Rules - 2011
[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4428]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-345F]
Schedules of Controlled Substances: Temporary Placement of Five
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
ACTION: Final order.
SUMMARY: The Administrator of the Drug Enforcement Administration (DEA)
is issuing this final order to temporarily place five synthetic
cannabinoids into the Controlled Substances Act (CSA) pursuant to the
temporary scheduling provisions. The substances are 1-pentyl-3-(1-
naphthoyl)indole (JWH-018), 1-butyl-3-(1-naphthoyl)indole (JWH-073), 1-
[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200), 5-(1,1-
dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497), and
(cannabicyclohexanol; CP-47,497 C8 homologue). This action is based on
a finding by the Administrator that the placement of these synthetic
cannabinoids into Schedule I of the CSA is necessary to avoid an
imminent hazard to the public safety. As a result of this order, the
full effect of the CSA and its implementing regulations including
criminal, civil and administrative penalties, sanctions and regulatory
controls of Schedule I substances will be imposed on the manufacture,
distribution, possession, importation, and exportation of these
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152, telephone (202) 307-7183, fax (202) 353-1263, or e-mail
DATES: Effective Date: March 1, 2011.
The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which
was signed into law on October 12, 1984, amended section 201 of the CSA
(21 U.S.C. 811) to give the Attorney General the authority to
temporarily place a substance into Schedule I of the CSA for one year
without regard to the requirements of 21 U.S.C. 811(b) if he finds that
such action is necessary to avoid imminent hazard to the public safety.
The Attorney General may extend the temporary scheduling up to six
months during pendency of proceedings under 21 U.S.C. 811(a)(1). A
substance may be temporarily scheduled under the emergency provisions
of the CSA 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 under 21 U.S.C. 355 for the substance. The Attorney General has
delegated his authority under 21 U.S.C. 811 to the DEA Administrator
(28 CFR 0.100).
As per section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)), the
Deputy Administrator, now Administrator, transmitted notice of her
intention to temporarily place JWH-018, JWH-073, JWH-200, CP-47,497,
and cannabicyclohexanol into Schedule I of the CSA to the Assistant
Secretary for Health of the Department of Health and Human Services
(HHS) in a letter dated October 6, 2010. In response to this
notification, the Assistant Secretary of Health, HHS communicated in a
letter dated November 22, 2010, to the then-DEA Acting Administrator
that there are no exemptions or approvals in effect for JWH-018, JWH-
073, JWH-200, CP-47,497, and cannabicyclohexanol under Section 505 of
the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355). The substances
are not listed in any other schedule in 21 U.S.C. 812.
A notice of intent to temporarily place JWH-018, JWH-073, JWH-200,
CP-47,497, and cannabicyclohexanol into Schedule I of the CSA was
published in the Federal Register on November 24, 2010 (75 FR 71635).
Before making a finding that temporarily placing a substance into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety, the Administrator must consider three of the eight
factors (factors 4, 5, and 6) set forth in section 201(c) of the CSA
(21 U.S.C. 811(c)). These factors are the history and current pattern
of abuse, the scope, duration, and significance of abuse, and what, if
any, risk there is to the public health, including actual abuse,
diversion from legitimate channels, and clandestine importation,
manufacture, or distribution. 21 U.S.C. 811(h)(3).
The temporary placement of these five synthetic cannabinoids into
Schedule I of the CSA is necessary in order to avoid an imminent hazard
to the public safety. First, these substances are not intended for
human consumption, but there has been a rapid and significant increase
in abuse of these substances in the United States. As a result of this
abuse, synthetic cannabinoids are banned in at least 18 states in the
United States and several countries, and all five branches of the U.S.
military prohibit military personnel from possessing or using synthetic
cannabinoids. Second, law enforcement has seized synthetic cannabinoids
in conjunction with controlled substances and based on self-reports to
law enforcement and health care professionals, synthetic cannabinoids
are abused for their psychoactive properties. Third, numerous state and
local public health departments and poison control centers have issued
health warnings describing the adverse health effects associated with
synthetic cannabinoids. Based on scientific data currently available,
these five substances have the potential to be extremely harmful and,
therefore, pose an imminent hazard to the public safety.
