[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Proposed Rules]
[Pages 12508-12514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4982]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-345]


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Drug Enforcement Administration (DEA) proposes placing 
five 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-(3-
hydroxycyclohexyl)-phenol (CP-47,497), and 5-(1,1-dimethyloctyl)-2-(3-
hydroxycyclohexyl)-phenol (cannabicyclohexanol, CP-47,497 C8 homologue) 
including their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
into Schedule I of the Controlled Substances Act (CSA). This proposed 
action is pursuant to the CSA which requires that

[[Page 12509]]

such actions be made on the record after opportunity for a hearing 
through formal rulemaking.

DATES: DEA will permit interested persons to file written comments on 
this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must 
be submitted and written comments must be postmarked on or before April 
30, 2012. Commenters should be aware that the electronic Federal Docket 
Management System will not accept comments after midnight Eastern Time 
on the last day of the comment period.
    Interested persons, defined as those ``adversely affected or 
aggrieved by any rule or proposed rule issuable pursuant to section 201 
of the Act (21 U.S.C. 811),'' \1\ may file a request for hearing or 
waiver of participation pursuant to 21 CFR 1308.44 and in accordance 
with 21 CFR 1316.45. Requests for hearing and waivers of participation 
must be received on or before April 2, 2012.
---------------------------------------------------------------------------

    \1\ 21 CFR 1300.01.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-345'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document and supplemental information 
to this proposed rule are also available at the http://www.regulations.gov Web site for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to www.regulations.gov will be posted for public review and 
are part of the official docket record. Should you, however, wish to 
submit written comments via regular or express mail, they should be 
sent to the Drug Enforcement Administration, Attention: DEA Federal 
Register Representative/OD, 8701 Morrissette Drive, Springfield, VA 
22152. All requests for hearing and waivers of participation must be 
sent to Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 
---------------------------------------------------------------------------
8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Alan G. Santos, Associate Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the DEA's public 
docket. Such information includes personal identifying information 
(such as your name, address, etc.) voluntarily submitted by the 
commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all of the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

Request for Hearing or Waiver of Participation in Hearing

    In accordance with the provisions of the CSA (21 U.S.C. 811(a)), 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557) 
and 21 CFR 1308.41. Pursuant to 21 CFR 1308.44(a) and (c), requests for 
hearing and waivers of participation may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).'' Requests for hearing must conform to the 
requirements of 21 CFR 1308.44(a) and 1316.47. A request should state, 
with particularity, the interest of the person in the proceeding and 
the objections or issues, if any, concerning which the person desires 
to be heard. Any waiver must conform to the requirements of 21 CFR 
1308.44(c), including a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of the hearing is restricted to ``(A) find[ing] that 
such drug or other substance has a potential for abuse, and (B) 
mak[ing] with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed * * *'' Requests for 
hearing and waivers of participation in the hearing should be submitted 
to DEA using the address information provided above.

Legal Authority

    The DEA implements and enforces Titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act and the Controlled 
Substances Import and Export Act (21 U.S.C. 801-971), as amended 
(hereinafter, ``CSA''). The implementing regulations for these statutes 
are found in Title 21 of the Code of Federal Regulations (CFR), parts 
1300 to 1321. Under the CSA, controlled substances are classified in 
one of five schedules based upon their potential for abuse, their 
currently accepted medical use, and the degree of dependence the 
substance may cause. 21 U.S.C. 812. The initial schedules of controlled 
substances by statute are found at 21 U.S.C. 812(c) and the current 
list of scheduled substances are published at 21 CFR Part 1308.
    The CSA permits these initial schedules to be modified by providing 
that scheduling of any drug or other substance may be initiated by the 
Attorney General (1) on his own motion; (2) at the request of the 
Secretary of HHS, or (3) on the petition of any interested party. 21 
U.S.C. 811(a). The Attorney General may, by rule, ``add to such a 
schedule or transfer between such schedules any drug or other substance 
if he (A) finds that such drug or other substance has a potential for 
abuse, and (B) makes with respect to such drug or other substance the 
findings prescribed by subsection (b) of section 812 of this title for 
the schedule in which such drug is to be placed * * *''

[[Page 12510]]

