Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 1 of 25
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`HEMP INDUSTRIES ASSOCIATION, et
`al.,
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`Plaintiffs,
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`v.
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`UNITED STATES DRUG
`ENFORCEMENT ADMINISTRATION, et
`al.,
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`Defendants.
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`Civil Action No. 20-2921 (JEB)
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`MEMORANDUM OPINION
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`While the debate over marijuana legalization and enforcement consumes officials both in
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`Washington and in various state capitals, this case focuses on its cousin: hemp. It principally
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`involves a Drug Enforcement Administration rule issued in response to a recent round of
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`statutory amendments to the Controlled Substances Act, 21 U.S.C. § 801 et seq. As relevant
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`here, the rule states that only hemp derivatives, extracts, and products exceeding 0.3% delta-9
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`tetrahydrocannabinol (THC) — the principal psychoactive component of the cannabis plant —
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`shall be stringently regulated by the CSA. Plaintiffs seek a declaration that two necessary
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`byproducts of the hemp-production process — specifically, intermediate hemp material (IHM)
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`and waste hemp material (WHM), both of which unavoidably exceed 0.3% delta-9 THC — do
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`not qualify as controlled substances subject to the CSA’s registration requirements. They
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`likewise pursue an injunction preventing DEA from enforcing the CSA against such material.
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`Interesting as this question may be, the Court ultimately concludes that it is powerless to
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`entertain the merits of Plaintiffs’ entreaty. Congress has provided an exclusive pathway for
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`1
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 2 of 25
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`federal-court challenges to final DEA decisions such as the Interim Final Rule at issue here:
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`namely, a petition for review filed in the court of appeals. See 21 U.S.C. § 877. As this lawsuit,
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`in sum and substance, challenges an assertion of agency authority set out in the IFR, it falls
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`squarely within the ambit of that exclusive-review provision. The Court, accordingly, will
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`dismiss this action for lack of subject-matter jurisdiction.
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`I.
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`Background
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`The Court begins with an overview of the relevant statutory and regulatory background,
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`then offers a brief survey of the hemp-production process at the core of this suit, and concludes
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`with a procedural history.
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`A. Legal Background
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`Passed in 1970 and enforced by DEA, the CSA creates a comprehensive regulatory
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`regime that criminalizes the unauthorized manufacture, distribution, and dispensation of
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`controlled substances. See 21 U.S.C. §§ 822, 841(a); see also 28 C.F.R. § 0.100(b) (Attorney
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`General delegating regulatory authority under CSA to DEA). The CSA groups such substances
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`into five “schedules” based on their potential for abuse, accepted medical uses, and accepted
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`safety for use under medical supervision. See 21 U.S.C. § 812(a)–(b); see also id. § 811(a)
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`(empowering DEA to add or remove substances from schedules). Substances in Schedule I —
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`which have “no currently accepted medical use in treatment in the United States” — are subject
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`to the most stringent controls. Id. § 812(a)–(b). For example, anyone who “manufactures,”
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`“distributes,” or “dispenses” such a controlled substance is generally required to register with
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`DEA. Id. § 822(a); see also id. § 823(a) (listing factors to be considered when registering
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`manufacturers of Schedule I substances).
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`2
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 3 of 25
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`Both marijuana and tetrahydrocannabinols are classified under Schedule I. Id. § 812,
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`Schedule I (c)(10), (17). Although Congress has long regulated these substances (the former
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`since 1937), the Agriculture Improvement Act of 2018 ushered in a new regulatory framework
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`for the plant Cannabis sativa L. and its various derivatives that have lower concentrations of
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`delta-9 THC (a specific type of tetrahydrocannabinol). Specifically, the statute introduced a
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`revised definition for “hemp”:
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`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.
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`7 U.S.C. § 1639o(1). With that definition in tow, the AIA then amended the CSA in two
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`relevant ways. First, it clarified that “[t]he term [marijuana] does not include . . . hemp, as
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`defined in [the AIA].” 21 U.S.C. § 802(16). Second, it carved out from Schedule I
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`“tetrahydrocannabinols in hemp (as defined under [the AIA]).” Id. § 812, Schedule I (c)(17).
