On May 21, 2024, the DEA finally published its proposed rule related to rescheduling marijuana and commenced a 60-day period where the public can submit comments regarding DEA's proposed move to reschedule marijuana (the "Proposed Rule.") In addition to the proposed rule, on May 16, 2024, the DEA also published an opinion from the Office of Legal Counsel ("OLC Opinion”) that provides a thorough analysis supporting why placing marijuana in schedule III is appropriate and legally justified. This blog post will provide a high-level overview of the Proposed Rule and OLC Opinion. Importantly, this process is far from over, and there is still a lot of work to do to ensure marijuana ends up in schedule III.

Rescheduling Marijuana to Schedule III: The OLC Memorandum Opinion for the Attorney General

The OLC Opinion provides legal support in three main areas important to the rescheduling of marijuana:

1. DEA’s current Currently Accepted Medical Use (CAMU) approach is impermissibly narrow, and HHS’ 2-part test is sufficient to establish CAMU, even if FDA has not approved the drug and the 2-part test would not satisfy DEA’s current approach

2. Once formal rulemaking is initiated, DEA is no longer bound by HHS’ medical and scientific determinations, but it must continue to accord HHS’ medical and scientific determinations significant deference

3. DEA may satisfy the United States’ Single Convention obligations by placing marijuana in Schedule III while imposing additional restrictions under the Controlled Substances Act’s (CSA) regulatory authorities

HHS' 2-Part CAMU Analysis

The OLC Opinion went into great detail about why HHS’ 2-part CAMU analysis is an appropriate method for determining whether a drug has a currently accepted medical use. OLC found that the two methods the DEA has used for the past 50 years to assess CAMU are impermissibly narrow since nowhere in the CSA does it require a drug to satisfy a DEA-created 5-part test or be a drug that has received FDA approval.

“Limiting the CAMU analysis to whether a drug has been approved by FDA or meets DEA’s five-part test also conflicts with the text of section 812(b) by erroneously equating identification of an ‘accepted’ medical use under the CSA with the ‘approval,’ or potential approvability, of the drug under the [Food, Drug, and Cosmetic Act] [(“]FDCA[“)].”

HHS’ 2-part test is just another way to account for a drug's CAMU.

Accounting for state medical programs and medical professionals is a fundamental aspect of this country.

“[T]he CSA ‘presume[s] and rel[ies] upon a functioning medical profession regulated under the States’ police powers. . .. [I]gnoring widespread clinical experience with a drug that is sanctioned by state medical licensing regulators when evaluating whether a drug has a CAMU is at odds with the plain meaning of [the CSA].”

That, combined with the fact that since Congress explicitly invokes the Federal Food, Drug, and Cosmetic Act (FDCA) standards in some parts of the CSA, but not in reference to CAMU, “strongly suggests that it did not mean to equate CAMU with the standards necessary for FDA approval.”

The OLC Opinion also discussed why D.C. Circuit precedent is not disturbed by accepting state-level data when determining whether marijuana has a CAMU. In 1977, the D.C. Circuit issued an opinion in a case between NORML and the DEA (it was several cases, but for purposes of this blog we will speak of them as one. For an overview of the separate cases, please see the OLC Opinion). That opinion discussed how state data could not be used because there was a lack of “‘widespread current experience with medical use of’ a schedule I drug in the United States by licensed health care practitioners ‘operating in accordance with implemented state-authorized programs, where the medical use is recognized by entities that regulate the practice of medicine.’” This, however, is no longer the case, so including such data in a medical and scientific review of marijuana both makes sense and does not run counter to the NORML decision. And that is important because opponents of marijuana reform have relied on this decision as a primary reason for why HHS’ 2-part CAMU analysis was inappropriate. As OLC points out, there is nothing in the CSA that would prohibit HHS from using state-level data to find that marijuana has a CAMU “particularly since doing so would be inconsistent with . . . the role of states as the central regulators of medical practice.”

Once DEA Initiates the Rulemaking Process, it is No Longer Bound to HHS Medical and Scientific Determinations

While this conclusion may come as a shock to many, the OLC Opinion explains why this conclusion actually makes sense. If the DEA remained bound to HHS’ medical and scientific determinations, then it would not need to review comments involving medical and scientific analysis. Since the CSA does not prohibit the public from submitting medical and scientific information, it only makes sense that the DEA be permitted to review such information and include it in its final determination.

“[T]o preclude DEA from considering such evidence would be inconsistent with the APA’s [(Administrative Procedures Act)] requirement that rules issued via formal rulemaking be based ‘on consideration of the whole record . . . and supported by and in accordance with the reliable, probative, and substantial evidence.’”

Importantly, however, the OLC opinion states that using “the word ‘binding’ in section 811(b) suggests that Congress intended HHS’s scientific and medical views to at least be a very significant input in the scheduling process. And there would seem to be little reason to make the HHS’s views binding at any stage in the process if DEA eventually could discard HHS’s determinations and review scientific and medical matters de novo.” Therefore, DEA cannot just disregard HHS’ analysis and must place great weight on the medical and scientific determinations set forth in its recommendation.

Placing Marijuana on Schedule III will not Violate International Treaty Obligations

The law is clear that placing marijuana in schedule III will not violate US obligations under International Drug Treaties. In fact, rescheduling will better promote the intent of these treaties by acknowledging that marijuana has a medical use in treatment. In fact, the OLC Opinion basically reiterates the points we discuss in "International Treaty Obligations and Marijuana Rescheduling: Meeting U.S. Treaty Obligations in Marijuana Rescheduling."

