President Biden's Cannabis Scheduling Directive: Part 2
By Shane Pennington
Oct 21, 2022
In an earlier post, I explained why President Biden’s request to Attorney General Garland and Secretary Becerra to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” is a big deal not just for cannabis, but for all controlled substances. That post was actually the introduction to a much longer one that includes a deep dive into the actual mechanics of the impending administrative review process. This is that much longer post, so get your coffee ready and your game faces on.
To appreciate the gravity of the President’s scheduling directive and what could happen next, you need to understand (1) how the administrative process the President has set in motion will actually work and (2) how the agencies in charge have used it to affirm and reaffirm cannabis’s schedule I1 status repeatedly throughout the Comprehensive Drug Abuse Prevention and Control Act of 1970’s (“CSA”) history. I cover those topics here.
In Part 3 of this series, which is yet to come, I’ll break down what different outcomes—descheduling and rescheduling to schedules II, III, IV, and V—would mean for various cannabis stakeholders and federal drug policy more broadly.
We’re just getting warmed up here, folks, so stay tuned.
I. The Administrative Process(es)
With limited exceptions not relevant here, the CSA divides substances into two groups for scheduling purposes: Those subject to certain international drug-control treaties and everything else. Those subject to the relevant treaties may be scheduled, descheduled, and rescheduled only through the simple process set forth in 21 U.S.C. 811(d), which leaves scheduling entirely to DEA’s2 unfettered discretion. Everything else may be scheduled, descheduled, and rescheduled only through the complex and arcane formal rulemaking procedures laid out in 21 U.S.C. 811(a)-(b). To understand the ins and outs of cannabis scheduling, you need to understand both processes.
(1) Deeming Orders Under Section 811(d)(1)
Substances that are subject to the relevant treaties are scheduled, descheduled, and rescheduled under the straightforward process set forth in 21 U.S.C. 811(d). Cannabis, for example, is subject to control under the Single Convention on Narcotic Drugs of 1961, an international treaty to which the U.S. is party. It is therefore subject to the scheduling procedures laid out in section 811(d)(1), which directs DEA to issue an order placing it in the schedule it “deems most appropriate to carry out such [treaty] obligations, without regard to the findings [and procedures] prescribed by [section 811(a)-(b)].” The same provision also emphasizes that in deciding what’s “most appropriate,” DEA need not consult the Department of Health and Human Services (“HHS”), consider any particular evidence, or make the specific findings ordinarily required before it may place a substance in a particular schedule. See 21 U.S.C. 811(d)(1) (“If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.”) (emphasis added).
Notice, however, that President Biden requested that the AG and the Secretary of HHS initiate the administrative process to reconsider cannabis’s schedule I status. The President couldn’t have been referencing section 811(d)(1) because HHS isn’t involved in the section 811(d)(1) process at all. It therefore seems likely that the President either isn’t intimately familiar with the ins and outs of cannabis scheduling (which wouldn’t surprise me as so very few people are) or he assumes the treaty-centric process of section 811(d)(1) no longer applies for some reason.
The latter option is a live possibility. After all, the United States has been out of compliance with the treaties in a number of ways throughout the CSA’s history. Matt and I uncovered the secret OLC Opinion that revealed how the NIDA monopoly—a 50 year old DEA/DOJ policy that blocked cannabis research for years—had placed the U.S. out of compliance with the Single Convention since the day DEA came into existence. And the International Narcotics Control Board (“INCB”)—the UN body responsible for overseeing member state compliance with the Single Convention—has repeatedly chastised the U.S. for violating the treaty by permitting the states to operate adult-use cannabis regimes.
Given the United States’ perennial non-compliance with the Single Convention, it wouldn’t be that outlandish for the White House to continue the same pattern by ignoring section 811(d)(1) in calling for this scheduling review. The White House may even see this administrative review as an opportunity for the United States to own its non-compliance in the spirit of finally working with its treaty partners around the world to modernize the international drug control treaties to align with post-War-on-Drugs policies and understandings. We shall see.
(2) Formal Rulemaking Under Section 811(a)-(b)
For substances not subject to the treaties referenced in section 811(d), the CSA requires DEA to base scheduling decisions on three criteria:
whether the substance in question has a medical use,
its potential for abuse, and
the extent to which the substance is unsafe or addictive.
See 21 U.S.C. § 812.
