The Dirtiest Little Secrets About Rescheduling
The Dirtiest Little Secrets About Rescheduling
Deep cuts and myth busting.
By now, everyone and their mom has heard that HHS recommended to DEA marijuana be moved to Schedule III. Early in the day, following a leak, Bloomberg reported that HHS recommended Schedule III. Shortly thereafter, the HHS Secretary confirmed that HHS had “follow[ed] the data and science” and wasn’t influenced by PR and politics by posting the following notice at 4:20 on Twitter X:
And shortly after that, everyone began spitting off takes of what rescheduling will mean.
While I’m not a fan of delivering this kind of news via “X,” I do welcome the recommendation. As stated in this essay, I view rescheduling as an essential step toward promoting equity. Or, as more bluntly put by Shane, “[t]his is essential to ending the dumpster fire that is cannabis policy.” So, I applaud those involved in bringing this about, particularly the President himself. In terms of Executive maneuvering, this President has probably done as much as he can do without Congress to fix cannabis policy. I’m serious.
At the same time, this isn’t a joke. It shouldn’t be treated as such, let alone senior officials in the Biden Administration. Remember: folks have had their lives ruined by marijuana’s Schedule I status. A serious process dictated by the “data and science” ought to be treated as such.
For me, that starts with transparency.
The most concerning aspect of all this is that the recommendation was leaked but not itself disclosed. To me, that’s inexcusable. Apparently, the public doesn’t get to see why HHS recommended Schedule III—plebes get just a tweet. Or whatever posts on “X” are called these days.
Ordinarily, a federal agency might withhold an interim recommendation on grounds that it is part of a deliberative process. This is called the “deliberative process” privilege. But, it is pretty basic law that agencies don’t get to make some parts of their deliberative processes public while withholding others, or leak a document to the press and then withhold the document from the public. And of course, the government may choose, in its discretion, not to hide information from the public.
Maybe I’m too much of a lawyer that likes having access to primary documents. Or maybe, I’m not trusting enough. But I find it bizarre, for example, that the Colorado Governor pens a (good) letter to the President about the “recommendation to move cannabis to Schedule III”1 and describing said letter as “evidence-based,” when we can’t even see the recommendation. Alternatively, if the Colorado Governor did get to see the “evidence-based” recommendation, then why don’t we? Should we really just be taking HHS’s word on this one?
As far as I can tell, few if anyone in the cannabis industry is focusing on this fact. So, as you may have guessed, I’ve filed a FOIA. Two, actually. (I’m told others have filed FOIAs too). We need a transparent process—which this process is not.
We’re the Experts. Period.
Before I delve into substance, let me begin with a “told ya so.”
We’ve been ahead of the issues for years and have long argued that Schedule III was the best achievable reform for the cannabis industry and simply required seeing the law (i.e., not more “science”) a different way:
Starting in 2019, we represented Scottsdale Research Institute in a mandamus action that forced the government’s hand and lead to the dismantling of the longstanding NIDA monopoly.
Less than a year later, we went to district court and sued under FOIA, asserting a novel affirmative disclosure claim, forcing the disclosure of a secret Office of Legal Counsel memo three weeks after filing a complaint.
In 2020, we brought Sisley v. DEA, where we made two claims that are central to the current rescheduling: that marijuana has a “currently accepted medical use in treatment” and, importantly, that the provision of the CSA regarding treaties isn’t constitutional.
In 2021-22, we litigated Craker v. DEA. In that case, we challenged DEA’s rules to govern the manufacture of medical marijuana. Immediately relevant here—and discussed below—DEA defined “medicinal cannabis” by regulation.
These cases all raised different legal issues. They hit different corners of the marijuana rescheduling universe. But together, they comprise essential knowledge to truly understand what has happened and can happen going forward.
We’ve literally written the book in these cases—and others—with little other than ourselves, great clients, and a handful of outstanding amici/co-counsel. If time spent engaging a topic is a proxy for expertise, nobody is more expert on these subjects than me and Shane—and Shane much more than myself, who has been in the trenches with rescheduling as his focus for more than a year.
