Fdaresponse

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 1 of 23
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.
ANSWER
Defendants, the U.S. Food and Drug Administration (FDA), Dr. Robert Califf, in his
official capacity as Commissioner of Food and Drugs, the U.S. Department of Health and
Human Services, and Sylvia M. Burwell, in her official capacity as Secretary of Health and
Human Services, hereby answer Plaintiffs complaint as follows:
INTRODUCTION
1.
Defendants admit that, on May 10, 2016, the 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) (the deeming rule).
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. The
balance of this paragraph contains characterizations of this lawsuit, argument, and conclusions of
law, not allegations of fact, and thus no response is required. To the extent a response is deemed
necessary, denied.
2.
This paragraph contains argument and conclusions of law, not allegations of fact,
and thus no response is required.

3.
Defendants admit that the FDA published the deeming rule on May 10, 2016.
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.
4.
Denied.
5.
Denied.
JURISDICTION AND VENUE
6.

7.

8.
and thus no response is required. To the extent a response is deemed necessary, denied.
PARTIES
9.
Defendants lack sufficient knowledge or information to form a belief about the
truth of the allegations in this paragraph.

10.
truth of the allegations in this paragraph. In addition, the fourth sentence contains argument and
conclusions of law, not allegations of fact, and thus no response is required.
11.
truth of the allegations in this paragraph.
12.
13.
14.
Defendants admit that the U.S. Department of Health and Human Services
(HHS) is a federal agency, and that HHS is headquartered at 200 Independence Avenue SW,
Washington, DC 20201.
15.
Defendants admit that the FDA is a federal agency. The balance of this paragraph
contains conclusions of law, not allegations of fact, and thus no response is required.
16.
Defendants admit that Sylvia M. Burwell is the Secretary of Health and Human
Services. The balance of this paragraph contains characterizations of this lawsuit and
conclusions of law, not allegations of fact, and thus no response is required.
17.
Defendants admit that Dr. Robert Califf is Commissioner of Food and Drugs.
The balance of this paragraph contains characterizations of this lawsuit and conclusions of law,
not allegations of fact, and thus no response is required.
BACKGROUND
A.
The Tobacco Control Act
1823. These paragraphs contain argument and conclusions of law, not allegations of
fact, and thus no response is required. To the extent a response is deemed necessary, denied.
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.
Defendants 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.
fact, and thus no response is required. To the extent a response is deemed necessary, 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).
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.
B.
FDAs 2014 Proposed Rule
30.
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). 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.
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.
Denied except to admit that the FDA published a preliminary regulatory impact
analysis. 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 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.
C.
Comments on the Proposed Rule
38.
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.
3941. These paragraphs contain argument and characterizations of public comments
submitted by CAA, ICPRA, and CRA. 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.
D.
The Final Rule
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.
47.
48.
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.
49.
and thus no response is required. To the extent a response is deemed necessary, 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.
50.
51.
any 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.
52.
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.
Defendants further deny the allegation that the FDA has been unable to timely review new
submissions.
53.
The first sentence is denied. The balance of 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, 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.
54.
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). Defendants deny any characterization of that rule, which speaks for itself,
55.
any characterization of the user fee rule, which speaks for itself, and respectfully refer the Court
56.
any characterization of the user fee rule, which speaks for itself, and respectfully refer the Court
57.
The first sentence is denied. With respect to the second sentence, Defendants
admit that IPCPR submitted a citizen petition regarding premium cigars to the FDA in August
2011. With respect to the third and fourth sentences, Defendants admit that the FDA responded
to IPCPRs August 2011 citizen petition in a May 5, 2016, letter from Beverly Chernaik that
contains the quoted text. Defendants deny any characterization of that letter, which speaks for
itself, and respectfully refer the Court to that letter for a complete and accurate statement of its
contents.
58.
admit that the FDA sent a draft of the proposed deeming rule to the Office of Management and
Budget (OMB). 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 contents. With respect to the third sentence, Defendants admit that the proposed deeming rule
contained an option (Option 2) that would have exempted premium cigars from the deeming
rule. 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. The fourth sentence is denied.
59.
60.
This paragraph contains argument and hypothetical statements, not allegations of
Court to that rule for a complete and accurate statement of its contents.
61.
The first sentence is denied. The second and third sentences contain argument
and conclusions of law, not allegations of fact, and thus no response is required. To the extent a
response is deemed necessary, denied. The fourth sentence is denied. The first clause of the
fifth sentence is denied. The second clause of the fifth sentence contains argument and
response is deemed necessary, denied.
62.
The first sentence is denied. The second sentence contains argument and
response is deemed necessary, 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.
63.
E.
FDAs Final Regulatory Impact Analysis
64.
Admitted.
65.
The first sentence is denied. The third sentence is denied except to admit that the
FDA published a final regulatory impact analysis that contains the quoted text. 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 http://www.fda.gov/
AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm500249.htm. The second
and fourth sentences contain argument and conclusions of law, not allegations of fact, and thus
no response is required. To the extent a response is deemed necessary, Defendants 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.
66.
Denied except to admit that Executive Order 12,866 contains the quoted text.
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.
The first sentence is denied except to admit that the final regulatory impact
analysis was published in May 2016. The balance of this paragraph is denied except to admit
that the final regulatory impact analysis contains the quoted text. 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.
68.
69.
admit that the final regulatory impact analysis contains the quoted text. 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. The third sentence is denied.
70.
10
71.
Denied except to admit that the final regulatory impact analysis contains the
quoted text. 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.
72.
contents.
73.
contents.
F.
The Backlog at the FDA and its Implications
74.
The first two sentences are denied. Defendants separately aver that, as explained
in the FDAs final regulatory impact analysis, Plaintiffs conflate[] provisional SE reports . . .
and regular SE submissions. See http://www.fda.gov/AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/ucm500249, at 33. New tobacco products that are the subject of
provisional SE reports may remain on the market until the agency issues a not substantially
equivalent order. Id. Moreover, [a]s of November 30, 2015, FDA has resolved 59 percent
(1193/2029) of all regular SE reports submitted. Id. With respect to the third sentence,
Defendants admit that the FDA received 967 regular SE reports in fiscal year 2015.
75.
The first sentence is denied except to admit that the FDA published a preliminary
regulatory impact analysis that estimated the number of substantial equivalence (SE) reports
11
expected for cigar products. 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 https://www.regulations.gov/document?D=FDA-2014-N-0189-20877. 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, 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.
76.
Denied except to admit that the FDA published a preliminary regulatory impact
analysis that estimated the number of SE reports expected. 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 https://www.regulations.gov/
document?D=FDA-2014-N-0189-20877.
77.
The first sentence contains characterizes the statute, and thus no response is
required. To the extent a response is deemed necessary, 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, not
allegations of fact, and thus no response is required. To the extent a response is deemed
necessary, denied.
78.
12
79.
80.
Denied.
81.
Denied except to admit, with respect to the third sentence, that the final regulatory
impact analysis contains the quoted text. 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.
CLAIMS FOR RELIEF
COUNT I
82.
Defendants restate and incorporate by reference the responses contained in all
preceding paragraphs.
83.
any characterization of the cited statutory provision, which speaks for itself, and respectfully
refer the Court to that provision for a complete and accurate statement of its contents.
84.
any characterization of the cited statutory provision, which speaks for itself, and respectfully
refer the Court to that provision for a complete and accurate statement of its contents.
85.
13
any 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.
Denied.
87.
any 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.
88.
89.
Defendants specifically deny any characterization of the referenced statutory provision and the
that rule for a complete and accurate statement of their contents.
90.
Defendants specifically deny any characterization of the referenced statutory provision and the
that rule for a complete and accurate statement of their contents.
14
91.
92.
Denied.
93.
94.
Denied.
95.
Denied.
96.

