HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

Scheduling Criteria Under the Controlled Substances Act (“CSA”)

Schedule I:
• High potential for abuse;
• No currently accepted medical use in treatment in the U.S.; and
• Lack of accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1).

Schedule III:
• Potential for abuse less than drugs or substances in schedules I and II;
• Currently accepted medical use in treatment in the U.S.; and
• Abuse may lead to moderate or low physical dependence or high psychological dependence.  Id. § 812(b)(3).

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Last October President Joe Biden asked the Secretary of the Department of Health and Human Services (“HHS”) 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).  Media outlets report, and HHS and Drug Enforcement Administration (“DEA”) officials confirm, that HHS has recommended rescheduling cannabis from schedule I to schedule III.  Bloomberg News reports that the National Institute on Drug Abuse agreed with the recommendation.  Riley Griffin, et al., US Health Officials Urge Moving Pot to Lower-Risk Tier, Bloomberg News (Aug. 30, 2023).

By recommending that DEA reschedule cannabis in schedule III, HHS has determined that cannabis does not meet schedule I nor schedule II criteria under the CSA.

HHS’ recommendation that DEA move cannabis to schedule III falls short of recommending total decontrol as many pro-cannabis advocates had hoped.  If DEA reschedules cannabis to schedule III, federal law will more closely align with that of the thirty-eight states that currently allow for some form of cannabis for medical use but would still conflict with the law of the twenty-three states where cannabis is legal for recreational use.

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner.  Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA.  Registrants would have to create and maintain inventory and transaction records, file certain reports and maintain adequate security.  Schedule III placement would loosen registration requirements for researchers.

Bloomberg News reports that it had seen HHS’ August 29^th letter stating that “FDA considered eight factors that determine the control status of a substance and recommended that marijuana be placed in the Schedule III category.”  Bloomberg News.  We surmise that the letter reviewed by Bloomberg News may have been the cover letter of HHS’ actual recommendation to DEA.

While HHS’ recommendation to move cannabis to schedule III delights some and disappoints others, it leads us to question how the agency arrived at its determination.  DEA and HHS last considered rescheduling cannabis in 2016.  DEA concluded, based on HHS’ evaluation, 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).

The CSA authorizes the Attorney General to schedule, reschedule or deschedule (decontrol) drugs or other substances after requesting a scientific and medical evaluation with scheduling recommendation from HHS.  21 U.S.C. § 811(b).  HHS’ recommendations are binding on DEA as to scientific and medical matters.  Id.  The scheduling analysis, commonly known as the “eight factor” analysis includes:

1. The drug’s actual or relative potential for abuse;
2. The scientific evidence of the drug’s pharmacologic effect, if known;
3. The state of current knowledge regarding the drug;
4. The drug’s history and current pattern of abuse;
5. The scope, duration, and significance of abuse;
6. The risk, if any, to public health;
7. The drug’s psychic or physiological dependence liability; and
8. Whether the drug is an immediate precursor of a controlled substance. § 811(c).

The 2016 review concluding that cannabis remain in schedule I was dependent on several factors.  DEA asserted that cannabis could only be rescheduled to schedule II in order for the U.S. to comply with its international treaty obligations.  Denial of Petitions at 53,688-89, 53,767-68.  The U.S. is still a signatory of the Single Convention on Narcotic Drugs, 1961, so we wonder how DEA might reschedule cannabis in any schedule other than schedule II.

While DEA made specific findings as to the eight factors in 2016, DEA also determined that rescheduling from schedule I to another schedule turned on whether cannabis had a currently accepted medical use in treatment in the U.S.  Id. at 53,689, 53,768.  Because HHS found that cannabis lacked an accepted medical use in treatment in the U.S., DEA had to deny the petitions to reschedule cannabis out of schedule I.

Why is HHS recommending rescheduling cannabis to schedule III now after concluding that there was no substantial evidence to move it from schedule I in 2016?  It is worth taking a closer look at the factors that led HHS and DEA to conclude that cannabis lacked a currently accepted medical use in 2016.

DEA and HHS agreed that a drug was considered to have a currently accepted medical use in treatment in the U.S. for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) or abbreviated new drug application (“ANDA”) under the federal Food, Drug and Cosmetic Act (21 U.S.C. § 355).  Id. at 53,740, 53,821.  FDA had not approved an NDA or ANDA for cannabis for any indication in 2016.  Id.  FDA did approve Epidiolex, a cannabidiol oral solution derived from cannabis, in June 2018.  FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy, FDA News Release (June 25, 2018).  (DEA initially placed Epidiolex in schedule V, then later decontrolled it).  Does HHS consider Epidiolex approved for cannabis rescheduling purposes?

Lacking an approved NDA or ANDA, DEA established a five-part test in 1992 to determine whether a drug had a currently accepted medical use in the U.S.  Id. at 53,740, 53,7821; Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,504-06 (Mar. 26, 1992).  Under the test, a drug is considered to have a currently accepted medical use only if it meets all five elements.  Denial of Petitions at 53,740, 53,821.  Those elements are:

1. The drug’s chemistry is known and reproducible;
2. There are adequate safety studies;
3. There are adequate and well-controlled studies proving efficacy;
4. The drug is accepted by qualified experts; and
5. The scientific evidence is widely available. Id.

DEA reviewed these five elements in 2016 and found that cannabis did not meet the alternative test establishing a currently accepted medical use in treatment in the U.S.  DEA found under element 1 that chemical constituents including delta-9 tetrahydrocannabinol (“THC”) and other cannabinoids varied significantly in different cannabis strains, concluding that chemical composition among different cannabis samples was not reproducible. Id. at 53,761, 53,840.  DEA noted, however, that chemistry may be consistent enough to derive standardized doses if a specific cannabis strain is processed under controlled conditions.  Id.  DEA found that there were no adequate safety studies on cannabis use in specific, recognized medical conditions, nor were there adequate, well-controlled studies determining efficacy.  Id.  In addition, there was no consensus of experts opinion about the medical utility of cannabis treating specific recognized disorders.  Id.  DEA stated that there was a lack of currently available data on cannabis that sufficiently addressed its chemistry, pharmacology, toxicology, and effectiveness.  Id.  DEA noted there was a lack of scientific evidence about cannabis’ chemistry to a specific strain that could be formulated into standardized and reproducible doses.  Id.  Applying the five-part test in 2016, DEA found that cannabis met none of the five elements.

We also note that as a schedule I substance, cannabis’ potential for abuse was “high” in 2016 and wonder how its potential for abuse is now “less than drugs or [other] substances in schedules I and II” as required by a schedule III recommendation.  And how is cannabis now safe to use when there was “a lack of accepted safety for use . . . under medical supervision” seven years ago?

We are certainly curious whether DEA will reschedule cannabis, and if so, in which schedule.  In the meantime, we wonder how HHS arrived at its current recommendation.