Again, receipts. Before we see the recommendation from FDA/HHS, I want to highlight the following point from our Sisley briefs and call my shot:
I haven’t seen the HHS recommendation yet. But how much do you want to bet that the Schedule III recommendation is based on some variant of what we identified above? After all, we know the following:
Marijuana hasn’t been approved by the FDA;
The science on marijuana as medicine hasn’t changed;
Marijuana still doesn’t otherwise meet the five-part test criteria;
What has changed is that many more states have medical marijuana; and
FDA asked for this state data during its rescheduling review.
We brought Sisley and urged rescheduling in 2020 (and still today) because we knew then that this was quite clearly the best, realistic legal change the cannabis industry and community could obtain based on politics and how the law actually works. Removing 280E will be tremendous: the cannabis lobby would have more money, for example, to advocate for other changes. We suggested that the cannabis industry submit a rescheduling petition of their own, laying out our arguments in Sisley. Receipts.2
The bottom line is that we’re both Gretzky over here. We’re skating where the puck is going to be, not where it has been. We’ve been doing so for years. Indeed, as discussed below, we recently published on the next shoe to drop on marijuana rescheduling: the Single Convention.3
To those in the industry that want to be ahead of the curve—and not behind—hire someone that actually knows. Spending money up front on subject matter experts can save you and your company millions on the backend. As the rest of this post will explain, there are ways rescheduling could go south, or at minimum, be delayed by months to years. And there are ways to head those possibilities off or minimize impact. There’s a reason pharma companies spend millions on lawyers proactively planning and maneuvering to eek out additional weeks of drug exclusivity: $$$.
Reactions to Reactions
Before I get to that meat of the article, I want to throw some bombs and take on a few misunderstandings I’ve come across, starting with the predictable “not enough” reaction from the social justice wing.
1.
The Drug Policy Alliance, put out the following statement:
In 2021, President Biden promised to “decriminalize the use of cannabis and automatically expunge all prior cannabis use convictions,” as well as eliminate mandatory minimums for all drug convictions…
Unfortunately, rescheduling marijuana to Schedule III would allow the failures of criminalization to continue. State medical and adult-use marijuana programs will still remain federally illegal, meaning patients, consumers, and workers would remain subject to federal arrest; noncitizens would remain subject to deportation simply for possessing marijuana or working in the industry; and federal marijuana arrests and prosecutions will continue, previous arrests will not be expunged, and thousands will remain incarcerated in federal prison for marijuana violations. It also means that federal benefits, such as housing and nutritional assistance, will still be denied to certain people with previous marijuana convictions and the federal government will continue to be unable to foster a fair business environment that allows small and minority-owned marijuana businesses to compete with large corporate marijuana operators.
While we appreciate the historic nature of today’s announcement, rescheduling falls woefully short of President Biden’s promise and the relief our communities need today. We call on President Biden to actively work with Congress to pass comprehensive legislation such as the Cannabis Administration and Opportunity Act (CAOA) (S.4591) that ends federal marijuana criminalization and repairs the harms caused by decades of racist enforcement of marijuana laws. Additionally, even while marijuana remains in Schedule I the President and his administrative agencies should work with advocates and those who have been directly impacted by marijuana criminalization to limit the harms of marijuana criminalization. These incremental actions could provide meaningful reform to those who have suffered the most under decades of racially discriminatory and class-based enforcement of marijuana criminalization.
The president of the Minority Cannabis Business Administration stated:
We have patiently waited for the Biden Administration to act on their word and it’s time to move past half-measures and towards genuine reform that will impact individuals, not just business owners. We urge President Biden to align his policy with the majority of Americans who favor legalization and move to create opportunities for people of color who have been disproportionately targeted by criminalization to start and succeed in the emerging legal cannabis industry
Here’s more:
Rescheduling would not allow legal access to state-authorized medical marijuana programs. It could, however, lead to marijuana products being prohibited as unapproved drugs by the Food and Drug Administration (FDA).
And:
A super-majority of Americans, including majorities of Democrats, Republicans, and independents, support ending the federal criminalization of marijuana, which would not be accomplished under rescheduling, as Schedule 3 maintains federal criminal penalties for mere possession, including against those in compliance with state adult-use and medical cannabis laws. In order for President Biden to truly fulfill his campaign promise to decriminalize marijuana, it must be removed from the CSA entirely
I have several differences with the views stated above.
