

#### [133] eden-health-international-inc-dba-eden-728279-06082026 | issued 06/08/2026 | Eden Health International Inc. dba Eden | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728279 To Eden: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Eden’s website, https://www.tryeden.com, FDA Establishment Identifier (FEI) 3044020039, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Eden” on the pictured label, suggesting Eden is the compounder of those drugs when in fact it is not. 2 2. Your website claims that the compounded drug products it offers are sourced from “FDA-licensed 503(a) outsourcing facilities.” [B113] [B211] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728279 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [134] ezra-holdco-llc-dba-ezra-730995-06082026 | issued 06/08/2026 | Ezra Holdco LLC dba Ezra | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 730995 To Ezra: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Ezra’s website, https://joinezra.com, FDA Establishment Identifier (FEI) 3045074898, in May 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Ezra” on the pictured label, suggesting Ezra is the compounder of those drugs when in fact it is not. [B286] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 730995 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B233] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [135] fitish-728280-06082026 | issued 06/08/2026 | FITISH | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728280 To FITISH: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of FITISH’s website, https://fitish.com, FDA Establishment Identifier (FEI) 3044018836, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “FITISH” on the pictured label, suggesting FITISH is the compounder of those drugs when in fact it is not. 2 2. [B74] “Semaglutide is the active ingredient in ozempic” [sic] “Tirzepatide is the active ingredient in Mounjaro® and Zepbound®” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728280 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [136] fitrx-llc-dba-am-rx-728275-06082026 | issued 06/08/2026 | FitRX, LLC dba AM RX | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728275 To Mr. Robertson: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of AM RX’s website, https://getamrx.com, FDA Establishment Identifier (FEI) 3044021238, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “AM Rx” on the pictured label, suggesting AM RX is the compounder of those drugs when in fact it is not. 2 2. [B128] “AM Rx also offers semaglutide, the active ingredient in Ozempic® and Wegovy®….” “Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….” “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728275 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [137] glow-medispa-llc-dba-mint-med-730390-06082026 | issued 06/08/2026 | Glow Medispa, LLC dba Mint Med | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 730390 To Mint Med: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Mint Med’s website, https://mintmed.com, FDA Establishment Identifier (FEI) 3044896930, in May 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Mint Med” on the pictured label, suggesting Mint Med is the compounder of those drugs when in fact it is not. [B286] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 730390 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B287] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [138] hydramed-iv-llc-dba-hydramed-728282-06082026 | issued 06/08/2026 | HydraMed IV LLC dba HydraMed | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728282 To HydraMed: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of HydraMed’s website, https://hydramed.com, FDA Establishment Identifier (FEI) 3044021141, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “HydraMed” on the pictured label, suggesting HydraMed is the compounder of those drugs when in fact it is not. 2 2. Your website claims that the compounded drug products it offers are sourced from an “FDA-approved pharmacy.” [B113] [B234] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728282 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [139] joi-and-blokes-dba-joi-blokes-728283-06082026 | issued 06/08/2026 | Joi and Blokes dba Joi + Blokes | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728283 To Joi + Blokes: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Joi + Blokes’ website, https://joiandblokes.com, FDA Establishment Identifier (FEI) 3044021205, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Joi + Blokes” on the pictured label, suggesting Joi + Blokes is the compounder of those drugs when in fact it is not. 2 2. [B128] “By utilizing the same bioidentical compound as Ozempic and Wegovy, Blokes can provide a cost-effective alternative.” “At Blokes, we offer a cost-effective semaglutide option that is bioidentical with more expensive brands.” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728283 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B233] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [140] maximus-health-inc-dba-maximus-730095-06082026 | issued 06/08/2026 | Maximus Health, Inc. dba Maximus | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 730095 To Maximus: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Maximus’ website, https://www.maximustribe.com, FDA Establishment Identifier (FEI) 3032037948, in May 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. [B74] “Clinically studied ingredients.” “Clinically studied to help patients….” “Proven to lose weight effectively” Compounded drug products are not FDA-approved. [B85] 2. Your website claims that the compounded drug products it offers are sourced from “FDA approved pharmacies.” [B113] [B211] 2 Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products. [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 730095 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B287] [B52] 2 While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products. [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [141] medica-weight-loss-728284-06082026 | issued 06/08/2026 | Medica Weight Loss | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728284 To Medica Weight Loss: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Medica Weight Loss’ website, https://medicaweightloss.com, FDA Establishment Identifier (FEI) 3044019522, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “medica weight loss” on the pictured label, suggesting Medica Weight Loss is the compounder of those drugs when in fact it is not. 2 2. [B74] “Clinical studies and FDA approval support [semaglutide’s] safety and effectiveness….” “Tirzepatide is FDA-approved….” Compounded drug products are not FDA-approved. [B85] 3. Your website claims that the compounded drug products it offers are sourced from an “FDA-approved pharmacy.” [B113] [B234] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728284 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [142] momentum-health-360-dba-momentum-health-728286-06082026 | issued 06/08/2026 | Momentum Health 360 dba Momentum Health | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728286 To Momentum Health: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Momentum Health’s website, https://momentumhealth360.com, FDA Establishment Identifier (FEI) 3043997131, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide, tirzepatide, and liraglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [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 FD&C Act [21 U.S.C. § 331(a)]. [B49] [B41] [B28] Your representations regarding compounded semaglutide, tirzepatide, and liraglutide products are false or misleading. [B60] [B61] More specifically, 1. The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Momentum Health” on the pictured label, suggesting Momentum Health is the compounder of those drugs when in fact it is not. 2 2. [B74] “Same active ingredient in Mounjaro® and Zepbound™…” “Same active ingredient in Wegovy® and Ozempic®…” “Our platform provides seamless access to advanced GLP-1 medications, such as compounded Semaglutide (found in Ozempic® and Wegovy®) and Tirzepatide (found in Mounjaro® and Zepbound™)…” Compounded drug products are not FDA-approved. [B85] 3. Your website claims “Compounded Semaglutide refers to a medication meticulously formulated [sic] FDA-licensed compounding facility….” [B113] [B211] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728286 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ______________________ 1 The semaglutide, tirzepatide, and liraglutide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [143] nativemed-llc-dba-nativemed-728287-06082026 | issued 06/08/2026 | NativeMed LLC dba NativeMed | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728287 To NativeMed: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of NativeMed’s website, https://www.nativemed.net, FDA Establishment Identifier (FEI) 3044024130, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded tirzepatide products displayed on your website feature NativeMed’s logo on the pictured label, suggesting NativeMed is the compounder of those drugs when in fact it is not. 2 2. [B128] “The same active ingredient in Ozempic® and Wegovy®” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728287 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B233] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [144] nexlife-inc-dba-nexlife-730096-06082026 | issued 06/08/2026 | Nexlife Inc. dba Nexlife | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 730096 To Nexlife: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Nexlife’s website, https://nexlife.us, FDA Establishment Identifier (FEI) 3044820290, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Nexlife” on the pictured label, suggesting Nexlife is the compounder of those drugs when in fact it is not. [B286] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 730096 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B287] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [145] nexus-health-solutions-llc-dba-harper-meds-728281-06082026 | issued 06/08/2026 | Nexus Health Solutions LLC dba Harper Meds | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728281 To Harper Meds: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Harper Meds’ website, https://www.harpermeds.com, FDA Establishment Identifier (FEI) 3044020867, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Harper Meds” on the pictured label, suggesting Harper Meds is the compounder of those drugs when in fact it is not. 2 2. [B128] “Same active ingredient as Ozempic™ & Wegovy™” Compounded drug products are not FDA-approved. [B85] 3. Your website claims that the compounded drug products it offers are sourced from “FDA-licensed 503A Outsourcing Facilities.” [B113] [B234] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728281 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B233] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [146] nova-vascular-llc-dba-novarx-728290-06082026 | issued 06/08/2026 | Nova Vascular LLC dba NOVARX | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728290 To NOVARX: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of NOVARX’s website, https://novarx.co, FDA Establishment Identifier (FEI) 3044022416, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “NOVA RX” on the pictured label, suggesting NOVARX is the compounder of those drugs when in fact it is not. 2 2. [B128] “…access to the same active ingredient found in Ozempic.” Compounded drug products are not FDA-approved. [B85] 3. Your website claims that the compounded drug products it offers are sourced from “FDA Approved Pharmacies.” [B113] [B234] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728290 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [147] orderlymeds-llc-dba-orderlymeds-728291-06082026 | issued 06/08/2026 | OrderlyMeds LLC dba OrderlyMeds | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728291 To Dr. Spears: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of OrderlyMeds’ website, https://orderlymeds.com, FDA Establishment Identifier (FEI) 