The Agriculture Improvement Act of 2018, Pub. L. 115-334 (the AIA), was signed into law on December 20, 2018. It provided a new statutory definition of “hemp” and amended the definition of marihuana under 21 U.S.C. 802(16) and the listing of tetrahydrocannabinols under 21 U.S.C. 812(c). The AIA thereby amends the regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents in the Controlled Substances Act (CSA).
This rulemaking makes four conforming changes to DEA’s existing regulations:
- It modifies 21 CFR 1308.11(d)(31) by adding language stating that the definition of “Tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.”
- It removes from control in schedule V under 21 CFR 1308.15(f) a “drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2–[1R–3–methyl–6R–(1– 4 methylethenyl)–2–cyclohexen–1–yl]–5–pentyl–1,3–benzenediol) derived from cannabis and no more than 0.1 % (w/w) residual tetrahydrocannabinols.”
- It also removes the import and export controls described in 21 CFR 1312.30(b) over those same substances.
- It modifies 21 CFR 1308.11(d)(58) by stating that the definition of “Marihuana Extract” is limited to extracts “containing greater than 0.3 percent delta-9- tetrahydrocannabinol on a dry weight basis.”
So what does it mean? Should the industry be concerned?
The short answer is no. It merely seeks to modify the DEA regulations and definitions to align with the de-scheduling of hemp that occurred with the passage of the 2018 Farm Bill. Not that in the DEA document they refer to the Farm Bill as the Agricultural Improvement Act (AIA).
What’s notable is that this IFR only refers to consumer products to ensure that they are D9 compliant. It does not address mid-process crude or distillate which often exceeds legal THC levels. So moving/selling those materials across state lines remains ambiguous and problematic. However, while this IFR does not alleviate that concerns it also does not make it worse.
What is potentially really positive in the IFR is the fact that the word decarboxylation does not appear anywhere in the document. While total THC remains the protocol in determining hemp to be compliant at the USDA/farm level, the fact that the DEA IFR only references D9 could provide some much needed breathing space for the smokable flower market. This will be even more beneficial as we work to relax the sampling protocols USDA uses to determine compliance by encouraging them to allow samples to be a whole plant composite and not just the top most potent portions of the flowers, and to push out the 15 day harvest window that USDA currently requires. Even with the 15 day harvest window it is possible that flowers may slightly exceed legal limits after compliance testing but before harvest, so this D9 only definition is welcome relief of that concern.
The issue of D8 THC is not addressed at all in this document. While this may be viewed by some to be a go ahead for marketing D8 products derived from hemp, there is another argument that D8 may fall under the category of synthesized tetrahydrocannabonoids and remain a schedule I substance.