# 91 FR 40917: Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2026-13580

## Section

- **Citation:** 91 FR 40917
- **Heading:** Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 91 / 91 FR 40917

## Text

hreshold in schedule I on a temporary basis to the Assistant Secretary for Health of HHS (Assistant Secretary). 9 By letter dated March 6, 2026, the Assistant Secretary responded to this notice and advised that based on a review by the Food and Drug Administration (FDA), there were currently no investigational new drug applications (IND) or approved new drug applications (NDA) for these substances. The Assistant Secretary also stated that HHS had no objection to the temporary placement of this substance above the specified threshold in schedule I of the CSA.
8 21 U.S.C. 811(h)(4).
9 The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, As Amended; Delegation of Authority, 58 FR 35460 (July 1, 1993).
To find that placing a substance temporarily in schedule I of the CSA is necessary to avoid an imminent hazard to public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811(c): the substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to public health. 10 This consideration includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of 7-hydroxymitragynine above the specified threshold. 11
10 21 U.S.C. 811(c)(4)-(6), (h)(3).
11 21 U.S.C. 811(h)(3).
Substances meeting the statutory requirements for temporary scheduling

may only be placed in schedule I. 12 Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, 13 and a lack of accepted safety for use under medical supervision. 14
12 21 U.S.C. 811(h)(1)
1
10 21 U.S.C. 811(c)(4)-(6), (h)(3).
11 21 U.S.C. 811(h)(3).
Substances meeting the statutory requirements for temporary scheduling

may only be placed in schedule I. 12 Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, 13 and a lack of accepted safety for use under medical supervision. 14
12 21 U.S.C. 811(h)(1).
13 When finding schedule I placement on a temporary basis is necessary to avoid imminent hazard to the public, 21 U.S.C 811(h) does not require DEA to consider whether the substance has a currently accepted medical use in treatment in the United States. Nonetheless, there is no evidence suggesting that 7-hydroxymitragynine has a currently accepted medical use in treatment in the United States. First, DEA looks to whether the drug or substance has FDA approval. When no FDA approval exists, DEA has traditionally applied a five-part test to determine whether a drug or substances has a currently accepted medical use: (1) the drug's chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available. Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 1994). DEA applied the traditional five-part test and concluded the test was not satisfied
7-hydroxymitragynine, as they have not been proven safe or effective for any use. 16 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' M. speciosa consumer market poses an imminent hazard to the public safety.
16 FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine | FDA, available at https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7hydroxymitragynine#:~:text=FDA%20Issues%20Warning%20Letters%20to%20Firms%20Marketing%20Products%20Containing%207%2DHydroxymitragynine,-Alkaloid%20known%20as&text=The%20U.S.%20Food%20and%20Drug,also%20known%20as%207%2DOH, Accessed July 31, 2025.
Available data and information for 7-hydroxymitragynine, summarized below, indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical