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`These changes thus exempted from the CSA’s registration requirements the cultivation and
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`processing of the cannabis plant under specified conditions. The AIA further granted the
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`Department of Agriculture — subject to several exceptions not immediately relevant — “sole
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`authority to promulgate Federal regulations and guidelines that relate to the production of hemp.”
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`7 U.S.C. § 1639r(b); see also id. § 1639o(3). Notwithstanding that provision, the CSA continues
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`to grant DEA general authority to promulgate and enforce regulations it deems necessary and
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`appropriate to execute its functions under the CSA. See 21 U.S.C. §§ 821, 871(b); see also 21
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`C.F.R. §§ 1300–1317.
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`Invoking those rulemaking powers, DEA on August 21, 2020, published an interim final
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`rule intended to “conform[] [its] regulations” to the AIA’s statutory amendments. See
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`3
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 4 of 25
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`Implementation of the Agriculture Improvement Act of 2018, 85 Fed. Reg. 51,639, 51,639 (Aug.
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`21, 2020). Notwithstanding its oxymoronic-sounding title, the IFR became effective and binding
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`upon regulated parties on the date of its publication and thus constitutes final agency action. Id.
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`The rule altered the agency’s Schedule I regulation to clarify that “[Marijuana] Extract” is
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`limited to extracts “containing greater than 0.3% delta-9-[THC] on a dry weight basis,” and that
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`“Tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that
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`falls within the [AIA’s] definition of hemp.” Id. at 51,640; see also 21 C.F.R. § 1308.11(d)(31),
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`(58). The agency also specifically addressed products derived from hemp plants, stating that
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`“[i]n order to meet the definition of ‘hemp,’ and thus qualify for the exemption from schedule I,
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`the derivative must not exceed the 0.3% [delta-9]-THC limit.” 85 Fed. Reg. at 51,641. In other
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`words, according to DEA, “a cannabis derivative, extract, or product that exceeds the 0.3%
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`[delta-9]-THC limit is a schedule I controlled substance, even if the plant from which it was
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`derived contained 0.3% or less [delta-9]-THC on a dry weight basis.” Id.; see also id. at 51,640–
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`41 (similar). This determination is at the core of Plaintiffs’ challenge here.
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`Finally, the CSA provides for original jurisdiction in the courts of appeals over “[a]ll
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`final determinations, findings, and conclusions” made by DEA under the statute. See 21 U.S.C.
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`§ 877. Any person “aggrieved by a final decision” may obtain review thereof by filing a petition
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`in the relevant court of appeals within thirty days. Id.
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`B. Factual Background
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`These statutory and regulatory developments occurred amidst an American hemp
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`economy witnessing rapid and substantial growth. As of 2019, nearly 512,000 acres of land
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`were licensed for hemp cultivation in the United States, and one survey the year after found more
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`than 5,400 state-licensed hemp processors — both significant increases from years prior. See
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`4
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 5 of 25
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`ECF No. 29 (Am. Compl.), ¶¶ 22, 26. A wide array of hemp products, in turn, have flooded the
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`consumer market; applications of the plant range from fabrics and textiles, to papermaking and
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`oil absorbents, to foods and cosmetics, and beyond. Id., ¶ 16.
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`Among the ingredients for each of these products are extracts derived from hemp plants.
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`Id., ¶ 29. In their final form, the extracts contain less than 0.3% delta-9 THC and are therefore
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`not psychoactive or subject to the CSA. Id., ¶¶ 15, 29. The problem here for Plaintiffs lies in the
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`hemp-extract production process. As a high-level understanding of that process is necessary to
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`grasp the substantive issues underlying this action, the Court — with useful assistance from
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`Plaintiffs — will briefly outline its key stages.