Schedule I substances are those that have “a high potential for abuse,” “no currently accepted medical use,” and for which “[t] here is a lack of accepted safety for use of the drug or other substance under medical supervision.” Schedule II substances also have “a high potential for abuse.” They are distinguished from schedule I substances because they have “a currently accepted medical use in treatment in the United States” and there is not a complete lack of safety for their use, although their abuse “may lead to severe psychological or physical dependence.” Substances in schedule III have a lower potential for abuse and risk of dependence than those in schedule II, and so on.
|Abuse Potential?||Accepted Medical Use?||Safety and Dependence|
|Schedule I||High||No||Lack of accepted safety for use under medical supervision|
|Schedule II||High||Yes||Abuse may lead to severe dependence|
|Schedule III||Less than schedules I and II||Yes||Abuse may lead to moderate or low physical dependence or high psychological dependence|
|Schedule IV||Less than schedule III||Yes||Abuse may lead to limited dependence relative to Schedule III|
|Schedule V||Less than schedule IV||Yes||Abuse may lead to limited dependence relative to Schedule IV|
The CSA provides that “a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance.” 21 U.S.C. 812(b). It requires that DEA make those findings in a particular way and through a particular process, which I go through in some detail below.
The CSA requires that DEA use a formal “on the record” process to schedule, reschedule, or deschedule substances. 21 U.S.C. 811(a) (“Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of Title 5.”). The process may be initiated “by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.” Id. That is why President Biden directed his instruction regarding cannabis’s scheduling status to the Attorney General and Secretary Becerra.
I’ll provide a thumbnail sketch of how the process works in just a second, but I want to flag one thing right up top:
This is not notice and comment rulemaking or any other familiar administrative process. This is formal rulemaking “on the record,” an administrative procedure so complex and unwieldy that it is almost unheard of in the modern era. Remarking on just how obscure it has become, Justice Thomas in 2015 dubbed it “the Yeti of administrative law.” See Perez v. Mortgage Bankers, 575 U.S. 92, 128 n.5 (2015) (Thomas, J., concurring in the judgment) (“Today, however, formal rulemaking is the Yeti of administrative law. There are isolated sightings of it in the ratemaking context, but elsewhere it proves elusive.”).
Very few lawyers alive know their way around the formal rulemaking process because very few lawyers alive have ever participated in it. It just so happens that one of the On Drugs authors, the inimitable Matthew C. Zorn, is among that rare breed who have in fact tangled with the Yeti—in a DEA scheduling proceeding no less. And guess what? He bested the beast!
But I digress. Here’s how the impending administrative process will go down.
Before Initiating Proceedings. Before DEA initiates proceedings to reconsider a substance’s scheduling status, it must
“gather the necessary data,”
request a scientific and medical evaluation from HHS, and
request a scheduling recommendation from HHS.
See 21 U.S.C. 811(b). The Secretary of HHS has delegated his duties in this regard to the Food and Drug Administration ("FDA"), which has assigned the actual preparation of the evaluation and scheduling recommendation to the Controlled Substances Staff ("CSS") within its Center for Drug Evaluation and Research ("CDER").3
Once CSS drafts a scheduling recommendation, the draft proceeds through a clearance process that includes CDER’s Office of the Center Director, FDA’s Office of the Commissioner, and the Office of the Assistant Secretary for Health (“OASH”) at HHS. Once the OASH signs off, the recommendation is forwarded along to DEA.
HHS’s evaluation and recommendation are binding on DEA as to scientific and medical issues. Id. Moreover, and this is important, if HHS recommends that a substance not be controlled, DEA “shall not control the … substance.” Id. Notice that HHS/FDA prepares its scheduling recommendation at a very early stage in this process and yet it could force DEA to deschedule. That’s a big deal for a couple of reasons:
It undermines arguments that descheduling is impossible here, and
It shows how important it is for advocates of descheduling to do everything conceivably possible to ensure that CSS has the data necessary to recommend “no control” in its scheduling recommendation to DEA. If HHS recommends a scheduling at schedule V or higher, DEA will hesitate to overrule its recommendation. After all, DEA is going to be bound by CSS’s conclusions as to the scientific and medical issues. So if it wants to put cannabis in less-restrictive schedule than the one FDA recommends—a possibility that strikes me as rather unlikely in the first place—it would have to rely entirely on considerations of abuse potential and the like (factors 1, 4, and 5 in the 8-factor analysis I discuss next).
