```

[Federal Register: November 24, 2010 (Volume 75, Number 226)]
[Proposed Rules]               
[Page 71635-71638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no10-45]                         

=======================================================================
-----------------------------------------------------------------------

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 
Justice.

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 
5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 
(cannabicyclohexanol; CP-47,497 C8 homologue). This intended action is 
based on a finding by the DEA Deputy

[[Page 71636]]

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 
ode@dea.usdoj.gov.

SUPPLEMENTARY INFORMATION:

Background

    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

    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 
control centers.
    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 
Columbia.

[[Page 71637]]

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 
material.
    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-
morpholinyl)ethyl]-3-(1-naphthoyl)indole, 5-(1,1-dimethylheptyl)-2-
[(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 Certifications

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, 
1-pentyl-3-(1-naphthoyl)indole, 1-[2-(4-morpholinyl)ethyl]-3-(1-
naphthoyl)indole, 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
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 
Reform.

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

[[Page 71638]]

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 
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) * * *
    (1) 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol-
7297
    (Other names: CP-47,497)
    (2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol-
7298
    (Other names: cannabicyclohexanol and CP-47,497 C8 homologue)
    (3) 1-Butyl-3-(1-naphthoyl)indole-7173
    (Other names: JWH-073)
    (4) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole-7200
    (Other names: JWH-200)
    (5) 1-Pentyl-3-(1-naphthoyl)indole-7118
    (Other names: JWH-018 and AM678)

    Dated: November 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-29600 Filed 11-23-10; 8:45 am]
BILLING CODE 4410-09-P
```