Hemp Industries Association v. DEA

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 19, 2022 Decided June 10, 2022

No. 21-5111

HEMP INDUSTRIES ASSOCIATION AND RE BOTANICALS, INC.,

APPELLANTS

v.

DRUG ENFORCEMENT ADMINISTRATION AND ANNE MILGRAM,

IN HER OFFICIAL CAPACITY AS ADMINISTRATOR OF THE UNITED

STATES DRUG ENFORCEMENT ADMINISTRATION,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 1:20-cv-02921)

Matthew C. Zorn argued the cause for appellants. With

him on the briefs were Shane Pennington, Shawn Hauser, and

David C. Kramer.

Sarah Carroll, Attorney, U.S. Department of Justice,

argued the cause for appellees. With her on the brief were

Brian M. Boynton, Acting Assistant Attorney General, and

Mark B. Stern, Attorney.

Before: HENDERSON and ROGERS, Circuit Judges, and

SILBERMAN, Senior Circuit Judge.

2

Opinion for the Court filed by Circuit Judge HENDERSON.

KAREN LECRAFT HENDERSON, Circuit Judge: This appeal

centers on recent statutory and regulatory changes to the legal

status of hemp—a non-psychoactive variant of the Cannabis

sativa L. (cannabis) plant that is related to but distinct from

marijuana, the more well-known psychoactive variant. In

August 2020, the United States Drug Enforcement

Administration (DEA) issued a rule meant to conform its

existing regulations to recent congressional amendments to the

Controlled Substances Act (CSA or Act), 21 U.S.C. § 801 et

seq., in its treatment of hemp. Shortly thereafter, the Hemp

Industries Association (Hemp Association), a trade association

of the hemp industry, and RE Botanicals, Inc. (RE Botanicals),

a manufacturer and seller of consumer products derived from

hemp, (collectively, the Plaintiffs) filed suit against the DEA,

seeking declaratory and injunctive relief preventing the agency

from enforcing the CSA against two necessary byproducts of

the hemp-extract production process. The district court

dismissed for lack of subject matter jurisdiction, concluding

that the Plaintiffs’ suit impermissibly challenged the DEA rule

by failing to use the statutory review provision for rules

promulgated under the CSA. See generally Hemp Indus. Ass’n

v. DEA, 539 F. Supp. 3d 120 (D.D.C. 2021). As detailed infra,

we affirm.

I. Background

At the motion-to-dismiss stage, we “assume the truth of all

material factual allegations in the complaint and ‘construe the

complaint liberally, granting plaintiff[s] the benefit of all

inferences that can be derived from the facts alleged.’” Am.

Nat’l Ins. Co. v. FDIC, 642 F.3d 1137, 1139 (D.C. Cir. 2011)

(quoting Thomas v. Principi, 394 F.3d 970, 972 (D.C. Cir.

2005)).

3

A.

In 1970, the Congress passed the Controlled Substances

1

Act, “a comprehensive statute designed to rationalize federal

control of dangerous drugs.” Nat’l Org. for Reform of

Marijuana Laws (NORML) v. DEA, 559 F.2d 735, 737 (D.C.

Cir. 1977). Under the CSA, each “controlled substance,” see

21 U.S.C. § 802(6) (defining the term), is placed on one of five

“schedules”—designated as Schedules I through V—of

descending regulatory severity based on the risks and benefits

associated with the substance. See id. § 812(a)–(b)

(establishing and defining each schedule). The controls

imposed on the manufacture, acquisition and distribution of

substances listed under the CSA and the penalties for violations

of those controls vary according to the schedule in which a

substance is listed. See id. §§ 821–32 (controls), 841–65

(offenses and penalties); see also Gonzales v. Raich, 545 U.S.

1, 13–14 (2005). For example, Schedule I substances—which

have “a high potential for abuse,” “no currently accepted

medical use in treatment” and “a lack of accepted safety for use

. . . under medical supervision”—are subject to the most

stringent controls and penalties. See id. §§ 812(b)(1)(A)–(C),

841. The Attorney General has delegated his authority under

the CSA, including his rulemaking and scheduling authority, to

the DEA. See 28 C.F.R. § 0.100(b); see also 21 U.S.C. § 871(a)

(permitting delegation). The court of appeals has exclusive

jurisdiction of “[a]ll final determinations, findings, and

conclusions” issued by the DEA pursuant to the CSA.

21 U.S.C. § 877; see John Doe, Inc. v. DEA, 484 F.3d 561, 568

(D.C. Cir. 2007).

1

The Controlled Substances Act comprises Title II of the

Comprehensive Drug Abuse Prevention and Control Act of 1970,

Pub. L. No. 91-513, 84 Stat. 1242.

4

The CSA lists marijuana as a Schedule I substance. See 21

U.S.C. § 812(c) (Schedule I (c)(10)). Before 2018, the statutory

definition of marijuana excluded hemp from its purview by

carving out the non-psychoactive parts of the cannabis plant:

The term “marihuana” 2 means all parts of the

plant Cannabis sativa L., whether growing or

not; the seeds thereof; the resin extracted from

any part of such plant; and every compound,

manufacture, salt, derivative, mixture, or

preparation of such plant, its seeds or resin.

Such term does not include the mature stalks of

such plant, fiber produced from such stalks, oil

or cake made from the seeds of such plant, any

other compound, manufacture, salt, derivative,

mixture, or preparation of such mature stalks

(except the resin extracted therefrom), fiber, oil,

or cake, or the sterilized seed of such plant

which is incapable of germination.

Id. § 802(16) (emphasis added) (2012). The Congress also

listed tetrahydrocannabinols (THC), the key psychoactive

compound found in the cannabis plant, as a Schedule I

controlled substance, see 21 U.S.C. § 812(c) (Schedule

I (c)(17)), but it did not define the term, leaving the definition

up to the DEA, see 21 C.F.R. § 1308.11(d)(31).

