Fdacigarresponsehealthgorups

Case 1:16-cv-01460-APM Document 44 Filed 08/07/17 Page 1 of 27
IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
CIGAR ASSOCIATION OF AMERICA,

et al.,
Plaintiffs,
v. Civil Action No. 16-1460 (APM)
UNITED STATES FOOD AND DRUG

ADMINISTRATION, et al.,
Defendants.
PLAINTIFFS OPPOSITION TO MOTION TO INTERVENE

TABLE OF CONTENTS
Page
INTRODUCTION ......................................................................................................................... 1
BACKGROUND ........................................................................................................................... 5
I. Seven Years After Passage of the Family Smoking Prevention and
Tobacco Control Act, the FDA Chose to Impose a Devastatingly
Burdensome Regulatory Scheme and to Assess Fees on Cigars and Pipe
Tobacco .................................................................................................................. 5
II. The Government Seeks Delays in this Litigation to Announce Proceedings
to Change the Deeming Rules Regulatory Scheme .............................................. 6
ARGUMENT ................................................................................................................................. 8
I. The Anti-Tobacco Groups Have Ample Opportunity to Advance
Arguments Defending the Rule as Amici and Fail to Satisfy the
Requirements for Intervention as of Right............................................................. 8
A. The Anti-Tobacco Groups Intervention Effort Is Untimely ..................... 9
B. The Anti-Tobacco Groups Have No Legally Protected Interest
That Would Be Practically Impaired Without Party Status ..................... 10
C. The Anti-Tobacco Groups Have Failed to Demonstrate Inadequate
Representation.......................................................................................... 13
II. This Court Should Deny Permissive Intervention ............................................... 14
III. The Anti-Tobacco Groups Cannot Intervene in this Case Because They
Lack Standing ...................................................................................................... 16
A. The Anti-Tobacco Groups Have No Imminent, Concrete Injury
that Is Fairly Traceable to Vacating the Deeming Rule and
Redressable .............................................................................................. 17
B. AAP Has Failed to Establish Associational Standing.............................. 20
C. The Anti-Tobacco Groups Intervention in Previous Cases Is
Immaterial ................................................................................................ 21
CONCLUSION ............................................................................................................................ 22
-i-
TABLE OF AUTHORITIES
Page(s)
Cases
*Alfa Intl Seafood v. Ross,

No. 17-cv-00031 (APM), 2017 U.S. Dist. LEXIS 58030 (D.D.C. Apr. 17,
2017)
............................................................................................................2, 4, 11, 13, 14, 15, 16, 19
Alternative Research & Dev. Found. v. Veneman,

262 F.3d 406 (D.C. Cir. 2001) .................................................................................................11
Amador Cty., Cal. v. U.S. Dept of Interior,

772 F.3d 901 (D.C. Cir. 2014) ...................................................................................................9
*Arpaio v. Obama,
797 F.3d 11 (D.C. Cir. 2015) .................................................................................16, 17, 19, 20
Bush v. Viterna,
740 F.2d 350 (5th Cir. 1984) ...................................................................................................15
*Clapper v. Amnesty Intl USA,

568 U.S. 398 (2013) ...............................................................................................16, 17, 19, 20
Common Cause v. FEC,

108 F.3d 413 (D.C. Cir. 1997) .................................................................................................20
Crossroads Grassroots Policy Strategies v. FEC,

788 F.3d 312 (D.C. Cir. 2015) .............................................................................................8, 13
Cyclops Vapor 2, LLC v. FDA,

Case No. 2:16-cv-556 (M.D. Ala.) ..........................................................................................18
Defenders of Wildlife v. Perciasepe,

714 F.3d 1317 (D.C. Cir. 2013) ...............................................................................................10
Deutsche Bank Natl Trust Co. v. FDIC,

717 F.3d 189 (D.C. Cir. 2013) .................................................................................................16
*Dist. of Columbia v. Potomac Elec. Power Co.,

826 F. Supp. 2d 227 (D.D.C. 2011) .............................................................................11, 12, 15
*In re Endangered Species Act Section 4 Deadline Litig.,

270 F.R.D. 1 (D.D.C. 2010).....................................................................................9, 10, 12, 15
Envtl. Def. v. Leavitt,

329 F. Supp. 2d 55 (D.D.C. 2004) ...........................................................................................12
-ii-
Fund for Animals v. Norton,

322 F.3d 728 (D.C. Cir. 2003) ...........................................................................................10, 16
Heckler v. Chaney,
470 U.S. 821 (1985) .................................................................................................................13
Jones v. Prince Georges Cty., Md.,

348 F.3d 1014 (D.C. Cir. 2003) .................................................................................................8
Keepseagle v. Vilsack,
307 F.R.D. 233 (D.D.C. 2014)...........................................................................................15, 16
Lamprecht v. FCC,
958 F.2d 382 (D.C. Cir. 1992) .................................................................................................12
Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) .................................................................................................................16
Natl Assn of Home Builders v. U.S. Army Corps of Engrs,

519 F. Supp. 2d 89 (D.D.C. 2007) ...........................................................................................15
Natl Assn of Regulatory Util. Commrs v. Interstate Commerce Commn,

41 F.3d 721 (D.C. Cir. 1994) ...................................................................................................12
Natl Taxpayers Union, Inc. v. United States,

68 F.3d 1428 (D.C. Cir. 1995) .................................................................................................20
Public Citizen v. FTC,

869 F.2d 1541 (D.C. Cir. 1989) ...............................................................................................21
Roane v. Leonart,
741 F.3d 147 (D.C. Cir. 2014) ...................................................................................................9
Sierra Club v. McCarthy,

308 F.R.D. 9 (D.D.C. 2015).....................................................................................................10
Spokeo, Inc. v. Robins,

136 S. Ct. 1540 (2016) .................................................................................................16, 17, 20
Stuart v. Huff,
706 F.3d 345 (4th Cir. 2013) ...................................................................................................15
Sweet Home Chapter of Cmtys. for Great Or. v. Lujan,

No. 91-1468, 1991 U.S. Dist. LEXIS 17449 (D.D.C. Dec. 10, 1991) ...............................10, 15
Turlock Irrigation Dist. v. FERC,

786 F.3d 18 (D.C. Cir. 2015) .............................................................................................17, 19
iii
United States v. Philip Morris USA, Inc.,

566 F.3d 1095 (D.C. Cir. 2009) ...............................................................................................21
United States v. Philip Morris USA, Inc.,

No. 99-2496, 2005 U.S. Dist. LEXIS 16196 (D.D.C. July 22, 2005) .....................................21
Williams & Humbert, Ltd. v. W. & H. Trade Marks, Ltd.,

