Proposed Rule2026-20942
Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I
Primary source
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Published
October 14, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule two 7- hydroxymitragynine-related substances (MGM-15 and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act (CSA). On August 26, 2026, DEA published a temporary order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I of the CSA. Today, DEA is providing notice of its intent to publish a new temporary order for MGM-15 and MGM-16 that will maintain the temporary placement of these substances in schedule I of the CSA without change. Separately in this Federal Register, DEA is publishing a notice of intent relating to mitragynine pseudoindoxyl, in response to a letter sent by the Department of Health and Human Services (HHS) dated October 6, 2026. HHS's letter related only to mitragynine pseudoindoxyl. Therefore, DEA is publishing this notice of intent only for the technical and procedural purpose of distinguishing MGM-15 and MGM-16 from mitragynine pseudoindoxyl. When issued, the temporary scheduling order addressing MGM-15 and MGM-16 will continue to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these two 7-hydroxymitragynine-related substances. The August 26, 2026 temporary order placing these substances in schedule I of the CSA remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.
Full Text
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<title>Federal Register, Volume 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Proposed Rules]
[Pages 65381-65387]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20942]
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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 MGM-15
and MGM-16 in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notice of intent.
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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this
notice of intent to publish a temporary order to schedule two 7-
hydroxymitragynine-related substances (MGM-15 and MGM-16), including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers, whenever the existence of such isomers, esters, ethers, and
salts is possible, in schedule I of the Controlled Substances Act
(CSA). On August 26, 2026, DEA published a temporary order placing
mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I of the CSA.
Today, DEA is providing notice of its intent to publish a new temporary
order for MGM-15 and MGM-16 that will maintain the temporary placement
of these substances in schedule I of the CSA without change. Separately
in this Federal Register, DEA is publishing a notice of intent relating
to mitragynine pseudoindoxyl, in response to a letter sent by the
Department of Health and Human Services (HHS) dated October 6, 2026.
HHS's letter related only to mitragynine pseudoindoxyl. Therefore, DEA
is publishing this notice of intent only for the technical and
procedural purpose of distinguishing MGM-15 and MGM-16 from mitragynine
pseudoindoxyl. When issued, the temporary scheduling order addressing
MGM-15 and MGM-16 will continue to impose the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess) or
propose to handle these two 7-hydroxymitragynine-related substances.
The August 26, 2026 temporary order placing these substances in
schedule I of the CSA remains in effect until either it expires or the
new temporary order is published and the previous order is withdrawn,
whichever occurs first.
DATES: October 14, 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 the following two 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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<bullet> 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 dihydro-7-hydroxymitragynine,
or MGM-15). Since nomenclature of this substance is not internationally
standardized, compounds of this structure, regardless of numerical
designation of atomic positions are covered.
<bullet> 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 9-fluoro-
dihydro-7-hydroxymitragynine, or MGM-16). Since nomenclature of this
substance is not internationally standardized, compounds of this
structure, regardless of numerical designation of atomic positions are
covered.
The temporary scheduling order will be published in the Federal
Register on or after November 13, 2026.\2\
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\2\ On August 26, 2026, DEA published a temporary order that
placed mitragynine pseudoindoxyl, MGM-15, and MGM-16, in schedule I
of the CSA. See Schedules of Controlled Substances: Temporary
Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in
Schedule I, 91 FR 54948 (Aug. 26, 2026). That temporary order is
effective until August 26, 2028, or until this new temporary order
placing MGM-15 and MGM-16 in schedule I is published and the
previous order withdrawn, whichever occurs first.
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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
[[Page 65382]]
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.\3\ 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.\4\
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\3\ 21 U.S.C. 811(h)(1).
\4\ 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.\5\ The Attorney General has delegated scheduling
authority under 21 U.S.C. 811 to the Administrator of DEA
(Administrator).\6\
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\5\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
\6\ 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 this intent to issue a
temporary scheduling order.\7\ By letter dated October 6, 2026,
Assistant Secretary for Health of HHS (Assistant Secretary) sent a
letter to DEA that, among other things, recommended controlling
mitragynine pseudoindoxyl above a certain threshold in schedule I.
Importantly, HHS did not recommend controlling MGM-15 or MGM-16 above
any threshold, and, therefore, the October 6, 2026 letter has no impact
on any of DEA's prior findings and conclusions regarding MGM-15 and
MGM-16. By letter dated October 8, 2026, the Administrator transmitted
the required notice to place MGM-15 and MGM-16 in schedule I on a
temporary basis to the Assistant Secretary.\8\ By letter dated January
20, 2026, the Assistant Secretary 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 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. The Assistant Secretary provided
no contrary information in its October 6, 2026 letter. MGM-15 and MGM-
16 are not currently listed in any other schedule than schedule I under
the CSA.
