Rules - 2010
[Federal Register: November 24, 2010 (Volume 75, Number 226)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-345N]
Schedules of Controlled Substances: Temporary Placement of Five
Synthetic Cannabinoids Into Schedule I
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
ACTION: Notice of Intent.
SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this notice of intent to temporarily
place five synthetic cannabinoids into the Controlled Substances Act
(CSA) pursuant to the temporary scheduling provisions under 21 U.S.C.
811(h) of the CSA. 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 intended action is
based on a finding by the DEA Deputy
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. Finalization of this action will impose criminal
sanctions and regulatory controls of Schedule I substances under the
CSA on the manufacture, distribution, possession, importation, and
exportation of these synthetic cannabinoids.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., 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
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. 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
Administrator of DEA (28 CFR 0.100). The Administrator has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR, appendix
to subpart R, section 12.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Deputy Administrator to notify the Assistant Secretary for Health,
delegate of the Secretary of Health and Human Services, of her
intention to temporarily place a substance into Schedule I of the CSA.
Comments submitted by the Assistant Secretary for Health in response to
this notification, including whether there is an exemption or approval
in effect for the substance in question under the Federal Food, Drug
and Cosmetic Act, shall be taken into consideration before a final
order is published.
In making a finding that placing a substance temporarily into
Schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety, the Deputy Administrator is required to consider three
of the eight factors set forth in section 201(c) of the CSA (21 U.S.C.
811(c)). These factors are as follows: (4) History and current pattern
of abuse; (5) The scope, duration and significance of abuse; and (6)
What, if any, risk there is to the public health.
Synthetic cannabinoids have been developed over the last 30 years
for research purposes to investigate the cannabinoid system. No
legitimate non-research uses have been identified for these synthetic
cannabinoids. They have not been approved by the U.S. Food and Drug
Administration for human consumption. These THC-like synthetic
cannabinoids, 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 5-(1,1-dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8
homologue), are so termed for their THC-like pharmacological
properties. Though they have similar properties to delta-9-
tetrahydrocannabinol (THC) found in marijuana and have been found to be
more potent than THC in animal studies. Numerous herbal products have
been analyzed and JWH-073, JWH-018, JWH-200, CP-47,497, and
cannabicyclohexanol have been identified in varying mixture profiles
and amounts spiked on plant material.
Factor 4. History and Current Pattern of Abuse
The emergence of these synthetic cannabinoids represents a recent
phenomenon in the designer drug market. Since the initial
identification of JWH-018 in December 2008, many additional synthetic
cannabinoids with purported psychotropic effects have been identified
in related products. The popularity of these THC-like synthetic
cannabinoids has greatly increased in the United States and they are
being abused for their psychoactive properties. Primarily found laced
on plant material, these synthetic cannabinoids are also being abused
alone as self-reported on Internet discussion boards. This abuse has
been characterized by both acute and long term public health and safety
problems. Even though there is no accepted use for these synthetic
cannabinoids, multiple shipments of JWH-018 and JWH-073 have been
intercepted by U.S. Customs and Border Protection in 2010, with one
being in excess of 50 kilograms. Additionally, bulk loads of JWH-018
and JWH-200 have been seized by law enforcement in 2010. In Casper,
Wyoming, products seized in a raid, which were laced with synthetic
cannabinoids, were found in conjunction with illicit drugs.
The products containing these THC-like synthetic cannabinoids are
marketed as "legal" alternatives to marijuana and are being sold over
the Internet and in tobacco and smoke shops, drug paraphernalia shops,
and convenience stores. These 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. DEA has been
made aware that smoking these synthetic cannabinoids for the purpose of
achieving intoxication and experiencing the psychoactive effects is
identified as a reason for emergency room visits and calls to poison
As of October 15, 2010, 15 states in the United States, European
and Scandinavian countries have controlled one or more of the synthetic
cannabinoids DEA is temporarily scheduling here.