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`The journey begins with the cultivation and harvest of hemp plants, which are soon
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`transferred to third-party processors for “milling” and “extraction.” Id., ¶¶ 32–34. Deploying a
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`series of complex procedures, the processors separate the hemp flower from the remainder of the
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`plant, extract cannabinoids from raw flower material (the remains of which are then discarded),
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`and evaporate the resulting oil in order to remove extraneous solvents, fats, and lipids. Id.,
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`¶¶ 33–35. Evaporation generates two outputs of particular relevance here: intermediate hemp
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`material and waste hemp material. Both substances “naturally (and unavoidably) exceed” 0.3%
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`delta-9 THC concentration, as prior steps in the production process have stripped away the low-
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`THC and THC-free parts of the hemp plant. Id., ¶¶ 35–37; see also id., ¶¶ 35–36 (explaining that
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`IHM and WHM “contain[] concentrated levels of cannabinoids”). According to Plaintiffs,
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`however, neither IHM nor WHM is added to or otherwise used as an ingredient in any consumer
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`product. Id., ¶¶ 35–36. IHM, rather, is further refined into extracts or isolates containing less
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`than 0.3% delta-9 THC, which are in turn used as ingredients in such consumer products. Id.,
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`¶¶ 35, 38. Plaintiffs do not discuss what processors or businesses do with WHM.
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`5
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 6 of 25
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`At bottom, then, certain in-process materials created in the course of hemp production
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`“will inevitably exceed 0.3% [delta-9]-THC,” even though both the initially harvested hemp
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`plant and the ultimate output of the extraction process contain less than that concentration. Id.,
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`¶¶ 38–39. Plaintiffs in this suit want this Court to approve that process, thereby alleviating their
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`fear of criminal enforcement and obviating any need to obtain a Schedule I registration from
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`DEA.
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`C. Procedural History
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`Plaintiffs here are the Hemp Industries Association and RE Botanicals, Inc. HIA, which
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`represents the interests of American hemp companies and consumers, has more than a thousand
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`business, farming, and individual members, roughly 300 of whom manufacture, process, or store
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`IHM and WHM. Id., ¶ 11. RE Botanicals, meanwhile, is a private corporation that produces and
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`markets hemp products (and thus handles the same two substances). Id., ¶ 12.
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`These two Plaintiffs first filed suit not in this district court, but rather upstairs in the D.C.
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`Circuit. Displeased with DEA’s August 2020 IFR — which, as previously noted, states that “a
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`cannabis derivative, extract, or product that exceeds the 0.3% [delta-9]-THC limit is a schedule I
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`controlled substance,” even if the product is “derived from a [below-threshold] hemp plant,” 85
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`Fed. Reg. at 51,641 — they lodged a petition for review of the rule in the court of appeals shortly
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`after its promulgation. See Hemp Indus. Ass’n v. DEA, No. 20-1376 (D.C. Cir. Sept. 18, 2020);
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`21 U.S.C. § 877 (requiring parties seeking review of final DEA decision to file petition in court
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`of appeals within thirty days). The petition attacked the IFR on both substantive and procedural
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`grounds. See Petition for Review at 5 (D.C. Cir. Sept. 18, 2020).
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`Plaintiffs, as it turned out, were just getting started: less than a month later, they
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`commenced a distinct action in this Court against DEA and its Acting Administrator. See ECF
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`6
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 7 of 25
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`No. 1 (Compl.). Their initial Complaint requested several forms of declaratory relief relating to
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`positions assertedly adopted by DEA in the IFR with respect to IHM and WHM, as well as “an
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`injunction enjoining the IFR.” Id., ¶¶ 85–116. Just eight days after lodging that pleading,
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`Plaintiffs moved to hold their D.C. Circuit case in abeyance “until an appealable decision is
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`reached in” these district-court proceedings. See Petitioners’ Motion to Hold in Abeyance at 1
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`(D.C. Cir. Oct. 20, 2020). They explained that their district-court action sought “declaratory
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`relief that involves interpretation of the same hemp-related amendments that the IFR purports to
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`implement,” and that such proceedings “may affect the outcome of” the D.C. Circuit case. Id. at
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`3. The court of appeals subsequently granted the motion. See Clerk’s Order (D.C. Cir. Oct. 21,
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`2020).
