Rules - 2011
[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Proposed Rules]
[Pages 55616-55619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23012]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-357]
Schedules of Controlled Substances: Temporary Placement of Three
Synthetic Cathinones Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of Intent.
SUMMARY: The Administrator of the Drug Enforcement Administration (DEA)
is issuing this notice of intent to temporarily schedule three
synthetic cathinones under the Controlled Substances Act (CSA) pursuant
to the temporary scheduling provisions of 21 U.S.C. 811(h). The
substances are 4-methyl-N-methylcathinone (mephedrone), 3,4-
methylenedioxy-N-methylcathinone (methylone), and 3,4-
methylenedioxypyrovalerone (MDPV). This action is based on a finding by
the Administrator that the placement of these synthetic cathinones into
schedule I of the CSA is necessary to avoid an imminent hazard to the
public safety. Any final order will be published in the Federal
Register and may not be issued prior to October 11, 2011. Any final
order will impose the administrative, civil, and criminal sanctions and
regulatory controls of schedule I substances under the CSA on the
manufacture, distribution, possession, importation, and exportation of
these synthetic cathinones.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone (202) 307-7165.
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.
21 U.S.C. 811(h); 21 CFR 1308.49. If proceedings to control a substance
are initiated under 21 U.S.C. 811(a)(1), the Attorney General may
extend the temporary scheduling up to six months. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be temporarily
scheduled 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 section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) for the substance. 21 U.S.C. 811(h)(1). The Attorney
General has delegated his authority under 21 U.S.C. 811 to the
Administrator of DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the
Administrator to notify the Secretary of Health and Human Services of
her intention to temporarily place a substance into schedule I of the
CSA.\1\
[[Page 55617]]
The Administrator has transmitted notice of her intent to place
mephedrone, methylone, and MDPV in schedule I on a temporary basis to
the Assistant Secretary by letter dated June 15, 2011. The Assistant
Secretary responded to this notice by letter dated July 25, 2011, and
advised that based on review by the Food and Drug Administration (FDA)
there are currently no investigational new drug applications (INDs) or
approved new drug applications (NDAs) for MDPV, mephedrone, or
methylone. The Assistant Secretary also stated that the Department of
Health and Human Services has no objection to the temporary placement
of MDPV, mephedrone, and methylone into schedule I of the CSA. DEA has
taken into consideration the Assistant Secretary's comments. As MDPV,
mephedrone, and methylone are not currently listed in any schedule
under the CSA, and as no exemptions or approvals are in effect for
MDPV, mephedrone, and methylone under Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), DEA believes that the
conditions of 21 U.S.C. 811(h)(1) have been satisfied. Any additional
comments submitted by the Assistant Secretary in response to this
notification shall also be taken into consideration before a final
order is published. 21 U.S.C. 811(h)(4).
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\1\ Because the Secretary of Health and Human Services has
delegated to the Assistant Secretary for Health of the Department of
Health and Human Services the authority to make domestic drug
scheduling recommendations, for purposes of this Notice of Intent,
all subsequent references to "Secretary" have been replaced with
"Assistant Secretary."
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To make 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 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: The substance's history and
current pattern of abuse; the scope, duration and significance of
abuse; and what, if any, risk there is to the public health. 21 U.S.C.
811(c)(4)-(6). Consideration of these factors includes actual abuse,
diversion from legitimate channels, and clandestine importation,
manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling (21 U.S.C. 811(h)(1)) may only be placed in schedule I.
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and lack accepted safety for use under medical supervision.
Available data and information for mephedrone, methylone, and MDPV
indicate that these three synthetic cathinones have a high potential
for abuse, no currently accepted medical use in treatment in the United
States, and lack accepted safety for use under medical supervision.
Synthetic Cathinones
These synthetic cathinones are not currently listed in any schedule
under the CSA. Synthetic cathinones are designer drugs of the
phenethylamine class which are structurally and pharmacologically
similar to amphetamine, 3,4-methylenedioxymethamphetamine (MDMA),
cathinone and other related substances. The addition of a beta-keto
([beta]-keto) substituent to the phenethylamine core structure produces
a group of substances that now have cathinone as the core structure.
These substances have been used as research chemicals. There is no
evidence in the scientific literature that these substances have any
legitimate non-research uses and the Assistant Secretary has advised
that there are no exemptions or approvals in effect under section 505
(21 U.S.C. 355) of the Federal Food, Drug and Cosmetic Act. In other
words, these synthetic cathinones have not been approved by the FDA for
human consumption.
