DEA Proposes To Reschedule Marijuana

On May 16, President Biden made official what was previously announced on May 3 – the Drug Enforcement Administration (DEA), through the Department of Justice (DOJ), is proposing via rulemaking, to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). We’ve been expecting the proposed rule for two weeks; a copy of the 90-page “pre-published” version of the proposed rule is available here.  The proposed rule has, according to the DOJ press release, been submitted directly to the Federal Register for publication (bypassing Office of Management and Budget review).


The introduction to the proposed rule states:


The [DOJ] proposes to transfer marijuana from schedule I of the [CSA] to schedule III of the CSA, consistent with the view of the Department of Health and Human Services (“HHS”) that marijuana has a currently accepted medical use as well as HHS’s views about marijuana’s abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA’s definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”). DOJ is soliciting comments on this proposal.


Public reports are indicating DOJ will provide a 60-day comment period, which will begin when the proposed rule is officially published in the Federal Register.


The proposed rule itself is very brief.  First, it amends the list of Schedule I substances in 21 C.F.R. 1308.11(d) to remove marijuana and amends the definition of tetrahydrocannabinols.  Second, the proposed rule adds the following list of substances to Schedule III, in 21 C.F.R. § 1308.13:


(h) Marijuana, as defined in 21 U.S.C. 802(16).

(i) Marijuana Extract, meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis, other than the separated resin (whether crude or purified) obtained from the plant.

(j) Naturally Derived Delta-9-Tetrahydrocannabinols.

(i) Meaning those delta-9-tetrahydrocannabinols, except as in paragraphs (j)(ii) and (j)(iii) of this section, that are naturally contained in a plant of the genus Cannabis (cannabis plant).

(ii) Naturally derived delta-9-tetrahydrocannabinols do not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.

(iii) Naturally derived delta-9-tetrahydrocannabinols do not include any delta-9-tetrahydrocannabinols contained in substances excluded from the definition of marijuana as set forth in 21 U.S.C. 802(16)(B)(ii).


Also posted is a legal analysis and opinion of the DOJ’s Office of Legal Counsel (OLC), available here.  In this 36-page analysis, OLC states that the Attorney General asked the Office to opine on three issues:

(1) Whether a drug can satisfy the legally required inquiry even if it has not been approved by the Food and Drug Administration (FDA).

(2) The extent to which HHS’s recommendation is binding on DEA.

(3) Whether treaty obligations require DEA to maintain marijuana in either Schedule I or Schedule II.


OLC concludes that DEA’s current approach to determining whether a drug has a currently accepted medical use (CAMU) is impermissibly narrow and that a drug can have a CAMU (and so not be Schedule I), even if the drug has not been approved by FDA.  However, OLC also concludes that HHS’s CAMU is not binding on DEA once initiation of formal rulemaking begins; nevertheless, DEA should afford HHS’s scientific and medical determinations significant deference, and the CSA does not allow DEA to undertake a brand new (referred to as a “de novo”) assessment of HHS’s findings.  OLC additionally concludes that DEA can satisfy the United States’ international treaty obligations by supplementing scheduling decisions with regulatory action, such as by placing marijuana in Schedule III and imposing additional controls. 


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Our cannabis team will be diving into the proposed rule.  If you have any questions or would like assistance in determining how this rule, if finalized as proposed, would impact your business please contact our team: Tish Pahl (tpahl@ofwlaw.com), Kyla Kaplan (kkaplan@ofwlaw.com), Denise Calle (dcalle@ofwlaw.com), and Ben Dash (bdash@ofwlaw.com).


OFW Law’s Cannabis Practice Team is an experienced and trusted guide through a treacherous and changing landscape. Whether your interests are in marijuana, hemp, cannabidiol (CBD), or the other components of the cannabis plant, we can help steer your business or trade association with legal, corporate, regulatory, and strategic policy advice.


Navigating the cannabis arena means understanding how FDA, DEA, USDA, and the States intersect. With experts in foods, crops, pharmaceuticals, controlled substances, dietary supplements, and cosmetics, OFW can provide the interdisciplinary approach cannabis businesses need. We can provide counsel if you’re a farming cooperative intending to cultivate hemp under the USDA domestic hemp program, a manufacturer looking at CBD containing cosmetics, foods, and supplements, a pharmaceutical developer hoping to bring a cannabis compound through the FDA drug approval process, a retailer trying to assess the business risk of CBD, or a trade association trying to answer member questions. Our cannabis team includes sought-after speakers, as our unique perspective allows us to offer our audiences an insider’s view on Washington DC cannabis policy.

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