Once DEA has all this information in front of it (and assuming HHS/FDA didn’t recommend no control), it assesses whether there is “substantial evidence” that the substance should be scheduled, rescheduled, or descheduled. 21 U.S.C. 811(b). If there is, DEA “shall initiate proceedings,” accordingly. Id.
To decide whether “substantial evidence” sufficient to initiate proceedings exists, DEA considers eight “factors” about the substance in question:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
Id. 811(c). HHS considers these same factors when formulating its scientific and medical evaluation and scheduling recommendation, except when it comes to factors 1, 4, and 5, its review is limited to “any scientific or medical considerations involved.” Id. 811(b).
Initiating Proceedings and The Proposed Rule. To initiate proceedings, DEA posts a proposed rule in the Federal Register along with supporting documents, which usually include its and HHS’s eight-factor analyses and HHS’s scheduling recommendation. In the proposed rule, DEA explains whether and why it believes the substance should be scheduled, rescheduled, or descheduled. As part of that explanation, DEA summarizes its and HHS’s “eight factor” analyses and the conclusions each agency draws from that analysis. It then walks through its reasons for (a) proposing to make the findings necessary to place the substance in a particular schedule or (b) concluding that it cannot make the findings necessary to place the substance in any schedule. See 21 U.S.C. 812 (listing findings DEA must make for each schedule); see also Table I supra.
Public Comment and Requests for Hearing. Once DEA publishes its proposed rule, it gives the public time to comment and interested persons time to request hearings on the record. The Administrative Procedure Act (“APA”) and DEA regulations govern the hearing stage of the formal rulemaking process. See 5 U.S.C. 556-67; 21 C.F.R. 1308.41-1308.45; 21 C.F.R. 1316. Under the APA, hearings are similar to proceedings in a court of law. An administrative law judge or “ALJ” presides over the hearing has authority to administer oaths, issue subpoenas, and exclude 'irrelevant, immaterial, or unduly repetitious evidence.
The Hearing Process. The process usually begins with a hearing to allow interested parties to state their position on the proposed rule and present evidence. This is followed by cross-examination, if necessary. A transcript of the hearing must record evidence and testimony to serve as the basis for the presiding officer’s decision. Formal rulemaking prohibits any communication between affected parties and agency officials, known as ex parte communications, while proceedings are pending.
The ALJ’s Decision. After the hearing, the ALJ compiles the entire record, including the evidence gathered during the hearing and public comment processes and transmits it to the Administrator of DEA. After reviewing the entire record, the DEA Administrator publishes a “final order” in the Federal Register setting forth the final rule and her findings of fact and conclusions of law supporting it.
The Administrator’s Final Order and Final Rule. Once the Administrator issues a final rule scheduling, rescheduling, or descheduling a substance, any interested person aggrieved by the decision may seek judicial review n the United States Court of Appeals for the District of Columbia Circuit or for the circuit in which his principal place of business is located within thirty days after notice of the decision. See 21 U.S.C. 877.
Part II: Why Past Administrative Reviews Confirmed Cannabis’s Schedule I Status
From its very earliest days, DEA has faced a near-constant stream of petitions under section 811(a) to remove cannabis from schedule I. Yet it has denied each and every one. In this section, I’ll discuss the key reasons it has given for reaching that conclusion.
To set the stage for this discussion, recall that DEA may place a substance in schedule I only if (a) treaty considerations make placement in schedule I “most appropriate” (21 U.S.C. 811(d)(1)) or (b) DEA makes the findings necessary to justify schedule I placement under 21 U.S.C. 812(b). We’ll discuss the treaty issue later. For now, it suffices to say that nobody—not even DEA—contends that treaty compliance requires keeping cannabis in schedule I. That means that DEA may only keep cannabis in schedule I if it finds that cannabis:
has a high potential for abuse;
has no currently accepted medical use in treatment in the United States;
there is a lack of accepted safety for cannabis use under medical supervision.
As you’ll soon learn, DEA’s rationale for each of these findings is shaky at best.
A. “High Potential for Abuse”
The CSA doesn’t define “potential for abuse,” so DEA relies on the statute’s legislative history, which identified four factors the agency might consider when “determin[ing] a substance has potential for abuse.” 76 Fed. Reg. 40552, 40553 (July 18, 2011) (relying on the four factors outlined in the legislative history to determine abuse potential). The four factors are:
Individuals are taking the substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.
There is a significant diversion of the drug or substance from legitimate drug channels.
Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such substances.
The substance is so related in its action to a substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.
See Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970) reprinted in U.S.C.C.A.N. 4566, 4603. Applying those factors to cannabis, DEA has repeatedly concluded that it has a high potential for abuse. Boiled down to essentials, its key reasons are:
Cannabis is the most widely used illicit substance in the United States.
Preclinical and clinical data show that it has reinforcing effects characteristic of drugs of abuse.
National databases on actual abuse show that cannabis is the most widely abused drug, including significant numbers of substance abuse treatment admissions.
Data on cannabis seizures show widespread availability and trafficking.
DEA’s reasoning on this score is problematic in several respects, but I’ll highlight just two here. First, whether you approve of using legislative history in statutory interpretation generally, the snippet of the CSA’s legislative history that DEA relies on for the four factor analysis above is pretty weak sauce. Recall that the CSA requires DEA to conclude that cannabis has a high potential for abuse. Yet the legislative history discussing the four factors addresses only the”the minimum needed to show any potential for abuse.” Grinspoon v. Drug Enforcement Admin., 828 F.2d 881, 893 (1st Cir. 1987). It says nothing about assessing relative abuse potential—the determination DEA is required to make under the CSA.
Second, many of the specific findings DEA relies on to support its “high potential for abuse” finding hinge on treating even medical cannabis use as “abuse.” Even assuming that state medical cannabis laws don’t prove that cannabis has a currently accepted medical use in treatment in the United States—an issue I’ll address shortly—it is a real stretch to conclude that patients using medical cannabis at their physician’s recommendation are drug abusers. If that were true, that would make their doctors drug dealers unworthy of a license to practice medicine. Yet nobody contends that doctors recommending cannabis in treatment in the United States in good faith and in compliance with state law ought to be liable for malpractice or stripped of their professional livelihoods.
Nor is it obvious that data showing that a large number of people use a substance recreationally necessarily proves “high potential for abuse.” A more sensible standard would have relative abuse potential turn on factors like problematic use and addiction and potential harms that use might cause. And as I’ll explain next, DEA appears to appreciate this point outside the cannabis context.
There are plenty of substances that people use all the time, have no medical utility, are abused recreationally and yet aren’t subject to control at all, much less in schedule I. Consider nutmeg. “Because of its euphoric and hallucinogenic effects, nutmeg has been widely abused as a cheap substitute for narcotic drugs since the 12th century.” See here. If you dig into it, you’ll learn that poison control centers receive calls about nutmeg ingestion pretty regularly. Nutmeg’s constituent compounds have effects similar to amphetamine, a schedule II drug available by prescription, and LSD, a schedule I drug.
Notably, Congress knew all about nutmeg back when the CSA was enacted. Nutmeg was a known drug of abuse, considered to be a narcotic, and believed to be dangerous when consumed in large quantities. Congress did not place nutmeg on the schedules, however. Nor has DEA ever attempted to schedule nutmeg, despite it being regarded as a drug having a potential for abuse and no accepted medical use. Indeed, there is evidence that American kids are abusing nutmeg. In 2020, for example, there was a dangerous trend on TikTok called the “nutmeg challenge” that encouraged TikTok users to consume quantities of nutmeg sufficient to cause hallucinations.
Despite open and potentially wide-spread abuse by youth, DEA has never taken any action to schedule nutmeg. Likely this is because, despite a well-documented danger of overdosing and hallucinations surrounding the substance, nutmeg is a common food item sold in grocery stores nationwide, and it takes a high quantity of consumption of nutmeg to cause harm.
The point here is that DEA has discretion to interpret “high potential for abuse” in a range of ways, and it has exercised that discretion inconsistently. So, how has it gotten away with it? Because courts tend to defer to federal agencies on issues like these that involve how best to interpret open-ended statutory language.
Grinspoon v. DEA, a 1987 decision from the First Circuit concerning the scheduling of MDMA, illustrates the point. 828 F.2d at 893. There, the Court acknowledged that DEA’s “Administrator articulated no standard for showing that MDMA had a relative potential for abuse sufficient to warrant placement in Schedule I.” Id. Nevertheless, the Court upheld DEA’s abuse-potential determination, explaining that the Administrator can permissibly reach a conclusion regarding a substance’s relative abuse potential simply by comparing the substance to drugs already scheduled under the CSA. Id. at 893-94. “Here the Administrator has done just that, offering several findings concerning the evidence of close structural and pharmacological similarity between MDMA and other substances, such as MDA, which already have been found to have a high potential for abuse and have been placed in Schedule I or II.” Id.