History and Current Pattern of Abuse
A "cannabinoid" is a class of chemical compounds in the marijuana
plant that are structurally related. The cannabinoid [Delta]9-
tetrahydrocannabinol (THC) is the primary psychoactive constituent of
marijuana. "Synthetic cannabinoids" are a large family of chemically
unrelated structures functionally (biologically) similar to THC, the
active principle of marijuana.
Two of the five synthetic cannabinoids (CP-47,497 and
cannabicyclohexanol) were synthesized in the early 1980s for research
in the investigation of the cannabinoid system. JWH-018, JWH-073, and
JWH-200 were prepared in the mid-1990s and evaluated to further advance
understanding of drug-receptor interactions regarding the cannabinoid
system. Developed and evaluated as research tools, no other known
legitimate uses have been identified for these five synthetic
cannabinoids. Furthermore, these five synthetic cannabinoids are not
intended for human consumption.
The emergence of these five synthetic cannabinoids represents a
recent phenomenon in the U.S. designer drug market. Since the initial
identification of JWH-018 by U.S. forensic laboratories, many
additional synthetic cannabinoids including JWH-073, JWH-200, CP-
47,497, and cannabicyclohexanol have been identified in related herbal
incense products and plant food. These synthetic cannabinoids have
purported psychotropic effects when smoked or ingested. These
substances are typically found in powder form or are dissolved in
appropriate solvents, such as acetone, before being sprayed on the
plant material contained in the herbal incense products.
The popularity of these THC-like synthetic cannabinoids has
significantly increased throughout the United States, and they are
being abused for their psychoactive properties as reported by law
enforcement, the medical community, and through scientific literature.
Some of the product names include, but are not limited to,
"Spice," "K2," and many more. Due to sophisticated marketing, the
products that contain these five THC-like synthetic cannabinoids are
perceived as "legal" alternatives to marijuana despite the fact that
they are typically advertised as herbal incense or plant food (Bonsai-
18) by Internet retailers, tobacco shops, head shops, and other
domestic brick and mortar retail venues, and labeled "Not For Human
Consumption." No evidence exists that these synthetic cannabinoids
have value as an additive to herbal incense products due to the absence
of odor associated with the substances.
Based on law enforcement encounters, these five substances are
typically found laced on plant material. The plant material is packaged
in small pouches or packets, and is being sold over the Internet, in
tobacco and smoke shops, drug paraphernalia shops, gas stations, and
convenience stores as herbal incense products, giving customers of all
ages direct access to these five substances. Research articles propose
that the packaging is professional and conspicuous, targeting young
people, possibly eager to use cannabis, but who are afraid of the
judicial consequences and/or association with illicit drugs.
According to Internet discussion boards and law enforcement
encounters reported directly to DEA, these five synthetic cannabinoids
are being both abused alone and/or being sprayed on plant material
(which is then smoked). The most common route of administration of
these synthetic cannabinoids is by smoking (using a pipe, a water pipe,
or rolling the drug-spiked plant material in cigarette papers).
These five synthetic cannabinoids alone or spiked on plant material
have the potential to be extremely harmful due to their method of
manufacture and high pharmacological potency. There is little
information regarding the pharmacology, toxicology, and safety of these
substances in humans given the minimal amount of pre-clinical
investigations undertaken regarding these substances; therefore, the
full danger of these drugs has not yet been determined.
As of January 31, 2011, 18 states in the United States and other
countries have controlled one or more of the five synthetic
cannabinoids. Moreover, all five branches of the military prohibit
their personnel from possessing or using synthetic cannabinoids
associated with products such as Spice and K2.
Scope, Duration, and Significance of Abuse
According to forensic laboratory reports, the initial appearance of
these synthetic cannabinoids in herbal incense products in the United
States occurred in November 2008 when U.S. Customs and Border
Protection first encountered products such as Spice.
The increasing abuse of the five synthetic cannabinoids is
demonstrated by the increase in federal, state, and local law
enforcement activity associated with these substances. The National
Forensic Laboratory Information System, a national repository for drug
evidence analyses from forensic laboratories across the United States,
has reported in excess of 500 exhibits containing synthetic cannabinoid
from January 2010 through September 2010. These exhibits came from
numerous states across the nation including Alabama, Arkansas,
California, Florida, Hawaii, Iowa, Indiana, Kansas, Kentucky,
Louisiana, Minnesota, Missouri, North Dakota, Nebraska, Nevada,
Oklahoma, Pennsylvania, South Carolina, Tennessee, and Virginia.