Synthetic cathinones, like amphetamine, cathinone, methcathinone,
and methamphetamine, are central nervous system (CNS) stimulants. The
three synthetic cathinones proposed for control, 4-methyl-N-
methylcathinone (mephedrone), 3,4-methylenedioxy-N-methylcathinone
(methylone), and 3,4-methylenedioxypyrovalerone (MDPV) cause
sympathomimetic effects such as agitation, tachycardia, dilated pupils,
hyperthermia, diaphoresis (profuse sweating), and hypertension. Because
the pharmacological effects of synthetic cathinones are similar to
those of methamphetamine, cathinone, methcathinone, and MDMA, the abuse
of synthetic cathinones is also likely to be similar to these
substances and potentially cause serious harm to the users.
Numerous retail products marketed under the guise of "bath salts"
and "plant food" have been analyzed and mephedrone, methylone, and
MDPV have been identified in varying mixture profiles and quantities in
these products. Mephedrone, methylone, and MDPV are the most commonly
encountered synthetic cathinones. These three substances represent more
than 98% of the 1429 reported synthetic cathinones that have been
seized by law enforcement, as reported to the National Forensic
Laboratory Information System (NFLIS), a national repository of drug
evidence analysis from forensic laboratories across the United States.
Of all the reports of these substances recorded by NFLIS from January
2009 to June 2011, 791 reports (55%) were MDPV, 331 reports (23%) were
mephedrone, and 279 reports (20%) were methylone. Thus, these three
synthetic cathinones are the subject of this notice of intent.\2\
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\2\ See "Background, Data and Analysis of Synthetic Cathinones:
Mephedrone (4-MMC), Methylone (MDMC) and 3,4-
Methylenedioxypyrovalerone (MDPV)," dated August 2011 in this
rulemaking docket found at http://www.regulations.gov.
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Factor 4. History and Current Pattern of Abuse
The synthetic cathinones mephedrone, methylone, and MDPV have
recently emerged on the United States' illicit drug market and are
being perceived as being 'legal' alternatives to cocaine,
methamphetamine, and MDMA. Although synthetic cathinones are new to the
United States' illicit drug market, they have been popular drugs of
abuse in Europe since 2007. MDPV is a derivative of pyrovalerone, which
is a psychoactive drug that was used to treat chronic lethargy and
fatigue. Research in anti-depressant and anti-parkinson agents resulted
in the development and patenting of methylone. Methylone, however, has
not been approved for these purposes. There are no currently accepted
medical uses in treatment in the United States for mephedrone,
methylone, or MDPV.
Mephedrone, methylone, and MDPV are falsely marketed as "research
chemicals," "plant food," or "bath salts." They are sold at smoke
shops, head shops, convenience stores, adult book stores, and gas
stations. They can also be purchased on the Internet and mailed using
the U.S. Postal Service or international mail services. The packages of
products containing these synthetic cathinones usually have the warning
"not for human consumption," most likely in an effort to circumvent
statutory restrictions for these substances. Despite disclaimers that
the products are not intended for human consumption, retailers promote
that routine urinalysis drug tests will not typically detect the
presence of these synthetic cathinones. However, analytical methods for
the detection of mephedrone, methylone, MDPV, and other synthetic
cathinones have recently been developed for these substances.
Evidence indicates that mephedrone, methylone, and MDPV are being
abused for their psychoactive properties. Drug surveys found that these
and other
[[Page 55618]]
synthetic cathinones are being used as recreational drugs and are used
as alternatives to illicit stimulants like MDMA and cocaine.
Accordingly, mephedrone, methylone, and MDPV have been identified in
human urine samples that were obtained for routine drug screenings,
they have been detected in samples from drivers suspected of driving
under the influence, and they have been detected by drug courts during
mandatory periodic drug screens. They have also been identified in
biological specimens from individuals (some exhibiting symptoms of
"extreme agitation" or "excited delirium") who have been arrested
for possession of a controlled substance, child endangerment, or
homicide. They have been detected in samples from deceased whose causes
of death were reported as drug-induced toxicity, multiple drug
toxicity, or other causes (e.g., blunt force trauma from a vehicular
collision or suicide).
Based on studies in the scientific literature, the marketing of
products that contain mephedrone, methylone, and MDPV is geared towards
teens and young adults. Accordingly, reports indicate that the main
users of synthetic cathinones are young male adults. These substances
are also used by mid-to-late adolescents and older adults. Many of
these abusers of synthetic cathinones have a previous history of drug
abuse.
