The Drug Enforcement Administration (DEA) will evaluate all applications according to the criteria required by the Controlled Substances Act (21 U. S. C. 811).
The cannabis plant (including hemp varieties) produces cannabinoids in glandular trichomes, which look like small golf balls, often in a small stem. This single-source requirement is a particular problem for manufacturers, since those who wish to conduct research in the United States on a cannabis-derived product that results in a confidentiality agreement (including phase 1 to 3 research and the necessary set of preclinical safety and toxicology studies) must be able to grow a large quantity of a specific variety of cannabis under the same conditions of constant control. Therefore, the Agricultural Improvement Act of 2018 (AIA) limits the control of tetrahydrocannabinols (for controlled substance code number 7370).For something to be considered a controlled substance under the Federal Controlled Substances Act (CSA), it must be specifically programmed and one of five classification criteria assigned. The revised definitions of the AIA for marijuana and tetrahydrocannabinols effectively miscontrol hemp as defined in the EIA.
This final provisional rule eliminates FDA-approved products containing CBD from list V control, including controls over the import and export of this class of drugs. The DEA believes that all entities that currently handle FDA-approved CBD products also handle other controlled substances. For this reason, the DEA has no solid basis for estimating the annual number of imported or exported hemp-derived extracts that no longer require permits as a result of the enactment of this final provisional rule, but after reviewing its data, it considers this figure to be minimal. Consequently, all of these mixtures that exceed the 0.3% limit are still list I controlled substances. This revised definition now includes the THC content limit of 0.3% for the extract, meaning that hemp-derived extracts containing less than 0.3% THC are also out of control along with the plant itself.
In this way, the AIA modifies regulatory controls on marijuana, tetrahydrocannabinols and other marijuana-related components in the Controlled Substances Act (CSA).To comply with the AIA definition of hemp and therefore qualify for the exception in the definition of marijuana, a product derived from cannabis must contain only 0.3% or less of Δ9-THC in dry weight. Even at that higher level, a large amount of hemp must be cultivated to extract a significant amount of CBD.