DEA Cannabis Scheduling

This case is currently in a stay status, pending the resolution of an interlocutory appeal that has been pending with the Drug Enforcement Administration (DEA) Administrator since January 13, 2025.  Although, during the period of the stay, I have retained limited jurisdiction over the case to address some routine, non-dispositive, procedural motions, the parties are herein notified that effective August 1, 2025, I will be retired from the bench.  My retirement will leave the DEA with no Administrative Law Judge to hear this matter or any of the Agency’s other pending administrative enforcement cases.  The Controlled Substances Act requires that DEA administrative enforcement hearing proceedings must be conducted in accordance with the Administrative Procedure Act and presided over by an Administrative Law Judge.  21 U.S.C. § 824(c)(4); 5 U.S.C. § 556(b)(3).  Until there is a change in this circumstance, all matters filed in this case will be forwarded to the DEA Administrator, for whatever action, if any, he deems appropriate.

All previously-issued procedural orders remain in full force and effect unless otherwise modified by a successor Administrative Law Judge, the DEA Administrator, or the Attorney General.  Naturally, I wish all the parties the best in resolving this important issue in a fair, transparent, and accurate manner, and extend my heartfelt gratitude to the parties and their representatives for their sincere, diligent, and indefatigable advocacy.

The SEC has since abandoned any argument that the removal protections are constitutional.  See Def.’s Reply at 10-11 (citing Notice of Change in Position, ECF No. 16).^[1]

^[1] The Commission filed a notice “to inform the Court that the Acting Solicitor General has decided that the multiple layers of removal restrictions for administrative law judges in 5 U.S.C. § 7521 do not comport with the separation of powers and Article II and that the United States will no longer defend them in litigation.” Notice of Change in Position at 1.

Sec. 7.  Rules of Conduct Guiding Federal Employees’ Interpretation of the Law.  The President and the Attorney General, subject to the President's supervision and control, shall provide authoritative interpretations of law for the executive branch.  The President and the Attorney General’s opinions on questions of law are controlling on all employees in the conduct of their official duties.  No employee of the executive branch acting in their official capacity may advance an interpretation of the law as the position of the United States that contravenes the President or the Attorney General’s opinion on a matter of law, including but not limited to the issuance of regulations, guidance, and positions advanced in litigation, unless authorized to do so by the President or in writing by the Attorney General.

“Today the Department of Justice determined that multiple layers of removal restrictions shielding administrative law judges (ALJs) are unconstitutional.

Unelected and constitutionally unaccountable ALJs have exercised immense power for far too long.  In accordance with Supreme Court precedent, the Department is restoring constitutional accountability so that Executive Branch officials answer to the President and to the people.”

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.  Id. at 1.

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.  Id. at 1.

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.  Id. at 1.

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).  Id. at 9.

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).  Id. at 10.

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).  Id. at 14.

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).  Id. at 15.

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 “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.  Id. at 15-16.

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 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.  Id. at 19-20.

On reviewing the Administrator’s decision, we found the eight-factor test for determining whether a drug had a “currently accepted medical use” to be “in the main acceptable.”  ACT, 930 F.2d at 937.  We noted the ambiguity of the phrase and the dearth of legislative history on point and deferred to the Administrator’s interpretation as reasonable.  Id. at 939 (citing Chevron U.S.A. Inc. v. Natural Resources Defense Council, 467 U.S. 837, 843-45 (1984) (court may not substitute its own construction of ambiguous statutory provision for reasonable interpretation by agency of statute entrusted to its administration)).  Id. at 1134.

The Final Order discards the earlier formulation and applies a new five-part test for determining whether a drug is in “currently accepted medical use”: (1) The drug’s chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available.  Id. at 1135.

We think that the Administrator’s interpretation of the statute was in the main acceptable, but he appears to have relied on several factors that are unreasonable because logically impossible to satisfy; therefore, we remand.  Id. at 937.

In a prior proceeding, the Administrator had employed an additional eight factor test to further elaborate the characteristics of a drug that he thought had a “currently accepted medical use”: ... 53 Fed. Reg. 5,156 (1988).  Id. at 938.

The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term “currently accepted medical use” therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.  See NLRB v. United Food & Commercial Workers Union, 484 U.S. 112, 123 (1987); Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843-45 (1984).  Id. at 939.

Impossible requirements imposed by an agency are perforce unreasonable: “Conditions imposed by [the] order are . . . unreasonable by virtue of being impossible to meet.”  D.C. Transit Sys., Inc. v. Washington Metropolitan Area Transit Comm’n, 466 F.2d 394, 402 (D.C. Cir.), cert. denied, 409 U.S. 1086 (1972).  These three factors are: (4) General availability of the substance and information regarding the substance and its use; (5) Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks; (8) Recognition and use of the substance by a substantial segment of the medical practitioners in the United States. Id. at 940.