840 F.2d 72 (D.C. Cir. 1988) ...................................................................................................10
Rules and Statutes
Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 11131, 123
Stat. 1776 (2009)....................................................................................................................1, 5
Fed. R. Civ. P. 24 .................................................................................................................8, 13, 14
Regulations
Requirements for the Submission of Data Needed to Calculate User Fees for
Domestic Manufacturers and Importers of Cigars and Pipe Tobacco, 81 Fed.
Reg. 28,707 (May 10, 2016) .......................................................................................................1
Final Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and
Cosmetic Act, 81 Fed. Reg. 28,974 (May 10, 2016) ...........................................1, 17, 18, 19, 20
iv
Plaintiffs Cigar Association of America, Cigar Rights of America, and International
Premium Cigar and Pipe Retailers Association (collectively Plaintiffs) file this opposition to
the Motion to Intervene (Motion) filed by the American Academy of Pediatrics, the American
Cancer Society Cancer Action Network, the American Heart Association, the American Lung
Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative (collectively Anti-
Tobacco Groups or Applicants).
INTRODUCTION
Plaintiffs, three trade associations representing manufacturers and retailers of cigars and
pipe tobacco, filed this litigation in July 2016 to challenge two related rules issued by the Food and
Drug Administration (the FDA) that arbitrarily, capriciously, and inequitably subject cigars and
pipe tobacco to crushing regulation. The first rule deems all cigars and pipe tobacco subject to
the Family Smoking Prevention and Tobacco Control Act and imposes on these distinctive
products, unmodified, the onerous regulatory scheme Congress devised for cigarettes. See Final
Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, 81
Fed. Reg. 28,974 (May 10, 2016) (the Deeming Rule or the Rule). The second rule assesses
user fees on manufacturers and importers in some, but not all, of the newly regulated tobacco
product industries to fund the FDAs regulatory scheme, effectively taxing cigar and pipe tobacco
manufacturers for the regulation of e-cigarettes. See Requirements for the Submission of Data
Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe
Tobacco, 81 Fed. Reg. 28,707 (May 10, 2016) (the User Fee Rule). Members of the e-cigarette
industry have brought their own challenges to the Deeming Rule in federal courts throughout the
country, asserting claims particular to e-cigarettes and electronic nicotine delivery systems
products used by youth in great numbers and often marketed as lower risk tobacco products
under the Administrative Procedure Act (APA) and the U.S. Constitution.
More than a year after this action was filed and on the eve of Defendants summary
judgment submission deadline, a faction of anti-tobacco groups filed this motion to intervene as
parties. They did so notwithstanding the fact that they had already soughtand were granted
leave to participate as amici curiae in the case. Vaguely pointing to actions of the Government
in recent months, the Anti-Tobacco Groups suspect that Defendants may not adequately
defend the Deeming Rule and may seek to weaken or rescind it, and ask to participate in the
lawsuit to urge full implementation of the Deeming Rule. Motion at 7, 11. The Anti-Tobacco
Groups take no position at all on the User Fee Rule, a vital aspect of this suit. Id. at 6 n.6.
This intervention motion springs entirely from the Anti-Tobacco Groups speculation that
the United States Department of Justice will put forward a half-hearted defense of the Rule, due
to the change in administrations. This is a justification for intervention that this Court rejected
just this April. See Alfa Intl Seafood v. Ross, No. 17-cv-00031 (APM), 2017 U.S. Dist. LEXIS
58030, at *1213 (D.D.C. Apr. 17, 2017) (Mehta, J.). Moreover, there is absolutely no
indication of any kind that the Government is poised to make less than its best effort to defend
against Plaintiffs challenges to the Rule or to intentionally lose this case. Should the Anti-
Tobacco Groups have concerns about the adequacy of the Governments defense, they will have
every opportunity to bolster the Governments position in amici curiae filings due a week after
the Government files its first substantive brief.
What is really concerning the Anti-Tobacco Groups, apparently, is that the FDA may
change the Rule in ways that alleviate or eliminate the need for this litigation. The Anti-Tobacco
Groups now focus on the FDAs July 28, 2017 announcement. Therein, the FDA said that it
would undertake new, formal administrative actions (i) extending certain of the Rules
compliance dates; (ii) providing guidance on what would be required in premarket review and
2
substantial equivalence applications; and (iii) opening a rulemaking docket to examine premium
cigars and to adjust the regulatory scheme applicable to them. See Press Release, U.S. Food &
Drug Admin., FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-
Related Disease, Death (July 28, 2017), available at https://www.fda.gov/newsevents/newsroom/
pressannouncements/ucm568923.htm (FDA Press Release) 1. Should these separate, formal
administrative actions change the Rule in ways that affect this litigation, the Anti-Tobacco
Groups are welcome to challenge any final agency action by filing their own lawsuit against the
Government. The July 28 FDA announcement is no excuse to intervene in this action, which
does not and cannot challenge modifications to the Rule that have not yet been formalized.
The Anti-Tobacco Groups second brief in support of intervention states their wish to
participate in any discussions between Plaintiffs and the Government to narrow the issues in this
case. But the Anti-Tobacco Groups have no right whatsoever to dictate the terms under which
Plaintiffs may dismiss, stay, or narrow this case, if the FDA announces its intention to alter the
Rules in ways that address the challenges in this suit. As Plaintiffs, the industry associations are
the masters of their own complaint. Clearly established law prohibits the Anti-Tobacco Groups
from enlarging the claims made by the Plaintiffs: If Plaintiffs do not challenge the new and
separate administrative actions the FDA is undertaking, the intervenors cannot hijack this action
to do so. If Plaintiffs become satisfied with changes that the FDA makes to the Rules and choose
to dismiss, stay, or narrow their claims, the Anti-Tobacco Groups have absolutely no right to
interfere with discussions to resolve this matter.
In any event, the Anti-Tobacco Groups lack the standing necessary to intervene in the
case. The groups affidavits in support of standing are largely cut and pasted from their parallel
1
The FDA Press Release is attached as Exhibit A.
3
effort to intervene in e-cigarette litigation against the Deeming Rule. Accordingly, those
affidavits focus on aspects of the Deeming Rule that bear only on e-cigarettes and are entirely
irrelevant to cigars and pipe tobacco. For instance, the affidavits place great emphasis on the
importance of the Rules prohibition of so-called modified risk claims about tobacco
productsspecifically, claims that e-cigarettes are safer than traditional cigarettes. But that is
not an issue in this case: Plaintiffs members here do not make such claims and have not
challenged that provision of the Rule.
Moreover, the Deeming Rule as applied to cigars and pipe tobacco is primarily what the
FDA itself calls an enabling rule: It establishes a premarket review scheme for the agency to
collect additional information from manufacturers, on the basis of which the agency intends to
take future regulatory action (e.g., granting or disallowing product applications). Plaintiffs have
challenged that application and information-gathering process as arbitrarily constructed and
excessively burdensome to the point of threatening the viability of their members businesses.
But the Anti-Tobacco Groups claimed standingbased on the supposed benefits to their
programs of the FDA mandating safer tobacco productsdepends not on the Rules application
and review process but on whatever substantive regulatory action the agency later takes against
particular cigar and pipe tobacco products. As this Court has recognized, claims of benefits that
depend on the actions that cannot be forced by the current litigationhere, how the agency may
later exercise its discretion in future regulatory actionsare too speculative to provide standing
for intervention. See Alfa Intl Seafood, 2017 U.S. Dist. LEXIS 58030, at *49.
4
BACKGROUND
I. Seven Years After Passage of the Family Smoking Prevention and Tobacco Control
Act, the FDA Chose to Impose a Devastatingly Burdensome Regulatory Scheme and
to Assess Fees on Cigars and Pipe Tobacco
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, Pub.
L. No. 11131, 123 Stat. 1776 (2009) (the TCA or the Act), mandating immediate FDA
regulation of cigarettes, roll-your-own tobacco, and smokeless tobacco. See Federal Food, Drug,
and Cosmetic Act 901(b), 21 U.S.C. 387a(b) (the FD&C Act). Congress passed the Act
upon express findings of the cigarette industrys history of product manipulation and youth
marketing schemes, including companies claims that certain cigarette products were safer than
others. TCA 2(38)(39), (47)(49), 123 Stat. at 177881 (findings regarding marketing and
product manipulation in the cigarette industry). Congress barely mentioned cigars and pipe
tobacco, and left the questions of whether and how to regulate those products to future FDA
rulemaking proceedings, within the limits of the Act and the APA. See FD&C Act 901(b), 21
U.S.C. 387a(b).
On May 10, 2016, the FDA promulgated the Deeming Rule, regulating cigars and pipe
tobacco for the first time. The Rule subjected all newly deemed products to the same demanding
regulatory scheme that Congress designed for cigarettes. Among the entities caught in the
FDAs regulatory net were family-owned premium cigar manufacturers, small business premium
cigar and pipe tobacco retailers, and artisans who craft wooden tobacco pipes. There are 100
cigarette products marketed in any significant numbers; there are more than 20,000 cigar
products, due to the ever-changing growing conditions and different blends of natural tobacco.
The cigarette premarket review process as set forth in the Rule is so exacting and expensive that
cigar manufacturers will be forced to withdraw thousands of products from the market, for
reasons having nothing to do with public health, and to eliminate tens of thousands of jobs. The
5
FDA attempted to defend this irrational outcome in its Rule release with an approach now
apparently urged by the Anti-Tobacco Groupstreating all tobacco products alike, despite
evidence of vast differences in production methods, product variety, user bases, and patterns of
use.
Simultaneously with the Deeming Rule, the FDA published the User Fee Rule,
mandating fees on some, but not all, tobacco products to fund FDA regulation. Critically, the
FDA exempted e-cigarettes from user fees, leaving other tobacco product manufacturers to pay
for the formidable task of e-cigarette regulation. In so doing, the FDA transformed what
Congress designated a user fee into a tax, violating the Act, the APA and constitutional
constraints.
II. The Government Seeks Delays in this Litigation to Announce Proceedings to

