[Federal Register Volume 91, Number 164 (Wednesday, August 26, 2026)]
[Rules and Regulations]
[Pages 54948-54956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-17429]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1644]
Schedules of Controlled Substances: Temporary Placement of
Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this
temporary order to schedule three 7-hydroxymitragynine-related
substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers, whenever the existence of such isomers, esters, ethers, and
salts is possible, in schedule I of the Controlled Substances Act. DEA
bases this action on a finding that placing mitragynine pseudoindoxyl,
MGM-15, and MGM-16 in schedule I is necessary to avoid an imminent
hazard to public safety. This order imposes the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess) or
propose to handle these three 7-hydroxymitragynine-related substances.
DATES: This temporary order is effective August 26, 2026, until August
26, 2028. If this order is extended or made permanent, DEA will publish
a document in the Federal Register.
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 Drug Enforcement Administration (DEA)
[[Page 54949]]
issues a temporary scheduling order \1\ (in the form of a temporary
amendment) to add three 7-hydroxymitragynine-related substances,
including their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers, whenever the existence of such isomers, esters,
ethers, and salts is possible, to schedule I under the Controlled
Substances Act (CSA):
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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.
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Methyl (E)-2-((1'S,6'S,7'S)-6'-ethyl-4-methoxy-3-oxo-
3',5',6',7',8',8a'-hexahydro-2'H-spiro[indoline-2,1'-indolizine]-7'-
yl)-3-methoxyacrylate (commonly known as mitragynine pseudoindoxyl).
Since nomenclature of this substance is not internationally
standardized, compounds of this structure, regardless of numerical
designation of atomic positions are covered.
Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-7a-hydroxy-8-
methoxy-1,2,3,4,6,7,7a,12,12a,12b-decahydroindolo[2,3-a]quinolizin-2-
yl)-3-methoxyacrylate (commonly known as MGM-15; also known as dihydro-
7-hydroxymitragynine). Since nomenclature of this substance is not
internationally standardized, compounds of this structure, regardless
of numerical designation of atomic positions are covered.
Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-9-fluoro-7a-
hydroxy-8-methoxy-1,2,3,4,6,7,7a,12,12a,12b-decahydroindolo[2,3-
a]quinolizin-2-yl)-3-methoxyacrylate (commonly known as MGM-16; also
known as 9-fluoro-dihydro-7-hydroxymitragynine; or 10-fluoro-dihydro-7-
hydroxymitragynine (depending on numbering convention). Since
nomenclature of this substance is not internationally standardized,
compounds of this structure, regardless of numerical designation of
atomic positions are covered.
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.\2\ 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.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 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, 21 U.S.C. 355.\4\ The Attorney General has delegated scheduling
authority under 21 U.S.C. 811 to the Administrator of DEA
(Administrator).\5\
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\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
\5\ 28 CFR 0.100.
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Background
The CSA requires the Administrator to notify the Secretary of the
Department of Health and Human Services (HHS) of an intent to
temporarily place a substance in schedule I of the CSA (i.e., to issue
a temporary scheduling order).\6\ By letter dated December 15, 2025,
the Administrator transmitted the required notice to place mitragynine
pseudoindoxyl, MGM-15, and MGM-16 in schedule I on a temporary basis to
the Assistant Secretary for Health of HHS (Assistant Secretary).\7\ By
letter dated January 20, 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
mitragynine pseudoindoxyl, MGM-15, and MGM-16. The Assistant Secretary
also stated that HHS had no objection to the temporary placement of
these substances in schedule I of the CSA.
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\6\ 21 U.S.C. 811(h)(4).
\7\ 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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DEA has taken into consideration the Assistant Secretary's comments
as required by 21 U.S.C. 811(h)(4). DEA has found the control of
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I on a
temporary basis is necessary to avoid an imminent hazard to public
safety.
As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule mitragynine pseudoindoxyl, MGM-15,
and MGM-16 in the Federal Register on July 6, 2026.\8\ That NOI
discussed findings from DEA's three-factor analysis dated May 2026,
which DEA made available on www.regulations.gov.
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\8\ Schedules of Controlled Substances: Temporary Placement of
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I, 91 FR
40909 (July 6, 2026).
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To find that temporarily placing a substance 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.\9\ Consideration of these factors includes
any information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
mitragynine pseudoindoxyl, MGM-15, and MGM-16.\10\
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\9\ 21 U.S.C. 811(c)(4)-(6), (h)(3).
\10\ 21 U.S.C. 811(h)(3).
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Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\11\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States,\12\ and a lack of accepted
[[Page 54950]]
safety for use under medical supervision.\13\
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\11\ 21 U.S.C. 811(h)(1).
\12\ 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 mitragynine
pseudoindoxyl, MGM-15, and MGM-16 have a currently accepted medical
use in treatment in the United States. First, DEA looks to whether
the drug or substance has FDA approval for marketing in interstate
commerce. 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. Since 2023, HHS has generally applied its own 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 temporary order, there is no
evidence that health care providers have widespread experience with
medical use of mitragynine pseudoindoxyl, MGM-15, and MGM-16, or
that the use of these substances is recognized by entities that
regulate the practice of medicine, so the two-part test also is not
satisfied. In its letter dated January 20, 2026, HHS advised DEA
that there were currently no approved NDAs or INDs for mitragynine
pseudoindoxyl, MGM-15, and MGM-16. Additionally, HHS noted it had no
objections to the temporary placement of these substances in
schedule I of the CSA.
\13\ 21 U.S.C. 812(b)(1).