To be sure, the Administrator did not explicitly rely on factors (4) and (8) in the analytical portion of his opinion (he did say “marijuana is not recognized as a medicine in generally accepted pharmacopeia, medical references, and textbooks,” indicating his reliance on factor (5)).  But since he did reaffirm the eight criteria’s applicability to this case, we simply cannot be certain what role, if any, factors (4) and (8) played in his decision.  Under our governing cases, we must remand for the requisite explanation.  See MCI Telecommunications Corp. v. FCC, 917 F.2d 30, 39-40 (D.C. Cir. 1990); City of Vernon v. FERC, 845 F.2d 1042, 1046-49 (D.C. Cir. 1988)..  Id. at 940-941.

In his October 13, 1986, decision, the Administrator held that the phrases “currently accepted medical use in treatment in the United States” and “accepted safety for use . . . under medical supervision” as used in the CSA, 21 U.S.C. § 812(b)(1), both mean that the FDA has evaluated the substance for safety and approved it for interstate marketing in the United States pursuant to the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), 21 U.S.C. § 355.  Id. at 884.

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.  Id. at 886.

In short, it is plainly possible that a substance may fail to obtain interstate marketing approval even if it has an accepted medical use.  Id. at 887.

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321(b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.  Id. at 887.

Although we find that the Administrator’s present interpretation of the second and third Schedule I criteria contravenes congressional intent, we are unable to ascertain with any certainty what Congress intended to be the proper interpretation of subsections (B) and (C).  In other words, while we are satisfied that Congress intended to preclude reliance on the absence of FDA approval in assessing whether a substance has an “accepted medical use” and “accepted safety for use . . . under medical supervision,” we have found nothing to indicate how Congress affirmatively intended these two ambiguous statutory phrases to be construed and applied.  It appears to us that Congress has implicitly delegated to the Administrator the authority to interpret these portions of the CSA, and we must therefore refrain from imposing our own statutory interpretation upon the agency.  Chevron, 467 U.S. at 843.  Hence, to avoid unduly infringing upon the Administrator’s legitimate discretion to develop a legally acceptable standard — i.e., one that does not conflict with the intentions of Congress, and makes sense in light of the statutory language, the legislative history, and the purposes of the entire legislative scheme — we remand the rule to the Administrator for reconsideration and for further proceedings not inconsistent with this opinion..  Id. at 892.

ORDERED AND ADJUDGED, by this Court, that this case be remanded in its entirety to the Drug Enforcement Administration. It is

FURTHER ORDERED, that the Drug Enforcement Administration refer all the substances at issue to the Department of Health and Human Resources for that Department's scientific and medical findings and recommendations on scheduling, as provided by 21 U.S.C. § 811(b) (1976).  These proceedings shall take into account new evidence concerning medical use of the substances at issue, and shall be consistent with both this order and the prior decisions of this Court in National Organization for the Reform of Marijuana Laws v. Drug Enforcement Administration, 559 F.2d 735 (D.C. Cir. 1977), and National Organization for the Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974).  We regrettably find it necessary to remind respondents of an agency’s obligation on remand not to “do anything which is contrary to either the letter or spirit of the mandate construed in the light of the opinion of [the] court deciding the case.”  City of Cleveland v. Federal Power Commission, 561 F.2d 344, 346 (D.C. Cir. 1977) (quoting Yablonski v. UMW, 454 F.2d 1036, 1038 (D.C. Cir. 1971), cert. denied, 406 U.S. 906 (1972).

Congress never intended to allow the Attorney General to displace the Secretary whenever any international obligations attach to a particular drug - especially in view of the fact that the vast majority of substances listed in the CSA are controlled by treaty.  Respondent’s reading of Section 201(d) would destroy a balance of power created by a deliberate and conscientious exercise of the legislative process.  Id. at 746.

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.  The Secretary of HEW is manifestly more competent to make these nonlegal evaluations and recommendations.  Id. at 747.

The Acting Administrator premised his conclusion on the assumption that placement in CSA Schedule I is automatically required if the substance has no currently accepted medical use in the United States.  Our analysis of the Act compels us to reject his finding.  Id. at 747.

If, as respondent contends, a determination that the substance has no accepted medical use ends the inquiry, then presumably Congress would have spelled that out in its procedural guidelines.  Id. at 748.

The legislative history of the CSA indicates that medical use is but one factor to be considered, and by no means the most important one.  Id. at 748.

At the hearing before ALJ Parker DEA’s Chief Counsel, Donald Miller, testified that several substances listed in CSA Schedule II, including poppy straw, have no currently accepted medical use.  Id. at 748.

The action was based on the ground that outstanding treaty commitments preclude any executive relief, and that becomes the crucial question before the court.  Id. at 657-658.

Even if we accept the argument now put forward by Government counsel as to the relationship between Article 21 of the Treaty and § 306 of the CSA, the point is not obvious or clear-cut, but requires a reflective consideration and analysis.  Id. at 659.

But the decision seems to go further and say that if some control is required by treaty then the decision of which Schedule is appropriate is a matter for the exclusive decision of the respondent as the delegee of the Attorney General.  This is a matter that gives us pause.  The respondent seems to be saying that even though the treaty does not require more control than schedule V provides, he can on his own say-so and without any reason insist on Schedule I.  We doubt that this was the intent of Congress.  Id. at 660-661.