Change the Deeming Rules Regulatory Scheme
This case has been pending for more than a year. Plaintiffs filed their Complaint on July
15, 2016, challenging the Deeming Rule and seeking to have it vacated. Dkt. 1. Plaintiffs filed
their Motion for Summary Judgment on February 13, 2017. Dkt. 22.
On March 21, 2017, the parties filed a joint motion to amend the scheduling order,
seeking a 30-day extension of all pending deadlines to allow new leadership personnel at the
Department of Health and Human Services to more fully consider the issues raised in this case
and determine how best to proceed. Dkt. 27 at 1. On April 3, 2017, the Campaign for Tobacco-
Free Kids filed a motion for leave to file an amicus curiae brief in support of the FDA, noting
that several other public health and medical groups were expected to join as signatories to the
brief. Dkt. 29 at 2. The Court granted the motion the same day. Dkt. 30.
On May 1, 2017, the parties sought to amend the scheduling order again by extending all
deadlines by three months. Dkt. 34. In that motion, the parties recognized the effect of the
6
extension for the Governments response on obtaining a ruling from the Court before significant
compliance dates under the Rule, leading to the FDA extending all deadlines in the Rule by the
same period of time. Id. at 2.
Allowing another two-and-a-half months to pass, the Anti-Tobacco Groups filed their
intervention motion on July 24, 2017, claiming they should be added to the case as parties
because they feared Defendants may not aggressively defend the Deeming Rule, or may seek to
alter or rescind the Rule, after their recent changes in leadership. Motion at 3.
On July 28, 2017, the FDA announced a new comprehensive plan for tobacco and
nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly
reduce tobacco-related disease and health. Exhibit A (FDA Press Release). The agency
articulated a new and comprehensive analytical framework for products that deliver nicotine,
explaining that cigarettes were the most dangerous along a continuum of tobacco products. Id.
To that end, the agency expressed its intention to open a rulemaking docket to reduce nicotine
levels in cigarettes. Id. The agency then declared its plan to issue a compliance policy for
cigars, pipe tobacco, and e-cigarettes subject to the Deeming Rule that would extend several key
compliance dates for submitting premarket review applications. Id. The extensions would allow
the agency, among other things, to issue guidance regarding the content of these applications
tailored to these newly deemed products and to make any resulting process more efficient for the
agency and, hopefully, the industries. Id. To refocus the agencys efforts, the agency said it
intends to issue Advanced Notices of Proposed Rulemaking seeking public comment on (a) the
role that flavors in tobacco products play in attracting youth, and (b) the patterns of use and
resulting public health impacts of premium cigars, the latter of which may result in amendments
to the Rule affecting the scope of tobacco products covered by the Rule. Id.
7
On August 1, 2017, the parties filed a joint motion to amend the scheduling order in light
of the FDAs announcement of its new comprehensive plan, which signaled significant potential
changes to the regulatory scheme challenged in this lawsuit. Dkt. 40. The parties acknowledged
that the plan may affect several claims raised in this case. They requested additional time to
consider the consequences of the plan on the litigation, to discuss ways to reduce the need to
litigate some of the issues presented in the case, and, if necessary, to confer on the most efficient
path forward. Id. at 3. One day later, the Anti-Tobacco Groups filed a Supplemental
Memorandum in support of their motion to intervene and seeking expedited consideration. Dkt.
41. In addition to their previously professed interests in the litigation, the Anti-Tobacco Groups
indicated they have a strong interest in participating as parties in ongoing discussions about
FDAs comprehensive plan and its implications for this litigation as well as the most efficient
path forward in this case. Id. at 2.
ARGUMENT
I. The Anti-Tobacco Groups Have Ample Opportunity to Advance Arguments

