R.J. Reynolds Tobacco Co. v. Food & Drug Admin

Decision Date24 August 2012
Docket Number12–5063.,Nos. 11–5332,s. 11–5332
Citation696 F.3d 1205
CourtU.S. Court of Appeals — District of Columbia Circuit
PartiesR.J. REYNOLDS TOBACCO COMPANY, et al., Appellees v. FOOD & DRUG ADMINISTRATION, et al., Appellants.

OPINION TEXT STARTS HERE

Appeals from the United States District Court for the District of Columbia, (No. 1:11–cv–01482).

Mark B. Stern, Attorney, U.S. Department of Justice, argued the cause for appellants. With him on the briefs were Tony West, Assistant Attorney General, Beth S. Brinkmann, Deputy Assistant Attorney General, Alisa B. Klein, Sarong V. Damle, Daniel Tenny, and Lindsey Powell, Attorneys, William B. Schultz, Acting General Counsel, U.S. Department of Health and Human Services, Eric M. Blumberg, Deputy Chief Counsel, and Karen E. Schifter, Senior Counsel. R. Craig Lawrence, Assistant U.S. Attorney, entered an appearance.

Gregory A. Beck and Allison M. Zieve were on the brief for amici curiae American Academy of Pediatrics, et al. in support of appellants.

Lawrence G. Wasden, Attorney General, Office of the Attorney General for the State of Idaho, Brett T. DeLange, Deputy Attorney General, John J. Burns, Attorney General, Office of the Attorney General for the State of Alaska, Tom Horns, Attorney General, Office of the Attorney General for the State of Arizona, Dustin McDaniel, Attorney General, Office of the Attorney General for the State of Arkansas, Kamala D. Harris, Attorney General, Office of the Attorney General for the State of California, George Jepsen, Attorney General, Office of the Attorney General for the State of Connecticut, Todd S. Kim, Solicitor General, Office of the Attorney General for the District of Columbia, David M. Louie, Attorney General, Office of the Attorney General for the State of Hawai‘i, Lisa Madigan, Attorney General, Office of the Attorney General for the State of Illinois, Thomas J. Miller, Attorney General, Office of the Attorney General for the State of Iowa, William J. Schneider, Attorney General, Office of the Attorney General for the State of Maine, Douglas F. Gansler, Attorney General, Office of the Attorney for the State of Maryland, Jim Hood, Attorney General, Office of the Attorney General for the State of Mississippi, Steve Bullock, Attorney General, Office of the Attorney General for the State of Montana, Michael A. Delaney, Attorney General, Office of the Attorney General for the State of New Hampshire, Gary K. King, Attorney General, Office of the Attorney General for the State of New Mexico, Michael DeWine, Attorney General, Office of the Attorney General for the State of Ohio, Peter F. Kilmartin, Attorney General, Office of the Attorney General for the State of Rhode Island, Marty J. Jackley, Attorney General, Office of the Attorney General for the State of South Dakota, Mark L. Shurtleff, Attorney General, Office of the Attorney General for the State of Utah, William H. Sorrell, Attorney General, Office of the Attorney General for the State of Vermont, Vincent F. Frazier, Attorney General,Office of the Attorney General for the Virgin Islands, Robert M. McKenna, Attorney General, Office of the Attorney General for the State of Washington, and Darrell V. McGraw, Jr., Attorney General, Office of the Attorney General for the State of West Virginia, were on the brief for amici curiae States.

Noel J. Francisco argued the cause for appellees. With him on the briefs were Warren D. Postman, Philip J. Perry, Jonathan D. Hacker, Floyd Abrams, Joel Kurtzberg, and Patricia A. Barald.

Bert W. Rein, John E. Barry, Robin S. Conrad, Kathryn Comerford Todd, and Sheldon Gilbert were on the brief for amicus curiae Chamber of Commerce of the United States of America in support of appellees.

Daniel J. Popeo, Cory L. Andrews, and Richard A. Samp were on the brief for amicus curiae Washington Legal Foundation.

Robert Corn–Revere and Ronald G. London were on the brief for amici curiae Association of National Advertisers Inc., et al. in support of appellees.

Jeffrey Light was on the brief for amicus curiae Defending Animal Rights Today & Tomorrow in support of neither party.

Before: ROGERS and BROWN, Circuit Judges, and RANDOLPH, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge BROWN.

Dissenting opinion filed by Circuit Judge ROGERS.

