Fdahealthgroupslawsuit

Case 1:16-cv-01460-APM Document 36 Filed 07/24/17 Page 1 of 28
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.
MOTION TO INTERVENE AS DEFENDANTS

TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES .......................................................................................................... ii
I. INTRODUCTION ...............................................................................................................1
II. FACTUAL AND LEGAL BACKGROUND ......................................................................3
A. The Deeming Rule ...................................................................................................3
B. Plaintiffs Challenge to the Deeming Rule ..............................................................6
C. Defendants Responses to Challenges to the Deeming Rule ...................................7
III. PUBLIC HEALTH INTERVENORS..................................................................................8
IV. ARGUMENT .....................................................................................................................11
A. Public Health Intervenors Have Standing to Intervene as

Defendants .............................................................................................................11
1. Organizational Standing.............................................................................12
2. Associational Standing...............................................................................14
B. Public Health Intervenors Are Entitled to Intervene as of Right ...........................15
1. Public Health Intervenors Motion to Intervene is Timely ........................15
2. Public Health Intervenors Have Legally Protected Interests

at Stake .......................................................................................................17
3. If Successful, Plaintiffs Action Would Impair Public

Health Intervenors Interests ......................................................................17
4. Public Health Intervenors Interests May Not Be

Adequately Represented by Defendants ....................................................18
C. Alternatively, the Court Should Permit Applicants to Intervene

Permissively ...........................................................................................................20
V. PROPOSED TIMELINE FOR INTERVENTION ............................................................21
VI. CONCLUSION ..................................................................................................................22
CERTIFICATE OF SERVICE
i
TABLE OF AUTHORITIES
Page(s)
CASES
Acree v. Republic of Iraq, 370 F.3d 41 (D.C. Cir. 2004) ...............................................................20
Crossroads Grassroots Policy Strategies v. FEC, 788 F.3d 312 (D.C. Cir. 2015) ...........11, 18, 19
Dimond v. District of Columbia, 792 F.2d 179 (D.C. Cir. 1986) ..................................................18
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) ...........................................3, 4
Foster v. Gueory, 655 F.2d 1319 (D.C. Cir. 1981) ........................................................................17
Friends of Animals v. Salazar, 626 F. Supp. 2d 102 (D.D.C. 2009) .............................................12
Fund for Animals, Inc. v. Norton, 322 F.3d 728 (D.C. Cir. 2003) ....................................17, 18, 19
Hardin v. Jackson, 600 F. Supp. 2d 13 (D.D.C. 2009) ..................................................................16
Kleissler v. U.S. Forest Service, 157 F.3d 964 (3d Cir. 1998) ......................................................19
Kootenai Tribe of Idaho v. Veneman, 313 F.3d 1094 (9th Cir. 2002) ...........................................19
Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) ....................................15
Natural Resources Defense Council v. Costle, 561 F.2d 904 (D.C. Cir. 1977).......................17, 19
Natural Resources Defense Council v. EPA, 489 F.3d 1364 (D.C. Cir. 2007) .......................14, 15
Nicopure Labs, LLC v. FDA, No. 1:16-cv-00878-ABJ (D.D.C. July 21, 2017) .............2, 6, 10, 13
Parker v. John Moriarty & Associates, 319 F.R.D. 18 (D.D.C. 2016)..........................................11
Smoke v. Norton, 252 F.3d 468 (D.C. Cir. 2001) ....................................................................15, 16
Southwest Center for Biological Diversity v. Berg, 268 F.3d 810 (9th Cir. 2001) ........................11
Trbovich v. United Mine Workers, 404 U.S. 528 (1972) .........................................................18, 20
United States v. AT&T Co., 642 F.2d 1285 (D.C. Cir. 1980) ............................................11, 15, 18
United States v. Philip Morris USA Inc., 566 F.3d 1095 (D.C. Cir. 2009) .........................3, 12, 17
United States v. Philip Morris USA Inc., No. 99-cv-2496, 2005 WL 1830815
(D.D.C. July 22, 2005) .......................................................................................................13
Wilderness Society v. Babbitt, 104 F. Supp. 2d 10 (D.D.C. 2000) ................................................15
ii
Williams & Humbert Ltd. v. Ruiz-Mateos, No. 83-cv-1905, 1991 WL 148283,

(D.D.C. Jan. 29, 1991) .......................................................................................................16
Williams & Humbert Ltd. v. W. & H. Trade Marks (Jersey) Ltd., 840 F.2d 72
(D.C. Cir. 1988) .................................................................................................................16
STATUTES, RULES, AND ADMINISTRATIVE MATERIALS
21 U.S.C.
387a ...............................................................................................................................2, 4
387b...................................................................................................................................5
387c ...................................................................................................................................5
387d...................................................................................................................................6
387e ...................................................................................................................................6
387g...................................................................................................................................2
387j ...................................................................................................................................6
387s ...................................................................................................................................6
D.D.C. LCvR 7 ................................................................................................................................1
Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,
123 Stat. 1776 (2009) ...................................................................................................2, 4, 5
FDA, May 2017: Web Statement, available at https://www.fda.gov/Tobacco

Products/NewsEvents/ucm556562.htm (last updated May 3, 2017) ...................................8
FDA, Three-Month Extension of Certain Tobacco Product Compliance Deadlines

Related to the Final Deeming Rule (May 2017), available at
https://www.fda.gov/downloads/TobaccoProducts/Labeling/Rules
RegulationsGuidance/UCM557716.pdf...........................................................................6, 8
Fed. R. Civ. P. 24 ................................................................................................................... passim
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) ...................................................................................6
Final Regulatory Impact Analysis, Docket No. FDA-2014-N-1089 (May 2016),

