The DEA announced a new rule clarifying that all hemp derivatives or extracts exceeding 0.3% delta-9 THC remain schedule I controlled substances.
On August 21, 2020, the Drug Enforcement Administration (DEA) published an interim final rule that may have far-reaching consequences for the entire hemp and CBD industry. In addition to modifying the definitions of “tetrahydrocannabinols” (THC) and “marijuana extract” to exclude legal hemp, and removing FDA-approved CBD-based drugs from scheduled control under the Controlled Substances Act (CSA), the DEA announced a new rule clarifying that all hemp derivatives or extracts exceeding 0.3% delta-9 THC remain schedule I controlled substances.
Although seemingly innocuous at first glance, this clarification may potentially create a profound practical obstacle to the legal manufacturing of most hemp-derived CBD products. As many processors and extractors in the industry know, hemp extract that is not in its final form almost invariably exceeds 0.3% delta-9 THC concentration at some point during the extraction process before that percentage is brought back into legal compliance for the final product.
The DEA explains its reasoning as follows:
[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 definition of ‘marihuana’ continues to state that ‘all parts of the plant Cannabis sativa L.,’ and ‘every compound, manufacture, salt, derivative, mixture, or preparation of such plant,’ are schedule I controlled substances unless they meet the definition of ‘hemp’ (by falling below the 0.3% D9-THC limit on a dry weight basis) or are from exempt parts of the plant (such as mature stalks or nongerminating seeds). See 21 U.S.C. 802(16) (emphasis added). As a result, 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.
The public has 60 days to submit comments to the DEA about its rule, which becomes effective immediately.