{"description":"Documents matching '7-hydroxymitragynine'","count":13,"total_pages":1,"results":[{"title":"Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information","type":"Notice","abstract":"The Office of the Assistant Secretary for Health (OASH or we) is opening a public docket to solicit input and comments on a proposed threshold for 7-hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act. Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General.","document_number":"2026-13608","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13608/temporary-placement-of-7-hydroxymitragynine-above-a-specified-threshold-in-schedule-i-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13608.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13608.pdf?1782936911","publication_date":"2026-07-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I.” In that document, the DEA noted their intent to issue a temporary scheduling order (in the form of a temporary amendment) to add 7-hydroxymitragynine above a specified threshold, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, to schedule I under the Controlled Substances Act (CSA). The DEA's specified threshold for 7-hydroxymitragynine is as follows:"},{"title":"Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I","type":"Proposed Rule","abstract":"The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine above a specified threshold, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 7-hydroxymitragynine above a specified threshold.","document_number":"2026-13580","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13580/schedules-of-controlled-substance-temporary-placement-of-7-hydroxymitragynine-above-a-specified","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13580.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13580.pdf?1782936911","publication_date":"2026-07-06","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"form, 7-hydroxymitragynine makes up less than two percent of the total alkaloid content or occurs in trace amount in \n M. speciosa. \n However, 7-hydroxymitragynine can be synthesized from mitragynine through a one-step chemical reaction, and it also exists as an active oxidized metabolite of mitragynine \n in vivo. \n Despite the different origins of 7-hydroxymitragynine, the chemical structures of synthetic and naturally occurring 7-hydroxymitragynine are identical. Consequently, the intrinsic pharmacological profile, receptor affinity, and mechanism"},{"title":"Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I","type":"Proposed Rule","abstract":"The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.","document_number":"2026-13581","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13581/schedules-of-controlled-substances-temporary-placement-of-mitragynine-pseudoindoxyl-mgm-15-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13581.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13581.pdf?1782936911","publication_date":"2026-07-06","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"S.C. 812(b)(1).\n \n \n Three 7-Hydroxymitragynine-Related Substances: Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 \n \n The prevalence and misuse of \n Mitragyna speciosa \n (commonly known as kratom) and its psychoactive alkaloids, including mitragynine and 7-hydroxymitragynine, have led to the proliferation of commercial products containing opioids chemically synthesized from mitragynine or 7-hydroxymitragynine. In recent years, mitragynine pseudoindoxyl, which is a chemical rearrangement product of 7-hydroxymitragynine, and MGM-15, which is a derivative"},{"title":"Schedules of Controlled Substances: Temporary Placement of 7- Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I","type":"Proposed Rule","abstract":"The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine and mitragynine pseudoindoxyl (including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible) when either substance alone, or their combined amount if both are present, is above a specified threshold, in schedule I of the Controlled Substances Act (CSA). Based on a different threshold provided by the Department of Health and Human Services (HHS) in July of 2025, DEA published a notice of intent to temporarily schedule 7-hydroxymitragynine above that lower threshold on July 7, 2026. Additionally, DEA published a temporary order placing mitragynine pseudoindoxyl without a threshold in schedule I of the CSA on August 26, 2026. On October 8, 2026, HHS sent a letter recommending that DEA place of the CSA 7-hydroxymitragynine and mitragynine pseudoindoxyl in schedule I when either substance alone, or their combined amount if both are present, is above a new specified threshold. Based on the October 8, 2026 letter, DEA is issuing this notice of intent. While the new threshold recommended by HHS would permit certain products to remain in the marketplace without being subject to schedule I controls, neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels. When a temporary order is issued, it will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 7- hydroxymitragynine and/or mitragynine pseudoindoxyl above the specified threshold. In a separate document contained in this issue of the Federal Register, DEA is withdrawing the July 7, 2026 notice of intent related to 7-hydroxymitragynine. The August 26, 2026 temporary order placing mitragynine pseudoindoxyl in schedule I of the CSA without a threshold remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.","document_number":"2026-20943","html_url":"https://www.federalregister.gov/documents/2026/10/14/2026-20943/schedules-of-controlled-substances-temporary-placement-of-7--hydroxymitragynine-and-mitragynine","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-14/pdf/2026-20943.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20943.pdf?1791561615","publication_date":"2026-10-14","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"additive regulation has authorized the use of 7-hydroxymitragynine in food supply. Furthermore, FDA has warned consumers against using products labeled as 7-hydroxymitragynine, as they have not been proven safe or effective for any use.