supervision. DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at www.regulations.gov under Docket Number DEA-1570.
Factor 4. History and Current Pattern of Abuse
7-Hydroxymitragynine is most commonly used in isolated form or as component of M. speciosa. Historically, M. speciosa has been used for a variety of purposes, including as an opium substitute and a treatment of various opioid withdrawal symptoms, such as pain, cough, anxiety, diarrhea, and intestinal difficulty. 17 While its use was once geographically limited, the marketing in the United States of 7-hydroxymitragynine products has been aggressive and often indistinguishable from the sale of M. speciosa
enforcement systems is currently limited, primarily because forensic chemists often prioritize the identification of mitragynine, the major alkaloid in M. speciosa, rather than extending analysis to the identification of minor alkaloids, such as 7-hydroxymitragynine. Furthermore, because 7-hydroxymitragynine is not federally controlled under the CSA, specific forensic identification may be limited. Consequently, some forensic laboratories may not place emphasis on analyzing or tracking the encounters of non-controlled substances, making it unlikely to be fully reported to forensic laboratories databases. Nonetheless, available data from the National Forensic Laboratory Information System (NFLIS) database 27 shows that, in 2025, there were 42 reports of 7-hydroxymitagynine from 12 states. This law enforcement data illustrates the widespread and increasing availability of products containing 7-hydroxymitragynine within the domestic kratom drug market.
27 NFLIS represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS is a comprehensive information system that includes data from forensic laboratories that handle more than 96 percent of an estimated 1.0 million distinct annual State and local drug analysis cases. NFLIS includes drug chemistry results from completed analyses only. While NFLIS data is not direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011). NFLIS data were queried on February 26, 2026.
FDA Warning Letters
Between June and July 2025, FDA issued seven warning letters 28 to marketers and distributors for the unlawful use of 7-hydroxymitragynine as a drug, dietary supplement, or added to conventional food
nd abused. See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011). NFLIS data were queried on February 26, 2026.
FDA Warning Letters
Between June and July 2025, FDA issued seven warning letters 28 to marketers and distributors for the unlawful use of 7-hydroxymitragynine as a drug, dietary supplement, or added to conventional food. The warning letters explicitly stated that 7-hydroxymitragyine is not an FDA-approved drug product and that no food additive regulation has authorized the use of 7-hydroxymitragynine in food. FDA further classified 7-hydroxymitragynine as a “new dietary ingredient” under section 413(d) of the FD&C Act, 21 U.S.C. 350b(d), because there is no evidence demonstrating it was marketed as a dietary ingredient in the United States before October 15, 1994. Additionally, some letters noted that, as a dietary supplement, 7-hydroxymitragynine is considered adulterated under section 402(f)(l)(B) of the FD&C Act,21 U.S.C. 342(f)(l)(B). This is because there is inadequate information providing reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury. Of note was FDA's warning letter issued on June 25, 2025, to a company selling “7OHMZ 7-Hydroxymitragynine Gummies,” 29 in which FDA cautioned that such products may be appealing to children due to their packaging. Other warning letters targeted the illegal sale of unapproved 7-hydroxymitragynine products marketed for the treatment of pain, relaxation, mood enhancement, and other medical conditions
f note was FDA's warning letter issued on June 25, 2025, to a company selling “7OHMZ 7-Hydroxymitragynine Gummies,” 29 in which FDA cautioned that such products may be appealing to children due to their packaging. Other warning letters targeted the illegal sale of unapproved 7-hydroxymitragynine products marketed for the treatment of pain, relaxation, mood enhancement, and other medical conditions. 30 Vendors utilized websites and social media pages to make unproven medical claims for 7-hydroxymitragynine, such as describing tablets as “expertly formulated to provide a potent dose” or promising “intense relaxation and a feeling of pure bliss.”
28 FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine | FDA, available at https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine ; 7Tabz Retail, LLC-709546-06/25/2025 | FDA, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/7tabz-retail-llc-709546-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hydroxie-llc-709661-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shaman-botanicals-llc-709622-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-diamond-imports-inc-709540-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thang-botanicals-inc-dba-7ohmz-7-ohmz-or-7ohmz-710190-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/relax-relief-rejuvenate-trading-llc-dba-rrr-trading-or-edp-kratom-709475-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/relax-relief-rejuvenate-trading-llc-dba-rrr-trading-or-edp-kratom-709475-06252025
ohmz-7-ohmz-or-7ohmz-710190-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/relax-relief-rejuvenate-trading-llc-dba-rrr-trading-or-edp-kratom-709475-06252025; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/relax-relief-rejuvenate-trading-llc-dba-rrr-trading-or-edp-kratom-709475-06252025.
29 Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ-710190-06/25/2025 | FDA, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thang-botanicals-inc-dba-7ohmz-7-ohmz-or-7ohmz-710190-06252025.
30 FDA Warning Letter, Royal Diamond Imports, Inc. (June 25, 2025), available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-diamond-imports-inc-709540-06252025; FDA Warning Letter, Hydroxie, LLC (June 25, 2025), available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hydroxie-llc-709661-06252025.
State Regulations and Controls
Due to concerns over its abuse, several states have regulated or banned the consumption of 7-hydroxymitragynine or M. speciosa. 31 Currently, nine states (Alabama, Arkansas, Florida, Indiana, Kentucky, Louisiana, Ohio, Vermont, and Wisconsin) have prohibited 7-hydroxymitragynine consumption. Additionally, some states, such as Arizona, Colorado, South Carolina, and Texas, have set restrictions on the limits of 7-hydroxymitragynine (not to exceed a specified percent of total alkaloid content).
31 Legislative Analysis and Public Policy Association, Kratom: Summary of State Laws (April 2025), available at https://legislativeanalysis.org/wp-content/uploads/2025/07/Kratom-Summary-of-State-Laws.pdf. Accessed August 8, 2025.
Furthermore, 19 states have enacted model legislation known as the “kratom consumer protection Act (KCPA),” which requires that M
percent of total alkaloid content).
31 Legislative Analysis and Public Policy Association, Kratom: Summary of State Laws (April 2025), available at https://legislativeanalysis.org/wp-content/uploads/2025/07/Kratom-Summary-of-State-Laws.pdf. Accessed August 8, 2025.
Furthermore, 19 states have enacted model legislation known as the “kratom consumer protection Act (KCPA),” which requires that M. speciosa, mitragynine, or 7-hydroxymitragynine be manufactured safely, labeled accurately, and distributed appropriately to protect consumer under a certain age. These states are Arizona, Colorado, Florida, Georgia, Kentucky, Oklahoma, Maryland, Mississippi, Nebraska, Nevada, New York, Oregon, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, and West Virginia. Other states, like Illinois, New Hampshire, North Carolina, and Tennessee, have bans in some localities. 32 Of note, the state of Mississippi has set the limit per weight basis to one percent of total alkaloid content of 7-hydroxymitragynine or 0.5 mg per container. DEA's intent to temporarily control 7-hydroxymitragynine above the specified threshold does not preempt more restrictive state law regarding the consumption of 7-hydroxymitragynine and 7-hydroxymitragynine-related products. 33
32 American Kratom Association, Kratom State Legality and Legislation, available at https://www.americankratom.org/aka-in-your-state. Accessed on February 26, 2026.
33 See 21 U.S.C. 903; 21 CFR 1307.02.
Poison Control Center Data (National Poison Data System)
The significance of 7-hydroxymitragynine abuse is demonstrated by an increasing volume of calls to poison control centers. Reporting for 7-hydroxymitragynine was historically limited within the National Poison Data System (NPDS); however, specific data codes for this substance were recently implemented between February and May 2025. During the initial tracking period from February