First, 280E is, at its core, a supreme equity destabilizer. So, while it is undeniably true that moving marijuana to Schedule III benefits marijuana businesses—perhaps it may save them from bankruptcy if it happens in time—that benefit also inures to all business owners, including minority business owners, as well as consumers.
Arguing something good shouldn’t happen just because it benefits big business, perhaps more so than consumers, doesn’t resonate with me. Policies or legal maneuvering that benefits Big Pharma doesn’t bother me; what bothers me are policies or maneuvers that enriches Big Pharma at the expense of the consumer. See Xyrem. Removing 280E penalties on marijuana trafficking benefits most everyone that touches the marijuana industry. And that is pro-equity.
Second, the view that rescheduling could “lead to marijuana products being prohibited as unapproved drugs by [FDA]” remains incoherent nonsense in my view. Today, as a Schedule I substance, marijuana products sold as drugs are prohibited as unapproved drugs when introduced into interstate commerce. As a legal matter, rescheduling therefore does not lead to anything. There is no objectively reasonable legal analysis by which one can truthfully conclude that rescheduling leads to marijuana being prohibited as unapproved drugs.
Now, rescheduling could plausibly lead to the mode of enforcing federal law changing. If marijuana moves from Schedule I to III, maybe enforcement shifts from prohibition under the CSA to prohibition under the FDCA. To me, that doesn’t seem likely: the FDA doesn’t have a fraction of the resources it would need to shut down state-legal markets. And there are maybe ways around this, such as operating purely intrastate, as I explain here.4
Marijuana, when sold as a drug, is unapproved today because no marijuana company has done the work to obtain FDA approval, not because of rescheduling.
Third, these social justice views above seem to express an overall sentiment that President Biden has not done enough and should be doing more—and doing something he most likely can’t do on his own.
Importantly, as I discuss more below, my view is that the President and the agencies he supervises can’t just de-schedule marijuana—or at least not without significant friction and vulnerability—because the CSA has a statutory provision that requires marijuana be somewhere on the schedules. Even moving marijuana to Schedule III requires some legal magic.
A full-out descheduling that totally bucks judicial and agency precedent and ignores treaty obligations wholesale is highly, highly vulnerable to judicial challenge from a prohibition crowd objector and risks the baby being thrown out with the bathwater. At minimum, some cantankerous interested person with Article III and APA standing could plausibly hold this up for months with a stay from a sympathetic appeals court. Why? Because (1) when agencies break new ground, they have to provide reasoned decisionmaking and (2) as recently as five years ago, DEA—the agency with the final word—took the position that treaties matter and preclude descheduling. This has been the agency position since the beginning of the CSA. Explaining descheduling against this backdrop isn’t impossible but is much harder and more vulnerable than rescheduling.
So while I again applaud the Governor Polis’s letter, to navigate these obstacles, it isn’t as simple as stating “There is also no reason why international treaties should be an obstacle to scheduling reform.” Actually, there are really excellent reasons why international treaties are an obstacle to scheduling reform—unless one accepts our law review article.
And that leads me to my final, biggest, and harshest criticism. Even though the President runs the Executive Branch, the above organizations are in a better position to create the change they want to see. President Biden runs the federal government and DOJ. That means he can set enforcement priorities, but he can’t strike down laws he and his Attorney General don’t like but are charged with enforcing. For better or worse, while the Executive Branch has great latitude, it enforces laws as they are currently written.
The President also cannot pass legislation without Congress. Stating that President Biden has fallen short of campaign promises that requires congressional cooperation (i.e., passing comprehensive legislation to legalize and regulate marijuana) glosses over the fact that there aren’t the votes—whether or not the President supported legislation. Congress hasn’t even passed SAFE Banking. True, President Biden promised to decriminalize marijuana use and hasn’t; maybe that is a promise he shouldn’t have made, likely because he can’t. But he has done the next best things. Whatever you want to say about this President’s drug policies—and going back in time, he has a fairly strong pro-drug war past—despite that track record, he has done more for marijuana reform than any President in history.