According to drug surveys, the reported average amount of synthetic
cathinones used per dose ranged from approximately 25 to 250 milligrams
and the average amount used per session (i.e., repeated administration
and binging) ranged from approximately 25 milligrams to five grams
depending on the substance consumed, duration of intake, and route of
administration. The most common routes of administration of these
substances are nasal insufflation by snorting the powder and oral
ingestion by swallowing capsules or tablets. Other reported methods of
administration include injection, rectal administration, and
"bombing" (wrapping a dose of powder in a paper wrap and swallowing).
Synthetic cathinones have also been reported to be used in binges.
Reasons cited for binging include to prolong the duration of effects,
to satisfy a "craving," or to satisfy a strong urge to re-dose.
According to information found in drug surveys, clinical case
reports, and law enforcement reports, users have reported using
products containing mephedrone, methylone, and MDPV with other
synthetic cathinones (e.g., butylone, fluoromethcathinone, 4-MEC,
etc.), pharmaceutical agents (e.g., lidocaine, caffeine, benzocaine,
etc.), or other recreational substances (e.g., amphetamine, MDMA,
cocaine, gamma-butyrolactone (GBL), kratom, N,N-benzylpiperazine (BZP),
and 1-(3-trifluoromethylphenyl)-piperazine (TFMPP)). Chemical analyses
of seized and purchased synthetic cathinone products indicate that some
products contain multiple substances. Furthermore, investigative
toxicology reports of drug screens in which more than one substance was
detected indicate that users have ingested products composed of drug
combinations (e.g., a tablet composed of MDPV and BZP) or multiple drug
products (e.g., a MDPV powder product and a MDMA tablet).
Factor 5. Scope, Duration and Significance of Abuse
The popularity of synthetic cathinones as recreational drugs has
increased since they first appeared on the United States' illicit drug
market. According to forensic laboratory reports, the first appearance
of these synthetic cathinones in the United States occurred in 2009. In
2009, NFLIS registered 15 exhibits from eight states containing these
three synthetic cathinones. In 2010, there were 560 reports from 29
states related to these substances registered in NFLIS and in the first
two quarters of 2011 (January to June 2011) there were 391.
Based on reports to DEA from law enforcement and public health
officials, synthetic cathinones are becoming increasingly prevalent and
abused throughout the United States. At just one United States point of
entry, the U.S. Customs and Border Protection (CBP) has encountered at
least 96 shipments containing primarily mephedrone, methylone, and
MDPV, as well as other synthetic cathinones like 4-MEC, butylone,
fluoromethcathinone, and dimethylcathinone. Most of these shipments
originated in China or India and were being shipped to destinations
throughout the United States such as Arizona, Alaska, Hawaii, Kansas,
Louisiana, Oklahoma, Oregon, Pennsylvania, Missouri, Virginia,
Washington, and West Virginia. The American Association of Poison
Control Centers, a non-profit, national organization that represents
the poison control centers of the United States, reported that in 2010,
poison control centers took 303 calls about synthetic cathinones.
However, in just the first seven months of 2011, poison control centers
have already received 4,137 calls relating to these products. These
calls were received in poison control centers representing at least 47
states and the District of Columbia. Individual state poison control
centers have also reported an increase in the number of calls regarding
"bath salts" from 2009 to 2011.
Concerns over the abuse of these and other synthetic cathinones
have prompted many states to control these substances. As of July 15,
2011, at least 33 states have emergency scheduled or enacted
legislation placing regulatory controls on some or many of the
synthetic cathinones. These states include Alabama, Arkansas, Florida,
Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana,
Maine, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New
Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, Texas, Tennessee, Utah, Virginia, Washington, West
Virginia, Wisconsin, and Wyoming. Several countries including all
members of the European Union have also placed controls on the
possession and/or sale of one or more of these substances. Moreover,
the use of synthetic cathinones by members of the U.S. Armed Forces is
prohibited.
Factor 6. What, If Any, Risk There Is to the Public Health
The risks to the public health associated with the abuse of
mephedrone, methylone, and MDPV relate to acute and long term public
health and safety problems. These synthetic cathinones have become a
serious drug abuse threat as there have been reports of emergency room
admissions and deaths associated with the abuse of these substances.
Clinical case reports indicate that these synthetic cathinones
produce a number of stimulant-like adverse effects such as palpitation,
seizure, vomiting, sweating, headache, discoloration of the skin,
hypertension, and hyper-reflexia. Adverse effects associated with
consumption of these drugs as reported by abusers include nose-bleeds,
bruxism (teeth grinding), paranoia, hot flashes, dilated pupils,
blurred vision, dry mouth/thirst, palpitations, muscular tension in the
jaw and limbs, headache, agitation, anxiety, tremor, and fever or
sweating. Consequently, numerous individuals have presented at
emergency departments in response to exposure incidents and several
cases of acute toxicity have been reported for the ingestion of
mephedrone, methylone, or MDPV. In addition, case reports have shown
that the abuse of synthetic cathinones can lead to psychological
dependence like that reported for other stimulant drugs.
