Federal Register, Volume 81 Issue 169 (Wednesday, August 31, 2016)

[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Proposed Rules]
[Pages 59929-59934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20803]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-442]

Schedules of Controlled Substances: Temporary Placement of
Mitragynine and 7-Hydroxymitragynine Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notice of intent to temporarily schedule the opioids
mitragynine and 7-hydroxymitragynine, which are the main active
constituents of the plant kratom, into schedule I pursuant to the
temporary scheduling provisions of the Controlled Substances Act. This
action is based on a finding by the Administrator that the placement of
these opioids into schedule I of the Controlled Substances Act is
necessary to avoid an imminent hazard to the public safety. Any final
order will impose the administrative, civil, and criminal sanctions and
regulatory controls applicable to schedule I controlled substances
under the Controlled Substances Act on the manufacture, distribution,
possession, importation, and exportation of, and research and conduct
of instructional activities of these opioids.

DATES: August 31, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: Any final order will be published in the
Federal Register and may not be effective prior to September 30, 2016.

Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purpose of this action. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), chapter II. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while providing for the legitimate medical, scientific,
research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are
controlled to protect the public health and safety.
Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a substance into
schedule I of the CSA for two years without regard to the requirements
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In
addition, if proceedings to control a substance are initiated under 21
U.S.C. 811(a)(1), the Attorney General may extend the temporary
scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 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 (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of his intention to temporarily place a substance
into schedule I of the CSA.\1\ The Administrator transmitted notice of
his intent to place mitragynine and 7-hydroxymitragynine in schedule I
on a temporary basis to the Assistant Secretary by letter dated May 6,
2016. The Assistant Secretary responded to this notice by letter dated
May 18, 2016, and advised that based on review by the Food and Drug
Administration (FDA), there are currently no investigational new drug
applications or approved new drug applications for mitragynine and 7-
hydroxymitragynine. The Assistant Secretary also stated that the HHS
has no objection to the temporary placement of mitragynine and 7-
hydroxymitragynine into schedule I of the CSA. Neither mitragynine nor
7-hydroxymitragynine is currently listed in any schedule under the CSA,
and no approved new drug applications or investigational new drug
applications for mitragynine or 7-hydroxymitragynine exist, 21 U.S.C.
355. The DEA has found that the control of mitragynine and 7-
hydroxymitragynine in schedule I on a temporary basis is necessary to
avoid an imminent hazard to public safety.
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\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the
Department of Health and Human Services (HHS) in carrying out the
Secretary's scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the
HHS has delegated to the Assistant Secretary for Health of the HHS
the authority to make domestic drug scheduling recommendations. 58
FR 35460, July 1, 1993.
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To find that placing a substance temporarily into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in section 201(c) of the CSA, 21 U.S.C.

[[Page 59930]]

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 the public health. 21 U.S.C. 811(h)(3). Consideration of these
factors includes actual abuse, diversion from legitimate channels, and
clandestine importation, manufacture, or distribution. 21 U.S.C.
811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1).
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. 21 U.S.C. 812(b)(1).

Mitragynine and 7-hydroxymitragynine, the Main Active Constituents of
the Plant Kratom

Mitragynine and 7-hydroxymitragynine are the main active
constituents of the plant Mitragyna speciosa Korth (commonly known as
kratom), an indigenous plant of Southeast Asia. Kratom is the only
known species of Mitragyna to contain mitragynine and 7-
hydroxymitragynine. Kratom is abused for its ability to produce opioid-
like effects. Kratom is available in several different forms to include
dried/crushed leaves, powder, capsules, tablets, liquids, and gum/
resin. Consequently, kratom, which contains the main active
constituents mitragynine and 7-hydroxymitragynine, is an increasingly
popular drug of abuse and readily available on the recreational drug
market in the United States. Attempted importations of kratom are
routinely misdeclared and falsely labeled. This is similar to other
attempts to import controlled substances or substances intended to
mimic controlled substances. The amount of kratom material seized by
law enforcement for the first half of 2016 greatly exceeds any previous
year totals and easily accounts for millions of dosage units intended
for the recreational market.\2\ Available data and information for
mitragynine and 7-hydroxymitragynine, the main active constituents of
the plant kratom, and the plant kratom, are summarized below. Available
information indicates that these opioid substances, constituents of the
plant kratom, 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. The DEA's three-factor
analysis is available in its entirety under of the public docket of
this action as a supporting document at www.regulations.gov under
Docket Number DEA-442.
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\2\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
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Factor 4. History and Current Pattern of Abuse