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`Additional proceedings in this Court ensued. Prior to any response from the
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`Government, Plaintiffs filed a self-styled Emergency Motion for Expedited Discovery seeking an
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`order compelling DEA to answer two interrogatories aimed at ascertaining whether IHM and
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`WHM were controlled substances under the CSA. See ECF No. 21 (Pl. Disc. Mot.) at 8. The
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`Court denied that invitation, noting that “as best [it] can tell, no court has ever ordered this kind
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`of pre-Answer discovery against a federal agency.” ECF No. 24 (Disc. Op.) at 2. In doing so,
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`the Court expressed its “present doubts” as to whether it even had subject-matter jurisdiction
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`over the lawsuit in light of Section 877’s command that challenges to final DEA determinations
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`be brought in the courts of appeals. Id. at 4–5. It nonetheless elected to “await Defendants’
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`fuller briefing” before tackling this jurisdictional issue. Id. (cleaned up) (citations omitted).
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`Such briefing has now arrived. As anticipated, the Government soon filed a Motion to
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`Dismiss for lack of subject-matter jurisdiction, see ECF No. 26, which Plaintiffs countered with
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`an Amended Complaint. The revised pleading seeks relief similar (but not identical) to its
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 8 of 25
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`predecessor — essentially, declaratory and injunctive relief preventing DEA from enforcing the
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`CSA against the manufacture and possession of IHM and WHM. See Am. Compl., ¶¶ 6, 105,
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`110. It no longer, at least explicitly, seeks an injunction “enjoining the IFR” itself. See Compl.,
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`¶ 114. Their earlier effort having been mooted, Defendants promptly renewed their bid for
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`dismissal, see ECF No. 30 (Def. Mot.), which Plaintiffs opposed. See ECF No. 33 (Pl. Opp.).
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`Plaintiffs have not moved for a temporary restraining order or a preliminary injunction.
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`II.
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`Legal Standard
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`Defendants’ Motion invokes the legal standard for dismissal under Rule 12(b)(1). When
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`a defendant brings a motion to dismiss under that Rule, the plaintiff must demonstrate that the
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`court has subject-matter jurisdiction to hear his claims. See Lujan v. Defs. of Wildlife, 504 U.S.
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`555, 561 (1992); U.S. Ecology, Inc. v. U.S. Dep’t of Interior, 231 F.3d 20, 24 (D.C. Cir. 2000).
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`“Because subject-matter jurisdiction focuses on the court’s power to hear the plaintiff’s claim,”
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`the court has “an affirmative obligation to ensure that it is acting within the scope of its
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`jurisdictional authority.” Grand Lodge of Fraternal Order of Police v. Ashcroft, 185 F. Supp. 2d
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`9, 13 (D.D.C. 2001). “Absent subject matter jurisdiction over a case, the court must dismiss it.”
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`Bell v. U.S. Dep’t of Health & Human Servs., 67 F. Supp. 3d 320, 322 (D.D.C. 2014).
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`In policing its jurisdictional borders, the court must scrutinize the complaint, granting the
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`plaintiff the benefit of all reasonable inferences that can be derived from the alleged facts. See
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`Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C. Cir. 2005). The court need not
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`rely “on the complaint standing alone,” however, but may also look to undisputed facts in the
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`record or resolve disputed ones. See Herbert v. Nat’l Acad. of Scis., 974 F.2d 192, 197 (D.C.
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`Cir. 1992). Nor need the court accept inferences drawn by the plaintiff if those inferences are
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`unsupported by facts alleged in the complaint or merely amount to legal conclusions. See
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 9 of 25
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`Browning v. Clinton, 292 F.3d 235, 242 (D.C. Cir. 2002).
