[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-ket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026":3,"fda-latest-sync-dates":28},{"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":26,"updated_at":27},59,"ket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026","Warning Letter","Ket Plug \u002F ketaminelab.org and buyketaminepowderonline.com",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2026-07-07","2026-06-23","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026","728919","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 class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">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 class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Ket Plug \u002F ketaminelab.org and buyketaminepowderonline.com\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:sale@ketaminelab.org\"> sale@ketaminelab.org\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:sale@buyketaminepowderonline.com\"> sale@buyketaminepowderonline.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\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 class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>June 23, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference Number: MARCS-CMS 728919\u003C\u002Fp>\u003Cp>To Ket Plug:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website www.buyketaminepowderonline.com (redirected from www.ketaminelab.org). Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>As discussed below, FDA has observed that www.buyketaminepowderonline.com introduces into interstate commerce an unapproved and misbranded ketamine drug product, which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision.\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Given the increased interest in the use of ketamine products, the easy availability of unapproved ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.\u003Cem>\u003Cstrong>\u003Csup>3\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.\u003C\u002Fp>\u003Cp>Accordingly, FDA requests that www.buyketaminepowderonline.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your website www.buyketaminepowderonline.com, FDA Establishment Identifier (FEI) 3044408515, in April 2026. Based on our review, your ketamine powder is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) (21 U.S.C. 331(d)) and 505(a) of the FD&C Act. Furthermore, your ketamine powder is a misbranded drug under section 502 of the FD&C Act (21 U.S.C. 352), and the introduction or delivering this product for introduction into interstate commerce violates section 301(a) of the FD&C Act (21 U.S.C. 331(a)).\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>\u003Cem>Unapproved New Drug Violations\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Based on a review of your website, your ketamine powder is a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\u003Cem>\u003Cstrong>\u003Csup>4\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Examples from your website labeling that provide evidence of the intended use (as defined in 21 Code of Federal Regulations (CFR) 201.128) of this product as a drug include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>On the webpage www.buyketaminepowderonline.com:\u003Cbr>• “Neuroscience and Brain Function Research . . . Researchers use Ketamine to model dissociative states and altered neural connectivity, helping to explore cognition, perception, and consciousness at a molecular and systems level.”\u003Cbr>• “Psychiatric and Mood Disorder Research Models . . . Ketamine is frequently studied in preclinical and mechanistic research related to depression and mood regulation, particularly in examining rapid-onset neuroplastic changes.”\u003C\u002Fp>\u003Cp>Your ketamine powder is a “new drug” under section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. No approved drug applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355), are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act.\u003C\u002Fp>\u003Cp>\u003Cem>Misbranded Drug Violations\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Your ketamine powder is also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), in that its labeling fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Your ketamine powder is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use. In addition, your ketamine powder is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, your ketamine powder is misbranded under section 502(f)(1) of the FD&C Act.\u003C\u002Fp>\u003Cp>The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act.\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 FDAAdvisory@fda.hhs.gov within 15 business days of receipt of this letter. 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. Identify your response with reference number “MARCS-CMS 728919” in the subject line of the email.\u003C\u002Fp>\u003Cp>If you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\u003C\u002Fp>\u003Cp>If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, MS\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling 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> REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Frisk-evaluation-and-mitigation-strategies-rems.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> FDA-approved esketamine, a ketamine derivative marketed under the brand name SPRAVATO, bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. Additionally, it is required to be available only through a restricted program, the SPRAVATO REMS.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> FDA-approved ketamine, including products marketed under the brand name KETALAR, is an intravenous or intramuscular injection.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> Despite statements on your website labeling marketing your product “for research and scientific use” and “for non-clinical purposes,” evidence obtained from your website labeling establishes that your product is intended to be a drug for human use.\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nKet Plug \u002F ketaminelab.org and buyketaminepowderonline.com\n\nUnited States\n\nsale@ketaminelab.org\n\nsale@buyketaminepowderonline.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nJune 23, 2026\nWARNING LETTER\nReference Number: MARCS-CMS 728919\nTo Ket Plug:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website www.buyketaminepowderonline.com (redirected from www.ketaminelab.org). Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\nAs discussed below, FDA has observed that www.buyketaminepowderonline.com introduces into interstate commerce an unapproved and misbranded ketamine drug product, which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision.2 Given the increased interest in the use of ketamine products, the easy availability of unapproved ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.3\nThere are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.\nAccordingly, FDA requests that www.buyketaminepowderonline.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.\nFDA Review\nViolations were identified and documented during a review of your website www.buyketaminepowderonline.com, FDA Establishment Identifier (FEI) 3044408515, in April 2026. Based on our review, your ketamine powder is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) (21 U.S.C. 331(d)) and 505(a) of the FD&C Act. Furthermore, your ketamine powder is a misbranded drug under section 502 of the FD&C Act (21 U.S.C. 352), and the introduction or delivering this product for introduction into interstate commerce violates section 301(a) of the FD&C Act (21 U.S.C. 331(a)).\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.\nUnapproved New Drug Violations\nBased on a review of your website, your ketamine powder is a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.4 Examples from your website labeling that provide evidence of the intended use (as defined in 21 Code of Federal Regulations (CFR) 201.128) of this product as a drug include, but may not be limited to, the following:\nOn the webpage www.buyketaminepowderonline.com:\n• “Neuroscience and Brain Function Research . . . Researchers use Ketamine to model dissociative states and altered neural connectivity, helping to explore cognition, perception, and consciousness at a molecular and systems level.”\n• “Psychiatric and Mood Disorder Research Models . . . Ketamine is frequently studied in preclinical and mechanistic research related to depression and mood regulation, particularly in examining rapid-onset neuroplastic changes.”\nYour ketamine powder is a “new drug” under section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. No approved drug applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355), are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act.\nMisbranded Drug Violations\nYour ketamine powder is also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), in that its labeling fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Your ketamine powder is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use. In addition, your ketamine powder is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, your ketamine powder is misbranded under section 502(f)(1) of the FD&C Act.\nThe introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act.\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 FDAAdvisory@fda.hhs.gov within 15 business days of receipt of this letter. 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. Identify your response with reference number “MARCS-CMS 728919” in the subject line of the email.\nIf you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\nIf you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.\nPlease note FDA posts warning letters on www.fda.gov.\nSincerely,\n\u002FS\u002F\nTina Smith, MS\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n____________________________\n1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Frisk-evaluation-and-mitigation-strategies-rems.\n2 FDA-approved esketamine, a ketamine derivative marketed under the brand name SPRAVATO, bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. Additionally, it is required to be available only through a restricted program, the SPRAVATO REMS.\n3 FDA-approved ketamine, including products marketed under the brand name KETALAR, is an intravenous or intramuscular injection.\n4 Despite statements on your website labeling marketing your product “for research and scientific use” and “for non-clinical purposes,” evidence obtained from your website labeling establishes that your product is intended to be a drug for human use.","2026-08-19T04:31:00.197+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2026-07-07T04:00:00Z\">07\u002F07\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-06-23T04:00:00Z\">06\u002F23\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026\">Ket Plug \u002F ketaminelab.org and buyketaminepowderonline.com\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]