CIGAR ASSOCIATION OF AMERICA v. FDA: JOINT STATUS REPORT, Dec. 13, 2018

December 14, 2018 10:34 pm by Gene Borio

The PDF is Here

EXCERPT:

Plaintiffs are concerned about the impending November 8, 2019 deadline for reporting of harmful and potentially harmful constituent (“HPHC”) testing for all cigars and pipe tobacco. . . .

With regard to the substantial equivalence and premarket review process and the arbitrary
failure to appropriately treat the category of the premium cigars challenged in Counts I, IV, and
V, Plaintiffs continue to monitor regulatory developments and are considering either continuing to
stay those claims with the Court’s permission or dismissing them without prejudice, assuming
appropriate protections for future litigation are put in place by agreement with the Government or
through Court order. Plaintiff associations will provide their respective views on the appropriate
disposition of those claims in their January 14, 2019 status report.

Defendants’ Statement: Defendants remain open to having the remaining claims in this
case—i.e., Counts I, IV, and V of the complaint—either further deferred or dismissed without
prejudice, as previously reported. See ECF No. 53, at 3; ECF No. 110, at 3; ECF No. 111, ¶ 2.
Defendants have not received a proposal for “appropriate protections” for those claims in the event
of dismissal, or for potential proceedings on any other, unpleaded claims, but will provide their
views once Plaintiffs determine how they wish to proceed.

END EXCERPT

FULL TEXT:

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

CIGAR ASSOCIATION OF AMERICA, et
al.,

Plaintiffs,

v.

UNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,

Defendants.

Civil Action No. 16-1460 (APM)

JOINT STATUS REPORT

Pursuant to the Court’s August 16, 2018 status conference and November 8 and December
4, 2018 minute entries, the parties respectfully submit this Joint Status Report.

Joint Statement: At this time, the parties agree to further defer briefing of Counts I, IV,
and V of the complaint in this case until January 14, 2019, at which time they propose submitting
a further status report with respect to these claims. The parties set forth separate statements below.

Plaintiffs’ Statement: As noted at the August 16, 2018 status conference before the Court
and in the November 1, 2018 status report, Plaintiffs are concerned about the impending November
8, 2019 deadline for reporting of harmful and potentially harmful constituent (“HPHC”) testing
for all cigars and pipe tobacco. In the Deeming Rule itself, FDA promised guidance regarding
HPHC reporting and a rule providing a methodology for HPHC testing, both well in advance of
the November 8, 2019 date. 81 Fed. Reg. at 28,980, 29,051. That has not happened. According
to the unified regulatory agenda, such a rule is not even in the agency’s pipeline. And even if it
were published today, it would not be early enough, as the November 8, 2019 deadline is to report
the results of testing thousands of cigar types, not to begin the testing itself. Moreover, the

pendency of FDA’s premium cigar docket may obviate the HPHC testing and reporting
requirements for premium cigars, but that docket will not be completed prior to the deadline. See
Cigar Ass’n of Am. v. U.S. Food & Drug Admin., 317 F. Supp. 3d 555, 563 (D.D.C. 2018) (quoting
Cigar Ass’n of Am. v. U.S. Food & Drug Admin., 315 F. Supp. 3d 143, 175 (D.D.C. 2018)).

An extension of the November 2019 deadline has been requested from FDA. Unless that
extension is granted, Plaintiffs will need to bring claims challenging the HPHC testing and
reporting requirement in January 2019. Options include seeking to amend the complaint, by
consent or by motion, or filing a separate complaint before this Court.

With regard to the substantial equivalence and premarket review process and the arbitrary
failure to appropriately treat the category of the premium cigars challenged in Counts I, IV, and
V, Plaintiffs continue to monitor regulatory developments and are considering either continuing to
stay those claims with the Court’s permission or dismissing them without prejudice, assuming
appropriate protections for future litigation are put in place by agreement with the Government or
through Court order. Plaintiff associations will provide their respective views on the appropriate
disposition of those claims in their January 14, 2019 status report.

Defendants’ Statement: Defendants remain open to having the remaining claims in this
case—i.e., Counts I, IV, and V of the complaint—either further deferred or dismissed without
prejudice, as previously reported. See ECF No. 53, at 3; ECF No. 110, at 3; ECF No. 111, ¶ 2.
Defendants have not received a proposal for “appropriate protections” for those claims in the event
of dismissal, or for potential proceedings on any other, unpleaded claims, but will provide their
views once Plaintiffs determine how they wish to proceed.

Dated: December 13, 2018

Respectfully submitted,

/s/ Michael J. Edney

Michael J. Edney, DC Bar No. 492024

Ryan E. Meltzer, Texas Bar No. 24092821

NORTON ROSE FULBRIGHT US LLP

799 9th Street, NW, Suite 1000

Washington, DC 20001-4501

Telephone: (202) 662-0200

Fax: (202) 662-4643

michael.edney@nortonrosef…

ryan.meltzer@nortonrosefu…

Attorneys for Plaintiffs International
Premium Cigar and Pipe Retailers
Association and Cigar Rights of America

/s/ Mark S. Raffman

Mark S. Raffman, DC Bar No. 414578

Andrew Kim, DC Bar No. 1029348

GOODWIN PROCTER LLP

901 New York Avenue, NW

Washington, DC 20001

Telephone: (202) 346-4000

Fax: (202) 346-4444

mraffman@goodwinlaw.com

andrewkim@goodwinlaw.com

Attorneys for Plaintiff Cigar Association of
America

Respectfully submitted,

JOSEPH H. HUNT

Assistant Attorney General

/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.go…

Counsel for Defendants

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