Kratom, which contains the main active alkaloids mitragynine and 7-
hydroxymitragynine, has a long history of use in Southeast Asia as an
opium substitute. Kratom is also known in Southeast Asia as thang,
thom, krathom, kakuam, ketum, and biak. In recent years, the presence
of the psychoactive plant kratom has increased dramatically on the
recreational market in the United States due to its opioid-like
effects. Numerous vendors selling kratom have appeared in the past few
years, markedly increasing its availability.
Kratom preparations, which contain the main active alkaloids
mitragynine and 7-hydroxymitragynine, are easily obtained from smoke
shops and over the Internet. The Internet is the most utilized source
for the purchase of kratom products, making kratom just ``a click''
away for users. In the United States, law enforcement has seized
kratom/mitragynine products in the following forms: powder/plant,
powder, plant or vegetable material, capsules, tablets, liquids, gum/
resin, and drug patch.
Since abusers obtain kratom, which contains the main active
alkaloids mitragynine and 7-hydroxymitragyine, through unknown sources,
the identity, purity, and quantity of these substances are uncertain
and inconsistent, thus posing significant adverse health risks to
users. Several studies have analyzed the concentrations of mitragynine
\3\ and/or 7-hydroxymitragynine \4\ in different kratom products. The
studies showed that there were inconsistencies in the levels of the
opioid mitragynine present in similar kratom products, and some
products contained other psychoactive substances (see 3-factor
analysis). Based on the variability of the mitragynine concentration in
each product, users may experience differing effects when consuming
similar amounts of different products.
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\3\ Mitragynine is the most abundant alkaloid in kratom and
constitutes about 66 percent of the total alkaloid content of the
plant. The alkaloid content of mitragynine was 45 percent of all
alkaloids detected during analyses performed. Such large relative
differences in proportions of plant alkaloids (66%:45%) are common
among plant species and will lead to variations in potency and the
risk of overdose.
\4\ 7-Hydroxymitragynine is a more potent agonist than
mitragynine although it only comprises about 1.6 percent of the
total alkaloid content of the plant. The alkaloid content of 7-
hydroxymitragynine was 4 percent of all alkaloids detected in
analyses performed. Such large relative differences in proportions
of plant alkaloids (4.0%:1.6%) are common among plant species and
will lead to variations in potency and the risk of overdose.
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Evidence suggests that kratom, which contains the main active
alkaloids mitragynine and 7-hydroxymitragynine, is abused individually,
and with other psychoactive substances. In a 2016 publication, the
Centers for Disease Control (CDC) characterized kratom exposures
reported to poison centers and uploaded to the National Poison Data
System (NPDS) \5\ from January 2010 through December 2015. During the
stated timeframe, U.S. poison centers received 660 calls related to
kratom exposure. Of the calls reported, 487 (73.8%) reported
intentional exposure to kratom, and 595 (90.2%) reported ingestion of
the drug. In addition to reports of isolated exposures to kratom (428
(64.8%)), reports of kratom being used with other substances (ethanol,
benzodiazepines, narcotics, acetaminophen, and other botanicals) were
also recorded. Additionally, forensic laboratory analyses of drug
evidence have identified kratom/mitragynine, along with synthetic
cannabinoids and synthetic opioids during the analyses of products
seized on the illicit market. The consumption of kratom individually,
or in conjunction with alcohol or other drugs, is of serious concern as
it can lead to severe adverse effects and death.
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\5\ The National Poison Data System (NPDS) is a national
database of information logged by the country's regional poison
centers serving all 50 United States, Puerto Rico and the District
of Columbia. The NPDS is maintained by the American Association of
Poison Control Centers. NPDS case records are the result of call
reports made by users (i.e., self-reports), friends and family
members, and health care providers.
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Kratom does not have an approved medical use in the United States
and has not been studied as a treatment agent in the United States.
Kratom has a history of being used as an opium substitute in Southeast
Asia. Kratom has also been used to self-treat chronic pain and
withdrawal symptoms from opioid use. Especially concerning, reports
note users have turned to kratom as a replacement for other opioids,
such as heroin.
In the United States, kratom is misused to self-treat chronic pain
and opioid withdrawal symptoms, with users reporting its effects to be
comparable to prescription opioids. Users have also reported dose-
dependent psychoactive effects to include euphoria, simultaneous
stimulation and relaxation, analgesia, vivid dreams, and sedation (at
higher

