DEPARTMENT OF HEALTH & HUMAN SERVICES Office ofthe Secretary

Mr. Thomas M. Harrigan Deputy Administrator Drug Enforcement Administration U.S. Department ofJustice 8701 Morrissette Drive Springfield, VA 22152

Dear Mr. Harrigan: Office ofthe Assistant Secretary for Health Washington, O.C. 20201



## DEC -4 2013

Thank you for your recent letter notifying me ofyour intention to temporarily place 4- methyl-N-ethylcathinone (4-MEC), 4-methyl-a-pyrrolidinopropiophenone (4-McPPP), alpha-pyrrolidinopentiophenone (u-PVP), 1-( 1,3-benzodioxol-5-yl)-2- (methylamino)butan-1-one (butylonc), 2-(mcthylamino)-1-phenylpentan-1-one (pentedrone), 1-(l,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pcntylone), 4- fluoro-N-methylcathinone (4-FMC), 3-tluoro-N-methylcathinone (3-FMC), naphthylpyrovalerone (naphyrone), and alpha-pyrrolidinobutiophenone (a-PBP) into Schedule I ofthe Controlled Substances Act (CSA).

I asked the Food and Drug Administration to review its tiles and the agency has advised

me that there are currently no approved new drug applications or investigational nev.: drug applications for any ofthese substances. Therefore, the Department ofHealth and Human Services has no objection regarding your plans to temporarily place 4-MEC, 4- MePPP, a-PYP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-Pl3J> into Schedule I ofthe CSA.

Sincerely yours,

Howard K. Koh, M.D., M.P.H. Assistant Secretary for Health

U.S. Public Health ServiceOffice of the DeputyAdministrator

Howard 

### K. Koh, M.D., M.P.H. Assistant Secretary for Health Department ofHealth and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201

Dear Dr. Koh: 

### U.S. DepartmentofJustice Drug EnforcementAdministration

Springfield, Va 22152

November 7, 2013

This letter serves as notification to the Secretary ofthe Department ofHealth and Human Services (Secretary) ofmy intention to publish an order in the Federal Register temporarily placing 4-methyl-N-ethylcathinone (4-MEC), 4-methyl-a-pyrrolidinopropiophenone (4-MePPP), alpha-pyrrolidinopentiophenone (a-PVP), 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone), 2-(methylamino)-1-phenylpentan-l-one (pentedrone), 1-(1,3-benzodioxol-5-yl)-2- (methylamino)pentan-1-one (pentylone), 4-fluoro-N-methylcathinone (4-FMC), 3-fluoro-Nmethylcathinone (3-FMC), naphthylpyrovalerone (naphyrone), and alphapyrrolidinobutiophenone (a-PBP) into schedule I ofthe Controlled Substances Act (CSA) pursuant to the temporary scheduling provision ofthe CSA (Title 21, United States Code, Section 81 l(h) (21 U.S.C. 

### § 81 l{h))). Emerging inrecent years, some ofthese synthetic cathinone substances appeared on the United States' illicit drug market in 2011. Similarto some ofthe schedule I synthetic cathinone substances, these new substances have also been found in products labeled as "bath salts," "jewelry cleaner," "stain remover," "plant food orfertilizer," and "insectrepellants" which are being sold at smoke shops, head shops, convenience stores, adult book stores, gas stations, and

can also be purchased onthe internet. 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP contain slight alterations ofthe chemical structure ofknown schedule I orII psychoactive substances (phenethylamines and**~-keto-phenethylamines)** such as mephedrone, methcathinone, methylene, methamphetarnine, 3,4-methylenedioxypyrovalerone (MDPV), and 3,4- methylenedioxymethamphetarnine (MOMA) and thus share structural homology with these controlled substances. These new synthetic cathinone substances also share many pharmacological similarities with these schedule I and schedule II substances.
Evidence ofthe public health risks associated with the use ofsynthetic cathinones indicates that 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP cancause acute health problems leadingto emergency department (ED) admissions, violent behaviors causing harm to selforothers, ordeath. Acute adverse effects reported include tachycardia, headache, palpitations, agitation, anxiety, mydriasis, tremor, fever or sweating, rhabdomyolysis, hyponatremia, hypertension, psychosis, paranoia, and hallucinations. TheseHoward K. Koh, M.D., M.P.H. Page 2

substances have no accepted medical use inthe United States and carry substantial public health risks similarto those ofschedule I and II substances.
These substances and their respective products are popularwith youth and young adults in the United States as potent alternatives to MOMA, mephedrone, MDPV, and methylone. Law enforcement data indicate thatthese new synthetic cathinone substances continue to be abused in the United States. TheNational Forensic Laboratory Information System (NFLIS), a Drug Enforcement Administration (DEA) sponsored program that systematically collects drug identification results and associated information from drug cases analyzed by state, local, and federal forensic laboratories, and the System To Retrieve Information from Drug Evidence (STRIDE), a federal database for the drug samples analyzed by DEA forensic laboratories, registered encounters of4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP. In 2009, NFLIS registered no reports in state and local law enforcement laboratories containing these new synthetic cathinone substances (analyzed on October 10, 2013). However, there were 13 reports related to these substancesregistered in NFLIS in 2010, 800 reports in 2011, 5,381 reports in 2012, and 1,403 reports for the first halfof 2013. STRIDE registered 879 drug exhibits from 2010 to 2012 pertaining to the trafficking, distribution and abuse ofthese substances.

In accordance with the provisions of21 U.S.C. § 81 l(h), controlling 4-MEC, 4-MePPP, aPVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP is necessary to avoid an imminenthazard to the public safety. Notification ofmy intentionto temporarily place these substances into schedule I will 

### be published inthe Federal Register. I intend to finalize this action with an order inthe Federal Register as soon as possible afterthe expiration of30 days from the date ofthis notification. In accordance with 21 U.S.C. § 81 l(h)(4), I will take into consideration any comments received from the Secretary, orherdelegate, in response to this notice, including information as to whether there is an exemption orapproval in effect for 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP under Section 505 ofthe Federal Food, Drug and Cosmetic Act (21U.S.C.§355).
Appropriate DEA staffmembers are available to respondto questions orcommentsregarding this matter. Mr. JosephT. Rannazzisi, Deputy Assistant Administrator, Office ofDiversion Control, will act as liaison for this exchange ofinformation and maybereached at (202) 307-7165.
Sincerely,

# t';,..;~.t: Deputy Administrator