Cigar Association of America v. United States Food and Drug Administration, Civil Action No. 2016-1460

Background

In May 2016 the FDA promulgated a "Deeming Rule" applying the Tobacco Control Act to cigars, pipe tobacco, and other products and establishing six rotating health warnings for cigar and pipe-tobacco packaging and advertising.
Cigar-industry associations sued in July 2016 challenging multiple aspects of the Rule (warnings, user fees, treatment of pipe-blending retailers as manufacturers, and classification of pipes as "components"). Plaintiffs later narrowed their active claims and moved for partial summary judgment seeking to enjoin the warning requirements among other relief.
Six public-health organizations (Proposed Intervenors) sought to intervene as defendants to defend the Rule, primarily to preserve the warning requirements; the court previously granted them amicus status.
Proposed Intervenors argued they would suffer cognizable organizational and associational injuries because vacating the warnings would force them to expend additional resources educating patients and the public.
The court held that proposed intervenors failed to demonstrate Article III standing: their asserted harms (additional, unspecified expenditures to educate the public) were too generalized and did not show the requisite "perceptible impairment" of organizational operations or concrete harm to AAP members.
The court denied permissive intervention in the exercise of its discretion, noting the defendants appear likely to defend the warnings and the intervenors may participate as amici.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Proposed Intervenors have Article III organizational standing to intervene	Intervenors: vacatur of warnings will force them to spend additional resources educating the public, constituting concrete injury	Defs: (implicitly) government action will be defended; harm is speculative and not a cognizable organizational injury	Denied — asserted increased expenditures were generalized and insufficient to show "perceptible impairment" or concrete injury
Whether AAP has associational standing on behalf of physician members	AAP: its members would spend more time counseling patients if warnings are struck, giving members Article III standing	Opposing view: asserted member burdens are generalized and not tied to the specific challenged rule provisions	Denied — affidavit failed to show particularized, concrete injury to members linked to the warning claim
Whether intervention as of right under Rule 24(a)(2) is warranted	Intervenors: timely motion, protected interests in preserving warnings, inadequate representation by defendants	Plaintiffs/Defs: Intervenors have not met standing requirement and interests are speculative	Denied — failure to satisfy Article III standing precludes intervention as of right
Whether permissive intervention under Rule 24(b) should be allowed	Intervenors: would aid defense of warnings and can limit briefing to avoid duplication	Court/Defs: intervention unnecessary because defendants will defend warnings and intervenors can appear as amici; permissive intervention is discretionary	Denied — court exercised discretion to refuse permissive intervention; amicus status sufficient

Key Cases Cited

Deutsche Bank Nat’l Trust Co. v. FDIC, 717 F.3d 189 (D.C. Cir.) (Rule 24(a) intervention factors and standing requirement for intervenors)
Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (Article III injury-in-fact requirements)
Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (D.C. Cir.) (organizational standing requires showing defendant's action perceptibly impaired organization's ability to provide services)
Crossroads Grassroots Policy Strategies v. FEC, 788 F.3d 312 (D.C. Cir.) (agency benefit to a party can create a cognizable interest when reversal would remove that benefit)
People for the Ethical Treatment of Animals v. USDA, 797 F.3d 1087 (D.C. Cir.) (denial of information and enforcement avenues can support organizational standing)
Rainbow/PUSH Coalition v. FCC, 396 F.3d 1235 (D.C. Cir.) (affidavits alleging generalized burdens insufficient for associational standing)