[[Page 59931]]

doses). As noted in the actions by the United States Food and Drug
Administration,\6\ kratom products have been encountered with false
claims, an extremely concerning issue for public health and safety.
These products are marketed as safe for self-medication, but have not
been approved by the Food and Drug Administration (FDA) for any medical
uses.
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\6\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
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Information from the published literature, poison control centers
data, and medical examiner data, suggests that kratom, which contains
the main active alkaloids mitragynine and 7-hydroxymitragynine, is
abused by a diverse population to include recreational opioid users,
young adults, and adults. The most commonly described route of
administration of kratom, which contains the main active alkaloids
mitragynine and 7-hydroxymitragynine, is oral. The leaves are typically
brewed and ingested as a tea; however, smoking, chewing the raw leaves
(done traditionally), and ingestion of kratom capsules or resin
extracts have also been reported.

Factor 5. Scope, Duration and Significance of Abuse

The abuse of kratom, containing the main active alkaloids
mitragynine and 7-hydroxymitragynine, is increasing in the United
States and remains extremely concerning for law enforcement and public
health. As the abuse of the plant increases, as demonstrated by the
increasing availability per border encounters,\7\ it has been noted
that physicians should be aware of the kratom's adverse health effects,
toxicity, dependence, and withdrawal .is.
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\7\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
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Reports from law enforcement indicate that kratom is being imported
for widespread distribution to the public within the United States.\8\
Between February 2014 and July 2016, over 55,000 kilograms (kg) of
kratom material were encountered by law enforcement at various ports of
entry within the United States.\9\ Additionally, over 57,000 kg of
kratom material offered for import at numerous ports of entry, between
2014 and 2016, are awaiting an FDA admissibility decision.\10\ The
amount of kratom currently seized or awaiting an admissibility decision
by law enforcement, between 2014 and 2016, is enough to produce over 12
million doses of kratom.\11\ Such alarming quantities create an
imminent public health and safety threat.
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\8\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
Represents Customs and Border Patrol (CBP) seizures from February
2014 through July 2016.
\9\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
Represents Customs and Border Patrol (CBP) seizures from February
2014 through July 2016.
\10\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
\11\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
Assuming a high dose of 9 g of kratom.
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According to press announcements released in 2014 and 2016, the FDA
requested the seizure, by US Marshals, of more than 25,000 pounds of
raw kratom material, nearly 90,000 bottles of dietary supplements
labeled as containing kratom, and over 100 cases of products labeled as
kratom, respectively.\12\ The FDA stated that kratom products ``pose a
risk to the public health and have the potential for abuse'' and the
seizure of certain kratom products was necessary ``to safeguard the
public from a dangerous product''.\13\ The FDA has also warned the
public not to use any products labeled as containing kratom due to
serious concerns about toxicity and potential health impacts.\14\ To
further protect the public health and safety from the large influx of
kratom materials, the FDA issued and updated two import alerts related
to numerous kratom and kratom-containing products.\15\ These import
alerts allow for detention without physical examination of dietary
supplements and bulk ingredients that are or contain kratom, and
detention without physical examination of unapproved new drugs promoted
in the United States, which includes kratom products that make false
health claims. Since 2014, 121 firms have been added to these import
alerts for importing kratom products.\16\
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\12\ Relevant press release can be found online at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416318.htm; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480344.htm;
and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515085.htm.
\13\ Relevant press release can be found online at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416318.htm.
\14\ Relevant press release can be found online at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515085.htm.
\15\ Relevant Import alerts (#'s 54-15 and 66-41) can be found
online at: www.accessdata.fda.gov/cms_ia/importalert_1137.html.and
www.accessdata.fda.gov/cms_ia/importalert_190.html.
\16\ 2015-CDER-DEA Memorandum of Understanding for sharing
information (Provided under 21 CFR 20.85) dated August 4, 2016.
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Drug reports pertaining to the trafficking, distribution, and abuse
of kratom/mitragynine \17\ were analyzed by Federal, State, and local
forensic laboratories.\18\ According to data from the System to
Retrieve Information from Drug Evidence (STRIDE) and STARLiMS (a web-
based, commercial laboratory information management system), from
January 2006 through March 2016, there were 293 records for kratom and/
or mitragynine. From January 2010 through May 2016, the National
Forensic Laboratory Information System (NFLIS) registered 720 reports
containing mitragynine (See 3-Factor analysis). NFLIS and STRIDE/
STARLiMS records/reports were reported across 43 States, thus showing
the widespread abuse and trafficking of kratom/mitragynine.\19\ The
presence of these substances during drug evidence analyses demonstrates
the presence of these substances on the recreational drug market.
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\17\ Mitrgynine is used to confirmatively identify plant
material as kratom.
\18\ While law enforcement data is not direct evidence of abuse,
it can lead to an inference that a drug has been diverted and
abused.
\19\ STRIDE, STARLiMS, and NFLIS data reflect data reported by
the forensic laboratory systems. Encounters reported in these
systems, and the overall number of seizures, may be low because
kratom/mitragynine is not federally controlled under the CSA.
Typically, after control, these numbers will increase.
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Growing concern over the use of kratom is reflected in the
increased requests for analyses of mitragynine and 7-hydroxymitragynine
in human toxicology panels (blood/urine samples) \20\ to private
analytical laboratories.\21\ These analyses have been requested by
addiction treatment facilities/pain management doctors, drug courts,
medical examiner/coroner offices, drug testing facilities, state
laboratory systems, state police department, and private entities.\22\
The number of positive results from these analyses increased as
follows: 31 positive results from August 2012 to July 2013 for
mitragynine and/or 7-hydroxymitragynine; \23\ 274 positive results for
mitragynine between July 2013 and May 2014; \24\ 555 positive

