[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Proposed Rules]
[Pages 55616-55619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23012]


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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.

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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