductions in HbA1c and body weight, outperforming GLP-1 receptor agonists and basal insulin comparators (Karagiannis et al. 2022). Reductions in fat mass, as confirmed via body composition studies, indicate preferential loss of adiposity over lean mass (Sokary & Bawadi 2025).” GLP-3-R (all variations) On the webpages https://pekcuralabs.com/shop/pcl-glp-3-r-10mg/ and https://pekcuralabs.com/shop/gmp-pcl-glp-3-r-30mg/: “What is GLP-3-R? . . . In controlled studies, GLP-3-R led to significant, dose-dependent reductions in body weight (up to -24.2%), BMI, and waist circumference over 48 weeks, alongside improvements in metabolic markers such as HbA1c, fasting glucose, and blood pressure. These effects are attributed to its multi-receptor mechanism enhancing energy expenditure, insulin secretion, and lipid metabolism (Abouelmagd et al., 2025).” Cag (1mg) Tirz (10mg) Blend On the webpage https://pekcuralabs.com/shop/pcl-ct-blend/: “What is C/T Blend? . . . The pairing of Cagrilintide’s amylinergic modulation with GLP-2-T’s incretin-based pathways presents a complementary approach to the investigation of integrated energy balance and metabolic regulation.” Bacteriostatic Water (all variations) Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug. Your PekCura Labs products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B232] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “721709” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 04/07/2026 Regulated Product(s)

#### [125] prime-sciences-721805-03312026 | issued 03/31/2026 | Prime Sciences | SUBJ: Unapproved New Drugs Sold Over the Internet
WARNING LETTER March 31, 2026 RE: 721805 Prime Sciences: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://prime-sciences.com/ from January to March 2026. The FDA has observed that your website offers “Cagrilintide,” “GLP1-R,” “GLP1-S,” “GLP1-T,” “Mazdutide,” and “BAC water” (hereinafter Prime Sciences products) for sale in the United States. [B230] 355(a). [B120] 331(d) and 355(a). [B121] [B122] Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “not for human consumption, medical use or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. [B231] Cagrilintide On the webpage https://prime-sciences.com/product/cagrilintide: “In one study, weight loss of 25% or more was achieved in 40.4% of patients receiving Cagri compared to 16.2% with semaglutide alone.” “Mechanism of action: Cagrilintide promotes weight loss through various mechanisms: Slowing gastric emptying. Reducing food intake. Modulating postprandial glucose spikes. Inducing satiety (feeling of fullness).” “Application: Research peptide with potential in diabetes management and obesity treatment.” GLP1-R (10MG) (identified as Retatrutide) On the webpage https://prime-sciences.com/product/glp1-r: “Retatrutide has shown higher weight loss results in clinical trials, with an average of up to 28% body weight reduction, compared to around 15% with semaglutide or Tirzapeptide.” “Retatrutide is a drug that works similarly to semaglutide and tirzepatide, but works in three different ways. Semaglutide targets your receptor of the GLP-1 hormone, which stabilizes your blood sugar, helping to reduce cravings while helping you to eat less, as well as slowing down your digestive system to help you feel fuller longer.” GLP1-S (10MG) (identified as Semaglutide) On the webpage https://prime-sciences.com/product/glp1-s: “Ozempic – Weight Loss Supplement.” “Semaglutide peptide therapy benefits include: o Participants taking semaglutide lost an average of 15.2% of their initial body weight . . . o Stimulates the pancreas to produce insulin and reduces the hunger hormone ghrelin o Reduces blood sugar levels to promote weight loss” “Application: Research peptide with potential in diabetes management and obesity treatment.” GLP1-T (10MG) (identified as Tirzepatide) On the webpage https://prime-sciences.com/product/glp1-t: “Tirzepatide therapy benefits include: o A phase 3 randomized, controlled clinical trial demonstrated that Tirzepatide led to a 20 percent reduction in body weight o Stimulates the production of insulin to lower blood sugar o Reduces appetite by slowing the time it takes the stomach to empty” “Application: Functionally, Tirzepatide stimulates insulin release from the pancreas and reduces hyperglycemia.” MAZDUTIDE (10MG) On the webpage https://prime-sciences.com/product/mazdutide: “Mazdutide peptide therapy benefits include: o Weight Management 􀂃 Significant weight loss: In a phase 3 trial (GLORY-1), once-weekly mazdutide led to an average body weight reduction of up to 14.8%.” “Improved metabolic health o Enhanced glycemic control: In patients with type 2 diabetes, mazdutide has been shown to significantly reduce blood glucose levels (HbA1c) and improve insulin sensitivity. o Reduced liver fat . . . some participants in a phase 3 trial achieving up to an 80% reduction.” o Lowered cardiometabolic risk factors: . . . Reduced blood pressure . . . Decreased total cholesterol and LDL . . . Lowered triglycerides” BAC water Your firm offers a “Reconstitution Kit” for sale, which contains “BAC water” and a syringe. This kit is offered for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of a kit containing the “BAC water” and a means of injection (a syringe) with these peptide drugs demonstrates that you intend for the “BAC water” to be used in combination for injection. Therefore, your “BAC water” is a drug. Your Prime Sciences products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B232] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B210] [B2] [B20] [B0] [B209] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B147] Please include your firm name and the unique identifier “721805” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 04/07/2026 Regulated Product(s)