2025 to April 2025, NPDS recorded a total of 53 case reports involving 7-hydroxymitragynine
volume of calls to poison control centers. Reporting for 7-hydroxymitragynine was historically limited within the National Poison Data System (NPDS); however, specific data codes for this substance were recently implemented between February and May 2025. During the initial tracking period from February

2025 to April 2025, NPDS recorded a total of 53 case reports involving 7-hydroxymitragynine. Of these exposure calls, 37 cases involved single-substance exposure of 7-hydroxymitragynine alone, and 24 cases were classified as abuse involving other substances in combination with 7-hydroxymitragynine. Among the single-substance exposure calls, 16 cases were categorized as intentional abuse, while 13 calls involved moderate medical outcomes where the patients exhibited pronounced and prolonged systemic symptoms.
Expanded data from United States poison centers indicates a rapid escalation in reported incidents. 34 From January 1 through July 31, 2025, there were 165 exposure cases involving 7-hydroxymitragynine. Of those reporting exposures to 7-hydroxymitragynine alone, 35 percent of these cases resulted in serious health problems, and 67 percent of individuals were treated at a healthcare facility. Patients exposed to 7-hydroxymitragynine frequently exhibit a range of severe physiological and neurological symptoms, including: gastrointestinal (nausea and vomiting), neurological (agitation, confusion, loss of consciousness, and seizure), cardiovascular (sweating, tachycardia, and hypertension), and respiratory (difficulty breathing). According to HHS' review, users report several reasons for using 7-hydroxymitragynine, including the following:
34 America's Poison Centers, Health Advisory: Serious Illnesses Associated with 7-OH Use, available at https://poisoncenters.org/news-alerts/13531044. Accessed on August 26, 2025.
Desired Effects: Euphoria and an opioid-like “buzz”/high as motivation for using 7-hydroxymitragynine
). According to HHS' review, users report several reasons for using 7-hydroxymitragynine, including the following:
34 America's Poison Centers, Health Advisory: Serious Illnesses Associated with 7-OH Use, available at https://poisoncenters.org/news-alerts/13531044. Accessed on August 26, 2025.
Desired Effects: Euphoria and an opioid-like “buzz”/high as motivation for using 7-hydroxymitragynine.
Product Appeal: The availability of “candy-like” formulations of some 7-hydroxymitragynine tablets, which some users acknowledge as carrying health risk due to possibility of overconsumption.
Self-Treatment: Claim of 7-hydroxymitragynine therapeutic value in self-treating pain and anxiety.
Risk Awareness: There is an acknowledgement among users of products containing 7-hydroxymitragynine that these products can lead to addiction, withdrawal symptoms, overdose, and other serious health outcomes, including death.
In summary, the abuse of 7-hydroxymitragynine in the United States is fueled by its pharmacological similarities to opioid analgesics, a lack of regulatory controls, and the relative ease of obtaining 7-hydroxymitragynine products via smoke shops and the internet. 35 Furthermore, the consumption of 7-hydroxymitragynine alongside other mind-altering substances may exacerbate the potential acute and long-term hazards and risks to the user, especially drug dependence. FDA responded to the increase in sales of 7-hydroxymitragynine products and unsubstantiated medical claims by issuing warning letters to companies to protect public safety. Available information from published literatures and poison control centers suggests that 7-hydroxymitragynine is used by a diverse population for the self-treatment of various health conditions. The ingestion of 7-hydroxymitragynine, a potent opioid, alone or co-ingestion with other substances, commonly a CNS depressant, is of serious concern
warning letters to companies to protect public safety. Available information from published literatures and poison control centers suggests that 7-hydroxymitragynine is used by a diverse population for the self-treatment of various health conditions. The ingestion of 7-hydroxymitragynine, a potent opioid, alone or co-ingestion with other substances, commonly a CNS depressant, is of serious concern. The poison control center data and popularity of 7-hydroxymitragynine-products collectively underscores the severity and significance of abuse of 7-hydroxymitragynine in the United States.
35 internet sellers advertise, market, and provide false medical claims.
Factor 6. What, If Any, Risk There Is to Public Health
