Office 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. Department ofJustice Drug EnforcementAdministration

Springfield, Va 22152



## SEP 032013

This letter serves as notification to the Secretary ofthe Department ofHealth and Human Services (Secretary) ofmy intentionto publish an order in the Federal Register temporarily placing 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-(4- chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe), and 2-(4-bromo2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NB0Me) into schedule I ofthe Controlled Substances Act (CSA) pursuant to the temporary scheduling provision ofthe CSA (Title 21, United States Code, Section 811 (h) (21 U.S.C. 

### § 811 (h)).

These three synthetic phenethylamines are available for purchase overthe Internet and through illicit channels, packaged as powders, liquid formulations, onblotterpaper, and in adulterated food items. Reports indicate these substances are oftenpurported to be, and are mistaken for LSD, extracts ofpsilocybinmushrooms, and other, less potent 2-C compounds.

Based on reports from law enforcement encounters, the prevalence ofthese substances is increasing at an alarming rate. In 2011, the National Forensic Laboratory Information System (NFLIS) received 10 reports ofanalyzed seizures of25I-NBOMe. In 2012, there were a total of 448 reports to NFLIS for 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. Forthe first three months of2013, there are already 231 reports to NFLIS, more than double the number of analyzed seizures ofLSD reported in the same time period.

The abuse ofthese substances has resulted in emergency department admissions and the deaths ofnumerous individuals. A number ofcase studies detail various adverse health effects observed for laboratory confirmed 251-NBOMe exposure, namely, tachycardia, hypertension, agitation, aggression, visual and auditory hallucinations, seizures, hyperpyrexia, clonus, elevated white cell count, elevated creatine kinase, metabolic acidosis, rhabdomyolysis, and acute kidney injury. One case described an individual that was hospitalized for 43 days following a single intravenous 25I-NBOMe exposure. Reports from medical examiners and toxicological analysis ofpostmortem samples have identified one or more ofthese three substances in 14 decedents from 11 states. Reports from media and law enforcement suggest that these substances may be involved in a number ofadditional fatalities where laboratory confirmation is not yet available.Howard K. Koh, M.D., M.P.H. Page 2

In accordance with the provisions of21 U.S.C. 

### § 811 (h), I find that the scheduling of25IN80Me, 25C-N80Me, and 258-N80Me is necessary to avoid an imminent hazard to the public safety. Notification ofmy 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 of30 days from the date ofthis notification. In accordance with 21 U.S.C. §811 (h)(4), Iwill 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 25I-N80Me, 25CN80Me, or 258-N80Meunder Section 505 ofthe Federal Food, Drug and Cosmetic Act (21 U.S.C. §355). Appropriate DEA staffmembers are available to respond to questions and comments regarding this matter. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, will act as liaison for this exchange ofinformation. He can be reached at (202) 307-7165.

Enclosures Sincerely, 

# /1--**~- ~** 

Thomas M.

## H~ Deputy Administrator