97.

98.
99.
Denied.
COUNT II
100.
101.
any characterization of the referenced statutory provision, which speaks for itself, and
15
respectfully refer the Court to that provision for a complete and accurate statement of its
contents.
102.
103.

104.

105.
106.
Denied.
COUNT III
107.
108.
any 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.
109.
Denied.
110.
Denied.
111.
16
112.

113.
114.
Denied.
COUNT IV
115.
116.
117.
any 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
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, Defendants deny any characterization of those comments, which
speak for themselves, and respectfully refer the Court to those comments for a complete and
17
119.
The first sentence is denied. The second sentence is denied except to admit that
the final regulatory impact analysis contains the quoted statements. Defendants specifically deny
that analysis for a complete and accurate statement of its contents.
120.
Denied.
121.

122.

123.
124.
Denied.
COUNT V
125.
126.
The first sentence contains argument and conclusions of law, not allegations of
Court to that rule for a complete and accurate statement of its contents. The second and third
sentences contains argument and conclusions of law, not allegations of fact, and thus no response
is required. To the extent a response is deemed necessary, denied. The fourth sentence is
denied.
18
127.
Defendants admit that the FDA published a final regulatory impact analysis that
addresses the effects of the deeming rule. 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.
128.
Defendants admit that the FDA published a final regulatory impact analysis that
addresses the effects of the deeming rule. 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.
129.
This paragraph contains argument and characterizations of the final regulatory
impact analysis, not allegations of fact, and thus no response is required. To the extent a
response is deemed necessary, 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.
The first and third sentences are denied except to admit that the FDA published a
final regulatory impact analysis that addresses the effects of the deeming rule. Defendants deny
that analysis for a complete and accurate statement of its contents. The second sentence is
denied.
131.
132.
133.
Denied.
19
COUNT VI
134.
135.
136.
137.
Denied.
138.

