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American Academy of Pediatrics v. United States Food and Drug Administration

United States District Court, D. Massachusetts

September 5, 2018

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,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant.

          MEMORANDUM AND ORDER

          Indira Talwani United States District Judge

         The 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[1] 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 DENIED.

         I. Background

         A. The Tobacco Control Act

         On June 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 (a)(1).

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.

         B. The First Legal Challenge

         Shortly 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 (2013).

         C. The FDA's Promulgation of a Final Rule

         Meanwhile, 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.

         On June 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.

         D. The Second Legal Challenge

         On 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.

         On 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 [#30-1].

         E. The FDA's Actions in the More Than Five Years Following Remand

         On 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 ...


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