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\7\ 21 U.S.C. 811(h)(4).
\8\ 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.\9\ This consideration includes any
information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
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 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 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. 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 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 HHS's letter dated January 20, 2026,
HHS advised DEA that there were currently no approved new drug
applications or investigational new drug applications for 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.
The Assistant Secretary provided no contrary information in its
October 6, 2026 letter.
\13\ 21 U.S.C. 812(b)(1).
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Two 7-Hydroxymitragynine-Related Substances: 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, MGM-15, which is a derivative of
7-hydroxymitragynine, has 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 MGM-15 and MGM-16 via chemical
modifications of purified isolates. Evidence from the Mitragyna
speciosa retail markets demonstrates that MGM-15 has 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 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 to include flavored chewable tablets, which increases
their appeal to a broader demographic. Also, the aggressive marketing
of these semi-synthetic opioids 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
[[Page 65383]]
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.
MGM-15 and MGM-16 are potent opioids that share a similar
pharmacological profile with 7-hydroxymitragynine. Available
pharmacology data demonstrate that MGM-15 and MGM-16 exhibit strong
affinity for the mu-opioid receptor (MOR) and function as MOR
agonists.<SUP>14 15</SUP> Data from preclinical studies show that these
substances produce analgesic effects that is more potent than
morphine.\16\ Because 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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\14\ 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.
\15\ 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.
\16\ 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 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 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 platform, revealed that at least some individuals intend to
abuse MGM-16. Recent online surveillance of a vendor site \17\ lists
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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\17\ MGM Series Guide: Science of MGM-15 Alkaloids [verbar]
Getwell Depot. <a href="https://getwelldepot.com/mgm/">https://getwelldepot.com/mgm/</a>. 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 and HHS's
October 6, 2026 letter are available in their entirety under
``Supporting and Related Material'' of the public docket for this
action at <a href="http://www.regulations.gov">www.regulations.gov</a> under Docket Number DEA-1644.
Factor 4. History and Current Pattern of Abuse
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 MGM-15
and MGM-16 are produced through synthetic modifications of purified
mitragynine isolates or 7-hydroxymitragynine.\18\ The chemical
scaffolds of mitragynine or 7-hydroxymitragynine were used in
scientific research to develop. 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.\19\
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\18\ 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.
\19\ Id, 13.
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Market Emergence and Designer-Drug Patterns
The emergence of MGM-15 in commercially available products was in
September 2025.\20\ The introduction of MGM-15 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.'' \21\
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\20\ 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.
\21\ Id, 24.
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Current Patterns of Use
Users seek 7-hydroxymitragynine-related 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 \22\ show that these products
are explicitly marketed as ``potent'' and ``fast-acting'' substances
and sold at low prices. For example, 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 (see Table 1). Further, open-
source signal detection demonstrates that users are seeking MGM-16 with
the intent to abuse.\23\
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\22\ Market Audit of Online Retailers, Jan. 2026.
\23\ Can anyone help with the MGM 16 rumors?r/KratomKorner.
<a href="https://www.reddit.com/r/KratomKorner/comments/1kpz2u3/can_anyone_help_with_the_mgm_16_rumors/?rdt=48097">https://www.reddit.com/r/KratomKorner/comments/1kpz2u3/can_anyone_help_with_the_mgm_16_rumors/?rdt=48097</a>. Accessed April 9,
2026.
[[Page 65384]]
Table 1--Retail Distribution of MGM-15 Products
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Brand Product form Stated concentration Marketing narrative
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Overseas Organix..................... Extract Tablets........ 15 mg MGM-15........... ``Ultra-potent for
experienced users who
want strong,
consistent effects
with small serving
sizes. available. 4-6-
hour duration.''
Majestic White....................... Sublingual Tablet...... 3.5 mg MGM-15 (+50 mg ``Next generation
MIT). kratom formulation.
Its sublingual design
allows for fast
absorption and precise
serving control.''
MGM-15 Tablets--Berries.............. Chewable Tablets 30 mg MGM-15........... ``This single, pocket-
(Berries). ready tablet delivers
consistent strength
without the guesswork.
Each tablet offering a
fast-acting,
predictable experience
you can count on. To
dissolve smoothly for
quick onset.''