available at https://www.fda.gov/downloads/aboutfda/reportsmanuals
forms/reports/economicanalyses/ucm500254.pdf .............................................................19
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, 2, 4, 5, 6
OTHER AUTHORITIES
Baker, Frank et al., Health Risks Associated with Cigar Smoking, 284 J. Am.
Med. Assn 735 (2000) ........................................................................................................5
iii
Campaign for Tobacco-Free Kids et al., Public Comment, Docket No. FDA-2014-
N-1089 (Aug. 8, 2014), available at https://www.regulations.gov/
document?D=FDA-2014-N-0189-79772.............................................................................4
iv
Pursuant to Federal Rule of Civil Procedure 24 and Local Rule 7(j), 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, Public Health Intervenors) hereby move for leave to
intervene as defendants in this case.1 Public Health Intervenors seek intervention as of right
under Rule 24(a)(2) or, in the alternative, permissive intervention under Rule 24(b)(1).2
Pursuant to Local Rule 7(m), Public Health Intervenors have contacted counsel for all
parties to determine whether they consent to intervention. Plaintiffs have stated that they oppose
this motion. Defendants reserve the right to oppose the motion.
I. INTRODUCTION
In this case, representatives of the tobacco industry ask the Court to set aside the
Deeming Rule,3 through which defendant U.S. Food and Drug Administration (FDA)
1
A proposed pleading has been lodged together with this motion. See Answer (Ex. 2).
2
On April 3, 2017, the Court granted the Campaign for Tobacco-Free Kids (Tobacco-
Free Kids) unopposed motion for leave to a file an amicus brief in this action. That same day,
the Court sent a Notice to Parties disclosing that its former law firm, Zuckerman Spaeder LLP,
has, from time to time, represented Tobacco-Free Kids, and requesting that the organization
disclose any actual or planned involvement of the Zuckerman Spaeder firm in the amicus brief
intended to be filed. Tobacco-Free Kids responded to the Courts notice on April 5, disclosing
the number of hours worked by the firm on this matter and the expectation that the firm would
provide substantial assistance in drafting the amicus brief going forward. Due to the extensions
of the pleading schedule described below, that amicus brief has not been filed with the Court.
Tobacco-Free Kids hereby informs the Court that the Zuckerman Spaeder firm is not
representing Tobacco-Free Kids or the other prospective intervenors in connection with this
motion to intervene and will not be involved in the case going forward. Carlos T. Angulo and
Andrew N. Goldfarb of the firm did provide advice and guidance to Tobacco-Free Kids on legal
issues relating to possible intervention in this case, but did not participate in the preparation of
the instant motion and supporting materials. Should the present motion to intervene be granted,
Tobacco-Free Kids will not file an amicus brief and will instead participate jointly with Public
Health Intervenors as intervenor-defendants in this case.
3
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
determined that cigars should be deemed subject to FDA regulation as tobacco products for the
purposes of the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123
Stat. 1776 (2009) (codified at 21 U.S.C. 387-387u) (TCA). The regulation applied to all
cigars, including so-called premium cigars, little cigars, and cigarillos. In the TCA, Congress
required the FDA to regulate certain types of tobacco products, such as cigarettes and smokeless
tobacco, and gave the FDA authority to regulate other tobacco products, including cigars, if the
FDA first deemed them to be subject to regulation. 21 U.S.C. 387a(b). On July 21, 2017,
Judge Jackson upheld the Deeming Rule, granting the government summary judgment and
rejecting a similar challenge to the Rule by e-cigarette companies. See Nicopure Labs, LLC v.
FDA, No. 1:16-cv-00878-ABJ (D.D.C. July 21, 2017) (Slip Op.).
The TCA banned flavored cigarettes (except for menthol) and cigarette advertising
practices targeted at minors in an effort to reduce the prevalence of youth smoking. See 21
U.S.C. 387g, 387a-1. But because these prohibitions did not apply to cigars in the absence of
a final rule deeming them subject to FDA regulation, manufacturers of tobacco products could
still create and market flavored cigars and design products and marketing strategies that appeal
particularly to young people. The cigar industry responded immediately. Manufacturers
consciously reoriented the market, resulting in a dramatic rise in the availability of flavored
cigarscigars that taste like candy, fruit, or chocolate and have names like Banana Split or
Wild Rushin order to appeal powerfully to minors. As a result, many studies find that cigar
smoking is more prevalent than cigarette smoking, or as prevalent, among youth. See 81 Fed.
Reg. at 29,023.
The Deeming Rule is a necessary predicate to FDA regulation of cigars and thus the only
way for the FDA to reverse this trend and reduce the public health risks that the unregulated
2
promotion and sale of cigars has created. Setting aside the Deeming Rule, as Plaintiffs request,
would have a direct adverse effect on public health, particularly among youth. Public Health
Intervenors are non-profit organizations that have worked for decades to protect the public from
the devastating harms caused by tobacco products. Dismantling the regulatory structure adopted
by the FDA in the Deeming Rule would increase the risk of those harms, particularly to young
people, and thus force Public Health Intervenors to expend greater resources to accomplish their
shared mission than if the Rule were preserved and fully implemented. Public Health
Intervenors therefore have a strong interest in defending the Deeming Rule.
Intervention by certain of these Public Health Intervenors has been permitted in other
tobacco cases. See, e.g., United States v. Philip Morris USA Inc. (Philip Morris II), 566 F.3d
1095, 1098, 1146 (D.C. Cir. 2009). In this case, the necessity of intervention is particularly
strong, given the recent indications that Defendants may not aggressively defend the Deeming
Rule, or may seek to alter or rescind the Rule, after their recent changes in leadership. Public
Health Intervenors have filed their motion prior to the filing of Defendants response to
Plaintiffs summary judgment motion to ensure that at least some parties to this case will
vigorously defend the Deeming Rule and to enable the motion to intervene to be decided
promptly after Defendants make known whether and how they will defend the Rule.
Public Health Intervenors therefore respectfully request that this Court grant leave to
intervene as defendants to protect their and their members interests in ensuring that the Deeming
Rule is not weakened, vacated, or rendered ineffective.
II. FACTUAL AND LEGAL BACKGROUND
A. The Deeming Rule
[T]obacco use, particularly among children and adolescents, poses perhaps the single
most significant threat to public health in the United States. FDA v. Brown & Williamson
3
Tobacco Corp., 529 U.S. 120, 161 (2000). Nonetheless, the Supreme Court held in 2000 that
Congress had not authorized the FDA to regulate tobacco products. Id. In response, Congress
enacted the TCA, providing that [t]obacco products shall be regulated by the Secretary [of
the Department of Health and Human Services]. 21 U.S.C. 387a(a). Congress applied the
TCA to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco as well
as any other tobacco products that the Secretary by regulation deems to be subject to this
subchapter. Id. 387a(b).
After passage of the TCA, several types of tobacco products remained unregulated,
including cigars, pipe tobacco, [and] waterpipe tobacco. 81 Fed. Reg. at 28,982. To determine
whether to exercise the deeming authority granted by Congress, the FDA engaged in a
comprehensive five-year review of the scientific literature on unregulated tobacco products,
analyzing more than 275 scientific studies and other reports and 135,000 public comments. It
concluded that [a]ll cigars pose serious negative health risks, with regular cigar smoking
responsible for approximately 9,000 premature deaths or almost 140,000 years of potential life
lost among adults 35 years or older in 2010. Id. at 29,020. All cigar smokers have an
increased risk of oral, esophageal, laryngeal, and lung cancer compared to non-tobacco users, as
well as other adverse health effects, such as increased risk of heart and pulmonary disease, a
marked increase in risk for chronic obstructive pulmonary disease, and a higher risk of fatal
and nonfatal stroke. Id. In addition, [a]ll cigars produce secondhand smoke, which causes
negative health effects such as heart disease and lung cancer in bystanders. Id.4
4
Indeed, as Public Health Intervenors along with several other public health groups noted
in commenting on the proposed rule, cigars emit significantly more harmful secondhand smoke
than cigarettes. See Campaign for Tobacco-Free Kids et al. Cmt. 14, Docket No. FDA-2014-N-
1089 (Aug. 8, 2014) (Compared with a [similarly smoked] cigarette , a large cigar emits
about 20 times the carbon monoxide, five times the respirable particles, and twice the amount of
4
The FDA explained that it remains most concerned about use by youth and young adults
given their unique susceptibility to the addictiveness of nicotine. 81 Fed. Reg. at 29,023.5 A
cigar can contain as much tobacco as an entire pack of cigarettes, and nicotine yields from
smoking a cigar can be up to eight times higher than yields from smoking a cigarette. Id. at
29,022. It is thus particularly troubling that youth cigar use has not declined when compared to
use of other tobacco products since the passage of the TCA. Id. at 29,023. Data from the 2014
National Youth Tobacco Survey showed that 8.2 percent of high school students (over 1.2
million young people) and 1.9% of middle school students (220,000) had smoked cigars
(including cigarillos and little cigars) in the past 30 days. Id. at 28,985. The 2014 National
Survey on Drug Use and Health revealed that more than 2,500 persons under the age of 18
smoke their first cigar each day. Id. Cigar smoking appears to have actually surpassed cigarette
smoking among youth in certain areas of the United States: In a survey of 21 cities, 8.6% of
high school students smoked cigars, compared to 7.7% who smoked cigarettes. Id. at 29,023.
In light of these and other findings, the FDA extend[ed] the Agencys tobacco product
authorities in the [Federal Food, Drug, and Cosmetic Act] to all other categories of products that
meet the statutory definition of tobacco product in the Act, except accessories of such newly
deemed tobacco products. 81 Fed. Reg. at 28,974. Because the FDA deemed cigars subject to
regulation under the TCA, cigars became subject to the provisions of the TCA, including, among
other things, prohibitions on adulteration and misbranding, 21 U.S.C. 387b-387c; reporting
polycyclic aromatic hydrocarbon. (quoting Baker et al., Health Risks Associated with Cigar
Smoking, 284 J. Am. Med. Assn 735, 738 (2000))).
5
See, e.g., 81 Fed. Reg. at 29,029 (The Surgeon General has stated that adolescents
appear to be particularly vulnerable to the adverse effects of nicotine on the central nervous
system.); id. at 29,033 ([N]icotine exposure during adolescence may have lasting adverse
consequences for brain development.).
5
and registration requirements, id. 387d-387e; and, most notably for this case, mandatory
premarket review of any tobacco product that was not commercially marketed in the United
States as of February 15, 2007, id. 387j(a)(1)(A). The FDA also establish[ed] specific
restrictions that are appropriate to the protection of the public health for the newly deemed
tobacco products, including prohibiting the sale of covered tobacco products (including cigars)
to individuals under the age of 18 and requiring the display of health warnings on tobacco
product labels and advertisements. 81 Fed. Reg. at 28,974-28,975.
The FDA concluded that the benefits of the final rule justify the costs, 81 Fed. Reg. at
29,075, a determination upheld in Nicopure as to e-cigarettes as a careful assessment of the
costs and benefits, Slip Op. 70. The FDA explained that the Rule would reduce the death and
disease from tobacco products and afford[] FDA additional tools to reduce the number of
illnesses and premature deaths associated with tobacco product use. 81 Fed. Reg. at 29,075. In
order to give manufacturers ample time to obtain FDA authorization, the FDA announced
lengthy compliance periodsand FDA has since extended these deadlines further. See FDA,
Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
Deeming Rule (May 2017) (Guidance).
B. Plaintiffs Challenge to the Deeming Rule
Three trade associations of tobacco industry participantsthe Cigar Association of
America, Inc., International Premium Cigar and Pipe Retailers Association, and Cigar Rights of
America (collectively, Plaintiffs)filed suit to challenge the Deeming Rule.6 Arguing that the
6
Plaintiffs also challenged a related rule dealing with the calculation of user fees levied
on tobacco manufacturers and importers under 21 U.S.C. 387s. 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). Public
Health Intervenors do not intend to take a position on Plaintiffs challenge to the User Fee Rule.
6
Deeming Rule is arbitrary and capricious and violates the First Amendment, they seek, among
other things, vacatur of the Deeming Rule, a permanent injunction restraining its implementation
or enforcement, and a declaration that its labeling requirements violate the First Amendment.
C. Defendants Responses to Challenges to the Deeming Rule
Similar suits challenging the Deeming Rule have been brought by e-cigarette
manufacturers and retailers.7 The furthest along is Nicopure Labs, LLC v. FDA, No. 16-cv-878
(D.D.C.),8 in which Judge Jackson, on July 21, 2017, granted summary judgment to the
government and upheld the Deeming Rule against a challenge by e-cigarette manufacturers
raising many arguments parallel to those made by Plaintiffs in the present case. In Nicopure,
Defendants had filed an 85-page cross-motion for summary judgment, vigorously defending the
Deeming Rule in full.
In recent months, however, it has become apparent that Defendants may not adequately
defend the Deeming Rule and may seek to weaken or rescind it. Twice in recent months the
Defendants have requested extensions of time to oppose Plaintiffs motion for summary
judgment and/or file a cross-motion for summary judgment in this case. The first such motion
was filed by Defendants jointly with the industry Plaintiffs on March 21, 2017. On May 1, 2017,
facing a deadline for their summary judgment motion, Defendants filed a joint motion with the
industry Plaintiffs requesting that all deadlines in this case be extended three months so that
7
See Nicopure Labs, LLC v. FDA, No. 16-cv-878 (D.D.C.); Right to be Smoke-Free
Coalition v. FDA, No. 16-cv-1210 (D.D.C.); Lost Art Liquids, LLC v. FDA, No. 16-cv-3468
(C.D. Cal.); Cyclops Vapor 2, LLC v. FDA, No. 16-cv-556 (M.D. Ala.); Faircloth v. FDA, No.
16-cv-5267 (S.D. W. Va.). A similar suit has also been brought by a cigar manufacturer and its
owner. See Sanchez Icaza & Global Premium Cigars v. FDA, No. 16-cv-21967 (S.D. Fla.).
8
A second suit, Right to Be Smoke-Free Coalition v. FDA, No. 16-cv-1210 (D.D.C.), is
consolidated with Nicopure. For simplicity, Public Health Intervenors refer to the consolidated
cases as Nicopure.
7
new leadership personnel at the Department of Health and Human Services can more fully
consider the Rule and the issues raised in this case and determine how to proceed. Doc. 34 at 2.
Two days later, the FDA delayed a May 10 compliance deadline and indicated its intent to defer
enforcement of all future compliance deadlines for all categories of newly regulated products for
three months. FDA, May 2017: Web Statement (Web Statement), available at
https://www.fda.gov/TobaccoProducts/NewsEvents/ucm556562.htm (last updated May 3, 2017);
see also Guidance 4-11. This extension was ostensibly for the purpose of allow[ing] new
leadership at the FDA and the Department of Health and Human Services additional time to
more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in
federal court. Web Statement. The FDA announcement states its action will extend compliance
dates for such fundamental regulatory requirements as the submission of plans for cigar health
warning labels, ingredient listing, the production of documents on the health effects of new
tobacco products, substantial equivalence and premarket tobacco applications, and the reporting
of harmful and potentially harmful product constituents to FDA. Id.
Accordingly, it is currently unclear whether Defendants will defend the Deeming Rule in
this litigation when their cross-motion for summary judgment and opposition to Plaintiffs
summary judgment motion are due on August 1.
III. PUBLIC HEALTH INTERVENORS
Public Health Intervenors include six public health organizations dedicated to combating
smoking and the diseases it causes. Each of the proposed intervenors expends substantial
resources to educate the public about the risks of smoking, to help users quit smoking, and to
advise the government on effective regulation of tobacco products.
For example, the American Academy of Pediatrics (AAP) publishes a Clinical Practice
Policy to Protect Children from Tobacco, Nicotine, and Tobacco Smoke, which describes
8
clinical practice recommendations to physicians on how to screen for tobacco use and counsel
their patients and patients parents. Del Monte Aff. 7 (Ex. 3). The American Lung
Association (ALA) expends substantial resources to support its highly acclaimed Freedom
From Smoking program, which has in-person, online, and telephonic options to help smokers
quit, including access by telephone to certified tobacco treatment specialists at ALAs Lung
Helpline. Wimmer Aff. 5 (Ex. 8).
Similarly, the American Heart Association (AHA) maintains a quality improvement
program to ensure that hospitals are screening for tobacco use among patients and providing
cessation resources when needed. Schoeberl Aff. 6 (Ex. 6). AHA also works directly with
local health care providers, church leaders, and school administrators, as well as historically
black colleges and universities, to ensure that strong tobacco-free policies are in place and to
provide tobacco users with the resources they need to quit. Id. 4-5. The American Cancer
Society Cancer Action Network (ACS CAN) has been a leader in educating the public about
the dangers of using tobacco products, including cigars, and in advocating policies and programs
to discourage smoking initiation and help smokers quit. Phillips Aff. 5 (Ex. 5).
The Campaign for Tobacco-Free Kids (Tobacco-Free Kids) has developed research
and public education material about the hazards of cigar smoking and the specific threat of
cheap, flavored cigars to young people, along with youth activities designed to educate young
people about the dangers of tobacco use, including cigar smoking. Myers Aff. 3 (Ex. 4).
Truth Initiatives nationally recognized truth campaign has reached hundreds of millions of
teens and young adults with information about the health effects and social costs of tobacco and,
through its on-line smoking cessation intervention, Become an Ex, has reached over 700,000
9
persons to date with information to help adults stop smoking, including information about the
health risks of cigars. Vargyas Aff. 6-7 (Ex. 7).
Because of their substantial interests in the regulation, each of the Public Health
Intervenors also participated in the administrative process leading to the Deeming Rule, helping
the FDA devise a reasoned regulation that appropriately protected public health. Public Health
Intervenors met with the FDA and other government agencies and submitted extensive public
comments evaluating the criticisms raised by Plaintiffs. See, e.g., Myers Aff. 7-8; Del Monte
Aff. 10. The comments filed by Public Health Intervenors and other public health and medical
groups were cited in upholding the Deeming Rule in Nicopure. See Slip Op. 53. And each of
the Public Health Intervenors has a long history of participating as amicus curiae, plaintiffs, or
intervenors in cases related to government regulation of the tobacco industry. See, e.g., Del
Monte Aff. 9; Phillips Aff. 6. All of the Public Health Intervenors, moreover, joined in filing
an amicus brief in support of the Deeming Rule in the Nicopure case.
Additionally, AAP is a professional membership organization of 66,000 pediatricians,
pediatric medical sub-specialists and pediatric surgical specialists. Del Monte Aff. 3. Their
mission is to attain optimal physical, mental and social health and well-being for all infants,
children, adolescents and young adults. Id. 5. As part of this mission, AAPs members
actively screen their patients for use of tobacco and provide counseling to their patients and
patients parents about the health hazards of tobacco use, in an effort to prevent tobacco
initiation. Id. 6. The presence of unregulated tobacco products undermines these efforts by
increasing the opportunities for young people to begin or continue using tobacco products. Id.
8. The prevalence of products such as flavored cigars forces AAP and its members to expend
additional resources to effectuate its policies. Id. 8, 15.
10
IV. ARGUMENT
Public Health Intervenors seek leave to intervene as Defendants so that they may
participate in this case to protect their interests and, in the case of AAP, the interests of their
pediatrician members. The failure to subject deadly and addictive cigars to regulation under the
full implementation of the Deeming Rule will force Public Health Intervenors to expend
substantial additional resources combatting the public health risks these products create. Public
Health Intervenors readily satisfy the requirements of Article III and Federal Rule of Civil
Procedure 24; indeed, the D.C. Circuit has repeatedly held that several of these very
organizations have standing to participate in tobacco-related litigation.
A. Public Health Intervenors Have Standing to Intervene as Defendants
Public Health Intervenors have standing to intervene in this action. See Crossroads
Grassroots Policy Strategies v. FEC, 788 F.3d 312, 316, 320 (D.C. Cir. 2015) (holding that
intervenor-defendants must show Article III standing, though they need not satisfy prudential
standing considerations). Under D.C. Circuit precedent, [t]he standing inquiry for an
intervening-defendant is the same as for a plaintiff: The intervenor must show injury in fact,
causation, and redressability. Id. at 316. There is generally a sufficient injury in fact where a
party benefits from agency action, the action is then challenged in court, and an unfavorable
decision would remove the partys benefit. Id. at 317.
On a motion to intervene, [c]ourts are to take all well-pleaded, nonconclusory
allegations in the motion to intervene, the proposed complaint or answer in intervention, and
declarations supporting the motion as true absent sham, frivolity or other objections. Parker v.
John Moriarty & Assocs., 319 F.R.D. 18, 20 (D.D.C. 2016) (quoting Southwest Ctr. for
Biological Diversity v. Berg, 268 F.3d 810, 820 (9th Cir. 2001)); see also, e.g., United States v.
AT&T Co., 642 F.2d 1285, 1291 (D.C. Cir. 1980) (at intervention stage, courts assess standing
11
on basis of proposed pleading and must accept a partys well-pleaded allegations as valid).
Where at least one proposed intervenor has standing, the court need not decide the standing
issue as to the remaining intervening public health organizations. Philip Morris II, 566 F.3d at
1146.
As the D.C. Circuit has repeatedly held, public health organizations have standing to
bring or intervene in cases regarding regulation of tobacco companies. See Philip Morris II, 566
F.3d at 1146; Public Citizen, 869 F.2d at 1546-53. Indeed, the D.C. Circuit has previously held
that several of the specific organizations seeking to intervene here have standing in such cases.
See Philip Morris II, 566 F.3d at 1108, 1146 (holding that American Cancer Society, AHA,
ALA, and Tobacco-Free Kids Action Fund had standing as intervenors); Public Citizen, 869 F.2d
at 1545, 1553 (holding that American Cancer Society, AHA, and ALA had standing as
plaintiffs).9
All Public Health Intervenors have organizational standing. AAP has associational
standing as well.
1. Organizational Standing
A plaintiff suffers an organizational injury if the alleged violation perceptibly
impair[s] its ability to carry out its activities. Friends of Animals v. Salazar, 626 F. Supp. 2d
102, 113 (D.D.C. 2009) (citation omitted). Public Health Intervenors expend substantial
resources to gather information on, educate the public about, and protect their members from the
9
ACS CAN, one of the proposed intervenors here, is a nonpartisan 501(c)(4) affiliate of
American Cancer Society, the party in Philip Morris and Public Citizen. Tobacco-Free Kids,
another proposed intervenor here, is the nonpartisan 501(c)(3) affiliate of Tobacco-Free Kids
Action Fund.
12
harms of smoking. As Judge Kessler found in evaluating the organizational standing of some of
these same Public Health Intervenors:
[t]here can be no question, based upon the declarations submitted and the long
history of these organizations in the public health arena, that they devote much of
their time and resources to convincing young people not to smoke and to
educating the public about the dangers of addiction and the difficulties of quitting
smoking. As John Kirkland, President and Chief Executive Officer of American
Lung Association, explained, the organization has long been active in research,
education and public policy advocacy on the adverse effects of tobacco products.
These are precisely the discrete programmatic concerns [that] are being directly
and adversely affected by the challenged action, which the Court of Appeals
ruled would demonstrate the requisite institutional injury to satisfy Article III
standing requirements.
United States v. Philip Morris USA Inc. (Philip Morris I), No. 99-cv-2496, 2005 WL 1830815,
at *4 (D.D.C. July 22, 2005).
The availability of unregulated cigars makes these efforts more difficult and more
expensive. Easy access to cigarsparticularly youth-friendly flavored cigarsincreases
the risk of youth initiation and continuation of smoking, thus increasing the amount of
public education and counseling needed to combat tobacco use among minors. See, e.g.,
Schoeberl Aff. 9, 16; Myers Aff. 13. Moreover, as the court noted in Nicopure, the
manufacturers of newly deemed products, if they remain unregulated, are free to
mislabel their products without consequence. Slip Op. 50. The burden created by the
unregulated marketing of these products makes it harder for Public Health Intervenors to
be effective in (a) giving the public, and particularly young people, an accurate
understanding of the dangers of cigar smoking; (b) discouraging initiation of cigar
smoking by young people; and (c) encouraging cigar smokers, particularly young people,
to quit. Schoeberl Aff. 16; see Phillips Aff. 11; Myers Aff. 13. The Deeming Rule
would reduce youth access to cigars and give FDA the authority to take youth-focused
cigars off the market, easing the challenge of fulfilling Public Health Intervenors
13
mission. Eliminating the Deeming Rule would allow tobacco manufacturers to make
unverified claims and to continue giving youth ready opportunities to smoke cigars,
making Public Health Intervenors mission harder. Upholding the Deeming Rule would
thus provide Public Health Intervenors meaningful redress.
2. Associational Standing
In addition, AAP has associational standing. To show associational standing, an
association must demonstrate that at least one member would have standing under
Article III to sue in his or her own right, that the interests it seeks to protect are germane
to its purposes, and that neither the claim asserted nor the relief requested requires that an
individual member participate in the lawsuit. Natural Res. Def. Council v. EPA, 489
F.3d 1364, 1370 (D.C. Cir. 2007).
AAP is a membership organization of 66,000 pediatricians and pediatric
specialists dedicated to improving the physical, mental, and social health and well-being
of infants, children, adolescents, and young adults. Del Monte Aff. 3, 5. To fulfill this
mission, AAPs members actively screen their patients for use of tobacco and provide
counseling to their patients and patients parents about the health hazards of tobacco use,
in an effort to prevent tobacco initiation. Id. 6. AAPs members must 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. They thus have a significant interest in defending the Deeming Rule.
The other requirements of associational standing are similarly satisfied. The
interests AAP seeks to protect are germane to [its] purpose[], namely, advancing the
health of infants, children, adolescents, and young adults. Natural Res. Def. Council, 489
F.3d at 1370. And the proposed defense does not require[] that an individual member
14
participate in the lawsuit, id., because the outcome of the case will not affect the rights
or obligations of any particular individual member differently from AAPs other
members.
B. Public Health Intervenors Are Entitled to Intervene as of Right
Under Federal Rule of Civil Procedure 24(a), a proposed intervenor is entitled to
intervention as of right if it (1) makes a timely motion, (2) claims an interest relating to
the property or transaction which is the subject of the action, (3) is so situated that the
disposition of the action may as a practical matter impair or impede the applicants ability
to protect that interest, and (4) may not be adequately represented by existing parties.
Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1074 (D.C. Cir. 1998) (quoting Fed. R.
Civ. P. 24(a)(2)). This Court takes a liberal approach to intervention. Wilderness
Socy v. Babbitt, 104 F. Supp. 2d 10, 18 (D.D.C. 2000).
Public Health Intervenors satisfy all four prongs of this test.
1. Public Health Intervenors Motion to Intervene is Timely
Courts determine the timeliness of motions to intervene in consideration of all
the circumstances, especially weighing the factors of 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. Smoke v. Norton, 252 F.3d 468, 471 (D.C. Cir. 2001)
(quoting AT&T, 642 F.2d at 1295).
This motion is timely. It comes at an early stage of the proceedings, before the
Court has made any substantive rulings or the first substantive motion has been fully
briefed. No discovery has taken place (or likely will take place), given that this case is
based on the administrative record. Courts routinely grant motions to intervene at similar
15
or even later stages. See, e.g., Williams & Humbert Ltd. v. W. & H. Trade Marks (Jersey)
Ltd., 840 F.2d 72, 74, 77 (D.C. Cir. 1988) (reversing denial of motion to intervene filed
after summary judgment briefing); Williams & Humbert Ltd. v. Ruiz-Mateos, No. 83-cv-
1905, 1991 WL 148283, at *2 (D.D.C. Jan. 29, 1991) (noting grant on remand of motion
to intervene); Hardin v. Jackson, 600 F. Supp. 2d 13, 14, 16 (D.D.C. 2009) (granting
intervention filed on same day defendant agency filed opposition to plaintiffs motion and
cross-motion for summary judgment).
Moreover, the need to intervene has grown increasingly clear since Plaintiffs filed
their motion for summary judgment on February 13. Before the change in
administrations, FDA strongly, and successfully, defended the Deeming Rule against an
industry challenge in the Nicopure case. But since February, FDA has sought and
received two extensions of time to file summary judgment papers in this and other
challenges to the Deeming Rule because it needed additional time to more fully
consider the issues raised by those legal challenges. Of even greater significance, FDA
in May announced a postponement of all industry compliance deadlines set for May 10,
2017 or thereafter, including deadlines for such crucial public health protections as cigar
warning label plans, ingredient listing, and the submission of documents to FDA
concerning the health effects of the deemed products. Intervention is sought here only
after it has become apparent that the government may not adequately represent the
interest of Public Health Intervenors. Cf. Smoke, 252 F.3d at 471 (motion to intervene
can be timely even after judgment, as long as that is when the potential inadequacy of
representation came into existence).
16
Finally, there will be no prejudice to the existing parties. If intervention is
granted, Public Health Intervenors intend to limit their briefing to avoid duplicative
arguments in the interest of judicial efficiency and to conserve the Courts and parties
resources. Intervention would likely delay the briefing schedule by no more than several
weeks, if a delay proved necessary at all.
2. Public Health Intervenors Have Legally Protected Interests at Stake
For the same reasons that Public Health Intervenors have Article III standing, they
possess an interest relating to the property or transaction that is the subject matter of the
litigation. See, e.g., Philip Morris II, 566 F.3d at 1146 ([B]y demonstrating Article III
standing, the intervenors adduce a sufficient interest.); Fund for Animals, Inc. v. Norton,
322 F.3d 728, 735 (D.C. Cir. 2003) (Our conclusion that [proposed intervenor] has
constitutional standing is alone sufficient to establish that the [it] has an interest relating
to the property or transaction which is the subject of the action. (quoting Fed. R. Civ. P.
24(a)(2))). The same factual allegations establishing Public Health Intervenors standing,
discussed above, establish a sufficient interest for intervention. See supra pp. 11-15.
3. If Successful, Plaintiffs Action Would Impair Public Health

