[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-ronanrx-inc-dba-ronanrx-737905-10302026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},22113,"ronanrx-inc-dba-ronanrx-737905-10302026","Warning Letter","RonanRx, Inc. dba RonanRx",null,"Center for Drug Evaluation and Research (CDER)","False & Misleading Claims\u002FMisbranded (Telehealth)","2026-11-03","2026-10-30","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fronanrx-inc-dba-ronanrx-737905-10302026","737905","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>RonanRx, Inc. dba RonanRx\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>1011 Old McDade Rd. Elgin, TX 78621 hello@ronanrx.com\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:hello@ronanrx.com\"> hello@ronanrx.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>October 30, 2026\u003C\u002Fp>\u003Cp>WARNING LETTER\u003Cbr>Reference number: MARCS-CMS 737905\u003C\u002Fp>\u003Cp>To RonanRx:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website and social media platforms and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is 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.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of RonanRx’s website, https:\u002F\u002Fronanrx.com and associated social media platforms, FDA Establishment Identifier (FEI) 3048890334, in September 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> 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 as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor quality drug products.\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The 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.\u003C\u002Fp>\u003Cp>Your website and social media platform “X” (formerly known as “Twitter”) contain false or misleading representations regarding your compounded semaglutide and tirzepatide products. 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.\u003C\u002Fp>\u003Cp>More specifically,\u003C\u002Fp>\u003Cp>1. The compounded tirzepatide products displayed on your website and posted on the social media platform “X” by @Ronan_Rx, identify “RonanRx” on the pictured label, suggesting RonanRx is the compounder of those drugs when in fact it is not.\u003C\u002Fp>\u003Cp>2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:\u003C\u002Fp>\u003Cul>\u003Cli>“Well-Studied Compounded Medications,” accompanied by the description, “Compounded medications with substantial human clinical evidence—randomized trials, mechanistic studies, and decades of use—though the specific compounded preparation may not itself be FDA-approved.”\u003C\u002Fli>\u003Cli>“FDA-Approved Compounded Medications,” accompanied by the description, “Compounded medications whose active ingredient has at least one FDA-approved branded form for the indication described.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>The following claims appear on the “X” social media platform, posted by @Ronan_Rx:\u003C\u002Fp>\u003Cul>\u003Cli>Your “Bio” header states, “Explore GLP-1s like Ozempic”\u003C\u002Fli>\u003Cli>A video reposted and pinned at the top of your feed states, “Yea, seventy-eight dollars a month, for drugs like Ozempic. But are our drugs even legit? No. Our drugs are super [bleep] legit.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>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. Website and video disclaimers that the specific compounded preparation “may not itself be FDA-approved” or that “[c]ompounded medications are not FDA-approved” do not cure the misleading overall impression created by these claims.\u003C\u002Fp>\u003Cp>3. The previously referenced video on the “X” social media platform posted by @Ronan_Rx represented that your products are “American made” and “farm-to-table drugs,” and ends with a background visual of confetti bursting around an unfurled American flag, with two individuals in sterile garments dancing in front of it. FDA’s records contain no drug listings for semaglutide or tirzepatide active pharmaceutical ingredients, intended for use in compounding, that identify a United States establishment registered with the FDA as the drug substance manufacturer. Describing the finished product as “American made” and “farm-to-table drugs” creates a misleading impression regarding the product’s true origin because, based on FDA’s records, the active pharmaceutical ingredient in the product was not made in the U.S. By falsely describing your compounded drug products as “American made” and “farm-to-table drugs,” and reinforcing these claims with celebratory imagery featuring the American flag, you conceal the true origin of your products and create the misleading impression that your products have a domestic origin indicative of superior quality.\u003C\u002Fp>\u003Cp>Accordingly, these representations cause the compounded drug products you offer for sale to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and 352(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)].\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As 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.\u003C\u002Fp>\u003Cp>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) working days of receipt of this letter. Identify your written response with reference number MARCS-CMS 737905 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:\u003C\u002Fp>\u003Cp>1. Identifying the entities that produce the compounded drug products offered on your website;\u003C\u002Fp>\u003Cp>2. Providing a representative sample of labeling for such drug products; and\u003C\u002Fp>\u003Cp>3. Addressing any other website claims that contain false or misleading representations about the compounded drug products you offer for sale or demonstrating that such claims have been removed or revised such that they are no longer false or misleading within the meaning of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>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) working days, state the reason for the delay and the time within which you will do so.\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.FDA.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Clint L. Narver, JD\u003Cbr>Director\u003Cbr>Office of Compounding Quality and Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>__________________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> The semaglutide and tirzepatide products offered on your website and associated social media platforms 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\u002For 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.