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
Talwani United States District Judge
Family Smoking Prevention and Tobacco Control Act of 2009
(“Tobacco Control Act” or “Act”)
required Defendant United States Food and Drug Administration
(“FDA”) to promulgate a final rule mandating
color graphic warnings on cigarette packs and in cigarette
advertisements by June 22, 2011. See Tobacco Control
Act Pub. L. No. 111-31, § 201, 123 Stat. 1776, 1845
(2009). Plaintiffs bring this action seeking a declaration
that the FDA “unlawfully withheld” or
“unreasonably delayed” promulgating a final rule
and an order compelling the FDA to expedite a final graphic
warnings rule. Pls.' Mot. Summ. J. 2 [#27]. On the
parties' cross-motions for summary judgment, the court
finds that the FDA has both “unlawfully withheld”
and “unreasonably delayed” agency action, and
that pursuant to the Administrative Procedure Act
(“APA”), the court must compel agency action.
Accordingly, and as set forth below, Plaintiffs'
Motion for Summary Judgment [#27] is ALLOWED and the
FDA's Cross-Motion for Summary Judgment [#32] is
The Tobacco Control Act
22, 2009, Congress passed the Tobacco Control Act, which
conferred upon the FDA the jurisdiction to regulate tobacco
products. Tobacco Control Act Pub. L. No. 111-31, 101(b), 123
Stat. 1776, 1786-87 (2009). The Tobacco Control Act directed
the FDA to regulate the labeling and advertising of
cigarettes, and specifically ordered the promulgation of
color graphic warnings to be placed on cigarette packaging.
Id. § 201. The statute required that:
Not later than 24 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the
Secretary shall issue regulations that require color graphics
depicting the negative health consequences of smoking to
accompany the label statements specified in subsection
Id. § 201, 123 Stat. at 1845, codified in 15
U.S.C. § 1333(d) (2012). The Act further required the
FDA to promulgate the new graphic warnings rule within two
years of enactment, or by June 22, 2011. Id.
The First Legal Challenge
after the Tobacco Control Act was enacted, a number of
tobacco companies brought a facial challenge, and in 2010,
the district court granted in part and denied in part
cross-motions for summary judgment. Commonwealth Brands,
Inc. v. United States, 678 F.Supp.2d 512, 541 (W.D. Ky.
2010). In 2012, the Sixth Circuit rejected the facial
challenge to the graphic and textual warnings for cigarette
packaging, finding that the requirement passed constitutional
muster as reasonably related to the government's interest
in preventing consumer deception. Discount Tobacco City
& Lottery, Inc. v. United States, 674 F.3d 509,
568-69 (6th Cir. 2012), cert. denied, 569 U.S. 946
The FDA's Promulgation of a Final Rule
in August 2009, the FDA formed the Center for Tobacco
Products to implement the Tobacco Control Act. Tobacco
Control Act Pub. L. No. 111-31, 101(b), 123 Stat. 1776, 1787
(2009). On November 12, 2010, the FDA published a notice of
proposed rulemaking, setting forth a proposed rule with nine
textual warnings accompanied by color graphics. Required
Warnings for Cigarette Packages & Advert., 75 Fed. Reg.
69523 (proposed Nov. 12, 2010) (to be codified at 21 C.F.R.
pt. 1141). The notice stated that the purpose of the warning
labels was to “promote greater public knowledge of the
health risks of using cigarettes” and to convey to the
public the adverse health consequences of smoking.
Id. at 69526. The notice stated further that the
textual warnings in use on cigarette packages and in
cigarette advertisements were “inadequate” as
they “often go unnoticed” and “fail to
convey relevant information in an effective manner.”
Id. at 69529-30. In contrast, according to the
notice, “larger, graphic warnings communicate more
effectively, ” get consumers' attention, influence
their awareness of cigarette-related health risks and reduce
the prevalence of smoking. Id. at 69531-33.
22, 2011, the FDA published its final rule requiring the use
of nine textual warnings accompanied by graphic images on
cigarette packaging and advertisements. Required Warnings for
Cigarette Packages & Advert., 76 Fed. Reg. 36627, 36628
(June 22, 2011) (to be codified at 21 C.F.R. pt. 1141). The
FDA set September 22, 2012, as the effective date of its new
warning requirements. Id.
The Second Legal Challenge
August 16, 2011, a group of tobacco product manufacturers and
sellers (including three of the plaintiffs in the earlier
case) brought suit alleging that the graphic image warnings
and the placement and type-style requirements for the
corresponding textual warnings violated their constitutional
right to free speech under the First Amendment. R.J.
Reynolds Tobacco Co. v. Food & Drug Admin., 845
F.Supp.2d 266, 271 (D.D.C. 2012). The suit did not include a
facial challenge and the companies conceded at oral argument
that “different graphic warning label requirements
could be constitutional.” Pls.' App. of Supp.
Evidentiary Materials (“Pls.' App.”) Ex. 1,
19:21-20:16 [#30-1]. The district court held the graphic
image warnings unconstitutional and enjoined enforcement of
the 2011 final rule. Reynolds, 845 F.Supp.2d at 277.
appeal, the companies “[did] not dispute Congress's
authority to require health warnings on cigarette packages,
nor [did] they challenge the substance of any of the nine
textual statements mandated by the Act.” R.J.
Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d
1205, 1211 (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 issue on appeal was whether
the graphic warning labels, which included the textual
warning, corresponding graphic image, and the
“1-800-QUIT-NOW” hotline number, violated the
First Amendment. Id. The D.C. Circuit vacated the
graphic warning requirements, holding that the FDA
“failed to present any data - much less the substantial
evidence required under the APA - showing that enacting their
proposed graphic warnings will accomplish the agency's
stated objective of reducing smoking rates” - and
remanded to the agency. Id. at 1222. The D.C.
Circuit denied the FDA's petition for rehearing en
banc in December 2012. Pls.' App. Ex. 2, 2-3
The FDA's Actions in the More Than Five Years
March 15, 2013, in a letter to Congress, the Attorney General
reported that the Justice Department had decided not to seek
review of the D.C. Circuit's decision and that the FDA
intended to undertake research to support a new graphic
warnings rule. Pls.' App. Ex. 2, 3 [#30-1]. That same
year, the FDA established a working group to develop a new
proposed graphic warnings rule. Def.'s L.R. 56.1
Statement of Undisputed Material Facts & Resp. to
Pls.' L.R. 56.1 Statement of Undisputed Facts
(“Def.'s SOF”) Attach. 1 (“Zeller
Decl.”) ¶ 12 [#35-1]. After the working
group's “review of literature and data” to