Intervenors Interests
Rule 24(a)s third prong is satisfied if there is a possibility that intervenors interests
may be practically impaired or impeded by the disposition of the plaintiffs suit. Foster v.
Gueory, 655 F.2d 1319, 1325 (D.C. Cir. 1981). Courts look to the practical consequences of
denying intervention, even where the possibility of future challenge to the regulation remain[s]
available. Fund for Animals, 322 F.3d at 735 (D.C. Cir. 2003) (quoting Natural Res. Def.
Council v. Costle, 561 F.2d 904, 909 (D.C. Cir. 1977)). If Plaintiffs suit succeeds, the cigar
industry may be unregulated (or at a minimum, less rigorously regulated) for years to come,
17
while the FDA determines whether to issue a new rule. This would undermine Public Health
Intervenors efforts to reduce cigar smoking in several ways: by exposing youth to cigars
marketed without the health warnings mandated by the Deeming Rule; by depriving FDA of the
authority to review cigars under the public health standard and take off the market candy- and
fruit-flavored cigars that appeal to young people; by preventing FDA from setting product
standards for cigars to reduce their harmfulness; by allowing cigar manufacturers and retailers to
make unproven and misleading health claims; and by eliminating restrictions on sale of cigars to
minors and other public health protections under the Rule. All of these changes would require
Public Health Intervenors to expend additional time and resources to their shared mission of
reducing the prevalence of cigar smoking, particularly by the young. Accordingly, the third
prong is also satisfied.
4. Public Health Intervenors Interests May Not Be Adequately