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`III. Analysis
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`The Court begins by explaining why 21 U.S.C. § 877, the CSA’s exclusive-review
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`provision, divests the Court of subject-matter jurisdiction over this action. It then concludes with
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`an examination of Plaintiffs’ separate contention that jurisdiction is nonetheless proper under
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`Leedom v. Kyne, 358 U.S. 184 (1958).
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`A. Exclusive-Review Provision
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`“Within constitutional bounds, Congress decides what cases the federal courts have
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`jurisdiction to consider.” Jarkesy v. SEC, 803 F.3d 9, 15 (D.C. Cir. 2015) (quoting Bowles v.
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`Russell, 551 U.S. 205, 212 (2007)). “Litigants generally may seek review of agency action in
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`district court under any applicable jurisdictional grant.” Id. Not so, however, when Congress
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`has established a “special statutory review scheme.” Id. In such circumstances, courts assume
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`that “Congress intended that procedure to be the exclusive means of obtaining judicial review in
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`those cases to which it applies.” Id. (quoting City of Rochester v. Bond, 603 F.2d 927, 931 (D.C.
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`Cir. 1979)); accord Telecomms. Rsch. & Action Ctr. v. FCC, 750 F.2d 70, 77 (D.C. Cir. 1984)
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`(“[A] statute which vests jurisdiction in a particular court cuts off original jurisdiction in other
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`courts in all cases covered by that statute.”).
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`The CSA contains such a statutory-review provision. It states, in relevant part:
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`All final determinations, findings, and conclusions of the Attorney
`General under this subchapter shall be final and conclusive
`decisions of the matters involved, except that any person aggrieved
`by a final decision of the Attorney General may obtain review of the
`decision in the United States Court of Appeals for the District of
`Columbia or for the circuit in which his principal place of business
`is located upon petition filed with the court and delivered to the
`Attorney General within thirty days after notice of the decision.
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 10 of 25
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`21 U.S.C. § 877; see 28 C.F.R. § 0.100(b) (Attorney General delegating regulatory authority
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`under CSA to DEA). The D.C. Circuit has confirmed that this provision “vests exclusive
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`jurisdiction in the courts of appeals over ‘[a]ll final determinations, findings, and conclusions’ of
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`the DEA applying the CSA.” John Doe, Inc. v. DEA, 484 F.3d 561, 568 (D.C. Cir. 2007)
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`(alteration in original). In other words, Section 877 overrides the more general federal-question
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`statute, see Ligon v. LaHood, 614 F.3d 150, 154–55 (5th Cir. 2010); Bold All. v. FERC, No. 17-
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`1822, 2018 WL 4681004, at *4 (D.D.C. Sept. 28, 2018), and provides the “exclusive means of
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`obtaining judicial review in those cases to which it applies.” Jarkesy, 803 F.3d at 15 (citation
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`omitted); see also City of Tacoma v. Taxpayers of Tacoma, 357 U.S. 320, 336 (1958)
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`(explaining that “all objections” to agency action encompassed by exclusive-review provision
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`“must be made in the Court of Appeals or not at all”).
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`Before considering the import of Section 877 for the present case, the Court finds it
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`useful to review a key D.C. Circuit precedent on the provision’s operation. In John Doe, Inc., a
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`plaintiff dissatisfied with DEA’s denial of an importing permit brought suit in district court,
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`arguing that the agency’s determination was contrary to law and seeking an injunction requiring
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`it to approve the application. See 484 F.3d at 564; John Doe, Inc. v. Gonzalez, No. 06-966, 2006
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`WL 1805685, at *11 (D.D.C. June 29, 2006). The Circuit affirmed the district court’s dismissal
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`for lack of subject-matter jurisdiction, holding that Section 877 assigned review of the plaintiff’s
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`claims regarding DEA’s “final determination” exclusively to the court of appeals. See 484 F.3d
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`at 568–70. As the district court explained, “[T]he CSA, pursuant to Section 877, provides one
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`explicit avenue for judicial review — i.e., via petition to the applicable court of appeals — and
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`nowhere does it contemplate that district courts should involve themselves in adjudicating CSA-
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`based determinations by the DEA.” 2006 WL 1805685, at *20. While the court of appeals could
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`entertain a separate petition for review filed by the plaintiff contesting the permit denial, the
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`district court lacked jurisdiction over the parallel lawsuit. See 484 F.3d at 570. The Circuit
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`warned that adopting a “narrow interpretation of § 877” would “encourage[] forum shopping,”
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`cause “dissatisfied claimants to ‘jump the gun’ by going directly to the district court to develop
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`their case instead of exhausting their administrative remedies before the agency,” and lead to
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`“duplicative and potentially conflicting review.” Id. at 570 (citation omitted).
