[Federal Register Volume 91, Number 127 (Monday, July 6, 2026)]
[Proposed Rules]
[Pages 40917-40924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-13580]
[[Page 40917]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1570]
Schedules of Controlled Substance: Temporary Placement of 7-
Hydroxymitragynine Above a Specified Threshold in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notice of intent.
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SUMMARY: 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.
DATES: July 6, 2026.
ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The notice of intent contained in this
document is issued pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to
issue a temporary scheduling order \1\ (in the form of a temporary
amendment) to add 7-hydroxymitragynine \2\ above a specified threshold
described herein, 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 specified threshold for 7-
hydroxymitragynine was adapted from the definition used by the
Department of Health and Human Services (HHS),\3\ which is described as
follows:
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice of intent
adheres to the statutory language of 21 U.S.C. 811(h), which refers
to a ``temporary scheduling order.'' No substantive change is
intended.
\2\ Chemical name: Methyl (E)-2-((2S,3S,7aS)-3-ethyl-7a-hydroxy-
8-methoxy-1,2,3,4,6,7,7a,12b-octahydroindolo[2,3-a]quinolizin-2-yl)-
3-methoxyacrylate (also known as: ([alpha]E,2S,3S,7aS,12bS)-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).
\3\ In a letter dated July 28, 2025, pursuant to 21 U.S.C.
811(b) and (c), HHS provided to DEA a scientific and medical
evaluation entitled ``Basis for the Recommendation to Control 7-
Hydroxymitragynine and its Salts, As Present in excess of the
Specified Threshold Limit Described Herein, in Schedule I of the
Controlled Substances Act.''
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(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 to that described in (A), that is:
i. Resulting from synthetic methods and containing 7-
hydroxymitragynine present in amounts greater than 0.050 percentage by
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 by weight/weight, weight/volume,
or volume/volume, or greater than 1.00 milligram of 7-
hydroxymitragynine in the article.
The temporary scheduling order will be published in the Federal
Register on or after August 5, 2026.
Legal Authority
The CSA provides the Attorney General with the authority to
temporarily place a substance in schedule I of the CSA for two years
without regard to the requirements of 21 U.S.C. 811(b), if he finds
that such action is necessary to avoid an imminent hazard to public
safety.\4\ In addition, if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily
controlled under section 811(h), the Attorney General may extend the
temporary scheduling for up to one year.\5\
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\4\ 21 U.S.C. 811(h)(1).
\5\ 21 U.S.C. 811(h)(2).
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Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
21 U.S.C. 812, or if there is no exemption or approval in effect for
the substance under section 505 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), 21 U.S.C. 355.\6\ The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of DEA
(Administrator).\7\
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\6\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
\7\ 28 CFR 0.100.
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Background
The CSA requires the Administrator to notify the Secretary of HHS
of this intent to issue a temporary scheduling order.\8\ By letter
dated February 24, 2026, the Administrator transmitted the required
notice to place 7-hydroxymitragynine above a specified threshold 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.
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\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).
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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\
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\10\ 21 U.S.C. 811(c)(4)-(6), (h)(3).
\11\ 21 U.S.C. 811(h)(3).
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Substances meeting the statutory requirements for temporary
scheduling
[[Page 40918]]
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\
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\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. In a recent published letter in a
different context, HHS applied an additional two-part test to
determine currently accepted medical use for substances that do not
satisfy the five-part test: (1) whether there exists widespread,
current experience with medical use of the substance by licensed
health care providers operating in accordance with implemented
jurisdiction-authorized programs, where medical use is recognized by
entities that regulate the practice of medicine, and, if so, (2)
whether there exists some credible scientific support for at least
one of the medical conditions for which part (1) is satisfied. On
April 11, 2024, the Department of Justice's Office of Legal Counsel
(OLC) issued an opinion, which, among other things, concluded that
HHS's two-part test would be sufficient to establish that a drug has
a currently accepted medical use. Office of Legal Counsel,
Memorandum for Merrick B. Garland Attorney General Re: Questions
Related to the Potential Rescheduling of Marijuana at 3 (April 11,
2024). For purposes of this notice of intent, there is no evidence
that health care providers have widespread experience with medical
use of 7-hydroxymitragynine or that the use of this substance is
recognized by entities that regulate the practice of medicine, so
the two-part test also is not satisfied. In HHS' letter dated March
6, 2026, HHS advised DEA that there were currently no approved NDAs
or INDs for these substances. Additionally, HHS noted it had no
objections to the temporary placement of this 7-hydroxymitragynine
above the specified threshold in schedule I of the CSA.