Represented by Defendants
The fourth requirement of Rule 24(a) is satisfied as long as the proposed intervenors can
show that representation of [their] interest may be inadequate; and the burden of making that
showing should be treated as minimal. Trbovich v. United Mine Workers, 404 U.S. 528, 538
n.10 (1972) (emphasis added); accord, e.g., Fund for Animals, 322 F.3d at 735. This
requirement is not onerous. Fund for Animals, 322 F.3d at 735 (quoting Dimond v. District of
Columbia, 792 F.2d 179, 192 (D.C. Cir. 1986)). The D.C. Circuit, moreover, look[s]
skeptically on government entities serving as adequate advocates for private parties.
Crossroads, 788 F.3d at 321. A proposed intervenor ordinarily should be allowed to intervene
unless it is clear that the party will provide adequate representation for the absentee. Fund for
Animals, 322 F.3d at 735 (quoting AT&T, 642 F.2d at 1293).
18
None of the current parties adequately represents Public Health Intervenors interests in
this matter. First, as explained above, FDA has postponed various compliance deadlines to
more fully consider issues raised by the legal challenges to the Deeming Rule when previously
the agency had strongly defended the Rule. Thus, it is not clear that Defendants new leadership
plans to defend the Deeming Rule at all, let alone defend it in full. See, e.g., Kootenai Tribe of
Idaho v. Veneman, 313 F.3d 1094, 1107 (9th Cir. 2002) (relying on change in administration in
granting intervention of right), abrogated on other grounds by Wilderness Socy v. U.S. Forest
Serv., 630 F.3d 1173 (9th Cir. 2011); Kleissler v. U.S. Forest Serv., 157 F.3d 964, 974 (3d Cir.
1998) (same).
Even without this postponement of compliance, there would be no guarantee of adequate
representation. The D.C. Circuit has stressed that even when the interest of a federal agency and
potential intervenor can be expected to coincide, that does not necessarily mean ... adequacy of
representation is ensured for purpose of Rule 24(a)(2). Crossroads, 788 F.3d at 321 (quoting
Costle, 561 F.2d at 912). Although there may be a partial congruence of interests, that does not
guarantee the adequacy of representation. Fund for Animals, 322 F.3d at 736-37. For example,
Public Health Intervenors may have different perspectives than FDA in assessing various aspects
of the challenged Rule, such as the weight to be given to the economic impact that the Deeming
Rule will have on the cigar industry, which Defendants considered in determining the
appropriate compliance deadlines and other rules. See Final Regulatory Impact Analysis, Docket
No. FDA-2014-N-1089 (May 2016).10 Given the minimal showing required to satisfy this prong,
10
To be clear, Public Health Intervenors do not intend to argue that the Deeming Rule
should be made more rigorous. Rather, the point is that Public Health Intervenors and
Defendants may come from different perspectives in assessing the propriety of the challenged
Rule.
19
this potential divergence of interests suffices to raise the possibility that representation may be
inadequate. Trbovich, 404 U.S. at 538 n.10 (internal quotation marks omitted).
Accordingly, the Court should grant intervention as of right under Rule 24(a).
C. Alternatively, the Court Should Permit Applicants to Intervene Permissively
In the alternative, Public Health Intervenors request leave to intervene under Rule 24(b).
Rule 24(b) allows intervention where a party files a timely motion and has a claim or defense
that shares with the main action a common question of law or fact. Fed. R. Civ. P. 24(b)(1). In
exercising its discretion, the court must consider whether the intervention will unduly delay or
prejudice the adjudication of the original parties rights. Fed. R. Civ. P. 24(b)(3); see e.g.,
Acree v. Republic of Iraq, 370 F.3d 41, 49 (D.C. Cir. 2004) ([A]n applicant may be permitted to
intervene if his claim shares a question of law or fact in common with the underlying action and
if the intervention will not unduly delay or prejudice the rights of the original parties.),
abrogated on other grounds by Republic of Iraq v. Beatry, 556 U.S. 848 (2009). Public Health
Intervenors respectfully submit that the Court should exercise its discretion to permit
intervention if it denies intervention as of right.
First, as explained above, Public Health Intervenors motion is timely. Supra pp. 15-17.
Second, Public Health Intervenors defense plainly shares a question of law or fact in
common with the underlying action, Acree, 370 F.3d at 49, given that it concerns the same
questions of law at issue in the Plaintiffs suitnamely, whether the Deeming Rule is consistent
with the statute, arbitrary and capricious, or unconstitutional.
Third, as explained above, intervention will not unduly delay or prejudice the rights of
the original parties. It would not inject any new issues into the case. Public Health Intervenors
intend to address, if necessary, the same issues currently scheduled to be briefedwhether
Plaintiffs or Defendants are entitled to summary judgment on Plaintiffs claims against the
20
Deeming Rule. Indeed, Public Health Intervenors views will already be at issue in this case,
because the Court has granted leave to file an amicus brief. See Doc. 30. At most, as discussed
below, intervention might require a delay of several weeks in an already extended briefing
schedule11and potentially even less, if Defendants adequately defend the Deeming Rule.
Public Health Intervenors therefore meet the criteria for permissive intervention.
Moreover, intervention would provide the Court with a valuable perspective on the issues at the
heart of this case. These organizations have spent decades analyzing the public health impacts of
smoking (including cigar smoking), working to help individuals overcome their dependency on
nicotine, developing effective programs to curb tobacco use, and working for regulations to
reduce the incidence of smoking in the United States. This substantial expertise will contribute
to reaching an informed conclusion on an issue that affects the health of millions of Americans.
Accordingly, at a minimum, the Court should permit Public Health Intervenors to
intervene under Rule 24(b).
V. PROPOSED TIMELINE FOR INTERVENTION
Public Health Intervenors will not burden the Court with duplicative briefing, and it is
possible that they will need only to supplement Defendants arguments. Public Health
Intervenors have moved to intervene now, before Defendants filing, so that the Court can
resolve the intervention motion expeditiously and set an appropriate briefing schedule after
Public Health Intervenors have reviewed Defendants summary judgment or other filings.
Accordingly, Public Health Intervenors propose that the Court set a status conference
shortly after August 1 so that the Court and parties can discuss the most efficient way to proceed
11
The briefing schedule already has been significantly extended by the joint action of
Defendants and the industry Plaintiffs.
21
once it is known whether and how Defendants are defending the Deeming Rule. Public Health
Intervenors will be available any time from August 3 through August 12 for a status conference.
If the Court prefers, they will also be prepared to submit a short statement proposing a briefing
schedule on August 2, once they review Defendants filing.
VI. CONCLUSION
For the foregoing reasons, the Court should grant Public Health Intervenors motion to
intervene and enter the attached proposed answer.
Dated: July 24, 2017 Respectfully submitted,
/s/ Kelly P. Dunbar