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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 MGM-15 is concerning due to its high opioid potency
and commercial availability. 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
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). These substance
combinations and marketing practices pose significant safety risk to
unsuspecting consumers by exposing them to high doses of opioids (see
Table 1). It is known that 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 clinic and
the need for opioid use disorder medication.\24\ Furthermore, these
products are labeled for ``strong mood enhancement'' and ``analgesic
properties.'' Finally, the presence of these products containing MGM-15
is deeply concerning because the identity, purity, and quality of these
products' formulation are uncertain, thus presenting additional safety
concerns for unsuspecting users. The potential presence of MGM-16 in
designer drug products would have similar concerns.
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\24\ 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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National E-commerce
Data from online sources show that the availability of MGM-15
products is not isolated to a single region but have rapidly spread
across the United States. Products containing MGM-15 are sold on the
internet and are delivered to most states where there are currently no
kratom use restrictions, suggesting national distribution network
facilitated by online sales and mass-market retail channels. The
significance of the abuse of 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.'' \25\ This prolonged duration increases the
likelihood of cumulative effects and potential for toxicity if doses
are repeated.
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\25\ See Pseudoindoxyl Chewable Tablets--Red Vein--Advanced
Alkaloids Descriptions, <a href="https://cbdamericanshaman.com/pseudoindoxyl-chewable-tablets-red-vein-advanced-alkaloids">https://cbdamericanshaman.com/pseudoindoxyl-chewable-tablets-red-vein-advanced-alkaloids</a>. 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 as a ``mental clarity.'' \26\ This marketing
encourages individuals with legitimate medical needs to utilize potent,
unlawful opioids as self-treatment.
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\26\ See Dozo Perks Extremely Potent Pseudoindoxyl Chewable
Tablet Grape 100mg Per Tablet, <a href="https://pureleafkratom.com/products/dozo-perks-100mg-pseudoindoxyl-grape-chewable-tablets-4ct.html">https://pureleafkratom.com/products/dozo-perks-100mg-pseudoindoxyl-grape-chewable-tablets-4ct.html</a>.
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
Recent monographs \27\ by Center for Forensic Science Research and
Education (CFSRE), report that MGM-15 has been detected in at least 2
drug materials. MGM-15 was detected as a
[[Page 65385]]
tan solid drug that originated from New England. 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, since
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.
---------------------------------------------------------------------------
\27\ <a href="https://www.cfsre.org/nps-discovery/monographs/mitragynine-pseudoindoxyl">https://www.cfsre.org/nps-discovery/monographs/mitragynine-pseudoindoxyl</a>. Report Date--November 7, 2025. Accessed January 9,
2026; <a href="https://www.cfsre.org/nps-discovery/monographs/dihydro-7-hydroxy-mitragynine">https://www.cfsre.org/nps-discovery/monographs/dihydro-7-hydroxy-mitragynine</a>. Report Date--November 11, 2025. Accessed
January 9, 2026.
---------------------------------------------------------------------------
The population likely to abuse 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),\28\ 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 base predominately non-
Hispanic White and male. The survey finding also revealed a link
between kratom use and substance use disorder, particularly nonmedical
prescription opioid use disorder, indicative of a strong trend of use
for self-managing opioid dependence.\29\
---------------------------------------------------------------------------
\28\ 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.
\29\ 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.
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Factor 6. What, If Any, Risk There Is to Public Health
MGM-15 and MGM-16 function as potent MOR agonist. 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,
MGM-15 products are sold in smoke shops, gas stations, and through
numerous online marketplaces, often marketed alongside traditional
supplements, which mask their potent opioid nature. Data from
preclinical studies demonstrate that MGM-15 and MGM-16 are about 50 and
240 times more potent than morphine in animal models, respectively.\30\
Because of the potency of these compounds, they can be abused in
smaller, concentrated doses. These products are easily accessible in
unregulated 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:
---------------------------------------------------------------------------
\30\ 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.
---------------------------------------------------------------------------
Potency Information: Marketing information of an MGM-15 product
indicates this product contains a very large amount of MGM-15 ``105 mg
total per bottle,'' \31\ which, given its extreme opioid potency,
presents a significant threat to public health.
---------------------------------------------------------------------------
\31\ 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'').\32\
---------------------------------------------------------------------------
\32\ 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''.\33\ The mention of overdose and death is a significant
indicator of the hazard these substances pose.
---------------------------------------------------------------------------
\33\ Id; See 7-OHFactory30mg MGM-15 Tablets--Berries. <a href="https://www.7ohfactory.com/products/30mg-mgm-15-tablets-berries">https://www.7ohfactory.com/products/30mg-mgm-15-tablets-berries</a> Accessed
March 2026.