Defending the Rule as Amici and Fail to Satisfy the Requirements for Intervention
as of Right
The Anti-Tobacco Groups have no right to intervene in this case, as they have failed to
satisfy the most basic requirements for intervention. In deciding whether a party may intervene
as of right, the D.C. Circuit employ[s] a four-factor test requiring: 1) timeliness of the
application to intervene; 2) a legally protected interest; 3) that the action, as a practical matter,
impairs or impedes that interest; and 4) that no party to the action can adequately represent the
potential intervenors interest. Crossroads Grassroots Policy Strategies v. FEC, 788 F.3d 312,
320 (D.C. Cir. 2015); see also Fed. R. Civ. P. 24(a)(2). The burden is on parties seeking to
intervene to demonstrate all four elements. See, e.g., Jones v. Prince Georges Cty., Md., 348
F.3d 1014, 1019 (D.C. Cir. 2003).
8
A. The Anti-Tobacco Groups Intervention Effort Is Untimely
The Anti-Tobacco Groups seek to intervene in this lawsuit more than a year after it was
filed and more than five months after Plaintiffs filed their summary judgment motion. The
Groups say they did not seek to intervene until after it . . . bec[a]me apparent that the
government may not adequately represent their interests. Motion at 16. Tellingly, the Anti-
Tobacco Groups fail to identify any event after which the Governments inability to represent
their interests became apparent. They sought intervention more than four months after the
Government requested additional time for new leadership personnel at the Department of Health
and Human Services to more fully consider the issues raised in this case and determine how
best to proceed. Dkt. 27 at 1. And they waited until the eve of the Governments revised due
date for opposing summary judgment to insist they be permitted to participate as parties rather
than amici, regardless of the resulting disruptions to the briefing schedule and to the parties
ongoing efforts to narrow or resolve the matter. What the Anti-Tobacco Groups are really
proposing is to interfere with the efficient judicial administration of this case without really any
marginal benefit for the airing of their views over their already-approved participation as amici.
See Amador Cty., Cal. v. U.S. Dept of Interior, 772 F.3d 901, 903 (D.C. Cir. 2014) (factors
bearing on timeliness include the time elapsed since the inception of the suit, the purpose for
which intervention is sought, the need for intervention as a means of preserving the applicants
rights, and the probability of prejudice to those already parties in the case).
Plaintiffs would be severely prejudiced by this disruption, as they face imminent, costly
deadlines under the regulatory regime challenged in this case. See Roane v. Leonart, 741 F.3d
147, 151 (D.C. Cir. 2014) (potential intervenors [should be prevented] from unduly disrupting
litigation, to the unfair detriment of the existing parties); In re Endangered Species Act Section
4 Deadline Litig., 270 F.R.D. 1, 6 (D.D.C. 2010) (disallowing intervention due to potential
9
undue delay and prejudice, where the court was unwilling to put [the applicant] in a position to
draw out ongoing settlement negotiations and to further delay the resolution of this case); Sweet
Home Chapter of Cmtys. for Great Or. v. Lujan, No. 91-1468, 1991 U.S. Dist. LEXIS 17449, at
*11 (D.D.C. Dec. 10, 1991) (denying intervention where allowing applicants to join as
defendantsas opposed to amicicould unduly delay the disposition of this case). Plaintiffs
and the Government have agreed to a short delay for purposes of conferring to streamline the
case in light of the FDAs announcement that it will issue separate agency actions delaying
certain compliance deadlines and will open rulemaking dockets that may change the Rule in
ways that make parts of this case unnecessary. But that measure is designed to speed up this
case rather than slow it down. 2
B. The Anti-Tobacco Groups Have No Legally Protected Interest That Would Be