Background

    On November 24, 2010, DEA published a Notice of Intent \2\ to 
temporarily place five synthetic cannabinoids into Schedule I pursuant 
to the temporary scheduling provisions of the CSA: 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-(3-hydroxycyclohexyl)-phenol (CP-47,497), and 5-(1,1-
dimethyloctyl)-2-(3-hydroxycyclohexyl)-phenol (cannabicyclohexanol, CP-
47,497 C8 homologue). 75 FR 71635. Following this, on March 1, 2011, 
the Administrator published a Final Order in the Federal Register 
amending 21 CFR 1308.11(g) to temporarily place the five synthetic 
cannabinoids into Schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). 76 FR 11075. This Final 
Order, which became effective on the date of publication, was based on 
findings by the Administrator that the temporary scheduling of the five 
synthetic cannabinoids was necessary to avoid an imminent hazard to the 
public safety. The CSA (21 U.S.C. 811(h)(2)) requires that the 
temporary scheduling of a substance expire at the end of one year from 
the date of issuance of the order. However, if proceedings to schedule 
a substance pursuant to 21 U.S.C. 811(a) are pending, the temporary 
scheduling of a substance may be extended for up to six months. Under 
this provision, the temporary scheduling of the cannabinoids, which 
would expire on February 29, 2012, may be extended to August 29, 2012. 
This extension is being ordered by the Administrator in a separate 
action.
---------------------------------------------------------------------------

    \2\ This Notice of Intent was corrected on January 13, 2011. 76 
FR 2287.
---------------------------------------------------------------------------

    As described in the March 1, 2011 Final Order, a ``cannabinoid'' is 
a class of chemical compounds in the marijuana \3\ 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 principal of 
marijuana.
---------------------------------------------------------------------------

    \3\ Note that ``marihuana'' is the spelling originally used in 
the Controlled Substances Act (CSA). This document uses the spelling 
that is more common in current usage, ``marijuana.''
---------------------------------------------------------------------------

    The emergence of these five synthetic cannabinoids represents a 
recent phenomenon in the U.S. designer drug market. Numerous products, 
marketed under the guise being ``herbal incense,'' with trade names 
such as ``Spice'' and ``K2'' have conclusively been found to contain 
these five substances. These products are manufactured by spiking plant 
material with the synthetic cannabinoids and then distributed in a way 
that poses dangerous consequences to the consumer. Marketed as 
``legal'' alternatives to marijuana, these products are being abused 
for their psychoactive properties and are packaged without information 
as to their health and safety risks.

Proposed Determination To Schedule Five Synthetic Cannabinoids

    This NPRM proposes the permanent scheduling of JWH-018, JWH-200, 
JWH-073, CP-47,497 and cannabicyclohexanol pursuant to 21 U.S.C. 
811(a)(1). On June 21, 2011, DEA requested a scientific and medical 
evaluation and scheduling recommendation from the Assistant Secretary 
of HHS for each of the five synthetic cannabinoids pursuant to 21 
U.S.C. 811(b). Upon receipt and evaluation of the scientific and 
medical evaluation and scheduling recommendations from the Assistant 
Secretary,\4\ DEA concluded its analysis of all other relevant data for 
the proposal to place JWH-018, JWH-200, JWH-073, CP-47,497 and 
cannabicyclohexanol into Schedule I of the CSA.
---------------------------------------------------------------------------

    \4\ DEA received separate Evaluations and Recommendation 
documents from HHS with respect to each of the five synthetic 
cannabinoids. HHS recommended Schedule I placement for each of these 
five substances on the following dates: 1-pentyl-3-(1-
naphthoyl)indole (JWH-018) (January 5, 2012); 1-pentyl-3-(1-
naphthoyl)indole (JWH-073) and 1-[2-(4-morpholinyl)ethyl]-3-(1-
naphthoyl)indole (JWH-200) (February 6, 2012), 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) (February 13, 2012).
---------------------------------------------------------------------------

