DEA Concurs: Marijuana Meets Schedule III Criteria

The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III.  US poised to ease restrictions on marijuana in historic shift, but it’ll remain controlled substance (Apr. 30, 2024).  Xochitl Hinosa, Justice Department Director of Public Affairs, confirmed that Attorney General Merrick Garland signed off on DEA’s proposal stating, “Today, the Attorney General circulated a proposal to reclassify marijuana from Schedule I to Schedule III.”  Quoted in Id.  The White House Office of Management and Budget will review the rescheduling proposal.  Afterwards DEA will publish a notice of proposed rulemaking for public comment in the Federal Register.  After the public comment period closes, DEA will review comments and issue a final rule.

Background

In October 2022, President Biden directed the Health and Human Services (“HHS”) Secretary and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.”  Statement from President Biden on Marijuana Reform, White House (Oct. 6, 2022).  Biden also pardoned prior federal simple possession offenses and encouraged governors to do the same.  Last August, the Food and Drug Administration (“FDA”) and HHS, after considering the eight-factor analysis required by the Controlled Substances Act (“CSA”) for scheduling substances of abuse, recommended DEA reschedule marijuana from schedule I to schedule III.  Letter to DEA Administrator Anne Milgram, from Assistant Secretary for Health Rachel Levine (Aug. 29, 2023).  By recommending rescheduling to schedule III, FDA/HHS determined that marijuana no longer meets schedule I criteria under the CSA and that it does not meet schedule II criteria either.

Since August the Attorney General and the DEA Administrator have been pressed by high profile politicians and others ranging from no rescheduling to total decontrol.  Former DEA Administrators and National Drug Policy Directors asserted that the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and rescheduling impact on prosecuting drug trafficking organizations required marijuana to remain in schedule I.  Letter to U.S. Attorney General Merrick and DEA Administrator Anne Milgram, from Michele Leonhart, et al. (Oct. 2023).  The Democratic governors of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York advocated for rescheduling to schedule III to protect the public against more dangerous drug use asserting that legal marijuana products sold in states where they are legal “are significantly safer than myriad alternatives, including opioids.”  Letter to President Joseph R. Biden, Jr., from Governor Jared Polis et al. (Dec. 5, 2023).  Democratic state attorneys general viewed rescheduling “as a public safety imperative” and also encouraged rescheduling to schedule III based on FDA’s “scientific and medical conclusions.”  Letter to DEA Administrator Anne Milgram, from Phil Weaver, et al. (Jan. 12, 2024).  Three Republican senators on the Foreign Relations Committee advised to consider U.S. treaty obligations in rescheduling.  Letter to Administrator Anne Milgram, from Mitt Romney, Pete Ricketts and James Risch (Mar. 27, 2024).  And twenty-one Democratic senators and members of Congress pushed not only “to promptly remove marijuana from Schedule I,” but to deschedule it altogether.  Letter to Attorney General Merrick Garland and Administrator Anne Milgram, from Senator Elizabeth Warren, et al. (Apr. 24, 2024).

Scheduling Under the CSA

Substances in schedule I of the CSA have a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lack accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1).  Those in schedule III have a potential for abuse less than schedule I or II substances, have a currently accepted use in treatment in the U.S., and their abuse may lead to moderate or low physical dependence or high psychological dependence.  21 U.S.C. § 812(b)(3).

The CSA requires analysis of eight statutory factors for scheduling actions of substances of abuse:

1. The drug’s actual or relative potential for abuse.
2. The drug’s scientific evidence of its pharmacological effect, if known.
3. The state of current scientific knowledge regarding the substance.
4. The drug’s history and current pattern of abuse.
5. The drug’s scope, duration, and significance of abuse.
6. The risk to public health.
7. The drug’s psychic or physiological dependence liability.
8. Whether the drug is an immediate precursor of a substance already controlled.

21 U.S.C. § 811(c).

FDA/HHS Analysis, 2023

FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria.  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).  FDA/HHS found that marijuana continued to have high potential for abuse and lacked accepted safety for use under medical supervision but, perhaps most important, had no currently accepted medical use in treatment in the U.S.  The scientific and medical finding was binding on DEA and, without a finding that marijuana had a currently accepted medical use in treatment, DEA denied the petitions to reschedule.