\n 17 \n \n Fatal overdoses involving 7-hydroxymitragynine have been reported, making its wide availability and unknown safety profile a significant threat to public health, which is particularly concerning in the midst of an opioid crisis. The availability of 7 hydroxymitragynine-containing substances in the United States'"},{"title":"Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I","type":"Rule","abstract":"The Drug Enforcement Administration (DEA) is issuing this temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I is necessary to avoid an imminent hazard to public safety. This order imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.","document_number":"2026-17429","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17429/schedules-of-controlled-substances-temporary-placement-of-mitragynine-pseudoindoxyl-mgm-15-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17429.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17429.pdf?1787602521","publication_date":"2026-08-26","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"S.C. 812(b)(1).\n \n \n Three 7-Hydroxymitragynine-Related Substances: Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 \n \n The prevalence and misuse of \n Mitragyna speciosa \n (commonly known as kratom) and its psychoactive alkaloids, including mitragynine and 7-hydroxymitragynine, have led to the proliferation of commercial products containing opioids chemically synthesized from mitragynine or 7-hydroxymitragynine. In recent years, mitragynine pseudoindoxyl, which is a chemical rearrangement product of 7-hydroxymitragynine, and MGM-15, which is a derivative"},{"title":"Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period","type":"Notice","abstract":"The Office of the Assistant Secretary for Health (OASH or we) is extending the comment period to solicit input and comments on a Request for Information (RFI) on a proposed threshold for 7- hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act that appeared in the Federal Register of July 6, 2026. Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General. We are taking this action in response to a request for an extension to allow interested persons additional time to provide comments and input.","document_number":"2026-17409","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17409/hydroxymitragynine-above-a-specified-threshold-in-schedule-i-extension-of-comment-period","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17409.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17409.pdf?1787661915","publication_date":"2026-08-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"Register \n of July 6, 2026, we published an RFI entitled “Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information” with a comment period that closed on July 31, 2026. This RFI sought input on the proposed 7-OH threshold that was listed by the Drug Enforcement Administration (DEA) that was issued in the \n Federal Register \n entitled “Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I.”\n \n OASH has received a request for an"},{"title":"Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I","type":"Proposed Rule","abstract":"The Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule two 7- hydroxymitragynine-related substances (MGM-15 and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act (CSA). On August 26, 2026, DEA published a temporary order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I of the CSA. Today, DEA is providing notice of its intent to publish a new temporary order for MGM-15 and MGM-16 that will maintain the temporary placement of these substances in schedule I of the CSA without change. Separately in this Federal Register, DEA is publishing a notice of intent relating to mitragynine pseudoindoxyl, in response to a letter sent by the Department of Health and Human Services (HHS) dated October 6, 2026. HHS's letter related only to mitragynine pseudoindoxyl. Therefore, DEA is publishing this notice of intent only for the technical and procedural purpose of distinguishing MGM-15 and MGM-16 from mitragynine pseudoindoxyl. When issued, the temporary scheduling order addressing MGM-15 and MGM-16 will continue to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these two 7-hydroxymitragynine-related substances. The August 26, 2026 temporary order placing these substances in schedule I of the CSA remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.","document_number":"2026-20942","html_url":"https://www.federalregister.gov/documents/2026/10/14/2026-20942/schedules-of-controlled-substances-temporary-placement-of-mgm-15-and-mgm-16-in-schedule-i","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-14/pdf/2026-20942.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20942.pdf?1791561615","publication_date":"2026-10-14","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"6, 2026 letter.\n \n \n \n \n 13 \n 21 U.S.C. 812(b)(1).\n \n \n Two 7-Hydroxymitragynine-Related Substances: MGM-15 and MGM-16 \n \n The prevalence and misuse of \n Mitragyna speciosa \n (commonly known as kratom) and its psychoactive alkaloids, including mitragynine and 7-hydroxymitragynine, have led to the proliferation of commercial products containing opioids chemically synthesized from mitragynine or 7-hydroxymitragynine. In recent years, MGM-15, which is a derivative of 7-hydroxymitragynine, has recently emerged on the \n Mitragyna speciosa \n consumer"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request: Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled \"Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.\"","document_number":"2024-17102","html_url":"https://www.federalregister.gov/documents/2024/08/02/2024-17102/agency-information-collection-activities-proposed-collection-comment-request-risksafety","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-02/pdf/2024-17102.