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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules
cannabinoids. In addition, there is no evidence by qualified experts that any of the five cannabinoids are accepted as having therapeutic uses. Therefore, 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 have no currently accepted medical use for treatment in the United States.
4. Its History and Current Pattern of Abuse: FUB-144 was first identified in seized drug evidence in January, 2014, followed by FUB-AKB48 March 2014, 5F-MDMB-PICA July 2014, 5F-EDMBPINACA October 2017 and 5FCUMYL-PINACA February 2018
National Forensic Laboratory Information System NFLIS, 2021.4
Following their manufacture in China, SCs are often encountered in countries including New Zealand, Australia and Russia before appearing throughout Europe and eventually in the United States. 5F-CUMYL-PINACA was first reported in the German and Swiss illicit drug market in 2015 but did not appear in the United States until February 2018. 5F-EDMB-PINACA was reported in China in 2016 but didnt appear in the United States until October 2017.
5F-MDMB-PICA was first reported in the scientific literature in Germany and Belgium in late 2016. While two reports of 5F-MDMB-PICA were noted in NFLIS
occurring in 2014 and 2016, it was not until 2017 and 2018 that there was a dramatic increase in 5F-MDMB-PICA
reports in the United States. These data further support that based upon trends, SCs appear in the illicit drug markets of other countries including those in Europe often before being reported in the United States. Law enforcement has seized 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA
and FUB-144 and misuse of these SCs has been associated with overdoses requiring emergency medical intervention see Factor 6.
The powder form of SCs is typically dissolved in solvents e.g., acetone before being applied to plant material, or dissolved in a propellant intended for use in electronic cigarette devices. In addition, 5F-EDMB-PINACA was identified as an adulterant on pieces of paper that were smuggled into a detention facility and later found partially burned see Factor 6. 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144, similar to other SCs, have been found in powder form or mixed with dried leaves or herbal blends that were marketed for human use.
4 NFLIS is a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by State and local forensic laboratories in the United States.

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5. The Scope, Duration, and Significance of Abuse: According to HHS, SCs continue to be encountered on the illicit market despite scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Novel SCs continue to be encountered that differ only by small chemical structural modifications intended to avoid prosecution, while maintaining the pharmacological effects.
Law enforcement and health care professionals continue to report the abuse of these substances and their associated products. NFLIS detailed 8,207 reports from forensic laboratories for these five substances as follows: 667
reports of 5F-EDMB-PINACA, 6,014
reports of 5F-MDMB-PICA, 411 reports of FUB-AKB48, 117 reports of 5FCUMYL-PINACA, and 998 reports of FUB-144 for a period from 2014 through 2020.5 A full presentation of the NFLIS
reports by substance and year are available in DEAs eight-factor analysis within the Supporting Documents section of the public docket available at http www.regulations.gov.
6. What, if Any, Risk There is to the Public Health: HHS and DEA
documented multiple cases where 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 have been identified in overdoses and/or cases involving death attributed to their abuse in the United States and abroad. Emergency medical intervention has been required as well as serious adverse health effects reported from these incidents involving 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.
Adverse effects have included seizures, diaphoresis, hypertension, tachycardia, cerebral edema and/or death. By sharing pharmacological similarities with other schedule I substances THC, JWH-018
and other temporarily and permanently controlled schedule I SCs, 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 pose serious risk to the abuser.
7. Its Psychic or Physiological Dependence Liability: There are no clinical studies evaluating dependence liabilities specific for 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.
However, scientific data indicate that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have pharmacological profiles that are similar to other schedule I SCs.
HHS stated that based upon this similar pharmacological profile, it is reasonable to assume that these cannabinoids retain 5 Query
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a physiological and psychological dependence liability that is similar to that of D9-THC a schedule I drug and to other schedule I synthetic cannabinoids, such as JWH-018, XLR11, and AKB-48.
8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA: As noted by HHS, 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 are not immediate precursors of any controlled substance of the CSA as defined by 21
U.S.C 80223.
Conclusion: After considering the scientific and medical evaluation conducted by HHS, HHSs recommendation, and DEAs own eightfactor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA
and FUB-144. As such, DEA hereby proposes to permanently schedule 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 as controlled substances under the CSA.
Proposed Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Acting Assistant Secretary for Health of HHS and review of all other available data, the Acting Administrator of DEA, pursuant to 21
U.S.C. 811a and 812b1, finds that:
1. 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA
and FUB-144 have a high potential for abuse that is comparable to other schedule I substances such as THC and JWH-018;
2. 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYL-PINACA
and FUB-144 have no currently accepted medical use in treatment in the United States; and 3. There is a lack of accepted safety for use of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, including their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrant
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