Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.”  Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53,688 (Aug. 12, 2016); Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. Reg. 53,767 (Aug. 12, 2016).  By recommending rescheduling to schedule III seven years later, HHS determined that marijuana no longer meets schedule I nor schedule II criteria.

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1).  For HHS to recommend rescheduling marijuana to schedule III, it must find that marijuana has a potential for abuse less than substances in schedules I and II, has a currently accepted medical use in treatment in the U.S., and its abuse may lead to only moderate or low physical dependence or high psychological dependence.  21 U.S.C. § 812(b)(3).

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022, we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation.  On Thursday, May 16, 2024, the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana.  The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024.  Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597 (May 21, 2024).  The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM.

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.”  NPRM at 44,619.  The Attorney General further determined “at this initial stage” of rulemaking that marijuana also does not meet schedule II criteria but its lower degree of abuse potential and moderate to low level of physical dependence weighs in favor of rescheduling to schedule III.  Id. at 44,620.

Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register.

Findings

The CSA requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse.  21 U.S.C. § 811(c).  DOJ reviewed HHS’ scientific and medical evaluation and scheduling recommendation and conducted a separate review of the eight factors.  NPRM at 44,601.  The NPRM noted that DEA “has not yet made a determination as to its views of the appropriate schedule for marijuana.”  Id.  For each factor, the NPRM noted that DEA’s position is that additional information during the rulemaking will further inform about the appropriate schedule for marijuana.  DEA further believes that factual evidence (including scientific data) and expert opinions with additional data on different forms, formulations, delivery methods, dosages, and concentrations “may be relevant.”  Id.

The eight factors with a summary of relevant findings follow.

1. Marijuana’s Actual or Relative Potential for Abuse

HHS determined that although epidemiological data indicate that marijuana has the potential for creating health hazards for the user and the community, its abuse liability compared with heroin (schedule I); oxycodone, hydrocodone, fentanyl, cocaine (schedule II); ketamine (schedule III), benzodiazepines, zolpidem, tramadol (schedule IV) and alcohol, marijuana does not produce the most frequent incidence of adverse outcomes.  Memorandum for DEA, from HHS, Re: Basis for the Recommendation to Reschedule Marijuana to Schedule III of the Controlled Substances Act, at 9 (Aug. 29, 2023) (“Basis”); NPRM at 44,603.

2. Scientific Evidence of Marijuana’s Pharmacological Effects, If Known

HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits.  Basis at 18; NPRM at 44,605.

3. The State of Current Scientific Knowledge Regarding Marijuana

HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration.  Basis at 24.  DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.”  NPRM at 44,607.  DEA explained that “the lack of consistent concentrations” of delta-9-THC and other substances in marijuana complicates the effects of different constituents within marijuana.  Id.

4. Marijuana’s History and Current Pattern of Abuse

HHS found that marijuana used for medical and nonmedical purposes in the U.S. is extensive but its use prevalence is less than for alcohol but “significantly more” than any other controlled substances.  Basis at 37; NPRM at 44,610.

5. The Scope, Duration, and Significance of Abuse

HHS’ evaluation of epidemiological databases related to medical outcomes from drug abuse placed marijuana in a lower position than alcohol, heroin, and cocaine.  Basis at 45; NPRM at 44,613.

6. What, if Any, Risk There Is to the Public Health

HHS found based on an evaluation of various epidemiological databases for emergency department visits, hospitalizations, unintentional exposures, and overdose deaths that public health risks posed by marijuana are low compared to other drugs of abuse.  Basis at 7-8; NPRM at 44,614.

7. Marijuana’s Psychic or Physiological Dependence Liability

HHS concluded that “experimental data and clinical reports demonstrate that chronic, but not acute, use of marijuana can produce both psychic and physical dependence in humans.”  Basis at 61; NPRM at 44,615.

8. Whether Marijuana Is an Immediate Precursor of a Substance Already Controlled Under the CSA

HHS concluded that marijuana is not an immediate precursor of another controlled substance.  Basis at 61; NPRM at 44,615.

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In addition to the eight factors, HHS provided three additional findings for determining the scheduling placement of marijuana:

1. Potential for Abuse

HHS conducted epidemiological analyses of marijuana abuse and its associated harms by comparison with heroin, fentanyl, oxycodone, hydrocodone, cocaine; ketamine, benzodiazepines, zolpidem, tramadol, and alcohol.  Basis at 62-63; NPRM at 44,616.  HHS found that while marijuana is associated with a high prevalence of abuse of nonmedical use, epidemiological indicators suggest that the drug does not produce negative outcomes as serious as those compared with schedule I or II drugs.  Basis at 62.  HHS concluded that marijuana is most appropriately controlled in schedule III.  Id. at 63.

The Attorney General considered HHS’ recommendations and conclusions and gave HHS’ scientific and medical determinations binding weight at this early stage in the rescheduling process.  NPRM at 44,616.  The Attorney General concurs for purposes of the initiation of rulemaking proceedings that marijuana has less potential for abuse than schedule I and II drugs.  Id.