In short, courts give agencies like DEA a wide berth when it comes to deciding factual questions that courts have no special expertise in answering. Without this sort of deference, DEA likely wouldn’t be able to maintain the fantasy that cannabis, which is relatively benign in terms of harm and potential for addiction compared to many other substances, has the same abuse potential as a substance like, say, heroin. Nor could it pretend that Marinol, a synthetic drug containing THC, belongs in Schedule III while cannabis languishes in schedule I. Rescheduling of the FDA Approved Product from Schedule II to III, 64 Fed. Reg. 35,928 (July 2, 1999).
B. “Currently Accepted Medical Use in Treatment in the United States”
Behold, the granddaddy of them all. The belly of the beast. DEA’s all-time favorite justification for keeping cannabis in schedule I. This one is so important to cannabis’s past and future under federal law, that I’m going to give you the complete, no-detail-spared breakdown here. So put the kids to bed and buckle up.
Our story begins in 1972, while the ink of President Nixon’s signature on the Controlled Substances Act was still drying.
1. The NORML Petition
In 1972, NORML petitioned to remove marijuana from schedule I. NORML v. DEA (“NORML I”), 497 F.2d 654 (D.C. Cir. 1974). DEA’s predecessor agency, the Bureau of Narcotics and Dangerous Drugs (“BNDD”), refused to accept the petition for filing, concluding that treaty obligations required marijuana remain in schedule I. Id. (citing 21 U.S.C. § 811(d)(1)).
The NORML I court reversed, holding DEA had erred by rejecting the petition without “reflective consideration and analysis.” Id. at 661. On remand, the newly-formed DEA concluded that while marijuana could theoretically move to schedule II, it had no currently accepted medical use and thus had to remain in schedule I. In support of that decision, DEA relied on a one-page letter from the Deparment of Health, Education, and Welfare’s (HHS’s predecessor agency, which I’ll refer to as “HEW”) Acting Assistant Secretary. NORML v. DEA (“NORML II”), 559 F.2d 735, 742 (D.C. Cir. 1977) (quoting 40 Fed. Reg. 44,164, 44,168 (1975)).
The D.C. Circuit vacated this decision as well. Id. DEA’s reliance on a terse letter, the court explained, could “hardly take the place of the elaborate referral machinery contemplated by Congress,” which required a hearing and determination on the record. Id. at 749.
On remand, DEA referred the petition to HEW, which concluded marijuana could be placed in either schedule I or II, but recommended schedule I as a better “fit.” 44 Fed. Reg. 36,123 at 36,127 (June 20, 1979). Ten days later, DEA denied the petition without a hearing. Id. at 36,125. That resulted in a third remand. NORML v. DEA, 1980 U.S. App. Lexis 13099 (D.C. Cir. Oct. 16, 1980) (“NORML III”). “[R]egrettably,” the order began, the Court found it necessary to remind the agency not to “‘do anything which is contrary to either the letter or spirit of the mandate construed in the light of the opinion of [the] court deciding the case.’” Id. (citation omitted).
With that, the NORML III court instructed DEA to reconsider all issues accounting for new evidence concerning medical use. Id.
2. How Reflexive Chevron Deference Birthed the Five-Factor Test That Has Kept Cannabis Locked Away in Schedule I for Decades.
The Supreme Court decided Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., in 1984, ushering in a new doctrine of judicial deference to agency interpretations of statutes. 467 U.S. 837 (1984). Soon after, following the NORML III remand, DEA unveiled a new interpretation of “no currently accepted medical use in treatment in the United States” via a series of circuitous judicial and administrative proceedings.
DEA first interpreted the phrase in proceedings placing MDMA in schedule I because it lacked FDA approval for interstate marketing and therefore had “no currently accepted medical use.” Grinspoon v. DEA, 828 F.2d 881, 884 (1st Cir. 1987).
The First Circuit rejected DEA’s reliance on the absence of FDA approval as contrary to congressional intent. Id. at 890. But it also concluded that it “appear[ed]” as if Congress had “implicitly delegated” to DEA “the authority to interpret these portions of the CSA.” Id. at 892. Accordingly, the Court remanded to DEA for reconsideration, instructing the agency that the absence of FDA approval could not be used as conclusive evidence of lacking accepted medical use. Id.