---------------------------------------------------------------------------
As with any MOR agonist, the potential health and safety risks for
users of 7-hydroxymitragynine-related substances are high. 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. Recent monographs by CFSRE report that MGM-15 (n =1) has been
detected in at least 12 toxicology cases. MGM-15 was co-identified with
mitragynine, 7-hydroxymitragynine, and trace ketamine.
The sale of products with 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 MGM-15. While MGM-15 has 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 \34\ 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.
---------------------------------------------------------------------------
\34\ MGM Series Guide: Science of MGM-15 Alkaloids [verbar]
Getwell Depot. <a href="https://getwelldepot.com/mgm/">https://getwelldepot.com/mgm/</a>. Accessed April 9,
2026. (Web content subsequently modified or removed; hardcopy
preserved in DEA administrative record)
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[[Page 65386]]
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 MGM-15 and
MGM-16 pose an imminent hazard to public safety. DEA is not aware of
any currently accepted medical uses for 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 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 October 8, 2026, of DEA's
intention to temporarily place MGM-15 and MGM-16 in schedule I.
Conclusion
Although DEA has already published a temporary order in the Federal
Register that placed MGM-15 and MGM-16 in schedule I of the CSA on
August 26, 2026, HHS has since sent a letter dated October 6, 2026, to
DEA, in which HHS now recommends controlling mitragynine pseudoindoxyl
above a specified threshold in schedule I of the CSA. However, as noted
above, HHS did not recommend imposing any threshold for either MGM-15
or MGM-16. 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 new temporary scheduling
order that will continue to impose the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess) or
propose to handle these two 7-hydroxymitragynine-related substances. 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 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 MGM-15 and MGM-16 in schedule I of the
CSA will take effect pursuant to a temporary scheduling order, which
will not be issued before November 13, 2026. Additionally, to avoid an
enforcement gap, the current temporary order that placed MGM-15 and
MGM-16 in schedule I remains in effect until either that order expires
or the new temporary order is published and the previous order is
withdrawn, whichever occurs first. 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.\35\ 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 new temporary order, MGM-15
and MGM-16 will continue to 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.
---------------------------------------------------------------------------
\35\ 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.\36\ The regular scheduling process of formal
rulemaking affords interested parties appropriate process and the
government any additional relevant information needed to make a
determination. It is DEA's intention to pursue formal rulemaking
proceedings under 21 U.S.C. 811(a) in this instance by gathering the
necessary data and requesting that HHS provide a scientific and medical
evaluation and scheduling recommendation for MGM-15 and MGM-16 pursuant
to 21 U.S.C. 811(b). Final decisions that conclude the regular
scheduling process of formal rulemaking are subject to judicial
review.\37\ Temporary scheduling orders are not subject to judicial
review.\38\
---------------------------------------------------------------------------
\36\ 21 U.S.C. 811.
\37\ 21 U.S.C. 877.
\38\ 21 U.S.C. 811(h)(6).
---------------------------------------------------------------------------
Regulatory Analyses
The CSA provides for expedited temporary scheduling actions where
necessary to avoid an imminent hazard to public safety. Under 21 U.S.C.
811(h)(1), the Administrator (as delegated by the Attorney General)
may, by order, temporarily schedule substances in schedule I. Such
orders may not be issued before the expiration of 30 days from: (1) the
publication of a notice in the Federal Register of the intent to issue
such order and the grounds upon which such order is to be issued, and
(2) the date that notice of the proposed temporary scheduling order is
transmitted to the Assistant Secretary of HHS, as delegated by the
Secretary of HHS.\39\
---------------------------------------------------------------------------
\39\ 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.''
\40\ 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.\41\ 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,\42\ it is noteworthy that, in
section 811(h)(1), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule.
---------------------------------------------------------------------------
\40\ 5 U.S.C. 551(6) (emphasis added).
\41\ 21 U.S.C. 811(a) and 877.
\42\ See 21 U.S.C. 811(a).
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[[Page 65387]]
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 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
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. As discussed above, DEA is
issuing this notice of intent pursuant to DEA's authority to issue a
temporary scheduling order.\43\ 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.
---------------------------------------------------------------------------
\43\ 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, 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 revise paragraph (h)(90) and (91) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(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 derivate of
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.......................................................
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 8, 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. 2026-20942 Filed 10-9-26; 12:00 pm]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 14, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.