    Included below is a brief summary of each factor as analyzed by HHS 
and DEA, and as considered by DEA in the scheduling decision. Please 
note that both the DEA and HHS analyses are available under 
``Supporting and Related Material'' of the public docket for this 
proposed rule at www.regulations.gov under docket number DEA-345.
    1. The Drug's Actual or Relative Potential for Abuse: The abuse 
potential of the five synthetic cannabinoids under evaluation is 
associated with their ability to evoke cannabinoid-like subjective 
effects similar to those evoked by the Schedule I cannabinoid delta-9-
tetrahydrocannabinol (THC).
    The legislative history of the CSA provides four factors to 
consider in determining whether a particular drug or substance has 
potential for abuse: \5\
---------------------------------------------------------------------------

    \5\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 
4566, 4601.
---------------------------------------------------------------------------

    i. There is evidence that individuals are taking the drug or other 
substance in amounts sufficient to create a hazard to their health or 
to the safety of other individuals or to the community; or
    ii. There is significant diversion of the drug or substance from 
legitimate drug channels; or
    iii. Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of medical 
advice from a practitioner licensed by law to administer such drugs in 
the course of his professional practice; or
    iv. The drug is a new drug so related in its action to a drug or 
other substance already listed as having a potential for abuse to make 
it likely that the drug or other substance will have the same potential 
for abuse as such drugs, thus making it reasonable to assume that there 
may be significant diversion from legitimate channels, significant use 
contrary to or without medical advice, or that it has a substantial 
capability of creating hazards to the health of the user or to the 
safety of the community.
    With respect to the first factor, a number of case reports and case 
series (article grouping several case reports) have shown that 
individuals are taking these substances and products containing these 
substances in amount sufficient to induce toxic effects similar to 
those induced by marijuana such as anxiety, tachycardia and 
hallucinations. Severe toxic effects including seizures, 
tachyarrhythmias, extreme anxiety leading to suicide and the 
precipitation of psychotic episodes have also been reported following 
abuse of these substances or products containing these substances.
    In considering evidence of significant diversion of the drug or 
substance from legitimate drug channels under the second factor, it 
must be noted that as of March 1, 2011, these synthetic cannabinoids 
have been temporarily controlled as Schedule I substances and thus have 
not been legally available unless for research purposes. The National 
Forensic Laboratory Information System (NFLIS) details over 5,450 
reports from state and local forensic laboratories identifying JWH-018, 
JWH-073, JWH-200, CP-47,497 or cannabicyclohexanol in drug related 
exhibits for a period from January 2009 to December 2011 from 39 
states. The System to Retrieve Information from Drug Evidence (STRIDE) 
also details

[[Page 12511]]

