United States District Court, D. Massachusetts
AMERICAN ACADEMY OF PEDIATRICS, MASSACHUSETTS CHAPTER OF AMERICAN ACADEMY OF PEDIATRICS, INC., AMERICAN CANCER SOCIETY, INC., AMERICAN CANCER SOCIETY ACTION NETWORK, INC., AMERICAN HEART ASSOCIATION, INC., AMERICAN LUNG ASSOCIATION, CAMPAIGN FOR TOBACCO-FREE KIDS, TRUTH INITIATIVE FOUNDATION, D/B/A TRUTH INITIATIVE, DR. TED KREMER, DR. JONATHAN WINICKOFF, and DR. LYNDA YOUNG, Plaintiffs,
UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant.
MEMORANDUM AND ORDER GRANTING INJUNCTIVE
Talwani United States District Judge
brought this action seeking a declaration that Defendant
United States Food and Drug Administration
(“FDA”) “unlawfully withheld” or
“unreasonably delayed” promulgating a final rule
mandating color graphic warnings on cigarette packs and in
cigarette advertisements as required by the Family Smoking
Prevention and Tobacco Control Act of 2009 (“Tobacco
Control Act”), Pub. L. No. 111-31, § 201, 123
Stat. 1776, 1845 (2009), and an order compelling the FDA to
expedite a final graphic warnings rule. Complaint [#1]; see
also Pls.' Mot. Summ. J. 2 [#27]. On the parties'
cross-motions for summary judgment, the court found that the
FDA has both “unlawfully withheld” and
“unreasonably delayed” agency action, and that
pursuant to the Administrative Procedure Act, 5 U.S.C. §
706(1), the court must compel agency action. Mem. &
Order, 2, 15 [#50].
court sought further input from the parties as to the proper
time frame for the agency to act. Id. at 15. Having
reviewed Defendant's Statement Regarding Proposed
Expedited Rulemaking Schedule (“Def. Proposed
Schedule”) [#53], and Plaintiffs' Response to
FDA's Proposed Schedule and Request for Urgent
Action (“Pl. Response”) [#54] and
Renewed Request for Urgent Action [#55], and taking
judicial notice of the Agency publicized rule-making
activities, the court compels the Agency to act in accordance
with the schedule set forth below.
background to this dispute is set forth in detail in the
Memorandum and Order [#50], which the court incorporates
herein. In brief, Congress directed the FDA that the new
graphic warning rule mandated by the Tobacco Control Act was
to be promulgated within two years of the statute's
enactment, or by June 22, 2011. Tobacco Control Act Pub. L.
No. 111-31, 101(b), 123 Stat. 1776, 1845 (2009), § 201,
codified in 15 U.S.C. § 1333(d) (2012). The FDA
initially met the deadline for promulgation of the rule, but
the United States District Court for the District of Columbia
enjoined the rule before its effective date, R.J.
Reynolds Tobacco Co. v. Food & Drug Admin., 823
F.Supp.2d 36 (D.D.C. 2012), and subsequently granted summary
judgment to the tobacco company challenging the rule.
R.J. Reynolds Tobacco Co. v. Food & Drug Admin.,
845 F.Supp.2d 266 (D.D.C. 2012). On appeal, the United States
Court of Appeals for the District Columbia Circuit found that
the FDA “failed to present any data - much less the
substantial evidence required under the Administrative
Procedure Act (‘APA') - showing that enacting their
proposed graphic warnings will accomplish the agency's
stated objective of reducing smoking rates.” R.J.
Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d
1205, 1222 (D.C. Cir. 2012), overruled in part by Am.