Practically Impaired Without Party Status
The Anti-Tobacco Groups also have not identified a legally protected interest that would
be practically impaired by denial of intervention. After all, the legally protected interests
justifying intervention must be of such a direct and immediate character that the intervenor will
either gain or lose by the direct legal operation and effect of the judgment. Sierra Club v.
McCarthy, 308 F.R.D. 9, 11 (D.D.C. 2015); In re Endangered Species Act, 270 F.R.D. at 5 (same
test for a legally protectable interest). And the intervenors must establish a practical account
of how that interest would be harmed. Defenders of Wildlife v. Perciasepe, 714 F.3d 1317, 1325,
1326 n.8 (D.C. Cir. 2013); see also Fund for Animals v. Norton, 322 F.3d 728, 735 (D.C. Cir.
2
Contrary to the Anti-Tobacco Groups representation, the D.C. Circuit did not rule in Williams
& Humbert, Ltd. v. W. & H. Trade Marks, Ltd., 840 F.2d 72 (D.C. Cir. 1988), that a motion to
intervene filed after summary judgment briefing had commenced was timely. The intervention
motion in that case was filed before summary judgment briefing had started, and the Court
rendered no holding on timeliness. Id. at 7375.
10
2003) (the court must look[] to the practical consequences of denying intervention, even where
the possibility of future challenge to the regulation remains available).
Early this year, the Anti-Tobacco Groups moved to participate as amici curiae in this
case. Neither Plaintiffs nor the Government opposed that motion, and the Court granted it. Dkt.
30. To the extent the Anti-Tobacco Groups wish to amplify the arguments made by the
Government, their participation as amici curiae gives them every opportunity to do so. See Dist.
of Columbia v. Potomac Elec. Power Co., 826 F. Supp. 2d 227, 234 (D.D.C. 2011) (intervention
is unwarranted when the applicant is granted leave to participate as amicus curiae because the
court has the opportunity to consider all of the applicants arguments and objections); Alfa Intl
Seafood, 2017 U.S. Dist. LEXIS 58030, at *15 n.1 (recognizing amicus participation as an
alternative to intervention). The Anti-Tobacco Groups conspicuously make no effort to explain
why their amici status is inadequate to protect their interests.
The Anti-Tobacco Groups real concern is that the agency will change the Rule. But that
is no reason to grant intervention. The FDA publicly announced a suite of administrative actions
on July 28, 2017, to include a compliance policy pushing back certain compliance deadlines for
cigars and pipe tobacco until 2021 and opening new rulemaking dockets that may result in
amending the scope of the Deeming Rule. Exhibit A (FDA Press Release). Should the agency
take final agency action in line with those announcements, this lawsuit is not the vehicle for
challenging those decisions. Instead, if the Anti-Tobacco Groups become unsatisfied with
alterations to the rule made through the administrative process, they can file their own lawsuits
against the FDA at the appropriate time. See Alternative Research & Dev. Found. v. Veneman,
262 F.3d 406, 411 (D.C. Cir. 2001) (per curiam) (intervention improper when resolution
provided for agencys initiation of rulemaking to amend certain animal welfare regulations, and
11
proposed intervenor could participate in the rulemaking process and challenge any resulting final
rule); In re Endangered Species Act, 270 F.R.D. at 6 (applicant could best serve its stated
interests by participating in the administrative review process, and if the agency ultimately took
unfavorable action, applicant could file its own lawsuit to protect those interests directly);
Envtl. Def. v. Leavitt, 329 F. Supp. 2d 55, 68 (D.D.C. 2004) (no intervention where nothing in
the [consent] decree would preclude [proposed intervenor] from participating in the rulemaking
or from challenging the final rule that emerges). 3
The Anti-Tobacco Groups most recent ground for seeking conversion from amici to
intervenors is that they want to participate in whatever discussions the parties have to resolve all
or part of this case. Should such a resolution occur, it will be the product of formal action by the
FDA addressing the issues underlying this lawsuit. Plaintiffs are the masters of their complaint;
they may dismiss this case, with the consent of the Government, for any reason or for no reason
at all. If the Plaintiffs do not challenge the FDAs new actions modifying the Rule or extending
compliance dates, intervenor status will not authorize the Anti-Tobacco Groups to do so. That is
because an intervenor must litigate only the claims presented by the Plaintiffs; they absolutely
have no right to enlarge those claims and prolong the case. See, e.g., Natl Assn of Regulatory
Util. Commrs v. Interstate Commerce Commn, 41 F.3d 721, 729 (D.C. Cir. 1994) (intervenors
may only argue issues that have been raised by the principal parties); Lamprecht v. FCC, 958
F.2d 382, 389 (D.C. Cir. 1992) (Except in extraordinary cases, . . . intervenors may only join
issue on a matter that has been brought before the court by another party. They cannot expand
the proceedings.); Potomac Elec., 826 F. Supp. 2d at 23334 (intervenors were not entitled to
3
In fact, these same public interest groups have not hesitated to file their own lawsuits against
the FDA in the past when dissatisfied with modifications to a Rule. See Am. Acad. of Pediatrics
v. U.S. Food & Drug Admin., No. 1:16-cv-11985-IT (D. Mass. filed Oct. 4, 2016).
12
block entry of consent decree). Accordingly, the FDAs July 28, 2017, announcement of
potential future actions modifying the Rule is a reason to deny intervention, not (as Applicants
claim) to grant it.
Finally, to the extent the Anti-Tobacco Groups are worried that the FDA will not
aggressively enforce the Rule, their claims are foreclosed by settled law. See Heckler v. Chaney,
470 U.S. 821, 83132 (1985) (the decision not to take enforcement action is generally
committed to an agencys absolute discretion and is presumptively immune from judicial
review under the APA). The Anti-Tobacco Groups simply have not demonstrated that they must
be converted from amici to parties to protect any valid interest.
C. The Anti-Tobacco Groups Have Failed to Demonstrate Inadequate Representation
The Anti-Tobacco Groups also have not demonstrated that the United States Department
of Justice will not adequately defend the Rule. See Fed. R. Civ. P. 24(a)(2); Crossroads, 788
F.3d at 320.
This Court rejected a very similar effort of the Natural Resources Defense Council and
other environmental groups to intervene in a challenge to the Commerce Departments Seafood
Traceability Rule. Alfa Intl Seafood, 2017 U.S. Dist. LEXIS 58030. The Courts reasoning in
Alfa International Seafood dispatches almost every single argument the Anti-Tobacco Groups
make in favor of intervention here. Oddly, the Anti-Tobacco Groups never even mention this
Courts entirely on-point opinion. First, this Court held that a concern that the new
Administration may be less zealous in defending an administrative rule is speculative and no
justification for intervention. Id at *12; compare Motion at 19 (arguing at length that the change
in administrations justifies intervention).
This Court also explained that conjecture about what the Government may do at some
point in the future to change the Rule is irrelevant. See Alfa Intl Seafood, 2017 U.S. Dist.
13
LEXIS 58030, at *12-13. The Government has now announced an extension of certain
enforcement deadlines under the Rule and the anticipated opening of new rulemaking dockets to
modify the rule. The aspiring intervenors in Alfa International Seafood also raised concern that
the new administration might adopt policies that negatively affect the force of the Rule. Id. at
*12. But this Court explained that issues about the Rules scope and the timing of [its]
implementation are not at issue in a case challeng[ing an agencys] authority to adopt the Rule
and the process by which they adopted it. Id. at *13. The same is true here. If the FDA
ultimately takes future formal regulatory actions modifying the Rule, intervention in this lawsuit
is not the proper vehicle for the Anti-Tobacco Groups to challenge those actions.
What the Anti-Tobacco Groups are left with is an assertion that the United States
Department of Justice will somehow seek to scuttle the Rule through a limp defense of this
litigation. There is absolutely no evidence for this guess, and indeed it is contrary to the
Departments long-standing tradition of advancing colorable legal arguments in defense of
statutes and rules that remain on the books. In addition, this Administration appears fully
prepared to address the appropriate regulatory scheme for tobacco transparently and head-on,
through formal administrative actions, as demonstrated by its July 28, 2017 announcement. See
Exhibit A (FDA Press Release). This Court should reject the Anti-Tobacco Groups unsupported
aspersions that there is some sub rosa Administration scheme to undermine the Rule through
litigation.
II. This Court Should Deny Permissive Intervention
The Anti-Tobacco Groups belated and halfhearted request for permissive intervention
fares no better. The motion is untimely, the Anti-Tobacco Groups ultimate claim is contingent
on future action by the FDA, and the delay occasioned by granting intervention would unduly
prejudice Plaintiffs. See Fed. R. Civ. P. 24(b)(1), (3) (permissive intervention requires a timely
14
motion and a claim or defense that shares with the main action a common question of law or
fact, and it must not unduly delay or prejudice the adjudication of the original parties rights).
In any event, the Court should nevertheless exercise its discretion to deny permissive
intervention. See In re Endangered Species Act, 270 F.R.D. at 6 (Because permissive
intervention is granted solely at the discretion of the district court, the Court may deny
permission to intervene even if the applicant satisfies the necessary criteria.).
For decades, courts have recognized amicus status as an important alternative to
intervention. See, e.g., Keepseagle v. Vilsack, 307 F.R.D. 233, 249 (D.D.C. 2014) (mem. op.)
(denying intervention but granting claimants leave to participate in proceedings as amici curiae);
Potomac Elec., 826 F. Supp. 2d at 237 (same); Natl Assn of Home Builders v. U.S. Army Corps
of Engrs, 519 F. Supp. 2d 89, 93-94 (D.D.C. 2007) (mem. op.) (same); Sweet Home Chapter of
Cmtys., 1991 U.S. Dist. LEXIS 17449, at *11; see also Stuart v. Huff, 706 F.3d 345, 355 (4th
Cir. 2013) (While a would-be intervenor may prefer party status to that of friend-of-court, the
fact remains that amici often make useful contributions to litigation. The availability of such
alternative avenues of expression reinforces our disinclination to drive district courts into multi-
cornered lawsuits by indiscriminately granting would-be intervenors party status and all the
privileges pertaining thereto.); Bush v. Viterna, 740 F.2d 350, 359 (5th Cir. 1984) (per curiam)
(In acting on a request for permissive intervention, it is proper for the court to consider the fact
that the Association has been granted amicus curiae status in this case.). This Court denied
permissive intervention in Alfa International Seafood because it was not clear on the present
record what additional perspective Applicants would offer on the disputed issues, particularly
the Governments authority to adopt the Rule and the process by which they did so, which is
best known to and defended by the Government. Alfa Intl Seafood, 2017 U.S. Dist. LEXIS
15
58030, at *14-15. So it is the case here in a challenge to the FDAs authority to adopt a rule.
Whatever the Anti-Tobacco Groups have to add can be accomplished as amici, the role this
Court long ago approved.
III. The Anti-Tobacco Groups Cannot Intervene in this Case Because They Lack
Standing
Even if the Anti-Tobacco Groups had met the requirements for intervention, they have
failed to establish standing. 4 To do so, the Anti-Tobacco Groups must establish that they have
(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the
defendant, and (3) that is likely to be redressed by a favorable judicial decision. Spokeo, Inc. v.
Robins, 136 S. Ct. 1540, 1547 (2016). An injury in fact is an invasion of a legally protected
interest that is concrete and particularized, and actual or imminent, not conjectural or
hypothetical. Id. at 1548 (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992)).
Moreover, as here, where standing is premised on future injury, [the party] must demonstrate a
realistic danger of sustaining a direct injury. Alfa Intl Seafood, 2017 U.S. Dist. LEXIS 58030,
at *8 (quoting Arpaio v. Obama, 797 F.3d 11, 21 (D.C. Cir. 2015)). [T]hreatened injury must
be certainly impending to constitute injury in fact and [a]llegations of possible future injury
are not sufficient. Clapper v. Amnesty Intl USA, 568 U.S. 398, 409 (2013).
For organizational standing, an organization must allege that the defendants conduct
perceptibly impaired the organizations ability to provide services in order to establish injury in
4
Article III standing is necessary for both mandatory and permissive intervention. Keepseagle,
307 F.R.D. at 24546, 24849. If courts were authorized to dispense with the standing
requirement for a defendant-intervenor, then any organization or individual with only a
philosophic identification with a defendantor a concern with a possible unfavorable
precedentcould attempt to intervene and influence the course of litigation. Id. at 245
(quoting Deutsche Bank Natl Trust Co. v. FDIC, 717 F.3d 189, 19596 (D.C. Cir. 2013)
(Silberman, J., concurring)); see also Fund for Animals, 322 F.3d at 732 ([B]ecause a Rule 24
intervenor seeks to participate on an equal footing with the original parties to the suit, he must
satisfy the standing requirements imposed on those parties.).
16
fact. Turlock Irrigation Dist. v. FERC, 786 F.3d 18, 24 (D.C. Cir. 2015). Alleging
impairment of its advocacy . . . will not suffice. Id.
A. The Anti-Tobacco Groups Have No Imminent, Concrete Injury that Is Fairly