Kelly P. Dunbar (D.C. Bar No. 500038)
Kevin M. Lamb (D.C. Bar No. 1030783)
WILMER CUTLER PICKERING HALE
AND DORR LLP
1875 Pennsylvania Avenue NW
Washington, DC 20006
kelly.dunbar@wilmerhale.com
kevin.lamb@wilmerhale.com
(202) 663-6000
Javier M. Guzman (D.C. Bar No. 462679)

DEMOCRACY FORWARD FOUNDATION
P.O. Box 34553
Washington, D.C. 20043
jguzman@democracyforward.org
(202) 448-9090
Dennis A. Henigan (D.C. Bar No. 951897)

Mark E. Greenwold (D.C. Bar No. 178186)
CAMPAIGN FOR TOBACCO-FREE KIDS
1400 I Street, NW
dhenigan@tobaccofreekids.org
mgreenwold@tobaccofreekids.org
(202) 296-5469
Counsel for proposed Intervenor-Defendants
22
CERTIFICATE OF SERVICE
I hereby certify that on this 24th day of July, 2017, I electronically transmitted the
foregoing document to the Clerks Office using the CM/ECF system, which will send a notice of
filing to all counsel of record.
/s/ Kelly P. Dunbar

KELLY P. DUNBAR
Case 1:16-cv-01460-APM Document 36-1 Filed 07/24/17 Page 1 of 2
EXHIBIT 1

Plaintiffs,

Defendants.
[PROPOSED] ORDER
The Court having read and considered the papers submitted by the parties, it is hereby
ORDERED that the proposed Public Health Intervenors motion to intervene is GRANTED.
The Answer filed by Public Health Intervenors with their motion to intervene is hereby
deemed filed with the Court.
SO ORDERED.
Dated ________________________
AMIT P. MEHTA
United States District Judge
EXHIBIT 2