\14\ 21 U.S.C. 812(b)(1).
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7-Hydroxymitragynine Above a Specified Threshold 7-
Hydroxymitragynine is a psychoactive alkaloid found in Mitragyna
speciosa (M. speciosa) plant, a tropical evergreen tree indigenous to
Southeast Asia. While the use of the plant was once geographically
limited, the use of M. speciosa has since extended to the United States
and other global markets. Among the numerous alkaloids identified in M.
speciosa, the indole alkaloids mitragynine (major) and 7-
hydroxymitragynine (minor) are primarily responsible for the plant's
psychoactive effects. In its natural botanical form, 7-
hydroxymitragynine makes up less than two percent of the total alkaloid
content or occurs in trace amount in M. speciosa. 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 in vivo. 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 of
action of 7-hydroxymitragynine molecule remain unchanged regardless of
its source. While consumers of raw plant matrix may experience a
modified or attenuated physiological effect due to the competitive, co-
occurring alkaloids inherent to M.speciosa, isolated or semi-
synthetically derived formulations deliver unattenuated, high-potency
effects of the target alkaloid directly, representing a distinct public
safety profile when concentrated above the proposed threshold.
Recently, the United States has seen a proliferation of 7-
hydroxymitragynine products. Evidence suggests that commercially
available products, including extracts and synthetic formulations,
contain a significantly higher concentration of 7-hydroxymitragynine
than what is found in botanical M. speciosa. These products are
commonly sold on the internet and in retail outlets, such as gas
stations and smoke shops, in various forms, including powders, tablets,
gummies, and sublingual films designed for rapid absorption. To date,
the safety profile of these concentrated products in humans remains
unknown because no controlled clinical trials have been conducted to
establish safe consumption limits or standardized dosing.
7-Hydroxymitragynine has opioidergic activity, sharing a similar
pharmacological profile to schedule II opioids like morphine.
Preclinical data \15\ indicates that 7-hydroxymitragynine carries a
high abuse potential with safety risks, including tolerance,
dependence, and respiratory depression, which are comparable to those
of classic opioid analgesics. The United States has recently seen an
emergence of products containing 7-hydroxymitragynine, which are often
characterized by ambiguous dosages and misleading marketing, frequently
being labeled as ``natural M. speciosa extracts.'' While sellers
promote these products for their euphoric and opioidergic effects,
evidence demonstrates they may also contain other opioid alkaloids,
such as mitragynine pseudoindoxyl. These combinations, coupled with a
lack of regulatory oversight, pose significant safety risk to
unsuspecting consumers by exposing them to high doses of opioids. The
absence of clinical evidence to support vendor health claims is deeply
concerning. Consequently, 7-hydroxymitragynine products sold as
unregulated dietary supplements pose significant health risks, as
essential information regarding their purity, identity, quantity and
long-term safety remain unknown.
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\15\ Hemby, S.E., McIntosh, S., Leon, F., Cutler, S.J., &
McCurdy, C.R. (2019). Abuse liability and therapeutic potential of
the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-
hydroxymitragynine. Addiction biology, 24(5), 874-885.
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7-Hydroxymitragynine does not meet the United States Food and Drug
Administration (FDA) safety standard for dietary supplements, or
dietary ingredients, and it has not been proven safe or effective for
any drug use. FDA has issued warning letters to companies clarifying
that 7-hydroxymitragyine is not an FDA-approved drug product and no
food 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.\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.
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\16\ FDA Issues Warning Letters to Firms Marketing Products
Containing 7-Hydroxymitragynine [verbar] 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%20F
irms%20Marketing%20Products%20Containing%207%2DHydroxymitragynine,-
Alkaloid%20known%20as&text=The%20U.S.%20Food%20and%20Drug,also%20know
n%20as%207%2DOH, Accessed July 31, 2025.
