Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-14-05226/USCOURTS-caDC-14-05226-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals 

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 7, 2015 Decided January 15, 2016

No. 14-5226

R.J. REYNOLDS TOBACCO COMPANY, ET AL.,

APPELLEES

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL.,

APPELLANTS

Appeal from the United States District Court

for the District of Columbia

(No. 1:11-cv-00440)

Mark B. Stern, Attorney, U.S. Department of Justice, 

argued the cause for appellants. With him on the briefs were

Benjamin C. Mizer, Acting Assistant Attorney General,

Ronald C. Machen, Jr., U.S. Attorney at the time the brief 

was filed, and Alisa B. Klein and Patrick G. Nemeroff, 

Attorneys.

Carlos T. Angulo, Andrew N. Goldfarb, Hope M. 

Babcock, and Mark Greenwold were on the brief for amici 

curiae Public Health Groups in support of appellants.

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Richard M. Cooper argued the cause for appellees. With 

him on the brief were Peter J. Anthony and Alan Mansfield. 

Laura M. Klaus entered an appearance.

William G. Kelly, Jr. was on the brief for amicus curiae 

Center for Regulatory Effectiveness in support of appellees.

Richard A. Samp was on the brief for amicus curiae 

Washington Legal Foundation in support of appellees.

Before: MILLETT and PILLARD, Circuit Judges, and 

WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge

WILLIAMS.

WILLIAMS, Senior Circuit Judge: With the Family 

Smoking Prevention and Tobacco Control Act of 2009, Pub. 

L. No. 111-31, § 101 (2009), Congress directed the Food and 

Drug Administration to establish a twelve-member Tobacco 

Products Scientific Advisory Committee, the duties of which

included reporting on the safety of menthol cigarettes. 21 

U.S.C. §§ 387g(e), 387q.1

 The Committee has now reported. 

While the FDA has issued a notice proposing adoption of 

special rules for such cigarettes, see Menthol in Cigarettes, 

Tobacco Products; Request for Comments, 78 Fed. Reg. 

44,484 (July 24, 2013), it has not adopted a final rule. The 

 

1 Although the enabling statute (cited in the text below) grants 

the relevant authority to the Secretary of Health and Human 

Services, see 46 Fed. Reg. 26,052-01 (May 11, 1981); FDA Staff 

Manual Guide 1410.10 (May 18, 2005), the custom followed 

generally and in the briefs before us is to refer to the FDA where 

(as here) it is the acting component of that Department. See, e.g., 1 

Food and Drug Administration § 4:15 (4th ed. 2015) (describing 

management review process for FDA rules). 

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plaintiffs, producers of menthol tobacco products or affiliates 

of such producers, claim that the FDA appointed to the 

Committee three members with pecuniary interests hostile to 

their products, in violation of relevant conflict-of-interests 

statutes and regulations, and that these appointments injured 

the plaintiffs.

Exact identification of the plaintiffs is complicated but 

largely irrelevant. R.J. Reynolds Tobacco Company and 

Lorillard Tobacco Company, together with Lorillard’s parent, 

brought suit initially. They are now all wholly owned 

subsidiaries of Reynolds’s parent, R. J. Reynolds Tobacco 

Holdings, Inc. We refer to the plaintiffs simply as plaintiffs 

except in describing events related only to a specific premerger company. 

Plaintiffs allege, and in summary judgment proceedings 

the district court found, that three of the twelve members 

appointed to the Committee had unlawful conflicts of interest 

and that the FDA improperly failed to exclude those members 

or to grant conflict-of-interest waivers for them. (As we 

understand plaintiffs’ position, they believe that a grant of 

waivers would have manifested acknowledgement of the 

conflicts of interest and thus adequately palliated their

injuries. Oral Arg. Tr. at 39-40 (“[I]f they did a waiver we’d 

have to come up with a claim, and I don’t know that we 

could.”)) All three of the challenged members have testified 

in lawsuits against tobacco-product manufacturers and had 

pending engagements to appear as expert witnesses in future 

suits; two of the three had hundreds of such engagements. 

Their individual billings for testimony have ranged as high as 

$50-60,000 per case. All three have also had financial 

relationships with pharmaceutical companies that 

manufacture smoking cessation products, which compete with 

tobacco products. 

