DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary 

Mr. Thomas M. Harrigan 

Deputy Administrator 

Drug Enforcement Administration 

U.S. Department of Justice 

8701 Morrissette Drive 

Springfield, VA 22152 

Dear Mr. Harrigan: 

Office of the Assistant Secretary for Health 

Washington, O.C. 20201 

DEC -4 2013 

Thank you for your recent letter notifying me of your intention to temporarily place 4-

methyl-N-ethylcathinone ( 4-MEC), 4-methyl-a-pyrrolidinopropiophenone ( 4-McPPP), 

alpha-pyrrol idinopentiophenone ( 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 of the 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 of these substances. Therefore, the Department of Health 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 of the CSA. 

Sincerely yours, 

Howard K. Koh, M.D., M.P.H. 

Assistant Secretary for Health 

U.S. Public Health Service 
Office of the Deputy Administrator 

Howard K. Koh, M.D., M.P.H. 

Assistant Secretary for Health 

Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, D.C. 20201 

Dear Dr. Koh: 

U.S. Department of Justice 

Drug Enforcement Administration 

Springfield, Va 22152 

November 7, 2013 

This letter serves as notification to the Secretary of the Department of Health and Human 

Services (Secretary) of my 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 of the Controlled Substances Act (CSA) 

pursuant to the temporary scheduling provision of the CSA (Title 21, United States Code, 

Section 81 l(h) (21 U.S.C. § 81 l{h))). 

Emerging in recent years, some of these synthetic cathinone substances appeared on the 

United States' illicit drug market in 2011. Similar to some of the schedule I synthetic cathinone 

substances, these new substances have also been found in products labeled as "bath salts," 

"jewelry cleaner," "stain remover," "plant food or fertilizer," and "insect repellants" which are 

being sold at smoke shops, head shops, convenience stores, adult book stores, gas stations, and 

can also be purchased on the internet. 

4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and 

a-PBP contain slight alterations of the chemical structure of known schedule I or II 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 of the public health risks associated with the use of synthetic cathinones indicates 

that 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 

and a-PBP can cause acute health problems leading to emergency department (ED) admissions, 

violent behaviors causing harm to self or others, or death. Acute adverse effects reported include 

tachycardia, headache, palpitations, agitation, anxiety, mydriasis, tremor, fever or sweating, 

rhabdomyolysis, hyponatremia, hypertension, psychosis, paranoia, and hallucinations. These 
Howard K. Koh, M.D., M.P.H. Page 2 

substances have no accepted medical use in the United States and carry substantial public health 

risks similar to those of schedule I and II substances. 

These substances and their respective products are popular with youth and young adults in 

the United States as potent alternatives to MOMA, mephedrone, MDPV, and methylone. Law 

enforcement data indicate that these new synthetic cathinone substances continue to be abused in 

the United States. The National 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 of 4-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 substances registered in 

NFLIS in 2010, 800 reports in 2011, 5,381 reports in 2012, and 1,403 reports for the first half of 

2013. STRIDE registered 879 drug exhibits from 2010 to 2012 pertaining to the trafficking, 

distribution and abuse of these substances. 

In accordance with the provisions of 21 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 imminent hazard to the public safety. Notification of my intention to temporarily place 

these substances into schedule I will be published in the Federal Register. I intend to finalize this 

action with an order in the Federal Register as soon as possible after the expiration of 30 days 

from the date of this notification. In accordance with 21 U.S.C. § 81 l(h)(4), I will take into 

consideration any comments received from the Secretary, or her delegate, in response to this 

notice, including information as to whether there is an exemption or approval in effect for 

4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and 

a-PBP under Section 505 of the Federal Food, Drug and Cosmetic Act (21U.S.C.§355). 

Appropriate DEA staff members are available to respond to questions or comments regarding 

this matter. Mr. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion 

Control, will act as liaison for this exchange of information and may be reached at 

(202) 307-7165. 

Sincerely, 

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