[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