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Plaintiffs claim that the FDA’s appointments of these

Committee members caused them three injuries: (1) an 

increased risk that the FDA will regulate menthol tobacco 

products adversely to plaintiffs’ interests; (2) access by the 

challenged Committee members to plaintiffs’ confidential 

information, with a probability of their using the information 

to plaintiffs’ detriment; and (3) the shaping of the menthol

report to support the challenged members’ consulting and 

expert witness businesses, with injuries flowing both from the 

report itself and from its use as support for their expert 

testimony and consulting. (Before the district court, plaintiff 

Lorillard also argued that it had been injured by a decline in 

its stock price, but the merged firm dropped that claim, and 

we do not consider it. Oral Arg. Tr. at 32.) 

The district court granted summary judgment for 

plaintiffs and issued an order dissolving the Committee and 

enjoining use of the Committee’s menthol report. Lorillard, 

Inc. v. FDA, 56 F. Supp. 3d 37, 56-57 (D.D.C. 2014). 

We review the district court’s grant of summary 

judgment de novo. Citizens for Responsibility & Ethics in 

Washington v. FEC, 711 F.3d 180, 184 (D.C. Cir. 2013). We 

address first—and as it proves last—the government’s 

defense that plaintiffs lack standing. Under the familiar 

threefold inquiry, plaintiffs must show an injury-in-fact that is 

“actual or imminent, not conjectural or hypothetical,” and 

must show causation and redressability. Lujan v. Defenders 

of Wildlife, 504 U.S. 555, 560-61 (1992) (internal citations 

and quotation marks omitted). At summary judgment, 

plaintiffs cannot rest on “‘mere allegations’ but must ‘set 

forth’ by affidavit or other evidence ‘specific facts.’” Id. at 

561 (quoting FED. R. CIV. P. 56(e)). 

Addressing the three alleged injuries in the order already 

presented, we conclude that all three are too remote and 

uncertain, or, to put the same thing another way, insufficiently 

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imminent. We therefore vacate the district court’s grant of 

summary judgment.

* * *

Risk of future FDA action. Since the FDA has not yet 

issued a rule, Lorillard’s prospective injury from that rule 

remains remote. We assume without deciding that the 

appointment of the challenged Committee members without 

following statutorily mandatory conflict-of-interest waiver 

procedures violated a procedural right intended “to protect 

[plaintiffs’] concrete interests.” Lujan, 504 U.S. at 572 n.7. 

A plaintiff who challenges the violation of such a right can 

establish standing “even though he cannot establish with any 

certainty that [provision of the right] will cause the [agency 

action] to be withheld or altered.” Id. Although the Court did 

not explain the relaxation of the causation element, a failure 

to relax it would probably, because of the uncertain 

relationship between a procedural opportunity and success on 

the merits, eviscerate judicial enforcement of procedural 

mandates. In any event, despite this relaxation, the plaintiff 

must still demonstrate “a distinct risk to a particularized 

interest.” Florida Audubon Soc’y v. Bentsen, 94 F.3d 658, 

664 (D.C. Cir. 1996) (en banc). 

Although the government raised a standing and not a 

ripeness defense, we nonetheless treat ripeness cases as 

pertinent to whether the risk of injury is imminent enough. 

Both doctrines address the imminence issue, using the same 

focus on contingencies that may render the risk of harm too 

slight. (This is of course not to suggest that the doctrines are 

twins. Both have many distinctive facets, some even bearing 

on imminence of harm.) A claim is not adequately “ripe for 

adjudication,” the Supreme Court has said, “if it rests upon 

contingent future events that may not occur as anticipated, or 

indeed may not occur at all.” Texas v. U.S., 523 U.S. 296, 

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300 (1998) (citations and internal quotation marks omitted). 

We applied this aspect of ripeness doctrine in, for example, 

Atlantic States Legal Foundation v. EPA, 325 F.3d 281, 284-

85 (D.C. Cir. 2003), declining to hear a challenge to federal 

regulations that could adversely affect petitioners only after 

New York State adopted them through further notice-andcomment rulemaking. And very similar uncertainties led us 

to find a want of standing in Occidental Permian Ltd. v. 

FERC, 673 F.3d 1024, 1026 (D.C. Cir. 2012), where a 

petitioner challenged FERC’s grant of authority to negotiate 

rates for services of an as-yet unfinished interconnection 

facility; uncertainties relating (for example) to whether the 

potentially connecting transmission lines would ever be 

authorized and built made the injury too remote. Compare 

Chlorine Inst., Inc. v. Fed. R.R. Admin., 718 F.3d 922, 928-29 

(D.C. Cir. 2013), where like uncertainties defeated ripeness. 