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Three 7-Hydroxymitragynine-Related Substances: Mitragynine
Pseudoindoxyl, MGM-15, and MGM-16
The prevalence and misuse of Mitragyna speciosa (commonly known as
kratom) and its psychoactive alkaloids, including mitragynine and 7-
hydroxymitragynine, have led to the proliferation of commercial
products containing opioids chemically synthesized from mitragynine or
7-hydroxymitragynine. In recent years, mitragynine pseudoindoxyl, which
is a chemical rearrangement product of 7-hydroxymitragynine, and MGM-
15, which is a derivative of 7-hydroxymitragynine, have recently
emerged on the Mitragyna speciosa consumer markets. MGM-16 is a highly
potent opioid and shares a similar pharmacological profile with
mitragynine pseudoindoxyl and MGM-15. The chemical scaffolds of
mitragynine or 7-hydroxymitragynine were used in scientific research to
develop mitragynine pseudoindoxyl, MGM-15, or MGM-16 via chemical
modifications of purified isolates. Evidence from the Mitragyna
speciosa retail markets demonstrates that mitragynine pseudoindoxyl and
MGM-15 have transitioned from experimental substances studied in
research to widely available commercial products. These products are
commonly sold in different forms such as powders, tablets, and liquid
shots. This is a significant evolution from the traditional
administration of Mitragyna speciosa, which was once restricted to
either chewing raw leaves or steeping the leaves into water decoctions
and teas.
These products are sold under numerous brand names like Kama,
Hydroxie, Fruity Perks, and Happie Tabs,\14\ and they are easily
purchased on the internet, as well as in gas stations, corner shops,
and vape shops. These products are available in consumer-friendly
forms, including flavored chewable tablets, which increases their
appeal to a broader demographic. Also, the aggressive marketing of
these semisynthetic opioids (mitragynine pseudoindoxyl, MGM-15) as
``precision-formulated products,'' ``botanical extracts,'' or as ``mood
boosters'' for the treatment of health conditions is deeply concerning.
The branding creates a false sense of safety for unknowing consumers
who may equate the term ``botanical'' with lower risk. Furthermore,
there is paucity of data on quality control or standardized dosage
available for these products, making their use especially dangerous.
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\14\ The list of brand names is illustrative, non-exhaustive,
and provided solely as market context.
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Mitragynine pseudoindoxyl, MGM-15, and MGM-16 are potent opioids
that share a similar pharmacological profile with 7-hydroxymitragynine
and morphine. Available pharmacology data demonstrate that mitragynine
pseudoindoxyl, MGM-15, and MGM-16 exhibit strong affinity for the mu-
opioid receptor (MOR) and function as MOR agonists.15 16
Data from preclinical studies show that these substances produce
analgesic effects that is more potent than morphine.\17\ Because
mitragynine pseudoindoxyl, MGM-15, and MGM-16 are potent MOR agonists,
they pose similar health risks as other mu-opioid agonists (i.e.,
morphine and fentanyl), including physical and psychological
dependence, and respiratory depression.
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\15\ Matsumoto, K., Narita, M., Muramatsu, N., Nakayama, T.,
Misawa, K., Kitajima, M., Tashima, K., Devi, L.A., Suzuki, T.,
Takayama, H., & Horie, S. (2014). Orally active opioid [mu]/[delta]
dual agonist MGM-16, a derivative of the indole alkaloid
mitragynine, exhibits potent antiallodynic effect on neuropathic
pain in mice. The Journal of Pharmacology and Experimental
Therapeutics, 348(3):383-392.
\16\ Yamamoto, L.T., Horie, S., Takayama, H., Aimi, N., Sakai,
S., Yano, S., Shan, J., Pang, P.K., Ponglux, D., & Watanabe, K.
(1999). Opioid receptor agonistic characteristics of mitragynine
pseudoindoxyl in comparison with mitragynine derived from Thai
medicinal plant Mitragyna speciosa. General Pharmacology, 33(1):73-
81.
\17\ V[aacute]radi, A., Marrone, G.F., Palmer, T.C., Narayan,
A., Szab[oacute], M.R., Le Rouzic, V., Grinnell, S.G., Subrath,
J.J., Warner, E., Kalra, S., Hunkele, A., Pagirsky, J., Eans, S.O.,
Medina, J.M., Xu, J., Pan, Y.X., Borics, A., Pasternak, G.W.,
McLaughlin, J.P., & Majumdar, S. (2016). Mitragynine/Corynantheidine
Pseudoindoxyls As Opioid Analgesics with Mu Agonism and Delta
Antagonism, Which Do Not Recruit [beta]-Arrestin-2. Journal of
Medicinal Chemistry, 59(18):8381-8397.
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A scan of retail data on the internet shows that vendors explicitly
market mitragynine pseudoindoxyl and MGM-15 for their ``clean and
powerful'' opioid-receptor activation, utilizing deceptive terminology
to target individuals seeking alternatives to pharmaceutical opioids.
These combinations and marketing strategies pose significant safety
risks to unsuspecting consumers who use these products by exposing them
to high doses of opioids. Recently, reports have confirmed the positive
identification of mitragynine pseudoindoxyl and MGM-15 in toxicology
cases in the United States, and evidence demonstrates that these
substances are being misused. The lack of clinical data regarding their
safety and efficacy, coupled with the risk of life-threatening
respiratory depression and addiction, underscores the danger of
marketing these unapproved, highly potent opioids under the guise of
therapeutic or wellness products.
While no evidence supports the presence of MGM-16 on the Mitragyna
speciosa consumer market, its profile as a highly potent opioid that is
structurally related to 7-hydroxymitragynine lends itself as an
attractive substitute that could emerge on the illicit drug market.
MGM-16 is synthetically manufactured for research purposes and is not
approved for any clinical indication in the United States. DEA's
investigation of publicly available information, including popular
online platforms, revealed that at least some individuals intend to
abuse MGM-16. Recent online surveillance of a vendor site \18\ listed
MGM-16 for upcoming sale. The sale of products containing mitragynine
pseudoindoxyl and MGM-15, and the potential sale of MGM-16, poses an
imminent hazard to public safety.
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\18\ MGM Series Guide: Science of MGM-15 Alkaloids [verbar]
Getwell Depot. https://getwelldepot.com/mgm/. Accessed April 9,
2026. (Web content subsequently modified or removed; hardcopy
preserved in DEA administrative record)
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Available data and information for mitragynine pseudoindoxyl, MGM-
15, and MGM-16, summarized below, indicate that these substances 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. 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-
1644.
