(Slip Opinion)

1

Questions Related to the Potential Rescheduling of Marijuana

The approach that the Drug Enforcement Administration currently uses to determine 

whether a drug has a “currently accepted medical use in treatment in the United 

States” under the Controlled Substances Act is impermissibly narrow. An alternative, 

two-part inquiry proposed by the Department of Health and Human Services is sufficient to establish that a drug has a “currently accepted medical use” even if the drug 

would not satisfy DEA’s current approach.

Under 21 U.S.C. § 811(b), a recommendation by HHS that a drug has or lacks a “currently acceptable medical use” does not bind DEA. In contrast, the scientific and medical 

determinations that underlie HHS’s “currently acceptable medical use” recommendation are binding on DEA, but only until the initiation of formal rulemaking proceedings to schedule a drug. Once DEA initiates a formal rulemaking, HHS’s determinations no longer bind DEA, but DEA must continue to accord HHS’s scientific and 

medical determinations significant deference, and the CSA does not allow DEA to 

undertake a de novo assessment of HHS’s findings at any point in the process.

Neither the Single Convention on Narcotic Drugs nor the CSA requires marijuana to be 

placed into Schedule I or II of the CSA. Both the Single Convention and the CSA allow DEA to satisfy the United States’ international obligations by supplementing 

scheduling decisions with regulatory action, at least in circumstances where there is a 

modest gap between the Convention’s requirements and the specific restrictions that 

follow from a drug’s placement on a particular schedule. As a result, DEA may satisfy 

the United States’ Single Convention obligations by placing marijuana in Schedule III 

while imposing additional restrictions pursuant to the CSA’s regulatory authorities.

April 11, 2024

MEMORANDUM OPINION FOR THE ATTORNEY GENERAL

The Controlled Substances Act (“CSA”)1 imposes a unified framework 

for controlling drugs and other substances that are found to pose a risk of 

abuse.2 In doing so, it seeks to balance several, often competing, interests. 

These interests include ensuring the availability of drugs that “have a 

1 In 1970, Congress enacted the Comprehensive Drug Abuse Prevention and Control 

Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236, the provisions of which are codified at 

Chapter 13 of Title 21 of the U.S. Code. The Act comprised several titles, including 

Title II, which it called the Controlled Substances Act, and Title III, which it called the 

Controlled Substances Import and Export Act. For ease of reference, we refer to the entire 

1970 law as the CSA.

2 The CSA applies to both drugs and “other substance[s]” that have been controlled. 

See 21 U.S.C. § 802(6). For ease of reference, we use the term “drug” to refer to both.
48 Op. O.L.C. __ (Apr. 11, 2024)

2

useful and legitimate medical purpose and are necessary to maintain the 

health and general welfare of the American people”; preventing the “illegal importation, manufacture, distribution, and possession and improper 

use of controlled substances [that] have a substantial and detrimental 

effect on the health and general welfare of the American people”; and 

ensuring that the United States complies with “international conventions 

designed to establish effective control over international and domestic 

traffic in controlled substances.” 21 U.S.C. § 801(1), (2), (7).

The CSA balances these purposes by placing each drug warranting control into one of five “schedules,” with drugs in Schedule I subject to the 

strictest regulatory and criminal provisions, and drugs in Schedule V 

subject to the least strict. See generally 21 U.S.C. §§ 821–832, 841–865, 

951–971. The CSA further authorizes the Attorney General to add, transfer, and remove drugs from the schedules using formal rulemaking procedures, see id. §§ 811, 812, and otherwise grants the Attorney General 

broad authority to take regulatory action consistent with the Act, see, e.g., 

id. §§ 821, 871(b). The Attorney General has in turn generally delegated

these functions to the Administrator of the Drug Enforcement Administration (“DEA”). 28 C.F.R. § 0.100(b). 

Marijuana has been a Schedule I drug since Congress enacted the CSA. 

See 21 U.S.C. § 812(c). To reschedule marijuana from Schedule I, DEA 

would need to determine, among other things, that the drug has a “currently accepted medical use in treatment in the United States” (“CAMU”). Id.

§ 812(b). Since 1992, however, DEA has determined that a drug has a

CAMU only if either the Food and Drug Administration (“FDA”) has 

approved the drug for marketing in interstate commerce under the Food, 

Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., or the drug 

meets a five-part test that tracks the “core standards developed under the 

FDCA.” 57 Fed. Reg. 10,499, 10,503–04, 10,506 (Mar. 26, 1992). And 

because FDA has not approved marijuana and DEA has determined that 

marijuana does not meet its five-part test, DEA has repeatedly rejected 

petitions to move marijuana to a less restrictive schedule.

On October 6, 2022, President Biden asked the Secretary of Health and 

Human Services (“Secretary”) and the Attorney General to initiate an 

“administrative process to review expeditiously how marijuana is scheduled under federal law.” Statement from President Biden on Marijuana 

Reform (Oct. 6, 2022), https://www.whitehouse.gov/briefing-room/
Questions Related to the Potential Rescheduling of Marijuana

3

statements-releases/2022/10/06/statement-from-president-biden-onmarijuana-reform. The CSA requires the Secretary to provide certain 

recommendations before the initiation of proceedings to schedule or 

reschedule a drug, and the statute provides that the Secretary’s recommendations “shall be binding” as to certain “scientific and medical matters.” 21 U.S.C. § 811(b).

Consistent with this requirement, in 2023, the Department of Health 

and Human Services (“HHS”) recommended that DEA reschedule marijuana to Schedule III. See Letter for Anne Milgram, Administrator, DEA, 

from Rachel L. Levine, M.D., Assistant Secretary for Health, HHS 

(Aug. 29, 2023). HHS concluded that, regardless of whether a drug was 

approved by FDA or satisfied DEA’s five-part test, the drug could have a 

CAMU if it satisfied a new, two-part inquiry. Part 1 of that inquiry asks 

whether licensed health care providers have “widespread current experience with medical use” of the drug “in accordance with implemented 

state-authorized programs, where the medical use is recognized by entities 

that regulate the practice of medicine.” Memorandum for the Commissioner, FDA, from the Assistant Secretary for Health, HHS, Re: Part 1 

Analysis at 1 (July 17, 2023) (“HHS Part 1 Analysis Memo”). If so, Part 2 

of the inquiry asks whether there is “some credible scientific support for 

at least one of the medical uses.” Id. at 2.

Against this backdrop, you have asked us three questions:3

(1) If a drug satisfies the two-part inquiry employed by HHS, does 

that establish a currently accepted medical use under the statute even 

if the drug has not been approved by FDA and even if the drug does 

not satisfy DEA’s five-part test?

(2) To what extent do the “scientific and medical matters” referenced 

in 21 U.S.C. § 811(b), which are binding upon the Attorney General, 

3 This opinion memorializes advice we provided you on February 16, 2024. To aid our 

analysis, we solicited and received written views from HHS and DEA on all three questions and from the State Department on the third question. See Memorandum for the 

Office of Legal Counsel from DEA (Jan. 30, 2024) (“DEA Response”); Memorandum for 

Gillian E. Metzger, Deputy Assistant Attorney General, Office of Legal Counsel, from 

Samuel R. Bagenstos, General Counsel, HHS, Re: OLC’s Request for Views on Issues 

Related to the Scheduling of Marijuana Under the Controlled Substances Act (Jan. 29, 

2024) (“HHS Response”); Single Convention Requirements for Cannabis and Scheduling 

Under the Controlled Substances Act (Feb. 12, 2024) (“State Response”).
48 Op. O.L.C. __ (Apr. 11, 2024)

4

include the Secretary’s evaluation of a drug’s currently accepted 

medical use or any scientific and medical considerations involved in 

that evaluation?

(3) Does the CSA, including the requirement that the Attorney General control drugs “under the schedule he deems most appropriate to 

carry out” the United States’ “obligations under international treaties, conventions, or protocols in effect on October 27, 1970,” id.

§ 811(d)(1), require DEA to place marijuana in either Schedule I or 

Schedule II to comply with the Single Convention on Narcotic 

Drugs, Mar. 30, 1961, 18 U.S.T. 1407 (“Single Convention”)?

As explained in more detail below, we conclude, first, that DEA’s current approach to determining whether a drug has a CAMU is impermissibly narrow, and that satisfying HHS’s two-part inquiry is sufficient to 

establish that a drug has a CAMU even if the drug has not been approved 

by FDA and would not satisfy DEA’s five-part test.

Second, we conclude that HHS’s overall CAMU recommendation is not 

binding on DEA. We also conclude that the scientific and medical determinations that underlie HHS’s CAMU recommendation are binding, but 

only until the initiation of formal rulemaking proceedings. Once DEA 

initiates formal rulemaking, HHS’s determinations no longer bind DEA, 

but DEA must continue to accord HHS’s scientific and medical determinations significant deference, and the CSA does not allow DEA to undertake a de novo assessment of HHS’s findings at any point in the process.

Third, we conclude that neither the Single Convention nor the CSA requires DEA to place marijuana in Schedule I or Schedule II. Both the 

Single Convention and the CSA allow DEA to satisfy the United States’ 

international obligations by supplementing scheduling decisions with 

regulatory action, at least in circumstances where there is a modest gap 

between the Convention’s requirements and the specific controls that 

follow from a drug’s placement on a particular schedule. As a result, we 

conclude that DEA may satisfy the United States’ Single Convention 

obligations by placing marijuana in Schedule III while imposing additional controls pursuant to the CSA’s regulatory authorities. 
Questions Related to the Potential Rescheduling of Marijuana

5

I.

A.