[[Page 59932]]

results for mitragynine between December 2014 and March 2016.\25\ The
increasing trend in the number of positive results from these analyses
demonstrates the growing abuse and popularity of these substances and
the concern related to the abuse of this plant material and its
psychoactive constituents.
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\20\ The quantitative values for mitragynine and 7-
hydroxymitragynine were not available for all positive results
shown.
\21\ Substances are tested as part of a toxicology panel that
includes illicit or commonly abused substances routinely analyzed.
\22\ Email correspondences with analytical laboratories in
Willow Grove, PA, Clearwater, FL, and Santa Rosa, CA.
\23\ Located in Willow Grove, PA, analyzed blood/urine samples
from Canada and thirteen U.S. states. Correspondences on file with
DEA.
\24\ Located in Clearwater, FL, analyzed urine samples from
multiple states across the U.S. Correspondences on file with DEA.
\25\ Located in Santa Rosa, CA, analyzed urine samples from
multiple states across the United States. Correspondences on file
with DEA.
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Evidence from poison control centers in the United States also
shows that there is an increase in the number of individuals abusing
kratom, which contains the main active alkaloids mitragynine and 7-
hydroxymitragynine. As such, there has been a steady increase in the
reporting of kratom exposures by poison control centers. The American
Association of Poison Control Centers identified two exposures to
kratom between 2000 and 2005. Additionally, the Texas Poison Center
Network (TPCN), which is comprised of six poison centers that service
the State of Texas, reported 14 exposures to kratom between January
2009 and September 2013. Between January 2010 and December 2015 U.S.
poison centers received 660 calls related to kratom exposure. During
this time, there was a tenfold increase in the number of calls
received, from 26 in 2010 to 263 in 2015.
Furthermore, the abuse and addictive properties of kratom, which
contains the main active alkaloids mitragynine, and 7-
hydroxymitragynine, have prompted at least 15 countries,\26\ and 6
states and the District of Columbia to ban kratom, mitragynine and/or
7-hydroxymitragynine and two states within the United States,\27\ to
place regulatory controls on these substances. Six other States within
the United States have proposed to ban or place regulatory controls on
these substances.\28\
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\26\ Z. Aziz, Kratom The Epidemiology, Use and Abuse, Addiction
Potential, and Legal Status, in Kratom and Other Mitragynines The
Chemistry and Pharmacology of Opioids from a Non-Opium Source 309-
319 (Raffa, R.B., ed 2014); European Monitoring Center for Drugs and
Drug Addiction, Drug Profiles: Kratom, www.emcdda.europa.eu/
publications/drug-profiles/kratom (accessed 08/28/2013); Misuse of
Drugs Act 1977 Order 2011 (S.I. No. 551/2011) (Ir.); Misuse of Drugs
(Amendment Regulations 2011 (S.I. No. 552/2011) (Ir.).
\27\ Alabama--Ala. Code Sec. 20-2-23; Arkansas--Ark. Admin.
Code 007.07.2; Illinois--IL ST CH 720 Sec. 642/5; Indiana--IC 35-
31.5-2-321; Louisiana--LA R.S. 40:989.3; Tennessee--T.C.A. Sec. 39-
17-452; Vermont--Vt. Admin. Code 12-5-23:4.0; Wisconsin--W.S.A.
961.14 and District of Columbia--22-B DC ADC Sec. 1201.
\28\ New Hampshire--2015 NH S.B. 540 and 2015 NH S.B. 540; New
Jersey--2016 NJ A.B. 3281; New York--2015 NY A.B. 9121, 2015 NY A.B.
9068, 2015 NY A.B. 8670, and 2015 NY S.B. 6345; North Carolina--2015
NC H.B. 747 (NS) and 2015 NC S.B. 830 (NS); Florida--2016 FL S.B.
1182 and 2016 FL H.B. 73; and Kentucky--2016 KY S.B. 136.
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Internationally, the increased presence and abuse of kratom,
containing the main active alkaloids mitragynine and 7-
hydroxymitragynine, have garnered the attention of the International
Narcotics Control Board (INCB).\29\ In a 2010 report, the INCB noted
the increased interest in the recreational use of kratom. The INCB
recommended that governments experiencing problems with persons
trafficking or using kratom \30\ recreationally should consider
controlling kratom and kratom preparations at the national level, where
necessary.
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\29\ The INCB is an independent monitoring body that is
responsible for evaluating the implementation of the United Nations
international drug controls conventions.
\30\ Kratom was listed as a plant material containing
psychoactive substances in the INCB report for which recommendations
were made for specified plant materials.
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Factor 6. What, if Any, Risk There Is to the Public Health