Plaintiffs,

Defendants.
ANSWER
Intervenor-Defendants, American Academy of Pediatrics, American Cancer Society
Cancer Action Network, American Heart Association, American Lung Association, Campaign
for Tobacco-Free Kids, and Truth Initiative, hereby answer Plaintiffs complaint as follows:
INTRODUCTION
1. This paragraph contains characterizations of this lawsuit, argument, and
conclusions of law to which no response is required. Intervenor-Defendants admit that, on May
10, 2016, the U.S. Food and Drug Administration (FDA) published a final rule deeming
cigars, pipe tobacco, and other tobacco products subject to the Family Smoking Prevention and
Tobacco Control Act of 2009. 81 Fed. Reg. 28,974 (May 10, 2016) (Deeming Rule).
2. This paragraph contains characterizations of this lawsuit, argument, and
conclusions of law, not allegations of fact, to which no response is required.
3. Intervenor-Defendants admit that the FDA published the Deeming Rule on
May 10, 2016 and deny Plaintiffs characterizations of the Deeming Rule; like Defendants,
1
Intervenor-Defendants respectfully refer the Court to that rule for a complete and accurate
statement of its contents.
4. Intervenor-Defendants deny the allegations in Paragraph 4.
5. Intervenor-Defendants deny the allegations in Paragraph 5.
JURISDICTION AND VENUE
6. This paragraph contains conclusions of law, not allegations of fact, to which no
response is required.
PARTIES
9. Intervenor-Defendants lack sufficient knowledge or information to form a belief
about the truth of the allegations in this paragraph.
12. This paragraph contains argument and conclusions of law, not allegations of fact,
to which no response is required; to the extent a response is deemed necessary, Intervenor-
Defendants deny the allegations contained therein.
2
13. This paragraph contains argument and conclusions of law, not allegations of fact,
to which no response is required; to the extent a response is deemed necessary, Intervenor-
Defendants deny the allegations contained therein.
14. Intervenor-Defendants admit that the U.S. Department of Health and Human
Services (HHS) is a federal agency and that HHS is headquartered in Washington, D.C.
15. Intervenor-Defendants admit that the FDA is a federal agency within HHS; the
balance of this paragraph contains conclusions of law to which no response is required.
16. Intervenor-Defendants admit that Sylvia M. Burwell was Secretary of HHS
when Plaintiffs filed their complaint and that Dr. Thomas E. Price is the current Secretary of
HHS; the balance of this paragraph contains conclusions of law to which no response is
required.
17. Intervenor-Defendants admit that Dr. Robert M. Califf was Commissioner of
Food and Drugs when Plaintiffs filed their complaint and that Dr. Scott Gottlieb is the current
Commissioner of Food and Drugs; the balance of this paragraph contains conclusions of law to
which no response is required.
BACKGROUND
18-23. These paragraphs contain argument and conclusions of law, to which no
response is required. To the extent a response is deemed necessary, denied. Intervenor-
Defendants specifically deny any characterization of the cited statutory provisions, which speak
for themselves, and respectfully refer the Court to those provisions for a complete and accurate
statement of their contents.
24. This paragraph contains argument and conclusions of law, to which no response
is required. To the extent a response is deemed necessary, denied. Intervenor-Defendants
3
specifically deny any characterization of the referenced statutory provisions and the Deeming
Rule, which speak for themselves, and respectfully refer the Court to those provisions and that
rule for a complete and accurate statement of their contents.
response is required. To the extent a response is deemed necessary, Intervenor-Defendants
deny any characterization of the applicable statutory provision, which speaks for itself, and
respectfully refer the Court to that provision for a complete and accurate statement of its
contents. See 21 U.S.C. 387j(a)(2)(B).
response is required. To the extent a response is deemed necessary, denied. Intervenor-
Defendants specifically deny any characterization of the cited statutory provisions and case law,
which speak for themselves, and respectfully refer the Court to those provisions and that case
law for a complete and accurate statement of their contents.
30. Intervenor-Defendants admit that, on April 25, 2014, the FDA published a
proposed rule titled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act;
Regulations on the Sale and Distribution of Tobacco Products and Required Warning
Statements for Tobacco Products. 79 Fed. Reg. 23,142 (Apr. 25, 2016) (the Proposed
Deeming Rule). Intervenor-Defendants deny any characterization of that proposed rule, which
speaks for itself, and respectfully refer the Court to that proposed rule for a complete and
accurate statement of its contents.
4
deny any characterization of the Proposed Deeming Rule, which speaks for itself, and
respectfully refer the Court to that proposed rule for a complete and accurate statement of its
contents.
33. This paragraph and the footnote accompanying it contain argument and
conclusions of law, to which no response is required. To the extent a response is deemed
necessary, Intervenor-Defendants deny any characterization of the Proposed Deeming Rule,
which speaks for itself, and respectfully refer the Court to that proposed rule for a complete and
is required. To the extent a response is deemed necessary, Intervenor-Defendants deny any
characterization of the Proposed Deeming Rule, which speaks for itself, and respectfully refer
the Court to that proposed rule for a complete and accurate statement of its contents.
35. Intervenor-Defendants deny the allegations in this paragraph except to admit
that the FDA published a preliminary regulatory impact analysis. Intervenor-Defendants deny
any characterization of that analysis, which speaks for itself, and respectfully refer the Court to
that analysis for a complete and accurate statement of its contents. See Preliminary Regulatory
Impact Analysis, Docket No. FDA-2014-N-1089 (Apr. 2014), available at
https://www.regulations.gov/document?D=FDA-2014-N-0189-20877.
deny any characterization of the Proposed Deeming Rule, which speaks for itself, and
respectfully refer the Court to that proposed rule for a complete and accurate statement of its
contents.
5
38. Intervenor-Defendants admit that the Cigar Association of America
(CAA), the International Premium Cigar and Pipe Retailers Association (ICPRA), and
Cigar Rights of America (CRA) submitted public comments on the proposed Deeming
Rule.
39-41. These paragraphs contain argument and characterizations of public
comments submitted by CAA, ICPRA, and CRA. Intervenor-Defendants deny any
characterization of those comments, which speak for themselves, and respectfully refer the
Court to those comments for a complete and accurate statement of their contents.
deny any characterization of the Deeming Rule, which speaks for itself, and respectfully
refer the Court to that rule for a complete and accurate statement of its contents.
is required. To the extent a response is deemed necessary, Intervenor-Defendants deny the
allegations contained therein.
allegations contained therein. Intervenor-Defendants specifically deny any characterization of
the Deeming Rule and the referenced statutory provision, which speak for themselves, and
respectfully refer the Court to that rule and provision for a complete and accurate statement of
their contents.
6
characterization of the Deeming Rule, which speaks for itself, and respectfully refer the Court
to that rule for a complete and accurate statement of its contents.
characterization of the referenced statutory provision, the Deeming Rule, and the proposed
Deeming Rule, which speak for themselves, and respectfully refer the Court to that provision
and those rules for a complete and accurate statement of their contents.
to that rule for a complete and accurate statement of its contents. Intervenor-Defendants lack
sufficient knowledge or information to form a belief about the truth of the remaining
allegations in this paragraph.
53. Intervenor-Defendants deny the allegations in the first sentence of this
paragraph. The remainder of this paragraph contains argument and conclusions of law, to
which no response is required. To the extent a response is deemed necessary, Intervenor-
Defendants deny any characterization of the Deeming Rule, which speaks for itself, and
respectfully refer the Court to that rule for a complete and accurate statement of its contents.
7
54. Intervenor-Defendants admit that, on May 10, 2016, the FDA published a final
rule titled 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). The remainder of this paragraph and its footnote
contains characterizations of this lawsuit, argument, and conclusions of law, to which no
response is required. To the extent a response is deemed necessary, Intervenor-Defendants lack
sufficient knowledge or information to form a belief about the truth of the remaining
allegations in this paragraph.
is required. To the extent a response is deemed necessary, Intervenor-Defendants lack
sufficient knowledge or information to form a belief about the truth of the allegations in this
paragraph.
paragraph.
57. Intervenor-Defendants lack sufficient knowledge or information to form a
belief about the truth of the allegations in this paragraph.
58. Defendant-Intervenors deny the allegations in the first sentence of this
paragraph. With respect to the second sentence, Intervenor-Defendants admit that the FDA sent
a draft of the Proposed Deeming Rule to the Office of Management and Budget (OMB).
Intervenor-Defendants deny any characterization of that document, which speaks for itself, and
respectfully refer the Court to that document for a complete and accurate statement of its
8
contents. With respect to the third sentence, Intervenor-Defendants admit that the Proposed
Deeming Rule contained an option (Option 2) that, if adopted, would have exempted
premium cigars from the Deeming Rule. Intervenor-Defendants deny any characterization of
the Proposed Deeming Rule, which speaks for itself, and respectfully refer the Court to that
proposed rule for a complete and accurate statement of its contents. Intervenor-Defendants
deny the allegations in the fourth sentence of this paragraph.
59. These paragraphs contain argument and conclusions of law, to which no
deny any characterization of the Deeming Rule, which speaks for itself, and respectfully refer
the Court to that rule for a complete and accurate statement of its contents.
60. This paragraph contains argument and hypothetical statements, not allegations of
fact, and thus no response is required. To the extent a response is deemed necessary,
Intervenor-Defendants deny any characterization of the Deeming Rule, which speaks for itself,
and respectfully refer the Court to that rule for a complete and accurate statement of its
contents.
61. Defendant-Intervenors deny the allegations in the first sentence of this
paragraph. The second and third sentences contain argument and conclusions of law, to which
no response is required. To the extent a response is deemed necessary, Intervenor-Defendants
deny the allegations in these sentences. Intervenor-Defendants deny the allegations in the
fourth sentence of this paragraph. The first clause of the fifth sentence is denied. The second
clause of the fifth sentence contains argument and conclusions of law, to which no response is
required. To the extent a response is deemed necessary, Defendant-Intervenors deny the
9
allegations therein. Intervenor-Defendants specifically deny any characterization of the
Deeming Rule, which speaks for itself, and respectfully refer the Court to that rule for a
complete and accurate statement of its contents.
63. This paragraph contains argument and conclusions of law to which no response
the Deeming Rule, which speaks for itself, and respectfully refer the Court to that rule for a
64. Intervenor-Defendants admit that the FDA published its Final Regulatory
Analysis in May 2016.
65. The first, second, and fourth sentences contain argument and conclusions of law
to which no response is required. To the extent a response is deemed necessary, Intervenor-
Defendants deny the allegations contained therein. Intervenor-Defendants specifically deny
any characterization of the cited statutory provisions, which speak for themselves, and
respectfully refer the Court to those provisions for a complete and accurate statement of their
contents. The third sentence is denied except to admit that the FDA published a final regulatory
impact analysis that contains the quoted text. Intervenor-Defendants deny any characterization
of that analysis, which speaks for itself, and respectfully refer the Court to that analysis for a
complete and accurate statement of its contents. See Final Regulatory Impact Analysis, Docket
No. FDA-2014-N-1089 (May 2016), available at https://www.fda.gov/downloads/aboutfda/
reportsmanualsforms/reports/economicanalyses/ucm500254.pdf.
10
66. Intervenor-Defendants deny the allegations of this paragraph except to admit that
Executive Order 12,866 contains the quoted text. Intervenor-Defendants specifically deny any
characterization of that order, which speaks for itself, and respectfully refer the Court to that
order for a complete and accurate statement of its contents.
67. Intervenor-Defendants deny the allegations contained in the first sentence of this
paragraph except to admit that the FDA published the final regulatory impact analysis in May
2016. The balance of this paragraph is denied except to admit that the final regulatory impact
analysis contains the quoted text. Intervenor-Defendants deny any characterization of that
analysis, which speaks for itself, and respectfully refer the Court to that analysis for a complete
and accurate statement of its contents.
69. Intervenor-Defendants deny the allegations contained in the first sentence of
this paragraph. With respect to the second sentence, Intervenor-Defendants admit that the
final regulatory impact analysis contains the quoted text. Intervenor-Defendants deny any
characterization of that analysis, which speaks for itself, and respectfully refer the Court to that
analysis for a complete and accurate statement of its contents. Intervenor-Defendants deny the
allegations contained in the third sentence of this paragraph.
11
71. Intervenor-Defendants deny the allegations contained in this paragraph except to
admit that the final regulatory impact analysis contains the quoted text. Intervenor-Defendants
specifically deny any characterization of that analysis, which speaks for itself, and respectfully
refer the Court to that analysis for a complete and accurate statement of its contents.
74. Intervenor-Defendants lack sufficient knowledge or information to form a
belief about the truth of the allegations in this paragraph.
about the truth of the allegations in the first sentence of this paragraph. The second sentence
characterizes CAAs public comments on the proposed rule, and thus no response is required.
To the extent a response is deemed necessary, Intervenor-Defendants deny any characterization
of those comments, which speak for themselves, and respectfully refer the Court to those
comments for a complete and accurate statement of their contents.
12
77. The first sentence of this paragraph contains characterizations of the statute to
which no response is required. To the extent a response is deemed necessary, Intervenor-
Defendants deny any characterization of the applicable statutory provision, which speaks for
itself, and respectfully refer the Court to that provision for a complete and accurate statement of
its contents. See 21 U.S.C. 387s(b). The second sentence contains argument, hypothetical
statements, and conclusions of law to which no response is required. To the extent a response
is deemed necessary, Intervenor-Defendants deny the allegations contained therein.
80. This paragraph contains argument and conclusions of law to which no response is
required. To the extent a response is deemed necessary, Intervenor-Defendants deny the
81. This paragraph contains argument and hypothetical statements to which no
deny the allegations contained therein except to admit, with respect to the third sentence, that
13
the final regulatory impact analysis contains the quoted text. Intervenor-Defendants
CLAIMS FOR RELIEF
COUNT I
82. Intervenor-Defendants restate and incorporate by reference the responses
contained in all preceding paragraphs.
is required. To the extent a response is deemed necessary, Intervenor-Defendants admit the
Deeming Rule is a final agency action.
is required.
characterization of the referenced statutory provisions, which speak for themselves, and
respectfully refer the Court to those provisions for a complete and accurate statement of their
contents.
86. Intervenor-Defendants deny the allegations contained in this paragraph.
characterization of the referenced statutory provision and the Deeming Rule, which speak for
themselves, and respectfully refer the Court to that provision and that rule for a complete and
accurate statement of their contents.
14
the referenced statutory provision and the Deeming Rule, which speak for themselves, and
respectfully refer the Court to that provision and that rule for a complete and accurate
the referenced statutory provision and the Deeming Rule, which speak for themselves, and
respectfully refer the Court to that provision and that rule for a complete and accurate
15
deny the allegations contained therein.
is required.
is required.
99. This paragraph constitutes a request for relief to which no response is required.
To the extent a response is deemed necessary, Intervenor-Defendants deny that Plaintiffs are
entitled to the requested relief.
16
COUNT II
101. This paragraph contains argument and conclusions of law to which no
response is required. To the extent a response is deemed necessary, Intervenor-
Defendants lack sufficient knowledge or information to form a belief about the truth of
the allegations in this paragraph.
is required.
is required.
paragraph.
17
COUNT III
characterization of the cited case law, which speaks for itself, and respectfully refer the Court to
that case law for a complete and accurate statement of its contents.
paragraph.
paragraph.
is required.
is required.
paragraph.
18
COUNT IV
characterization of the cited statutory provisions and executive order, which speak for
themselves, and respectfully refer the Court to those provisions and that order for a complete
and accurate statement of their contents.
118. This paragraph characterizes Plaintiffs comments on the proposed rule and/or
preliminary regulatory impact analysis, and thus no response is required. To the extent a
response is deemed necessary, Intervenor-Defendants admit that Plaintiffs submitted
comments but deny any characterization of those comments, which speak for themselves, and
respectfully refer the Court to those comments for a complete and accurate statement of their
contents.
119. Intervenor-Defendants deny the allegations contained in the first sentence of this
paragraph. Intervenor-Defendants deny the allegations contained in the second sentence of this
19
paragraph, except to admit that the final regulatory impact analysis contains the quoted
statements. Intervenor-Defendants specifically deny any characterization of that analysis,
which speaks for itself, and respectfully refer the Court to that analysis for a complete and
120. This paragraph contains argument and conclusions of law, not allegations of
fact, and thus no response is required. To the extent a response is deemed necessary,
Intervenor-Defendants deny the allegations therein. Intervenor-Defendants specifically deny
any characterization of the cited rules, which speak for themselves, and respectfully refer the
Court to those provisions and that order for a complete and accurate statement of their
contents.
fact, and thus no response is required.
fact, and thus no response is required.
fact, and thus no response is required. To the extent a response is deemed necessary, denied.
COUNT V
20
126. The first sentence contains argument and conclusions of law to which no
admit that the Deeming Rule contains the quoted language but deny any characterization of the
Deeming Rule, which speaks for itself, and respectfully refer the Court to that rule for a
complete and accurate statement of its contents. The second, third, and fourth sentences
contains argument and conclusions of law to which no response is required. To the extent a
response is deemed necessary, Intervenor-Defendants deny the allegations contained therein.
127. Intervenor-Defendants admit that the FDA published a final regulatory impact
analysis that addresses the effects of the Deeming Rule. Intervenor-Defendants deny any
analysis for a complete and accurate statement of its contents.
128. Intervenor-Defendants admit that the FDA published a final regulatory impact
analysis that addresses the effects of the Deeming Rule. Intervenor-Defendants deny any
analysis for a complete and accurate statement of its contents.
129. This paragraph contains argument and characterizations of the final
regulatory impact analysis, not allegations of fact, to which no response is required. To the
extent a response is deemed necessary, Intervenor-Defendants deny any characterization of
the final regulatory impact analysis, which speaks for itself, and respectfully refer the Court
to that analysis for a complete and accurate statement of its contents.
130. Intervenor-Defendants deny the allegations contained in this paragraph, except
to admit that the FDA published a final regulatory impact analysis that addresses the effects of
the Deeming Rule. Intervenor-Defendants deny any characterization of that analysis, which
21
speaks for itself, and respectfully refer the Court to that analysis for a complete and accurate
statement of its contents.
deny the allegations contained therein.
COUNT VI
137. Intervenor-Defendants deny the allegations contained in this paragraph.
22
is required.
is required.
COUNT VII
is required.
23
is required.
COUNT VIII
is required.
is required.
24
COUNT IX
is required.
is required.
PRAYER FOR RELIEF
The remaining paragraphs of the complaint contain a prayer for relief, to which no
25
deny the allegations contained in the prayer for relief, and further aver that Plaintiffs are not
entitled to the requested relief or any other relief from Defendants.
Intervenor-Defendants deny any and all allegations in the complaint not expressly
admitted herein to which a response is deemed required.
DEFENSES
1. The complaint fails to state a claim upon which relief can be granted.
2. Defendants actions did not violate the U.S. Constitution, the Administrative
Procedure Act, the Federal Food, Drug, and Cosmetic Act, the Tobacco Control Act, or any
other statutory or regulatory provision.
3. Intervenor-Defendants hereby adopt and incorporate by reference any other
statement of defense asserted by Defendants in this action.
CONCLUSION
WHEREFORE, having fully answered, Intervenor-Defendants respectfully request
that the Court enter judgment dismissing this action with prejudice.
26
Dated: July 24, 2017 Respectfully submitted,
/s/ Kelly P. Dunbar