Factor 4. History and Current Pattern of Abuse
Mitragynine pseudoindoxyl, MGM-15, and MGM-16 are synthetic
derivatives of the indole alkaloids, mitragynine or 7-
hydroxymitragynine, of the Mitragyna speciosa plant. Unlike the indole
alkaloids mitragynine and 7-hydroxymitragynine, which are naturally
occurring in the plant, mitragynine pseudoindoxyl, MGM-15,
[[Page 54951]]
and MGM-16 are produced through synthetic modifications of purified
mitragynine isolates or 7-hydroxymitragynine.\19\ The chemical
scaffolds of mitragynine or 7-hydroxymitragynine were used in
scientific research to develop novel mitragynine pseudoindoxyl, MGM-15,
and MGM-16. The first mention of mitragynine pseudoindoxyl in
scientific literature dates to 1974 when mitragynine pseudoindoxyl was
isolated as a metabolite from bio-transformed mitragynine. In 2014, as
part of a drug discovery research, MGM-15 and MGM-16 were developed as
potent opioid agonists, with potential therapeutic utility for
pain.\20\
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\19\ Id. 13;14; Takayama, H., Ishikawa, H., Kurihara, M.,
Kitajima, M., Aimi, N., Ponglux, D., Koyama, F., Matsumoto, K.,
Moriyama, T., Yamamoto, L.T., Watanabe, K., Murayama, T., & Horie,
S. (2002). Studies on the synthesis and opioid agonistic activities
of mitragynine-related indole alkaloids: discovery of opioid
agonists structurally different from other opioid ligands. Journal
of Medicinal Chemistry, 45(9):1949-1956.
\20\ Id. 13.
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Market Emergence and Designer-Drug Patterns
The first confirmed appearance of mitragynine pseudoindoxyl in
consumer products was reported in 2024.\21\ The emergence of MGM-15 in
commercially available products was in September 2025.\22\ The
introduction of these substances into the Mitragyna speciosa consumer
market follows a classic pattern of new designer drugs, where packaging
appears like those of designer novel psychoactive substances and are
often advertised as ``sold strictly for laboratory, botanical, and
research purposes only'' and ``not intended for human consumption.''
\23\ A study on products sold online containing mitragynine
pseudoindoxyl showed that of the 51 total products sold online, 35 had
an appealing flavor (e.g., various berry, mint, watermelon, pink
lemonade, candy apple, grape, citrus, mango, pistachio, and vanilla
bean), and 32 of the products had packaging that was formulated using
bright colors. Seventy-six percent (39 of 51) of these products were
chewable tablets, 18 percent were liquids (9 of 51), and the remaining
three were either dried ice cream cones with ice cream (two products)
or a chocolate bar (one product).\24\ Many of the products typically
feature serving sizes that require consumers to split tablets or doses.
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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; Krotulski, A.J.; Denn, M.T., Brower, J.O.,
Papsun, D.M., & Logan, B.K. (2025). Evaluation of Commercially
Available Smoke Shop Products Marketed as ``7-Hydroxy Mitragynine''
& Related Alkaloids, Center for Forensic Science Research and
Education, United States; Vadiei, N., Evoy, K.E., & Grundmann, O.
(2025). The Impact of Diverse Kratom Products on Use Patterns,
Dependence, and Toxicity. Current Psychiatry Reports, 27(10):584-
592.
\22\ Gour, A., Mukhopadhyay, S., Henderson, A., Awad, A.,
Seabra, M.A., Pullman, M., Leon, F., Cutler, J.C., McCurdy, C.R., &
Sharma A. (2025). From Kratom to Semi-Synthetic Opioids: The Rise
and Risks of MGM-15. Drug Testing and Analysis, 17(12):2384-2389.
\23\ Id. 24.
\24\ White, C.M., Belcourt, J., & Sedensky, A. (2025). A
Descriptive Assessment of Products Containing the Opioid Receptor
Stimulator Mitragynine Pseudoindoxyl. Substance Use & Misuse,
60(12):1950-1954.
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Current Patterns of Use
Users seek mitragynine pseudoindoxyl and MGM-15 products for their
psychoactive effects and products are often advertised as mood
enhancers or alternative to prescription opioid analgesics (see Factor
5). These products are commonly sold in different product forms, such
as powders, tablets, or liquid shots, which is a sharp contrast from
the traditional mode of administration of Mitragyna speciosa, which was
confined to either water decoctions or brewed into tea or chewing of
fresh leaves. A review of vendor websites \25\ show that these products
are explicitly marketed as ``potent'' and ``fast-acting'' substances
and sold at low prices. For example, mitragynine pseudoindoxyl and MGM-
15 tablets are sold in varying fruit flavors and in bright colors, and
prices vary from about $2-4 per tablet or $34.99 per pack (single pack
and 10-pack bulk). Of great concern to DEA is that the price of these
products may facilitate high-frequency and rapid escalation of use.
Further, open-source signal detection demonstrates that users are
seeking MGM-16 with the intent to abuse.\26\
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\25\ Market Audit of Online Retailers, Jan. 2026.
\26\ Can anyone help with the MGM 16 rumors? r/
KratomKornerhttps://www.reddit.com/r/KratomKorner/comments/1kpz2u3/can_anyone_help_with_the_mgm_16_rumors/?rdt=48097. Accessed April 9,
2026.
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The shift from natural leaf decoctions of Mitragyna speciosa to
flavored, standardized, and high-potency semi-synthetic substances
suggests an intentional market strategy to maximize consumer appeal and
sale of products with rapid onset of effects. The use of ``research
chemical'' labeling, a common tactic to bypass regulatory oversight,
for flavored chewable products further demonstrates a pattern to reach
a broader consumer demographics.
Factor 5. Scope, Duration, and Significance of Abuse
The abuse of mitragynine pseudoindoxyl and MGM-15 is concerning due
to their high opioid potency and commercial availability. Mitragynine
pseudoindoxyl and MGM-15 products are sold in formulations that
facilitate ease of use, bypass the traditional, lower-alkaloid
preparation (chewing leaves or drinking tea), and provide a highly
potent effect that mimics classical opioids such as morphine.
