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. 20-1376

HEMP INDUSTRIES ASSOCIATION AND RE BOTANICALS, INC.,
PETITIONERS

v.

DRUG ENFORCEMENT ADMINISTRATION AND ANNE MILGRAM,
ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION,
RESPONDENTS

On Petition for Review of a Final Rule
of the Drug Enforcement Administration

Shane Pennington argued the cause for petitioners.
With him on the briefs were Matthew C. Zorn, Shawn Hauser,
and David C. Kramer.

Sarah Carroll, Attorney, U.S. Department of Justice,
argued the cause for respondents. 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 Senior Circuit Judge
SILBERMAN.

SILBERMAN, Senior Circuit Judge: Petitioners bring a
rather weak case. They seek review of an interim final rule
issued by the Drug Enforcement Administration. But
Petitioners 1 are wholly unable to show their injury in fact and
therefore lack standing.

I.

Members of the Hemp Industries Association manufacture
various products using the cannabis plant as raw material. That
plant, however, also produces marijuana and its psychoactive
component tetrahydrocannabinol (“THC”). Those drugs are
subject to stringent regulation under the Controlled Substances
Act. 2 Marijuana is defined by statute to include all parts of a
cannabis plant, its seeds, its resin, and any derivates from those
components. 21 U.S.C. § 802(16). Exempt from the definition
of marijuana are mature stalks, fiber or other derivate of the
stalks (except for resin), oil or cake made from the seeds, and
sterilized seed. Id. THC is also subject to regulation through
a separate statutory provision. 21 U.S.C. § 812 (Schedule I)
(c)(17).

In 2018, Congress modified the marijuana and THC
provisions through the Farm Bill, apparently relaxing
regulation of the cannabis plant. Congress introduced the

1
Petitioners are the Hemp Industries Association and one of its
members, RE Botanicals, Inc.
2
Marijuana and THC are on Schedule I, the list of drugs for which
the manufacture or trafficking are subject to the harshest penalties.
21 U.S.C. § 802(16); 21 U.S.C. § 812 (Schedule I) (c)(17). There
are four more schedules (II–V)—with descending harshness in
associated penalties.
 3
statutory concept of “hemp” which it also exempted from the
definition of marijuana. 21 U.S.C. § 802(16)(B). Hemp in turn
is defined as any part—including parts not previously
exempt—of the cannabis plant with a delta-9
tetrahydrocannabinol concentration of not more than 0.3% on
a dry weight basis. 3 As a corollary, Congress also redefined
THC to exempt THC found “in hemp.” 21 U.S.C. § 812
(Schedule I) (c)(17); see also Agriculture Improvement Act of
2018, § 12619(b).

The DEA has broad authority to promulgate regulations
implementing the Controlled Substances Act. Shortly after the
passage of the Farm Bill, the DEA accordingly issued an
interim final rule implementing the statute. The regulation
modified the existing regulatory definition of THC to make
clear that it does not include, “any material, compound,
mixture, or preparation that falls within the definition of hemp
set forth in 7 U.S.C. 1639o.” 85 Fed. Reg. 51,639, 51,640
(codified at 21 C.F.R. § 1308.11(d)(31)). It also—consistent
with the changed statutory definition of marijuana—modified
the prior regulatory definition of marijuana extract limiting it
to a substance “containing greater than 0.3 percent delta-9-
tetrahydrocannabinol on a dry weight basis.” Id. (codified at
21 C.F.R. § 1308.11(d)(58)). Then, it addressed an entirely
different drug, Epidiolex. It removed Epidiolex from Schedule
V regulation and accompanying import-export controls since it
had less than 0.1% THC.

II.

Perhaps most mystifying is Petitioners’ claim that
removing Epidiolex from Schedule V conflicts with United

3
Agriculture Improvement Act of 2018, Pub. L. No. 115-334,
§10113, 132 Stat. 4490, 4908 (2018) (codified at 7 U.S.C. § 1639o).
 4
States treaty obligations (regulation of Epidiolex was
abandoned because its THC concentration is only 0.1%, far less
than the 0.3% threshold devised by the Farm Bill). But
Petitioners provide no evidence that they produce Epidiolex or
that Epidiolex is a competitor to Petitioners. So we cannot even
imagine how Petitioners could be injured by the DEA’s
relaxation of regulation of a non-marijuana drug. Their
argument raised for the first time in a reply brief (and therefore
subject to forfeiture, Sierra Club v. EPA, 292 F.3d 895, 900–
01 (D.C. Cir. 2002)) is that in their view the DEA had not
sufficiently explained why it removed Epidiolex from
regulation and the DEA’s reasoning for that action might affect
them in some other context. This contention is frankly
ridiculous. Petitioners cannot challenge the reasoning of a case
that does not directly affect them—it is far too speculative to
be an injury in fact. See Clapper v. Amnesty International USA,
et al., 569 U.S. 398, 401 (2013).

***

The core of Petitioners’ challenge to the regulation is not
much better. Petitioners explicitly do not quarrel with the Farm
Bill itself but only the implementing regulation. Although
Petitioners’ opening brief suggests that the language of the
implementing regulation is different from the language of the
statute, they never explain the significance in their view of the
textual difference nor why the textual difference causes them
injury. There is simply the claim that the regulation increases
DEA authority over what the statute contemplates. 4 It is not

4
In a parallel challenge that Petitioners bring in the district court,
Petitioners seem to indicate that their concern is that, during the
processing of hemp, the THC concentration of intermediate hemp
material and waste hemp material would rise above 0.3% and no
longer be exempt as hemp. Hemp Industries Association v. DEA, 21-
5111 (D.C. Cir. 2022) (slip op., at 7–10). But, Petitioners, perhaps
 5
until the reply brief that Petitioners claim that the statute’s
language “in hemp” has a different meaning than the
regulation’s language “within the definition of hemp” and that
this difference could hypothetically injure them. Compare 21
U.S.C. § 812 (Schedule I) (c)(17), with 21 C.F.R.
§ 1308.11(d)(31). Be that as it may, even if the argument was
legitimately presented in the opening brief, it is not worth
exploring the language differences because the government
reiterated at oral argument that the DEA did not intend any
difference between the regulatory language and the statute. See
also 85 Fed. Reg. at 51,640 (“This interim final rule merely
conforms DEA’s regulations to the statutory amendments to
the CSA that have already taken effect, and it does not add
additional requirements to the regulations.”). Therefore,
Petitioners’ primary argument is simply pushing on an open
door because there is no dispute with the government. In other
words, jurisdiction is absent—over the major issue—not just
because Petitioners lack injury, but also because we do not
even have before us a case or controversy. Flast v. Cohen, 392
U.S. 83, 95 (1968); see also Weissman v. Nat’l R.R. Passenger
Corp., 21 F.4th 854, 862 (D.C. Cir. 2021) (Silberman, J.,
concurring).

***

Accordingly, we dismiss the petition.

in an attempt to preserve their characterization of that suit as not
challenging the interim final rule, did not raise that before us in this
petition.