Traceable to Vacating the Deeming Rule and Redressable
The injuries alleged by the Anti-Tobacco Groups neither are certainly impending nor
qualify as a concrete harm capable of supporting standing. See Clapper, 568 U.S. at 401, 409;
see also Spokeo, 136 S. Ct. at 1548 (a concrete injury must be real, not abstract). Rather,
they are conjectural injuries built on layers of speculation about future actions the FDA might
take. See Arpaio, 797 F.3d at 21.
Time and again, the Anti-Tobacco Groups are either cutting and pasting from their
arguments against e-cigarettes or failing to recognize that the Rule is primarily a method for the
agency to gather information for future regulatory action, albeit in a crushingly expensive and
arbitrary way. First, the Anti-Tobacco Groups voice the concern that, absent regulation, cigar
and pipe tobacco manufacturers are free to mislabel their products without consequence,
quoting the analysis of another district court in Nicopure v. FDA. Motion at 13 (citing Nicopure,
slip op. at 50). But the Nicopure case was entirely about e-cigarettes, a novel product that has
significant variability in the concentration of chemicals amongst products -- including
variability between labeled content and concentration . . . and actual content and concentration.
Nicopure, slip. op. at 50 (citing 81 Fed. Reg. at 29,984). The Anti-Tobacco Groups point to no
such risk for cigar or pipe tobacco products. And for good reason: They are not novel or
unknown products; they have been made the same way for centuries.
This concern about mislabeling is echoed in discussions about the proliferation of
unverified claims about the health effects of tobacco products. The Anti-Tobacco Groups
supporting affidavits fixate on manufacturer comparative health claims undermining their
17
consumer education efforts. See, e.g., Exhibit 3 14; Exhibit 4 12; Exhibit 5 11; Exhibit 6
15; Exhibit 8 11. 5 But Plaintiffs do not challenge the Rules restriction on describing a tobacco
product as healthier than another, the so-called modified-risk-descriptor provision. The reason is
simple. There is no evidence in the administrative record that cigars and pipe tobacco are
marketed as lower-risk tobacco products. The Anti-Tobacco Groups standing arguments are
really vestiges of the documents they used to seek intervention in the e-cigarette cases, such as
the Nicopure case, where e-cigarette manufacturers making unverified claims about the
comparative health effects of their products was a huge issue. The relevant content of the
affidavits was literally copied from the e-cigarette litigation. See Exhibit B (representative
affidavit from Cyclops Vapor 2, LLC v. FDA, Case No. 2:16-cv-556 (M.D. Ala.)).
Second, the Anti-Tobacco Groups talk about the effect of flavored cigars and their
alleged appeal to youth, claiming that their continued sale will hamper the groups efforts to keep
youth away from tobacco. Motion at 2, 13, 14, 18. Again, they do not link their injury to the
Rule they wish to defend. The Rule does not ban flavored cigars or impose different or
additional labeling requirements for flavored cigars. See 81 Fed. Reg. at 29,055. The
appropriate place for the Anti-Tobacco Groups concerns is in response to whatever action the
agency takes pursuant to its newly announced rulemaking docket regarding flavored tobacco
products. See Exhibit A (FDA Press Release).
Third, the Anti-Tobacco Groups entirely miss the fact that the FDA itself calls the Rule
an enabling rule, authorizing the agency to gather information for future regulatory action,
which will later generate health benefits. See 81 Fed. Reg. at 29,075. The FDA claims that the
5
All numbered exhibits refer to Applicants exhibits in support of their Motion.
18
benefits of the Deeming Rule cannot be quantified now, because its actual effects on anti-
smoking efforts will only come later through future agency action. See id.
The Anti-Tobacco Groups simply cannot rest their standing on speculation of what the
FDA might do once it gathers the information required by the Rule. See Arpaio, 797 F.3d at 21;
Turlock, 786 F.3d at 24 (cannot stack[ ] speculation upon hypothetical upon speculation to
establish standing); see also Clapper, 568 U.S. at 414 (We decline to abandon our usual
reluctance to endorse standing theories that rest on speculation about the decisions of
independent actors.). The Rule imposes certain and devastating costs on the industry Plaintiffs.
But because of the requirement of a further, discretionary agency action before alleged public
health benefits occur, the Anti-Tobacco Groups do not face direct, tangible injury if the
agencys action [is] reversed. Alfa Intl Seafood, 2017 U.S. Dist. LEXIS 58030, at *89. This
Court rejected efforts by public interest organizations to intervene in a challenge to an
administrative rule where their standing reli[es] on the anticipated conduct of third parties and
future actions that are not being challenged and cannot be controlled by the Court. Id. This case
is thus entirely different than the cases chiefly relied on by the Anti-Tobacco Groups, where the
challenged Rules prohibited or required primary conduct that directlywithout the intervention
of future agency actioneased the operations of a public interest group. 6
6
The Anti-Tobacco Groups vaguely claim that they will have to expend more resources if the
Deeming Rule is struck down. See, e.g., Motion at 3; Exhibit 3 15. But there is no indication
that the Anti-Tobacco Groups had planned to cut their budgets for cigar- or pipe-specific public
education or advocacy after implementation of the Deeming Rule. Nor are there factual
allegations that the additional expenditures would keep the Anti-Tobacco Groups from pursuing
their true purpose, as is necessary for such expenditures to count in the standing inquiry. Natl
Taxpayers Union, Inc. v. United States, 68 F.3d 1428, 1434 (D.C. Cir. 1995). Further, it has long
been settled that an organization cannot convert its ordinary program costs into an injury in
fact. Id.
19
All of this further demonstrates that the anti-tobacco groups alleged harms are not fairly
traceable to vacating the Deeming Rule and cannot be redressed through participation in this
case. See Spokeo, 136 S. Ct. at 1547; Arpaio, 797 F.3d at 15 (rejecting allegations of
redressability impermissibly resting on chains of supposition and contradict[ing] acknowledged
realities). Rather than focus on the actual requirements of the Deeming Rule, the Anti-Tobacco
Groups largely tie their alleged harms to whether newly deemed products or tobacco products
are unregulated generally. See, e.g., Motion at 10, 13; Exhibit 6 9. They do not show how
particular requirements relevant to cigars and pipe tobacco would benefit them. Standing is
lacking.
B. AAP Has Failed to Establish Associational Standing
The American Academy of Pediatrics (AAP) has also failed to establish associational
standing, as none of its members has standing in their own right. See Common Cause v. FEC,
108 F.3d 413, 417 (D.C. Cir. 1997). AAP claims that its memberspediatricians and pediatric
specialistsmust spend more time counseling patients and their parents not to smoke when
cigar manufacturers are unregulated and therefore permitted to create and market candy-flavored
products that appeal to youth. Motion at 14. But all of that assumes that this Rule is going to
reduce the incidence of smoking cigars or ban flavored products, both of which depend on
further FDA regulatory action that this litigation cannot force. See 81 Fed. Reg. at 29,055
(FDA is not banning flavored tobacco products with this final deeming rule.); see also
Clapper, 568 U.S. at 414 (standing theories that rest on speculation about the decisions of
independent actors are improper). The AAP members standing suffers from all the defects of
the organizations: Their alleged injuries are speculative and indirect, and are not fairly
traceable to and redressable by upholding the Rule.
20
C. The Anti-Tobacco Groups Intervention in Previous Cases Is Immaterial
Finally, the Anti-Tobacco Groups historical participation in other tobacco-related cases
is irrelevant here. See Motion at 12 (discussing United States v. Philip Morris USA, Inc., 566
F.3d 1095 (D.C. Cir. 2009) (Philip Morris II), and Public Citizen v. FTC, 869 F.2d 1541 (D.C.
Cir. 1989)). The standing inquiry for intervention is a highly case-specific endeavor, Pub.
Citizen, 869 F.2d at 1546, and the cases cited by the Anti-Tobacco Groups were materially
different. Philip Morris II was not a challenge to an administrative rule; instead the Government
was suing the defendants to enjoin specific practices allegedly designed to mislead the public
about the health effects of cigarette smoking. Philip Morris II, 566 F.3d at 110506, 1109.
Various organizations sought intervention after the defendants were found liable, id. at 1108,
for the very limited purpose of being heard on the issue of the permissible and appropriate
remedies, United States v. Philip Morris USA, Inc., No. 99-2496, 2005 U.S. Dist. LEXIS
16196, at *11 (D.D.C. July 22, 2005). The Anti-Tobacco Groups seek much greater involvement
in this case, but have not bothered to even propose a remedy that will have an immediate effect
on their operations.
In Public Citizen, public health organizations themselves sued the FTC claiming that its
rule arbitrarily and capriciously exempted branded hats and shirts from a regulation of cigarette
promotional materials that the organizations claimed were directly attracting youth to cigarettes.
Pub. Citizen, 869 F.2d at 1542. The case was not about intervention and concerned a regulation
of primary conduct, rather than a rule primarily targeted at information collection and enabling
future agency action.
21
CONCLUSION
The Anti-Tobacco Groups have not met the requirements for intervening in this case and
already will have their voices heard on the merits as amici curiae. Accordingly, their Motion to
Intervene as Defendants should be denied in full.
Dated: August 7, 2017 Respectfully submitted,
/s/ Michael J. Edney