reports from federal forensic laboratories identifying JWH-018, JWH-
073, and JWH-200 in drug related exhibits for a period from January 
2009 to December 2011.
    For the third factor, there is no currently accepted medical use 
for any of the five synthetic cannabinoids, and, outside of an 
extremely limited research setting, no medical practitioner is 
currently licensed by law to administer them. Thus, with no accepted 
medical use or administering practitioners, any individuals currently 
taking using products containing JWH-018, JWH-073, JWH-200, CP-47,497 
or cannabicyclohexanol are doing so on their own initiative without 
medical advice from a practitioner licensed to administer those 
substances.
    Related to the fourth factor, HHS states that JWH-018, JWH-073, 
JWH-200, CP-47,497 and cannabicyclohexanol are cannabinoids with a 
potential for abuse similar to the Schedule I substances marijuana and 
THC. These synthetic cannabinoids appear to be marketed solely for 
abuse of their marijuana-like activity and because, prior to the March 
1, 2011 Final Order, they were not controlled under the CSA. As such, 
commerce involving these synthetic cannabinoids can only be for the 
purposes of abuse and escaping the regulatory and criminal penalties of 
the CSA that pertain to marijuana.
    JWH-018, JWH-200, JWH-073, CP-47,497 and cannabicyclohexanol have 
agonist properties at the CB1 receptor. The CB1 receptors are thought 
to be responsible for the euphoric and psychoactive effects of THC and 
related cannabinoids.
    Drug discrimination is a method in which laboratory animals 
indicate whether a test drug produces physical or psychic perceptions 
similar to those produced by a known drug of abuse. Drug discrimination 
studies in rats suggest that JWH-018, JWH-200, JWH-073, CP-47,497, and 
cannabicyclohexanol have similar subjective effects as THC, while 
numerous anecdotal self-reports, as well as case reports and case 
series substantiate that these substances and their associated products 
are abused by humans for their hallucinogenic effects. An indication of 
the extent of such abuse may be found in the results of the 2011 
Monitoring the Future survey of high schools students, where 1 in 9 
high school seniors (11.4%) reported having used ``synthetic 
marijuana'' (products often containing synthetic cannabinoids) in the 
past year. These statistics make it one of the most frequently 
mentioned among high school seniors, second only to marijuana. 
Additionally, while products containing synthetic cannabinoids appear 
to produce subjective effects similar to marijuana, they are dissimilar 
to other licit and illicit drugs.
    As evidence of abuse on the national scale, State public health and 
poison centers have issued warnings in response to adverse health 
effects associated with abuse of herbal incense products containing 
these synthetic cannabinoids. These adverse effects included 
tachycardia, elevated blood pressure, unconsciousness, tremors, 
seizures, vomiting, hallucinations, agitation, anxiety, pallor, 
numbness and tingling. This is in addition to the numerous public 
health and poison centers which have similarly issued warnings 
regarding the abuse of these synthetic cannabinoids and their 
associated products, and the ban on the use of these synthetic 
cannabinoids by military personnel issued in response to reported 
instances of abuse by active personnel.
    2. Scientific Evidence of the Drug's Pharmacological Effects, If 
Known: In their recommendations for the placement of the five synthetic 
cannabinoids, HHS states that in vitro and preclinical studies suggest 
that the pharmacological effects of JWH-018, JWH-200, JWH-073, CP-
47,497 and cannabicyclohexanol are similar to those of THC.
    The CB1 receptors are thought to be responsible for the euphoric 
and psychoactive effects of THC and related cannabinoids. JWH-018, JWH-
200, JWH-073, CP-47,497 and cannabicyclohexanol have agonist properties 
at the CB1 receptor.
    Animal studies also provided evidence of cannabinoid-like 
pharmacological effects of these synthetic cannabinoids. JWH-018, JWH-
200, CP-47,497 and cannabicyclohexanol were shown to be active in all 
four parameters of the mouse tetrad, a well-established paradigm for 
evaluating substances for cannabimimetic properties, while JWH-073 was 
only tested, and shown to be active, in three of the four parameters of 
the tetrad test. JWH-018, JWH-200, JWH-073, CP-47,497 and 
cannabicyclohexanol substitute fully for the discriminative stimulus 
effects of THC in laboratory animals, suggesting that they are likely 
to have similar subjective effects as THC, the main active ingredient 
of marijuana.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: The appearance of these substances in the designer 
drug market can be traced to the initial forensic laboratory 
confirmation in mid-December 2008. A commercial laboratory in 
Frankfurt, Germany announced the identification of JWH-018 in samples 
of herbal incense and others were identified shortly after this initial 
determination.
    These five cannabinoid substances have been termed `synthetic' or 
`non-classical' because they are agonists at the CB1 receptor but are 
structurally distinct from naturally occurring cannabinoids.
    HHS has confirmed to DEA in a letter dated November 22, 2010, that 
there are no Investigational New Drug Applications (INDs) or New Drug 
Applications (NDAs) for these synthetic cannabinoids. DEA is also not 
aware of any accepted medical use for these five synthetic 
cannabinoids.
    4. Its History and Current Pattern of Abuse: Synthetic cannabinoids 
have been developed over the last 30 years to investigate their 
cannabimimetic properties and as research tools to investigate the 
cannabinoid systems (Huffman et al., 1994; Wiley et al., 1998). 
Trafficking of synthetic cannabinoids was first reported in the United 
States in a December 2008 encounter, where a shipment of `Spice' was 
seized and analyzed by U.S. Customs and Border Patrol in Dayton, Ohio. 
Around the same time, in December 2008, JWH-018 and cannabicyclohexanol 
were identified by German forensic laboratories (EMCDDA, 2009).
    JWH-018, JWH-073, JWH-200, CP-47,497, and Cannabicyclohexanol have 
been found alone and found laced on products that are marketed as 
herbal incense. The abuse of these substances and their associated 
products for their psychoactive effects has been widely reported and 
their popularity has spread rapidly since December 2008. The NFLIS has 
detailed over 5,450 reports from state and local forensic laboratories 
identifying JWH-018, JWH-073, JWH-200, CP-47,497 and/or 
cannabicyclohexanol in drug related exhibits for a period from January 
2009 to December 2011 from 39 states. Prior to being temporarily placed 
in Schedule I on March 1, 2011, these products were promoted as legal 
alternatives to marijuana, were widely available over the Internet, and 
were found to be sold in gas stations, convenience stores, tobacco and 
head shops to all populations.
    As of January 13, 2012, forty-eight states in the U.S. as well as 
numerous local jurisdictions and countries have controlled at least one 
of these five synthetic cannabinoids.

