RIN 1117-AB53/Docket No. DEA-500 Hemp’dIn LLC 2506 Cottage Row Road Cedar Falls, IA, 50613 319-231-6683 Mr. Timothy J. Shea Via Email Acting Administrator U.S. Drug Enforcement Agency 7000 Army-Navy Dr. Arlington, VA 22202 Washington, DC RE: RIN 1117-AB53/Docket No. DEA-500 Comments to the U.S. Drug Enforcement Agency’s Interim Final Rule Interpreting the Agricultural Improvement Act of 2018 Dear Mr. Shea: We write you to express our formal opposition to the referenced Interim Final Rule (“IFR”) promulgated by the Drug Enforcement Agency (“DEA”) published on August 21, 2020 regarding the DEA’s interpretation of the Agricultural Improvement Act of 20181 (“AIA” or “Farm Bill”). Through the IFR, we believe the DEA is attempting to create new law that is different in spirit and substance from what Congress intended when it passed the AIA. Further, we believe DEA’s attempt to create new law is in violation of Administrative Procedure Act2 (“APA”) and the Controlled Substances Act3 (“CSA”). Accordingly, through this letter, we respectfully request that the DEA withdraw or amend the IFR in order to bring its position in line with the spirit and substance of the APA in particular with 1 AIA, Public Law 115-334, signed December 20, 2018 2 5 U.S.C. § § 702, 706 3 21 U. S. C. § 877 RIN 1117-AB53/Docket No. DEA-500 regard to the legality of intermediate hemp materials and derivatives of hemp such as delta-8 tetrahydrocannabinol (“∆8 -THC”). I. The Agricultural Improvement Act of 2018 The AIA defines hemp as: the plant Cannabis sativa L and any part of that plant… and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of no more than 0.3 percent on a dry weight basis.4 (Emphasis added) It is important to recognize that the AIA defines hemp as any part of the plant, any derivative thereof, any extract thereof and any cannabinoids derived therefrom, amongst others. Therefore, from a regulatory perspective, a C. sativa L. plant part as well as a derivative of that plant part are both defined as “hemp”, so long as the ∆9 -THC concentration is no more than 0.3% dry weight. To be clear, in chemistry, a “derivative” is “a compound that is derived from a similar compound by a chemical reaction.”5 This is distinguished from an analog also known as a structural analog which is a compound having a structure similar to that of another compound, but differing from it in respect to a certain component.6 The AIA amended the Controlled Substances Act so that hemp is now distinguished from marijuana: The term ‘marihuana’ does not include – (i) hemp, as defined in section 1639 of title 7. 7 II. Tetrahydrocannabinoids in Hemp are Not Controlled Substances Pursuant to the AIA, by definition, cannabinoids, of which tetrahydrocannabinoids are a subset, are not controlled substances. ∆8 -THC is a tetrahydrocannabinoid found in hemp. By definition it, like all other cannabinoids derived from hemp, is not a controlled substance under the CSA. 4 7 U.S.C § 1639o(1) 5 See: https://en.wikipedia.org/wiki/Derivative_(chemistry) 6 See: https://en.wikipedia.org/wiki/Structural_analog 7 21 U.S.C § 802 (16)(B). RIN 1117-AB53/Docket No. DEA-500 III. ∆8 -THC is Not a Controlled Substance under the Federal Analogue Act The Federal Analogue Act8 (“AA”) classifies any chemical substance that is “substantially similar” to a controlled substance found in DEA’s Schedule I or II and which “has a stimulant, depressant or hallucinogenic effect on the central nervous system (CNS) that is substantially similar to or greater than”9 (Emphasis added) the controlled substance will be treated the same as if it were on Schedule I when intended for human consumption. ∆8 -THC cannot be classified as an analog of ∆9 -THC because the effect of ∆8 -THC on the CNS is not “substantially similar” to that of ∆9 -THC. It has been documented that, in fact, the CNS effect of ∆8 -THC on a subject is equivalent to about 66% of the CNS effect of ∆9 -THC.10 Two- thirds of the effect cannot be considered “substantially similar to or greater than”. Congress, through legislation, can at some future date determine that, notwithstanding the comparison to ∆9 -THC, ∆8 -THC should be restricted in some way. Or Congress can decide that the definition of a “substantially similar” analogue – for purposes of the AA- shall mean at least 66% of the CNS effect as a controlled substance. But until this happens, ∆8 -THC does not meet the definition of analogue under the AA because it falls outside the definition of “substantially similar”. What DEA cannot do is create new laws merely by labeling them as “interpretations” of an existing law, in this case the Farm Bill. Doing so is a violation of the Administrative Procedure Act and the Controlled Substances Act. 8 21 U.S.C § 813 9 Id. 10 L. E. Hollister, H. K Gillespie, Delta-8-and delta-9-tetrahydrocannabinol comparison in man by oral and intravenous administration, Clin. Pharmacol. Ther., May-June 1973; 14(3): 353-7. RIN 1117-AB53/Docket No. DEA-500 IV. Conclusion Through the IFR, we believe the DEA is attempting to create new law that is different in spirit and substance from what Congress intended when it passed the AIA. Further, we believe DEA’s attempt to create new law is in violation of Administrative Procedure Act11 (“APA”) and the Controlled Substances Act12 (“CSA”). Accordingly, we respectfully request that the DEA withdraw or amend the IFR in order to bring its position in line with the spirit and substance of the APA in particular with regard to the legality of intermediate hemp materials and derivatives of hemp such as delta-8 tetrahydrocannabinol (“∆8 -THC”). Sincerely, Corey Coleman Corey Coleman CEO [email protected] CC: Edgar J. Asebey, Esq. Asebey Life Science Law PLLC 11 5 U.S.C. § § 702, 706 12 21 U. S. C. § 877 .