Michael J. Edney, DC Bar No. 492024
Caroline M. Mew, DC Bar No. 467354
NORTON ROSE FULBRIGHT US LLP
799 9th Street, NW, Suite 1000
Washington, DC 20001-4501
Telephone: (202) 662-0200
Fax: (202) 662-4643
michael.edney@nortonrosefulbright.com
caroline.mew@nortonrosefulbright.com
Attorneys for Plaintiffs International Premium

Cigar and Pipe Retailers Association and Cigar
Rights of America
/s/ Mark A. Heller

Mark A. Heller, DC Bar No. 357046
Mark S. Raffman, DC Bar No. 414578
GOODWIN PROCTER LLP
901 New York Avenue, NW
Washington, DC 20001
Telephone: (202) 346-4000
mheller@goodwinprocter.com
mraffman@goodwinprocter.com
Attorneys for Plaintiff Cigar Association of

America
22
Case 1:16-cv-01460-APM Document 44-1 Filed 08/07/17 Page 1 of 5


et al.,
Plaintiffs,

Defendants.
EXHIBIT A
Press Announcements > FDA announces comprehensive regulatory plan to shift trajector... Page 1 of 4
FDA News Release
FDA announces comprehensive

regulatory plan to shift trajectory of
tobacco-related disease, death
Agency to pursue lowering nicotine in cigarettes to non-addictive levels and create more
predictability in tobacco regulation
For Immediate Release
July 28, 2017
Release
Espaol (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm569126.htm)
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco
and nicotine regulation that will serve as a multi-year roadmap to better protect kids and
significantly reduce tobacco-related disease and death. The approach places nicotine, and the
issue of addiction, at the center of the agencys tobacco regulation efforts. The goal is to ensure
that the FDA has the proper scientific and regulatory foundation to efficiently and effectively
implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA
is striking an appropriate balance between regulation and encouraging development of innovative
tobacco products that may be less dangerous than cigarettes, the agency is also providing
targeted relief on some timelines described in the May 2016 final rule that extended the FDAs
authority to additional tobacco products. The agency will also seek input on critical public health
issues such as the role of flavors in tobacco products.
Tobacco use remains the leading cause of preventable disease and death in the United States,
causing more than 480,000 deaths every single year. In addition to the devastating human toll
caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society,
with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of
the FDAs approach is demonstrating a greater awareness that nicotine while highly addictive
is delivered through products that represent a continuum of risk and is most harmful when
delivered through smoke particles in combustible cigarettes.
https://www.fda.gov/newsevents/newsroom/%20pressannouncements/ucm568923.htm 8/7/2017
The overwhelming amount of death and disease attributable to tobacco is caused by addiction to
cigarettes the only legal consumer product that, when used as intended, will kill half of all long-
term users, said FDA Commissioner Scott Gottlieb, M.D. Unless we change course, 5.6 million
young people alive today will die prematurely later in life from tobacco use. Envisioning a world
where cigarettes would no longer create or sustain addiction, and where adults who still need or
want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of
our efforts and we believe its vital that we pursue this common ground.
The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes
to non-addictive levels through achievable product standards. The agency intends to issue an
Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health
benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90
percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their
first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that
future generations become addicted to cigarettes and allow more currently addicted smokers to
quit.
Because nicotine lives at the core of both the problem and the solution to the question of
addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the
FDAs strategy for addressing the devastating, addiction crisis that is threatening American
families, said Commissioner Gottlieb. Our approach to nicotine must be accompanied by a firm
foundation of rules and standards for newly-regulated products. To be successful all of these steps
must be done in concert and not in isolation.
The FDA is committed to encouraging innovations that have the potential to make a notable public
health difference and inform policies and efforts that will best protect kids and help smokers quit
cigarettes. To make this effort successful, the agency intends to extend timelines to submit
tobacco product review applications for newly regulated tobacco products that were on the market
as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful
measures to make tobacco products less toxic, appealing and addictive. For example, the FDA
intends to develop product standards to protect against known public health risks such as
electronic nicotine delivery systems (ENDS) battery issues and concerns about childrens
exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher
quality, more complete applications informed by additional guidance from the agency.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under
expected revised timelines, applications for newly-regulated combustible products, such as cigars,
pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-
combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022.
Additionally, the FDA expects that manufacturers would continue to market products while the
agency reviews product applications.
Importantly, the anticipated new enforcement policy will not affect any current requirements for
cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and
e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance
deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal
sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but
not limited to, required warning statements, ingredient listing, health document submissions,
harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e.,
"light," "low," or "mild," or similar descriptors.
In order to further explore how best to protect public health in the evolving tobacco marketplace,
the agency also will seek input from the public on a variety of significant topics, including
approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA
intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in
tobacco products play in attracting youth and may play in helping some smokers switch to
potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific
data related to the patterns of use and resulting public health impacts from premium cigars, which
were included in the FDAs 2016 rule. Additionally, the agency plans to examine actions to
increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to
consider what steps can be taken under the safety and efficacy standard for products intended to
help smokers quit.
This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply
the powerful tools given by Congress to achieve the most significant public health impact, said
Mitch Zeller, J.D., director of the FDAs Center for Tobacco Products. Public input on these
complex issues will help ensure the agency has the proper science-based policies in place to
meaningfully reduce the harms caused by tobacco use.
To complement these larger policy considerations, the FDA plans to issue foundational rules to
make the product review process more efficient, predictable, and transparent for manufacturers,
while upholding the agencys public health mission. Among other things, the FDA intends to issue
regulations outlining what information the agency expects to be included in Premarket Tobacco
Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to
demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it
intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in
complying with federal tobacco regulations through online information, meetings, webinars and
guidance documents.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and
protects the public health by, among other things, assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human use, and medical
devices. The agency also is responsible for the safety and security of our nations food supply,
cosmetics, dietary supplements, products that give off electronic radiation, and for regulating
tobacco products.
###
Inquiries
Media
Michael Felberbaum (mailto:michael.felberbaum@fda.hhs.gov)