Sections 811 and 812 of the CSA set forth the procedures and standards 

the Attorney General (and thus DEA) must follow to add a drug to a 

schedule, transfer a drug between schedules, or remove a drug from the 

schedules of control. Section 811(a) authorizes the Attorney General to 

add or transfer a drug to, or remove a drug from, a schedule by issuing a 

rule “made on the record after opportunity for a hearing” pursuant to the 

formal rulemaking procedures of the Administrative Procedure Act 

(“APA”), 5 U.S.C. §§ 553(c), 556, 557. In promulgating such rules, the 

Attorney General is required to make particular findings, based on substantial evidence, that correspond to the schedule in which the drug is to 

be placed. 21 U.S.C. §§ 811(a)(1)(A)–(B), 812(b); see also id. § 811(b); 

5 U.S.C. § 556(d). 

Section 812(b) lists the findings the Attorney General must make to 

place a drug in a particular schedule, with the findings varying by 

schedule. For example, the Attorney General may place a drug in 

Schedule I only if the Attorney General finds that the drug “has a high 

potential for abuse,” 21 U.S.C. § 812(b)(1)(A); “has no currently accepted 

medical use in treatment in the United States,” id. § 812(b)(1)(B); and 

“[t]here is a lack of accepted safety for use” of the drug “under medical 

supervision,” id. § 812(b)(1)(C). To place drugs in other schedules, the 

Attorney General must similarly make three findings, except that drugs on 

the other schedules must have a CAMU (or, in the case of Schedule II 

drugs, a CAMU with “severe restrictions”). Id. § 812(b)(2)(B), (b)(3)(B), 

(b)(4)(B), (b)(5)(B). Drugs are to be placed in less restrictive schedules as 

their potential for abuse and likelihood of leading to physiological or 

physical dependence declines. Id. § 812(b)(2)–(5). In the course of 

making these findings, section 811(c) requires the Attorney General to 

consider eight medical, scientific, and law-enforcement factors regarding 

the drug:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.
48 Op. O.L.C. __ (Apr. 11, 2024)

6

(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).

Although section 811 provides that the Attorney General will issue the 

final rule to schedule a drug, see id. § 811(a), the CSA also assigns a 

significant role in scheduling decisions to the Secretary. Section 811(b) 

requires the Attorney General, before initiating a rulemaking proceeding 

to schedule or reschedule a drug, to request both a scientific and medical 

evaluation of the drug from the Secretary and the Secretary’s recommendation as to the schedule, if any, in which the drug should be placed. The 

Secretary’s recommendations “shall be binding on the Attorney General 

as to such scientific and medical matters” and the Attorney General is 

prohibited from controlling a drug if the Secretary recommends that it not 

be controlled. Id. § 811(b). After receiving the views of the Secretary, the 

Attorney General must initiate rulemaking proceedings if there is sufficient evidence to do so. See id.

The legislative history of section 811(b) indicates that its purpose was 

to place scientific and medical judgments in the hands of the Secretary. 

The report of the House Committee on Interstate and Foreign Commerce 

explains that “[c]onsiderable controversy arose” during the drafting process over the scheduling provisions of the bill, in particular “with respect 

to the proper role of the Attorney General and the Secretary of Health, 

Education, and Welfare [(‘HEW’)]4 in making determinations concerning 

which drugs should be controlled.” H.R. Rep. No. 91-1444, at 22 (1970).

4 In 1979, Congress created the Department of Education and changed the name of the 

Department of Health, Education, and Welfare to the Department of Health and Human 

Services. Department of Education Organization Act, Pub. L. No. 96-88, §§ 201, 509, 

93 Stat. 668, 671, 695 (1979).
Questions Related to the Potential Rescheduling of Marijuana

7

This controversy appears to have stemmed from the fact that the version of the CSA that passed the Senate vested full decisionmaking authority regarding scheduling in the Attorney General alone and required only 

that the Attorney General obtain the “advice” of the Secretary in connection with scheduling decisions. S. 3246, 91st Cong. § 201(a) (1970); see 

116 Cong. Rec. 1671, 1672 (1970). During the House’s consideration of 

the bill, Members of Congress, HEW officials, and scientific and medical 

professionals raised concerns over the dominant role the Senate bill assigned to the Attorney General, arguing that scheduling decisions largely 

require scientific and medical expertise and that HEW, not the Department of Justice, had this expertise. See, e.g., Drug Abuse Control Amendments—1970: Hearings Before the Subcomm. on Pub. Health & Welfare 

of the H. Comm. on Interstate & Foreign Commerce, 91st Cong. 102–04, 

194–95, 199, 550, 557, 580–81 (1970) (“House Hearing”).

Reflecting these concerns, the House version of the bill, H.R. 18583, 

91st Cong. (1970), made several changes to what is now 21 U.S.C. 

§ 811(b) that expanded the role of the Secretary and eventually became 

law. The requirement that the Attorney General obtain “advice” was 

changed to an obligation to obtain “recommendations” that bound the 

Attorney General with respect to scientific and medical matters. H.R. 

18583, § 201(b). The House bill also added a requirement that the Secretary give a recommendation regarding the schedule in which the drug 

should be placed and provided that the Attorney General could not control 

a drug that the Secretary recommended not be controlled. Id.

B.

As noted above, Congress classified marijuana as a Schedule I drug 

when it enacted the CSA in 1970. See 21 U.S.C. § 812(c). Shortly thereafter, several organizations petitioned to move marijuana from Schedule I to 

Schedule V. See 37 Fed. Reg. 18,097 (Sept. 7, 1972). The petition was 

denied three times, but each time on review the United States Court of 

Appeals for the District of Columbia Circuit remanded for further analysis. See Nat’l Org. for the Reform of Marijuana Laws v. Ingersoll, 497 

F.2d 654, 661 (D.C. Cir. 1974); Nat’l Org. for the Reform of Marijuana 

Laws v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977) (“NORML II”); Nat’l 

Org. for the Reform of Marijuana Laws v. DEA, No. 79-1660, 1980 U.S. 

App. LEXIS 13099, at *1 (D.C. Cir. Oct. 16, 1980) (per curiam). 
48 Op. O.L.C. __ (Apr. 11, 2024)

8

After the third remand, DEA denied the rescheduling petition once 

more, concluding that marijuana did not have a CAMU. See 54 Fed. Reg. 

53,767, 53,767, 53,783–84 (Dec. 29, 1989). In reaching that conclusion, 

DEA relied on an eight-part test for determining whether a drug had a 

CAMU that included the following three factors: whether the drug was 

generally available; whether its use was generally recognized in various 

medical reference works; and whether its use was recognized by “a substantial segment of the medical practitioners in the United States.” Id. at 

53,783. As before, the petitioners sought review and the D.C. Circuit 

remanded the case to DEA, concluding that these three factors were 

arbitrary and capricious because they would be “logically impossible” for 

drugs in Schedule I to satisfy. All. for Cannabis Therapeutics v. DEA, 930 

F.2d 936, 937, 940 (D.C. Cir. 1991) (“ACT I”). But the court held that 

DEA’s interpretation of the statutory phrase “currently accepted medical 

use” was “in the main acceptable,” and rejected petitioners’ principal 

argument that DEA’s interpretation unreasonably relied upon “the absence of demonstrated scientific evidence that the drug is medically useful 

and safe.” Id. at 937, 939. In particular, the court noted that the petitioners 

had presented only “anecdotal evidence” that “a number of physicians 

believe marijuana is medically useful.” Id. at 939.

On remand a fourth time, DEA again denied the petition, again finding 

that marijuana did not have a CAMU. 57 Fed. Reg. at 10,499. DEA stated 

that a drug would have a CAMU if it had been approved by FDA under its 

“New Drug Application” process or if the drug met the criteria to be 

recognized by FDA as “Generally Recognized As Safe and Effective.” Id.

at 10,503 (citing 21 U.S.C. §§ 321(p), 355). In addition, DEA concluded 

that a drug would have a CAMU if it satisfied a new, five-part test (a 

revised version of DEA’s previous eight-part test that the D.C. Circuit 

considered in ACT I). Id. at 10,504. Under DEA’s new test, a drug has a 

CAMU if the following elements are satisfied:

(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) scientific evidence about the drug is widely available.
Questions Related to the Potential Rescheduling of Marijuana

9

Id. at 10,503–06. All five parts were based on the “core FDCA standards 

for acceptance of drugs for medical use,” and four were expressly derived 

from the FDCA or FDA regulations setting forth requirements that a drug 

must meet before receiving FDA approval. Id. at 10,504–05 (citing 

21 U.S.C. §§ 321(p), (w), 355(d); and 21 C.F.R. §§ 314.103(c)(3), 

314.50(d)(1), 314.125(b), 314.126). DEA concluded that marijuana did 

not meet any of these criteria and accordingly denied the request to remove marijuana from Schedule I. Id. at 10,507–08.

This time the D.C. Circuit upheld DEA’s decision. See All. for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1133 (D.C. Cir. 1994) (“ACT II”).

It rejected the petitioners’ “central claim” that DEA’s order rested on an 

“unreasonable interpretation of the statute.” Id. The court noted that it had 

already concluded in ACT I that DEA’s interpretation of the CSA was 

generally reasonable, and it refused to reconsider that determination. Id. at 

1134. It further reasoned that none of the criteria in DEA’s new five-part 

test were “impossible for a Schedule I drug to meet” and that DEA had 

“corrected the flaws [the court] identified in” ACT I. Id. at 1135. 

Since ACT II, DEA has denied several petitions that sought rescheduling of marijuana after applying its five-part test and concluding that 

marijuana did not have a CAMU. See, e.g., 66 Fed. Reg. 20,038, 20,038 

(Apr. 18, 2001); 76 Fed. Reg. 40,552, 40,552 (July 8, 2011); 81 Fed. Reg. 

53,688, 53,688 (Aug. 12, 2016); 81 Fed. Reg. 53,767, 53,767 (Aug. 12, 

2016). Efforts to challenge these denials in court have proven unsuccessful. See Ams. for Safe Access v. DEA, 706 F.3d 438, 450 (D.C. Cir. 2013); 

Krumm v. DEA, 739 F. App’x 655 (D.C. Cir. 2018). In recent years, 

however, several jurists have raised serious concerns about DEA’s conclusion that marijuana does not have a CAMU. See United States v. 

Green, 222 F. Supp. 3d 267, 275 (W.D.N.Y. 2016); United States v. 

Amalfi, 47 F.4th 114, 125 (2d Cir. 2022); Sisley v. DEA, 11 F.4th 1029, 

1036 (9th Cir. 2021) (Watford, J., concurring). 