Deceptive Branding and Market Infiltration
Analysis of marketed mitragynine pseudoindoxyl products revealed
misleading marketing strategies with claims that the products are
``kratom.'' Available information on vendor website indicates that the
concentrated alkaloid products often contain more than one alkaloid
with opioid activity (e.g., mitragynine and MGM-15 or 7-
hydroxymitragynine and mitragynine pseudoindoxyl). These substance
combinations and marketing practices pose significant safety risk to
unsuspecting consumers by exposing them to high doses of opioids, and
repeated use of opioids can lead to psychological and physical
dependence. In fact, data show that chronic use of 7-hydroxymitragynine
has sent users to opioid detox clinics and the need for opioid use
disorder medication.\27\ Furthermore, these products are labeled for
``strong mood enhancement'' and ``analgesic properties.'' Finally, the
presence of these products containing mitragynine pseudoindoxyl and
MGM-15 is deeply concerning because the identity, purity, and quality
of these products' formulations are uncertain, thus presenting
additional safety concerns for unsuspecting users. The potential
presence of MGM-16 in designer products would have similar concerns.
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\27\ Wightman, R.S., & Hu, D. (2025). A Case of 7-OH Mitragynine
Use Requiring Inpatient Medically Managed Withdrawal. Journal of
Addiction Medicine, 10.1097/ADM.0000000000001558. Advance online
publication.
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A study of products sold as mitragynine pseudoindoxyl over the
internet found that the 51 unique products sold online as mitragynine
pseudoindoxyl were marketed in child-appealing forms and contained
other opioid alkaloids, with limited consumer safety information. The
serving size varied and alkaloid concentrations for these marketed
products were often higher than those in naturally occurring Mitragyna
speciosa leaves. The analysis
[[Page 54952]]
revealed that among the products sampled, 71 percent featured a
combination of mitragynine pseudoindoxyl and 7-hydroxymitragynine,
while 24 percent contained mitragynine pseudoindoxyl only. The
remaining 6 percent contained a combination of mitragynine
pseudoindoxyl and other hydroxymitragynine forms (8-hydroxymitragynine
or 11-hydroxymitragynine).\28\
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\28\ Wilson, L.L., Chakraborty, S., Eans, S.O., Cirino, T.J.,
Stacy, H.M., Simons, C.A., Uprety, R., Majumdar, S., & McLaughlin,
J.P. (2021). Kratom Alkaloids, Natural and Semi-Synthetic, Show Less
Physical Dependence and Ameliorate Opioid Withdrawal. Cell Mol
Neurobiol., 41(5):1131-1143. doi: 10.1007/s10571-020-01034-7.
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National E-Commerce
Data from online sources show that the availability of mitragynine
pseudoindoxyl and MGM-15 are not isolated to a single region but have
rapidly spread across the United States. Products containing
mitragynine pseudoindoxyl and MGM-15 are sold on the internet and are
delivered to most states where there are currently no kratom use
restrictions, suggesting a national distribution network facilitated by
online sales and mass-market retail channels. The significance of the
abuse of mitragynine pseudoindoxyl and MGM-15 is underscored by the
potent opioid pharmacological profile of these substances and the
specific health warnings acknowledged even by those who are marketing
the substances. Vendor descriptions listed below provide insight into
the duration and pattern of use that characterizes the abuse of these
compounds:
Sustained Effect: The duration of effects is reported to last
``several hours.'' \29\ This prolonged duration increases the
likelihood of cumulative effects and potential for toxicity if doses
are repeated.
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\29\ See Pseudoindoxyl Chewable Tablets--Red Vein--Advanced
Alkaloids Descriptions, https://cbdamericanshaman.com/pseudoindoxyl-chewable-tablets-red-vein-advanced-alkaloids. Accessed January 2026.
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Deceptive Marketing for Medical Conditions: Despite having no FDA-
approved medical use, these products are explicitly marketed for
``easing stress and tension,'' ``internal calm and reduced
restlessness,'' and providing ``mental clarity.'' \30\ This marketing
encourages individuals with legitimate medical needs to utilize potent,
unlawful opioids as self-treatment.
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\30\ See Dozo Perks Extremely Potent Pseudoindoxyl Chewable
Tablet Grape 100mg Per Tablet, https://pureleafkratom.com/products/dozo-perks-100mg-pseudoindoxyl-grape-chewable-tablets-4ct.html.
Accessed January 2026.
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Deceptive ``Natural'' Branding: Vendors frequently frame these
substances as ``clean and powerful'' alternatives to traditional
kratom. This branding is used to minimize the perceived risk of what
are highly potent semi-synthetic opioid agonists.
Deceptive Safety Profiles: While products are marketed as a
``midday stress relief'' or ``mental reset,'' the inclusion of warnings
for lethal respiratory depression on retail sites confirms that the
products possess a toxicity profile identical to scheduled opioids.
Low Barrier to Entry: The use of ``fruity'' flavors and
``chewable'' formats (e.g., Fruity Perks) suggests an effort to appeal
to a broader, potentially younger demographic, significantly increasing
the scope of potential abuse.
Forensic Surveillance and Identification
According to the National Forensic Laboratory Information System
(NFLIS) \31\ database, which collects drug identification results from
drug cases submitted to and analyzed by Federal State and local
forensic laboratories, there have been 19 reports of mitragynine
pseudoindoxyl in Arkansas (n = 15), New York (n = 1), Ohio (n = 1), and
Wyoming (n = 2) (queried June 23, 2026). Monographs \32\ by the Center
for Forensic Science Research and Education (CFSRE) report that
mitragynine pseudoindoxyl (n > 10) and MGM-15 (n = 2) were detected in
at least 12 drug materials. MGM-15 was detected as a tan solid drug
that originated from New England, and those involving mitragynine
pseudoindoxyl (pills and tablets) initially originated from
Pennsylvania and Illinois. Furthermore, a CFSRE \33\ trend report
identified mitragynine pseudoindoxyl in 103 toxicology specimens and 12
drug materials; similarly, MGM-15 appeared in 21 toxicology specimens
and 3 drug materials. This surge in prevalence is underscored by law
enforcement action, including a federal and local authorities raid on a
Florida-based business distributing 7-hydroxymitragynine and MGM-15
products.