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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
[[Page 40919]]
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.\18\ In recent years, 7-
hydroxymitragynine has been unlawfully marketed as a dietary supplement
\19\ or natural extract despite failing to meet FDA's safety standard
for dietary supplements or dietary ingredients. Anecdotal information
from users who post on social media indicates that many users are self-
treating chronic pain with unregulated 7-hydroxymitragynine
products.\20\
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\17\ Grundmann, O., Green, M., Berthold, E., Yoon, S.L., & Ray,
D. (2025). Prevalence and Use Patterns of Kratom (Mitragyna speciosa
Korth.) in a US Nationally Representative Sample. Journal of
psychoactive drugs, 1-9.
\18\ Smith, K.E., Boyer, E.W., Grundmann, O., McCurdy, C.R., &
Sharma, A. (2025). The rise of novel, semi-synthetic 7-
hydroxymitragnine products. Addiction (Abingdon, England), 120(2),
387-388.
\19\ FDA issued warning letters to firms marketing products
containing 7-hydroxymitragynine stating it is not a lawful dietary
supplement, food additive, or ingredient in any approved drug''. FDA
Issues Warning Letters to Firms Marketing Products Containing 7-
Hydroxymitragynine [verbar] FDA, available at https://www.fda.gov/
news-events/press-announcements/fda-issues-warning-letters-firms-
marketing-products-containing-7-
hydroxymitragynine#:~:text=FDA%20Issues%20Warning%20Letters%20to%20Fi
rms%20Marketing%20Products%20Containing%207%2DHydroxymitragynine,-
Alkaloid%20known%20as&text=The%20U.S.%20Food%20and%20Drug,also%20know
n%20as%207%2DOH, accessed on July 15, 2025.
\20\ National Drug Early Warning System (NDEWS). (2025). Alert
from the NDEWS Web Monitoring Team: Online mentions of Kratom and
Derivatives (May 30, 2025). Retrieved from ndews.org.
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Product Formulation and Marketing Claims
7-Hydroxymitragynine products are readily obtained from smoke
shops, gas stations, and online vendors in various forms, including
tablets, liquid oral beverages (shots), capsules, powder, syrup, vapes,
sublingual pouch/strips, nasal spray, chewable, and liquid extracts.
These products are commonly sold with names such as ``7 Ohmz,'' ``7-
hydroxy,'', and ``7-OH,'' and they are presented in colorful packages.
One investigation identified 250 products sold between September 2024
through February 2025, noting that chewable/sublingual tablets were the
most common formulation.\21\ These products were sold for general
wellbeing and claims of increased focus. The investigation further
highlighted the concerns regarding standardized dosing and cost. The
concentration of 7-hydroxymitragynine products varied significantly,
ranging from 1 mg to 700 mg in a single dose or serving. The average
cost per dose across most products containing 7-hydroxymitragynine was
about $3.97.
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\21\ Hill, K., Boyer, E.W., Grundmann, O., & Smith, K.E. (2025).
De facto opioids: Characterization of novel 7-hydroxymitragynine and
mitragynine pseudoindoxyl product marketing. Drug and Alcohol
Dependence, 272, 112701.
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Anecdotal information synthesized from user-contributed reports and
subsequently analyzed by clinical educators \22\ between 2024 and early
2025 provide additional information on abuse patterns. Users
consistently report transition from traditional kratom leaf to 7-
hydroxymitragynine tablets (e.g., 7OHMZ, Press'd, Hydroxie). 7-
Hydroxymitragynine was described as ``the cleanest and most euphoric
high'' that lacks ``ceiling effect of nausea'' of the plain leaf. A
dominant theme is the short-lived nature of the 7-hydroxymitragynine
high. Users report the urge to redose frequently.
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\22\ University of Connecticut School of Pharmacy and
Pharmaceutical Sciences. (2025), Kratom and Knock Offs, Should You
Leaf Them Alone: You Asked for It!. available at https://pharmacy.uconn.edu/course/kratom/.
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The National Drug Early Warning System (NDEWS) conducted web
monitoring on reddit mentions of kratom and its derivates. In the
report, information provided by reddit discussants surrounding kratom
and 7-hydroxymitragynine shows that users often compare 7-
hydroxymitragynine effects to prescription opioids, like oxycodone and
hydrocodone, with users expressing worry on how such potent products
are legally available at smoke shops. Commenters mentioned the ease and
convenience of buying products at gas stations and noted how this can
be a concern for impulse use due to ease of accessibility. Further,
discussions on full commercial retail package prices ranged from $15-40
per retail unit,\23\ which is consistent with multi-dose presentation
of these commercial formulations.