On the overlap of the doctrines, see generally Louisiana 

Environmental Action Network v. Browner, 87 F.3d 1379, 

1383-84 (D.C. Cir. 1996). 

Here, the appointment of the challenged committee 

members by no means rendered the risk of eventual adverse 

FDA action substantially probable or imminent. It remains 

unclear whether the FDA will issue a final rule, and what it 

would say. In particular, in any such rulemaking, the extent 

to which the FDA would be persuaded by the content of the 

Committee’s report is quite speculative. The FDA need only 

“consider[]” the Committee’s report, 21 U.S.C. § 387g(d)(1), 

along with the comments of persons responding to its notice 

of proposed rulemaking, id. § 387g(c), which of course the 

Administrative Procedure Act requires it to “consider[],” 5 

U.S.C. § 553(c). And it is to adopt the proposed standard 

only if it finds, after “consider[ing] scientific evidence” on a 

range of issues, 21 U.S.C. § 387g(a)(3)(B)(i), that it “would 

be appropriate for the protection of the public health.” 21 

U.S.C. § 387g(d)(1)(A). If the report influences a proposed 

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rule to plaintiffs’ detriment in the way they anticipate, they 

will have an opportunity to raise concerns about the report’s

scientific claims, including assertions of bias. Review of any 

claims that the (still hypothetical) rule was in excess of 

statutory authority or arbitrary and capricious would proceed 

along conventional lines. Even if we were to assume 

arguendo that the FDA’s selection of these committee 

members materially increased the risk of its adoption of a rule 

more adverse to plaintiffs than the rule it might otherwise 

have adopted (or no rule at all), that would still fall short of

saying that the selection rendered adoption of a more adverse 

rule imminent. For similar reasons, we held that plaintiffs in 

Metcalf v. National Petroleum Council, 553 F.2d 176, 184, 

188 (D.C. Cir. 1977), lacked standing to challenge the 

composition of an advisory committee where, among other 

things, there was “no allegation that [the agency] took action 

based on” one of the committee’s recommendations.

Ripeness concerns underscore this point: part of the reason 

the injury is too remote is that, if the FDA chooses not to 

issue a rule, this case “may not require adjudication at all.” 

Friends of Keeseville, Inc. v. FERC, 859 F.2d 230, 235 (D.C. 

Cir. 1988).

Plaintiffs cite our decision in Wyoming Outdoor Council

v. U.S. Forest Service, 165 F.3d 43 (D.C. Cir. 1999), for its 

recognition of the general proposition that the constitutional 

minima of standing are somewhat relaxed when applied to 

procedural violations, Appellee Br. 29, a point we noted in 

some detail above. Wyoming Outdoor Council is in fact 

somewhat unusual in finding standing where the ultimate 

agency action threatening harm to plaintiffs—there, issuance 

of oil and gas leases—had not occurred when they brought 

suit. Although the lack of final leases obviously left 

uncertainty, we found that the Forest Service’s failure to make 

each of the required predicate findings put plaintiffs’ 

environmental interests “in genuine danger.” Id. at 51. 

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Crucially, however, leases had been issued by the time of 

decision, id. at 47, and, unlike the situation as to NEPA 

claims in the case, the record on the issue was complete, id. 

See also Center for Biological Diversity v. U.S. Dep’t of the 

Interior, 563 F.3d 466, 473, 479 (D.C. Cir. 2009) (finding 

standing to challenge violation of certain procedural 

prerequisites to approval of a leasing program, even though 

leases had not been issued). Neither of these cases is brought 

into play here, and accordingly we find the alleged increased

risk of an FDA rule on menthol cigarettes too uncertain for 

standing. 

Confidential information. Plaintiffs assert that they have 

been injured by the challenged Committee members’ access 

to confidential information, which they could disclose to 

plaintiffs’ competitors or could use in their expert witness 

work. Yet plaintiffs have not set forth by affidavit or other 

evidence specific facts suggesting that the challenged 

members have made or will make improper use of 

confidential information. They have only presented evidence 

that the Committee members received such information in the 

course of their time on the Committee—not that they used it 

the way plaintiffs fear. See, e.g., Mem. in Supp. of 

Defendants’ Motion for Summary Judgment 11 n.5 (Doc. 65 

June 21, 2013) (acknowledging that confidential information 

was presented to the Menthol Report writing group, of which 

Drs. Benowitz and Samet were members, J.A. 2436); J.A. 