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\31\ NFLIS represents an important resource in monitoring
illicit drug trafficking, including the diversion of legally
manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a
comprehensive information system that includes data from forensic
laboratories that handle the nation's drug analysis cases. NFLIS-
Drug participation rate, defined as the percentage of the national
drug caseload represented by laboratories that have joined NFLIS, is
currently 98.5 percent. 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 was queried on March 25, 2026.
\32\ https://www.cfsre.org/nps-discovery/monographs/mitragynine-pseudoindoxyl. Report Date--November 7, 2025. Accessed January 9,
2026; https://www.cfsre.org/nps-discovery/monographs/dihydro-7-hydroxy-mitragynine. Report Date--November 11, 2025. Accessed
January 9, 2026.
\33\ https://www.cfsre.org/images/trendreports/2026_Q1_CFSRE_NPS_Discovery_Trend_Reports.pdf. Quarter 1, 2026 Trend
reports. Accessed May 7, 2026.
---------------------------------------------------------------------------
The paucity or lack of seizure data for some of these 7-
hydroxymitragynine-related substances as reported in forensic
laboratories casework may be due to lack of readily available
analytical reference standards and other analytic challenges. Because
these are new substances, it often takes time for forensic laboratories
to develop and validate the necessary testing methods required for
substance identification. Specifically, mitragynine pseudoindoxyl is an
oxidative metabolite of 7-hydroxymitragynine, and such closely related
compounds require specific method and instrumentation for accurate
identification. Also, as these 7-hydroxymitragynine-related substances
are not federally controlled under the CSA, some forensic laboratories
may not analyze and track encounters of non-controlled substances, and
thus reporting could be limited.
The population likely to abuse mitragynine pseudoindoxyl, MGM-15,
and MGM-16 appear to be the same as those abusing Mitragyna speciosa
and prescription opioid analgesics. According to data from the National
Survey on Drug Use and Health (NSDUH),\34\ as of 2021, an estimated 1.7
million people aged 12 years or older used kratom in the past year. The
highest users were among adults aged 26 or older (1.4 million people).
The analysis of 2019 NSDUH survey data showed that kratom users are
predominately non-Hispanic White and male. The survey finding also
revealed a link between kratom use and substance use disorder,
particularly
[[Page 54953]]
nonmedical prescription opioid use disorder, indicative of a strong
trend of use for self-managing opioid dependence.\35\ By 2022, the
prevalence of people who reported past year kratom use had increased to
1.9 million.\36\
---------------------------------------------------------------------------
\34\ The NSDUH, formerly known as the National Household Survey
on Drug Abuse (NHSDA), is conducted annually by the Department of
Health and Human Services Substance Abuse and Mental Health Services
Administration (SAMHSA). It is the primary source of estimates of
the prevalence and incidence of nonmedical use of pharmaceutical
drugs, illicit drugs, alcohol, and tobacco use in the United States.
The survey is based on a nationally representative sample of the
civilian, non-institutionalized population 12 years of age and
older. The survey excludes homeless people who do not use shelters,
active military personnel, and residents of institutional group
quarters such as jails and hospitals. The NSDUH provides yearly
national and state level estimates of drug abuse, and includes
prevalence estimates by lifetime (i.e., ever used), past year, and
past month abuse or dependence.
\35\ Palamar, J. J. (2021). Past-Year Kratom Use in the U.S.:
Estimates From a Nationally Representative Sample. Am J Prev Med.,
61(2):240-245: Rogers, J. M., Smith, K. E., Strickland, J. C., &
Epstein, D. H. (2021). Kratom Use in the US: Both a Regional
Phenomenon and a White Middle-Class Phenomenon? Evidence From NSDUH
2019 and an Online Convenience Sample. Frontiers in Pharmacology,
12:789075.
\36\ https://www.samhsa.gov/data/sites/default/files/reports/rpt42728/NSDUHDetailedTabs2022/NSDUHDetailedTabs2022/NSDUHDetTabs8-21to8-23pe2022.pdf. Accessed April 2, 2026.
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Factor 6. What, If Any, Risk There Is to Public Health
Mitragynine pseudoindoxyl, MGM-15, and MGM-16 function as potent
MOR agonists. This mechanism of action is inherently associated with
high potential of abuse, physical dependence, and psychological
dependence, consistent with the effects of controlled schedule I and II
opioid substances. As of early 2026, mitragynine pseudoindoxyl and MGM-
15 products are sold in smoke shops, gas stations, and through numerous
online marketplaces, often positioned alongside dietary supplements,
which mask their potent opioid nature. Data from preclinical studies
demonstrate that mitragynine pseudoindoxyl is about 100 times more
potent than mitragynine at the MOR, and MGM-15 and MGM-16 are about 50
and 240 times more potent than morphine in animal models,
respectively.\37\ Because of the potency of these compounds, they can
be abused in smaller, concentrated doses. It has been demonstrated that
mitragynine pseudoindoxyl may cause development of signs of opioid
physical dependence after chronic use in rodents. Pre-clinical studies
demonstrated that chronic twice-daily administration of mitragynine
pseudoindoxyl in rodents induces signs of opioid physical dependence
and withdrawal symptoms in morphine addiction rodent models as
evidenced by increased diarrhea, jumping, and rearing frequency
occurring when naloxone was administered or when treatment with this
alkaloid was tapered.\38\
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\37\ Matsumoto, K., Narita, M., Muramatsu, N., Nakayama, T.,
Misawa, K., Kitajima, M., Tashima, K., Devi, L.A., Suzuki, T.,
Takayama, H., & Horie, S. (2014). Orally active opioid [mu]/[delta]
dual agonist MGM-16, a derivative of the indole alkaloid
mitragynine, exhibits potent antiallodynic effect on neuropathic
pain in mice. The Journal of Pharmacology and Experimental
Therapeutics, 348(3):383-392; Yamamoto, L.T., Horie, S., Takayama,
H., Aimi, N., Sakai, S., Yano, S., Shan, J., Pang, P.K., Ponglux,
D., & Watanabe, K. (1999). Opioid receptor agonistic characteristics
of mitragynine pseudoindoxyl in comparison with mitragynine derived
from Thai medicinal plant Mitragyna speciosa. General Pharmacology,
33(1):73-81; V[aacute]radi, A., Marrone, G.F., Palmer, T.C.,
Narayan, A., Szab[oacute], M.R., Le Rouzic, V., Grinnell, S.G.,
Subrath, J.J., Warner, E., Kalra, S., Hunkele, A., Pagirsky, J.,
Eans, S.O., Medina, J.M., Xu, J., Pan, Y.X., Borics, A., Pasternak,
G.W., McLaughlin, J.P., & Majumdar, S. (2016). Mitragynine/
Corynantheidine Pseudoindoxyls As Opioid Analgesics with Mu Agonism
and Delta Antagonism, Which Do Not Recruit [beta]-Arrestin-2.
