HEMP INDUSTRIES ASSOCIATION AND RE BOTANICALS, INC. v. DRUG ENFORCEMENT ADMINISTRATION AND ANNE MILGRAM, IN HER OFFICIAL CAPACITY AS ADMINISTRATOR OF THE UNITED STATES DRUG ENFORCEMENT ADMINISTRATION
No. 21-5111
Unitеd States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
Decided June 10, 2022
Argued April 19, 2022
Matthew C. Zorn argued the cause for appellants. With him on the briefs were
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.
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),
I. Background
At the motion-to-dismiss stage, we “assume the truth of all material factual allegаtions 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)).
A.
In 1970, the Congress passed the Controlled Substances Act,1 “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
The CSA lists marijuana as a Schedule I substance. See
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.
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. 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.
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 Implementatiоn 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
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. Hеmp 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 in, any consumer product; rathеr, IHM is refined into extracts or isolates containing not more than 0.3% [delta-9] THC.” Id. at ¶ 35. If the processor creates cannabinoid
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 pеtition 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 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
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
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 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
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
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.
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 provisiоns, 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 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 proceеd notwithstanding
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
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 еven the Plaintiffs cannot help but reach—meaning that the classification/authorization distinction drawn by
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 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 unavoidably) 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 “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 [
Taken together, the Plaintiffs’ amended complaint, “[i]n substance,” seeks review of the “same issue[]” the IFR рurportedly addresses—whether CSA controls continue to 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
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 “charactеrization” of the complaint. In fact, “constru[ing] [a] 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
The Plaintiffs finally spill much ink arguing that the district court erred in not applying Thunder Basin to determine whether
We have already answered the first part of the Thunder Basin framework with respect to the exclusivity of
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,”
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) (intеrnal 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 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 tо 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
The Plaintiffs also point to several statements by DEA officials that purportedly highlight the view “that IHM аnd WHM are illegal,” Am. Compl. ¶ 84, and have caused the 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 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
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 possessiоn 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 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. Sеe 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 repeatеd 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. 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.