3044027176, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website feature OrderlyMeds’ logo on the pictured label, suggesting OrderlyMeds is the compounder of those drugs when in fact it is not. 2 2. Your website claims that the compounded drug products it offers are sourced from an “FDA-licensed pharmacy.” [B113] [B234] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728291 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [148] public-health-solution-llc-dba-drmedhealth-728278-06082026 | issued 06/08/2026 | Public Health Solution LLC dba DrMedHealth | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728278 To DrMedHealth: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of DrMedHealth’s website, https://drmedhealth.com, FDA Establishment Identifier (FEI) 3044020737, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. [B74] “Same active ingredient as Ozempic®” “Same active ingredient as Mounjaro®” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728278 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] Content current as of: 06/16/2026 Regulated Product(s)

#### [149] ready-med-730317-06082026 | issued 06/08/2026 | Ready Med | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 730317 To Ready Med: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Ready Med’s website, https://readymednow.com, FDA Establishment Identifier (FEI) 3044868483, in May 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Ready Med” or “Ready Med Medical Weight Loss Center” on the pictured label, suggesting Ready Med is the compounder of those drugs when in fact it is not. 2 2. [B74] “The same active ingredient in Mounjaro® and Zepbound™” “The same active ingredient in Ozempic® and Rybelsus®” Compounded drug products are not FDA-approved. [B85] 3. Your website claims that the compounded drug products it offers are sourced from an “FDA licensed compounding facility.” [B113] [B211] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 730317 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [150] roen-health-inc-dba-roenrx-728293-06082026 | issued 06/08/2026 | Roen Health, Inc. dba RoenRx | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728293 To Mr. Robertson: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of RoenRx’s website, https://roenrx.com, FDA Establishment Identifier (FEI) 3044022969, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide 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 (FD&C Act) [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 FD&C Act [21 U.S.C. § 331(a)]. [B49] [B41] [B28] Your representations regarding compounded semaglutide products are false or misleading. [B60] [B61] More specifically, 1. The compounded semaglutide products displayed on your website identify “RoenRx” on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not. 2 2. [B128] “Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….” “RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….” “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728293 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ______________________ 1 The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [151] thrivelab-co-dba-thrivelab-728294-06082026 | issued 06/08/2026 | Thrivelab Co. dba Thrivelab | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728294 To Mr. Host: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Thrivelab’s website, https://www.thrivelab.com, FDA Establishment Identifier (FEI) 3043997633, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide 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 (FD&C Act) [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 FD&C Act [21 U.S.C. § 331(a)]. [B49] [B41] [B28] Your representations regarding compounded semaglutide products are false or misleading. [B60] [B61] More specifically, 1. The compounded semaglutide products displayed on your website identify “thrivelab” on the pictured label, suggesting Thrivelab is the compounder of those drugs when in fact it is not. 2 2. [B128] “Same active ingredient as Ozempic®” “Same active ingredient as Wegovy and Ozempic” “clinically proven to work” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728294 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ______________________ 1 The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [152] trinity-healthcare-supply-llc-dba-altrx-728236-06082026 | issued 06/08/2026 | Trinity HealthCare Supply, LLC dba altRx | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728236 To altRx: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of altRx’s website, https://www.altrx.com, FDA Establishment Identifier (FEI) 3044175714, in May 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “altRx” on the pictured label, suggesting altRx is the compounder of those drugs when in fact it is not. 2 2. [B74] “GLP-1s are clinically proven medications….” “…clinically proven weight loss.” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728236 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B287] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [153] viviomd-group-llc-dba-viviomd-728295-06082026 | issued 06/08/2026 | VivioMD Group LLC dba VivioMD | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728295 To VivioMD: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of VivioMD’s website, https://viviomd.com, FDA Establishment Identifier (FEI) 3044027316, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “VivioMD” on the pictured label, suggesting VivioMD is the compounder of those drugs when in fact it is not. [B286] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728295 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] 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 FD&C Act [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. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [154] biodrive-inc-731846-08242026 | issued 08/24/2026 | BioDrive, Inc. | SUBJ: Dietary Supplement/Adulterated
WARNING LETTER CMS #731846 Dear Mr. Henderson: This letter concerns your Evolv GLP-1 Biomimetic dietary supplement. Your product labeling identifies Saccharomyces cerevisiae S288C EV-1 Peptide as a dietary ingredient. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Adulterated Dietary Supplements The labeling of your Evolv GLP-1 Biomimetic dietary supplement declares “ Saccharomyces cerevisiae S288C EV-1 Peptide” (hereinafter “EV1-Peptide”) as a dietary ingredient. EV1-Peptide is a “dietary ingredient” under section 201(ff)(1)(F) of the Act [21 U.S.C. § 321(ff)(1)(F)]. EV1-Peptide is also a “new dietary ingredient” under section 413(d) of the Act [21 U.S.C. § 350b(d)] because, to the best of FDA’s knowledge, there is no information demonstrating that EV1-Peptide was marketed as a dietary ingredient in the United States before October 15, 1994. A dietary supplement is adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)] if it contains a new dietary ingredient for which there is inadequate information to provide a reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that EV1-Peptide does not present a significant or unreasonable risk of illness or injury. Therefore, your Evolv GLP-1 Biomimetic containing the EV1-Peptide is adulterated under section 402(f)(1)(B) of the Act. The introduction of the adulterated dietary supplement into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. Moreover, available information on the use of EV1-Peptide in products raises serious safety concerns. You submitted two new dietary ingredient notifications (NDINs) to FDA in which we determined there was inadequate information to conclude that a dietary supplement containing EV1-Peptide would reasonably be expected to be safe. Specifically, FDA identified safety concerns due to potential toxicity, which raised concerns for adverse clinical consequences. You proceeded to market Evolv GLP-1 Biomimetic despite FDA’s objections due to safety concerns. [B135] [B2] [B20] [B83] [B136] [B242] [B87] If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your written reply should be directed to Jamie M. Bumpas, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835, or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #713846 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov. Sincerely, /S/ Maria S. Knirk, JD, MBA Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 09/22/2026 Regulated Product(s)

#### [155] nuscience-peptides-llc-733652-08242026 | issued 08/24/2026 | NuScience Peptides LLC | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER Reference Number: 733652 To Joseph and Ratsamy DeRosa: [B237] [B42] [B26] [B159] [B20] [B160] [B121] [B122] FDA Review Violations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). [B120] 331(d) and 355(a). [B238] [B41] [B28] Unapproved New Drug Violations Based on a review of your website, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. [B244] 1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: GLP-2 Tirz Peptide On the webpage https://nusciencepeptides.com/product/glp-2-tz-2/: “GLP-2 Tirz, a research peptide of significant interest, is known for its dual agonist activity on glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This peptide has been extensively studied in rodent models, particularly rats, to explore its metabolic effects and potential therapeutic applications in various conditions. Researchers use these models to gain valuable insights into the complex mechanisms of metabolic regulation and the integrated actions of incretin hormones.” GLP-1 Sema Research Peptide On the webpage https://pubchem.ncbi.nlm.nih.gov/compound/56843331#datasheet=LCSS (hyperlinked from https://nusciencepeptides.com/product/glp-1-sm/): “**Mechanism of cardiovascular benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration.” GLP-3 RT (Retatrutide) Research Peptide On the webpage https://nusciencepeptides.com/product/glp-3-rt/: “GLP-3 RT (Retatrutide) is a novel investigational peptide being explored for its potential research applications in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple receptor agonist — a glp3 peptide that targets the GLP-1, GIP, and glucagon receptor pathways simultaneously” Survodutide On the webpage https://nusciencepeptides.com/product/survodutide/: “Survodutide (BI 456906) is a dual agonist targeting both the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent models have demonstrated its efficacy in promoting weight loss and improving glycemic control.” “In conclusion, survodutide’s dual GCGR/GLP-1R agonism offers a multifaceted approach to treating metabolic disorders. Its efficacy in preclinical models supports further investigation and development as a subject of investigation for obesity and metabolic disorder research.” Mazdutide On the webpage https://nusciencepeptides.com/product/mazdutide/: “Mazdutide (IBI362), a dual agonist targeting both GLP-1 and glucagon receptors, has shown promising results in clinical trials for weight management and metabolic disorders. This mazdutide peptide has been extensively studied in humans, but preclinical research, particularly in rat models, remains limited.” “Furthermore, mazdutide has been associated with reductions in liver fat content and improvements in insulin sensitivity in clinical trials, highlighting its potential for treating non-alcoholic fatty liver disease and type 2 diabetes.” PT-141 Peptide (Bremelanotide) On the webpage https://nusciencepeptides.com/product/pt-141-bremelanotide/: “PT-141, also known as bremelanotide, is a synthetic PT-141 peptide classified as a non-selective agonist of melanocortin receptors, with primary activity at MC3R and MC4R. This research peptide has been widely examined in preclinical models to better understand melanocortin-mediated signaling pathways involved in sexual behavior and neuroendocrine regulation.” “Additional studies examining melanocortin receptor agonists support the role of PT-141 in modulating sexual behaviors across sexes through central nervous system pathways. The involvement of the melanocortin system highlights the relevance of PT-141 peptide in experimental research exploring neural control of sexual function.” Tesamorelin Research Peptide