[Federal Register: March 1, 2011 (Volume 76, Number 40)]
[Rules and Regulations]               
[Page 11075-11078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr11-1]    

=============================

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 
Justice.

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 
5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 
(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 
synthetic cannabinoids.

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 
ode@usdoj.gov.

DATES: Effective Date: March 1, 2011.

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 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 
purposes

[[Page 11076]]

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 
probation departments.
    Case reports describe psychotic episodes, withdrawal, and 
dependence associated with use of these synthetic cannabinoids, similar 
to syndromes

[[Page 11077]]

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 
enforcement.
    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-
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 temporary placement of these synthetic cannabinoids into Schedule 
I of the CSA is necessary to avoid an imminent hazard to the public 
safety.

Regulatory Requirements

    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, 
2011.
    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 
packaging requirements.
    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, 
CP-

[[Page 11078]]

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 
13132.

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

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. 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, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7297 (Other names: CP-47,497)
    (2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7298 (Other names: cannabicyclohexanol and CP-47,497 C8 
homologue)
    (3) 1-Butyl-3-(1-naphthoyl)indole, its optical, positional, and 
geometric isomers, salts and salts of isomers--7173 (Other names: JWH-
073)
    (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,
Administrator.
[FR Doc. 2011-4428 Filed 2-28-11; 8:45 am]
BILLING CODE 4410-09-P

[Federal Register: January 13, 2011 (Volume 76, Number 9)]
[Proposed Rules]               
[Page 2287-2288]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja11-12] 

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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-345C]

Schedules of Controlled Substances: Temporary Placement of Five 
Synthetic Cannabinoids Into Schedule I; Correction

AGENCY: Drug Enforcement Administration (DEA), U.S. Department of 
Justice.

ACTION: Notice of Intent; correction.

-----------------------------------------------------------------------

SUMMARY: On November 24, 2010, the Drug Enforcement Administration 
(DEA) published a Notice of Intent announcing its intention to 
temporarily place five synthetic cannabinoids into Schedule I of the 
Controlled Substances Act. This notice corrects two administrative 
errors made in that document.

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 
ode@dea.usdoj.gov.

SUPPLEMENTARY INFORMATION: In a November 24, 2010, Notice of Intent 
published in the Federal Register (75 FR 71635), DEA announced its 
intention to temporarily place five synthetic cannabinoids into 
schedule I of the Controlled Substances Act (CSA) pursuant to 21 U.S.C. 
811(h). Due to an administrative error, DEA included in that notice a 
paragraph addressing the Regulatory Flexibility Act (RFA) in the 
``Regulatory Certifications'' section of that document. The provisions 
of the RFA have no application to temporary scheduling orders issued 
under 21 U.S.C. 811(h) or to notices of intention to issue such orders. 
Accordingly, DEA certification under the RFA is not

[[Page 2288]]

legally required for this temporary scheduling order. Therefore, I 
hereby order that this paragraph (the first full paragraph in the right 
column on page 71637), as well as the ``Regulatory Flexibility Act'' 
heading that precedes it, be stricken.
    DEA also inadvertently included in its Notice of Intent a 
certification relating to the Congressional Review Act. The 
Congressional Review Act only applies to ``final'' rules. Accordingly, 
inclusion of the paragraph relating to the Congressional Review Act in 
the Notice of Intent was premature. Therefore, I hereby order that this 
paragraph (the fifth paragraph in the right column on page 71637 and 
continued on the top of page 71638), as well as the ``Congressional 
Review Act'' heading that precedes it, also be stricken.

    Dated: January 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-683 Filed 1-10-11; 4:15 pm]
BILLING CODE 4410-09-P

[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