After what one can fairly characterize as a series of

longstanding disputes among the hemp industry, the DEA,

States and the Congress regarding the DEA’s authority to

regulate hemp, see Am. Compl. ¶¶ 40–61; see also Monson v.

DEA, 589 F.3d 952, 957 (8th Cir. 2009); United States v.

2

The Controlled Substances Act and implementing regulations

often use the “marihuana” spelling. Other than direct references to or

quotations of either, we use “marijuana.”

5

Mallory, 372 F. Supp. 3d 377, 382–83, 384–85 (S.D. W. Va.

2019), the Congress significantly altered the CSA regulation of

hemp as part of the Agricultural Improvement Act of 2018,

Pub. L. No. 115–334, 132 Stat. 4490 (2018 Farm Bill).

Relevant here, the 2018 Farm Bill included a new definition of

“hemp”:

“[H]emp” means the plant Cannabis sativa L.

and any part of that plant, including the seeds

thereof and all derivatives, extracts,

cannabinoids, isomers, acids, salts, and salts of

isomers, whether growing or not, with a delta-9

tetrahydrocannabinol concentration of not more

than 0.3 percent on a dry weight basis.

7 U.S.C. § 1639o(1). 3 It also amended the CSA in two key

respects. First, it clarified that “[t]he term ‘marihuana’ does not

include . . . hemp, as defined in section 1639o of Title 7.” 21

U.S.C. § 802(16)(B)(i). Second, it removed “[THC] in hemp

(as defined under section 1639o of Title 7)” from the statutory

listing of THC. Id. § 812(c) (Schedule I (c)(17)). The 2018

Farm Bill granted the Secretary of the United States

Department of Agriculture (USDA)—subject to exceptions not

pertinent here—“sole authority to promulgate Federal

regulations and guidelines that relate to the production of

hemp,” 7 U.S.C. § 1639r(b); see also id. § 1639o(3), and

3

The Congress first differentiated hemp from marijuana based

on delta-9 THC concentration in the Agricultural Act of 2014, Pub.

L. No. 113-79, 128 Stat. 649, which authorized the cultivation of

“industrial hemp,” defined according to the same 0.3 per cent delta-

9 THC concentration threshold as the 2018 Farm Bill’s definition of

“hemp,” for agricultural and academic purposes pursuant to a state

pilot program. See 7 U.S.C. § 5940.

6

directed the USDA Secretary to administer and implement

hemp production plans, 4 see id. §§ 1639q, 1639p.

In August 2020, the DEA published an interim final rule

intended to “conform[] [its] regulations” to the 2018 Farm

Bill’s amendments to the CSA. See Implementation of the

Agriculture Improvement Act of 2018, 85 Fed. Reg. 51,639,

51,639 (Aug. 21, 2020) (Interim Final Rule or IFR). The IFR

noted that to be deemed marijuana under the CSA, “cannabis

and cannabis-derived material must both fall within the pre-

[2018 Farm Bill] CSA definition of marihuana”—the

definition that excluded particular parts of the cannabis plant—

“and contain more than 0.3 percent [delta-9]-THC on a dry

weight basis.” Id. at 51,640–41. The rule accordingly limited

the agency’s definition of THC, a Schedule I controlled

substance, to exclude “any material, compound, mixture, or

preparation that falls within the [2018 Farm Bill’s] definition

of hemp set forth in 7 U.S.C. § 1639o.” Id. at 51,641; see also

21 C.F.R. § 1308.11(d)(31)(ii). Of note here, the DEA

specifically addressed products derived from the hemp plant,

stating that “the definition of hemp does not automatically

exempt any product derived from a hemp plant, regardless of

the [delta-9]-THC content of the derivative” and “[i]n order to

meet the definition of ‘hemp,’ and thus qualify for the

exemption from schedule I, the derivative must not exceed the

0.3% [delta-9]-THC limit.” 85 Fed. Reg. at 51,641. The agency

also declared that “entities no longer require a DEA registration

4

The USDA has since issued a rule for the regulation of hemp

production. See Establishment of a Domestic Hemp Production

Program, 86 Fed. Reg. 5,596 (Jan. 19, 2021). Notably, its rule

“do[es] not cover hemp or its products beyond production,” noting

that “DEA has issued regulations covering some of these products or

‘in-process materials.’” Id. at 5,649.

7

or import and export permits to handle hemp extract that does

not exceed the statutory 0.3% THC limit.” Id. at 51,644.

B.

As an agricultural commodity, hemp has a wide variety of

uses, including in the production of textiles, fabrics and paper.

Hemp seeds are used in beverages and foods. Hemp extracts

are used in a wide range of products like soaps, shampoo,

lotions, bath gels and cosmetics. Hemp extracts can be

particularly lucrative; according to the Plaintiffs, “[t]he U.S.

wholesale market for hemp extracts currently stands at $2

billion” and “the wholesale market for products containing

extracts exceeds $5 billion.” Am. Compl. ¶ 29.