C.

Since 1996, 38 States, the District of Columbia, and four federal territories have legalized the use of medical marijuana. See HHS Part 1 Analysis 

Memo at 4. These laws typically allow the cultivation, sale, and use of 

marijuana by patients (or their caregivers) whose health care practitioners 

have recommended that they use marijuana to treat certain, specified 
48 Op. O.L.C. __ (Apr. 11, 2024)

10

conditions. See, e.g., Ohio Rev. Code §§ 3796.01(A)(6)(a)–(v), 

3796.08(A); N.Y. Cannabis Law §§ 3(18), 30, 31; N.M. Stat. 

§§ 26-2B-3(F)(1)–(23), 26-2B-3(N), 26-2B-4(A). Conditions can be added 

to, or removed from, the list of illnesses that may be treated with marijuana, often by (or at the recommendation of) a state’s public health authorities or special boards convened to consider such matters. See, e.g., Conn. 

Gen. Stat. § 21a-408l(a), (c); 410 Ill. Comp. Stat. §§ 130/10(h)(2), 

130/45; Or. Admin. Rule 333-008-0090. In each fiscal year since 2015, 

Congress has also adopted an appropriations rider that prohibits the Department of Justice from using funds to prevent certain states, territories, 

and the District of Columbia from implementing their own laws with 

respect to medical marijuana. E.g., Consolidated Appropriations Act, 

2024, Pub. L. No. 118-42, § 531, 138 Stat. 25; Consolidated Appropriations Act, 2023, Pub. L. No. 117-328, § 531, 136 Stat. 4459, 4561 (2022); 

see Cong. Rsch. Serv., R44782, The Evolution of Marijuana as a Controlled Substance and the Federal-State Policy Gap at 26 & n.159 (updated Apr. 7, 2022) (collecting laws). 

On October 6, 2022, as noted above, President Biden asked the Secretary and the Attorney General to review how marijuana is scheduled under 

federal law. As part of its analysis in response to this request, HHS considered whether DEA’s test for determining if a drug has a CAMU was 

consistent with the text of the CSA. HHS Response at 5–6. HHS agreed 

that if a drug met the requirements for FDA approval or DEA’s five-part 

test, the drug would have a CAMU. Id. at 8. But it concluded that it would 

be inconsistent with the text and purpose of the CSA for those standards 

to be the “sole basis for determining whether a substance has a [CAMU].” 

Id. at 7. 

HHS’s analysis instead relied on an additional, two-part inquiry for 

considering whether a drug has a CAMU. Part 1 of HHS’s inquiry focuses 

on the extent and nature of medical use. It asks whether there is “widespread current experience with medical use of the substance in the United 

States by licensed health care practitioners . . . operating in accordance 

with implemented state-authorized programs, where the medical use is 

recognized by entities that regulate the practice of medicine.” HHS Part 1 

Analysis Memo at 1. HHS further identifies several factors to consider in 

undertaking this analysis, none being dispositive on its own—specifically, 

(1) “[w]hether a substantial number of licensed health care practitioners 
Questions Related to the Potential Rescheduling of Marijuana

11

have gained clinical experience with at least one specific medical use of the 

substance under existing and implemented state-authorized programs,” id. 

at 3; (2) “[w]hether a substantial number of entities that regulate the 

practice of medicine recognize at least one specific medical use of the 

substance,” id.; and (3) “[w]hether licensed health care practitioners’ 

clinical experience with the medical use of the substance is of sufficient 

extent and duration to help evaluate potential clinical uses and longer term 

toxicities and potential harms of the substance when used under medical 

supervision,” id. at 5.

Part 2 of HHS’s test focuses on the scientific basis for any identified 

medical use. It asks whether there is “some credible scientific support for 

at least one medical use of the substance for which Part 1 is met.” Id. at 2. 

According to HHS, although again not dispositive, factors that count in 

favor of the conclusion that some credible scientific support exists include 

(1) whether “favorable clinical studies of the medical use” of the drug, 

although not FDA approval-level studies, “have been published in peerreviewed journals” and (2) whether “[q]ualified expert organizations (e.g., 

academic or professional societies, government agencies) have opined in 

favor of the medical use or provided guidance to practitioners on the 

medical use.” Ctr. for Drug Evaluation & Rsch., FDA, Considerations for 

Whether Marijuana Has a Currently Accepted Medical Use in the United 

States for Purposes of Section 202(b) of the Controlled Substances Act

at 4 (Aug. 28, 2023) (“HHS Part 2 Analysis Memo”). By contrast, factors 

weighing against the conclusion that such credible scientific support 

exists include (1) whether “data or information indicates that medical use 

of the substance poses unacceptably high safety risks for the likely patient 

population, e.g., due to toxicity concerns”; (2) whether “clinical studies 

with negative efficacy findings for the medical use have been published in 

peer reviewed journals”; and (3) whether “qualified expert organizations 

(e.g., academic or professional societies, government agencies) have 

recommended against the medical use of the substance.” Id. at 4–5.

Applying this two-part inquiry, HHS concluded that marijuana has a 

CAMU. Id. It found that Part 1 of its inquiry was satisfied because more 

than 30,000 licensed health care practitioners across 43 jurisdictions are 

authorized to recommend the use of marijuana for more than six million 

registered patients for at least 15 medical conditions. HHS Part 1 Analysis 

Memo at 1. HHS also found that Part 2 of its inquiry was satisfied. See 
48 Op. O.L.C. __ (Apr. 11, 2024)

12

HHS Part 2 Analysis Memo at 7. Although noting that no professional 

medical organization currently recommends use of marijuana (and that 

one recommends against its use), HHS concluded after reviewing several 

studies that there was some credible scientific support that marijuana 

could be used to effectively treat pain, anorexia, and nausea and vomiting 

and that using medical marijuana to treat these conditions did not pose 

“unacceptably high safety risks.” Id. at 7. Consistent with this conclusion, 

and in light of other findings it made, HHS recommended to DEA that 

marijuana be placed in Schedule III of the CSA. 

II.

As discussed above, DEA currently concludes that a drug has a CAMU

only if FDA has approved the drug under the FDCA or the drug meets 

DEA’s five-part test. 57 Fed. Reg. at 10,505–06. HHS agrees with DEA 

that FDA approval and DEA’s five-part test are sufficient to establish that 

a drug has a CAMU, see HHS Response at 8, and we also agree. To 

receive FDA approval, a drug must satisfy “rigorous testing and safety 

reviews” showing that the drug is “both safe and effective.” Sadoz Inc. v. 

Becerra, 57 F.4th 272, 282 (D.C. Cir. 2023). And the entire purpose of 

FDA’s rigorous approval process is to identify drugs that can be safely 

and effectively used to treat medical conditions. See FDA v. Brown & 

Williamson Tobacco Corp., 529 U.S. 120, 133–34 (2000). It would thus 

make no sense to keep a drug that has met—or could meet—FDA’s standards on Schedule I, which would prevent the drug from being used to treat 

medical conditions. See 21 U.S.C. §§ 829, 841–43.

HHS argues, however, that DEA’s approach to CAMU is impermissibly narrow and that HHS’s two-part inquiry is a permissible way to establish that a drug has a CAMU. You have asked whether, if a drug satisfies 

the two-part inquiry employed by HHS, that establishes that the drug has 

a CAMU regardless of whether the drug has been approved by FDA or 

satisfies DEA’s five-part test. For the reasons that follow, we agree with 

HHS and conclude that limiting the CAMU analysis to whether a drug has 

been approved by FDA or meets DEA’s five-part test is an impermissibly 

narrow interpretation of section 812(b) and that satisfying HHS’s two-part 

inquiry is sufficient to establish that a drug has a CAMU.
Questions Related to the Potential Rescheduling of Marijuana

13

A.

Section 812(b) requires the Attorney General (and thus DEA), in making scheduling decisions under the CSA, to determine whether a drug has a 

“currently accepted medical use in treatment in the United States.” It is 

hard to square DEA’s exclusive reliance on FDA approval and its five-part 

test with this language.

To begin, DEA’s approach conflicts with the text of section 812(b) by ignoring a wide range of activity that is plainly relevant to whether a drug meets 

the statutory standard. At the time the CSA was adopted (and as is still true 

today) the word “accepted” meant “widely used or found” or “generally 

approved.” Accepted, Webster’s Third New International Dictionary 11 

(1971); see also Accepted, The American Heritage Dictionary of the English 

Language 8 (1970) (“Generally approved, believed, or recognized.”); Accepted, Merriam-Webster.com, https://www.merriam-webster.com/dictionary/

accepted (last visited Apr. 2, 2024) (defining “accepted” to mean “regarded favorably” or “generally approved or used”). And the focus on “medical use” suggests that the relevant inquiry is whether the medical community has accepted that a drug has a “use in treatment.” 21 U.S.C. 

§ 812(b)(1)(B).

Any examination of whether the medical community “accept[s]” that a 

drug has a “use in treatment,” id., naturally requires an examination of 

what licensed health care practitioners are actually doing. Practitioners 

treat patients, after all, and their treatment decisions and clinical experience with a drug (where such experience exists) provide important evidence in determining whether a medical use is accepted. Moreover, an 

understanding of what the medical community accepts would also naturally require consideration of the views of the principal regulators of the 

medical profession: state entities that license and police healthcare practitioners. As the Supreme Court has noted, the CSA “presume[s] and 

rel[ies] upon a functioning medical profession regulated under the States’ 

police powers.” Gonzales v. Oregon, 546 U.S. 243, 270 (2006).