and Tesamorelin Ipamorelin Blend On the webpage https://nusciencepeptides.com/product/tesamorelin/: “Beyond metabolic effects, tesamorelin has demonstrated the ability to reduce muscle fat and increase muscle area in clinical studies . . . [s]uch findings are particularly relevant for exploring interventions in muscle-wasting conditions.” “Furthermore, research indicates that tesamorelin may enhance cognitive function, including improvements in executive function and verbal memory.” On the webpage https://nusciencepeptides.com/product/tesamorelin-ipamorelin/: “Tesamorelin, a growth hormone-releasing hormone (GHRH) analog, has been shown to significantly reduce visceral adipose tissue and improve liver health by decreasing liver fat and preventing fibrosis progression.” “[R]esearch has indicated that ipamorelin can counteract glucocorticoid-induced reductions in bone formation, suggesting its potential in mitigating bone density loss associated with glucocorticoid therapy.” Bacteriostatic water for Peptides (BAC Water) Your firm offers “Bacteriostatic water for Peptides (BAC Water)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic water for Peptides (BAC Water)” to be used in combination for injection. Therefore, your “Bacteriostatic water for Peptides (BAC Water)” is a drug. “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B235] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B29] [B236] [B27] Identify your response with reference number “733652” in the subject line of the email. [B25] [B158] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B239] Food and Drug Administration __________________________ 1 Despite statements on your product labeling marketing your products “for laboratory, research, and analytical use” and “not intended for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a “peptide calculator,” a resource that provides the means to prepare an injectable drug for human administration. Content current as of: 09/01/2026 Regulated Product(s)

#### [156] peak-performance-peptides-735127-08242026 | issued 08/24/2026 | Peak Performance Peptides | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER Reference Number: 735127 To Jeffrey Deng: [B237] [B42] [B26] [B159] [B20] [B160] [B121] [B122] FDA Review Violations were identified and documented during a review of your website pppepz.com in July 2026. Based on our review, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” 1 are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). [B120] 331(d) and 355(a). [B238] [B41] [B28] Unapproved New Drug Violations Based on a review of your website, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. [B244] 2 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: GLP-3R (retatrutide) On, e.g., the webpage https://pppepz.com/product/retatrutide-5mg/: 3 “GLP-3R is a synthetic peptide under investigation for its potential effects on metabolic regulation, body weight management, and glycemic control. It acts as a multi-receptor agonist targeting GIP, GLP-1, and glucagon receptors in research settings.” “GLP-3R has been explored for its influence on appetite suppression, energy expenditure, and fat distribution. It is commonly considered in preclinical models studying obesity, metabolic health, and endocrine signaling.” “Studied for effects on glycemic control and insulin sensitivity” “Investigated for influence on appetite regulation and satiety pathways”“Explored for potential impact on body weight and fat distribution” “Considered in preclinical models of cardiometabolic and metabolic research” Semaglutide On, e.g., the webpage https://pppepz.com/product/semaglutide-5mg/: 4 “Semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist studied for its potential effects on glucose regulation, appetite control, and metabolic health.” “Semaglutide has been investigated for its influence on insulin secretion, satiety pathways, and body weight management. It is commonly considered in preclinical models exploring endocrine signaling, diabetes, and obesity-related research.” “Studied for effects on insulin secretion and glycemic control” “Investigated for influence on appetite regulation and satiety pathways” “Explored for potential impact on body weight and metabolic health” “Considered in preclinical models of endocrine and cardiometabolic research” SS-31 On the webpage https://pppepz.com/product/ss-31-10mg/: “SS-31 (Elamipretide) is a mitochondria-targeted peptide studied for its potential to reduce oxidative stress, improve mitochondrial function, and support cellular energy production.” “SS-31 has been investigated for its effects on mitochondrial health, neuroprotection, and cardiovascular function. It is commonly considered in preclinical models exploring metabolic disorders, age-related diseases, and tissue protection.” “Studied for mitochondrial protection and enhancement of energy metabolism” “Investigated for effects on oxidative stress and cellular health” “Explored for potential neuroprotective and cardiovascular benefits” “Considered in preclinical models of aging, metabolic, and degenerative diseases” PT-141 On the webpage https://pppepz.com/product/pt-141-10mg/: “PT-141 is a synthetic peptide studied for its potential effects on sexual arousal and neuroendocrine regulation. It acts on melanocortin receptors, influencing central nervous system pathways related to libido and reproductive signaling.” “PT-141 has been investigated for its effects on sexual behavior, central nervous system modulation, and endocrine signaling. It is commonly considered in preclinical models exploring sexual health, reproductive research, and neuroendocrine pathways.” “Studied for effects on sexual arousal and libido” “Investigated for modulation of melanocortin receptors and CNS pathways” “Explored for influence on reproductive endocrine signaling” “Considered in preclinical models of sexual health and neuroendocrine research” Tesamorelin On, e.g., the webpage https://pppepz.com/product/tesamorelin-5mg/: 5 “Tesamorelin is a synthetic growth hormone–releasing hormone (GHRH) analog studied