This appeal focuses on the hemp-extract production

process. As the Plaintiffs see it, the process produces

intermediate and waste byproducts that exceed the 0.3 per cent

delta-9 THC concentration threshold, thereby raising

understandable confusion regarding DEA regulation even after

the 2018 Farm Bill. To briefly summarize the production

process: After hemp plants are determined to be below the 0.3

per cent delta-9 THC threshold and cultivated, the milling

process separates the hemp flowers, which are high in THC,

from the remainder of the plant, which is comparatively low in

THC. The milled hemp flower material is then mixed with an

extraction solvent meant to extract the cannabinoids—

compounds including THC and cannabidiol (CBD) found in

the cannabis plant. The hemp flower material is discarded,

leaving behind an oil comprised of the extracted cannabinoids

and the extraction solvent. The oil is subjected to evaporation

in order to isolate what the Plaintiffs call “intermediate hemp

material” (IHM), which, at this point, contains highly

concentrated levels of cannabinoids like THC. The Plaintiffs

assert that “IHM itself is not added to, or used as an ingredient

8

in, any consumer product; rather, IHM is refined into extracts

or isolates containing not more than 0.3% [delta-9] THC.” Id.

at ¶ 35. If the processor creates cannabinoid isolates, the

evaporation process generates a waste output the Plaintiffs call

“waste hemp material” (WHM), which they similarly assert “is

not added to, or used as an ingredient in, any consumer

product.” Id. at ¶ 36. Because both IHM and WHM are

produced after stripping or evaporating away parts of the hemp

plant that are low in THC, the two byproducts have high THC

concentrations. “As a result, IHM and WHM naturally (and

unavoidably) exceed 0.3% [delta-9] THC,” notwithstanding

the “harvested hemp plant contains 0.3% or less [delta-9]

THC.” Id. at ¶ 39.

C.

In September 2020, the Plaintiffs petitioned for review of

the IFR. See Hemp Indus. Ass’n v. DEA, No. 20-1376 (D.C.

Cir.). While the petition levies a series of challenges against the

IFR, it does not make any explicit reference to the status of

IHM, WHM or any particular byproduct of the hemp-extract

production process under the CSA. See generally Pet. for

Review, Hemp Indus. Ass’n v. DEA, No. 20-1376 (D.C. Cir.).

Less than one month later, the Plaintiffs filed suit in district

court. They initially sought a declaration that IHM and WHM

are no longer subject to the CSA after the enactment of the

2018 Farm Bill regardless of their THC concentration, see

Compl. ¶¶ 85–102, a related declaration that the DEA lacks

authority to regulate “any aspect of hemp production, including

the production of IHM and WHM[,]” after the 2018 Farm Bill,

see id. at ¶¶ 103–110, and “an injunction enjoining the IFR and

enjoining DEA from promulgating rules that relate to the

production of hemp,” id. at ¶ 111–14. While the Plaintiffs’ suit

was pending in the district court, they requested this Court to

9

hold their September 2020 petition for review in abeyance

pendente lite, which we granted. See Order, Hemp Indus. Ass’n

v. DEA, No. 20-1376 (D.C. Cir. Oct. 21, 2021). 5

The DEA moved to dismiss the Plaintiffs’ initial complaint

for lack of subject matter jurisdiction on a variety of grounds,

including that 21 U.S.C. § 877 divested the district court of

jurisdiction and that the Plaintiffs lacked standing; the

Plaintiffs then amended their complaint. The amended

complaint sought a judicial declaration that either the definition

of “hemp” set forth in 7 U.S.C. § 1639o encompasses IHM and

WHM or that the 2018 Farm Bill otherwise immunizes the

possession and manufacture of IHM and WHM so that “the

possession and manufacture of IHM and WHM during the

hemp production process does not require registration under

the CSA,” Am. Compl. ¶ 105, as well as an injunction

“enjoining DEA from enforcing the CSA as to IHM and

WHM,” see id. at ¶ 110. The Plaintiffs alleged that the DEA

“publicized its view” that it possessed authority to regulate

hemp byproducts like IHM and WHM “in multiple forums,

including in the explanatory text of its August 2020 interim

final rule . . . and through the public statements of [DEA] staff

and representatives.” Id. at ¶ 3. The amended complaint

dropped the Plaintiffs’ original request to enjoin the IFR but it

repeatedly references and challenges the DEA’s conclusions

contained therein. See, e.g., id. at ¶ 82 (“In defiance of

Congress’s delegation of exclusive authority to regulate hemp

production to USDA, DEA promulgated its own interim final

rule . . . .”); id. at 84 (describing IFR as “DEA’s most direct

5

The abeyance was lifted once the district court dismissed the

Plaintiffs’ suit. Oral argument on the petition was held on the same

day as the instant appeal and the petition is today dismissed. See

Hemp Indus. Ass’n v. DEA, No. 20-1376, slip op. at 5 (D.C. Cir. June

10, 2020).

10

claim that IHM and WHM are illegal”); id. at ¶ 101 (quoting

IFR in describing instant suit against DEA).

The district court granted the DEA’s motion to dismiss for

lack of subject matter jurisdiction, concluding that the

Plaintiffs erroneously sought review of the IFR in district court,

instead of this Court, in contravention of 21 U.S.C. § 877. See

Hemp Indus. Ass’n, 539 F. Supp. 3d at 123. The district court

acknowledged that the Plaintiffs’ amended complaint did not

“seek a declaration that the IFR itself is invalid or an injunction

directly enjoining its application” but it also recognized that the

“Amended Complaint specifically identifies the IFR as

embodying what [Plaintiffs] contend is an incorrect

interpretation of the relevant statutes and an unlawful assertion

[of] regulatory authority.” Id. at 129–30. Further, it held, that

the Plaintiffs effectively “seek an injunction enjoining DEA

from asserting that regulatory authority and a judicial

declaration that their own, contrary interpretation is the correct

one, and that they should be exempt from its application.” Id.

at 129 (second and third alterations in original) (internal

quotation marks and citation omitted); see also id. (“For relief,

[the Plaintiffs] seek a declaration that—contrary to the IFR—

‘the definition of hemp as set forth in [the 2018 Farm Bill]

includes IHM and WHM,’ or that the [2018 Farm Bill]

‘authorizes and/or immunizes the possession and manufacture

of IHM and WHM’ such that the substances need not be

registered under the CSA.” (quoting Am. Compl. ¶ 105)). The

Plaintiffs timely appealed and we have appellate jurisdiction

pursuant to 28 U.S.C. § 1291.