But neither FDA approval nor DEA’s five-part test examines whether 

health care practitioners are actually using a drug to treat a condition or 

whether the entities regulating those practitioners allow the drug to be so 

used. Instead, FDA approval and DEA’s five-part test rely exclusively on 

certain scientific evidence and the views of some experts and FDA. Simp-
48 Op. O.L.C. __ (Apr. 11, 2024)

14

ly put, ignoring widespread clinical experience with a drug that is sanctioned by state medical licensing regulators when evaluating whether a 

drug has a CAMU is at odds with the plain meaning of section 812(b).5

Limiting the CAMU analysis to whether a drug has been approved by 

FDA or meets DEA’s five-part test also conflicts with the text of section 

812(b) by erroneously equating identification of an “accepted” medical 

use under the CSA with the “approval,” or potential approvability, of the 

drug under the FDCA. Under the CSA, a substance can only be placed on 

Schedule I if it lacks both a “currently accepted medical use in treatment 

in the United States” and an “accepted safety for use . . . under medical 

supervision.” 21 U.S.C. § 812(b)(1)(B), (C). By contrast, “the FDCA does 

not even mention the term ‘medical use,’” Grinspoon v. DEA, 828 F.2d 

881, 887 (1st Cir. 1987), and under the FDCA approval can be denied 

either because the drug is unsafe or because it is ineffective, see 21 U.S.C. 

§ 355(d)(2), (5). FDA may also deny approval for several other reasons 

that have nothing to do with medical use, including that the application did 

not contain the necessary patent information, see id. § 355(d)(6), or that 

the methods used to manufacture, process, and pack the drug “are inadequate to preserve its identity, strength, quality, and purity,” id. § 355(d)(3).

Moreover, other CSA provisions confirm that a drug having a CAMU is 

distinct from it being approved (or approvable) by FDA. Among other 

things, the CSA elsewhere repeatedly refers to, and in some places explicitly relies on, the FDCA. As an example, 21 U.S.C. § 829 prohibits the 

dispensing of “prescription drug[s] as determined under the [FDCA]” that 

are controlled under Schedules II through IV without a prescription from a 

practitioner, subject to certain exceptions. See also, e.g., id. §§ 811(g)(1), 

825(e). Congress’s decision to explicitly invoke the FDCA’s standards 

with respect to some parts of the CSA, but not with respect to whether a 

drug has a CAMU, strongly suggests that it did not mean to equate CAMU

with the standards necessary for FDA approval.

5 The First Circuit’s decision in Grinspoon v. DEA, 828 F.2d 881 (1st Cir. 1987), is not 

to the contrary. Grinspoon rejected the argument that Congress meant to privilege the 

views of “certain members of the medical community” in determining if a drug has a

CAMU. Id. at 892. The court did not consider, however, the broader understanding of the 

relevant inquiry that we offer here—i.e., whether the medical community as a whole, 

including practitioners and regulators (among others), has “accepted” that a drug has a 

“medical use in treatment.” 21 U.S.C. § 812(b)(1)(B). 
Questions Related to the Potential Rescheduling of Marijuana

15

Amendments to the CSA reinforce this conclusion. Congress added the 

“emergency scheduling” provision to the CSA in 1984. Pub. L. No. 

98-473, § 508, 98 Stat. 1837, 2071–72 (1984) (codified as amended 

at 21 U.S.C. § 811(h)). That provision allows the Attorney General to 

place certain substances in Schedule I on a temporary basis without following the normal scheduling criteria if “necessary to avoid an imminent 

hazard to the public safety.” 21 U.S.C. § 811(h). But this authority does 

not apply where an “exemption or approval is in effect for the [drug] 

under section 505” of the FDCA—i.e., where FDA allows the drug to be 

marketed in interstate commerce. See id.; see also Controlled Substances 

Analogue Enforcement Act of 1986, Pub. L. No. 99-570, tit. I, subtit. E, 

100 Stat. 3207, 3207-13 to -14 (codified as amended at 21 U.S.C. 

§ 801(32)) (exempting drugs that have been approved by FDA from the 

definition of controlled substance analogue). As the First Circuit has 

observed, these provisions demonstrate that “absolute reliance on the 

absence of FDA approval” outside of these limited contexts “would be 

inappropriate and, indeed, contrary to the intent of Congress in enacting 

the CSA.” Grinspoon, 828 F.2d at 890.

We recognize that our conclusion that DEA cannot rely exclusively on 

FDA approval or its five-part test in determining whether a drug has a 

CAMU is in some tension with the D.C. Circuit’s decisions in ACT I and 

ACT II. The record in those cases, however, was materially different from 

the one contemplated by HHS’s two-part inquiry: the petitioners in ACT I

and ACT II had shown that, at most, a “number of physicians believe[d] 

that marijuana is medically useful”—evidence that the court twice said 

was “anecdotal.” ACT I, 930 F.2d at 939; see also id. (describing petitioner’s evidence as “largely anecdotal”). Indeed, although the court noted 

that it “ha[d] no grounds” on the record before it “to dispute [DEA’s] 

premise that without much more complete scientific data American physicians will not ‘accept’ marijuana,” it further observed that DEA’s conclusion would be “more vulnerable” if “virtually all doctors in the United 

States were vociferous in their espousal of marijuana for medical treatment—notwithstanding scientific uncertainties.” Id.; see also ACT II, 

15 F.3d at 1134–35 (holding that DEA’s interpretation of “currently 

accepted medical use” was reasonable on law of the case grounds). 

In other words, neither ACT I nor ACT II assessed DEA’s approach in 

the circumstance envisioned by HHS’s two-part inquiry—where there is 
48 Op. O.L.C. __ (Apr. 11, 2024)

16

“widespread current experience with medical use of” a Schedule I drug in 

the United States by licensed health care practitioners “operating in accordance with implemented state-authorized programs, where the medical 

use is recognized by entities that regulate the practice of medicine.” HHS 

Part 1 Analysis Memo at 1. To the contrary, the D.C. Circuit suggested 

that such circumstances might never occur, as one of its reasons for rejecting DEA’s original eight-part test was that it “appear[ed] impossible” for 

a Schedule I drug to meet the requirement that there be “[r]ecognition and 

use of the [drug] by a substantial segment of the medical practitioners in 

the United States.” ACT I, 930 F.2d at 938, 940. Yet with respect to at 

least one drug—marijuana—subsequent events have shown that a drug 

can be in Schedule I but still be recommended for medical use by a large 

number of medical practitioners in the United States. And for the reasons 

we have explained, when these circumstances exist, the plain text of 

section 812 mandates that they be taken into account when determining 

whether a drug has a CAMU.

B.

Having explained why DEA’s construction of the phrase “currently accepted medical use in treatment in the United States” is impermissibly 

narrow, we turn to why HHS’s two-part inquiry is sufficient to determine 

whether a drug has a CAMU. 

1.

Part II.A explained that, to determine if a drug has a CAMU, section 

812(b) requires an analysis of whether, at the present time, the medical 

community widely understands that a drug has a “use in treatment in the 

United States.” Although there is no single right answer as to how specifically DEA should make this determination, the text of the CSA establishes certain basic parameters to guide the inquiry.

As an initial matter, the definitions discussed above indicate that “accepted” means that something is “widely used or found” or “generally

approved.” Accepted, Webster’s Third New International Dictionary 11 

(emphasis added). It therefore follows from the word’s plain meaning that 

“anecdotal evidence” that a “number of physicians believe that [a drug] is 

medically useful” is not enough to show that the medical community has 
Questions Related to the Potential Rescheduling of Marijuana

17

accepted that a drug has a use in treatment in the United States. ACT I, 

930 F.2d at 939. At the same time, however, “accepted” does not require 

universal consensus. Rather, it is sufficient if there is a widespread understanding in the medical community that a drug has a use in treatment.

Relatedly, nothing in the text of the CSA suggests that establishing that 

a drug has a CAMU requires the medical community to believe that the 

drug is the best way to treat a condition. So long as there is widespread 

understanding in the medical community that a drug is a permissible and 

reasonable way to treat a condition, it has a CAMU. That reflects a basic 

reality about the medical profession: that “in medicine there is often a 

range of reasonable treatments[.]” Young v. United States, 942 F.3d 349, 

352 (7th Cir. 2019).

Moreover, the medical community is not a monolith: It contains individuals and entities with a range of expertise and experiences, including 

licensed health care practitioners who specialize in certain areas of medicine, generalists with broader expertise, researchers, and regulators. In 

assessing the views of the medical community, section 812(b)(1)(B)’s 

emphasis on a “medical use in treatment” indicates that the views of all 

these constituencies are not equally important in every case. Instead, to 

determine whether the medical community understands using a particular 

drug to be within the range of reasonable treatment options, it is the views 

and practices of the health care practitioners who actually treat a given 

condition, as well as the regulators charged with enforcing applicable 

norms of practice, that are often especially relevant.

Finally, we believe a CAMU test must include consideration of the scientific evidence that supports the relevant medical use. This follows from 

section 811(c)’s requirement that the Attorney General “shall consider” 

eight factors in making the CAMU determination and other findings under 

section 812(b), some number of which inherently require consideration of 

scientific evidence. Although it is unclear exactly how the eight factors 

listed in section 811(c) correlate to the findings required by section 

812(b), it is plain that at least two of those factors—the “scientific evidence of [the drug’s] pharmacological effect, if known” and the “state of 

current scientific knowledge regarding the drug,” 21 U.S.C. § 811(c)(2), 

(3)—bear on whether a drug has a currently accepted medical use, and 

that those factors necessarily require evaluation of scientific evidence. In 

addition, the requirement to consider “[w]hat, if any, risk there is to the 
48 Op. O.L.C. __ (Apr. 11, 2024)

18

public health” and the drug’s “psychic or physiological dependence liability,” id. § 811(c)(6), (7), further suggests that an assessment of the available science is an integral part of a CAMU determination. Reviewing the 

available scientific evidence as part of the CAMU analysis is also consistent with the common-sense intuition that there is an inherent connection between whether the medical community has “accepted” a drug for 

“use in treatment,” id. § 812(b)(1)(B), and the scientific evidence supporting that conclusion. We generally would not expect the medical community to understand that it is reasonable to use a drug to treat a condition 

unless (as HHS suggests) there is at least some scientific evidence in 

support of that conclusion—evidence demonstrating, for example, that the 

drug was effective in treating the condition or does not create unacceptably high safety risks. HHS Part 2 Analysis Memo at 4–5.

2. 