for its role in stimulating endogenous growth hormone secretion and regulating metabolic pathways.” “Tesamorelin has been investigated for its effects on body composition, lipid metabolism, and tissue repair. It is commonly used in preclinical research exploring endocrine regulation, fat distribution, and regenerative pathways.” “Studied for stimulation of endogenous growth hormone release” “Investigated for influence on metabolism and lipid regulation” “Explored for potential effects on body composition and tissue repair” “Considered in preclinical models of endocrine and metabolic research” Bac water Your firm offers “Bac water” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, 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. “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B235] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B29] [B236] [B27] Identify your response with reference number “735127” in the subject line of the email. [B25] [B158] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B239] Food and Drug Administration ____________________ 1 Many of these are offered in different strengths. 2 Despite statements on your product labeling marketing your products for “research use only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration. 3 Also found on your webpages https://pppepz.com/product/retatrutide-10mg/; https://pppepz.com/product/retatrutide-20mg/; and https://pppepz.com/product/retatrutide-30mg/. 4 Also found on your webpages https://pppepz.com/product/semaglutide-10mg/ and https://pppepz.com/product/semaglutide-20mg/. 5 Also found on your webpage https://pppepz.com/product/tesamorelin-10mg/. Content current as of: 09/01/2026 Regulated Product(s)

#### [157] peptide-partners-llc-735063-08242026 | issued 08/24/2026 | Peptide Partners LLC | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER Reference Number: 735063 To Zachary David Hoff: [B237] [B42] [B26] [B159] [B20] [B160] [B121] [B122] FDA Review Violations were identified and documented during a review of your website https://peptide.partners/ in July 2026. Based on our review,“GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” “SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). [B120] 331(d) and 355(a). [B238] [B41] [B28] Unapproved New Drug Violations Based on a review of your website, “GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” “SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. [B244] 1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: GLP-1 S (Semaglutide) On the webpage https://peptide.partners/product/glp-1-semaglutide/: “This laboratory study . . . suggests that semaglutide could have potential benefits for bone health by promoting the generation of new bone tissue.” “[T]his lab experiment . . . [suggests] that semaglutide might help improve metabolism by making muscle cells better at producing energy, even if it doesn’t directly fix the insulin resistance problem.” “[T]his laboratory study . . . suggests that semaglutide could have a protective effect on brain cells, which might be relevant for neurodegenerative diseases like Alzheimer’s.” GLP-2 T (Tirzepatide) On the webpage https://peptide.partners/product/glp-2-tirzepatide/: “This research explains how tirzepatide . . . mainly activates the GIP receptor strongly but only partly activates the GLP-1 receptor . . . [which] may help explain why tirzepatide is effective in lowering blood sugar and reducing weight.” “This study shows that tirzepatide . . . help[s] improve blood sugar and lipid levels without increasing fat mass, offering a better understanding of how tirzepatide works to improve metabolic health in diabetes and obesity.” “This study shows that tirzepatide . . . has direct protective effects on the kidneys, which could be beneficial for patients with diabetic kidney disease.” GLP-3 Reta (Retatrutide) On the webpage https://peptide.partners/product/glp-3-retatrutide-12mg-vials/: “Retatrutide . . . can activate three different hormone receptors in the body that control appetite and metabolism . . . allow[ing] it to effectively ‘talk’ to all three at once, leading to its powerful effects on weight loss and blood sugar control.” “Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . part of Retatrutide’s effectiveness in improving cholesterol levels comes from its direct action on the liver.” “Scientists have discovered how the weight-loss drug Retatrutide can also help treat a type of breast cancer that is more common in obese patients . . . made the cancer cells more sensitive to chemotherapy . . . uncover[ing] a new way that obesity affects cancer and suggests that drugs like Retatrutide could be used to improve cancer treatment in obese patients.” SS-31 (Elamipretide) On the webpage https://peptide.partners/product/ss-31/: “This lab study looked at how the peptide SS-31 could protect eye cells from damage . . . when the cells were treated with SS-31 beforehand, they were better able to survive and had less damage . . . suggest[ing] that SS-31 could be a potential treatment to protect the retina.” “SS-31 helps the cells to clean out waste and damaged parts . . . suggesting it could be a promising agent for treating liver inflammation.” Tesa Peptide (Tesamorelin) On the webpage https://peptide.partners/product/tesamorelin/: “[R]esearchers investigated how Tesamorelin affects the liver in people with HIV-associated fatty liver disease . . . and found that the drug changed the activity of genes involved in inflammation, tissue repair, and cell division . . . provid[ing] important insights into the molecular mechanisms by which Tesamorelin improves liver health in this patient population.” PT-141 (Bremelanotide) On the webpage https://peptide.partners/product/pt-141/: “PT-141 works by binding to and activating specific protein receptors on cell surfaces called melanocortin receptors . . . important for understanding how the drug might work in the body to affect sexual function and other processes controlled by these receptors.” “This study discovered that bremelanotide can kill brain cancer cells (glioblastoma) grown in laboratory culture dishes without harming normal cells.” Reconstitution Solution (BAC) Your firm offers “Reconstitution Solution (BAC)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend for your “Reconstitution Solution (BAC)” to be used in combination for injection. Therefore, your “Reconstitution Solution (BAC)” is a drug. “GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” ”SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B235] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B29] [B236] [B27] Identify your response with reference number “735063” in the subject line of the email. [B25] [B158] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B239] Food and Drug Administration _______________________ 1 Despite statements on your product labeling marketing your products “for research use only” and “not for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration. Content current as of: 09/01/2026 Regulated Product(s)

#### [158] royal-peptides-llc-734884-08242026 | issued 08/24/2026 | Royal Peptides LLC | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER Reference Number: 734884 To Rocco Abate and Michael Fraunfelter: [B237] [B42] [B26] [B159] [B20] [B160] [B121] [B122] FDA Review Violations were identified and documented during a review of your website royal-peptides.com in July 2026. Based on our review, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). [B120] 331(d) and 355(a). [B238] [B41] [B28] Unapproved New Drug Violations Based on a review of your website, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 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 any function of the body.1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: Tirzepatide, Retatrutide, and Semaglutide On the webpage https://royal-peptides.com/shop/tirzepatide-vials/: “Tirzepatide has become a major focus of metabolic, endocrinology, obesity, and peptide science due to its unique activity at both the GLP-1 (Glucagon-Like Peptide-1) and GIP (Glucose-Dependent Insulinotropic Polypeptide) receptors.” “Tirzepatide is a synthetic peptide engineered to activate both the GIP receptor and GLP-1 receptor, making it the first widely researched dual incretin agonist. Unlike traditional GLP-1 receptor agonists that target only one metabolic pathway, Tirzepatide simultaneously stimulates two naturally occurring incretin systems involved in glucose regulation and metabolic signaling.” On the webpage http://royal-peptides.com/tirzepatide-vs-retatrutide-weight-loss-peptides/: “Benefits of Tirzepatide: Enhances insulin sensitivity and glucose control[,] Reduces appetite and cravings[,] Promotes sustainable weight loss[, and] Once-weekly injection for convenience Clinical Results for Weight Loss In studies, Tirzepatide has led to up to 22.5% body weight reduction in participants over 72 weeks—comparable to or even better than Semaglutide (Wegovy, Ozempic).” “Benefits of Retatrutide: Boosts metabolism by activating glucagon receptors[,] Enhances glucose control and insulin function[,] Leads to faster and more substantial weight loss than Tirzepatide[, and] Once-weekly dosing Clinical Results for Weight Loss Early trials suggest that Retatrutide may result in up to 24.2% body weight reduction in just 48 weeks, making it one of the most effective weight loss peptides currently being studied.” On the webpage https://royal-peptides.com/retatrutide-vs-tirzepatide/: “One of the main reasons Retatrutide is searched so heavily is its connection to body composition research. Tirzepatide already became a major comparison point in metabolic studies because of its dual GIP and GLP-1 receptor activity. Retatrutide builds on that research conversation by adding glucagon receptor activity. Retatrutide Research Interest Retatrutide is studied for how triple agonist activity may influence metabolic research models. The addition of glucagon receptor activity is especially important because glucagon is involved in energy balance and hepatic glucose output. This makes Retatrutide interesting in models where researchers are examining energy expenditure, body composition, and metabolic regulation.” On the webpage https://royal-peptides.com/shop/tirzepatide-retatrutide-10mg-mix-kit-55-pack/: “Unlock dual research potential with Royal Peptides’ Mix 10-Pack Kit, combining 5 vials of Tirzepatide 10mg and 5 vials of Retatrutide 10mg—two powerhouse GLP-1/GIP receptor agonists studied for their roles in metabolic and weight management research.” On the webpage https://royal-peptides.com/shop/retatrutide-vial/: “Researchers studying incretin biology have long investigated the effects of GLP-1 and GIP receptor activity. Retatrutide expands on this concept by incorporating glucagon receptor activity into the molecule’s design. This additional receptor interaction has created widespread interest among scientists studying metabolic regulation and energy balance.” On the webpage https://royal-peptides.com/shop/semaglutide/: “Semaglutide Single Vials is categorized under metabolic signaling research. It may be examined in research involving metabolic signaling, receptor selectivity and related biochemical pathways.” SS-31 (Elamipretide) On the webpage https://royal-peptides.com/shop/31pv/: “SS-31 (Elamipretide) is a breakthrough mitochondria-targeted tetrapeptide researched for its potential in reducing oxidative stress, enhancing cellular energy production, and supporting mitochondrial function.” “Advanced Research Use: Mitochondrial repair, anti-aging, neuroprotection” Tesamorelin and BIMORELIN On the webpage https://royal-peptides.com/shop/tesamorelin-10mg/: “Tesamorelin is categorized under growth-signaling research. It may be examined in research involving peptide signaling, endocrine pathways and growth-hormone-related mechanisms.” On the webpage https://royal-peptides.com/shop/tesamorelin-ipamorelin-blend/: “BIMORELIN is a cutting-edge dual peptide blend combining Tesamorelin (10mg) and Ipamorelin (3mg) for advanced research into hormone modulation, body composition, and cellular recovery.” “Tesamorelin