[[Page 12512]]

    5. The Scope, Duration, and Significance of Abuse: HHS states that 
the current scope and duration of use of the synthetic cannabinoids is 
likely underestimated because of the lack of widely available 
toxicological methods to identify its use using routine analyses 
(Peters and Martinez-Ramirez 2010). Additionally, since these 
substances were never intended for human consumption, minimal 
information exists as to the health implications resulting from 
exposure to these substances (Griffiths et al., 2010; Vardakou et al., 
2010). As forensic procedures and toxicology screens are being 
developed, the amount of information concerning these substances and 
the associated products is increasing.
    The abuse of synthetic cannabinoids has been associated with both 
acute and long-term public health and safety concerns. In the past 
year, increased exposure incidents have been documented by poison 
control centers in the United States. As of December 31, 2011, the 
American Association of Poison Centers (AAPCC) has reported receiving 
9,992 calls corresponding to products purportedly laced with synthetic 
cannabinoids. The calls represented exposed individuals from all 50 
states and the District of Columbia, as well as a few calls regarding 
exposed individuals in Puerto Rico, U.S. Territories, foreign 
countries, and a category identified as ``overseas/US military/
diplomatic.'' Several of these exposures were confirmed to involve JWH-
018 (141), and JWH-073 (12).
    The increased abuse of these synthetic cannabinoids in the United 
States is supported by an increasing number of encounters by law 
enforcement. Over the past year in the United States there has been a 
significant increase in availability, trafficking and abuse of these 
substances as evident from the increasing number of encounters reported 
by forensic laboratories (NFLIS and STRIDE data). Product manufacturing 
and synthesis laboratories have been discovered, and laboratories have 
been found manufacturing products by lacing plant material with 
synthetic cannabinoids.
    6. What, if any, Risk There is to the Public Health: Law 
enforcement, military, and public health officials have reported 
exposure incidents that demonstrate the dangers associated with these 
substances to both the individual abusers and other affected 
individuals. Two suicides, one also involving a murder, have been 
linked to the abuse of synthetic cannabinoids (law enforcement 
communication to DEA). Warnings regarding the dangers of synthetic 
cannabinoid abuse and associated products have been issued by numerous 
state public health departments and poison centers and private 
organizations. Detailed product analyses describe variations in the 
amount and type of synthetic cannabinoid laced on the plant material; 
this is true even within samplings of the same product.
    Because they share pharmacological similarities with the Schedule I 
substance THC, the synthetic cannabinoids JWH-018, JWH-073, JWH-200, 
CP-47,497, and cannabicyclohexanol pose substantial risks to the 
abuser. Numerous emergency department admissions have been connected to 
these substances, while law enforcement communications to DEA indicate 
multiple violent episodes linked to smoking these synthetic 
cannabinoids. Health warnings issued by numerous state public health 
departments and poison centers have described adverse health effects 
associated with smoking (inhaling) these products, including agitation, 
vomiting, tachycardia, elevated blood pressure, seizures, paranoia, 
hallucinations and non-responsiveness, and fatality.
    Case reports describe presentations to emergency departments of 
individuals exposed to synthetic cannabinoids with symptoms that 
include anxiety and panic attacks, tremors, generalized convulsions, 
psychosis, heart palpitations and elevated pulse, severe 
gastrointestinal distress, tremors, blurred peripheral vision, nausea, 
and persistent vomiting with retching. Such abuse also includes 
instances of persons suspected of driving under the influence of these 
synthetic cannabinoids, including one incident where an automobile was 
driven through a residence. In that case the driver claimed to have no 
memory of the event while a toxicology analysis confirmed that the 
driver had smoked a product containing JWH-018, but not any other 
drugs.
    7. Its Psychic or Physiological Dependence Liability: HHS states 
that the pharmacological profile of JWH-018, JWH-200, JWH-073, CP-
47,497 and cannabicyclohexanol strongly suggests that they possess 
physiological and psychological dependence liability similar to that of 
the Schedule I controlled substances marijuana and THC. While no 
laboratory controlled clinical studies of the psychic or physical 
dependence potential of these five synthetic cannabinoids are currently 
available, their pharmacological profile indicates that the substances 
will have high psychic and physiologic dependence capacity.
    Case reports have shown that herbal products containing synthetic 
cannabinoids could produce physical dependence and a withdrawal 
syndrome. The HHS analysis discusses one case report in which the 
authors concluded that the patient satisfied criteria for a diagnosis 
of DSM-IV and ICD-10 dependency syndrome on JWH-018. Some reported 
withdrawal symptoms included elevated blood pressure, restlessness, 
drug craving, nightmares, sweating, nausea, tremor and headache.
    Because these substances act through the same molecular target as 
THC, the main active ingredient of marijuana, it can be reasonably 
expected that their physical dependence liability will be similar. 
Long-term, regular use of marijuana can lead to physical dependence and 
withdrawal following discontinuation as well as psychic addiction or 
dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: JWH-018, JWH-073, JWH-200, CP-47,497, 
and cannabicyclohexanol are not considered immediate precursors of any 
controlled substance of the CSA as defined by Title 21, U.S.C. 802(23).
    Conclusion: Based on consideration of the scientific and medical 
evaluations and accompanying recommendations of HHS, and based on DEA's 
consideration of its own eight-factor analyses, DEA finds that these 
facts and all relevant data constitute substantial evidence of 
potential for abuse of JWH-018, JWH-073, JWH-200, CP-47,497 and 
cannabicyclohexanol. As such, DEA hereby proposes to schedule JWH-018, 
JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol as controlled 
substances under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as Schedules I, II, III, IV, and V. The statute outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendations of the Assistant Secretary for Health of HHS and review 
of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 
812(b)(1), finds that:
    (1) 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-(3-