On remand, DEA returned to FDA criteria anyway, outlining eight “characteristics of a drug or other substance with an accepted medical use” cribbed from FDA standards. Applying this eight-factor test, DEA once again concluded that MDMA belonged in Schedule I because it lacked FDA approval and had no “currently accepted medical use in treatment in the United States.” 53 Fed. Reg. 5,156 (Feb. 22, 1988). The petitioner didn’t pursue the matter further.
Nearly seven years after the NORML III remand, hearings on the 1972 NORML petition began. They focused on two issues: whether marijuana had a “currently accepted medical use in treatment in the United States” and whether there was a lack of “accepted safety for use of the marijuana plant under medical supervision.” In the matter of Marijuana Rescheduling Petition, Dkt. 86-22 at 7 (DOJ Sept. 6, 1988) (“ALJ Opinion”). After hearing extensive evidence, the ALJ issued a detailed opinion, explaining, among other things, how marijuana use prevented or diminished chemotherapy-induced nausea, and thus concluding marijuana had an accepted medical use in treatment of certain cancer patients. See id. at 67-68.
Using the eight FDA-centric characteristics for “currently accepted medical use” developed after Grinspoon, DEA rejected the ALJ Opinion and denied NORML’s petition a fourth time. See 54 Fed. Reg. 53,767 at 53,783-85 (Dec. 29, 1989).
Two more appeals followed. In Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991) (“ACT I”), petitioners challenged the eight-factor test. Like the court in Grinspoon, the D.C. Circuit found no textual support for DEA’s interpretation but deferred to it under Chevron anyway. Id. at 939. Although the Court found DEA’s interpretation “in the main acceptable,” it explained that another remand was necessary because three of the eight factors were “logically impossible to satisfy.” Id. at 937.
Following remand four, DEA remained convinced that “Congress equated the term ‘currently accepted medical use in treatment in the United States’ as used in the [Act] with the core FDCA standards for acceptance of drugs for medical use.” 57 Fed. Reg. 10,499 at 10,504 (Mar. 26, 1992) (“1992 Rule”). Thus, it discarded the three impossible factors and applied a conjunctive five-factor test for “currently accepted medical use,” id. at 10,504-06:
The drug’s chemistry is known and reproducible;
There are adequate safety studies;
There are adequate and well-controlled studies showing efficacy;
The drug is accepted by qualified experts; and
The scientific evidence is widely available.
In the final order explaining the rationale for that standard, DEA’s Administrator admitted it was incompatible with 21 U.S.C. § 812(b)(1)’s plain language but imposed it anyway, insisting that the statutory text was “inconsistent with scientific reality.” 57 Fed. Reg. at 10,504.
Shockingly, the D.C. Circuit deferred to the agency’s interpretation of the statute under Chevron. The only reason any of this was possible was because the D.C. Circuit happened to review DEA’s interpretation during an era of reflexive Chevron deference that the federal courts have categorically rejected since. Compare ACT I, 930 at 939 (“[Because] neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use’ … we are obliged to defer.”) and Medina Tovar v. Zuchowski, 982 F.3d 631, 634-35 (9th Cir. 2020) (en banc) (“To maintain the proper separation of powers … we must exhaust all the traditional tools of construction before we wave the ambiguity flag.”) (quot. omitted). Unfortunately, DEA’s rewrite of the statutory text hasn’t faced the scrutiny of judicial review since.
The D.C. Circuit Judge who blessed DEA’s obnoxious interpretation of “currently accepted medical use” under Chevron was Larry Silberman. President Reagan appointed him to the bench during the Heyday of the War on Drugs. He died earlier this month at the age of 86.
Applying this slimmed-down test, DEA denied the NORML petition again, this time explaining that “claims that marijuana is medicine are false, dangerous and cruel,” that “[m]arijuana is likely to be more cancer-causing than tobacco,” that “impressions or beliefs of physicians, no matter how fervently held, are treacherous,” and that “[t]hose who insist marijuana has medical uses would serve society better by promoting or sponsoring more legitimate scientific research, rather than throwing their time, money and rhetoric into lobbying, public relations campaigns and perennial litigation.” Id at 10,500, 02-03.
A fifth judicial proceeding followed. Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1134 (D.C. Cir. 1994) (“ACT II”). Petitioners again questioned DEA’s interpretation of the statute but the Court declined to reconsider the issue citing the law-of-the-case doctrine. Id. at 1134-35.
Twenty-two years after NORML first filed its petition, it finally stood denied.