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`Although John Doe, Inc. does not squarely control this case, for the reasons that follow,
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`the Court concludes that — much as in that precedent — Plaintiffs here are effectively
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`challenging a “final determination[]” or “conclusion[]” made by DEA — specifically, its August
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`2020 IFR. See 21 U.S.C. § 877. While they (no longer) seek formal invalidation of the rule in
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`this lawsuit, they pursue declaratory and injunctive relief that would functionally nullify the
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`precise position that they claim the agency has adopted in the IFR. Because Plaintiffs may only
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`“obtain review of [that] decision” in the court of appeals, this Court lacks jurisdiction to
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`separately entertain their claims. Id.; see also John Doe, Inc., 484 F.3d at 570.
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`As a preliminary matter, both parties appear to agree that the IFR — which, once again,
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`became effective and binding on regulated parties upon its promulgation, see 85 Fed. Reg. at
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`51,639 — constitutes a “final decision” under Section 877. The Government so maintains, see,
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`e.g., Def. Mot. at 8–9; ECF No. 34 (Def. Reply) at 5, 14, and Plaintiffs never suggest otherwise.
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`Indeed, their aforementioned petition for review challenging the IFR in the D.C. Circuit
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`explicitly cites Section 877 as its jurisdictional basis. See Petition for Review at 4 (D.C. Cir.
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`Sept. 18, 2020). The Court thus agrees that Section 877’s threshold requirement is satisfied. See
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`Hemp Indus. Ass’n v. DEA, 357 F.3d 1012, 1014 (9th Cir. 2004) (noting court of appeals’
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`jurisdiction over challenge to rule issued under CSA); Oregon v. Ashcroft, 368 F.3d 1118, 1120
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 12 of 25
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`(9th Cir. 2004) (same for interpretive rule), aff’d sub nom. Gonzales v. Oregon, 546 U.S. 243
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`(2006); Monson v. DEA, 589 F.3d 952, 960 (8th Cir. 2009) (noting that challenge to rule
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`promulgated under CSA must be filed in court of appeals); cf. O.A. v. Trump, 404 F. Supp. 3d
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`109, 132 n.8 (D.D.C. 2019) (finding that interim final rule was final agency action even though
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`agency had invited public comment on it); Mack Trucks, Inc. v. EPA, 682 F.3d 87, 95 (D.C. Cir.
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`2012) (reviewing and vacating interim final rule even though agency was “in the process of
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`promulgating a final rule” covering same issue).
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`The question, then, becomes whether Plaintiffs’ lawsuit challenges the IFR, such that
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`review thereof may only be had in the court of appeals per the plain terms of the CSA’s
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`exclusive-review provision. Three steps make clear that it does.