[[Page 12513]]

hydroxycyclohexyl)-phenol (CP-47,497), and 5-(1,1-dimethyloctyl)-2-(3-
hydroxycyclohexyl)-phenol (cannabicyclohexanol, CP-47,497 C8 homologue) 
have a high potential for abuse;
    (2) 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-(3-
hydroxycyclohexyl)-phenol (CP-47,497), and 5-(1,1-dimethyloctyl)-2-(3-
hydroxycyclohexyl)-phenol (cannabicyclohexanol, CP-47,497 C8 homologue) 
have no currently accepted medical use in treatment in the United 
States; and
    (3) there is a lack of accepted safety for use of 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-(3-hydroxycyclohexyl)-phenol (CP-47,497), and 5-(1,1-
dimethyloctyl)-2-(3-hydroxycyclohexyl)-phenol (cannabicyclohexanol, CP-
47,497 C8 homologue) under medical supervision.
    Based on these findings, the Administrator of DEA concludes that 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-(3-hydroxycyclohexyl)-phenol (CP-47,497), and 
5-(1,1-dimethyloctyl)-2-(3-hydroxycyclohexyl)-phenol 
(cannabicyclohexanol, CP-47,497 C8 homologue), including their salts, 
isomers and salts of isomers, whenever the existence of such salts, 
isomers, and salts of isomers is possible, warrant control in Schedule 
I of the CSA (21 U.S.C. 812(b)(1)).