2. Currently Accepted Medical Use in Treatment in the U.S.

In 2016, HHS and DEA determined that marijuana did not have a currently accepted medical use (“CAMU”) in treatment in the U.S. because it was not the subject of an approved new drug application (“NDA”) nor an abbreviated new drug application (“ANDA”) under the Federal Food, Drug, and Cosmetic Act.  Lacking an NDA or ANDA, DEA applied a five-part test established in 1992 and found that marijuana did not meet that alternative test either so therefore lacked a CAMU.  Denial of Petition at 53,700-02; Denial of Petition at 53,779-81.

In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU.  The Office of the Assistant Secretary for Health (“OASH”) found that more than 30,000 healthcare professionals “are authorized to recommend the use of marijuana for more than six million registered patients, constituting widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States.”  Basis at 24; NPRM at 44,617.  (Thirty-eight states authorize marijuana for specific qualifying medical conditions.)  OASH concluded “there is widespread current experience with medical use of marijuana in the United States” by licensed healthcare providers “operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions.”  Basis at 63; NPRM at 44,617.  For OASH, the findings warranted a Food and Drug Administration (“FDA”) assessment under a second part to determine if credible scientific evidence supports at least one of the medical conditions.

The FDA reviewed studies investigating the safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and FDA-approved products’ labeling.  Basis at 63-64.  FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder.  Basis at 63; NPRM at 44,617.  HHS concluded that “there exists some credible scientific support for the medical use of marijuana in at least one” of the following indications: the treatment of anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain for which there is a widespread current experience in the U.S.  Basis at 64; NPRM at 44,619.

HHS noted that lack of accepted safety for the use of a drug under medical supervision is among schedule I criteria but concluded that there is accepted safety for the use of marijuana under medical supervision for the treatment of anorexia related to a medical condition, nausea, and vomiting (e.g., chemotherapy-induced), and pain.  Basis at 64.  HHS concluded that marijuana does not meet schedule I criteria.  Id. at 64.

The Attorney General asked OLC to advise whether HHS’ test and findings established a CAMU if a drug has not been approved FDAFDA nor meets DEA’s five-part test.  NPRM at 44,617.  OLC advised that DEA’s determination of whether a drug has a CAMU is “impermissibly narrow, because it ‘ignor[es] widespread clinical experience with a drug that is sanctioned by state medical licensing regulators.’”  Id.  OLC opined that satisfying HHS’ two-part inquiry is sufficient to establish a CAMU and that while HHS’ recommendation is not binding on DEA, the medical and scientific determinations are binding until initiation of formal rulemaking proceedings, and DEA must accord those determinations “significant deference” throughout rulemaking.  Id.

The Attorney General agreed that there is widespread clinical experience with marijuana for at least one medical condition and concurred with HHS that for purposes of initiating rulemaking, marijuana has a CAMU.  Id. at 44,617, 44,619.

3. Level of Physical or Psychological Dependence

HHS conceded that clinical studies demonstrate that marijuana produces physical and psychological dependence, and abuse may lead to moderate or low physical dependence depending on the frequency and degree of marijuana exposure.  Basis at 64-65.  But while exposure can produce psychic dependence, HHS noted that the likelihood of serious outcomes is low.  Basis at 65; NPRM at 44,619.  The Attorney General considered HHS’ conclusions and gave HHS’ scientific and medical determinations binding weight at the initial rulemaking stage, and concurred with HHS’ conclusion that the abuse of marijuana may lead to moderate or low physical dependence depending on frequency and degree of exposure.  NPRM at 44,619.

“Marijuana” Subject to Rescheduling

The proposed rescheduling would only apply to marijuana (drug code 7360) defined under the CSA (21 U.S.C. § 802(16)) and regulated by 21 C.F.R. §1308.11(d)(23) and marijuana extracts (drug code 7350) regulated by 21 C.F.R. §1308.11(d)(58).  Id. at 44,620, 44,622.  Rescheduling would also apply to delta-9-tetrahydrocannabinol (“THC”) derived from the marijuana plant (not from the mature stalks and seeds) that falls outside the definition of hemp.  Id.

The proposed rescheduling would not apply to synthetically derived THC outside of the CSA definition of marijuana, which would remain in schedule I.  Id.  HHS’ recommendation related only to marijuana as defined in the CSA.  Rescheduling would also not apply to unscheduled hemp or any previously schedule synthetic cannabinoids.  Id.

International Treaty Obligations

Prior rescheduling proceedings established that marijuana could not be rescheduled in any less restrictive schedule than schedule II for the U.S. to comply with its treaty obligations.  The United States is a signatory to the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971.  Marijuana is a schedule I substance under the Single Convention and delta-9-THC is a schedule II substance under the Convention on Psychotropic Substances. Id. at 44,620-21

The Attorney General, based on OLC advice, concluded that marijuana could be rescheduled to schedule III, and that DEA would consider supplementing schedule III requirements with additional marijuana-specific controls such as manufacturing quotas and import and export authorizations to satisfy treaty obligations.  Id.