We conclude that HHS’s two-part inquiry falls within the basic parameters the CSA provides for establishing that a drug has a CAMU.

Part 1 of HHS’s test requires an assessment of whether health care 

practitioners are recommending that patients use a drug to treat a medical 

condition and whether they are doing so in accordance with guidelines 

issued by entities that regulate the practice of medicine. This approach is 

consistent with our view that determining whether a drug has a CAMU

requires assessing whether there is a widespread understanding in the 

medical community that using the drug to treat a condition falls within the 

range of reasonable treatment options. In particular, the actual recommendations of practitioners made under applicable regulatory guidelines 

constitute strong evidence of whether the medical community understands 

a drug to be a reasonable treatment option.

The three non-dispositive factors HHS includes in its Part 1 analysis 

further demonstrate why its test is sufficient. Two of HHS’s factors look, 

respectively, at whether a “substantial number of licensed health care 

practitioners” have gained clinical experience with a drug under a 

state-authorized program and whether a “substantial number” of entities 

that regulate the practice of medicine have authorized the use of a drug for 

medical purposes. See HHS Part 1 Analysis Memo at 3. In our view, these 

inquiries provide good evidence of whether there is widespread agreement 

within the medical community that using the drug would be a reasonable 
Questions Related to the Potential Rescheduling of Marijuana

19

treatment option. Similarly, it is more likely that the medical community 

would widely understand that a drug represents a reasonable treatment 

option if HHS’s third factor is present—i.e., that practitioners’ clinical 

experience with the drug is of a “sufficient extent and duration” to help 

evaluate whether there are “potential clinical uses,” “longer-term toxicities,” and “potential harms.” Id. at 5. 

Moreover, Part 2 of HHS’s test adequately takes the available scientific 

evidence into account by asking whether there is some credible scientific 

support for a least one of the medical uses for which the Part 1 test is met 

and then providing guidance as to what counts as “credible” scientific 

support. See HHS Part 2 Analysis Memo at 4 (identifying “favorable 

clinical studies” published in peer-reviewed journals as cutting in favor of 

the conclusion that the drug has a CAMU); id. (identifying data or information that “indicate[s] that medical use of the [drug] is associated with 

unacceptably high safety risks for the likely patient population” because 

of “toxicity concerns” as cutting against the conclusion that the drug has a 

CAMU). Neither section 811(c) nor section 812(b) requires a particular 

threshold of scientific support to conclude that a drug has a CAMU, and 

we believe that Part 2’s requirement of some credible scientific support is 

sufficient in a context where health care practitioners have extensive 

experience with a drug and medical regulators have sanctioned the drug’s 

use. Such clinical experience and regulatory sanction provide alternative 

sources of information about a drug, thereby making it reasonable not to 

require the high level of scientific support that might be demanded before 

a new and untried drug is determined to have a CAMU. 

DEA’s main concern with HHS’s two-part inquiry is that it places too 

much emphasis on state regulatory decisions. Specifically, DEA suggests 

that HHS’s emphasis on states is “misplaced” because, in DEA’s view, 

the processes states follow for enacting legislation “are generally less 

rigorous than the requirements placed on federal agencies when they act 

pursuant to the APA.” DEA Response at 11. But there is nothing in the 

text of the CSA that would warrant categorically discounting state practice in this fashion, particularly since doing so would be inconsistent with 

both the role of states as the central regulators of medical practice, see 

Oregon, 546 U.S. at 270, 274–75, and the fact that they are afforded 

“great leeway” in adopting measures to “protect public health and safety,” 

Mackey v. Montrym, 443 U.S. 1, 17 (1979). Indeed, Congress has already 
48 Op. O.L.C. __ (Apr. 11, 2024)

20

recognized the importance of states’ views on whether marijuana in 

particular may be used to treat medical conditions by annually adopting 

an appropriations rider that prohibits the Department of Justice from using 

funds to prevent certain states, territories, and the District of Columbia 

from implementing their own laws with respect to medical marijuana. See 

supra Part I.C.

In addition, states do often look to scientific and medical judgment in 

regulating medical marijuana. States typically only allow medical practitioners to recommend medical marijuana to treat specific conditions. See, 

e.g., Ohio Rev. Code § 3796.01(A)(6)(a)–(v); N.Y. Cannabis Law § 3(18).

In some states, practitioners may only recommend the use of medical 

marijuana after determining that the patient suffers from one of those

conditions and that the “potential benefits of the palliative use of marijuana would likely outweigh the health risks of such use.” E.g., Conn. Gen. 

Stat. § 21a-408c(a); see also Fla. Stat. § 381.986(4). Several states have 

also established processes through which experts can recommend additions 

to, or removals from, the list of conditions that marijuana may be used to 

treat, see, e.g., Conn. Gen. Stat. § 21a-408l(a), (c)(1), (d); Or. Admin. Rule 

333-008-0090(3)(e), (4)(a)—indeed, HHS has informed us that 17 jurisdictions have added conditions that may be treated with marijuana using 

such processes, see HHS Part 1 Analysis Memo at 4. In short, it is simply 

not the case that state practice concerning medical marijuana is completely divorced from scientific and medical assessment.

III.

As discussed above, the CSA authorizes the Attorney General to place 

drugs in particular schedules if, after a formal rulemaking, the Attorney 

General makes certain findings. A particularly important finding is 

whether a drug has a CAMU, as the Attorney General may only keep or 

place a drug in Schedule I if it lacks a CAMU. Before initiating a rulemaking proceeding to schedule or reschedule a drug, however, the Attorney General is required to request recommendations from the Secretary 

that must include whether the drug has a CAMU. See 21 U.S.C. § 811(b). 

The CSA further makes these recommendations binding “as to” certain 

“scientific and medical matters.” Id.

Since HHS has recommended that marijuana has a CAMU, you have 

asked about the extent to which the “scientific and medical matters” that 
Questions Related to the Potential Rescheduling of Marijuana

21

are binding on the Attorney General, and thus DEA, include HHS’s 

CAMU recommendation or any scientific and medical determinations 

underlying that recommendation. For the reasons that follow, we conclude, first, that HHS’s overall CAMU recommendation is not binding on 

DEA. Second, we conclude that the scientific and medical determinations 

that underlie HHS’s CAMU recommendation are binding, but only until 

the initiation of formal rulemaking proceedings. Once DEA initiates 

formal rulemaking, HHS’s determinations no longer bind DEA, but DEA 

must continue to accord HHS’s scientific and medical determinations 

significant deference, and the CSA does not allow DEA to undertake a de 

novo assessment of HHS’s findings at any point in the process.

A.

We first explain why HHS’s overall CAMU recommendation does not 

bind DEA, starting with the two CSA provisions that govern the CAMU

determination. Section 811(a) authorizes the Attorney General to schedule 

or reschedule a drug if the Attorney General makes certain findings “on 

the record after opportunity for a hearing pursuant to the rulemaking 

procedures prescribed by [the APA].” Section 812(b) then lays out the 

relevant findings the Attorney General must make to schedule a drug, 

including whether the drug has a CAMU. 

Taken together, these two provisions commit exclusively to the Attorney General the ultimate responsibility for making the findings required 

to schedule a drug, including a CAMU finding, and neither mentions the 

Secretary at all. Instead, the role of the Secretary is addressed in a separate provision of the CSA, section 811(b), which reads as follows:

The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to remove a drug 

or other substance entirely from the schedules, and after gathering 

the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or 

other substance should be so controlled or removed as a controlled 

substance. In making such evaluation and recommendations, the 

Secretary shall consider the factors listed in paragraphs (2), (3), (6), 

(7), and (8) of subsection (c) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The 
48 Op. O.L.C. __ (Apr. 11, 2024)

22

recommendations of the Secretary shall include recommendations 

with respect to the appropriate schedule, if any, under which such 

drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding 

on the Attorney General as to such scientific and medical matters, 

and if the Secretary recommends that a drug or other substance not 

be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and 

all other relevant data constitute substantial evidence of potential for 

abuse such as to warrant control or substantial evidence that the drug 

or other substance should be removed entirely from the schedules, he 

shall initiate proceedings for control or removal, as the case may be, 

under subsection (a).

This provision makes clear that the Secretary plays a crucial role in the 

scheduling process. It expressly directs the Attorney General to obtain a 

scheduling recommendation from the Secretary before initiating the scheduling process and to treat as binding certain “scientific or medical matters.” Id.6 But section 811(b) does not so much as mention the Secretary’s 

6 In two recent rulemakings, DEA has stated that HHS’s scientific and medical recommendations only bind DEA with respect to factors (1), (4), and (5) of section 811(c). 

See 86 Fed. Reg. 29,506, 29,507–08 (June 2, 2021); 86 Fed. Reg. 27,803, 27,805 

(May 24, 2021). This view appears to be based on a contrast in section 811(b)’s text: it 

directs the Secretary to “consider the factors listed in paragraphs (2), (3), (6), (7), and (8) 

of [section 811(c)],” and “any scientific or medical considerations involved in paragraphs 

(1), (4), and (5) of [section 811(c)],” with the Secretary’s recommendations being “binding . . . as to such scientific and medical matters.” But section 811(b) highlights the 

“scientific and medical considerations” in factors (1), (4), and (5) not because HHS 

should consider the science and medicine underlying only those factors, but rather 

because those factors all relate to a drug’s abuse potential, the analysis of which Congress 

understood as resting primarily on law enforcement considerations. See H.R. Rep. 

No. 91-1444, at 33–36; House Hearing at 718. By comparison, there is no need to direct 

HHS to consider the “scientific or medical considerations” involved with factors (2), (3), 

(6), (7), and (8) since those factors involve inquiries that are predominantly, if not entirely, scientific and medical in nature. We thus think it plain that HHS’s recommendations 

with respect to “scientific and medical matters” are binding for all eight factors listed in 

section 811(c). See H.R. Rep. 91-1444, at 33; see also id. at 22–23 (“[A]ll scientific and 
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23

CAMU recommendation. Instead, section 811(b) expressly identifies a 

different circumstance in which the Secretary’s recommendation concerning an ultimate scheduling determination is dispositive: when the Secretary 

recommends against controlling a drug. This fact—that section 811(b) 

identifies a separate scheduling recommendation as binding—makes its 

silence on the Secretary’s CAMU recommendation all the more conspicuous.