In contrast, advocacy organizations can do something about bad laws. When I went to law school, we learned about groups like the NAACP, ACLU, Southern Poverty Law Center, and so on fighting manifest injustice in the courts with coherent litigation strategies. So, too, with other interest groups and lobbies like the NRA and PhRMA. These days, in the cannabis industry, I see non-profits multiplying like flies, companies flailing, and nothing except white papers and political action committees to show for it. The group doing the most to end the Drug War right now in my view? Maybe the libertarian Institute For Justice that has a concrete platform against civil forfeiture and qualified immunity—and is fighting around the country to end these injustices.
So, I agree with many of the underlying sentiments of this crowd. The marijuana reform movement has not adequately addressed repealing harms caused by the War on Drugs. For that reason, I’ve called it a failure. But I’m not so sure opposing rescheduling is a productive way to air this grievance. The white paper has never been an effective weapon of civil rights movements, and in my view, organizations serious about decriminalizing the use of cannabis federally and ending some of the more pernicious practices of the War on Drugs should focus resources in other ways.
Okay, next.
2.
Rolling Stone asks, “If it were rescheduled, weed would be in the same category as some types of Tylenol — does that mean I could pick it up at my local pharmacy?”
The response offered by Rolling Stone:
Yes, actually! It’s likely that this move could mean weed would be made available at a drugstore near you in the not-too-distant future. “If the proposal to move to Schedule III were to be fully adopted, there would be a path where, after FDA research, cannabis could be sold through pharmacies,” Vicente says. Right now, of course, that’s not the case — it’s currently sold only through licensed dispensaries. And that reality is a ways away, he adds. “I think we’re talking years for the FDA to study this product and to get it, essentially, behind the counter at Walgreens.”
Correct response: No, certainly not. There are several misconceptions with the above.
First, there is little relation between whether a substance is available for sale through pharmacies and what CSA schedule that drug is in. Take, for example, lysergic acid and ergine, which have been classified as a Schedule III hallucinogen and psychedelic substances since 1970. Can you buy LSA at any pharmacy? No.
The real determiner is FDA-approval, which automatically triggers rescheduling by law. In other words, if a marijuana-drug is approved by FDA, that drug is automatically rescheduled and (usually) available for sale through pharmacies.
Second, as we’ve noted many times here, the main difficulty with obtaining FDA approval for a marijuana-based medicine is economics, not CSA scheduling status. Companies in the marijuana industry aren’t putting up the money to do FDA clinical trials, and perhaps reasonably so considering the illicit market and how easy it is to grow marijuana. The pharma-IP case for marijuana is thinner.
Nothing about a Schedule III classification provides additional money for marijuana research—except the fact that marijuana companies may be flush with more cash to spend on R&D. Also, psilocybin and other psychedelics are in Schedule I, but plenty of capital has been raised. So, color me skeptical that rescheduling will “expand potential for research in the sector.” There’s plenty of research in the psychedelic sector, and many psychedelics are Schedule I substances.
Third, a little birdie tells me that the FDA is blocking clinical trials designed to evaluate smoked and vaped marijuana, which is the preferred administration methods of many medical marijuana patients. Quite obviously, rescheduling does little to change FDA’s mind on this topic. And since consumers often prefer inhalation, any approved product that doesn’t capture this market share could fall far short of capturing enough revenue to be worthwhile in the end.
Fourth, as Shane expertly noted here, the recently enacted Medical Marijuana and Cannabidiol Research Act rewrote the CSA to prevent the easing of research restrictions that would have resulted with rescheduling. Moreover, as I discuss below, nobody seems to be discussing the “Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana”—rules we unsuccessfully challenged in 2021-2022 (again, like most of what we do in court, no industry support) precisely because we foresaw where this puck was heading; i.e., these rules could present a problem years later if rescheduling occurred and potentially result in DEA retrenchment.
Anyone spit-balling about whether rescheduling is going to result in marijuana being sold at pharmacies ought to first read these regulations. Did you know, in § 1318.02 for example, that DEA defined “medicinal cannabis” to mean “a drug product made from the cannabis plant, or derivatives thereof, that can be legally marketed under the Federal Food, Drug, and Cosmetic Act”?
In sum, rescheduling actually does shockingly little to facilitate research or FDA-approval.