The use of kratom and associated products, which contains the main
active alkaloids mitragynine and 7-hydroxymitragine, pose an imminent
hazard to public safety. These substances produce opioid-like effects,
making their abuse a serious public health concern. Information from
published literature, public health officials, and poison control
center data demonstrate that the use of kratom, which contains the main
active alkaloids mitragynine and 7-hydroxymitragynine, has caused
numerous adverse effects on users.
In a 2016 publication, the CDC characterized kratom exposures
reported to poison centers and uploaded to the NPDS from January 2010
through December 2015.\31\ These exposures resulted in medical outcomes
that varied in severity, ranging from minor (having minimal signs or
symptoms that resolved rapidly with no residual disability), moderate
(having non-life threatening and no residual disability, but requiring
some form of treatment), major (having life-threatening signs or
symptoms with some residual disability), and death. Additionally,
several adverse effects related to kratom exposure were reported, which
include agitation or irritability, tachycardia, nausea, drowsiness, and
hypertension. The severity of the reported outcomes, health effects,
and increased use of kratom suggests an emerging public health threat.
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\31\ Calls from healthcare providers comprised a large portion
of calls received, representing 75.2% of calls reported.
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Information from the scientific literature also demonstrates the
health risks associated with kratom use. Reports of hepatotoxicity,
psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor
concentration, hallucinations, and death associated with kratom use
have been documented. Additionally, published case reports describe
events where individuals sought medical care for the purported use of
kratom. Some examples of the reported adverse events involving kratom
exposure are described in the 3-factor analysis.
Numerous deaths associated with kratom, which contains the main
active constituents mitragynine and 7-hydroxymitragynine, have been
reported indicating that this substance is a serious public health
threat. In 2016, DEA has received correspondences from public/state
officials which indicate that there were a significant number of
overdoses and traffic fatalities directly, or indirectly, involving
kratom.\32\ Deaths related to kratom exposure have been reported in the
scientific literature beginning in 2009-2010, with a cluster of nine
deaths in Sweden from use of the kratom product ``Krypton''. Since
then, five more deaths related to kratom exposure were reported in the
scientific literature, and sixteen other deaths related to kratom
exposure, have been confirmed by autopsy/medical examiner reports
(mitragynine and/or 7-hydroxymitragynine were identified in biological
samples).\33\ Of these deaths, 15 occurred between 2014 and 2016. This
information demonstrates the severe risks associated with kratom misuse
and the increasing occurrence of fatal outcomes related to kratom
exposure. Details of some of these events are summarized in the 3-
factor analysis.
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\32\ Correspondences on file with DEA (dated April 19, 2016).
\33\ Autopsy/Medical Examiner (ME) reports on file with DEA.
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Since abusers obtain kratom, which contains the main active
alkaloids mitragynine and 7-hydroxymitragyine, through unknown sources,
the identity, purity, and quantity of these substances are uncertain
and inconsistent, thus posing significant adverse health risks to
users. According to the FDA, in a letter dated May 18, 2016, there are
no approved new drug applications, or investigational new drug
applications for mitragynine or 7-hydroxymitragynine. As such, kratom
products have no accepted medical use