Moreover, we do not believe the Secretary’s authority to bind the Attorney General with respect to “scientific and medical matters” encompasses a CAMU determination, because such a determination involves 

judgments that are neither wholly scientific nor wholly medical. For 

example, as the discussion in Part II indicates, assessing whether a drug 

has a CAMU may involve, in part, determining whether the extent of 

medical use present is sufficient to qualify as “accepted” within the medical community. 21 U.S.C. § 812(b)(1)(B). This inquiry is more akin to the 

application of a legal standard to a set of facts than a judgment necessarily 

requiring medical or scientific expertise, as it could turn (at least in part) 

on reasoning or facts that are neither scientific nor medical in nature, such 

as determining how many states have authorized use of a drug in treating 

a medical condition. Cf., e.g., United States v. Garcia, 413 F.3d 201, 215 

(2d Cir. 2005) (conclusions that are the “product of reasoning processes 

familiar to the average person in everyday life” do not require specialized 

expertise); accord United States v. Vega, 813 F.3d 386, 394–95 (1st Cir. 

2016) (conclusions based on “logic and pattern recognition” do not require specialized expertise). Because a CAMU determination can include 

elements that fall outside the substantive scope of HHS’s authority to bind 

DEA, HHS’s overall determination that a substance has (or lacks) a 

CAMU cannot be binding.

B. 

We next explain why the scientific and medical determinations underlying HHS’s overall CAMU recommendations bind DEA, although only 

until the initiation of formal rulemaking, and why DEA is nonetheless 

obligated to accord the findings significant deference thereafter.

medical determinations [will be] made by the Secretary of Health, Education, and Welfare[.]” (emphasis added)).
48 Op. O.L.C. __ (Apr. 11, 2024)

24

As a threshold matter, the text and legislative history of section 811(b) 

demonstrate that the “scientific and medical matters” binding on the 

Attorney General include the scientific and medical determinations that 

underlie the Secretary’s CAMU recommendation. See H.R. Rep. No. 

91-1444, at 33; HHS Response at 10; DEA Response at 16. For example, 

whether some credible scientific support exists for a particular widespread 

clinical use, see supra Part I.C, is undoubtedly relevant to a CAMU

finding—and undoubtedly a “scientific and medical matter.” 

The more difficult question, however, is whether HHS’s scientific and 

medical determinations remain binding throughout the scheduling process—a question on which DEA and HHS hold sharply different views. 

DEA argues that it “is only bound by HHS’s evaluation as to scientific 

and medical matters . . . at the beginning of the [scheduling] process,” but 

“[o]nce rulemaking has begun, DEA can—and must—consider material 

submitted during the administrative process in reaching a final scheduling 

determination.” DEA Response at 13; see also 76 Fed. Reg. 77,330, 

77,334–36 (Dec. 12, 2011) (adopting this position). HHS takes the opposite view, arguing that its scientific and medical recommendations bind 

DEA throughout the scheduling process, including the formal rulemaking. 

See HHS Response at 10–11.

The CSA is unquestionably hard to parse on this issue. It does not expressly address for what portion of the administrative proceedings HHS’s 

determinations are binding, nor does it specify how, if at all, such determinations must be considered during the formal rulemaking proceedings. 

Moreover, what clues the statute does offer point in two opposing directions: On the one hand, the statute requires the Attorney General alone to 

make the ultimate findings required for scheduling after an on-the-record 

formal rulemaking, which implies that the Attorney General must consider contrary scientific or medical evidence submitted during that process. 

See 21 U.S.C. § 811(a). On the other hand, the statute makes the Secretary’s scientific and medical determinations “binding” on the Attorney 

General without expressly limiting the binding nature of those determinations to any particular stage of the scheduling process. See id. § 811(b).

Although a close question, we think Congress’s decision to make 

scheduling decisions subject to a formal rulemaking process ultimately 

provides the answer. Fundamentally, the proposition that HHS’s determinations bind DEA for the entirety of the scheduling process cannot be 
Questions Related to the Potential Rescheduling of Marijuana

25

squared with the nature of the formal rulemaking that section 811(a) 

requires. Nothing in the CSA limits outside participants to submitting 

only nonscientific and nonmedical evidence at a rulemaking hearing. 

Given the possibility that parties may submit contrary scientific or medical evidence, construing section 811(b) to preclude DEA from considering 

such evidence would be inconsistent with the APA’s requirement that 

rules issued via formal rulemaking be based “on consideration of the 

whole record . . . and supported by and in accordance with the reliable, 

probative, and substantial evidence.” 5 U.S.C. § 556(d); see Universal 

Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951) (“The substantiality of 

evidence must take into account whatever in the record fairly detracts 

from its weight. This is clearly the significance of the requirement . . . [to] 

consider the whole record.”). In short, DEA would not be making a decision based on the “whole record” and “in accordance with the reliable, 

probative, and substantial evidence,” 5 U.S.C. § 556(d), if HHS’s determinations barred DEA from considering contrary scientific or medical 

evidence. Two courts of appeals have suggested in dicta that they view 

the issue similarly. See Grinspoon, 828 F.2d at 890; Reckitt & Colman, 

Ltd. v. Administrator, DEA, 788 F.2d 22, 27 n.8 (D.C. Cir. 1986). 

The fact that HHS’s recommendations as to certain “scientific and medical matters” do not bind DEA for the entire scheduling process does not 

mean, however, that they are without effect. Rather, in order to give force 

to the statutory command that HHS’s recommendations “bind[]” DEA, we 

believe HHS’s scientific and medical determinations must be binding 

until the issuance of a notice of proposed rulemaking (“NPRM”). Up to 

this point, the formal rulemaking procedures required by section 811(a) 

are not yet in effect, see 21 C.F.R. §§ 1308.43(f), 1316.42(g), meaning 

there is no conflict between the statutory commands to consider contrary 

evidence in the record and accord binding effect to HHS’s recommendations.

In addition, DEA may not simply cast aside HHS’s scientific and medical recommendations once it initiates formal rulemaking proceedings by 

issuing an NPRM. The categorical use of the word “binding” in section 

811(b) suggests that Congress intended HHS’s scientific and medical 

views to at least be a very significant input in the scheduling process. And 

there would seem to be little reason to make the HHS’s views binding at 

any stage in the process if DEA eventually could discard HHS’s determi-
48 Op. O.L.C. __ (Apr. 11, 2024)

26

nations and review scientific and medical matters de novo. Cf. Reno v. 

Am.-Arab Anti-Discrimination Comm., 525 U.S. 471, 487 (1999) (statutes 

should be read in a manner that “makes sense of the statutory scheme as a 

whole”). 

The legislative history of the CSA supports the view that HHS’s scientific and medical determinations should remain significant throughout the 

rulemaking process. The House report on the CSA states that Congress 

intended “all scientific and medical determinations” to be “made by the 

Secretary,” rather than the Attorney General, and nothing in the legislative history suggests that the Attorney General would be free to make de 

novo scientific and medical judgments once the formal rulemaking is 

underway. H.R. Rep. No. 91-1444, at 22–23. Indeed, the House report 

emphasized that section 811 was “not intended to authorize the Attorney 

General to undertake or support medical and scientific research” for the 

purpose of scheduling, as that research “is within the competence of 

[HHS].” Id. at 33. And considering this same legislative history, the 

Supreme Court noted in Gonzales that the CSA places “medical judgments” made under the Act in the “hands of the Secretary.” 546 U.S. at 

265. 

We therefore conclude that, to give proper effect to HHS’s scientific 

and medical determinations, DEA must continue to accord significant 

deference to those determinations even once formal rulemaking has commenced and may not undertake a de novo assessment of HHS’s findings at 

any point in the rulemaking process.

IV.

The Single Convention requires parties to impose controls on the cultivation, manufacture, and distribution of various drugs, including “cannabis.”7 Among other things, parties to the Convention generally must 

7 The Convention defines “cannabis” as “the flowering or fruiting tops of the cannabis 

plant (excluding the seeds and leaves when not accompanied by the tops) from which the 

resin has not been extracted, by whatever name they may be designated.” Single Convention art. 1(1)(b). We understand the marijuana in use in the United States to fall within 

this definition, although the definition of cannabis under the Single Convention is slightly 

less inclusive than the CSA’s definition of “marihuana,” which includes all parts of the 

Cannabis sativa L. plant with certain exceptions, including mature stalks and sterilized 

seeds that are incapable of germination. See 21 U.S.C. § 802(16).
Questions Related to the Potential Rescheduling of Marijuana

27

require that manufacturers, distributors, importers, and exporters of cannabis secure a license, Single Convention arts. 29–31; impose quotas on 

the import and manufacture of cannabis, id. art. 21(1); generally prohibit 

the unauthorized possession of cannabis, id. art. 33; and adopt penal 

provisions making violations of the controls required by the Convention 

punishable offenses, id. art. 36.

Several provisions of the CSA—including sections 801(7), 811(d)(1), 

812(b), 823(a), 953(a), and 958(a)—“reflect Congress’s intent to comply 

with the obligations imposed by the Single Convention.” Control of 

Papaver bracteatum, 1 Op. O.L.C. 93, 95 (1977). Of particular relevance 

here, section 811(d)(1) provides:

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 described by subsections (a) and (b) of this section.

The Single Convention entered into force for the United States on June 

24, 1967, and was thus “in effect on October 27, 1970.” Id. Both our 

Office and the D.C. Circuit have interpreted section 811(d)(1) to apply to 

any scheduling action by the Attorney General concerning a drug covered 

by the Single Convention, including actions to transfer a drug between 

schedules. Memorandum for John E. Ingersoll, Director, Bureau of Narcotics & Dangerous Drugs, from Mary C. Lawton, Deputy Assistant 

Attorney General, Office of Legal Counsel, Re: Petition to Decontrol 

Marihuana; Interpretation of Section 201 of the Controlled Substances 

Act of 1970 at 9 (Aug. 21, 1972) (“Lawton Memo”); NORML II, 559 F.2d 

at 747.