3.
Claim: “The U.S. attorney general now has 90 days from receiving this recommendation to issue a ruling.”
Reaction? Nah. Although 21 U.S.C. § 811(j)(1) puts a 30-day clock when it comes to HHS recommendations related to New Drug Applications approvals (thanks to the Improving Regulatory Transparency Act, another issue we are very familiar with). But of course, marijuana isn’t an approved new drug.
Did there need to be an HHS Review?
Perhaps the biggest myth of all: the role of HHS.
Again, I welcome a Schedule III recommendation from HHS. As we’ve formally advocated for years, per the plain meaning of the CSA, marijuana does not belong in Schedule I because it has a “currently accepted medical use in treatment in the United States” based solely the existence current state medical marijuana programs. Having HHS aboard with that conclusion moves us closer to a correct legal result and more sense in the way the CSA is carried out.
But the dirty little secret is that there didn’t need to be HHS review. At least not based on the way DEA currently reads the CSA as recently as five-years ago.
The reason for that rests on 21 U.S.C. § 811(d)(1), a “carve-out” for international treaties:
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.
Yeah, we read that too. Pretty closely, because in this law review article, we argue that this section of the CSA is unconstitutional based on an arcane doctrine known as the private non-delegation doctrine. That article drew on an argument in the Sisley brief. We made that argument precisely because DEA has, in the past, argued that 21 U.S.C. 811(d)(1) is binding and requires marijuana be placed in Schedules I or II. We wanted Schedule III.
You read that right. DEA does not agree with us. No surprise there. It thinks 21 U.S.C. § 811(d)(1) is binding. And not just once or long ago. As recently as several months ago, DEA placed Brorphine by way of a final order. Here is what it said when it did that:
Therefore, consistent with 21 U.S.C. 811(d)(1), DEA concludes that brorphine has no currently accepted medical use in treatment in the United States [] and is most appropriately placed in schedule I of the CSA, the same schedule in which it currently resides. Because control is required under the Single Convention, DEA will not be initiating regular rulemaking proceedings to schedule brorphine pursuant to 21 U.S.C. 811(a).
Or consider the most recent DEA marijuana rescheduling petition denial from 2016. Here is what the agency said there:
As the Controlled Substances Act (CSA) recognizes, the United States is a party to the Single Convention on Narcotic Drugs, 1961 (referred to here as the Single Convention or the treaty). 21 U.S.C. 801(7). Parties to the Single Convention are obligated to maintain various control provisions related to the drugs that are covered by the treaty. Many of the provisions of the CSA were enacted by Congress for the specific purpose of ensuring U.S. compliance with the treaty. Among these is a scheduling provision, 21 U.S.C. 811(d)(1). Section 811(d)(1) provides that, where a drug is subject to control under the Single Convention, the DEA Administrator (by delegation from the Attorney General) must “issue an order controlling such drug under the schedule he deems most appropriate to carry out such [treaty] obligations, without regard to the findings required by [21 U.S.C. 811(a) or 812(b)] and without regard to the procedures prescribed by [21 U.S.C. 811(a) and (b)].”
…
As indicated, where section 811(d)(1) applies to a drug that is the subject of a rescheduling petition, the DEA Administrator must issue an order controlling the drug under the schedule he deems most appropriate to carry out United States obligations under the Single Convention, without regard to the findings required by sections 811(a) or 812(b) and without regard to the procedures prescribed by sections 811(a) and (b). Thus, since the only determinative issue in evaluating the present scheduling petition is whether marijuana has a currently accepted medical use in treatment in the United States, DEA need not consider the findings of sections 811(a) or 812(b) that have no bearing on that determination, and DEA likewise need not follow the procedures prescribed by sections 811(a) and (b) with respect to such irrelevant findings. Specifically, DEA need not evaluate the relative abuse potential of marijuana or the relative extent to which abuse of marijuana may lead to physical or psychological dependence.
In the normal course, while the eight-factor analysis in the scheduling/rescheduling process and an ultimate scheduling recommendation is handled both by HHS and DEA, the carve-out is managed by DEA alone. That means (1) the (undisclosed) HHS recommendation may not say anything about treaty compliance and (2) despite a Schedule III recommendation, DEA could legally conclude that marijuana should be in Schedule II because of its analysis of the treaty.