According to clinical case reports, investigative toxicological
reports, and
[[Page 55619]]
autopsy reports, mephedrone, methylone, and MDPV have been implicated
in drug induced overdose deaths. In at least three reported deaths, one
of these synthetic cathinones was ruled as the cause of death. Other
deaths involved individuals under the influence of these synthetic
cathinones who acted violently and unpredictably in causing harm to
themselves or others. There have also been reports in the scientific
literature of deaths caused by individuals who were driving under the
influence of these synthetic cathinones.
A number of synthetic cathinones and their products, as identified
by CBP and reported in the scientific literature, appear to originate
from foreign sources. The manufacturers and retailers who make and sell
these products do not fully disclose the product ingredients including
the active ingredients or the health risks and potential hazards
associated with these products. This poses significant risk to abusers
who may not know what they are purchasing or the risk associated with
the use of those products.
Available evidence on the overall health and social risks of
mephedrone, methylone, and MDPV indicates that these substances can
cause acute health problems, can potentially lead to dependency, or can
cause death. The abuse of synthetic cathinones has been characterized
by both acute and long term public health and safety problems and has
resulted in deaths.
Finding of Necessity of Schedule I Scheduling To Avoid Imminent Hazard
to Public Safety
Based on the above data and information, the continued uncontrolled
manufacture, distribution, importation, exportation, and abuse of
mephedrone, methylone, and MDPV pose an imminent hazard to the public
safety. DEA is not aware of any recognized therapeutic uses of these
synthetic cathinones in the United States. A substance meeting the
statutory requirements for temporary scheduling (21 U.S.C. 811(h)(1))
may only be placed in schedule I. Substances in Schedule I are those
that have a high potential for abuse, no currently accepted medical use
in treatment in the United States, and lack accepted safety for use
under medical supervision. Available data and information for
mephedrone, methylone, and MDPV indicate that these three synthetic
cathinones have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and lack accepted safety
for use under medical supervision.
Conclusion
This notice of intent initiates expedited temporary scheduling
action and provides the 30-day notice pursuant to section 201(h) of the
CSA (21 U.S.C. 811(h)). In accordance with the provisions of section
201(h) of the CSA (21 U.S.C. 811(h)), the Administrator has considered
available data and information and has set forth herein the grounds for
her determination that it is necessary to temporarily schedule three
synthetic cathinones, 4-methyl-N-methylcathinone (mephedrone), 3,4-
methylenedioxy-N-methylcathinone (methylone), and 3,4-
methylenedioxypyrovalerone (MDPV) in Schedule I of the CSA to avoid an
imminent hazard to the public safety.
Because the Administrator hereby finds that it is necessary to
temporarily place these synthetic cathinones into Schedule I to avoid
an imminent hazard to the public safety, any subsequent final order
temporarily scheduling these substances will be effective on the date
of publication in the Federal Register, and will be in effect for a
period of up to 18 months pending completion of the permanent or
regular scheduling process. It is the intention of the Administrator to
issue such a final order as soon as possible after the expiration of 30
days from the date of publication of this notice. Mephedrone,
methylone, and MDPV will then 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.
Regular scheduling actions in accordance with 21 U.S.C. 811(a) are
subject to formal rulemaking procedures done "on the record after
opportunity for a hearing" conducted pursuant to the provisions of 5
U.S.C. 556 and 557. The CSA sets forth specific criteria for scheduling
a drug or other substance. While temporary scheduling orders are not
subject to judicial review (21 U.S.C. 811(h)(6)), the regular
scheduling process of formal rulemaking affords interested parties with
appropriate process and the government with any additional relevant
information needed to make a determination. Final decisions which
conclude the regular scheduling process of formal rulemaking are
subject to judicial review. 21 U.S.C. 877.
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
Administrator of the DEA by Department of Justice regulations (28 CFR
0.100), the 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)(6), (7)
and (8) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(6) 4-methyl-N-methylcathinone--1248 (Other names: mephedrone)
(7) 3,4-methylenedioxy-N-methylcathinone--7540 (Other names:
methylone)
(8) 3,4-methylenedioxypyrovalerone--7535 (Other names: MDPV)
Dated: September 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-23012 Filed 9-7-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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