On August 21, 2020, nearly two years after the passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill), the Drug Enforcement Administration (DEA or the Agency) published an interim final rule that, according to the Agency, “merely conforms DEA’s regulations to the statutory amendments to the CSA [Controlled Substances Act] that have already taken effect.” 

As we have noted previously (see our prior posts here, here, and here), the 2018 Farm Bill removed “hemp” (defined as cannabis and derivatives or extracts of cannabis with no more than 0.3 percent delta-9 tetrahydrocannabinol (THC) by dry weight) from the definition of “marihuana” under the CSA.  Any cannabis or cannabis derivative with more than 0.3 percent THC is a Schedule I controlled substance.

The interim final rule codifies four key changes to existing DEA regulations:

1. It modifies 21 C.F.R. § 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;”
2. It removes from Schedule V under 21 C.F.R. § 1308.15(f) a “drug product” in finished dosage formulation that has been approved by the U.S. Food and Drug Administration (FDA) that contains cannabidiol (CBD) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols (but, importantly, CBD in a mixture with a THC concentration greater than 0.3 percent by dry weight is not exempted from the definition of “marihuana,” and such a mixture would remain under Schedule I);
3. It removes the import and export controls described in 21 C.F.R. § 1312.30(b) over those same substances (meaning that entities no longer require DEA registration or import and export permits to handle hemp extract that does not exceed 0.3 percent THC); and
4. It modifies 21 C.F.R. § 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.”

DEA notes that, because the 2018 Farm Bill has been in effect since December 20, 2018, DEA “finds good cause” to make the foregoing requirements effective immediately upon publication.  DEA also notes that, although “publishing a notice of proposed rulemaking and soliciting public comment prior to publication are unnecessary in this instance” because “these regulations merely implement statutory changes over which the agency has no discretion,” the Agency is nevertheless soliciting public comments.  Any comments to the interim final rule must be filed through regulations.gov within 60 days after its publication in the Federal Register.

While it seems to merely formalize existing practice and understanding, DEA’s interim final rule can be viewed as a bit of forward progress from an agency that has historically moved quite slowly related to cannabis and cannabis-derived drug research and development.  As we noted in our recent alert, industry is eager for DEA to begin allowing additional growers and bulk manufacturers to register with the Agency to produce and distribute cannabis for research purposes.  Since the early 1970s, the University of Mississippi’s National Center for Natural Products Research has been the sole marijuana grower approved by DEA.  While the interim final rule does not provide any indication of when the Agency will make good on its promise to expand sources of research cannabis, stakeholders are hopeful that the policy development is a sign of good things to come vis-à-vis DEA’s approach to cannabis.

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We will continue to closely monitor this space as DEA’s and FDA’s regulatory approaches to cannabis and cannabis-derived products evolve.