Hemp Industries Association v. United States Drug Enforcement Administration

CourtDistrict Court, District of Columbia
DecidedMay 3, 2021
DocketCivil Action No. 2020-2921
StatusPublished

This text of Hemp Industries Association v. United States Drug Enforcement Administration (Hemp Industries Association v. United States Drug Enforcement Administration) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hemp Industries Association v. United States Drug Enforcement Administration, (D.D.C. 2021).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

HEMP INDUSTRIES ASSOCIATION, et al.,

Plaintiffs, v. Civil Action No. 20-2921 (JEB) UNITED STATES DRUG ENFORCEMENT ADMINISTRATION, et al.,

Defendants.

MEMORANDUM OPINION

While the debate over marijuana legalization and enforcement consumes officials both in

Washington and in various state capitals, this case focuses on its cousin: hemp. It principally

involves a Drug Enforcement Administration rule issued in response to a recent round of

statutory amendments to the Controlled Substances Act, 21 U.S.C. § 801 et seq. As relevant

here, the rule states that only hemp derivatives, extracts, and products exceeding 0.3% delta-9

tetrahydrocannabinol (THC) — the principal psychoactive component of the cannabis plant —

shall be stringently regulated by the CSA. Plaintiffs seek a declaration that two necessary

byproducts of the hemp-production process — specifically, intermediate hemp material (IHM)

and waste hemp material (WHM), both of which unavoidably exceed 0.3% delta-9 THC — do

not qualify as controlled substances subject to the CSA’s registration requirements. They

likewise pursue an injunction preventing DEA from enforcing the CSA against such material.

Interesting as this question may be, the Court ultimately concludes that it is powerless to

entertain the merits of Plaintiffs’ entreaty. Congress has provided an exclusive pathway for

1 federal-court challenges to final DEA decisions such as the Interim Final Rule at issue here:

namely, a petition for review filed in the court of appeals. See 21 U.S.C. § 877. As this lawsuit,

in sum and substance, challenges an assertion of agency authority set out in the IFR, it falls

squarely within the ambit of that exclusive-review provision. The Court, accordingly, will

dismiss this action for lack of subject-matter jurisdiction.

I. Background

The Court begins with an overview of the relevant statutory and regulatory background,

then offers a brief survey of the hemp-production process at the core of this suit, and concludes

with a procedural history.

A. Legal Background

Passed in 1970 and enforced by DEA, the CSA creates a comprehensive regulatory

regime that criminalizes the unauthorized manufacture, distribution, and dispensation of

controlled substances. See 21 U.S.C. §§ 822, 841(a); see also 28 C.F.R. § 0.100(b) (Attorney

General delegating regulatory authority under CSA to DEA). The CSA groups such substances

into five “schedules” based on their potential for abuse, accepted medical uses, and accepted

safety for use under medical supervision. See 21 U.S.C. § 812(a)–(b); see also id. § 811(a)

(empowering DEA to add or remove substances from schedules). Substances in Schedule I —

which have “no currently accepted medical use in treatment in the United States” — are subject

to the most stringent controls. Id. § 812(a)–(b). For example, anyone who “manufactures,”

“distributes,” or “dispenses” such a controlled substance is generally required to register with

DEA. Id. § 822(a); see also id. § 823(a) (listing factors to be considered when registering

manufacturers of Schedule I substances).

2 Both marijuana and tetrahydrocannabinols are classified under Schedule I. Id. § 812,

Schedule I (c)(10), (17). Although Congress has long regulated these substances (the former

since 1937), the Agriculture Improvement Act of 2018 ushered in a new regulatory framework

for the plant Cannabis sativa L. and its various derivatives that have lower concentrations of

delta-9 THC (a specific type of tetrahydrocannabinol). Specifically, the statute introduced a

revised definition for “hemp”:

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.

7 U.S.C. § 1639o(1). With that definition in tow, the AIA then amended the CSA in two

relevant ways. First, it clarified that “[t]he term [marijuana] does not include . . . hemp, as

defined in [the AIA].” 21 U.S.C. § 802(16). Second, it carved out from Schedule I

“tetrahydrocannabinols in hemp (as defined under [the AIA]).” Id. § 812, Schedule I (c)(17).

These changes thus exempted from the CSA’s registration requirements the cultivation and

processing of the cannabis plant under specified conditions. The AIA further granted the

Department of Agriculture — subject to several exceptions not immediately relevant — “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). Notwithstanding that provision, the CSA continues

to grant DEA general authority to promulgate and enforce regulations it deems necessary and

appropriate to execute its functions under the CSA. See 21 U.S.C. §§ 821, 871(b); see also 21

C.F.R. §§ 1300–1317.

Invoking those rulemaking powers, DEA on August 21, 2020, published an interim final

rule intended to “conform[] [its] regulations” to the AIA’s statutory amendments. See

3 Implementation of the Agriculture Improvement Act of 2018, 85 Fed. Reg. 51,639, 51,639 (Aug.

21, 2020). Notwithstanding its oxymoronic-sounding title, the IFR became effective and binding

upon regulated parties on the date of its publication and thus constitutes final agency action. Id.

The rule altered the agency’s Schedule I regulation to clarify that “[Marijuana] Extract” is

limited to extracts “containing greater than 0.3% delta-9-[THC] on a dry weight basis,” and that

“Tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that

falls within the [AIA’s] definition of hemp.” Id. at 51,640; see also 21 C.F.R. § 1308.11(d)(31),

(58). The agency also specifically addressed products derived from hemp plants, stating that

“[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. In other

words, according to DEA, “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.” Id.; see also id. at 51,640–

41 (similar).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

City of Tacoma v. Taxpayers of Tacoma
357 U.S. 320 (Supreme Court, 1958)
Leedom v. Kyne
358 U.S. 184 (Supreme Court, 1958)
Lujan v. Defenders of Wildlife
504 U.S. 555 (Supreme Court, 1992)
Gonzales v. Oregon
546 U.S. 243 (Supreme Court, 2006)
Bowles v. Russell
551 U.S. 205 (Supreme Court, 2007)
Ligon v. LaHood
614 F.3d 150 (Fifth Circuit, 2010)
John Doe, Inc. v. Drug Enforcement Administration
484 F.3d 561 (D.C. Circuit, 2007)
Daniels v. Union Pacific Railroad
530 F.3d 936 (D.C. Circuit, 2008)
New Hampshire Hemp Council, Inc. v. Marshall
203 F.3d 1 (First Circuit, 2000)
Victor Herbert v. National Academy of Sciences
974 F.2d 192 (D.C. Circuit, 1992)

Cite This Page — Counsel Stack

Bluebook (online)
Hemp Industries Association v. United States Drug Enforcement Administration, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hemp-industries-association-v-united-states-drug-enforcement-dcd-2021.