II. Analysis

In reviewing a district court’s dismissal of a complaint for

lack of subject matter jurisdiction, we review the district

court’s legal determinations de novo. See Am. Nat’l Ins., 642

11

F.3d at 1139; Am. Clinical Lab’y Ass’n v. Azar, 931 F.3d 1195,

1202–03 (D.C. Cir. 2019). As explained infra, we, like the

district court, conclude that the Plaintiffs’ amended complaint

impermissibly seeks review of the same issues addressed in the

IFR—the authorization (or lack thereof) of the manufacture

and possession of IHM and WHM—outside the review scheme

set forth in 21 U.S.C. § 877. In addition, to the extent the

Plaintiffs seek a declaration that the IFR does not address either

authorization or liability regarding IHM and WHM, they have

failed to plead a plausible injury-in-fact related to enforcement

against their manufacture or possession of IHM and WHM.

A.

“Within constitutional bounds, Congress decides what

cases the federal courts have jurisdiction to consider.” Am.

Fed’n of Gov’t Emps., AFL-CIO v. Trump, 929 F.3d 748, 754

(D.C. Cir. 2019) (quoting Bowles v. Russell, 551 U.S. 205, 212

(2007)). The district court possesses jurisdiction of questions

of federal law by statute, see 28 U.S.C. § 1331, but the

Congress may circumscribe this authority “by establishing an

alternative statutory scheme for administrative and judicial

review.” Am. Fed’n of Gov’t Emps., 929 F.3d at 754. “If a

special statutory review scheme exists, . . . ‘it is ordinarily

supposed that Congress intended that procedure to be the

exclusive means of obtaining judicial review in those cases to

which it applies.’” Jarkesy v. SEC, 803 F.3d 9, 15 (D.C. Cir.

2015) (quoting City of Rochester v. Bond, 603 F.2d 927, 931

(D.C. Cir. 1979)); see also Telecomms. Rsch. & Action Ctr. v.

FCC, 750 F.2d 70, 77 (D.C. Cir. 1984) (“[A] statute which

vests jurisdiction in a particular court cuts off original

jurisdiction in other courts in all cases covered by that

statute.”).

12

The CSA provides that the DEA’s “final determinations,

findings, and conclusions” under the CSA “shall be final and

conclusive decisions of the matters involved, except that any

person aggrieved by a final decision” of the DEA “may obtain

review of the decision” in the court of appeals. 21 U.S.C. § 877.

This Court has previously concluded that section 877 “vests

exclusive jurisdiction in the courts of appeals over ‘[a]ll final

determinations, findings, and conclusions’ of the DEA

applying the CSA.” John Doe, Inc., 484 F.3d at 568 (alteration

in original) (quoting 21 U.S.C. § 877). Thus, claims falling

within the ambit of section 877—those challenging a final

decision of the DEA under the CSA—are considered by the

courts of appeals, not the district courts. The question here is

whether the Plaintiffs’ claims challenge a final decision of the

DEA—namely the IFR. 6 If so, section 877 deprives the district

court of subject matter jurisdiction. See Jarkesy, 803 F.3d at

15.

The Plaintiffs’ principal argument on appeal is that their

amended complaint does not seek to challenge or invalidate the

IFR but instead seeks a declaratory judgment that the

manufacture and possession of hemp byproducts is authorized

by the 2018 Farm Bill or otherwise immune from the CSA’s

registration and enforcement provisions, whether or not it is

deemed a controlled substance by the DEA per its IFR. See

Appellants’ Br. 30–31; see also Am. Compl. ¶ 105. The

Plaintiffs attempt to draw a meaningful distinction between

what the IFR purportedly does—that is, it conforms DEA’s

regulations to the 2018 Farm Bill’s classification decision

6

The district court concluded that the IFR is a “final decision”

under 21 U.S.C. § 877, see Hemp Indus. Ass’n, 539 F. Supp. 3d at

128, and the Plaintiffs do not argue otherwise. Further, the fact that

a rule is characterized as an “interim” rule is of no consequence. See

Mack Trucks, Inc. v. EPA, 682 F.3d 87, 95 (D.C. Cir. 2012)

(reviewing and vacating interim final rule).

13

regarding hemp and hemp-based substances—and the relief the

Plaintiffs seek—immunization from registration requirements

for IHM and WHM, regardless of the classification decision.

See Appellants’ Br. 31–32. In the Plaintiffs’ view, the IFR

“adopts no position on the question of whether the 2018 Farm

Bill authorizes the manufacture and possession of intermediate

and waste hemp material,” which they contend is the crux of

their challenge, and that silence allows their suit to proceed

notwithstanding 21 U.S.C. § 877. Id. at 35.

The classification/liability distinction drawn by the

Plaintiffs has some superficial appeal. Granted, the CSA is

intended to be a “comprehensive regime” to control the

“legitimate and illegitimate traffic in controlled substances,”

Raich, 545 U.S. at 12, but its individual Parts serve distinct

purposes in achieving those ends: Part B defines a controlled

substance, see 21 U.S.C. §§ 811–14, Part C provides regulatory

requirements (e.g., registering, labeling and packaging, and

recordkeeping) for those substances, see id. §§ 821–32, and

Parts D and E provide enforcement mechanisms and penalties

to enforce the controls placed on controlled substances, see id.

§§ 841–65 (Part D), 871–90 (Part E).

The problem for the Plaintiffs is that the IFR addresses

both classification (whether IHM and WHM are controlled)

and authorization (what controls or immunities do or do not

apply to IHM and WHM)—a conclusion that even the

Plaintiffs cannot help but reach—meaning that the

classification/authorization distinction drawn by the Plaintiffs

does not help them evade 21 U.S.C. § 877. See Hemp Indus.

Ass’n, 539 F. Supp. 3d at 128–30.