7-hydroxymitragynine has opioidergic and addictive properties. Available preclinical data demonstrates that 7-hydroxymitragynine has an abuse potential similar to that of schedule I and II opioids, such as heroin, morphine, and fentanyl. 36 The abuse of 7-hydroxymitragynine presents severe risks to public health, including tolerance, dependence and addiction, respiratory depression, and death. Public health assessment is further complicated because 7-hydroxymitragynine is a known metabolite of mitragynine, making it difficult to distinguish between the ingestion of M. speciosa and other isolated 7-hydroxymitragynine products.
36 Alsbrook, S., Pro, G., & Koturbash, I. (2025). From kratom to 7-hydroxymitragynine: evolution of a natural remedy into a public-health threat. Pharmaceutical Biology, 63(1), 896-911.
FDA-Adverse Event Reporting System (FAERS)
On August 11, 2025, DEA queried the FAERS public dashboard for 7-hydroxymitragynine and noted that there were 1 case count in 2023, 2 cases in 2024, and 11 cases as of June 30, 2025. Most of the cases involved drug dependence (n = 6) and withdrawal syndrome (n = 4). A recent query of the database on February 27, 2026, revealed an increase in cases involving 7-hydroxymitragynine
d concentration of 0.15 mg/L. Pullman et al. (2026) 43 29 y/o male Cardiopulmonary arrest Naloxone Reversal: Confirmed 7-hydroxymitragynine causes opioid respiratory depression reversible with standard antagonist drug. Wightman and Hu (2025) 44 38 y/o male Severe Dependence Clinical Detoxification: Patient required inpatient buprenorphine stabilization for high dose 7-hydroxymitragynine withdrawal. These 7-hydroxymitragynine products are obtained through unknown sources, where the identity, purity, and concentration of active ingredients are often unknown, uncertain, and inconsistent; thus, posing significant adverse health risks to users. The abuse of 7-hydroxymitragynine poses a substantial hazard to public safety. 7-Hydroxymitragynine is being abused for its opioid-like effects and shares health risks similar to other mu-opioid receptor agonists, such as morphine (schedule II). With no approved medical use, the positive identification of 7-hydroxymitragynine in non-fatal and fatal overdose cases poses a threat to public safety. 7-Hydroxymitragynine products are obtained through unknown sources (commonly through the internet); the identity, purity, and quantity of these substances are uncertain and inconsistent, thus posing significant adverse health risks to users.
41 Broul, M., Rudenko, X., Bajus, A., Král, J., Kyenge, D.M., Staňková, Z., & Albrecht, J. (2025). Case Report: Cannabis and kratom-induced self-amputation of ears and penis. Frontiers in psychiatry, 16, 1479863.
42 Karinen R., Posen J.T., Rogde S., & Vindenes V. (2014). An accidental poisoning with mitragynine. Forensic Science International, 245, 29-32.
43 Pullman M.K., Raju Kanumuri S.R., Leon J.F., Cutler S.F., McCurdy C.R., & Sharma. A. (2026). Cardio-pulmonary arrest in a patient revived with naloxone following reported use of 7-hydroxymitragynine. Clinical Toxicology, 64(1), 65-66.
44 Wightman, R.S., & Hu, D. (2025). A Case of 7-OH Mitragynine Use Requiring Inpatient Medically Managed Withdrawal. Journal of Addiction Medicine, Aug 4
-32.
43 Pullman M.K., Raju Kanumuri S.R., Leon J.F., Cutler S.F., McCurdy C.R., & Sharma. A. (2026). Cardio-pulmonary arrest in a patient revived with naloxone following reported use of 7-hydroxymitragynine. Clinical Toxicology, 64(1), 65-66.
44 Wightman, R.S., & Hu, D. (2025). A Case of 7-OH Mitragynine Use Requiring Inpatient Medically Managed Withdrawal. Journal of Addiction Medicine, Aug 4. doi: 10.1097/ADM.0000000000001558. Advance online publication.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 7-hydroxymitragynine pose an imminent hazard to public safety. DEA is not aware of any currently accepted medical uses for 7-hydroxymitragynine in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 7-hydroxymitragynine indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
As required by 21 U.S.C. 811(h)(4), the Administrator notified the Assistant Secretary, via letter dated February 24, 2026, of DEA's intention to temporarily place 7-hydroxymitragynine above a specified threshold in schedule I. In a letter dated March 6, 2026, the Assistant Secretary for Health had no objection to the temporary placement of 7-hydroxymitragynine above the specified threshold in schedule I