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17102.pdf?1722516337","publication_date":"2024-08-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"opioid ecosystem, suggesting that it can potentially present the risks of abuse, addiction, and misuse. It is noteworthy that FDA has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components, mitragynine and 7-hydroxymitragynine (7-OH-mitragynine). Hence, while the Agency actively encourages interested researchers to study kratom to address the knowledge gap about its full risk/safety effects when ingested by humans by conducting rigorous randomized clinical studies, currently, there are no"},{"title":"International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Brorphine; Metonitazene; Eutylone; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2022. This notice is issued under the Controlled Substances Act (CSA).","document_number":"2022-03229","html_url":"https://www.federalregister.gov/documents/2022/02/15/2022-03229/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-15/pdf/2022-03229.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-03229.pdf?1644846344","publication_date":"2022-02-15","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"psychoactive components of kratom are mitragynine and 7-hydroxymitragynine, both of which are found in the leaves of Mitragyna speciosa. Mitragynine is the most abundant alkaloid in kratom. \n Whilst 7-hydroxymitragynine is a minor alkaloid, it is also a metabolite of mitragynine. \n WHO Review History \n Kratom has been under ECDD surveillance since 2020 due to a country level report indicating the potential for abuse, dependence, and harm to public health from mitragynine and 7-hydroxymitragynine, and a report from an international organization regarding"},{"title":"International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Reopening Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled \"International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut\" that appeared in the Federal Register of July 23, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances.","document_number":"2021-17498","html_url":"https://www.federalregister.gov/documents/2021/08/16/2021-17498/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-08-16/pdf/2021-17498.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-17498.pdf?1628712923","publication_date":"2021-08-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut” that appeared in the \n Federal Register \n of July 23, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. These comments will be considered in preparing a response from the United States to the World Health"},{"title":"International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of seven drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).","document_number":"2021-15685","html_url":"https://www.federalregister.gov/documents/2021/07/23/2021-15685/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-07-23/pdf/2021-15685.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-15685.pdf?1626957931","publication_date":"2021-07-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"FDA-2021-N-0739 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management"},{"title":"Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I","type":"Proposed Rule","abstract":"On August 31, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine, which are the main psychoactive constituents of the plant Mitragyna speciosa, also referred to as kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Since publishing that notice, DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action. In addition, DEA will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested. DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.","document_number":"2016-24659","html_url":"https://www.federalregister.gov/documents/2016/10/13/2016-24659/withdrawal-of-notice-of-intent-to-temporarily-place-mitragynine-and-7-hydroxymitragynine-into","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-13/pdf/2016-24659.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-24659.pdf?1476276323","publication_date":"2016-10-13","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"evaluation and making the recommendation.\n \n \n \n Accordingly, the August 31, 2016, notice of intent to temporarily place mitragynine and 7-hydroxymitragynine in schedule I is withdrawn. Mitragynine and 7-hydroxymitragynine therefore remain—as has been the case—noncontrolled substances under federal law.\n 3 \n \n \n \n \n 3 \n Under some state and local laws, kratom and/or its constituents mitragynine and 7-hydroxymitragynine are currently listed as controlled substances or otherwise subject to control. Nothing in this publication alters the validity of such"},{"title":"Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I","type":"Proposed Rule","abstract":"The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine, which are the main active constituents of the plant kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of these opioids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, and exportation of, and research and conduct of instructional activities of these opioids.","document_number":"2016-20803","html_url":"https://www.federalregister.gov/documents/2016/08/31/2016-20803/schedules-of-controlled-substances-temporary-placement-of-mitragynine-and-7-hydroxymitragynine-into","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-31/pdf/2016-20803.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-20803.pdf?1472588183","publication_date":"2016-08-31","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"mitragynine and 7-hydroxymitragynine in schedule I on a temporary basis to the Assistant Secretary by letter dated May 6, 2016. The Assistant Secretary responded to this notice by letter dated May 18, 2016, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for mitragynine and 7-hydroxymitragynine. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of mitragynine and 7-hydroxymitragynine into schedule"}]}