Begin with the DEA’s position on hemp and hemp-derived

substances as articulated in the IFR. The DEA adopts the view,

as the Plaintiffs relate in their amended complaint, that “the

14

definition of hemp [in the 2018 Farm Bill] does not

automatically exempt [from Schedule I] any product derived

from a hemp plant, regardless of the [delta-9]-THC content of

the derivative” and that “a cannabis derivative, extract, or

product that exceeds the 0.3% [delta-9]-THC limit is a schedule

I controlled substance, even if the plant from which it was

derived contained 0.3% or less [delta-9]-THC on a dry weight

basis.” 85 Fed. Reg. at 51,641; see Am. Compl. ¶ 83 (quoting

same). Because, as the Plaintiffs assert, both IHM and WHM,

which are “derived from” the cannabis plant, generally exceed

this 0.3 per cent threshold, see Am. Compl. ¶ 37 (“IHM and

WHM naturally (and avoidably) exceed 0.3% [delta 9]-

THC.”), the DEA could reasonably view both byproducts as

controlled substances. But the IFR also abjures regulation of

cannabis-derived substances below the 0.3 per cent delta-9

THC concentration threshold: “[E]ntities no longer require a

DEA registration or import and export permits to handle hemp

extract that does not exceed the statutory 0.3% THC limit.” 85

Fed. Reg. at 51,644; see Am. Compl. ¶ 83 (quoting same).

These two provisions could lead to the not unreasonable

interpretation that notwithstanding the 2018 Farm Bill, hemp-

derived substances exceeding the 0.3 per cent threshold—a

group that could include IHM and WHM—are still subject to

registration requirements and import/export controls.

Indeed, the Plaintiffs allege that “the necessary

implication” of the IFR’s explanatory language is “that the

CSA’s registration requirements do continue to apply to

entities handling any hemp extract that exceeds the 0.3%

[delta-9]-THC limit, including IHM and WHM.” Am. Compl.

¶ 83 (emphases omitted); see also id. at ¶ 3 (alleging the IFR

“publicized” the DEA’s “mistaken[]” view that it possesses

“authority to impose criminal and/or civil liability against

unregistered hemp processors who manufacture and/or process

IHM and WHM”); id. at ¶ 84 (characterizing the IFR as

15

“DEA’s most direct claim that IHM and WHM are illegal”); id.

at ¶¶ 100–01 (quoting the IFR as evidence of DEA’s position

that the 2018 Farm Bill does not “authorize[] the manufacture

of byproducts necessarily or unavoidably created during the

production of hemp-based” substances). Thus, the Plaintiffs

cannot avoid the conclusion that the IFR is as much about

registration requirements and liability as it is about

classification.

This brings us to the Plaintiffs’ amended complaint and

requested relief. They allege that the DEA’s “asserti[on] [of]

authority to regulate the hemp production process” constitutes

“an affront to Congress’s clear command that possession and

manufacture of IHM and WHM be permitted.” Id. at ¶ 90; see

also id. at ¶¶ 99–101; id. at ¶ 83 (“The explanatory language

accompanying the text of the IFR, however, confirms DEA’s

intent to regulate hemp production in defiance of Congress’s

express mandate in the 2018 Farm Bill.”); id. at ¶ 88 (touting

letters from senators and members of Congress asserting the

IFR “rewrites the 2018 Farm Bill contrary to Congressional

intent”). Accordingly, the Plaintiffs request “a judicial

determination” that, contrary to the IFR, “the definition of

‘hemp’ as set forth in [7 U.S.C. § 1639o], includes IHM and

WHM” or that the 2018 Farm Bill “authorizes and/or

immunizes the possession and manufacture of IHM and

WHM”—with the result of either declaration being that “the

possession and manufacture of IHM and WHM during the

hemp production process does not require registration under

the CSA.” Id. at ¶ 105. The Plaintiffs also request injunctive

relief that, again contrary to the IFR, “enjoin[s] DEA from

enforcing the CSA as to IHM and WHM.” Id. at ¶ 110.

Taken together, the Plaintiffs’ amended complaint, “[i]n

substance,” seeks review of the “same issue[]” the IFR

purportedly addresses—whether CSA controls continue to

16

apply to the manufacture and possession of hemp-derived

substances like IHM and WHM—and requests the district court

“require the [DEA] to conduct future [action] on the terms that

[the Plaintiffs] proposed.” FCC v. ITT World Commc’ns, Inc.,

466 U.S. 463, 468 & n.5 (1984); see also Hemp Indus. Ass’n,

539 F. Supp. 3d at 131 (Plaintiffs “ask the Court to endorse

their own desired statutory interpretation—which just so

happens to be the complete opposite of the position they claim

DEA adopted in a promulgated rule—and to enjoin the agency

from acting any differently.”). Both the Supreme Court and this

Court have stressed, however, that “[l]itigants may not evade”

an exclusive review provision like 21 U.S.C. § 877 “by

requesting the District Court to enjoin action that is the

outcome of the agency’s order.” ITT World Commc’ns, 466

U.S. at 468; see also Heller, Ehrman, White & MacAuliffe v.

Babbitt, 992 F.2d 360, 361, 363–64 (D.C. Cir. 1993) (“[E]ager

litigant[s]” may not “circumvent a congressional grant of

exclusive jurisdiction . . . by simply converting the suit into one

for injunctive relief.”); Daniels v. Union Pac. R.R. Co., 530

F.3d 936, 942–43 (D.C. Cir. 2008) (Litigants may not

“circumvent[] review of the [agency’s] regulations in this

Court . . . by instead indirectly . . . seeking review of the

regulations in district court.”).