Kelly P. Dunbar (D.C. Bar No. 500038)
Kevin M. Lamb (D.C. Bar No. 1030783)
WILMER CUTLER PICKERING HALE
AND DORR LLP
1875 Pennsylvania Avenue NW
kelly.dunbar@wilmerhale.com
kevin.lamb@wilmerhale.com
(202) 663-6000
Javier M. Guzman (D.C. Bar No. 462679)

DEMOCRACY FORWARD FOUNDATION
P.O. Box 34553
Washington, D.C. 20043
jguzman@democracyforward.org
(202) 448-9090
Dennis A. Henigan (D.C. Bar No. 951897)

Mark E. Greenwold (D.C. Bar No. 178186)
CAMPAIGN FOR TOBACCO-FREE KIDS
1400 I Street, NW
dhenigan@tobaccofreekids.org
mgreenwold@tobaccofreekids.org
(202) 296-5469
Counsel for Intervenor-Defendants
27
EXHIBIT 3
EXHIBIT 4
)
CIGAR ASSOCIATION OF AMERICA, et al. )
)
Plaintiffs, )
)
v. ) Civ. No. 16-1460 (APM)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRATION, et al. )
)
)
Defendants. )
)
)
AFFIDAVIT OF MATTHEW L. MYERS
I, Matthew L. Myers, state as follows under the pains and penalties of perjury.
1. I am the President of the Campaign for Tobacco-Free Kids (Tobacco-Free
Kids), a prospective intervenor in this action.
2. The information set forth in this declaration is based upon my personal
knowledge.
3. Tobacco-Free Kids is a tax exempt non-profit corporation under section 501(c)(3)
of the Internal Revenue Code, organized under the laws of the District of Columbia. Its principal
place of business is 1400 I (Eye) Street, NW, Suite 1200, Washington, D.C. 20005. Tobacco-
Free Kids works to reduce tobacco use and its deadly toll in the United States and around the
world. It engages in public education about the dangers of cigarettes, cigars, e-cigarettes and
other tobacco products as well as advocating public policies and sponsoring activities to prevent
kids from using tobacco products, help tobacco users quit and protect everyone from secondhand
smoke. Through its youth initiatives, Tobacco-Free Kids sponsors youth activities to educate
young people about the dangers of tobacco use, including cigar smoking, and engage them in
activities designed to discourage youth from initiating use of tobacco products and encourage
young users of tobacco product to quit.
4. Tobacco-Free Kids, together with other public health organizations, has been
granted intervenor status and has actively participated in briefing and argument in both the
district court and court of appeals proceedings in the federal governments RICO case against the
major tobacco companies, U.S. v. Philip Morris USA, Inc., 449 Fed. Supp. 2d 1 (D.D.C. 2006),
affd in relevant part, 595 F. 2d, 566 (D.C. Cir. 2007). Proceedings in that case are still ongoing.
Tobacco-Free Kids and the other public health organizations have frequently participated as
amici curiae to in support of the FDA in cases attacking the validity of FDA regulatory action
under the Tobacco Control Act. Discount City Tobacco & Lottery Inc. v. U.S., 674 F. 3d 509 (6th
Cir. 2011) (challenge to the constitutionality of many provisions of the Tobacco Control Act);
R.J. Reynolds Tobacco Company v. FDA, 845 F. Supp. 2d 266, affd, 696 F. 3d 1205 (D.C. Cir.
2012), (challenge to graphic warning labels on cigarette packs promulgated pursuant to the
TCA); Lorillard Tobacco Company v. FDA., 56 F. Supp. 3d 37 (D.D.C. 2014), revd,, 810 F.3d
827 (D.C. Cir. 2016) (challenge to composition of Tobacco Products Scientific Advisory
Committee under the Tobacco Control Act). Tobacco-Free Kids and other public health
organizations were also amici curiae in the case that established the status of e-cigarettes as
tobacco products subject to regulation under the Tobacco Control Act. Sottera, Inc. v. FDA,
627 F. 3d 891 (D.C. Cir. 2011). Tobacco-Free Kids, together with other public health
organizations, also filed an amicus curiae brief in Nicopure, Labs, LLC v. FDA (D.D.C., Civ.
Docket No. 16-cv-838), a case brought by e-cigarette manufacturers challenging the validity of
the deeming rule.
5. As an example of TFKs activities with youth, Tobacco-Free Kids sponsors Kick
Butts Day, a national day of activities that engage youth to speak up against the dangers of
tobacco use, generating more than 1,000 events across the United States. The youth participants
plan and conduct events that focus attention on the deadly dangers of tobacco use, including
cigar smoking, and urge their peers to be tobacco-free.
6. Through its training program, Taking Down Tobacco, Tobacco-Free Kids
provides online and in-person trainings to youth about the dangers of tobacco use, the many
types of tobacco products and how they are marketed, including information specific to cigar
smoking.
7. Tobacco-Free Kids participated extensively in the development and promulgation
of the deeming rule. From the time FDA announced that it was planning to issue a deeming rule
to cover other tobacco products, including cigars and e-cigarettes, Tobacco-Free Kids urged
FDA to issue the rule and to ensure that it made all tobacco products subject to FDA jurisdiction.
Prior to the issuance of the deeming rule, Tobacco-Free Kids corresponded with FDA,
participated in FDA working groups and other public sessions, and met with FDA personnel to
urge them to issue the deeming rule.

8. On August 8, 2014 Tobacco-Free Kids, in coalition with other public health
organizations, submitted extensive comments to FDA on the proposed deeming rule and also
submitted separate comments in the same docket. These comments addressed nearly every issue
raised in this lawsuit and provided facts in support of arguments for the assertion of FDA
authority that is being challenged in this lawsuit. These issues included: the need for FDA to
assert jurisdiction to ensure that newly-deemed tobacco products put on the market subsequent to
February 15, 2007 are subject to the premarket review requirements of Section 910; the need for
FDA to retain the date of February 15, 2007 as the demarcation date for new tobacco products
and reject arguments made by others to establish a different date; the need for FDA to require
warning labels on all newly-deemed tobacco products; the need to subject all newly-deemed
tobacco products to regulation and to avoid any exemption for so-called premium cigars. In
addition, after FDA promulgated the proposed deeming rule in April 2014, Tobacco-Free Kids
met with the staff of the Office of Information and Regulatory Affairs of the Office of
Management and Budget (OIRA) to urge OIRA to act promptly to ensure that the rule would
be issued and without weakening revisions, including the importance of not exempting any class
of tobacco products from the rule. Tobacco-Free Kids also provided comments to FDA in
support of the requirement for the issuance of warning labels on cigars on September 29, 2016
pursuant to the provisions of the regulation that plaintiffs are challenging in this case.
9. In addition, Tobacco-Free Kids, in association with a number of other public
health organizations, repeatedly urged the Obama administration to move forward with the
regulation of other tobacco products, including cigars and e-cigarettes, through issuance of a
deeming rule. Tobacco-Free Kids wrote to President Obama in support of such regulation on
September 19, 2013 and again on April 1, 2014 urging the issuance of the rule that is under
challenge in this proceeding. In addition, Tobacco-Free Kids met with OIRA to urge
promulgation of the proposed rule and then, in 2015 and 2016, urging promulgation of the final
rule.
10. In addition, CTFK has developed research and public education material about the
hazards of cigar smoking and the specific threat of cheap, flavored cigars to young people. For
example, in 2013, Tobacco-Free Kids published the report Not Your Grandfathers Cigar: A
New Generation of Cheap and Sweet Cigars Threatens a New Generation of Kids, documenting
the emergence of flavored cigars developed after the Tobacco Control Act prohibited flavored
cigarettes, as a way to keep the youth market interested in smoking, and calling on FDA to assert
its regulatory authority over cigars through issuance of a deeming rule to counter industry efforts
to attract kids to smoking. In March, 2017, Tobacco-Free Kids, along with other public health
groups, issued the report The Flavor Trap: How Tobacco Companies Are Luring Kids with
Candy-Flavored E-Cigarettes and Cigars, explaining the harmful role of flavored cigars and
other flavored products in attracting young people to tobacco use and which was featured in the
organizations Kick Butts Day and other young education activities.
11. The relief sought by Plaintiffs would undermine the work of Tobacco-Free Kids
to discourage cigar smoking, particularly among young people, because plaintiffs seek to:
(1) prevent FDA from engaging in review of new tobacco products introduced to the market after
the grandfather date of February 15, 2007, including new cigars, to ensure that they are
appropriate to the protection of the public health under the Tobacco Control Act, thus
depriving the agency of its most powerful tool to take timely action to remove from the market
small, flavored cigars that appeal to young people and other particularly hazardous tobacco
products; (2) exempt entirely from regulation so-called premium cigars, even though FDA
found that all cigars, including premium cigars, cause disease and premature death and which,
contrary to plaintiffs assertion, are used by young people; and (3) nullify health warnings on
cigars required by the deeming rule that are far more prominent and effective than the current
cigar health warnings required by an FTC consent decree, and that would apply to more cigar
manufacturers and brands than the current warnings on cigars.
12. The deeming rule requires that tobacco product manufacturers seeking to claim
that their products are less hazardous than other tobacco products (modified risk claims) must
provide evidence in support of the truth of the claim and obtain an order from FDA before
making such a claim. If the deeming rule is not implemented, the public, including young
people, may be exposed to misleading or inaccurate claims of modified risk, which may cause
initiation of cigar use or continued use, particularly among young people. Moreover, in the
course of the regulatory process by which FDA would review such modified risk claims under
the deeming rule, a substantial amount of information regarding the health effects of the products
and the claims sought to be asserted is made public, enabling Intervenors to have access to
important scientific information regarding the health effects of such products. In the absence of
the deeming rule, manufacturers of cigars would not be required to submit such information prior
to making such claims and public health organizations such as Tobacco-Free Kids would never
have access to the information.
13. The relief sought by plaintiffs would make it more difficult for Tobacco-Free
Kids public education and youth activities to be effective in (a) giving the public, and
particularly young people, an accurate understanding of the dangers of cigar smoking; (b)
discouraging initiation of cigar smoking by young people; and (c) encouraging cigar smokers,
particularly young people, to quit. If plaintiffs obtain the relief they seek, the Tobacco-Free Kids
would face additional obstacles and would have to expend more resources to achieve the
objectives of its public education and youth activities than it would have if the considerable
public health benefits of the deeming rule were left in place.
14. In a similar case brought by a manufacturer of e-cigarette products that has been
fully briefed and argued, the FDA filed briefs presenting a strong defense of all aspects of the
deeming rule. Nicopure Labs, LLC v. FDA, Docket No. 1:16-cv-0878 (D.D.C.). However, in
this case, due to the recent change in administrations, the FDA sought and received
postponement of filing deadlines for briefs opposing plaintiffs motions for summary judgment
and in support of the governments cross-motion for summary judgment, in order to more fully
consider the issues raised in this case and determine how best to proceed. In addition, it sua
sponte granted a 90-day extension of all deadlines established in the deeming rule that had not
yet occurred. These actions raise the possibility that FDA may not provide an adequate defense
of the deeming rule.
Signed under the pains and penalties of perjury this 20th day of July, 2017.
___________________________________
Matthew L. Myers
President, Campaign for Tobacco-Free Kids
EXHIBIT 5
EXHIBIT 6
EXHIBIT 7
)
CIGAR ASSOCIATION OF AMERICA, et al. )
)
Plaintiffs, )
)
v. ) Civ. No. 16-1460 (APM)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRATION, et al. )
)
)
Defendants. )
)
)
AFFIDAVIT OF ELLEN VARGYAS