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\23\ Alert from the NDEWS Web Monitoring Team: Online mentions
of Kratom and Derivatives (May 30, 2025). Retrieved from ndews.org.
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In summary, 7-hydroxymitragynine products are available in
different forms and can be purchased easily via several avenues,
predominantly via the internet. This is a shift from traditional
botanical use to aggressive marketing of highly concentrated opioid
products in the United States.
Factor 5. Scope, Duration, and Significance of Abuse
The abuse of 7-hydroxymitragynine is increasing and widespread.
Given its pharmacological profile as an opioid agonist and high abuse
potential,\24\ the marketing of 7-hydroxymitragynine products to
consumers as botanical supplements constitute a significant public
health risk. 7-Hydroxymitragynine, a potent opioid, presents overdose
risk and toxicity to users because its chemical manufacturing process
is inconsistent and does not adhere to good manufacturing practices.
This lack of oversight may lead to variation in doses and composition
in final products. Further, 7-hydroxymitragynine is sold as sublingual
pouch/tablet, a formulation known to deliver drugs rapidly into the
systemic circulation. This rapid delivery, coupled with 7-
hydroxymitragynine's known pharmacokinetic profile, contributes to its
high potential for abuse.\25\
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\24\ Hemby, S.E., McIntosh, S., Leon, F., Cutler, S.J., &
McCurdy, C.R. (2019). Abuse liability and therapeutic potential of
the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-
hydroxymitragynine. Addiction Biology, 24(5), 874-885.
\25\ Hill, K., Boyer, E. W., Grundmann, O., & Smith, K.E.
(2025). De facto opioids: Characterization of novel 7-
hydroxymitragynine and mitragynine pseudoindoxyl product marketing.
Drug and Alcohol Dependence, 272, 112701; Sharma, A., Smith, K.E.,
Kuntz, M.A., Berthold, E.C., Elashkar, O.I., Guadagnoli, N.,
Kanumuri, S. R.R., Mukhopadhyay, S., Panlilio, L.V., Epstein, D.H.,
& McCurdy, C. R. (2025). Chemical Analysis and Alkaloid Intake for
Kratom Products Available in the United States. Drug Testing and
Analysis, 17(10), 1974-1984.
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7-hydroxymitragynine sellers make claims of its opioidergic
effects. Evidence demonstrates that 7-hydroxymitragynine products have
been identified to contain other opioid alkaloids, such as mitragynine
pseudoindoxyl.\26\ These combinations and practice pose significant
safety risks to unsuspecting consumers by exposing them to high doses
of opioids. The lack of evidence to support health claims made by
vendors selling 7-hydroxymitragynine products is
[[Page 40920]]
worrisome. Hence, 7-hydroxymitragynine products sold as dietary
supplements pose significant health risks to users because information
on their purity, identity, quantity and safety is unknown.
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\26\ 7-Hydroxy Mitragynine NPS Discovery, available at https://www.cfsre.org/images/content/reports/public_alerts/7-Hydroxy_Mitragynine_NPS_Discovery_033125.pdf, accessed March 10,
2026.
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Law Enforcement Encounters
The number of seizures for 7-hydroxymitragynine as reported in law
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.
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\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.
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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.\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.''
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\28\ FDA Issues Warning Letters to Firms Marketing Products
Containing 7-Hydroxymitragynine [verbar] 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 [verbar] 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.
\29\ Thang Botanicals, Inc. d/b/a 7[ohm]HMZ, 7-OHMZ, or 7OHMZ-
710190-06/25/2025 [verbar] 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.
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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.
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
[[Page 40921]]
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.
---------------------------------------------------------------------------
[ssquf] Desired Effects: Euphoria and an opioid-like ``buzz''/high
as motivation for using 7-hydroxymitragynine.
[ssquf] 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.
[ssquf] Self-Treatment: Claim of 7-hydroxymitragynine therapeutic
value in self-treating pain and anxiety.
[ssquf] 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. 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. The total count for 2025
increased to 66 with 17 new cases already reported for 2026. Of the
total 86 cases currently within the database, 79 cases were reported as
serious, including death. To date, 9 cases within the FAERS database
have resulted in death.
DEA Toxicology Testing Program (DEA TOX)
DEA TOX program, which investigates the presence of new
psychoactive substances in biological samples from drug overdoses, has
identified 7-hydroxymitragynine in 85 cases since 2019.\37\ Of these,
55 were fatal and 30 were non-fatal cases. These cases involved both
males and females with a median age of 36. The average concentration of
7-hydroxymitragynine detected in biological samples was 463.23 ng/mL.
