36 F.4th 278
D.C. Cir.2022Background
- The 2018 Farm Bill redefined "hemp" (Cannabis sativa L. with ≤0.3% Δ9‑THC) and removed THC in hemp from the CSA Schedule I listing; USDA was given primary authority over hemp production.
- In August 2020 the DEA issued an interim final rule (IFR) purporting to conform DEA regulations to the 2018 Farm Bill, excluding hemp meeting the 0.3% Δ9‑THC threshold but stating derivatives that exceed 0.3% remain Schedule I and that registration is not required for hemp extracts below 0.3%.
- Hemp processors produce intermediate hemp material (IHM) and waste hemp material (WHM) during extraction; those byproducts often exceed 0.3% Δ9‑THC even when harvested plants are within limits.
- Hemp Industries Ass’n and RE Botanicals sued the DEA in district court seeking declarations and an injunction that IHM and WHM are authorized/immunized from CSA registration and enforcement; district court dismissed for lack of subject‑matter jurisdiction under 21 U.S.C. § 877 (exclusive appellate review of DEA final actions).
- The D.C. Circuit affirmed, holding plaintiffs’ claims in substance challenge the IFR (a final DEA decision) and so fall within § 877’s exclusive review; alternatively, plaintiffs failed to plead a concrete, imminent enforcement injury.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether district court has jurisdiction given 21 U.S.C. § 877 exclusivity | Complaint does not challenge the IFR; seeks independent declaration that IHM/WHM are authorized/immunized | Plaintiffs’ requested relief effectively seeks review and reversal of the IFR, so § 877 vests exclusive jurisdiction in the courts of appeals | Held for DEA: § 877 bars district‑court review because plaintiffs’ suit in substance challenges DEA’s IFR |
| Whether the classification/authorization distinction permits district‑court review | IFR addresses only classification; authorization/immunity is a separate question for district court | IFR’s explanatory language and plaintiffs’ requested relief address registration/liability as well, so distinction is illusory | Held for DEA: Court rejects the distinction—IFR implicates both classification and authorization |
| Application of Thunder Basin exclusivity framework | Plaintiffs argued exclusivity inapplicable or that district court should apply Thunder Basin differently | DEA: exclusivity is "fairly discernible" and plaintiffs’ claims are the type Congress meant to be reviewed under § 877 | Held for DEA: exclusivity under § 877 is clear and applies to these claims |
| Standing / injury‑in‑fact for pre‑enforcement declaratory relief | DEA statements and regulatory uncertainty create imminent threat of enforcement, chilling operations and financial harm | No threatened or imminent enforcement against plaintiffs; agency statements are general; market effects speculative | Held for DEA: plaintiffs failed to allege a certainly‑impending or substantial risk of enforcement and so lack Article III injury if IFR were treated as agnostic |
Key Cases Cited
- John Doe, Inc. v. DEA, 484 F.3d 561 (D.C. Cir. 2007) (§ 877 vests exclusive appellate jurisdiction over DEA final determinations under the CSA)
- ITT World Commc’ns, Inc. v. FCC, 466 U.S. 463 (U.S. 1984) (litigants may not evade exclusive review provisions by reframing relief as injunctive)
- Jarkesy v. SEC, 803 F.3d 9 (D.C. Cir. 2015) (framework for deciding whether Congress intended exclusive review)
- Thunder Basin Coal Co. v. Reich, 510 U.S. 200 (U.S. 1994) (test for when statutory review schemes are exclusive)
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (U.S. 2007) (pre‑enforcement declaratory relief permitted but requires credible threat of enforcement)
- Susan B. Anthony List v. Driehaus, 573 U.S. 149 (U.S. 2014) (pre‑enforcement standing principles)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (Article III injury‑in‑fact requirements)
- Gonzales v. Raich, 545 U.S. 1 (U.S. 2005) (Controlled Substances Act as a comprehensive federal regime)
- Heller, Ehrman, White & MacAuliffe v. Babbitt, 992 F.2d 360 (D.C. Cir. 1993) (courts should look past creative framing to determine whether exclusive review applies)