Even though there is no evidence of legitimate non-research related
use for these synthetic cannabinoids, multiple shipments of JWH-018 and
JWH-073 have been encountered by U.S. Customs and Border Protection in
2010. One enforcement operation encountered five shipments of JWH-018
totaling over 50 kilograms (110.2 pounds) of powder. In addition, bulk
loads of JWH-018 and JWH-200 have been encountered by law enforcement
in 2010. For example, in Casper, Wyoming, DEA agents encountered large
quantities of herbal incense products laced with the synthetic
cannabinoid JWH-018 in conjunction with methamphetamine and other
illegal drugs in execution of search and arrest warrants.
On March 24, 2010, the American Association of Poison Control
Centers reported receiving 112 calls from 15 states related to
synthetic cannabinoids to U.S. poison centers since 2009. Just nine
months later, the number of calls increased to over 2,700 from 49
states and the District of Columbia.
What, If Any, Risk There Is to the Public Health
Health warnings have been issued by numerous state and local public
health departments and poison control centers describing the adverse
health effects associated with these synthetic cannabinoids and their
related products, including agitation, anxiety, nausea, vomiting,
tachycardia (fast, racing heartbeat), elevated blood pressure, tremor,
seizures, hallucinations, paranoid behavior, and non-responsiveness.
Smoking these synthetic cannabinoids for the purpose of achieving
intoxication and experiencing the psychoactive effects has been
identified as a reason for emergency room visits and calls to poison
control centers. In a fact sheet by the National Drug Court Institute,
the problem of synthetic cannabinoid abuse is described as
"significant and disturbing." This is supported by information that
was communicated to DEA from one of the major private toxicology
laboratories. Based on laboratory findings from drug screens for the
period of July 2010 through November 2010, over 3,700 specimens tested
positive for either JWH-018 or JWH-073. They also indicated that they
were finding 30-35% positivity for specimens submitted by juvenile
Case reports describe psychotic episodes, withdrawal, and
dependence associated with use of these synthetic cannabinoids, similar
observed in marijuana abuse. In addition, based on law enforcement
encounters reported directly to DEA, when responding to incidents
involving individuals who have reportedly smoked these synthetic
cannabinoids, first responders report that these individuals have
suffered from intense hallucinations. Moreover, emergency department
physicians and toxicologists have reported the adverse health effects
associated with smoking herbal incense products laced with these
substances. Furthermore, based on law enforcement encounters, suspected
Driving Under the Influence of Drug incidents are attributed to the
smoking of synthetic cannabinoids. For example, in September 2010,
police in Nebraska responded to an incident involving a teenage male
who had careened his truck into the side of a residence. After striking
the residence and several more items, the teen continued several more
yards before coming to a complete stop. Prior to crashing the truck,
the individual had driven past a junior high school and nearly struck a
child. Upon further investigation, the driver of the vehicle admitted
to smoking "Wicked X," a product marketed as "herbal incense" and
known to contain synthetic cannabinoids, prior to the accident.
Preliminary toxicology reports indicated that the individual did not
have any alcohol or other illegal substances in his system.
Detailed chemical analyses by DEA and other investigators have
found these synthetic cannabinoids spiked on plant material in herbal
incense products marketed to the general public. Product analyses have
found variations in both the synthetic cannabinoid found on the plant
material and the amount. As proposed in scientific literature, the risk
of adverse health effects is further increased by the fact that similar
products vary in the composition and concentration of synthetic
cannabinoids spiked on the plant material.
Self-reported abuse of these THC-like synthetic cannabinoids either
alone (e.g., in pills with the substance in powder form) or spiked on
plant material appear extensively on Internet discussion boards, and
abuse has been reported to public health officials and law enforcement.
The abuse of these substances spiked on plant material is corroborated
by forensic laboratory analysis of products encountered by law
According to the U.S. Customs and Border Protection, a number of
the products and synthetic cannabinoids appear to originate from
foreign sources. Product manufacturing operations encountered by law
enforcement corroborate that the herbal incense products are
manufactured in the absence of quality controls and devoid of
regulatory oversight. Law enforcement has encountered the manufacture
of herbal incense products occurring in such places as residential
neighborhoods. These products and associated synthetic cannabinoids are
readily accessible via the Internet.