The Plaintiffs’ remaining arguments are unavailing. They

first fault the district court for not “accept[ing] [their] view of

the case at the pleadings stage”—presumably their assertion

that they do not directly attack the IFR. Appellants’ Br. 30. A

court is obliged to accept “as true all of the factual allegations

contained in the complaint and draw[] all inferences in favor of

the nonmoving party,” City of Harper Woods Emps.’ Ret. Sys.

v. Olver, 589 F.3d 1292, 1298 (D.C. Cir. 2009); see Browning

v. Clinton, 292 F.3d 235, 240 (D.C. Cir. 2002) (same), but there

is no such requirement with respect to a litigant’s “view” or

“characterization” of the complaint. In fact, “constru[ing] [a]

17

complaint liberally in the plaintiff’s favor” does not entail

“accept[ing] inferences unsupported by facts or legal

conclusions cast in the form of factual allegations.” Harper

Woods, 589 F.3d at 1298 (citing Kowal v. MCI Commc’ns

Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994)). Further, in the

context of exclusive review statutes, we have cautioned against

being lulled to sleep by “creative[] framing.” Heller, Ehrman,

White & MacAuliffe, 992 F.2d at 363; Daniels, 530 F.3d at

942–43; accord ITT World Commc’ns, 466 U.S. at 468. We

therefore find no basis for the Plaintiffs’ proposition that the

district court was obligated to accept their “view” of the case.

The Plaintiffs also assert that their action is nothing more

than a “mirror image” of a government action brought under 21

U.S.C. § 882. See Appellants’ Br. 45–46 (quoting Menominee

Indian Tribe of Wis. v. DEA, 190 F. Supp. 3d 843, 850 (E.D.

Wis. 2016)). Section 882 grants “district courts of the United

States . . . jurisdiction in proceedings” brought by the

government “to enjoin violations of” the CSA. 21 U.S.C.

§ 882. But a narrow grant of jurisdiction in favor of the

government simply underscores that the Congress “knew how

to provide alternative forums for judicial review based on the

nature of a[] [plaintiff’s] claim,” Elgin v. Dep’t of Treasury,

567 U.S. 1, 13 (2012), and instead chose to require that litigants

“proceed exclusively through” section 877 in making a

challenge within its scope, Jarkesy, 803 F.3d at 15; cf. id. at 17

(“Congress, though, gave the SEC the option to pursue

violations in district court. Congress did not thereby

necessarily enable respondents in administrative

proceedings to collaterally attack those proceedings in court.”

(emphases in original)).

The Plaintiffs finally spill much ink arguing that the

district court erred in not applying Thunder Basin to determine

whether 21 U.S.C. § 877 in fact divested it of jurisdiction. See

18

Appellants’ Br. 43–58; see generally Thunder Basin Coal Co.

v. Reich, 510 U.S. 200 (1994). But Thunder Basin is

unilluminating here. The “ultimate question” Thunder Basin

asks is “whether Congress intended exclusivity when it

established the statutory scheme” at issue. Jarkesy, 803 F.3d at

12. Following the Supreme Court’s lead, our Court employs a

two-part framework: “Congress intended that a litigant proceed

exclusively through a statutory scheme . . . when (i) such intent

is fairly discernible in the statutory scheme, and (ii) the

litigant’s claims are of the type Congress intended to be

reviewed within [the] statutory structure.” Am. Fed’n of Gov’t

Emps., 929 F.3d at 754 (internal quotation marks omitted)

(quoting Jarkesy, 803 F.3d at 15); accord Free Enter. Fund v.

Pub. Co. Acct. Oversight Bd., 561 U.S. 477, 489–90 (2010);

Elgin, 567 U.S. at 10, 15.

We have already answered the first part of the Thunder

Basin framework with respect to the exclusivity of 21 U.S.C.

§ 877 by concluding that it “vests exclusive jurisdiction in the

courts of appeals over ‘[a]ll final determinations, findings, and

conclusions’ of the DEA applying the CSA.” John Doe, Inc.,

484 F.3d at 568 (emphasis added) (quoting 21 U.S.C. § 877).

Thus, we can definitively “discern that Congress intended the

statutory scheme to be exclusive with respect to claims within

its scope.” Am. Fed’n of Gov’t Emps., 929 F.3d at 755. The

second step, whether a claim is “of the type Congress intended

to be reviewed within [the] statutory structure,” id. at 754

(quoting Jarkesy, 803 F.3d at 15), reduces to whether the

Plaintiffs’ claims challenge a final agency decision subject to

section 877. See Hemp Indus. Ass’n, 539 F. Supp. 3d at 134.

We have already affirmed that it does.

19

B.

Alternatively, the Plaintiffs strenuously argue on appeal

that the IFR makes no “mention [of] the manufacture and

possession of hemp byproducts.” Appellants’ Br. 35. But even

if we accept this reframing of the Plaintiffs’ position, see supra

p. 14–15, there we fail to find any plausible basis to support the

requisite injury-in-fact to support the Plaintiffs’ claims. 7 We

note that at the pleading stage, a complaint need only contain

“sufficient factual matter, accepted as true, to state a claim [of

standing] that is plausible on its face.” Kareem v. Haspel, 986

F.3d 859, 866 (D.C. Cir. 2021) (internal quotation marks

omitted and alteration in original) (quoting Ashcroft v. Iqbal,

566 U.S. 662, 678 (2009)).

In their amended complaint, the Plaintiffs invoked the

district court’s authority under the Declaratory Judgment Act,

see Am. Compl. ¶ 8, which provides that “[i]n a case of actual

controversy within its jurisdiction,” a district court may

“declare the rights and other legal relations of any interested

party seeking such declaration, whether or not further relief is

or could be sought,” 28 U.S.C. § 2201(a), and order “[f]urther

necessary or proper relief based on [the] declaratory judgment

or decree,” id. § 2202. “[J]ust like suits for every other type of

remedy, declaratory-judgment actions must satisfy Article III’s

case-or-controversy requirement.” California v. Texas, 141 S.