Unlike its 2016 analysis, FDA’s/HHS’ 2023 analysis considers marijuana to have a currently accepted medical use in treatment in the U.S.  The 2023 analysis “largely focused on modern scientific considerations on whether marijuana has a CAMU [currently accepted medical use] and on new epidemiological data related to abuse of marijuana” since 2016.  FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 5.  FDA conducted epidemiological analyses of marijuana abuse and its associated harms through comparisons with heroin (schedule I); fentanyl, oxycodone, and hydrocodone (schedule II); ketamine (schedule III); benzodiazepines, zolpidem, and tramadol (schedule IV); and alcohol.  Id.  FDA/HHS concluded that marijuana should be rescheduled to schedule III.  FDA/HHS found that even with a high prevalence of nonmedical use, epidemiological indicators suggest that marijuana does not produce outcomes as serious as those of schedule I or II drugs.  Id. at 62.

FDA/HHS conducted a two-part test to determine whether marijuana has a currently accepted medical use in treatment in the U.S.  The Office of the Assistant Secretary (“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.”  Id. at 24.  (Thirty-eight states currently authorize marijuana in different formulations for specific qualifying medical conditions).  OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.”  Id.

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products.  Id. at 63.  FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and chemotherapy-induced vomiting, pain, and post-traumatic stress disorder.  FDA/HHS concluded that “some creditable scientific support” exists for the medical use of marijuana for the treatment of anorexia related to a medical condition, chemotherapy-induced nausea and vomiting and pain.  Id. at 63-64.  HHS/FDA also concluded that there is accepted safety for using marijuana under medical supervision for treatment of these conditions.  FDA/HHS concluded that marijuana does not meet schedule I criteria.  Id. at 64.

FDA further noted that clinical studies demonstrate that marijuana produces physical and psychological dependence, and abuse may lead to moderate or low physical dependence depending on frequency and degree of marijuana exposure.  Id. at 64-65.

U.S. Treaty Obligations

As a signatory to the Single Convention on Narcotic Drugs, 1961, the U.S. is obligated to maintain certain provisions related to drugs controlled under that treaty.  Congress has enacted a number of CSA provisions to ensure compliance.  The CSA requires the Attorney General, by delegation the DEA Administrator, to carry out treaty obligations without regard to findings required by 21 U.S.C. §§ 811(a) or 812(b), and without regard to procedures required by 21 U.S.C. §§ 811(a) and (b).  21 U.S.C. § 811(d)(1).  The Administrator must control marijuana in the schedule she deems most appropriate to comply with U.S. treaty obligations under the Single Convention.

Cannabis and cannabis resin are schedule I substances under the Single Convention.  United Nations, International Drug Control Conventions, Schedules of the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, as of May 17, 2023 (2023).  The Single Convention requires manufacturing quotas and import/export permits for schedule I substances.  Single Convention, Arts. 19, Par 1(a)-(d); 31, Par. 4(a).  Under the CSA, import and export permits are required only for schedule I and II substances and schedule III narcotics, but not for non-narcotic schedule III substances.  Schedule III substances do not require manufacturing quotas.  To comply with the treaty obligations as a schedule III substance, DEA may have to require marijuana import/export permits and manufacturing quotas.

Federal CSA Implications

Rescheduling marijuana to schedule III would have significant implications for growers, processors, and dispensaries.  Those entities will likely need to obtain and maintain a DEA registration.  They will likely need to take initial and biennial inventories, maintain transaction records, file suspicious order and theft/loss reports, and maintain adequate security.  Will dispensing marijuana, as with other schedule III substances, require a prescription issued for legitimate medical purpose by a DEA-registered, state-licensed practitioner?

State Implications

In addition to DEA, the states, commonwealths, and territories also regulate controlled substances within their jurisdictions.  Most states’ controlled substance regulatory regimes mirror the federal CSA and DEA regulations, but most vary on how they regulate marijuana:

• 38 states authorize different dosage formulations for specific medical conditions
• 24 states including DC authorize adult recreational use
• 5 states criminalize all marijuana use

Depending upon the jurisdiction, substances of abuse are regulated as controlled substances if, as with the federal CSA, they meet certain criteria.  At least half the states require the same eight-factor analysis as the feds, but some (New Mexico and Oregon) have fewer criteria while others (Illinois and Wyoming) consider additional factors.  Any federal scheduling action will require a handful of states to automatically regulate the substance consistent with the federal action.  This will likely prove inconsistent with a state’s authorization of marijuana for medical or recreational purposes.  Federal scheduling actions automatically require about sixteen states to control with the CSA unless there is an objection, a public hearing, and state authority decision.  Other states have discretionary scheduling authority not tied to federal scheduling.

For states that authorize marijuana for medical or recreational use, this may represent a sea change and potential culture shift.  State authorities should begin to take stock of potential federal marijuana rescheduling by assessing and understanding how it will impact their state.  Were DEA to reschedule marijuana to schedule III, and states regulate in a less restrictive schedule or allow continued recreational use, how will DEA and DOJ respond?