And it wouldn’t be illogical. Under the CSA, compliance with international treaties simply isn’t something HHS is tasked with considering. Because marijuana is subject to the Single Convention, according to DEA’s position, DEA could have rescheduled marijuana without consulting HHS. Does DEA need to run through the statutory process, including a public comment period? According to what it has said in the past, actually, no.
Don’t believe me? Let’s hit the Federal Register again. This is exactly what DEA said in September 2018 with the Epidiolex rescheduling.
It bears emphasis that where, as here, control of a drug is required by the Single Convention, the DEA Administrator ‘‘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 [21 U.S.C. 811 (a) or 812(b)] and without regard to the procedures prescribed by [21 U.S.C. 811 (a) or (b)].’’ 21 U.S.C. 811(d)(1) (emphasis added). Thus, in such circumstances, the Administrator is not obligated to request a medical and scientific evaluation or scheduling recommendation from the Department of Health and Human Services (HHS) (as is normally done pursuant to section 811(b))
Indeed, DEA was adamant. If you look in the third column above you see that DEA even states that the carve-out overrides the Administrative Procedure Act.
If this is correct, DEA, according to DEA, could have rescheduled marijuana last week; nobody needed to consult HHS; and there doesn’t need to be a public rulemaking docket opened or comment period. DEA could just issue an “order” moving marijuana from Schedule I to III.
The NORML Petition and Treaty Trial
As is often the case with DEA interpretations, there are other ways of reading the Controlled Substances Act. And, perhaps not surprisingly, the way DEA reads the CSA above isn’t consistent with what another authority said on the matter.
In the early 1970s, NORML petitioned DEA to “decontrol marijuana” or “place it in Schedule V.” As documents I obtained from the Nixon Presidential Library show (in our Library), that put DEA’s predecessor drug-control agency “in the middle of a serious predicament”:
DEA’s predecessor denied the petition on grounds that the “regular scheduling provisions” are not applicable in the case of substances controlled by treaties:
That decision caused a kerfuffle within the Nixon Administrations and “considerable displeasure of over the matter.” Nobody could figure out what to do:
BNDD (the predecessor to DEA) then peremptorily refused the petition citing 811(d), culminating in a case called “NORML I.” In that case, the D.C. Circuit rejected BNDD’s move, stating that BNDD hadn’t provided “reasoned decision-making” and urged “a new look and a hard look at the questions raised by the petition.”
BNDD then reorganizes as DEA. DEA takes a harder look. In fact, it actually held a public hearing to determine the regulatory controls necessary to satisfy the Single Convention. NORML called two witnesses who were experts on the Single Convention. DEA called two chemists and its Chief Counsel.5
Following the hearing, the ALJ issues a recommendation and concludes:
The US is not required by any treaty, convention, or protocol to control cannabis seeds or artificial cannabis (i.e., synthetic THC)
The US is required by the Single Convention to control cannabis, cannabis resin, and cannabis leaves
US treaty obligations can be satisfied if cannabis and cannabis resin are placed in Schedule II of the CSA and if cannabis leaves are placed in Schedule V
The ALJ then recommended the DEA Administrator seek a medical evaluation from HEW, the predecessor to HHS, and in a footnote importantly adds:
This phrase is included to make it clear that the Secretary, while he might recommend it, could not bind the Attorney General to place cannabis and cannabis resin la Schedules III-V or decontrol cannabis leaves since such action would violate the United States' treaty obligations
DEA denied the petition. The DEA Administrator agreed that the Single Convention required control of cannabis and that the mechanisms of Schedule I and II were sufficient. That discussion then gives way to the role of HHS:
The Acting Administrator uses the phrase "appears to recommend" because under Judge Parker's total recommendation on the Secretary of HEW is not really to be permitted to make the medical and scientific evaluation contemplated by Section 201(b). As the footnote to the recommendation shows, the Secretary is to make an evaluation limited by legal interpretations of an international treaty. This situation demonstrates the problem which faced the Congress on the subject of drugs which are controlled by domestic law and international agreement.
