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DEA Issues IFR on Hemp

Executive Summary
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. Note that in the DEA document they refer to the Farm Bill as the Agricultural Improvement Act (AIA).

While the DEA makes clear that it’s intent is merely to restate the language from the AIA and incorporate it into its regulations, in the executive summary document it does mention the THC content of extracted materials noting that “a cannabis derivative, extract, or product that exceeds the 0.3% Δ9-THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less Δ9-THC on a dry weight basis.” While this is broadly consistent with the language of the AIA, it is the first time that the DEA comes out and specifically says that an intermediary product such as crude oil extract that is over 0.3% is a schedule I substance – even if it will subsequently be diluted in the final product. So moving/selling those materials across state lines remains ambiguous and problematic. This is an issue that we will continue to work to rectify and will include in our public comments.

What is potentially positive in the IFR is the fact that the word decarboxylation does not appear 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 Δ9-THC could provide some 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 the15 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 Δ9-THC only definition is welcome relief of that concern. It should also pave the way for USDA to consider alternative remediation methods for ‘hot crops’ other than destruction.

The issue of Δ8-THC is not addressed at all in this document. While this may be viewed by some to be a go ahead for marketing Δ8-THC products derived from hemp, there is another argument that Δ8-THC may fall under the category of synthesized tetrahydrocannabonoids and remain a schedule I substance.

In conclusion we see this as a good step that further removes the DEA from the Hemp Industry. It’s not perfect, but regulations and legislation seldom are. It is a process and it takes time to get it right. There is now a public comment period open until October 20, 2020. NHA will participate in the public comments and continue to report back to you as developments occur. Should you have questions, comments or concerns you would like to see us address please contact Erica Stark at erica@nationalhempassociation.org.

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