240-402-9548
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888-INFO-FDA
Related Information
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco

(/NewsEvents/Speeches/ucm569024.htm)
FDA's New Plan for Tobacco and Nicotine Regulation

(/TobaccoProducts/NewsEvents/ucm568425.htm)
FDA Center for Tobacco Products (/TobaccoProducts/default.htm)
Follow FDA
Follow @US_FDA (https://twitter.com/US_FDA)

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More in Press Announcements

(/NewsEvents/Newsroom/PressAnnouncements/default.htm)
2016 (/NewsEvents/Newsroom/PressAnnouncements/2016/default.htm)
2015 (/NewsEvents/Newsroom/PressAnnouncements/2015/default.htm)


et al.,
Plaintiffs,

Defendants.
EXHIBIT B
Case
Case
2:16-cv-00556-MHT-CSC
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et al.,
Plaintiffs,

Defendants.
[PROPOSED] ORDER
This matter is before the Court on the Motion to Intervene as Defendants filed by the
American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the
American Heart Association, the American Lung Association, the Campaign for Tobacco-Free
Kids, and the Truth Initiative (collectively Applicants). Applicants seek to intervene in this case
as of right or permissibly, in the alternative.
Upon consideration of the moving and opposing papers, and the record in this case, the
Court finds that Applicants have failed to meet the requirements for intervention as of right. The
Court also denies Applicants request for permissive intervention. Applicants motion is therefore
DENIED.
SO ORDERED.
Dated: ________________, 2017
___________________________________
AMIT P. MEHTA
United States District Judge

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Case 1:16-cv-01460-APM Document 44 Filed 08/07/17 Page 1 of 27

IN THE UNITED STATES DISTRICT COURT

CIGAR ASSOCIATION OF AMERICA,

v. Civil Action No. 16-1460 (APM)

UNITED STATES FOOD AND DRUG

PLAINTIFFS OPPOSITION TO MOTION TO INTERVENE

*Alfa Intl Seafood v. Ross,

Alternative Research & Dev. Found. v. Veneman,

Amador Cty., Cal. v. U.S. Dept of Interior,

*Clapper v. Amnesty Intl USA,

Common Cause v. FEC,

Crossroads Grassroots Policy Strategies v. FEC,

Cyclops Vapor 2, LLC v. FDA,

Defenders of Wildlife v. Perciasepe,

Deutsche Bank Natl Trust Co. v. FDIC,

*Dist. of Columbia v. Potomac Elec. Power Co.,

*In re Endangered Species Act Section 4 Deadline Litig.,

Envtl. Def. v. Leavitt,

Fund for Animals v. Norton,

Jones v. Prince Georges Cty., Md.,

Lujan v. Defenders of Wildlife,

Natl Assn of Home Builders v. U.S. Army Corps of Engrs,

Natl Assn of Regulatory Util. Commrs v. Interstate Commerce Commn,

Natl Taxpayers Union, Inc. v. United States,

Public Citizen v. FTC,

Sierra Club v. McCarthy,

Spokeo, Inc. v. Robins,

Sweet Home Chapter of Cmtys. for Great Or. v. Lujan,

Turlock Irrigation Dist. v. FERC,

United States v. Philip Morris USA, Inc.,

United States v. Philip Morris USA, Inc.,

Williams & Humbert, Ltd. v. W. & H. Trade Marks, Ltd.,

Rules and Statutes

Fed. R. Civ. P. 24 .................................................................................................................8, 13, 14

Plaintiffs Cigar Association of America, Cigar Rights of America, and International

Tobacco Groups or Applicants).

the Government files its first substantive brief.

Related Disease, Death (July 28, 2017), available at https://www.fda.gov/newsevents/newsroom/

pressannouncements/ucm568923.htm (FDA Press Release) 1. Should these separate, formal

interfere with discussions to resolve this matter.

challenged that provision of the Rule.

challenged that application and information-gathering process as arbitrarily constructed and

II. The Government Seeks Delays in this Litigation to Announce Proceedings to

same period of time. Id. at 2.

path forward in this case. Id. at 2.

I. The Anti-Tobacco Groups Have Ample Opportunity to Advance Arguments

F.3d 1014, 1019 (D.C. Cir. 2003).

A. The Anti-Tobacco Groups Intervention Effort Is Untimely

case rather than slow it down. 2

B. The Anti-Tobacco Groups Have No Legally Protected Interest That Would Be

the possibility of future challenge to the regulation remains available).

alternative to intervention). The Anti-Tobacco Groups conspicuously make no effort to explain

why their amici status is inadequate to protect their interests.

or from challenging the final rule that emerges). 3

claim) to grant it.

committed to an agencys absolute discretion and is presumptively immune from judicial

be converted from amici to parties to protect any valid interest.

C. The Anti-Tobacco Groups Have Failed to Demonstrate Inadequate Representation

other environmental groups to intervene in a challenge to the Commerce Departments Seafood

Administration may be less zealous in defending an administrative rule is speculative and no

in administrations justifies intervention).

Departments long-standing tradition of advancing colorable legal arguments in defense of

II. This Court Should Deny Permissive Intervention

Michael Felberbaum (mailto:michael.felberbaum@fda.hhs.gov)