(Again, I pause and again highly recommend reading the article Shane and I published on the unconstitutionality of Section 811(d)(1). We foresaw this years ago. The issue is obviously extremely relevant to the present moment and the entire cannabis industry.)
The Acting Administrator then explained that when international treaty obligations came into play, and that Congress decided to place in the Attorney General “the ability to resolve the mixed questions of law and science and medicine.” And in the findings section, he remarks:
The United States Department of State interprets the Single Convention to require U.S. control of the flowering or fruiting tops of the cannabis plant and cannabis resin in Schedule I or Schedule II of the Act. The Department further interprets the Single Convention to require U.S. control of the leaves of the plant and it questions whether it is practical to apply one level of control to the leaves alone and another level of control when other parts of the cannabis plant are mixed with the leaves…
In short, Congress intended (and must have believed) that the Act and the treaty would be consistent…. [and that] there is no latitude to decontrol any part of the cannabis plant.
That decision gives rise to NORML II. The NORML II court gets into the weeds of the procedural obligations. In a 2-1 decision, the court reads Section 811(d)(1) differently from DEA’s Acting Administrator: “Congress never intended to allow the Attorney General to displace the Secretary whenever any international obligations attach to a particular drug.”
The proper procedure, according to the NORML II court,
directs the Attorney General, as an initial matter, to make a legal judgment as to controls necessitated by international commitments. He then establishes a minimum schedule or level of control below which placement of the substance may not fall. Determination of a minimum schedule ensures that the Secretary's recommendation, which ordinarily would be binding as to medical and scientific findings, does not cause a substance to be scheduled in violation of treaty obligations. However, once that minimum schedule is established by the Attorney General, the decision whether to impose controls more restrictive than required by treaty implicates the same medical and scientific considerations as do scheduling decisions regarding those few substances not controlled by treaty.
Even under Section 811(d)(1), only a formal referral and hearing would be consistent with the CSA’s rulemaking procedures:
According to the procedures set out in Section 201(a)-(c) of the CSA, the Acting Administrator should first have referred the rescheduling petition to HEW for its binding scientific and medical evaluations and recommendations. Those recommendations would have set the upper limits of the Acting Administrator's discretion to reschedule. The issue could then have been fully litigated at a DEA rulemaking hearing. At that point in the proceedings the Acting Administrator would have been in a far better position to make an informed determination. The Acting Administrator's determination in this case was not made in conformity with Section 201(a)-(c).
That brings me to two bigger picture points.
First, many say DEA should just ignore the treaty. This position is ahistorical. And, more important, it is not on solid legal footing whatsoever. This issue was litigated. DEA took a position that the treaty cannot be ignored that has been endorsed by the courts. And DEA maintains that position. Consistently. But as I next explain, with rescheduling (not descheduling), this position can be worked around.
Second, this is procedurally very complex and we’re potentially not that far along. Today, the baton is with DEA. It is doing its own analysis. If we go by what the Court stated in NORML II court, Administrator Milgram will recommend something. No matter the recommendation, the issue may be litigated before the agency if an interested party with standing requests a formal DEA rulemaking hearing. BTW: I’m one of the very few folks who has done one of these. There is plenty of runway left.
Rube Goldberg Epidiolex Treaty Magic
Now, fast forward to today. Let’s return to the 2016 Notice and the following passage, which cites the NORML II case:
It has been established in prior marijuana rescheduling proceedings that placement of marijuana in either schedule I or schedule II of the CSA is “necessary as well as sufficient to satisfy our international obligations” under the Single Convention. NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977).
In other words, as of 2016, DEA took the position that “placement of marijuana in either schedule I or schedule II of the CSA” is required.
Note, however, that DEA’s quotation is extremely misleading. What the court in fact stated in NORML II is that
The parties further agree that, without imposition of additional restrictions on lower schedules, CSA Schedule II is necessary as well as sufficient to satisfy our international obligations
There is, of course, a wild difference between parties stipulating to a proposition and a court establishing one. Moreover, DEA’s omission “without imposition of additional restrictions on lower schedules” is a pretty material one.
Fortunately, today in 2023, there is clearly another way. And we can thank On Drugs favorite pharma company, Jazz Pharma, and its cannabis-derivative drug Epidiolex for this treaty magic.