Journal of Medicinal Chemistry, 59(18):8381-8397.
\38\ Wilson, L.L., Chakraborty, S., Eans, S.O, Cirino, T.J.,
Stacy, H.M., & Simons, C.A., Uprety, R., Majumdar, S., & McLaughlin,
J.P. (2021). Kratom Alkaloids, Natural and Semi-Synthetic, Show Less
Physical Dependence and Ameliorate Opioid Withdrawal. Cell Mol
Neurobiol., 41(5):1131-1143.
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These products are easily accessible in retail environments often
with no age restrictions, amplifying public health concerns,
particularly to vulnerable populations. Vendor descriptions provide
insight into the public health threat posed by the abuse of these
compounds:
Rapid Onset: Marketing materials for mitragynine pseudoindoxyl
products emphasize a ``quick onset,'' typically occurring within 10 to
60 minutes, often described as a ``wave of calm clarity,'' ``dual-
action formula featuring 100mg per piece for maximum potency and a
fast-acting hit.'' \39\
---------------------------------------------------------------------------
\39\ See Kama Kratom https://greatcbdshop.com/product-category/brands/kama-kratom/ and Pure Leaf Kratom https://pureleafkratom.com/kama-kratom/. Accessed March 2026. (Web content subsequently
modified or removed; hardcopy preserved in DEA administrative
record).
---------------------------------------------------------------------------
Sustained Effect: The duration of effects is reported to last
``several hours.'' \40\ This prolonged duration increases the
likelihood of cumulative effects and potential for toxicity if doses
are repeated.
---------------------------------------------------------------------------
\40\ Id. 26.
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Potency Information: Marketing information of an MGM-15 product
indicates the products contain a very large amount of MGM-15 ``105 mg
total per bottle,'' \41\ which, given its extreme opioid potency,
presents a significant threat to public health.
---------------------------------------------------------------------------
\41\ MGM-15 [verbar] 7 count--15mg tablets (105mg total)--Can
Vertex Bioscience Accessed March 2026. (Web content subsequently
modified or removed; hardcopy preserved in DEA administrative
record).
---------------------------------------------------------------------------
Opioid Receptor Activation: Marketing materials explicitly state
that these compounds directly activate opioid receptors and are ``full
agonist at mu receptors,'' providing effects that mirror analgesic and
stimulant effects (pain relief and mood enhancement).\42\
---------------------------------------------------------------------------
\42\ Id.
---------------------------------------------------------------------------
Acknowledgment of Severe Risks: Notably, vendors acknowledge
significant public health risks, advising users to monitor for ``habit-
forming behavior,'' ``high euphoria,'' ``dependence,'' ``overdose,''
and ``death.'' \43\ The mention of overdose and death is a significant
indicator of the hazard these substances pose.
---------------------------------------------------------------------------
\43\ Id; See 7-OHFactory30mg MGM-15 Tablets--Berries. https://www.7ohfactory.com/products/30mg-mgm-15-tablets-berries. Accessed
March 2026. (Web content subsequently modified or removed; hardcopy
preserved in DEA administrative record).
---------------------------------------------------------------------------
As with any MOR agonist, the potential health and safety risks for
users of 7-hydroxymitragynine-related substances are high. Mitragynine
pseudoindoxyl, MGM-15, and MGM-16 abuse carry a high risk of
cardiotoxicity, hepatic and renal toxicity, respiratory depression,
neurological effects, and physical dependence and withdrawal. According
to data from poison control centers, from January to July 2025, there
have been 1,690 exposure calls involving kratom, a significant increase
from 2024 exposure calls. A recent CDC morbidity and mortality weekly
report (MMWR) notes the marked surge in calls related to kratom
exposure to poison centers by over 1,200% between 2015 (n = 258) and
2025 (n = 3,434). The MMWR notes that United States poison centers
received a total of 14,449 kratom exposure reports during the past 11
years.\44\
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\44\ Towers EB, Thomas YT, Holstege CP, Farah R. Increases in
Kratom-Related Reports to Poison Centers--National Poison Data
System, United States, 2015-2025. MMWR Morb Mortal Wkly Rep
2026;75:139-145.
---------------------------------------------------------------------------
According to data from DEA Toxicology Testing Program (DEA
TOX),\45\ between February 2025-May 2026, mitragynine pseudoindoxyl has
been identified in at least 56 overdose cases, of which 48 were fatal
events. From February through April 2026, DEA TOX detected MGM-15 in 17
overdose cases, 16 resulting from a fatal event.
---------------------------------------------------------------------------
\45\ 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. Query date May 15, 2026.
---------------------------------------------------------------------------
A recent clinical case report \46\ highlights the severe acute
risks associated with mitragynine pseudoindoxyl consumption. A 34-year-
old male escalated from powdered kratom use to 7-hydroxymitragynine
tablets and then to mitragynine pseudoindoxyl tablets, eventually
consuming nine 20 mg doses daily (including one to two nocturnal
doses). The individual attempted to reduce dose and frequency of use
but was
[[Page 54954]]
unsuccessful due to withdrawal characterized as ``crawling out of skin
symptom.'' \47\ The patient presented with a clinical opiate withdrawal
scale score of 31 (categorized as severe), alongside autonomic
instability, including hypertension, tachycardia, and physical symptoms
(such as severe body aches, tremors, diaphoresis, gastrointestinal
distress and chills). The patient required supportive management
(clonidine, hydroxyzine, gabapentin, loperamide, and antiemetics) over
a 72-96-hour period. In addition, on days 5 and 6, the patient was
administered naltrexone depot (Vivitrol) injection.