ired by 21 U.S.C. 811(h)(4), the Administrator notified the Assistant Secretary, via letter dated February 24, 2026, of DEA's intention to temporarily place 7-hydroxymitragynine above a specified threshold in schedule I. In a letter dated March 6, 2026, the Assistant Secretary for Health had no objection to the temporary placement of 7-hydroxymitragynine above the specified threshold in schedule I.
Conclusion
This notice of intent provides the 30-day notice pursuant to 21 U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order. In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule 7-hydroxymitragynine above a specified threshold in schedule I of the CSA, and finds that placement of this substance above a specified threshold in schedule I of the CSA is necessary in order to avoid an imminent hazard to the public's safety.
The temporary placement of 7-hydroxymitragynine above a specified threshold in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before August 5, 2026. Because the Administrator hereby finds that this temporary scheduling order is necessary to avoid an imminent hazard to public safety, it will take effect on the date the order is published in the Federal Register and remain in effect for two years, with a possible extension of an additional year, pending completion of the regular (permanent) scheduling process. 45 The Administrator intends to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this document
fety, it will take effect on the date the order is published in the Federal Register and remain in effect for two years, with a possible extension of an additional year, pending completion of the regular (permanent) scheduling process. 45 The Administrator intends to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this document. Upon publication of the temporary order, 7-hydroxymitragynine above a specified threshold will then be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession.
45 21 U.S.C. 811(h)(1) and (2).
The CSA sets forth specific criteria for scheduling drugs or other substances. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 46 The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 47 Temporary scheduling orders are not subject to judicial review. 48
46 21 U.S.C. 811.
47 21 U.S.C. 877.
48 21 U.S.C. 811(h)(6).
Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to public safety. Under 21 U.S.C. 811(h)(1), the Administrator (as delegated by the Attorney General) may, by order, temporarily schedule substances in schedule I
ders are not subject to judicial review. 48
46 21 U.S.C. 811.
47 21 U.S.C. 877.
48 21 U.S.C. 811(h)(6).
Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to public safety. Under 21 U.S.C. 811(h)(1), the Administrator (as delegated by the Attorney General) may, by order, temporarily schedule substances in schedule I. Such orders may not be issued before the expiration of 30 days from: (1) the publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary of HHS, as delegated by the Secretary of HHS. 49
49 21 U.S.C. 811(h)(1).
Inasmuch as section 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, including the requirement of a publication in the Federal Register of a notice of intent, the notice-and-comment requirements of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. The APA expressly differentiates between an order and a rule, as it defines an “order” to mean a “final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making. ” 50 This contrasts with permanent scheduling actions, which are subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” and final decisions that conclude the scheduling process and are subject to judicial review. 51 The specific language chosen by Congress indicates its intent that DEA issue orders instead of proceeding by rulemaking when temporarily scheduling substances
ponse to the notice that DEA transmitted to the Acting Assistant Secretary pursuant to such subsection.
Further, DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. As discussed above, DEA is issuing this notice of intent pursuant to DEA's authority to issue a temporary scheduling order. 53 Therefore, in this instance, since DEA believes this temporary scheduling action is not a “rule,” it is not subject to the requirements of the RFA when issuing this temporary action.
53 21 U.S.C. 811(h)(1).
In accordance with the principles of Executive Orders (E.O.) 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. Because this is not a rulemaking action, this is not a significant regulatory action as defined in Section 3(f) of E.O. 12866. In addition, DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.
This action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O
t to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.
This action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.