[[Page 59933]]

within the United States. Despite FDA warnings, kratom products
continue to be easily available and abused by diverse populations.
Distributors of kratom are knowingly putting the public at risk.
Unknown factors including detailed product analysis and dosage
variations between various packages present a significant danger to an
abusing individual. With no accepted medical use, the abuse of kratom,
which contains mitragynine and 7-hydroxymitragynine, poses an imminent
hazard to the public safety.

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 continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession, and
abuse of mitragynine and 7-hydroxymitragynine pose an imminent hazard
to the public safety. The DEA is not aware of any currently accepted
medical uses for these substances in the United States. A substance
meeting the statutory requirements for temporary scheduling, 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 and 7-hydroxymitragynine 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 section
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a
letter dated May 6, 2016, notified the Assistant Secretary of the
Department of Health and Human Services of the DEA's intention to
temporarily place these substances in schedule I.

Conclusion

This notice of intent initiates an expedited temporary scheduling
action and provides the 30-day notice pursuant to section 201(h) of the
CSA, 21 U.S.C. 811(h). In accordance with the provisions of section
201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered
available data and information, herein set forth the grounds for his
determination that it is necessary to temporarily schedule mitragynine
and 7-hydroxymitragynine in schedule I of the CSA, and finds that
placement of these opioid substances into schedule I of the CSA is
necessary in order to avoid an imminent hazard to the public safety.
Because the Administrator hereby finds that it is necessary to
temporarily place these opioids into schedule I to avoid an imminent
hazard to the public safety, any subsequent final order temporarily
scheduling these substances will be effective on the date of
publication in the Federal Register, and will be in effect for a period
of two years, with a possible extension of one additional year, pending
completion of the regular scheduling process. 21 U.S.C. 811(h) (1) and
(2). It is the intention of the Administrator to issue such a final
order as soon as possible after the expiration of 30 days from the date
of publication of this notice. Mitragynine and 7-hydroxymitragynine
will then be subject to the 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 of a schedule I controlled substance.
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).

Regulatory Matters

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
schedule I on a temporary basis. Such an order may not be issued before
the expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention 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. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of section 553 of the Administrative Procedure
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the
alternative, even assuming that this notice of intent might be subject
to section 553 of the APA, the Administrator finds that there is good
cause to forgo the notice and comment requirements of section 553, as
any further delays in the process for issuance of temporary scheduling
orders would be impracticable and contrary to the public interest in
view of the manifest urgency to avoid an imminent hazard to the public
safety.
Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Administrator will take into
consideration any comments submitted by the Assistant Secretary with
regard to the proposed temporary scheduling order.
Further, the 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, the DEA is not required by section 553 of the APA or any other
law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).
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 Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.

[[Page 59934]]

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, the 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), unless otherwise noted.

0
2. In Sec. 1308.11, add paragraphs (h)(28) and (29) to read as
follows:

Sec. 1308.11 Schedule I

* * * * *
(h) * * *
(28) Mitragynine (to include synthetic equivalents as well as
mitragynine naturally contained in the plant of the genus and species
name: Mitragyna speciosa Korth, also known as kratom) its isomers,
esters, ethers, salts and salts of isomers, esters and ethers . . .
(9823)
(29) 7-Hydroxymitragynine (to include synthetic equivalents as well
as 7-hydroxymitragynine naturally contained in the plant of the genus
and species name: Mitragyna speciosa Korth, also known as kratom) its
isomers, esters, ethers, salts and salts of isomers, esters and ethers
. . . (9838)

Dated: August 25, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-20803 Filed 8-30-16; 8:45 am]
BILLING CODE 4410-09-P