Given this, your third question asks whether the CSA or the Single 

Convention requires marijuana to be placed in Schedule I or Schedule II. 

This question is one our Office has considered before: in 1972, we concluded that the Convention requires marijuana to be placed in Schedule I 

or II because placing marijuana in Schedules III, IV, or V would not 

enable the United States to satisfy its Convention obligations. See Lawton 

Memo at 12–13. In particular, we emphasized that the “quotas on manu-
48 Op. O.L.C. __ (Apr. 11, 2024)

28

facture and importation of a substance required by the Convention could 

not be maintained under existing statutory authority were marihuana listed 

in Schedules III, IV, or V.” Id.; see also NORML II, 559 F.2d at 750–51 

(agreeing with the Lawton Memo that Schedule I or II was necessary to 

meet the United States’ Single Convention obligations). In reaching this 

conclusion, however, we did not address an issue that both HHS and the 

State Department now ask us to consider: whether under the CSA the 

United States can comply with its Single Convention obligations by 

placing marijuana in Schedule III while “adopting such additional regulations as are necessary for treaty compliance.” HHS Response at 13; State 

Response at 5–7; see also NORML II, 559 F.2d at 752–53 (recognizing 

the possibility of a similar regulatory approach but taking no position on 

its availability).

We think this question is a close one. For the reasons that follow, however, we believe that the Single Convention does not require DEA to 

place marijuana in Schedule I or Schedule II. Both the Single Convention 

and the CSA allow DEA to satisfy the United States’ international obligations by supplementing scheduling decisions with regulatory action, at 

least in circumstances where there is a modest gap between the Convention’s requirements and the specific controls that follow from a drug’s 

placement on a particular schedule. And consistent with this conclusion, 

we believe DEA may satisfy the United States’ Single Convention obligations by placing marijuana in Schedule III while imposing additional 

controls pursuant to the CSA’s regulatory authorities.

A.

To begin, nothing in the Single Convention requires the United States 

to comply with its international obligations by placing a drug in a statutory “schedule” that specifically authorizes all the necessary restrictions. To 

the contrary, the Single Convention states that parties will implement the 

Convention using both “laws and regulations.” Single Convention 

art. 18(1)(b) (emphasis added); see also id. art. 4 (referring to the use of 

“legislative and administrative measures” to carry out the Single Convention (emphasis added)). The Single Convention thus appears to explicitly 

contemplate a scenario in which DEA decides to implement the United 

States’ obligations through a combination of scheduling and regulatory 

actions.
Questions Related to the Potential Rescheduling of Marijuana

29

As a result, any limitation on satisfying the United States’ Single Convention obligations by supplementing a scheduling decision with regulatory action would have to come from domestic law. Nothing in the CSA, 

however, states that a drug must be placed into Schedule I or II, or any 

other particular schedule, to comply with the Single Convention. Nor does 

the CSA expressly foreclose DEA from satisfying the United States’ 

international obligations with a combination of scheduling and regulatory 

actions. Rather, section 811(d)(1) directs the Attorney General to “control[]” a drug “under the schedule [the Attorney General] deems most 

appropriate” (emphasis added)—language that signals a broad grant of 

discretion to the Attorney General (and thus DEA), see Rex Chainbelt, 

Inc. v. Volpe, 486 F.2d 757, 761 (7th Cir. 1973). To be sure, the very 

same language could be read to mean that DEA must select a schedule 

without resort to regulatory supplementation. See 21 U.S.C. § 802(5) 

(defining “control” as “to add a drug . . . to a schedule” (emphasis added)). But we are reluctant to adopt a restrictive reading of such broad 

discretionary language, particularly when doing so would preclude DEA 

from relying on regulatory supplementation to close even relatively minor 

gaps between a schedule and the United States’ international obligations. 

Indeed, consistent with this reading, DEA has previously placed a drug 

with the psychoactive chemicals found in cannabis into Schedule V and 

then imposed additional controls through regulation to comply with the 

United States’ international obligations. See 83 Fed. Reg. 48,950, 48,952 

(Sept. 28, 2018).8

The CSA’s varied, and potentially conflicting, purposes further show 

why it is appropriate to read section 811(d)(1)’s broad grant of authority 

in this way. Consider a hypothetical case in which the Single Convention 

imposes obligations that DEA determines would, absent regulatory action, 

8 We have taken a similar interpretive approach to section 811(d)(1)’s language specifying that the Attorney General meet international obligations “without regard” to the 

findings and procedures otherwise required by sections 811(a) through (b) and 812(b). 

Rather than viewing this language as precluding the Attorney General from following 

ordinary scheduling practices when international obligations are involved, both our Office 

and the D.C. Circuit have understood it to allow the Attorney General to identify which 

schedules would satisfy the United States’ international obligations with respect to a 

particular drug, and then—if more than one schedule would do so—select which schedule 

to use through the section 811(a) through (b) and 812(b) procedures. Lawton Memo at 10; 

accord NORML II, 559 F.2d at 747.
48 Op. O.L.C. __ (Apr. 11, 2024)

30

require placement on Schedule I or Schedule II, but DEA has also determined that the same drug’s abuse potential, medical usefulness, and health 

effects warrant placing the drug in Schedule III. See 21 U.S.C. §§ 801(1), 

(2), 812(b)(3). In such a circumstance, reading section 811(d)(1) to allow 

for consideration of regulatory action allows DEA to conclude that 

Schedule III is the “most appropriate” schedule by pairing that choice 

with regulatory actions that ensure compliance with the Single Convention. This enables DEA to comply with the United States’ international 

obligations while furthering the CSA’s other purposes, thus fulfilling both 

sets of objectives. 

The broad regulatory authority provided by the CSA further suggests 

that DEA need not rely on scheduling decisions alone to comply with the 

Single Convention. The CSA authorizes the Attorney General (and thus 

DEA) both to “promulgate rules and regulations . . . relating to the registration and control of the manufacture, distribution, and dispensing of 

controlled substances,” id. § 821, and to “promulgate and enforce any 

rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions,” id. § 871(b). Courts 

recognize that broad, discretionary language such as this conveys “extensive” regulatory authority, Volpe, 486 F.2d at 761; see also, e.g., Friends 

of Animals v. Bernhardt, 961 F.3d 1197, 1209 (D.C. Cir. 2020)—and, here, 

the language by its plain terms would seem to encompass regulatory actions that DEA may take to satisfy Single Convention obligations not met 

by a drug’s schedule alone.

Likewise, the CSA provides the Attorney General with a number of 

more specific regulatory authorities that DEA may use to enable compliance with particular Single Convention obligations, such as the CSA’s 

registration requirements. Subject to certain limited exceptions, section 

822(a) requires “[e]very person who manufactures or distributes” or 

“dispenses” a drug to “obtain annually a registration issued by the Attorney General in accordance with rules and regulations promulgated by 

him,” and section 822(b) further specifies that “[p]ersons registered by the 

Attorney General under this subchapter to manufacture, distribute, or 

dispense controlled substances . . . are authorized to possess, manufacture, 

distribute, or dispense such substances . . . to the extent authorized by 

their registration.” These provisions give DEA the authority to impose a 

number of controls on a particular drug through registration. Other CSA 
Questions Related to the Potential Rescheduling of Marijuana

31

provisions provide similar regulatory authority that could enable a drug 

on a schedule other than Schedule I or Schedule II to comply with the 

Single Convention. See, e.g., 21 U.S.C. §§ 823(e), (f), 827(e), 952(b)(2), 

953(e)(2), 958(c).

Finally, past practice also supports our conclusion. Specifically, in addition to the example recounted above of DEA imposing additional controls through regulation to comply with the United States’ international 

obligations, see 83 Fed. Reg. at 48,952, we understand that DEA previously has relied on a combination of the Attorney General’s registration 

power and general regulatory authority to promulgate extensive safety and 

security regulations that govern manufacturers and distributors of controlled substances. See 21 C.F.R. §§ 1301.71–.77. And our Office has 

previously read the Attorney General’s authority to register manufacturers 

broadly to permit the imposition of certain controls that would enable 

compliance with the Single Convention. See Licensing Marijuana Cultivation in Compliance with the Single Convention on Narcotic Drugs, 

42 Op. O.L.C. __, at *24 (June 6, 2018) (“Licensing Marijuana Cultivation”). These prior regulatory actions indicate that the broad and varied 

provisions discussed above provide authority that may be used to impose 

additional controls to satisfy the United States’ international obligations.

We recognize that reading the CSA as allowing DEA to use regulatory 

authorities to close gaps in our compliance with international obligations 

could be viewed as in tension with certain aspects of the CSA’s text and 

structure. As the Lawton Memo noted, several provisions of the CSA 

implementing controls required by the Single Convention draw a distinction between Schedules I and II, on the one hand, and Schedules III 

through V, on the other, in a manner that can be read to suggest that 

Congress understood the United States would comply with its Convention 

obligations by placing drugs into Schedules I or II. Lawton Memo at 12; 

see, e.g., 21 U.S.C. §§ 823(a), (d), (e), 826(a), 842(b), 952(a), (b), 958(a),

(c). Moreover, Congress designed the CSA to include five schedules, each 

with a distinct bundle of requirements and consequences, and allowing 

DEA to add or subtract controls would arguably have the practical effect 

of enabling DEA to create new schedules.

These arguments have some force, but they do not carry the day. Since 

the CSA’s enactment, Congress has amended the Act in a manner that 

indicates the distinction between Schedules I and II and Schedules III 
48 Op. O.L.C. __ (Apr. 11, 2024)

32

through V may not be as sharp as the argument above suggests. See infra 

Part IV.B (describing how amendments that added sections 952(b)(2), 

953(e)(2), and 827(e) enable the United States to meet certain Single 

Convention obligations while placing nonnarcotic drugs in Schedule III). 