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`Begin with what the IFR says. As previously discussed, the IFR amends DEA’s
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`regulatory definition of marijuana extract and tetrahydrocannabinols. See 85 Fed. Reg. 51,645
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`(defining marijuana extract to include extracts “containing greater than 0.3 percent delta-9-
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`[THC] on a dry weight basis” and defining “Tetrahydrocannabinols” to exclude “any material,
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`compound, mixture, or preparation that falls within the [AIA’s] definition of hemp”) (citing 21
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`C.F.R. § 1308.11(d)(31)(ii), (58)). It goes on to adopt the definitive position, as Plaintiffs relate
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`in their Amended Complaint, see Am. Compl., ¶ 83, that “the definition of hemp [in the AIA]
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`does not automatically exempt [from Schedule I] any product derived from a hemp plant,
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`regardless of the [delta-9]-THC content of the derivative” and that “a cannabis derivative,
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`extract, or product that exceeds the 0.3% [delta-9]-THC limit is a schedule I controlled
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`substance, even if the plant from which it was derived contained 0.3% or less [delta-9]-THC on a
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`dry weight basis.” 85 Fed. Reg. at 51,641. It further declares that “entities no longer require a
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 13 of 25
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`DEA registration or import and export permits to handle hemp extract that does not exceed the
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`statutory 0.3% THC limit.” Id. at 51,644; see Am. Compl., ¶ 83.
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`Second, consider what Plaintiffs claim the IFR means. At its core, they believe that the
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`rule establishes that “the CSA’s registration requirements do continue to apply to entities
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`handling . . . IHM and WHM.” Am. Compl., ¶ 83. In other words, Plaintiffs maintain, DEA
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`“publicized its view” in the IFR that IHM and WHM “are Schedule I substances,” thereby
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`“assert[ing] its authority to impose criminal and/or civil liability against unregistered hemp
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`processors who manufacture and/or process IHM and WHM.” Id., ¶ 3. The IFR thus both
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`“constitute[s] DEA’s most direct claim that IHM and WHM are illegal,” id., ¶ 84, and “confirms
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`[the agency’s] intent to regulate hemp production.” Id., ¶ 83; see also id., ¶¶ 100–01 (quoting
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`IFR as evidence of DEA’s position that IHM and WHM are not exempt from Schedule I); Pl.
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`Disc. Mot. at 5 (arguing that IFR “effectively reschedules hemp derivatives and extracts” and
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`“criminalize[s]” an “essential intermediate step in the production of hemp” products).
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`Finally — and this is the key point that closes the loop — the Court looks at Plaintiffs’
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`position in this lawsuit and the relief they seek. According to them, the DEA stance outlined
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`above — i.e., its “asserti[on] [of] authority to regulate the hemp production process” —
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`constitutes “an affront to Congress’s clear command that possession and manufacture of IHM
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`and WHM be permitted.” Id., ¶ 90. Put differently, they argue that the very regulatory authority
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`laid out in the IFR flouts the AIA. Id., ¶¶ 87, 99–101; see id., ¶ 83 (contending that IFR
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`“confirms DEA’s intent to regulate hemp production in defiance of Congress’s express mandate
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`in the [AIA]”). For relief, they seek a declaration that — contrary to the IFR — “the definition
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`of ‘hemp’ as set forth in [the AIA] includes IHM and WHM,” or that the AIA “authorizes and/or
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`immunizes the possession and manufacture of IHM and WHM” such that the substances need
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`Case 1:20-cv-02921-JEB Document 36 Filed 05/03/21 Page 14 of 25
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`not be registered under the CSA. Id., ¶ 105. Similarly, they pursue an injunction that — once
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`again contrary to the IFR — would prevent “DEA from enforcing the CSA as to IHM and
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`WHM.” Id., ¶ 110.
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`It is clear that such relief would have a singular effect: nullifying the unlawful assertion
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`of agency authority that Plaintiffs insist the IFR sets forth. Put simply, the Amended Complaint
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`“specifically identifies the IFR as embodying what [Plaintiffs] contend is an incorrect
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`interpretation of the relevant statutes and an unlawful assertion [of] regulatory authority. They
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`seek an injunction enjoining DEA from asserting that regulatory authority and a judicial
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`declaration that their own, contrary interpretation is the correct one, and that they should be
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`exempt from its application.” Def. Reply at 6–7. It is thus difficult to see how this lawsuit —
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`which arrived less than two months after the IFR’s promulgation — is anything but a challenge
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`to the IFR that falls within the “exclusive jurisdiction [of] the courts of appeals.” John Doe, Inc.,
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`484 F.3d at 568 (citing 21 U.S.C. § 877).
