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US Department of Justice Drug Enforcement Administration Methyl 2 U.S. Department of Justice Drug Enforcement Administration Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F- ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3- methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3- carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1- (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA] Eight Factors Data Review document Pursuant to 21 U.S.C. 812(a) Prepared by Diversion Control Division, Drug and Chemical Evaluation Section Washington, D.C. 20537 March 2019 DEA/DC/DP/DPE Page 1 of 47 March 2019 I. Background On April 10, 2017, the Acting Administrator of the Drug Enforcement Administration (DEA) published a Final Order in the Federal Register (82 FR 17119) temporarily placing six synthetic cannabinoid (SC) substances in schedule I of the Controlled Substances Act (CSA) upon finding that these substances pose an imminent threat to public safety. The six SCs temporarily controlled under the CSA are methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)- 1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3- dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB- FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)- 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA]. These six SCs have not been investigated for medical use nor are they intended for human use. With no known legitimate use and safety information, manufacturers are surreptitiously adulterating plant material with these SCs and distributors are selling the associated products which pose potentially dangerous consequences to the consumer. The adulterated products, such as “Spice”, “K2” and many others, are marketed under the guise of “herbal incense” or “potpourri” products and as “legal alternatives to marijuana” or “legal high”. Data from law enforcement, health care practitioners, and scientific and medical literature indicate that these products are being abused for their psychoactive properties in the absence of information regarding their safety. There have been reports of admissions to hospital emergency departments (ED) following abuse of these synthetic cannabinoids. SCs are substances synthesized in laboratories that mimic the biological effects of delta- 9-tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. It is believed SCs were first introduced on the designer drug market in several European countries as “herbal incense” before the initial encounter in the United States by U.S. Customs and Border Protection (CBP) in November 2008. The misuse of SCs began to increase in the United States in 2009, with law enforcement encounters describing SCs applied onto plant material and in other designer drug products intended for human consumption. It has been demonstrated via DEA/DC/DP/DPE Page 2 of 47 March 2019 medical examiner reports, scientific publications and law enforcement reports that the substances and the associated designer drug products are abused for their psychoactive properties. With many generations of SCs having been encountered since 2009, 5F-ADB, 5F- AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are some of the latest, and the abuse of these substances is negatively impacting communities. As observed by the DEA and CBP, SCs originate from foreign sources, such as China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. According to online discussion boards and law enforcement encounters, spraying or mixing the SCs with plant material provides a vehicle for the most common route of administration— smoking (using a pipe, a water pipe, or rolling the drug-laced plant material in cigarette papers). 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA have no accepted medical use in the United States. Use of these specific SCs has been reported (see factor 6) to result in adverse effects including deaths. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB- FUBINACA are SCs (figure 1) that have pharmacological effects similar to the schedule I hallucinogen THC (Janowsky et al., 2014; Hasegawa, 2015a,b; correspondence from law enforcement and laboratory data transmitted to the DEA (see factor 6)) and other temporarily and permanently controlled schedule I synthetic cannabinoid substances (e.g., JWH-018). In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB- CHMICA and/or MDMB-FUBINACA has been associated with either overdoses requiring emergency medical intervention or death (see factor 6). With no approved medical use and limited safety or toxicological information, 5F-ADB, 5F-AMB, 5F-APINACA, ADB- FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, and the abuse of these substances for their psychoactive properties is concerning. Section 1152 of the Food and Drug Administration Safety and Innovation Act (section 1152) amended the CSA by placing cannabimimetic agents and 26 specific substances (including 15 DEA/DC/DP/DPE Page 3 of 47 March 2019 SCs, 2 synthetic cathinones, and 9 phenethylamines of the 2C-series) in schedule I. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA were not included among the 15 SCs that are specifically named in section 1152, and do not fall under the legal definition of cannabimimetic agents as provided under this section. On April 22, 2016, the Acting Administrator of the DEA notified the Department of Health and Human Services (HHS) of his intention to publish in the Federal Register a Notice of Intent to temporarily place 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in schedule I of the CSA. The Assistant Secretary of Health for the U.S. Department of Health and Human Services (HHS) advised DEA on May 2, 2016 that there are no approved new drug applications (NDAs) or investigational new drug applications (INDs) for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB- FUBINACA under section 505 (21 U.S.C. 355) of the Federal Food, Drug, and Cosmetic Act. HHS had no objection regarding the temporary placement of 5F-ADB, 5F-AMB, 5F- APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA into schedule 1 of the CSA. To protect the public health and safety, the DEA then temporarily placed 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in schedule I of the CSA on April 10, 2017. 82 FR 17119. After assessing all the available data, the Food and Drug Administration (FDA) recommended that methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole- 3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H- indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2- yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1- (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA] be permanently placed into schedule I of the CSA. The National Institute on Drug Abuse (NIDA) concurred with the FDA recommendation. Schedule I drugs are classified as having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug under medical supervision. DEA/DC/DP/DPE Page 4 of 47 March 2019 II. Eight Factors Determinative of Control In accordance with the provisions of 21 U.S.C. 811(b) of the Controlled Substances Act (CSA), the DEA has gathered the necessary data, including scientific, public health, and law enforcement information on these six substances, as well as their associated products. The DEA collected data in light of the information to be considered under 21 U.S.C. 811(c). On September 27, 2017, the DEA requested from the Acting Assistant Secretary of Health for HHS a scientific and medical evaluation and scheduling recommendation for 5F-ADB, 5F-AMB, 5F- APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA pursuant to 21 U.S.C. 811(b). Administrative responsibilities for evaluating a substance for control under the CSA are performed for the HHS by the FDA, with the concurrence of the NIDA ((Memorandum of Understanding, 50 FR 9518–20) (Mar. 8, 1985)). Upon receipt and evaluation of the scientific and medical evaluation and scheduling recommendation from the Assistant Secretary on March 21, 2019, the DEA reviewed these documents and all other relevant data and conducted its own eight-factor analysis on these SCs pursuant to 21 U.S.C. 811(c). The DEA’s eight-factor review as presented below finds that 5F-ADB, 5F-AMB, 5F- APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, and their salts, isomers, and salts of isomers warrant control in schedule I of the CSA. Factor 1: The Actual or Relative Potential for Abuse The first factor the DEA must consider is the actual or relative potential for abuse of 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB- FUBINACA.
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