Requirements for Handling Five Synthetic Cannabinoids

    If this rule is finalized as proposed, JWH-018, JWH-200, JWH-073, 
CP-47,497 and cannabicyclohexanol would be permanently, as they are 
currently temporarily, subject to the CSA and the Controlled Substances 
Import and Export Act (CSIEA) regulatory controls and administrative, 
civil, and criminal sanctions applicable to the manufacture, 
distribution, dispensing, importing, and exporting of a Schedule I 
controlled substance, including the following:
    Registration. Any person who manufactures, distributes, dispenses, 
imports, exports, engages in research or conducts instructional 
activities with JWH-018, JWH-200, JWH-073, CP-47,497 or 
cannabicyclohexanols, or who desires to manufacture, distribute, 
dispense, import, export, engage in research or conduct instructional 
activities with any of the five synthetic cannabinoids, would need to 
be registered to conduct such activities pursuant to 21 U.S.C. 822 and 
958 and in accordance with 21 CFR part 1301.
    Security. JWH-018, JWH-200, JWH-073, CP-47,497 or 
cannabicyclohexanol would be subject to Schedule I security 
requirements and would need to be manufactured, distributed, and stored 
pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 
1301.72(a), (c) and (d), 1301.73, 1301.74, 1301.75(a) and (c), 1301.76.
    Labeling and Packaging. All labels and labeling for commercial 
containers of JWH-018, JWH-200, JWH-073, CP-47,497 or 
cannabicyclohexanol which are distributed on or after the effective 
date of the finalization of this rule would need to be in accordance 
with 21 CFR 1302.03-1302.07, pursuant to 21 U.S.C. 825.
    Quotas. Quotas for JWH-018, JWH-200, JWH-073, 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.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of JWH-018, JWH-200, JWH-073, CP-47,497 or 
cannabicyclohexanol would be required to keep an inventory of all 
stocks of any of the five synthetic cannabinoids on hand pursuant to 21 
U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 
Every registrant who desires registration in Schedule I for any of the 
five synthetic cannabinoids would be required to conduct an inventory 
of all stocks of the substance on hand at the time of registration.
    Records. All registrants would be required to keep records pursuant 
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, 
1304.21, 1304.22, and 1304.23.
    Reports. All registrants required to submit reports pursuant to 21 
U.S.C. 827 and in accordance with 21 CFR 1304.33 would be required to 
do so regarding JWH-018, JWH-200, JWH-073, CP-47,497 and 
cannabicyclohexanol.
    Order Forms. All registrants involved in the distribution of JWH-
018, JWH-200, JWH-073, CP-47,497 or cannabicyclohexanol pursuant to 21 
U.S.C. 828 would be required to comply with the order form requirements 
of 21 CFR 1305.
    Importation and Exportation. All importation and exportation of 
JWH-018, JWH-200, JWH-073, CP-47,497 or cannabicyclohexanol would need 
to be done in accordance with 21 CFR Part 1312, pursuant to 21 U.S.C. 
952, 953, 957, and 958.
    Criminal Liability. Any activity with JWH-018, JWH-200, JWH-073, 
CP-47,497 or cannabicyclohexanol not authorized by, or in violation of, 
Subchapter I Part D and Subchapter II of the CSA or the CSIEA occurring 
on or after effective date of the finalization of this proposed rule 
would be unlawful.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget pursuant to Section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132

    This proposed 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.

Executive Order 13175

    This proposed rule will not have tribal implications and will not 
impose substantial direct compliance costs on Indian tribal 
governments.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control,

[[Page 12514]]

Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR Part 1308 is proposed to be 
amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for 21 CFR 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 redesignating paragraphs (d)(18) 
through (35) as paragraphs (d)(19) through (36) and adding a new 
paragraph (d)(18) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
    (18) Cannabimimetic agents

 
 
 
(i) 1-Butyl-3-(1-naphthoyl)indole (Other names: JWH-073)            7173
(ii) 5-(1,1-Dimethylheptyl)-2-(3-hydroxycyclohexyl)-                7297
 phenol (Other names: CP-47,497)........................
(iii) 5-(1,1-Dimethyloctyl)-2-(3-hydroxycyclohexyl)-                7298
 phenol (Other names: Cannabicyclohexanol and CP-47,497
 C8 homologue)..........................................
(iv) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole               7200
 (Other names: JWH-200).................................
(v) 1-Pentyl-3-(1-naphthoyl)indole (Other names: JWH-018            7118
 and AM678).............................................
 

* * * * *

    Dated: February 24, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-4982 Filed 2-28-12; 11:15 am]
BILLING CODE 4410-09-P