In any event, right alongside the provisions that could impliedly suggest 

Schedules I and II will be used to comply with the United States’ Single 

Convention obligations are provisions that expressly grant the Attorney 

General (and thus DEA) both broad discretion to select the schedule 

“most appropriate” to satisfy the United States’ international obligations, 

see 21 U.S.C. § 811(d)(1), and broad regulatory authority, see, e.g., id. 

§§ 821, 871(b). And given the plain meaning of the CSA’s regulatory 

provisions, we do not believe that the CSA’s five-schedule structure can 

be reasonably understood to preclude DEA from taking at least some 

regulatory actions to comply with the United States’ international obligations. Indeed, it would be particularly strange to view DEA as so constrained in the context of treaty compliance, given section 811(d)(1)’s 

express grant of broad discretion to meet international obligations. We 

therefore believe that something more than such textual and structural 

inferences are needed to foreclose use of these broad and express statutory 

grants of regulatory authority to impose additional controls to meet the 

United States’ international obligations. 

Thus, while we take no position on the full extent to which DEA may 

use the CSA’s broad regulatory authority to impose additional controls to 

meet international obligations, we do not read the CSA as precluding 

DEA from ever satisfying the United States’ Single Convention obligations by supplementing scheduling decisions with regulatory action. 

Rather, we believe that the CSA provides DEA with the discretion to 

decide, at least in some circumstances, that such a scheduling and regulatory approach is the most appropriate way to strike a balance between the 

CSA’s varied—and potentially conflicting—purposes of curtailing the 

improper use of drugs with abuse potential, complying with the United 

States’ international obligations, and ensuring that medically useful drugs 

remain available for legitimate purposes. See 21 U.S.C. § 801(1), (2), (7).
Questions Related to the Potential Rescheduling of Marijuana

33

B.

We next consider the specific question of whether DEA may comply 

with the United States’ obligations under the Single Convention by supplementing a decision to place marijuana in Schedule III with regulatory 

action.

As a threshold matter, we understand that, if marijuana were placed on 

Schedule III, the gap that DEA would need to fill would be modest. To be 

sure, the Lawton Memo and the D.C. Circuit expressed concern that 

placing marijuana into Schedule III would create compliance concerns 

with respect to certain Single Convention requirements. In its submission 

to us, however, the State Department observed that, even if marijuana 

were listed in Schedule III, most of the United States’ Single Convention 

obligations would continue to be met. See State Response at 4–7. The 

State Department’s view reflects amendments to the CSA that postdate 

the Lawton Memo (from 1972) and the D.C. Circuit’s consideration of the 

issue (in 1977) and that specifically authorize certain controls required by 

the Single Convention to be placed on drugs outside Schedules I and II. 

Given these amendments, many of the gaps previously identified in Single 

Convention compliance would no longer exist if marijuana were placed in 

Schedule III.

In particular, the Lawton Memo and D.C. Circuit both pointed to the 

manufacturing and import quotas required by Article 21 of the Single 

Convention as potential gaps, see Lawton Memo at 12–13, while the D.C. 

Circuit also identified the estimates and statistical reports required by 

Articles 19 and 20 and the import and export authorizations required by 

Article 31(4), see NORML II, 559 F.2d at 751 n.71. In 1978, however, 

Congress enacted 21 U.S.C. § 827(e), which specifically authorizes the 

Attorney General, among other things, to prescribe measures necessary to 

comply with the reporting requirements of Articles 19 and 20 of the 

Single Convention for drugs in any schedule, not just those in Schedules I 

and II. See Psychotropic Substances Act of 1978, Pub. L. No. 95-633, 

§ 104, 92 Stat. 3768, 3772. In addition, in 1984 Congress amended the 

CSA provisions that implement the import and export permit requirements 

to specifically authorize the use of permits for a nonnarcotic Schedule III 

drug. See 21 U.S.C. §§ 952(b)(2), 953(e) (enacted by the Controlled 

Substances Penalties Amendments Act of 1984, Pub. L. No. 98-473, 
48 Op. O.L.C. __ (Apr. 11, 2024)

34

§§ 521–522, 98 Stat. 1837, 2075–76). If marijuana, a nonnarcotic drug, 

were placed in Schedule III, we believe these statutory provisions would 

ensure compliance with both the import quota obligation of Article 21 and 

the import and export authorization requirements of Article 31(4).

These subsequent enactments address most of the concerns the Lawton 

Memo and D.C. Circuit identified, with the exception of the manufacturing quota requirements of Article 21 of the Convention. But we believe 

this remaining gap is addressable using the CSA’s regulatory authorities. 

Several different authorities appear potentially applicable. A regulation 

imposing a manufacturing quota on a drug would fall easily within the 

broad language of section 821, as it would be “relat[ed] to the . . . control 

of the manufacture” of a drug. 21 U.S.C. § 821. DEA likewise could deem 

a regulation imposing a manufacturing quota as “necessary and appropriate for the efficient execution of” the CSA function of controlling drugs 

to meet the United States’ international obligations. Id. § 871(b); see id.

§ 811(d)(1). By their plain terms, the CSA’s registration authorities would 

also give DEA the authority to impose a manufacturing quota on a particular drug through regulation: no person can manufacture a drug (including 

marijuana) without a registration issued by DEA, see id. § 822(a), and in 

that registration DEA can limit the “extent” to which any person is “authorized to . . . manufacture” marijuana under their registration, id. 

§ 822(b). Section 823(e) provides yet another potential source of authority 

for imposing a manufacturing quota on a Schedule III drug, as DEA could 

conclude under section 823(e) that registrations to manufacture marijuana 

would be “inconsistent with the public interest” unless a quota consistent 

with Article 21 of the Single Convention was implemented to maintain 

“effective controls against diversion.” Id. § 823(e); see also Oregon, 546 

U.S. at 260 (identifying similar language in section 823(a) as providing 

regulatory authority).9

9 We note that section 823(a) provides that the Attorney General shall register manufacturers of Schedule I and Schedule II drugs upon determining that “such registration is 

consistent with the public interest and with United States obligations under international 

treaties, conventions, or protocols in effect on May 1, 1971.” (Emphasis added.) In 

Licensing Marijuana Cultivation, we emphasized section 823(a)’s invocation of international obligations in concluding that DEA could promulgate regulatory controls necessary 

to meet certain of the United States’ obligations under the Single Convention. See 42 Op.

O.L.C. __, at *24. Although section 823(e) does not include a similar requirement to 
Questions Related to the Potential Rescheduling of Marijuana

35

In concluding that the CSA provides numerous sources of authority that 

could be used to impose a manufacturing quota, we recognize that section 

826 expressly requires manufacturing quotas for drugs in Schedules I and 

II.10 But that requirement should not be read as implicitly foreclosing the 

imposition of such quotas for drugs in Schedules III through V. As the 

D.C. Circuit has recognized, “a congressional mandate in one section and 

silence in another often suggests not a prohibition but simply a decision . . . to leave the question to agency discretion.” Catawba County v. 

EPA, 571 F.3d 20, 36 (D.C. Cir. 2009) (per curiam) (quotation marks 

omitted).

We therefore conclude that both the Single Convention and the CSA 

permit DEA to place marijuana in Schedule III while imposing additional 

controls, pursuant to the CSA’s regulatory authorities, to close a modest 

gap between the requirements of the Single Convention and the requirements that follow from placement on Schedule III.

V.

For the reasons set forth above, we conclude, first, that DEA’s current 

approach to determining whether a drug has a CAMU is impermissibly 

narrow, and that satisfying HHS’s two-part inquiry is sufficient to establish that a drug has a CAMU even if the drug has not been approved by 

consider international obligations, it does require the Attorney General to consider 

whether registration is “inconsistent with the public interest,” 21 U.S.C. § 823(e), and 

complying with the United States’ international obligations is plainly in the public 

interest. Against this backdrop, we do not read Congress’s silence with respect to international obligations in section 823(e) as precluding DEA from relying on that section to 

comply with international obligations. See Catawba County v. EPA, 571 F.3d 20, 36 (D.C. 

Cir. 2009) (per curiam).

10 Although the CSA refers to quotas on the “production” of drugs and the Single Convention to quotas on the “manufacture” of drugs, we understand the scope of these terms 

to largely overlap. The CSA defines “production” to include the “manufacture, planting, 

cultivation, growing, or harvesting of a controlled substance,” 21 U.S.C. § 802(22), and, 

in turn, defines “manufacture” to include the “production, preparation, propagation, 

compounding, or processing of a drug,” id. § 802(15). The Single Convention defines 

“manufacture” to mean “all processes . . . by which drugs may be obtained and includes 

refining as well as the transformation of drugs into other drugs,” Single Convention art. 

1(1)(n), but excludes “the separation of . . . cannabis and cannabis resin from the plants 

from which they are obtained,” id. art. 1(1)(t).
48 Op. O.L.C. __ (Apr. 11, 2024)

36

FDA and would not satisfy DEA’s five-part test. Second, we conclude 

that HHS’s overall CAMU recommendation is not binding on DEA and 

that the scientific and medical determinations that underlie HHS’s CAMU

recommendation are binding, but only until the initiation of formal rulemaking proceedings. Once DEA initiates formal rulemaking, HHS’s 

determinations no longer bind DEA, but DEA must continue to accord 

HHS’s scientific and medical determinations significant deference, and 

the CSA does not allow DEA to undertake a de novo assessment of HHS’s 

findings at any point in the process. Finally, we conclude that neither the 

Single Convention nor the CSA requires marijuana to be placed into 

Schedule I or II. Both the Single Convention and the CSA allow DEA to 

satisfy the United States’ international obligations by supplementing 

scheduling decisions with regulatory action, at least in circumstances 

where there is a modest gap between the Convention’s requirements and 

the specific restrictions that follow from a drug’s placement on a particular schedule. As a result, DEA may satisfy the United States’ Single 

Convention obligations by placing marijuana in Schedule III while imposing additional restrictions pursuant to the CSA’s regulatory authorities.

CHRISTOPHER C. FONZONE

Assistant Attorney General

Office of Legal Counsel