Ct. 2104, 2115 (2021) (citing MedImmune, Inc. v. Genentech,

7

The district court did not reach the DEA’s argument that the

Plaintiffs lack standing, see Hemp Indus. Ass’n, 539 F. Supp. 3d at

135, but the DEA has raised the argument on appeal, see Appellee’s

Br. 32–33. And, of course, we operate under the “well established”

background principle that courts have the “independent obligation to

assure that standing exists.” Shea v. Kerry, 796 F.3d 42, 49–50 (D.C.

Cir. 2015) (quoting Summers v. Earth Island Inst., 555 U.S. 488, 499

(2009)).

20

Inc., 549 U.S. 118, 126–27 (2007)). This includes, inter alia,

demonstrating an injury-in-fact that is both “concrete and

particularized” and “actual or imminent, not conjectural or

hypothetical.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 560

(1992) (internal quotation marks and citation omitted). In other

words, a plaintiff cannot simply rest on some abstract desire to

know his rights or status under a statute, see, e.g., Ashcroft v.

Mattis, 431 U.S. 171, 172 (1977); Golden v. Zwickler, 394 U.S.

103, 109 (1969), but rather needs to connect the requested

declaration to some actual or imminent injury, see Steffel v.

Thompson, 415 U.S. 452, 458–59 (1974).

The Plaintiffs’ asserted injury is that the DEA’s position

on hemp byproducts like IHM and WHM presents them with

“the immediate dilemma of choosing between ceasing to

process, manufacture and/or store hemp; obtaining a Schedule

I registration from DEA; or risking criminal and/or civil

prosecution under the CSA by DEA for conducting such

activities.” Am. Compl. ¶ 102. Neither the Plaintiffs nor the

DEA asserts that the agency is currently undertaking or has

undertaken an enforcement action against the Plaintiffs’

possession or manufacture of hemp byproducts, meaning that

the Plaintiffs’ challenge is therefore grounded in the alleged

threat of enforcement. Although a plaintiff requesting pre-

enforcement review “is not required ‘to expose himself to

liability before bringing suit to challenge the basis’ for an

enforcement action by the government,” Matthew A. Goldstein,

PLLC v. U.S. Dep’t of State, 851 F.3d 1, 4 (D.C. Cir. 2017)

(quoting MedImmune, 549 U.S. at 128–29); see also Susan B.

Anthony List v. Driehaus (SBA List), 573 U.S. 149, 158 (2014)

(“When an individual is subject to [] a threat, an actual arrest,

prosecution, or other enforcement action is not a prerequisite

to challenging the law.”), he must nevertheless demonstrate

that either the threatened enforcement injury is “certainly

impending” or there is a “substantial risk” such injury will

21

occur, see Attias v. Carefirst, Inc., 865 F.3d 620, 627 (D.C. Cir.

2017) (quoting SBA List, 573 U.S. at 158); see also TransUnion

LLC v. Ramirez, 141 S. Ct. 2190, 2210 (2021) (“[A] person

exposed to a risk of future harm may pursue forward-looking,

injunctive relief to prevent the harm from occurring, at least so

long as the risk of harm is sufficiently imminent and

substantial.”).

Here, the Plaintiffs have failed to assert a sufficiently

imminent or substantial risk of enforcement against their

desired course of conduct: handling hemp byproducts, like

IHM and WHM, that exceed the 0.3 per cent delta-9 THC

concentration threshold set forth in the 2018 Farm Bill. If we

accept the Plaintiffs’ preferred interpretation, the IFR answers

only the question whether hemp byproducts are “controlled in

the schedules after the 2018 Farm Bill,” not the separate

question whether “the manufacture and possession of hemp

byproducts during the hemp production process [is]

authorized” or, conversely, prohibited absent DEA registration.

Appellants’ Br. 32; see also id. at 35 (“The [IFR] adopts no

position on the question of whether the 2018 Farm Bill

authorizes the manufacture and possession of intermediate and

waste hemp material.”). We would be hard-pressed to conclude

that an agency rule that allegedly takes no position on the

liability or immunity of a desired course of conduct can

simultaneously proscribe or deny immunity for that same

conduct. Cf. Matthew A. Goldstein, 851 F.3d at 5 (finding lack

of credible threat of enforcement from plaintiff’s allegations of

“vague and general descriptions of legal activities that the firm

intends to undertake, none of which the State Department

views as” unlawful).

The Plaintiffs also point to several statements by DEA

officials that purportedly highlight the view “that IHM and

WHM are illegal,” Am. Compl. ¶ 84, and have caused the

22

Plaintiffs and their members to live in fear of DEA action, see

id. at ¶ 93; see also Decl. of Rick Trojan III (Trojan Decl.) ¶ 4,

reprinted in Appendix (App.) 098–99. For example, the

Plaintiffs cite a statement from Chief of the DEA Office of

Intergovernmental Affairs Sean Mitchell:

When asked about DEA’s position regarding

elevated levels of [delta-9]-THC during “CBD

extraction,” Mr. Mitchell responded that DEA

retains discretion to enforce the CSA as to hemp

byproducts such as IHM and WHM, adding

“you’ll never hear DEA say that we’re not going

to enforce any federal law . . . .”

Am. Compl. ¶ 84 (emphasis added). They also point to

Mitchell’s statement that allegedly “equated hemp processors

with pharmaceutical companies that ‘take[]non-controlled raw

materials’ but are nevertheless ‘required to be [] registered with

DEA as a controlled substance manufacturer’ because they

‘produce[] or manufacture[] controlled substances . . .’ ‘during

th[e] manufacturing of that not controlled end product.’” Id. at

¶ 85 (alterations in original). But even if we accept these

statements as true—as well as the Plaintiffs’ legal contention

that the 2018 Farm Bill leaves the DEA no enforcement

discretion with respect to IHM and WHM—they fail to evince

any credible or imminent threat that the DEA will use its

enforcement discretion against the Plaintiffs or any of the

Hemp Association’s members. Mitchell’s statements are akin

to a statement of intent to “prosecut[e] all violators of the

statute under normal prosecutorial standards” that, absent

allegations of “prior threats” or “characteristics indicating an

especially high probability of enforcement,” do not constitute

a threat of enforcement. Seegars v. Gonzales, 396 F.3d 1248,

1255 (D.C. Cir. 2005) (internal quotation marks and citation

omitted); see also Aeronautical Radio, Inc. v. FCC, 983 F.2d

23

275, 284 (D.C. Cir. 1993) (finding “no indication in the record

. . . that the [agency] is likely to attempt to [enforce the

challenged interpretation against the petitioner]” and

concluding that the petitioner’s “alleged injury is therefore

merely conjectural” (internal quotation marks omitted)).