139.

140.
141.
Denied.
COUNT VII
142.
20
143.
144.
Denied.
145.

146.

147.
148.
Denied.
COUNT VIII
149.
150.
Denied.
151.

152.

153.
154.
Denied.
21
COUNT IX
155.
156.
Denied.
157.

158.

159.
160.
Denied.
PRAYER FOR RELIEF
The remaining paragraphs of the complaint contain a prayer for relief, to which no
response is required. To the extent a response is deemed necessary, Defendants 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.
Defendants deny any and all allegations in the Complaint not expressly admitted herein
to which a response is deemed required.
DEFENSES
1.
This Court lacks subject matter jurisdiction over this action.
2.
The complaint fails to state a claim upon which relief can be granted.
22
3.
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.
CONCLUSION
WHEREFORE, having fully answered, Defendants respectfully request that the Court
enter judgment dismissing this action with prejudice and awarding Defendants costs and such
other relief as the Court may deem appropriate.
Dated: October 26, 2016
Respectfully submitted,
Of counsel:
BENJAMIN C. MIZER
Principal Deputy Assistant Attorney General
DAVID J. HOROWITZ
Deputy General Counsel
Office of General Counsel
U.S. Dept of Health and Human Services
ELIZABETH H. DICKINSON
Chief Counsel
PERHAM GORJI
Deputy Chief Counsel for Litigation
WENDY S. VICENTE
Senior Counsel
Office of the Chief Counsel
Food and Drug Administration
10903 New Hampshire Avenue
White Oak 31, Room 4562
Silver Spring, MD 20993-0002
SHEILA LIEBER
Deputy Director
/s/ Eric Beckenhauer
ERIC B. BECKENHAUER
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
20 Massachusetts Ave. NW
Washington, DC 20530
Tel: (202) 514-3338
Fax: (202) 616-8470
E-mail: Eric.Beckenhauer@usdoj.gov
Counsel for Defendants
23

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Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 1 of 23

IN THE UNITED STATES DISTRICT COURT

Civil Action No. 16-1460 (APM)

UNITED STATES FOOD AND DRUG

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 2 of 23

and thus no response is required.

and thus no response is required.

and thus no response is required.

Defendants lack sufficient knowledge or information to form a belief about the

truth of the allegations in this paragraph.

Defendants lack sufficient knowledge or information to form a belief about the

Defendants lack sufficient knowledge or information to form a belief about the

truth of the allegations in this paragraph.

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 3 of 23

The Tobacco Control Act

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 4 of 23

FDAs 2014 Proposed Rule

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 5 of 23

Comments on the Proposed Rule

Defendants admit that the Cigar Association of America (CAA), the

The Final Rule

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 6 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 7 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 8 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 9 of 23

This paragraph contains argument and hypothetical statements, not allegations of

FDAs Final Regulatory Impact Analysis

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 10 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 11 of 23

The Backlog at the FDA and its Implications

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 12 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 13 of 23

Defendants restate and incorporate by reference the responses contained in all

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 14 of 23

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 15 of 23

This paragraph contains argument and hypothetical statements, not allegations of

and thus no response is required.

and thus no response is required.

Defendants restate and incorporate by reference the responses contained in all

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 16 of 23

and thus no response is required.

and thus no response is required.

Defendants restate and incorporate by reference the responses contained in all

and thus no response is required.

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 17 of 23

and thus no response is required.

Defendants restate and incorporate by reference the responses contained in all

This paragraph characterizes Plaintiffs comments on the proposed rule and/or

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 18 of 23

and thus no response is required.

and thus no response is required.

Defendants restate and incorporate by reference the responses contained in all

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 19 of 23

This paragraph contains argument and characterizations of the final regulatory

This paragraph contains argument and hypothetical statements, not allegations of

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 20 of 23

Defendants restate and incorporate by reference the responses contained in all

and thus no response is required.

and thus no response is required.

Defendants restate and incorporate by reference the responses contained in all

Case 1:16-cv-01460-APM Document 10 Filed 10/26/16 Page 21 of 23

and thus no response is required.

and thus no response is required.