Based on the above data, the continued uncontrolled manufacture,
distribution, importation, exportation, and possession of JWH-018, JWH-
073, JWH-200, CP-47,497, and cannabicyclohexanol pose an imminent
hazard to the public safety. DEA is not aware of any recognized
therapeutic uses of these synthetic cannabinoids in the United States.
DEA has considered the three criteria for placing a substance into
Schedule I of the CSA (21 U.S.C. 812). The data available and reviewed
for JWH-073, JWH-018, JWH-200, CP47,497, and cannabicyclohexanol
indicate that these synthetic cannabinoids each has a high potential
for abuse, no currently accepted medical use in treatment in the United
States and a lack of accepted safety for use under medical supervision.
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)) and 28 CFR 0.100, the Administrator has considered the
available data and the three factors required to support a
determination to temporarily schedule five synthetic cannabinoids: 1-
butyl-3-(1-naphthoyl)indole, 1-pentyl-3-(1-naphthoyl)indole, 1-[2-(4-
[(1R,3S)-3-hydroxycyclohexyl]-phenol, and 5-(1,1-dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol in Schedule I of the CSA and finds
that temporary placement of these synthetic cannabinoids into Schedule
I of the CSA is necessary to avoid an imminent hazard to the public
With the issuance of this final order, JWH-018, JWH-073, JWH-200,
CP-47,497, and cannabicyclohexanol become subject to the regulatory
controls and administrative, civil and criminal sanctions applicable to
the manufacture, distribution, possession, importation, and exportation
of a Schedule I controlled substance under the CSA.
1. Registration. Any person who manufactures, distributes,
dispenses, imports, exports, or possesses JWH-018, JWH-073, JWH-200,
CP-47,497, or cannabicyclohexanol or who engages in research or
conducts instructional activities with respect to JWH-018, JWH-073,
JWH-200, CP-47,497, or cannabicyclohexanol, or who proposes to engage
in such activities, must be registered to conduct such activities in
accordance with 21 U.S.C. 823 and 958. Any person who is currently
engaged in any of the above activities and is not registered with DEA
must submit an application for registration and may not continue their
activities until DEA has approved that application. Retail sales of
Schedule I controlled substances to the general public are not allowed
under the Controlled Substances Act.
2. Security. JWH-018, JWH-073, JWH-200, CP-47,497, and
cannabicyclohexanol are subject to Schedule I security requirements.
Accordingly, appropriately registered DEA registrants must manufacture,
distribute and store these substances in accordance with 1301.71;
1301.72(a), (c), and (d); 1301.73; 1301.74; 1301.75(a) and (c); and
1301.76 of Title 21 of the Code of Federal Regulations as of March 1,
3. Labeling and packaging. All labeling and packaging requirements
for controlled substances set forth in Part 1302 of Title 21 of the
Code of Federal Regulations shall apply to commercial containers of
JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol. Current
DEA registrants shall have thirty (30) calendar days from the effective
date of this Final Order to be in compliance with all labeling and
4. Quotas. Quotas for JWH-018, JWH-073, JWH-200, CP-47,497, and
cannabicyclohexanol will be established based on registrations granted
and quota applications received pursuant to part 1303 of Title 21 of
the Code of Federal Regulations.
5. Inventory. Every DEA registrant who possesses any quantity of
JWH-018, JWH-073, JWH-200, CP-47,497, or cannabicyclohexanol is
required to keep inventory of all stocks of these substances on hand
pursuant to 1304.03, 1304.04, and 1304.11 of Title 21 of the Code of
Federal Regulations. Every current DEA registrant who desires
registration in Schedule I for JWH-018, JWH-073, JWH-200, CP-47,497, or
cannabicyclohexanol shall conduct an inventory of all stocks of these
substances. Current DEA registrants shall have thirty (30) calendar
days from the effective date of this Final Order to be in compliance
with all inventory requirements.
6. Records. All registrants who handle JWH-018, JWH-073, JWH-200,
47,497, or cannabicyclohexanol are required to keep records pursuant to
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code
of Federal Regulations. Current DEA registrants shall have thirty (30)
calendar days from the effective date of this Final Order to be in
compliance with all recordkeeping requirements.
7. Reports. All registrants are required to submit reports in
accordance with 1304.33 of Title 21 of the Code of Federal Regulations.
Registrants who manufacture or distribute JWH-018, JWH-073, JWH-200,
CP-47,497, or cannabicyclohexanol are required to comply with these
reporting requirements and shall do so as of March 1, 2011.