\u003C\u002Fp>\u003Cp>\u003Cstrong>2\u003C\u002Fstrong> You are advised to reassess your advertisements and promotional materials across all platforms, including television and social media.\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRonanRx, Inc. dba RonanRx\n\n1011 Old McDade Rd. Elgin, TX 78621 hello@ronanrx.com\n\nUnited States\n\nhello@ronanrx.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 30, 2026\nWARNING LETTER\nReference number: MARCS-CMS 737905\nTo RonanRx:\nThis warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website and social media platforms and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is 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.\nFDA Review\nViolations were identified and documented during a review of RonanRx’s website, https:\u002F\u002Fronanrx.com and associated social media platforms, FDA Establishment Identifier (FEI) 3048890334, in September 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 as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor quality drug products.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe 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.\nYour website and social media platform “X” (formerly known as “Twitter”) contain false or misleading representations regarding your compounded semaglutide and tirzepatide products. 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.\nMore specifically,\n1. The compounded tirzepatide products displayed on your website and posted on the social media platform “X” by @Ronan_Rx, identify “RonanRx” on the pictured label, suggesting RonanRx is the compounder of those drugs when in fact it is not.\n2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:\n“Well-Studied Compounded Medications,” accompanied by the description, “Compounded medications with substantial human clinical evidence—randomized trials, mechanistic studies, and decades of use—though the specific compounded preparation may not itself be FDA-approved.”\n“FDA-Approved Compounded Medications,” accompanied by the description, “Compounded medications whose active ingredient has at least one FDA-approved branded form for the indication described.”\nThe following claims appear on the “X” social media platform, posted by @Ronan_Rx:\nYour “Bio” header states, “Explore GLP-1s like Ozempic”\nA video reposted and pinned at the top of your feed states, “Yea, seventy-eight dollars a month, for drugs like Ozempic. But are our drugs even legit? No. Our drugs are super [bleep] legit.”\nCompounded 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. Website and video disclaimers that the specific compounded preparation “may not itself be FDA-approved” or that “[c]ompounded medications are not FDA-approved” do not cure the misleading overall impression created by these claims.\n3. The previously referenced video on the “X” social media platform posted by @Ronan_Rx represented that your products are “American made” and “farm-to-table drugs,” and ends with a background visual of confetti bursting around an unfurled American flag, with two individuals in sterile garments dancing in front of it. FDA’s records contain no drug listings for semaglutide or tirzepatide active pharmaceutical ingredients, intended for use in compounding, that identify a United States establishment registered with the FDA as the drug substance manufacturer. Describing the finished product as “American made” and “farm-to-table drugs” creates a misleading impression regarding the product’s true origin because, based on FDA’s records, the active pharmaceutical ingredient in the product was not made in the U.S. By falsely describing your compounded drug products as “American made” and “farm-to-table drugs,” and reinforcing these claims with celebratory imagery featuring the American flag, you conceal the true origin of your products and create the misleading impression that your products have a domestic origin indicative of superior quality.\nAccordingly, these representations cause the compounded drug products you offer for sale to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and 352(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)].\nYou 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.\nConclusion\nAs 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.\nSend 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) working days of receipt of this letter. Identify your written response with reference number MARCS-CMS 737905 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:\n1. Identifying the entities that produce the compounded drug products offered on your website;\n2. Providing a representative sample of labeling for such drug products; and\n3. Addressing any other website claims that contain false or misleading representations about the compounded drug products you offer for sale or demonstrating that such claims have been removed or revised such that they are no longer false or misleading within the meaning of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].2\nThis 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) working days, state the reason for the delay and the time within which you will do so.\nIf 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.\nPlease note FDA posts warning letters on www.FDA.gov.\nSincerely,\n\u002FS\u002F\nClint L. Narver, JD\nDirector\nOffice of Compounding Quality and Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n__________________________\n1 The semaglutide and tirzepatide products offered on your website and associated social media platforms 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\u002For 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.\n2 You are advised to reassess your advertisements and promotional materials across all platforms, including television and social media.","2026-11-10T01:03:33.393+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-30T04:00:00Z\">10\u002F30\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fronanrx-inc-dba-ronanrx-737905-10302026\">RonanRx, Inc. dba RonanRx\u003C\u002Fa>","False & Misleading Claims\u002FMisbranded (Telehealth)\u003Cbr \u002F>\r\n","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:03:33.548856+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]