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

696 F.3d 1205, 402 U.S. App. D.C. 438, 2012 WL 3632003, 2012 U.S. App. LEXIS 17925
CourtCourt of Appeals for the D.C. Circuit
DecidedAugust 24, 2012
Docket11-5332, 12-5063
StatusPublished
Cited by42 cases

This text of 696 F.3d 1205 (R.J. Reynolds Tobacco Co. v. Food & Drug Administration) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
R.J. Reynolds Tobacco Co. v. Food & Drug Administration, 696 F.3d 1205, 402 U.S. App. D.C. 438, 2012 WL 3632003, 2012 U.S. App. LEXIS 17925 (D.C. Cir. 2012).

Opinions

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.

1. 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 regula[1209]*1209tions identifying the graphic component of the warnings by June 22, 2011, and provides that the revised health warnings will take effect by September 22, 2012. See 15 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 FecLReg. 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 conveying] 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. See Required 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 eom[1210]*1210ments — 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. Namely, participants were recruited from an internet panel and offered the opportunity to participate in an FDA-sponsored research study. Id. at 36,643. FDA avoided the substance of this argument by conceding that its study “provides insight on the relative effectiveness of the various warnings under consideration,” not on the “absolute effects of the warnings in general.” Id.

Some comments also criticized the lack of statistical evidence supporting FDA’s belief that requiring cigarette packages to bear the graphic warnings would reduce smoking rates. See id. For example, the Companies noted that the Canadian data revealed no statistically significant decline in smoking rates for adolescents and adults after the introduction of similar graphic warnings, which implied that the warnings were ineffective and that FDA’s warnings would be ineffective as well. Id. FDA summarily disagreed, stating that the images it selected would satisfy its “primary goal, which is to effectively convey the negative health consequences of smoking on cigarette packages and in advertisements,” which can help “both to discourage nonsmokers ... from initiating cigarette use and to encourage current smokers to consider cessation.” Final Rule at 36,633. FDA also explained that the data from Canada did not indicate that the warnings had been ineffective, because other studies showed that the warnings had been “effective at providing ...

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Bluebook (online)
696 F.3d 1205, 402 U.S. App. D.C. 438, 2012 WL 3632003, 2012 U.S. App. LEXIS 17925, Counsel Stack Legal Research, https://law.counselstack.com/opinion/rj-reynolds-tobacco-co-v-food-drug-administration-cadc-2012.