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\46\ Stanciu C. N. (2026). Severe Early-Onset Withdrawal
Following Intentional Use of Mitragynine Pseudoindoxyl: A Case
Report and Emerging Clinical Considerations. Cureus, 18(3), e105224.
\47\ Id.
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The sale of products with a combination of high-potency opioids,
explicit marketing for medical ailments, and the acknowledged potential
for life-threatening respiratory depression and addiction highlights
the danger posed by mitragynine pseudoindoxyl and MGM-15. While
mitragynine pseudoindoxyl and MGM-15 have already been identified in
fatal toxicological screening, the pharmacological profile of MGM-16
presents a significant health risk. As previously mentioned, MGM-16 is
an opioid agonist with approximately 240-times the antinociceptive
potency of morphine in animal studies. Recent online surveillance of a
vendor site \48\ lists MGM-16 for upcoming sale. This transition from a
research grade chemical to an accessible consumer product, combined
with its opioid mechanism of action, underscores its potential as a
highly attractive but lethal substitute. Thus, to schedule MGM-15
without MGM-16 would create a regulatory loophole that manufacturers
are already poised to exploit. Its inclusion is necessary to prevent a
market shift toward an even more potent derivative that poses a
significant risk of respiratory depression.
---------------------------------------------------------------------------
\48\ MGM Series Guide: Science of MGM-15 Alkaloids [verbar]
Getwell Depot. https://getwelldepot.com/mgm/. Accessed April 9,
2026.
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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 mitragynine
pseudoindoxyl, MGM-15, and MGM-16 pose an imminent hazard to public
safety. DEA is not aware of any currently accepted medical uses for
mitragynine pseudoindoxyl, MGM-15, and MGM-16 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 mitragynine
pseudoindoxyl, MGM-15, and MGM-16 indicate that these substances 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.
As required by 21 U.S.C. 811(h)(4), the Administrator notified the
Assistant Secretary, via letter dated December 15, 2025, of DEA's
intention to temporarily place mitragynine pseudoindoxyl, MGM-15, and
MGM-16 in schedule I. In a letter dated January 20, 2026, the Assistant
Secretary for Health stated that HHS had no objection to the temporary
placement of these substances in schedule I. DEA subsequently published
this NOI in the Federal Register on July 6, 2026.\49\
---------------------------------------------------------------------------
\49\ Schedules of Controlled Substances: Temporary Placement of
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I, 91 FR
40909 (July 6, 2026).
---------------------------------------------------------------------------
Conclusion
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
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I of the CSA,
and finds that placement of these substances in schedule I of the CSA
is necessary in order to avoid an imminent hazard to the public's
safety.
The temporary placement of mitragynine pseudoindoxyl, MGM-15, and
MGM-16 in schedule I of the CSA will take effect on the date the order
is published in the Federal Register and will remain in effect for two
years, with a possible extension of one year, pending completion of the
regular (permanent) scheduling process.\50\
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\50\ 21 U.S.C. 811(h)(1) and (2).
---------------------------------------------------------------------------
The CSA sets forth specific criteria for scheduling drugs or other
substances. Permanent 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.\51\ The permanent 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 permanent scheduling
process of formal rulemaking are subject to judicial review.\52\
Temporary scheduling orders are not subject to judicial review.\53\
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\51\ 21 U.S.C. 811.
\52\ 21 U.S.C. 877.
\53\ 21 U.S.C. 811(h)(6).
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Requirements for Handling
Upon the effective date of this temporary order, mitragynine
pseudoindoxyl, MGM-15, and MGM-16 will be subject to the regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, reverse distribution, importation,
exportation, possession of, and engagement in research and conduct of
instructional activities or chemical analysis with, schedule I
controlled substances, including but not limited to the following:
1. Registration. Any person who handles (possesses, manufactures,
distributes, reverse distributes, imports, exports, engages in
research, or conducts instructional activities or chemical analysis
with) or desires to handle, mitragynine pseudoindoxyl, MGM-15, and MGM-
16 must be registered with DEA to conduct such activities, pursuant to
21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts
1301 and 1312, as of August 26, 2026. Any person who currently handles
mitragynine pseudoindoxyl, MGM-15, and MGM-16 and is not registered
with DEA to conduct research with a schedule I controlled substance
must submit an application for registration and may not continue to
handle mitragynine pseudoindoxyl, MGM-15, and MGM-16 as of August 26,
2026, unless DEA has approved that application for registration
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21
CFR parts 1301 and 1312.
Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on
August 26, 2026, a person is conducting research on mitragynine
pseudoindoxyl, MGM-15, and MGM-16 and is already registered to conduct
research with another controlled substance in schedule I, the person
may continue to conduct research on mitragynine pseudoindoxyl, MGM-15,
and MGM-16 if they submit a completed application for registration or
modification of
[[Page 54955]]
existing registration, as applicable, to conduct research with
mitragynine pseudoindoxyl, MGM-15, and MGM-16 not later than 90
calendar days after August 26, 2026. The person may continue to conduct
such research until the person withdraws the application or the
Administrator serves on the person an order to show cause proposing
denial of the application pursuant to 21 U.S.C. 824(c) and in
accordance with 21 CFR 1301.37. If the Administrator serves an order to
show cause proposing denial of the application or modification, the
person may not continue to conduct research with mitragynine
pseudoindoxyl, MGM-15, and MGM-16 and may not receive or otherwise
obtain additional mitragynine pseudoindoxyl, MGM-15, and MGM-16. If an
order to show cause is served and the person requests a hearing in
accordance with 21 CFR 1301.37(d), the hearing shall be held in
accordance with 21 CFR 1301.41-1301.46 on an expedited basis and not
later than 45 calendar days after the request is made, except that the
hearing may be held at a later time if so requested by the person. If
the person sends a copy of the application to a manufacturer or
distributor of mitragynine pseudoindoxyl, MGM-15, and MGM-16, receipt
of the copy by the manufacturer or distributor constitutes sufficient
evidence that the person is authorized to receive mitragynine
pseudoindoxyl, MGM-15, or MGM-16 pursuant to 21 U.S.C. 822(h)(4).
