[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