and Ipamorelin are synthetic peptides frequently utilized in scientific research involving cellular communication, metabolic regulation, recovery pathways, tissue maintenance, and physiological performance studies. When combined, researchers can investigate potential complementary effects across multiple biological systems and signaling networks.” PT-141 On the webpage https://royal-peptides.com/shop/pt-141-10mg-vial/: “PT-141, also called Bremelanotide (generic clinical name), is a heavily modified synthetic derivative of alpha-melanocyte-stimulating hormone. It has been tested in clinical trials as a treatment for hypoactive sexual desire disorder and acute hemorrhage.” “Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction” “PT-141: a melanocortin agonist for the treatment of sexual dysfunction” “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” “PT-141,” “Tesamorelin,” and “BIMORELIN” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B235] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B29] [B236] [B27] Identify your response with reference number “734884” in the subject line of the email. [B25] [B158] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B239] Food and Drug Administration ________________________ 1 Despite statements on your product labeling marketing your products “for research use only” and “not for human or animal consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water alongside a “peptide guide” and “peptide calculator,” resources that collectively provide the means to prepare an injectable drug for human administration. Content current as of: 09/01/2026 Regulated Product(s)

#### [159] txp-innovations-llc-dba-tex-peptides-735067-08242026 | issued 08/24/2026 | TXP Innovations LLC dba Tex Peptides | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER Reference Number: 735067 To Felicia Romero: [B237] [B42] [B26] [B159] [B20] [B160] [B121] [B122] FDA Review Violations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, “Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). [B120] 331(d) and 355(a). [B238] [B41] [B28] Unapproved New Drug Violations Based on a review of your website,“Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 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 any function of the body.1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: GLP-1 SEM (Semaglutide) On the webpage https://texpeptide.com/product/glp-1-sem/: “By binding to GLP-1 receptors, it enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, ultimately helping to regulate blood glucose levels. This makes GLP-1 SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders.” “In addition to its glucose-lowering effects, GLP-1 SEM has been shown to support weight loss by reducing appetite and promoting a feeling of fullness, making it a valuable therapeutic candidate in obesity management. Research also suggests potential benefits for cardiovascular health, liver function, and neuroprotection, expanding its relevance beyond diabetes care.” GLP-2 TRZ (Tirzepatide) On the webpage https://texpeptide.com/product/glp-2-trz/: “GLP-2 TRZ enhances insulin secretion, reduces glucagon levels, and promotes appetite regulation, offering a powerful approach to improving blood sugar control and weight management.” “Beyond its primary effects on glucose metabolism and weight loss, GLP-2 TRZ is being investigated for its potential in cardiovascular health, lipid regulation, and reducing systemic inflammation. Its role in insulin sensitivity, appetite suppression, and long-term metabolic improvements makes it a promising therapeutic option in endocrinology and obesity research.” GLP-3 RT (Retatrutide) On the webpage https://texpeptide.com/product/glp-3-rt/: “GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management.” “Early research suggests that GLP-3 RT may provide superior outcomes compared to GLP-1 or dual agonists alone, including greater weight reduction, improved insulin sensitivity, enhanced lipid metabolism, and better long-term metabolic stability. Additionally, studies are investigating its potential in cardiovascular protection, liver health (NAFLD/NASH), and neuroendocrine regulation.” SS-31 (Elamipretide) On the webpage https://texpeptide.com/product/ss-31/: “SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP).” “This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction.” Tesamorelin On the webpage https://texpeptide.com/product/tesamorelin/: “Tesamorelin is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH), a naturally occurring hormone that stimulates the pituitary gland to release growth hormone (GH). By mimicking the natural activity of GHRH, Tesamorelin effectively increases the production and secretion of growth hormone, which in turn elevates levels of insulin-like growth factor-1 (IGF-1) in the body.” PT-141 (Bremelanotide) On the webpage https://texpeptide.com/product/pt-141/: “PT-141, also known as bremelanotide . . . is specifically researched for its ability to increase arousal and desire. PT-141 targets the central nervous system directly to improve libido and pleasure. It’s an effective and powerful enhancer for both mood and your senses.” Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml) Your firm offers “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” to be used in combination for injection. Therefore, your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” is a drug. Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. [B235] [B107] 355(a). [B86] 355, are in effect for these products. [B123] [B119] 331(d) and 355(a). [B29] [B236] [B27] Identify your response with reference number “735067” in the subject line of the email. [B25] [B158] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B239] Food and Drug Administration ___________________ 1 Despite statements on your product labeling marketing your products “research use only”, “for research and laboratory use only”, and “not for human or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration. Content current as of: 09/01/2026 Regulated Product(s)