2545-85 (a draft chapter of the subcommittee report showing 

Dr. Henningfield’s tracked changes and (through redactions) 

the presence of confidential information in the report at J.A. 

2554). 

There is considerable reason to believe that the 

challenged members will not disclose such information. 

Disclosure would subject them to criminal and civil penalties. 

See 18 U.S.C. § 1905 (prescribing fines and imprisonment of 

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up to a year); 5 C.F.R. § 2635.801(d) (incorporating 18 

U.S.C. § 1905 by reference to Subpart I of the regulation; see

5 C.F.R. § 2635.902(aa)). We have rejected assertions of 

imminent injury where the prospective injury depends on 

future illegal activity, finding, for example, that a sheriff 

lacked standing to challenge President Obama’s immigration 

policy partly because the plaintiff’s theory depended on 

immigrants’ committing crimes in the future. Arpaio v. 

Obama, 797 F.3d 11, 22 (D.C. Cir. 2015). More generally, 

we are relatively hesitant to find standing when the asserted 

injury “depends on the unfettered choices made by 

independent actors not before the courts.” Lujan, 504 U.S. at 

562 (citation and internal quotation marks omitted). Plaintiffs 

have not presented evidence—or at least evidence sufficient 

to support summary judgment—that the challenged members’

access to confidential information poses an imminent risk of 

injury.

Shaping of the Menthol Report. Plaintiffs’ evidence that 

they have been injured by any shaping of the report by the 

challenged Committee members to support their expert 

testimony is similarly weak. Although they note hundreds of 

pending tobacco cases in which the challenged Committee 

members are identified as prospective witnesses, Appellee Br. 

6-7; J.A. 273, 278-79, they have presented no evidence on 

how many of the cases concern menthol tobacco products.

They cite only a handful of mentions of the menthol report in 

challenged members’ testimony and are only able to point to 

two cases that involved a menthol smoker. Appellee Supp. 

Br. 5. Moreover, their examples of such testimony do not 

support their contention that the shaping of the report caused 

any injury. For example, Dr. Henningfield, one of the 

challenged Committee members, mentioned the report when 

deposed in a case against (pre-merger) R.J. Reynolds (J.A. 

2460-61), but he said that “[m]y testimony on menthol would 

not be different than it has been in earlier cases when menthol 

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has come up.” J.A. 2460. Plaintiffs have not sought to refute 

this. Henningfield described his testimony as consistent with 

the report, but did not rely on it to bolster his credibility, and 

in fact suggested that its findings on how menthol influences

the transition from use to dependence were not relevant to the 

plaintiff in that case, as he had allegedly become addicted to 

cigarettes before he started smoking menthols. J.A. 2461.

Plaintiffs have also presented no facts supporting their 

contention that the challenged members shaped the report to 

support their testimony, or used the report’s concurrence in 

their views to validate those views. Of course plaintiffs can 

press their objections to the report during cross-examination 

of the expert witnesses in pending cases.

Finally, the challenged members’ opportunity to shape 

the menthol report to characterize menthol tobacco products 

as unsafe did not give rise to an imminent reputational injury. 

Plaintiffs’ reliance on Meese v. Keene, 481 U.S. 465, 473-76 

(1987), is misplaced. There a congressional statute identified 

certain foreign films as “political propaganda,” and the Court 

found standing for a politician who wanted to show the films 

but claimed that doing so, in the face of the congressional 

characterization, would damage his professional reputation 

and impair his chances of securing reelection to the California 

State Senate. He backed the claim up with powerful 

supportive polling data. Id. at 472-75 & 473-74 n.7. 

Plaintiffs offer no comparable evidence that the Committee’s 

report is likely to inflict such an injury on their reputations. 

* * *

In sum, plaintiffs have not demonstrated that any of their 

three injuries is sufficiently imminent to confer standing. We 

therefore vacate the judgment of the district court for lack of 

jurisdiction and dissolve its injunction barring the use of the 

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menthol report and ordering the reconstitution of the 

Committee.

So ordered. 

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