BROWN, Circuit Judge:

The Family Smoking Prevention and Tobacco Control Act (“the Act”), Pub.L. No. 111–31, 123 Stat. 1776 (2009), directed the Secretary of the U.S. Department of Health and Human Services to issue regulations requiring all cigarette packages manufactured or sold in the United States to bear one of nine new textual warnings, as well as “color graphics depicting the negative health consequences of smoking.” See id. § 201(a). Pursuant to this authority, the Food and Drug Administration (FDA) initiated a rulemaking proceeding through which it selected the nine images that would accompany the statutorily-prescribed warnings. Five tobacco companies (“the Companies”) challenged the rule, alleging that FDA's proposed graphic warnings violated the First Amendment. See Compl. at 35–36.1 The district court granted the Companies' motion for summary judgment on February 29, 2012.2 FDA appeals, and we affirm.

I. Background

The Act gives FDA the authority to regulate the manufacture and sale of tobacco products, including cigarettes. In addition to requiring cigarette packages and advertisements to bear one of nine new warning statements, the Act mandates that the new warning labels comprise the top 50 percent of the front and rear panels of cigarette packages and 20 percent of the area of each cigarette advertisement. Act § 201(a), 123 Stat. at 1842–45. The Act directs the Secretary to issue final regulationsidentifying the graphic component of the warnings by June 22, 2011, and provides that the revised health warnings will take effect by September 22, 2012. See15 U.S.C. § 1333 note.

Pursuant to the statutory directive, FDA issued a Proposed Rule seeking comment on thirty-six potential images for the new graphic warning labels. Required Warnings for Cigarette Packages and Advertisements, 75 Fed.Reg. 69,524, 69,534 (Nov. 12, 2010) (hereinafter Proposed Rule). At the outset of the Proposed Rule, FDA asserted the government's “substantial interest in reducing the number of Americans, particularly children and adolescents, who use cigarettes and other tobacco products in order to prevent the life-threatening health consequences associated with tobacco use.” Id. at 69,525. In accordance with the requirements of the Act, FDA proposed a dramatic expansion of the existing health warnings, which it justified based on scientific literature and a “strong worldwide consensus” 3 regarding the relative effectiveness of graphic warnings compared to the text-only warnings the United States currently requires. Id. The agency explained that by “clearly and effectively convey[ing] the negative health consequences of smoking,” the new warnings would discourage nonsmokers, particularly minors, from “initiating cigarette use,” and encourage current smokers to quit. Id. at 69,526.

FDA promulgated the final set of nine images—one for each warning statement—by regulations issued on June 22, 2011. SeeRequired Warnings for Cigarette Packages and Advertisements, 76 Fed.Reg. 36,628 (June 22, 2011) (hereinafter Final Rule). FDA also required each graphic image to bear the phone number of the National Cancer Institute's “Network of Tobacco Cessation Quitlines,” which uses the telephone portal “1–800–QUIT–NOW.” Id. at 36,681.

FDA based its selection of the final images on an 18,000–person internet-based consumer study it commissioned. The study divided respondents into two groups: a control group that was shown the new text in the format of the current warnings (located on the side of cigarette packages), and a separate treatment group that was shown the proposed graphic warnings, which included the new text, the accompanying graphic image, and the 1–800–QUIT–NOW number. Id. at 36,638. Each group then answered questions designed to assess, among other things, whether the graphic warnings, relative to the text-only control, (1) increased viewers' intention to quit or refrain from smoking; (2) increased viewers' knowledge of the health risks of smoking or secondhand smoke; and (3) were “salient,” which FDA defined in part as causing viewers to feel “depressed,” “discouraged,” or “afraid.” Id.

In selecting these nine images, FDA reviewed and responded to over a thousand public comments, including joint comments submitted by plaintiffs-appellees RJ Reynolds, Lorillard, and Commonwealth Brands. See id. at 36,629. Several comments—including comments from cancer researchers, nonprofits, and academics—criticized the single exposure study design, noting it prevented the government from assessing the long-term or actual effects of the proposed warnings. Two of these comments recommended FDA conduct longitudinal research or post-market surveillance to assess actual long-term effects. Id. at 36,639. FDA conceded the study did not permit it to reach “firm” conclusions about the “long-term, real-world effects” of the proposed warnings, but claimed the existing scientific literature “provides a substantial basis for our conclusion that the required warnings will effectively communicate the health risks of smoking, thereby encouraging smoking cessation and discouraging smoking initiation.” Id. Still other comments asserted that FDA's research study failed to provide evidence that the proposed warnings would actually affect smoking rates, significantly affect consumers knowledge of the risks of smoking, or bring about actual behavior change. See id. at 36,640. But FDA disagreed, again relying on the “substantial research” showing the effectiveness of similar graphic health warnings in other countries. Id. (citing Proposed Rule at 69,531–34).4 Another comment asserted that the study's selection bias constituted a serious methodological flaw....

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