Continuation of research under 21 U.S.C. 822(h) does not authorize any
other handling (e.g., distribution) of mitragynine pseudoindoxyl, MGM-
15, or MGM-16.
Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of
mitragynine pseudoindoxyl, MGM-15, or MGM-16 in a manner not authorized
by the CSA on or after August 26, 2026 is unlawful, and those in
possession of any quantity of mitragynine pseudoindoxyl, MGM-15, and
MGM-16 may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is unable
to obtain a schedule I registration to handle mitragynine
pseudoindoxyl, MGM-15, or MGM-16 must surrender all currently held
quantities of this substance.
3. Security. Mitragynine pseudoindoxyl, MGM-15, or MGM-16 is
subject to schedule I security requirements and must be handled in
accordance with 21 CFR 1301.71-1301.93, as of August 26, 2026.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of mitragynine pseudoindoxyl, MGM-15, or MGM-16
must comply with 21 U.S.C. 825 and 958(e) and 21 CFR part 1302. Current
DEA registrants will have 30 calendar days from August 26, 2026, to
comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
mitragynine pseudoindoxyl, MGM-15, or MGM-16 on the effective date of
this order must take an inventory of all stocks of this substance on
hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11. Current DEA registrants will have 30
calendar days from the effective date of this order to comply with all
inventory requirements. After the initial inventory, every DEA
registrant must take an inventory of all controlled substances
(including mitragynine pseudoindoxyl, MGM-15, and MGM-16) on hand on a
biennial basis pursuant to 21 U.S.C. 827 and 958 and in accordance with
21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect
to mitragynine pseudoindoxyl, MGM-15, and MGM-16 pursuant to 21 U.S.C.
827 and 958(e) and in accordance with 21 CFR parts 1304, 1312, and
1317, and section 1307.11. Current DEA registrants authorized to handle
mitragynine pseudoindoxyl, MGM-15, or MGM-16 shall have 30 calendar
days from the effective date of this order to comply with all
recordkeeping requirements.
7. Reports. All DEA registrants must submit reports with respect to
mitragynine pseudoindoxyl, MGM-15, and MGM-16 pursuant to 21 U.S.C. 827
and in accordance with 21 CFR parts 1304, 1312, and 1317, and sections
1301.74(c) and 1301.76(b), as of August 26, 2026. Manufacturers and
distributors must also submit reports regarding mitragynine
pseudoindoxyl, MGM-15, and MGM-16 to the Automation of Reports and
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304 and 1312.
8. Order Forms. All DEA registrants who distribute mitragynine
pseudoindoxyl, MGM-15, and MGM-16 must comply with order form
requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR
part 1305 as of August 26, 2026.
9. Importation and Exportation. All importation and exportation of
mitragynine pseudoindoxyl, MGM-15, and MGM-16 must be in compliance
with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR
part 1312 as of August 26, 2026.
10. Quota. Only DEA-registered manufacturers may manufacture
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in accordance with a
quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR
part 1303, as of August 26, 2026.
11. Liability. Any activity involving mitragynine pseudoindoxyl,
MGM-15, and MGM-16 not authorized by or in violation of the CSA,
occurring as of August 26, 2026, is unlawful, and may subject the
person to administrative, civil, and/or criminal sanctions.
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.\54\
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\54\ 21 U.S.C. 811(h)(1).
---------------------------------------------------------------------------
Inasmuch as section 811(h) directs that temporary scheduling
actions be issued by order (as distinct from a rule) and sets forth the
procedures by which such orders are to be issued, DEA believes the
notice-and-comment requirements of the Administrative Procedure Act
(APA) at 5 U.S.C. 553, which are applicable to rulemaking, do not apply
to this temporary scheduling order. 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.''
\55\ 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.\56\ 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
[[Page 54956]]
procedures for other kinds of scheduling actions,\57\ it is noteworthy
that, in section 811(h)(1), Congress authorized the issuance of
temporary scheduling actions by order rather than by rule.
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\55\ 5 U.S.C. 551(6) (emphasis added).
\56\ 21 U.S.C. 811(a) and 877.
\57\ See 21 U.S.C. 811(a).
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Even assuming that this action is subject to the notice-and-comment
requirements of the APA, the Administrator finds that there is good
cause to forgo these 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 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 Assistant Secretary in
response to the notice that DEA transmitted to the 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. 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.
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. Section 3(f) of E.O.
12866 provides the definition of a ``significant regulatory action,''
requiring review by the Office of Management and Budget. 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 amends 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 paragraphs (h)(89) through (91) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
------------------------------------------------------------------------
* * * * * * *
(89) Methyl (E)-2-((1'S,6'S,7'S)-6'-ethyl-4-methoxy-3-oxo- 9672
3',5',6',7',8',8a'-hexahydro-2'H-spiro[indoline-2,1'-
indolizine]-7'-yl)-3-methoxyacrylate (commonly known as
mitragynine pseudoindoxyl) 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. Since nomenclature of this substance is not
internationally standardized, compounds of this structure,
regardless of numerical designation of atomic positions are
covered.......................................................
(90) Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-7a-hydroxy-8- 9673
methoxy-1,2,3,4,6,7,7a,12,12a,12b-decahydroindolo[2,3-
a]quinolizin-2-yl)-3-methoxyacrylate (commonly known as MGM-
15; also known as dihydro-7-hydroxymitragynine) 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. Since nomenclature of this
substance is not internationally standardized, compounds of
this structure, regardless of numerical designation of atomic
positions are covered.........................................
(91) Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-9-fluoro-7a- 9674
hydroxy-8- methoxy-1,2,3,4,6,7,7a,12,12a,12b-
decahydroindolo[2,3-a]quinolizin-2-yl)-3-methoxyacrylate
(commonly known as MGM-16; also known as 9-fluoro-dihydro-7-
hydroxymitragynine; or 10-fluoro-dihydro-7-hydroxymitragynine
(depending on numbering convention)) 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. Since nomenclature of this
substance is not internationally standardized, compounds of
this structure, regardless of numerical designation of atomic
positions are covered.........................................
------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 24, 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. 2026-17429 Filed 8-24-26; 4:15 pm]
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