Samples often contained other related alkaloids (mitragynine and
mitragynine pseudoindoxyl) or other drug classes, such as opioids (e.g.
fentanyl), benzodiazepines (e.g. bromazolam), and ketamine. Between
2020 and 2025, there has been a significant increase in the positive
identification of 7-hydroxymitragynine in fatal overdose cases.
---------------------------------------------------------------------------
\37\ DEA TOX is a surveillance program that aims to detect novel
psychoactive substances in fatal and nonfatal overdose cases within
the United States. From these cases, biological samples, as well as
drug paraphernalia (on limited occasions), are submitted for
analysis by hospitals, medical examiners, poison centers, and law
enforcement nationwide. Queried on March 5, 2026.
---------------------------------------------------------------------------
Case Reports Involving 7-Hydroxymitragynine
In 2025, California,\38\ Pennsylvania,\39\ and Texas health
authorities linked 7-hydroxymitragynine and concentrated extracts to
several illness and overdose cases.\40\ Other notable cases are
summarized in the table below:
---------------------------------------------------------------------------
\38\ LISTING OF DEPARTMENT OF PUBLIC HEALTH PRESS RELEASES,
available at http://publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5156. October 10, 2025.
\39\ Increased Volume of Calls Related to Kratom/Mitragynine and
7-hydroxymitragynine (7-OH) to Pennsylvania's Poison Centers,
available at https://www.pa.gov/content/dam/copapwp-pagov/en/health/documents/topics/documents/2025%20HAN/2025-802-%208-4-%20Kratom.pdf.
August 4, 2025.
\40\ Serious Illnesses Associated with 7-OH Use [verbar] Texas
DSHS, available at https://www.dshs.texas.gov/news-alerts/serious-illnesses-associated-7-oh-use. September 2, 2025.
[[Page 40922]]
7-Hydroxymitragynine Case reports
[2014-2026]
----------------------------------------------------------------------------------------------------------------
Case report author Patient profile Primary complication Clinical finding
----------------------------------------------------------------------------------------------------------------
Broul et al. (2025) \41\........... 31 y/o male........... Acute Psychosis....... Severe Self-Harm:
Documented 7-
hydroxymitragynine induced
psychosis leading to self-
amputation (ears/
genitalia).
Karinen et al. (2014) \42\......... 24 y/o male........... Fatal Overdose........ Fatality: Identified a 7-
hydroxymitragynine blood
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., Kr[aacute]l, J., Kyenge,
D.M., Sta[ncaron]kov[aacute], 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. doi: 10.1097/ADM.0000000000001558.
Advance online publication.
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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.
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. 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).
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[[Page 40923]]
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. Given that Congress specifically requires the Administrator
(as delegated by the Attorney General) to follow rulemaking procedures
for other kinds of scheduling actions,\52\ it is noteworthy that, in
section 811(h)(1), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule.
---------------------------------------------------------------------------
\50\ 5 U.S.C. 551(6) (emphasis added).
\51\ 21 U.S.C. 811(a) and 877.
\52\ See 21 U.S.C. 811(a).
---------------------------------------------------------------------------
Even assuming that this notice of intent is subject to the notice-
and-comment requirements of the APA, the Administrator finds that there
is good cause to forgo the those requirements pursuant to 5 U.S.C.
553(b)(B), as any further delays in the process for issuing temporary
scheduling orders would be impracticable and contrary to the public
interest given the manifest urgency to avoid an imminent hazard to
public safety.
Although DEA believes this notice of intent to issue a temporary
scheduling order is not subject to the notice-and-comment requirements
of the APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the
Administrator took into consideration comments submitted by the Acting
Assistant Secretary in response 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. 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
0
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.
0
2. In Sec. 1308.11: Add paragraph (h)(91) to read as follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(91) Methyl (E)2-((2S,3S,7aS)-3-ethyl-7a-hydroxy-8- 9675
methoxy-1,2,3,4,6,7,7a,12b-octahydroindolo[2,3-
a]quinolizin-2-yl)-3-methoxyacrylate (commonly known as
7-hydroxymitragynine; also known as
([alpha]E,2S,3S,7aS,12bS)-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:
(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..........
[[Page 40924]]
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