Factor 5. Scope, Duration and Significance of Abuse
According to forensic laboratory reports, the first appearance of
these synthetic cannabinoids in the United States occurred in November
2008, when U.S. Customs and Border Protection analyzed "Spice"
products. From January 2010 through September 2010, the National
Forensic Laboratory Information System, a national repository of drug
evidence analyses from forensic laboratories across the United States,
reported over 500 exhibits relating to these synthetic cannabinoids
from various States including Alabama, Arkansas, California, Florida,
Hawaii, Iowa, Indiana, Kansas, Kentucky, Louisiana, Minnesota,
Missouri, North Dakota, Nebraska, Nevada, Oklahoma, Pennsylvania, South
Carolina, Tennessee, and Virginia. Additionally, the American
Association of Poison Control Centers (AAPCC) has reported receiving
over 1,500 calls as of September 27, 2010, relating to products spiked
with these synthetic cannabinoids from 48 states and the District of
Factor 6. What, if Any, Risk There Is to the Public Health
JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol share
pharmacological similarities with the Schedule I substance THC. Health
warnings have been issued by numerous state public health departments
and poison control centers describing the adverse health effects
associated with these synthetic cannabinoids and their related products
including agitation, anxiety, vomiting, tachycardia, elevated blood
pressure, seizures, hallucinations and non-responsiveness. Case reports
describe psychotic episodes, withdrawal, and dependence associated with
use of these synthetic cannabinoids, similar to syndromes observed in
cannabis abuse. Emergency room physicians have reported admissions
connected to the abuse of these synthetic cannabinoids. Additionally,
when responding to incidents involving individuals who have reportedly
smoked these synthetic cannabinoids, first responders report that these
individuals suffer from intense hallucinations. Detailed chemical
analysis by DEA and other investigators have found these synthetic
cannabinoids spiked on plant material in products marketed to the
general public. The risk of adverse health effects is further increased
by the fact that similar products vary in the composition and
concentration of synthetic cannabinoids(s) spiked on the plant
Self-reported abuse of these THC-like synthetic cannabinoids alone
and spiked on plant material appear on Internet discussion boards.
According to self-reports, these substances are cannabis-like (or THC-
like) in their psychoactive effects and are more potent than THC in
this regard. The most common route of administration of these synthetic
cannabinoids is by smoking, using a pipe, water pipe, or rolling the
drug-spiked plant material in cigarette papers.
The marketing of products that contain one or more of these
synthetic cannabinoids is geared towards teens and young adults.
Despite disclaimers that the products are not intended for human
consumption, retailers promote that routine urinalysis tests will not
typically detect the presence of these synthetic cannabinoids.
Furthermore, a number of the products and synthetic cannabinoids
appear to originate from foreign sources and are manufactured in the
absence of quality controls and devoid of regulatory oversight. These
products and associated synthetic cannabinoids are readily accessible
via the Internet.
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, CP-47,497, and cannabicyclohexanol
indicate that these synthetic cannabinoids each have a high potential
for abuse, no currently accepted medical use in treatment in the United
States and are not safe for use under medical supervision.
Based on the above data, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse 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. As required by
section 201(h)(4) of the CSA (21 U.S.C. 811(h)), the Deputy
Administrator in a letter dated October 6, 2010, notified the Assistant
Secretary of Health of the intention to temporarily place five
synthetic cannabinoids in Schedule I.
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)) and 28 CFR 0.100, the Deputy 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 placement of these synthetic cannabinoids into Schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety.
Because the Deputy Administrator finds that it is necessary to
temporarily place these synthetic cannabinoids into Schedule I to avoid
an imminent hazard to the public safety, the final order, if issued,
will be effective on the date of publication of the order in the
Federal Register. JWH-018, JWH-073, JWH-200, CP-47,497, and
cannabicyclohexanol will be subject to the regulatory controls and
administrative, civil and criminal sanctions applicable to the
manufacture, distribution, possession, importing and exporting of a
Schedule I controlled substance under the CSA. Further, it is the
intention of the Deputy Administrator to issue such a final order as
soon as possible after the expiration of thirty days from the date of
publication of this notice and the date that notification was
transmitted to the Assistant Secretary for Health.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. This action provides
a notice of intent to temporarily place 1-butyl-3-(1-naphthoyl)indole,
hydroxycyclohexyl]-phenol, and 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol into Schedule I of the CSA. DEA is not aware
of any legitimate non-research uses for these synthetic cannabinoids in
the United States.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Executive Order 13132
This rulemaking 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 rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule 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.
Congressional Review Act
This rule is not a major rule as defined by 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). This rule will not result in an annual effect on the
economy of $100,000,000 or more; a major increase in costs or prices;
or significant adverse effects on
competition, employment, investment, productivity, innovation, or on
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.
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)), and delegated to the Deputy
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100, and section 12 of the Appendix to Subpart R), the Deputy
Administrator hereby intends to order that 21 CFR part 1308 be amended
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for part 1308 continues to read as
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) * * *
(Other names: CP-47,497)
(Other names: cannabicyclohexanol and CP-47,497 C8 homologue)
(Other names: JWH-073)
(Other names: JWH-200)
(Other names: JWH-018 and AM678)
Dated: November 15, 2010.
Michele M. Leonhart,
[FR Doc. 2010-29600 Filed 11-23-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).