8. Order Forms. All registrants involved in the distribution of
JWH-018, JWH-073, JWH-200, CP-47,497, or cannabicyclohexanol must
comply with order form requirements of part 1305 of Title 21 of the
Code of Federal Regulations as of March 1, 2011.
9. Importation and Exportation. All importation and exportation of
JWH-018, JWH-073, JWH-200, CP-47,497, or cannabicyclohexanol must be
conducted by appropriately registered DEA registrants in compliance
with part 1312 of Title 21 of the Code of Federal Regulations on or
after March 1, 2011.
10. Criminal Liability. The manufacture, distribution,
dispensation, or possession with the intent to conduct these
activities; possession; importation; or exportation of JWH-018, JWH-
073, JWH-200, CP-47,497, or cannabicyclohexanol not authorized by, or
in violation of the CSA or the Controlled Substances Import and Export
Act occurring as of March 1, 2011 is unlawful.
Executive Order 12988
This final temporary scheduling order meets the applicable
standards set forth in sections 3(a) and 3(b)(2) of Executive Order
12988 Civil Justice Reform.
Executive Order 13132
This final temporary scheduling order does not preempt or modify
any provision of State law; nor does it impose enforcement
responsibilities on any State; nor does it diminish the power of any
State to enforce its own laws. Accordingly, this order does not have
federalism implications warranting the application of Executive Order
Congressional Review Act
Pursuant to section 808(2) of the Congressional Review Act, the
agency is not required to comply with the Act if it makes a good faith
finding that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest. It is in the public
interest to schedule these cannabinoids immediately because they pose a
public health risk. Use of materials spiked with these cannabinoids has
been the cause of emergency room visits and calls to poison control
centers. The adverse health effects associated with these synthetic
cannabinoids and their related products include agitation, anxiety,
nausea, vomiting, tachycardia (fast, racing heartbeat), elevated blood
pressure, tremor, seizures, hallucinations, paranoid behavior, and non-
responsiveness. The materials have been marketed on products that are
available to the general public, and their manufacture is devoid of
quality controls and unregulated.
This temporary scheduling action is taken pursuant to section
811(h), which is specifically designed to enable DEA to act in an
expeditious manner to avoid an imminent hazard to the public safety
from new or designer drugs or abuse of those drugs. Section 811(h)
exempts the temporary scheduling order from standard notice and comment
rulemaking procedures to ensure that the process moves swiftly. For the
same reasons that underlie section 811(h), that is, DEA's need to move
quickly to place these five cannabinoids into Schedule 1 because they
pose a threat to public health, it would be contrary to the public
interest to delay implementation of the temporary scheduling order by
requiring DEA to undertake the procedures necessary to comply with the
Congressional Review Act prior to the order taking effect.
Unfunded Mandates Reform Act of 1995
This final temporary scheduling order will not result in the
expenditure by State, local and tribal governments, in the aggregate,
or by the private sector, of $126,400,000 or more (adjusting for
inflation) in any one year, and it will not significantly or uniquely
affect small governments. Therefore, no actions were deemed necessary
under the provisions of the Unfunded Mandates Reform Act of 1995.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
Under the authority vested in the Attorney General by section
201(h) of the CSA (21 U.S.C. 811(h)), the Administrator hereby amends
21 CFR part 1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
- 1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
- 2. Section 1308.11 is amended by adding new paragraphs (g)(1), (2),
(3), (4), and (5) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
its optical, positional, and geometric isomers, salts and salts of
isomers--7297 (Other names: CP-47,497)
its optical, positional, and geometric isomers, salts and salts of
isomers--7298 (Other names: cannabicyclohexanol and CP-47,497 C8
(3) 1-Butyl-3-(1-naphthoyl)indole, its optical, positional, and
geometric isomers, salts and salts of isomers--7173 (Other names: JWH-
(4) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole, its optical,
positional, and geometric isomers, salts and salts of isomers--7200
(Other names: JWH-200)
(5) 1-Pentyl-3-(1-naphthoyl)indole, its optical, positional, and
geometric isomers, salts and salts of isomers--7118 (Other names: JWH-
018 and AM678)
Dated: February 18, 2011.
Michele M. Leonhart,
[FR Doc. 2011-4428 Filed 2-28-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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