Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Public Health Solution LLC dba DrMedHealth2003 Plank Road, #1283Fredericksburg, VA 22401United Statessupport@drmedhealth.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728278To DrMedHealth:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of DrMedHealth’s website, https://drmedhealth.com, FDA Establishment Identifier (FEI) 3044020737, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.More specifically,1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“Same active ingredient as Ozempic®”“Same active ingredient as Mounjaro®”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728278 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

昆明三稻医疗设备有限公司报告，由于产品铭牌警示标志不符合要求，昆明三稻医疗设备有限公司对其生产的妊高征监测分析系统（注册证编号：滇械注准20192070076）主动召回。召回级别为三级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件：医疗器械召回事件报告表   2026年6月16日

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Ezra Holdco LLC dba Ezra30 N Gould St.Suite 63027Sheridan, WY 82801United Stateslegal@joinezra.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 730995To Ezra:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of Ezra’s website, https://joinezra.com, FDA Establishment Identifier (FEI) 3045074898, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.2Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 730995 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Ready Med2451 N McMullen Booth RdClearwater, FL 33759United Statesreadymedstaff@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 730317To Ready Med:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of Ready Med’s website, https://readymednow.com, FDA Establishment Identifier (FEI) 3044868483, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.22. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“The same active ingredient in Mounjaro® and Zepbound™”“The same active ingredient in Ozempic® and Rybelsus®”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.3. Your website claims that the compounded drug products it offers are sourced from an “FDA licensed compounding facility.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.3 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.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 730317 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].3 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. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products. Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:FITISH2316 Gravel DriveFort Worth, TX 76118United Statesinfo@fitish.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728280To FITISH:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of FITISH’s website, https://fitish.com, FDA Establishment Identifier (FEI) 3044018836, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.22. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“Semaglutide is the active ingredient in ozempic” [sic]“Tirzepatide is the active ingredient in Mounjaro® and Zepbound®”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728280 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Brian Spears, MDChief Medical OfficerOrderlyMeds LLC dba OrderlyMeds235 Ponce De Leon Pl., Suite M347Decatur, GA 30030United Statessupport@orderlymeds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728291To Dr. Spears:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of OrderlyMeds’ website, https://orderlymeds.com, FDA Establishment Identifier (FEI) 3044027176, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.22. Your website claims that the compounded drug products it offers are sourced from an “FDA-licensed pharmacy.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities.3 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.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728291 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].3 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. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products. Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Kyle RobertsonFounder & Chief Executive OfficerRoen Health, Inc. dba RoenRx30 Irving PlNew York, NY 10003United Statessupport@roenrx.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728293To Mr. Robertson:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.22. The following claims concerning compounded semaglutide products appear on your website:“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. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728293 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Nova Vascular LLC dba NOVARX99 Wall Street, #878New York, NY 10005United Statesinfo@novarx.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728290To NOVARX:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of NOVARX’s website, https://novarx.co, FDA Establishment Identifier (FEI) 3044022416, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.22. The following claims concerning compounded semaglutide products appear on your website:“…access to the same active ingredient found in Ozempic.”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.3. Your website claims that the compounded drug products it offers are sourced from “FDA Approved Pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities.3 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.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728290 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].3 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. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products. Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Maximus Health, Inc. dba Maximus2219 Main Street, #347Santa Monica, CA 90405United Stateshello@maximustribe.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 730095To Maximus:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of Maximus’ website, https://www.maximustribe.com, FDA Establishment Identifier (FEI) 3032037948, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.More specifically,1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“Clinically studied ingredients.”“Clinically studied to help patients….”“Proven to lose weight effectively”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.2. Your website claims that the compounded drug products it offers are sourced from “FDA approved pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.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.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 730095 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.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. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products. Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Glow Medispa, LLC dba Mint Med8833 Chapel Square Dr.Cincinnati, OH 45249United Stateshelp@mintmed.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 730390To Mint Med:This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of Mint Med’s website, https://mintmed.com, FDA Establishment Identifier (FEI) 3044896930, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide 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)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.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.2Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 730390 and Response to Warning Letter in the subject line of the email. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. 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. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].