AFFIDAVIT OF ELLEN VARGYAS
I, Ellen Vargyas, state as follows under the pains and penalties of perjury:
1. I am the General Counsel and Corporate Secretary for the Truth Initiative
Foundation, d/b/a Truth Initiative ("Truth Initiative"). Truth Initiative seeks to intervene as a
plaintiff in this action.
2. The information set forth in this affidavit is based upon my personal knowledge.
3. Truth Initiative is a Delaware corporation created in 1999 out of the 1998 Master
Settlement Agreement ("MSA") resolving litigation brought by 46 states, five U.S. territories
and the District of Columbia against the major U.S. cigarette companies. It was formerly known
as the American Legacy Foundation.
4. Truth Initiative is a tax-exempt corporation under section 50I(c)(3) of the Internal
Revenue Code. Its headquarters are located at 900 G Street, NW, 4th Floor, Washington, DC
20001.
5. Truth Initiative's purposes are to study and support programs in the United States
to reduce youth tobacco use and to prevent diseases associated with tobacco use.
6. Truth Initiative supports innovative and highly successful programming to
educate young people about all forms of tobacco so they make informed choices about its use
and programming that encourages and assists smokers to quit. For example, Truth Initiative's
nationally recognized truth campaign has reached hundreds of millions of teens and young
adults through television, radio and print advertisements, social media, the internet, earned
media, and in-person events, with information about the health effects and social costs of tobacco
in order to enable young people to make informed decisions about tobacco use. Recognizing the
popularity of little cigars and cigarillos among youth, particularly minority youth, along with the
widespread lack of understanding that they are as dangerous and addictive as cigarettes, truth
has addressed little cigars and cigarillos in advertisements and on social media. It provides
information on cigars on its website, thetruth.com and via social media.
7. Since 2008, Truth Initiative has offered a free, evidence-based, on-line smoking
cessation intervention, Become an Ex, to help adults stop smoking. EX has reached over
700,000 persons to date. Become an Ex provides information to its users on the substantial
health risks of cigar use.
8. Truth Initiative conducts a program to educate students at Historically Black
Colleges and Universities (HBCUs) about the health risks of tobacco and encourage them to take
an active role in helping their communities become smoke free. This program specifically
addresses the dangers of little cigar and cigarillo use based on its high prevalence rates among
African-American youth and young adults.
9. Truth Initiative conducts and analyzes research on the prevalence, addictiveness
and health risks of cigar use and provides information to the public on these subjects via articles
on its website, social media, and through a variety of other mechanisms.
10. Truth Initiative, along with other public health organizations, has frequently
participated as amicus curiae in support of the FDA in cases attacking the validity of FDA
regulatory action under the Tobacco Control Act. Discount City Tobacco & Lottery Inc. v. U.S.,
674 F. 3d 509 (61h Cir. 2011) (challenge to the constitutionality of many provisions of the
Tobacco Control Act); R.J Reynolds Tobacco Company v. FDA, 845 F. Supp. 2d 266, ajf'd, 696
F. 3d 1205 (D.C. Cir. 2012), (challenge to graphic warning labels on cigarette packs promulgated
pursuant to the TCA); Lorillard Tobacco Company v. FDA. , 56 F. Supp. 3d 37 (D.D.C. 2014),
rev 'd,, 810 F.3d 827 (D.C. Cir. 2016) (challenge to composition of Tobacco Products Scientific
Advisory Committee under the Tobacco Control Act). Truth Initiative was also amicus curiae in
the case that established the status of e-cigarettes as "tobacco products" subject to regulation
under the Tobacco Control Act. Sottera, Inc. v. FDA, 627 F. 3d 891 (D.C. Cir. 2011).
11. Truth Initiative participated extensively in the development and promulgation of
the deeming rule. From the time FDA announced that it was planning to issue a rule that would
extend its jurisdiction to other tobacco products, including cigars and e-cigarettes, Truth
Initiative encouraged FDA to issue such a rule and to ensure that it covered all other tobacco
products. Before FDA issued the deeming rule, Truth Initiative, in coordination with other
public health groups, sent letters to FDA and met with FDA personnel to urge them to issue the
deeming rule. Truth Initiative twice joined letters to President Obama, in September 2013 and
again in April 2014, urging the issuance of the rule that is under challenge in this proceeding.
12. On August 8, 2014, Truth Initiative submitted detailed comments to the FDA on
the then-proposed deeming regulation. On the same date, Truth Initiative also joined 23 other
health groups in an additional comment on the proposed regulation. Both comments emphasized
the important public health benefits that would flow from the proposed regulation. Both
comments specifically addressed the considerable health risks presented by all cigars, including
little cigars, cigarillos and premium cigars. They both supported the regulation of all cigars
including, but by no means limited to, the importance of requiring, for the first time, warning
labels for cigar products.
13. Truth Initiative' s programs and its ability to achieve its corporate purposes would
be directly harmed if the deeming regulation' s applicability to all cigars, including premium
cigars, little cigars and cigarillos, were to be limited in any fashion . Truth Initiative would
either have to spend more funds and devote additional other resources to educate youth, young
adults and adults about the fact that all cigars pose substantial health risks and are, in fact, no
safer than cigarettes or, alternatively, forego providing life-saving information.
Signed under the pains and penalties of perjury this / J~

day of July, 2017.
Ellen Vargyas o
General Counsel/Corporate Secretary
Truth Initiative
900 G Street, NW, 4th Floor
Washington, DC 2000 I
202-454-5592
evargyas@truthini tiati ve.org
EXHIBIT 8

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Case 1:16-cv-01460-APM Document 36 Filed 07/24/17 Page 1 of 28

IN THE UNITED STATES DISTRICT COURT

CIGAR ASSOCIATION OF AMERICA, et al.,

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

UNITED STATES FOOD AND DRUG

MOTION TO INTERVENE AS DEFENDANTS

II. FACTUAL AND LEGAL BACKGROUND ......................................................................3

A. The Deeming Rule ...................................................................................................3

B. Plaintiffs Challenge to the Deeming Rule ..............................................................6

C. Defendants Responses to Challenges to the Deeming Rule ...................................7

III. PUBLIC HEALTH INTERVENORS..................................................................................8

IV. ARGUMENT .....................................................................................................................11

A. Public Health Intervenors Have Standing to Intervene as

B. Public Health Intervenors Are Entitled to Intervene as of Right ...........................15

1. Public Health Intervenors Motion to Intervene is Timely ........................15

2. Public Health Intervenors Have Legally Protected Interests

3. If Successful, Plaintiffs Action Would Impair Public

4. Public Health Intervenors Interests May Not Be

C. Alternatively, the Court Should Permit Applicants to Intervene

V. PROPOSED TIMELINE FOR INTERVENTION ............................................................21

VI. CONCLUSION ..................................................................................................................22

Acree v. Republic of Iraq, 370 F.3d 41 (D.C. Cir. 2004) ...............................................................20

Foster v. Gueory, 655 F.2d 1319 (D.C. Cir. 1981) ........................................................................17

Friends of Animals v. Salazar, 626 F. Supp. 2d 102 (D.D.C. 2009) .............................................12

Hardin v. Jackson, 600 F. Supp. 2d 13 (D.D.C. 2009) ..................................................................16

Parker v. John Moriarty & Associates, 319 F.R.D. 18 (D.D.C. 2016)..........................................11

Smoke v. Norton, 252 F.3d 468 (D.C. Cir. 2001) ....................................................................15, 16

Trbovich v. United Mine Workers, 404 U.S. 528 (1972) .........................................................18, 20

Wilderness Society v. Babbitt, 104 F. Supp. 2d 10 (D.D.C. 2000) ................................................15

Williams & Humbert Ltd. v. Ruiz-Mateos, No. 83-cv-1905, 1991 WL 148283,

STATUTES, RULES, AND ADMINISTRATIVE MATERIALS

D.D.C. LCvR 7 ................................................................................................................................1

FDA, May 2017: Web Statement, available at https://www.fda.gov/Tobacco

FDA, Three-Month Extension of Certain Tobacco Product Compliance Deadlines

Fed. R. Civ. P. 24 ................................................................................................................... passim

Final Regulatory Impact Analysis, Docket No. FDA-2014-N-1089 (May 2016),

this motion. Defendants reserve the right to oppose the motion.

FDA, No. 1:16-cv-00878-ABJ (D.D.C. July 21, 2017) (Slip Op.).

particularly to young people. The cigar industry responded immediately. Manufacturers

Intervenors therefore have a strong interest in defending the Deeming Rule.

Rule is not weakened, vacated, or rendered ineffective.

II. FACTUAL AND LEGAL BACKGROUND

A. The Deeming Rule

subchapter. Id. 387a(b).

comprehensive five-year review of the scientific literature on unregulated tobacco products,

other things, prohibitions on adulteration and misbranding, 21 U.S.C. 387b-387c; reporting

product labels and advertisements. 81 Fed. Reg. at 28,974-28,975.

29,075, a determination upheld in Nicopure as to e-cigarettes as a careful assessment of the

Deeming Rule (May 2017) (Guidance).

B. Plaintiffs Challenge to the Deeming Rule

Three trade associations of tobacco industry participantsthe Cigar Association of

C. Defendants Responses to Challenges to the Deeming Rule

Deeming Rule in full.

https://www.fda.gov/TobaccoProducts/NewsEvents/ucm556562.htm (last updated May 3, 2017);

of harmful and potentially harmful product constituents to FDA. Id.

summary judgment motion are due on August 1.

III. PUBLIC HEALTH INTERVENORS

advise the government on effective regulation of tobacco products.

Helpline. Wimmer Aff. 5 (Ex. 8).

Similarly, the American Heart Association (AHA) maintains a quality improvement

health risks of cigars. Vargyas Aff. 6-7 (Ex. 7).

an amicus brief in support of the Deeming Rule in the Nicopure case.

Additionally, AAP is a professional membership organization of 66,000 pediatricians,