As noted above, in September 2018, shortly after the FDA approval Epidiolex, DEA issued a final order rescheduling Epidiolex. As that final order explains, DEA had to remove Epidiolex from Schedule I because it had been approved by the FDA. That established a “currently accepted medical use in treatment in the United States for purposes of the CSA,” which disqualified placement in Schedule I. Because Epidiolex is a marijuana derivative, according to the 2016 analysis, that makes rescheduling an easy call. If it isn’t Schedule I, it has to be Schedule II.
But of course, Epidiolex never ended up in Schedule II. And here is how DEA finagled that.
For starters, the Epidiolex rescheduling rule makes a huge fuss about treaties and DEA’s obligations thereunder. DEA even busts out some ridiculous discussion about the Supremacy Clause, noting that 21 U.S.C. 811(d)(1) “is consistent with the Supremacy Clause of the U.S. Constitution (art. VI, sec. 2), which provides that all treaties made under the authority of the United States ‘‘shall be the supreme Law of the Land.’” The next sentence is dirtier: “In accordance with this constitutional mandate, to ensure that compliance by the United States with our nation’s obligations under the Single Convention is given top consideration when it comes to scheduling determinations.”
Top consideration, eh? If that were the end of the story, one would expect the purported HHS Schedule III recommendation for marijuana to be in jeopardy. Not so.
First, DEA noted that “[p]arties to the Single Convention are required to impose a number of control measures with regard to drugs listed in Schedule I of the Convention.” For example, parties must limit “exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of such drugs.” As it happens, “many of the CSA’s provisions directly implement the foregoing treaty requirements.” So, by including a drug under the Single Convention under any schedule, most of these Single Control controls are satisfied.
Put another way, the U.S. would be in non-compliance with treaties if it removed a Single Convention drug entirely. But by merely including a drug on any schedule—including Schedule V—most treaty obligations are satisfied.
[Again, let me drive a legal point home. The President is getting criticized by many for not de-scheduling marijuana. But as recently as Fall 2018, DEA concluded that it is not possible for it to administratively deschedule a drug under the CSA. Whether that conclusion is legally correct is up for debate. But one can be certain that if DEA contradicted itself less than five years later, it could very likely find itself in court in litigation brought by an anti-marijuana org. It is entirely reasonable, in my view, for the Administration to head-off this type of challenge by not pushing for de-scheduling.]
Second, back to the Epidiolex rescheduling, while many of the above requirements are satisfied by control under any schedule, some requirements require a Schedule I / II placement. The Single Convention’s quota requirement, for example, can only be satisfied with a Schedule I or II CSA placement. Here is a reproduction of a chart I made for our opening brief in AIMS I:
Third, is the magic. Although DEA insisted it was not bound by the HHS recommendation with Epidiolex, it asked for the HHS recommendation anyway. HHS had concluded that Epidiolex had a very low potential for abuse and, therefore, recommended that, if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in schedule V of the CSA. And that is what DEA did. The DEA Administrator, exercised his discretion to “choose the option that most closely aligns to the HHS recommendation” and chose Schedule V.
But how? The Administrator noted that Schedule V would result in treaty non-compliance under the Section 811(d)(1) carve-out:
As noted, this order placing the Epidiolex formulation in schedule V will only comport with section 811(d)(1) if all importations and exportations of the drug remain subject to the permit requirement. Until now, since the Epidiolex formulation had been a schedule I controlled substance, the importation of the drug from its foreign production facility has always been subject to the permit requirement. To ensure this requirement remains in place (and thus to prevent any lapse in compliance with the requirements of the Single Convention), this order will amend the DEA regulations (21 CFR 1312.30) to add the Epidiolex formulation to the list of nonnarcotic schedule III through V controlled substances that are subject to the import and export permit requirement.
That’s the magic fix.
When a drug falls in the carve-out, DEA can place it in whatever schedule matches the HHS recommendation and still comply with treaties by going back and amend DEA regulations to add back whatever requirements from more restrictive schedules are needed to comply with the treaty.
Of course, that methodology defeats the purpose of having a “uniform” scheduling regime. But then again, did you think the schedules actually made sense and weren’t arbitrary?6