As we have argued all along, the DEA may satisfy the United States’ Single Convention obligations by placing marijuana in schedule III while imposing additional restrictions pursuant to the CSA’s regulatory authorities. Nothing in the Single Convention requires marijuana to be placed in any specific schedule; it merely requires certain protections against diversion to be implemented. Applying this “Reschedule and Reregulate” method, in 2018, the DEA placed Epidiolex into schedule V (at the time, Epidiolex was considered marijuana under the CSA) and promulgated regulations to ensure compliance with international treaty obligations. Here, the DEA would need to do the same thing. The CSA contemplates granting DEA authority to make certain modest regulatory adjustments to account for international treaty obligations, and if marijuana were placed in schedule III, resulting regulatory gap would be modest and within DEA’s authority to fill.

Rescheduling Marijuana to Schedule III: The DEA’s Proposed Rule

The proposed rule provides an in-depth review of the HHS’ recommendation, the OLC Opinion, and discussions on how the DEA views the move to schedule III. Overall, DEA refrained from agreeing or disagreeing with the proposed move to schedule III. In fact, the DEA Administrator did not sign off on the proposed rule; the Attorney General did. The Department of Justice (DOJ) “concurs with HHS’s recommendation, for purposes of initiation of these rulemaking proceedings, that marijuana has a potential for abuse less than the drugs or other substances in schedules I and II” and schedule III may be a more appropriate classification for marijuana. This concurrence can change based on the comment period (and potential hearing) that will ensue.

The proposed rule is as follows:

The proposed rule would move “marihuana” (the current spelling in the CSA, which may finally be changed to “marijuana” if this rule becomes final) from schedule I to schedule III. This move would not affect “hemp” which was removed from the definition of marijuana in 2018 and would leave synthetic forms of THC in schedule I. Specifically, the proposed rule “would not apply to synthetically derived THC, which is outside the CSA’s definition of marijuana. Those tetrahydrocannabinols that can be derived only through a process of artificial synthesis (e.g., delta-10-tetrahydrocannabinol) are excluded.” While the CSA and the DEA have made clear that certain synthetic cannabinoids derived from hemp are Schedule I controlled substances, the definition of what constitutes a synthetic is not defined in the CSA and will continue to be hotly debated and litigated well after this rule becomes final.

The revisions would read as follows:

§ 1308.11 Schedule I.

* * * * *

(d) * * *

(30) Tetrahydrocannabinols - 7370

(i) Meaning tetrahydrocannabinols, except as in paragraphs (d)(30)(ii) and (iii) of this section, naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extracts of such plant, or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant.

(ii) Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 USC 1639o.

(iii) Tetrahydrocannabinols does not include any substance that falls within the definition of marijuana set forth in 21 USC 802(16).

* * * * *

3. Amend § 1308.13 by adding paragraphs (h) through (j) to read as follows:

§ 1308.13 Schedule III.

* * * * *

(h) Marijuana. Marijuana, as defined in 21 USC 802(16).

(i) Marijuana extract. 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.

Timing of the Proposed Rule and Public Comment Period

The proposed rule was published in the Federal Register on May 21, 2024. Publication triggered a 60-day comment period where the public can submit comments for or against a move schedule III. Within the first 30 days, "any person adversely affected or aggrieved by the proposed rule (an “Interested Person”) can also request a hearing in front of an administrative law judge (“ALJ Hearing”). This hearing runs much like a court and it is unclear how long this process might take. Since the status quo won't really change with marijuana being placed in schedule III, it is also unclear whether anyone would qualify as an Interested Person. DEA Administer Milgram will make the final determination as to whether an in-person ALJ Hearing will be permitted.

Focus of Comments and Potential Hearing

DEA appears to be interested in receiving comments specific to:

• HHS’ 8-part test for determining whether a drug should be rescheduled (unlike DEA’s self-created 5-part test, this 8-part test is based in statute)

• International treaty obligations

• The rule's potential economic impact

Within the 8-part test, DEA is particularly seeking information that discusses:

1. Information related to the diversion of state-legal marijuana (it should be noted that all state-legal markets should not actually be considered for diversion purposes, since diversion for purposes of DEA’s 8-part analysis should focus on diversion from DEA registered operators)

2. Updated epidemiological survey data since 2022

3. Updated data on marijuana potential for abuse

4. Additional data on marijuana’s pharmacological effects

5. Additional data on other marijuana constituents, routes of administration of marijuana, and the impact on Δ9-THC potency

6. Additional data on marijuana’s pattern of abuse, including the scope, duration, and significance of marijuana abuse

7. Additional data on public safety risks, risks from acute and chronic marijuana use via oral and inhaled administration routes, and the impact of Δ9-THC potency

8. Additional psychic or physiological dependence liability

9. Information showing that marijuana is an immediate precursor of another substance already controlled under the CSA

Conclusion

The move from schedule I to schedule III is far from over. The information submitted during the comment period and any ALJ hearing will likely determine whether marijuana is ultimately moved into schedule III. One thing is certain, marijuana does not belong in schedule I next to heroin, or in schedule II next to fentanyl. As long as this process follows legal, medical, and scientific principals, incremental reform will finally see marijuana moved into a more appropriate schedule. Leading to, one day, decriminalization and legalization.

Make Your Voices Heard!

Public comments regarding the DEA's proposed move to reschedule marijuana must be submitted on or before Monday, July 22, 2024.

Watch our special briefing "Cannabis Rescheduling: Implications & Next Steps