The Plaintiffs also cite a statement from “DEA spokesman

Michael Miller” that the 2018 Farm Bill “‘exempted any

product from a Cannabis sativa L. plant with a delta-9 THC

content of less than 0.3% by dry weight basis.’” Am. Compl.

¶ 86. This is nothing more than a restatement of law that cannot

plausibly constitute a threat of enforcement. Compare 7 U.S.C.

§ 1639o(1) (“The term ‘hemp’ means the plant Cannabis sativa

L. and any part of that plant, including the seeds thereof and all

derivatives, extracts, cannabinoids, isomers, acids, salts, and

salts of isomers, whether growing or not, with a delta-9

tetrahydrocannabinol concentration of not more than 0.3

percent on a dry weight basis.”), with 21 U.S.C.

§ 802(16)(B)(i) (“The term ‘marihuana’ does not include . . .

hemp, as defined in section 1639o of Title 7.”).

The Plaintiffs also point to three additional sources for

their alleged threat of enforcement, none of which provides a

plausible basis for a threat of enforcement against the

possession and/or manufacture of IHM and WHM. First, the

Plaintiffs point to letters from a handful of Senators and

members of Congress objecting to the DEA’s stance and

asserting that the IFR “criminalizes the intermediate steps of

hemp processing, which is wholly inconsistent with . . . the

2018 Farm Bill.” Letter from Senators Ron Wyden and Jeffrey

A. Merkley to Acting DEA Administrator Timothy J. Shea

(Oct. 22, 2020), reprinted in App. 093; see also Letter from

Members of Congress to Acting DEA Administrator Timothy

J. Shea (Oct. 20, 2020), reprinted in App. 095–97. But these

letters involve the DEA’s assertion of authority under the IFR

24

and, if anything, largely support our overarching conclusion

that the source of the Plaintiffs’ aggrievement is the IFR.

Second, the Plaintiffs point to instances of alleged DEA

overreach in the marijuana and hemp industries predating the

2018 Farm Bill. See Am. Compl. ¶¶ 40–61; Appellants’ Reply

Br. 24–25. “‘[P]ast wrongs’ may serve as ‘evidence bearing on

whether there is a real and immediate threat of repeated

injury,’” N.B. ex rel. Peacock v. District of Columbia, 682 F.3d

77, 84 (D.C. Cir. 2012) (quoting City of Los Angeles v. Lyons,

461 U.S. 95, 102 (1983)), but a plaintiff seeking prospective

declaratory and injunctive relief may not rest on past injuries

alone, see Dearth v. Holder, 641 F.3d 499, 502 (D.C. Cir.

2011); Arpaio v. Obama, 797 F.3d 11, 19 (D.C. Cir. 2015).

Further, the pre-2018 Farm Bill conduct cited by the Plaintiffs

involves the agency’s treatment of THC naturally occurring in

the cannabis plant, see Am. Compl. ¶¶ 44–49, and hemp pilot

programs administered by states for academic and research

purposes, see id. at ¶¶ 50–59, meaning it has nothing to do with

IHM, WHM or any other byproduct of the hemp-extract

production process and no “bearing on whether there is a real

and immediate threat of repeated injury” to the Plaintiffs’

production of hemp extracts after the 2018 Farm Bill. N.B. ex

rel. Peacock, 682 F.3d at 84 (quoting Lyons, 461 U.S. at 102).

Third, and finally, the Plaintiffs assert that the DEA’s

statements and history of enforcement conduct have caused

hemp manufacturers to curtail their operations and reduced

their access to financial services. See Am. Compl. ¶¶ 91–95;

see also Trojan Decl. at ¶¶ 4–7. But we have previously held

that “broad-based market effects stemming from regulatory

uncertainty are quintessentially conjectural, and it is difficult to

imagine a[n] [agency] action that would not

confer standing under this theory.” New England Power

Generators Ass’n, Inc. v. FERC, 707 F.3d 364, 369 (D.C. Cir.

25

2013) (rejecting petitioner’s argument that “chilling effect” on

petitioner’s ability to attract capital investments conferred

standing) (citing Shell Oil Co. v. FERC, 47 F.3d 1186, 1202

(D.C. Cir. 1995)); cf. Clapper v. Amnesty Int’l USA, 568 U.S.

398, 418 (2013) (“[A]llegations of subjective chill are not an

adequate substitute for a claim of specific present objective

harm or a threat of specific harm.” (internal quotation marks

omitted) (quoting Laird v. Tatum, 408 U.S. 1, 13–14 (1972))).

In sum, if we were to view the IFR as agnostic regarding

the manufacture and/or possession of IHM and WHM, the

Plaintiffs fail to plausibly allege an enforcement action that is

“certainly impending” nor a “substantial risk” that such action

will occur, thereby failing to assert a sufficient injury-in-fact to

survive dismissal. See Attias, 865 F.3d at 627 (quoting SBA

List, 573 U.S. at 158). This accords with our overarching

conclusion that the IFR is the target of the Plaintiffs’ challenge.

For the foregoing reasons, the district court’s judgment is

affirmed.

So ordered.