3. Recent Failed Efforts to Reschedule Marijuana
In 2005, the Supreme Court found the “evidence proffered by respondents … regarding the effective medical uses for marijuana” noteworthy, explaining that “if found credible after trial, [it] would cast serious doubt on the accuracy of the findings that require marijuana to be listed in Schedule I.” Raich, 545 U.S. at 27 n.37.
Today, more than two-thirds of the States have passed laws establishing comprehensive medical-marijuana programs for treating enumerated conditions. But efforts since ACT I and II to reschedule marijuana have fallen flat.
Importantly, none has seriously called into question the underpinnings of DEA’s five-part test. In 1995, Jon Gettman petitioned for rescheduling of marijuana. Six years later, DEA applied the five-part test and denied his petition. 66 Fed. Reg. 20,038 (Apr. 18, 2001). The D.C. Circuit dismissed Gettman’s petition for review for lack of standing. See Gettman v. DEA, 290 F.3d 430, 432 (D.C. Cir. 2002).
In 2002, the Coalition to Reschedule Cannabis filed a rescheduling petition. Nine years later, DEA denied it, asserting little had changed since 1992. 76 Fed. Reg. 40,552 (July 8, 2011). The D.C. Circuit’s opinion rejecting the subsequent petition for review emphasized that the petitioners had not “seriously disput[ed] the propriety of the five-part test.” Americans for Safe Access v. DEA, 706 F.3d 438, 448-50 (D.C. Cir. 2013).
In a 2011 rescheduling petition, the Governors of Rhode Island and Washington noted the growing schism between state and federal law on marijuana and declared marijuana’s continued placement in schedule I “fundamentally wrong.” Ltr. from Gov. Chafee and Gov. Gregoire, Rulemaking Petition to Reclassify Cannabis for Medical Use from a Schedule I Controlled Substance to Schedule II (Nov. 30, 2011). Applying the five-part test, DEA denied the petition a half-decade later. 81 Fed. Reg. 53,688 (Aug. 11, 2016). Although it recognized that twenty-three States had laws permitting medical-marijuana use, id. at 53,700- 01, 53,713, in the letter accompanying the decision, DEA explained that marijuana had to remain in schedule I under “established scientific standards” derived from the “FDA drug approval process … as the statute demands.” Ltr. from DEA Acting Administrator Rosenberg to Gov. Raimondo, Gov. Inslee, and Krumm (Aug. 11, 2016).
C. “Accepted Safety for Use Under Medical Supervision”
The third finding necessary to place or keep a substance in schedule I is that it have “no accepted safety for use under medical supervision.” 21 U.S.C. 812(b)(1)(C). Of course, as mentioned earlier, DEA’s ridiculous interpretation of “currently accepted medical use” requires proof of safety studies, thus reading this third criteria out of the statute entirely. It bears repeating that DEA knows and acknowledges that this is the case. See, e.g., 57 Fed. Reg. at 10,504 (“The scheduling criteria of the Controlled Substances Act appear to treat the lack of medical use and lack of safety as separate considerations. Prior rulings of this Agency purported to treat safety as a distinct factor. In retrospect, this is inconsistent with scientific reality. Safety cannot be treated as a separate analytical question.”). Given this admitted reality, it will not surprise you to learn that DEA’s rationale for this conclusion simply repeats its absurd rationale for concluding that cannabis has no currently accepted medical use:
At present, there are no U.S. Food and Drug Administration (FDA)-approved marijuana products, nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication. The HHS evaluation states that marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.
81 Fed. Reg. 53767 (Aug. 12, 2016).
I think that speaks for itself.
As you can see, DEA’s reasons for keeping cannabis in schedule I are indefensible. The only reason they survived judicial review is that they were blessed by the D.C. Circuit during the reign of a style of reflexive Chevron deference that courts have long since abandoned.
The President’s scheduling directive gives DEA and FDA an opportunity to right a ship that veered off course long ago. To do so, however, the agencies will have to at long last abandon the absurd interpretations of the CSA that have kept cannabis in schedule I unlawfully for decades. In Part 3, which I’ll post soon, I’ll go go through the various ways the impending scheduling review can make that happen and provide my thoughts about what the Administration can and should do to get this right.
Did you miss part 1 on the topic? Read it here.
Originally posted on On Drugs, which offers "Cutting Edge Thoughts on Drug Regulation by Matt Zorn and Shane Pennington." Subscribe here.