For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for part 1308 continues to read as follows:
Authority:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
2. In § 1308.11: Add paragraph (h)(91) to read as follows:
§ 1308.11 Schedule I
(h) * * *
*         *         *         *         *         *         * (91) Methyl ( E )2-((2 S, 3 S, 7 aS )-3-ethyl-7 a -hydroxy-8-methoxy-1,2,3,4,6,7,7 a, 12 b -octahydroindolo[2,3- a ]quinolizin-2-yl)-3-methoxyacrylate (commonly known as 7-hydroxymitragynine; also known as (αE,2 S, 3 S, 7a S, 12b S )-3-ethyl-l,2,3,4,6,7,7a,12b-octahydro-7a-hydroxy-8-methoxy-a-(methoxymethylene)-indolo[2,3- a ]quinolizine-2-acetic acid, methyl ester) above a specified threshold, described as: 9675 (A) Any botanical material of the plant Mitragyna speciosa, also known as kratom, and contains more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis, or (B) Any alternative article or material to that described in (A), that is: i. Resulting from synthetic methods and containing 7-hydroxymitragynine present in amounts greater than 0.050 percentage weight/weight, weight/volume, or volume/volume or greater than 1.00 milligram of 7-hydroxymitragynine in the article, or ii
ins more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis, or (B) Any alternative article or material to that described in (A), that is: i. Resulting from synthetic methods and containing 7-hydroxymitragynine present in amounts greater than 0.050 percentage weight/weight, weight/volume, or volume/volume or greater than 1.00 milligram of 7-hydroxymitragynine in the article, or ii. Material derived from Mitragyna speciosa and further processed to manufacture alternative dosage forms such as extracts, concentrates, processed edibles, or pressed pills, and which may have materials that have been exposed to chemical, thermal, or other methods leading to chemical transformations that result in 7-hydroxymitragynine present in amounts greater than 0.050 percentage weight/weight, weight/volume, or volume/volume or greater than 1.00 milligram of 7-hydroxymitragynine in the article. *         *         *         *         *         *         *
Signing Authority
This document of the Drug Enforcement Administration was signed on July 1, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration.

[FR Doc. 2026-13580 Filed 7-1-26; 4:15 pm] BILLING CODE P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2026-13580. Check the current official text before relying on it. Not legal advice.