Case 1:16-cv-01460-APM Document 40 Filed 08/01/17 Page 1 of 4

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; UNITED STATES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES; THOMAS E. PRICE,
M.D., in his official capacity as Secretary of
Health and Human Services; and SCOTT
GOTTLIEB, M.D., in his official capacity as
Acting Commissioner of Food and Drugs,1

Defendants.

JOINT MOTION TO AMEND SCHEDULING ORDER

The parties jointly move the Court for a 30-day extension of briefing deadlines in view of

the U.S. Food and Drug Administrations announcement of a new comprehensive plan for the

regulation of tobacco products. In support of this motion, the parties state as follows:

1. Plaintiffs challenge, among other things, U.S. Food and Drug Administration

(FDA) rules that deem cigars and pipe tobacco to be tobacco products subject to FDA

regulation and that assess users fees on manufacturers and importers in some, but not all, of the

newly-regulated tobacco product industries to fund the regulatory scheme. See FDA, 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; Restrictions on the Sale and

1
Pursuant to Fed. R. Civ. P. 25(d), Dr. Thomas Price and Dr. Scott Gottlieb are substituted for
their predecessors in office.
 Case 1:16-cv-01460-APM Document 40 Filed 08/01/17 Page 2 of 4

Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, No.

FDA-2014-N-0189, 81 Fed. Reg. 28,973 (May 10, 2016), and 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 Rules).

2. Plaintiffs filed their motion for summary judgment on February 13, 2017. See ECF

No. 22. Under the current briefing schedule, Defendants opposition and cross-motion are due on

August 1; Plaintiffs reply and opposition are due on September 14; and Defendants reply is due

on October 16. See id. Oral argument is currently scheduled for December 8. See id.

3. After the recent change in administrations, the Court granted two similar joint

motions to extend briefing deadlines, together extending those deadlines by a total of four months,

to allow new leadership personnel at the Department of Health and Human Services additional

time to more fully consider the Rules and the issues raised in this case and determine how best to

proceed. See Minute Order (Mar. 22, 2017); Order (May 2, 2017) (ECF No. 35).

4. On July 28, 2017, the FDA announced a new comprehensive plan for the

regulation of tobacco products. FDA, Press Release, FDA Announces Comprehensive Regulatory

Plan to Shift Trajectory of Tobacco-Related Disease, Death (July 28, 2017), available at

https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/UCM568923.htm.

5. As part of that plan, the FDA announced that it intends to issue guidance describing

a new enforcement policy that, among other things, would extend until August 2021 the

compliance period for submitting applications for newly-regulated combustible products such as

cigars and pipe tobacco that were on the market as of August 8, 2016, and the FDA expects that

manufacturers would continue to market the products while those applications are pending. Id.

The agency also intends to issue Advanced Notices of Proposed Rulemaking (ANPRMs)

seeking, among other things, public comment on (a) the role that flavors in tobacco products play

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 Case 1:16-cv-01460-APM Document 40 Filed 08/01/17 Page 3 of 4

in attracting youth and (b) the patterns of use and resulting public health impacts of premium

cigars. Id. And the agency intends to issue regulations outlining the information it expects to be

included in SE reports, PMTAs, and modified risk tobacco product (MRTP) applications. Id.

6. The approach outlined in the FDAs new comprehensive plan may affect several

claims raised in this case. Accordingly, the parties respectfully seek a 30-day extension of the

August 1 deadline for Defendants to file an opposition to Plaintiffs motion for summary

judgment, as well as the parties subsequent opposition and reply deadlines, to consider the

consequences of the new comprehensive plan on this litigation, to discuss ways to reduce the need

to litgate some of the issues presented in this case, and, if necessary, to confer regarding the most

efficient path forward for presenting any remaining challenges to the Rules.

WHEREFORE, the parties respectfully request that the Court extend briefing deadlines in

this case for 30 days. A proposed order is attached.

Dated: August 1, 2017 Respectfully submitted,

/s/ Mark A. Heller . BRETT A. SHUMATE

Mark A. Heller, DC Bar No. 357046
Mark S. Raffman, DC Bar No. 414578
GOODWIN PROCTER LLP
901 New York Avenue, N.W.
Washington, DC 20001
Telephone: (202) 346-4000
mheller@goodwinprocter.com
Attorneys for Plaintiff Cigar Association of
America
/s/ Michael James Edney
Michael James Edney
Caroline M. Mew
NORTON, ROSE, FULBRIGHT US, LLP
799 9th Street, NW, Suite 1000
Washington, DC 20001
(202) 662-0410
Fax: (202) 662-4643
michael.edney@nortonrosefulbright.com
Deputy Assistant Attorney General
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
r Washington, DC 20530
Tel: (202) 514-3338
Fax: (202) 616-8470
E-mail: Eric.Beckenhauer@usdoj.gov
Counsel for Defendants

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 Case 1:16-cv-01460-APM Document 40 Filed 08/01/17 Page 4 of 4

Attorneys for Plaintiffs International Premium

Cigar and Pipe Retailers Association and Cigar
Rights of America

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 Case 1:16-cv-01460-APM Document 40-1 Filed 08/01/17 Page 1 of 2

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; UNITED STATES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES; THOMAS E. PRICE,
M.D., in his official capacity as Secretary of
Health and Human Services; and SCOTT
GOTTLIEB, M.D., in his official capacity as
Acting Commissioner of Food and Drugs,1

Defendants.

[PROPOSED] ORDER

Upon consideration of the parties joint motion to amend the scheduling order, it is hereby

ORDERED that the motion is GRANTED; and it is

FURTHER ORDERED that the [35] scheduling order in this case is amended as follows:

Defendants opposition to Plaintiffs motion for summary judgment and cross-motion

for summary judgment shall be filed by: August 31, 2017

Briefs of any amici granted leave to file in support of Defendants shall be filed by:
September 7, 2017

Plaintiffs reply in support of their motion for summary judgment and opposition to
Defendants cross-motion for summary judgment shall be filed by: October 16, 2017

Defendants reply in support of their cross-motion for summary judgment shall be filed
by: November 15, 2017

1
Pursuant to Fed. R. Civ. P. 25(d), Dr. Thomas Price and Dr. Scott Gottlieb are substituted for
their predecessors in office.
 Case 1:16-cv-01460-APM Document 40-1 Filed 08/01/17 Page 2 of 2

Plaintiffs shall file the appendix of excerpts of the administrative record by: November
29, 2017

Oral argument shall be rescheduled for a date and time that suits the Court.

SO ORDERED.

Dated: ______________________________ ___________________________________

AMIT P. MEHTA
United States District Judge