The U.S. Drug Enforcement Administration (DEA) has laid out its views on hemp and CBD in interim rules released Aug. 20, part of the process of making the Agency compliant under the 2018 Farm Bill, which legalized industrial hemp across the USA.
Key to the rules are revised definitions of THC and cannabis extracts under the U.S. Controlled Substances Act that exclude substances containing less than 0.3 percent THC – the threshold for industrial hemp. The rules would also remove from Schedule V any CBD-based drugs approved by the Food and Drug Administration (FDA), and end restrictions on importing and exporting hemp and its derivatives.
Worries over extracts
Policies laid out in interim rules have already been in effect since hemp was federally legalized, according to the DEA. But some observers noted the Agency has set itself in conflict with the Farm Bill through restrictions on hemp extracts which the 2018 Bill expressly permits.
The restrictions, which address only partially processed extracts not intended for consumption, state that “a cannabis derivative, extract, or product that exceeds the 0.3% D9 -THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less D9 -THC on a dry weight basis.”
“[T]he definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the D9 -THC content of the derivative. In order to meet the definition of ‘hemp,’ and thus qualify for the exemption from schedule I, the derivative must not exceed the 0.3% D9 -THC limit,” the rule says.
Critics say that under most normal hemp extraction and manufacturing processes it is impossible to avoid a stage at which the extract is both “wet” and within the 0.3% THC limitation, arguing that the Farm Bill specifically refers only to “dry weight” levels of THC: “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,” according to the Farm Bill.
DEA has aggressively and persistently asserted itself into the U.S. hemp industry, despite the Farm Bill’s express removal of hemp from the Controlled Substances Act. Critics said the rules, which are effective immediately, are simply DEA continuing its unnecessary interference.
While the rules took immediate effect with publication in the U.S. Federal Register today, they are not final, with the agency taking comments from stakeholders through Oct. 20.