Meat Inst. v. U.S Dep't of Agric., 760 F.3d 18, 26
(D.C. Cir. 2014) (en banc). The D.C. Circuit vacated both the
rule and the permanent injunction issued by the district
court, and remanded to the FDA. Id. On March 15,
2013, the Attorney General reported to Congress that the FDA
intended to undertake research to support a new graphic
warnings rule. Pls.' App. Ex. 2, 3 [#30-1]. It is the
FDA's subsequent action (or lack of action) that prompted
to the court's issuance of its Memorandum & Order,
the FDA estimated that a final rule mandating color graphic
warnings as required by the Tobacco Control Act would be
submitted to the Office of the Federal Register in November
2021, First Suppl. Def.'s L.R. 56.1 Statement of
Undisputed Material Facts (“Def.'s 1st
Suppl.”) 2 [#42], a date more than eight and a half
years after the Attorney General's March 15, 2013, report
to Congress. Plaintiffs argued that the FDA has violated the
Administrative Procedures Act by “unlawfully
withholding” agency action by failing to promulgate the
new graphic warnings, or in the alternative, has
“unreasonably delayed” the final rule. Pls.'
Mem. in Supp. of Mot. Summ. J. (“Pls.' Mem.”)
2 [#28], citing 5 U.S.C. § 706(1).
the “unlawfully withheld” analysis, the court
concluded that the D.C. Circuit's vacatur and remand back
to the agency did not free the FDA from Congressional
mandates and allow the FDA to promulgate this rule at
whatever pace it chooses. Instead, “[w]hile the vacatur
may reset the two-year clock, it does not negate the
FDA's continuing obligation to comply with Congress'
deadlines.” Mem. & Order [#50] at 10. The court
also found that in light of the timeline originally set forth
by Congress, the FDA's proposed timeline (and work
completed thus far), the human health and welfare at stake,
and the lack of competing priorities enumerated in the
FDA's brief, the FDA has failed the factors set forth in
Telecommunications Research and Action Center, et. al. v.
Federal Communications Commission, 750 F.2d 70 (D.C.
Cir. 1984) (“TRAC”), that the FDA asked the court
to apply. Mem. & Order, 15 [#50].
court concluded that because the FDA has both
“unlawfully withheld” and “unreasonably
delayed” agency action, the court must compel agency
action pursuant to 5 U.S.C. § 706(1). Id. The
court nonetheless provided the FDA a final opportunity to
utilize its expertise to offer an expedited schedule that
would respond sufficiently to the urgency expressed by the
The Schedule Going Forward
this court's admonition that Congress's two-year
deadline had restarted when the matter was remanded to the
agency in 2013, and the court's directive that the FDA
propose an expedited schedule, in an October 2018 response,
the FDA proposed publication of a final rule in the Federal
Register in May 2021, more than two and a half years from the
date of the proposal, more than four and a half years after
the Plaintiffs brought this litigation, and more than eight
years after advising Congress that it was undertaking
research to support a new rule. The court rejects FDA's
The Final Qualitative Study of Nine Graphic Warnings and
Analysis shall be completed by April 15, 2019 On
September 26, 2018, the FDA published a Federal Register
notice pursuant to the Paperwork Reduction Act
(“PRA”). Agency Information Collection
Activities; Proposed Collection; Comment Request;
Experimental Study of Cigarette Warnings, 83 Fed. Reg. 48,
624, 68, 626 (Sept. 26, 2018). According to the government
website, the initial comment period closed on November 26,
2018, the request was submitted to the Office of Management
and Budget Review on December 18, 2018, and a second comment
period closed on January 22, 2019.
Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Experimental
Study of Cigarette Warnings,
(last visited Mar. 5, 2019).
only comment received was from Plaintiffs here. Id.
The court finds no reason for further delay.
Defendant has previously conceded, the PRA requires OMB to
respond to an agency's request within 60 days. [#48],
citing 44 U.S.C. § 3507(c)(2), (c)(3). Where OMB has
failed to timely respond, the FDA “may request, and OMB
shall assign without further delay, an OMB control number . .
. .” Id., citing 5 C.F.R. § 1320.10(c).
Defendant also has ...