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`To be sure, and as they repeatedly state, Plaintiffs do not in these proceedings seek a
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`declaration that the IFR itself is invalid or an injunction directly enjoining its application. They
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`expressly sought the latter relief in their initial Complaint, see Compl., ¶ 114, a claim
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`indistinguishable from the direct assault on the permit denial in John Doe, Inc. that the D.C.
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`Circuit determined could only proceed in the court of appeals. See 484 F.3d at 570. But the fact
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`that Plaintiffs’ amended pleading attacks the very position that they claim DEA adopted in the
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`IFR without explicitly seeking to invalidate or reverse the IFR itself by name does not make this
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`suit any less of a challenge to the IFR or any less of an attempt to “obtain review of” the
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`assertion of regulatory authority contained therein. See 21 U.S.C. § 877. Plaintiffs cannot avoid
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`Section 877 by shrewdly styling their Amended Complaint as technically eschewing a formal
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`challenge to the IFR while functionally seeking a judicial pronouncement as to the validity of its
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`substance. They may not, in other words, “circumvent a congressional grant of exclusive
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`jurisdiction” by “creatively framing their complaint.” Heller, Ehrman, White & MacAuliffe v.
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`Babbitt, 992 F.2d 360, 363 (D.C. Cir. 1993).
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`Ample authority reinforces this commonsense result. For instance, in FCC v. ITT World
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`Communications, Inc., 466 U.S. 463 (1984), the Supreme Court held that a district court lacked
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`jurisdiction to consider a claim raising the same substantive issues that were at stake in a final
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`agency decision, review of which a statutory provision committed to the exclusive jurisdiction of
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`the court of appeals. The procedural posture was relatively straightforward. First, the FCC
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`denied the plaintiff’s petition for rulemaking to curtail the agency’s negotiations with foreign
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`governments. Id. at 465. Having appealed that denial to the D.C. Circuit, the plaintiff
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`simultaneously filed a lawsuit in the district court seeking to enjoin the agency from conducting
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`the very same foreign negotiations. Id. at 466, 468. The Supreme Court determined that the
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`district court lacked jurisdiction over such claim, remarking that “[l]itigants may not evade
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`[exclusive-review] provisions by requesting the District Court to enjoin action that is the
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`outcome of the agency’s order.” Id. at 468–69. The plaintiff could not file a complaint in the
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`district court raising, “[i]n substance,” the “same issues” and attempting “to enforce the same
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`restrictions upon agency conduct as did the petition for rulemaking,” review of which was only
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`proper in the court of appeals. Id.; see also Sandwich Isles Commc’ns, Inc. v. Nat’l Exch.
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`Carrier Ass’n, 799 F. Supp. 2d 44, 49–50 (D.D.C. 2011) (similarly determining that court lacked
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`jurisdiction to hear claim where plaintiffs “in essence . . . are seeking review of an FCC order”
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`— notwithstanding their insistence that the “case does not amount to an effort to obtain judicial
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`review of” such order as a formal matter — because review of agency orders was committed to
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`“exclusive jurisdiction” of court of appeals).
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`So too here: Plaintiffs may not “evade” Section 877 by filing a district-court action that,
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`“[i]n substance,” seeks review of the “same issues” that the IFR purportedly addresses, and that
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`further seeks — much like their (presently pending) petition for review in the court of appeals —
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`“to require [DEA] to conduct future [action] on the terms that [Plaintiffs] propose[].” ITT
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`World, 466 U.S. at 468 & n.5; see also Daniels v. Union Pac. R.R. Co., 530 F.3d 936, 942–43
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`(D.C. Cir. 2008) (holding that district court lacked subject-matter jurisdiction over claim that, in
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`substance but not in name, challenged agency’s interpretation of its regulations, thus rejecting
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`attempt to “circumvent[] review of the [