Legal Status of Delta-8-THC Derived From Hemp
DeltaGenix requested that our office provide a legal opinion on the status of Delta-8-Tetrahydrocannabinol ("Delta-8-THC") derived from Hemp (as defined below) under the Controlled Substances Act. Subject to the qualifications noted below, our opinion is that Delta-8-THC derived from is not a controlled substance under United States federal law. This opinion is based on the following:
The Agriculture Improvement Act of 2018 (also known as the "2018 Farm Bill") was signed into law on December 20, 2018 and removed Hemp from schedule I of the Controlled Substances Act. "Marijuana", which includes all parts and derivatives of the Cannabis sativa L. plant, is a schedule I controlled substance under the Controlled Substances Act. (21 U.S.C. 802(16)(A);21 U.S.C. 812(c), Schedule 1 (c)(10).) Tetrahydrocannabinols ("THC"), the principal psychoactive constituents of cannabis, are also schedule I controlled substances. (21 U.S.C. 812(c),Schedule I (c)(17).)
However, "marijuana" as used in the Controlled Substances Act now excludes Hemp. (21 U.S.C. 802(16)(B)(i).) Moreover, THC in Hemp is also specifically excluded from the Controlled Substances Act. (21 U.S.C. 812(c), Schedule I (c)(17).) The conclusion that these changes effectively removed Hemp and its derivatives from the Controlled Substances Act has been noted by both the United States Department of Agriculture and the United States Food and Drug Administration. Thus, Delta-8-THC derived from Hemp is not a controlled substance under the Controlled Substances Act because Hemp is not controlled substance and because THC in Hemp is not a controlled substance.
We are of the opinion that Delta-8-THC derived from Hemp is not subject to the Federal Analogue Act. Under this act, a "controlled substance analogue" is a substance:
(i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II;
(ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or
(iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.
(21 U.S.C. 802)
A substance found to be a controlled substance analogue is treated as a controlled substance under federal law. (21 U.S.C. 813) Case law is not settled as to whether only one of the three elements listed above is sufficient to qualify a substance as a "controlled substance analogue", or if section (i) must be satisfied in combination with either section (ii) or (iii), so there is an insufficient legal basis to claim that failing to satisfy just one of these three elements will remove a substance from being considered a "controlled substance analogue". No opinion is made as to whether Delta-8-THC derived from Hemp would satisfy any or all of these elements.
Regardless, the Controlled Substances Act specifically excepts THC in Hemp from controlled substances, so Delta-8-THC derived from Hemp is also excluded and is not a controlled substance.
The opinions set forth in this letter are qualified by the following:
1. Hemp is defined as "the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis." (7 U.S.C. 1639o.) Delta-8-THC derived from Hemp as used in this letter is specifically limited to Delta-8-THC derived from hemp as defined in 7 U.S.C. 1639o.
2. We have been unable to locate any published court cases addressing the legal status of Delta-8-THC derived from hemp under United States federal law, so our opinion is based on our interpretation and reading of existing laws. ordinances and regulations in effect as of the date hereof and as they presently apply, as well as case law interpreting and deciding on tangential but potentially analogous legal issues.
3. The 2018 Farm Bill did not affect or modify the authority of the federal government, including the U.S. Department of Agriculture and the U.S. Food and Drug Administration, to regulate Hemp and Delta-8-THC products. The 2018 Farm Bill also reserved to the States and Indian Tribes authority to enact and enforce more stringent laws regarding the production of Hemp. These issues are beyond the scope of the opinions expressed in this letter.
4. The firm has not been provided with any specific samples of any Delta-8-THC derived from Hemp or any products containing any Delta-8-THC derived from Hemp and we express no opinion on any specific products containing Delta-8-THC derived from Hemp. This letter is only intended to offer a general legal opinion on the status of Delta-8-THC derived from Hemp under the Controlled Substances Act.
The opinions expressed in this letter are given solely to, and solely for the benefit of Savage Enterprises and its evaluation of potential business opportunities generally involving Delta-8-THC derived from Hemp. The opinions contained in this letter are limited to the matters expressly stated herein, and no opinion may be implied or inferred beyond those expressly stated. The opinions expressed in this letter are rendered as of the date hereof and we express no opinion as to circumstances or events that may occur subsequent to such date.
