R.J. REYNOLDS TOBACCO COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al

Filing 27

AMICUS BRIEF by AMERICAN ADVERTISING FEDERATION, ASSOCIATION OF NATIONAL ADVERTISERS. (znmw, )

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA R.J. REYNOLDS TOBACCO COMPANY, LORILLARD TOBACCO COMPANY, COMMONWEALTH BRANDS, INC., LIGGETT GROUP LLC, and SANTA FE NATURAL TOBACCO COMPANY, INC., Civil Action No. 11-01482 (RCL) Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET HAMBURG, Commissioner of the United States Food and Drug Administration, and KATHLEEN SEBELIUS, Secretary of the United States Department of Health and Human Services, Defendants. BRIEF OF AMICI CURIAE ASSOCIATION OF NATIONAL ADVERTISERS, INC. AND THE AMERICAN ADVERTISING FEDERATION Robert Corn-Revere (D.C. Bar No. 375415) Ronald G. London (D.C. Bar No. 456284) DAVIS WRIGHT TREMAINE LLP 1919 Pennsylvania Avenue, N.W., Suite 800 Washington, D.C. 20006-3401 Tel: (202) 973-4200 Fax: (202) 973-4499 Counsel for Amici Curiae September 16, 2011 DISCLOSURE STATEMENT Pursuant to Fed. R. Civ. P. 7.1 and LCvR 7.1, the Association of National Advertisers, Inc., attests that it is incorporated as a nonprofit trade association, has no parent corporation, and has no stock or other interest owned by a publicly held company, and the American Advertising Federation attests that it is a nonprofit trade association with no stock and no parent corporation. i TABLE OF CONTENTS Page DISCLOSURE STATEMENT ....................................................................................................... i TABLE OF AUTHORITIES ........................................................................................................ iii TABLE OF AUTHORITIES ........................................................................................................ iii INTRODUCTION ........................................................................................................................ 1 INTEREST OF AMICI ................................................................................................................. 2 BACKGROUND ........................................................................................................................... 4 ARGUMENT................................................................................................................................. 6 I. THE GRAPHIC WARNINGS RULE IS AN ILLEGITIMATE EFFORT TO DEPUTIZE PRODUCT PRODUCERS AND ADVERTISERS TO PROMOTE THE GOVERNMENT’S MESSAGE ..........................................................7 A. The Government’s Goal is to Change Behavior, Not to Inform........................................7 B. The Graphic Warnings Rule’s Purpose is Illegitimate .........................................................13 C. The Graphic Warnings Rule Unconstitutionally Compels Speech ....................................16 II. THE CONSTITUTIONAL ISSUES AT STAKE TRANSCEND FREE EXPRESSION REGARDING TOBACCO PRODUCTS ............................................20 CONCLUSION ........................................................................................................................... 25 ii TABLE OF AUTHORITIES CASES Page 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1986) .................................................7, 14, 18 Arizona Free Enterprise Club’s Freedom Club PAC v. Bennett, 131 S. Ct. 2806 (2011) ..................................................................................................8, 20 Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N.Y., 447 U.S. 557 (1980).............................................................................................................3 Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512 (W.D. Ky. 2010), appeal docketed sub nom., Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir. Mar. 9, 2010) .......................................3, 4, 19 Davis v. Pension Benefit Guarantee Corp., 571 F.3d 1288 (D.C. Cir. 2009) ...............................6 Edenfield v. Fane, 507 U.S. 761 (1993) ..........................................................................................1 Entertainment Software Ass’n v. Blagojevich, 469 F.3d 641 (7th Cir. 2006) ............................18 Friends of Earth v. FCC, 449 F.2d 1164 (D.C. Cir. 1971) .....................................................23, 24 Glassner v. R.J. Reynolds Tobacco Co., 223 F.3d 343 (6th Cir. 2000)...........................................8 Greater New Orleans Broad. Ass’n v. United States, 527 U.S. 173 (1999) ...................................6 Green v. FCC, 447 F.2d 323 (D.C. Cir. 1971) .............................................................................23 Linmark Assocs., Inc. v. Township of Willingboro, 431 U.S. 85 (1977) ............................................................................................................13 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001)....................................................................16 Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324 (2010).......................................................................................................17 iii National Citizens Comm. for Broad. v. FCC, 567 F.2d 1094 (D.C. Cir. 1977) ........................................................................................24 National Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d 104 (2d Cir. 2001) .............................................................................................17 Neckritz v. FCC, 502 F.2d 411 (D.C. Cir. 1974) .........................................................................23 New York State Restaurant Ass’n v. New York City Bd. of Health, 556 F.3d 114 (2d Cir. 2009) .............................................................................................17 Pacific Gas & Elec. Co. v. Public Utils. Comm’n, 475 U.S. 1 (1986) ...............................16, 17, 18 People for the Ethical Treatment of Animals v. Gittens, 215 F. Supp. 2d 120 (D.D.C. 2002) ...................................................................................6 Public Interest Research Group v. FCC, 522 F.2d 1060 (1st Cir. 1975) .....................................23 RAV v. City of St. Paul, 505 U.S. 377 (1992) .............................................................................15 Retail Store Employee’s Union, Local 880 Retail Clerks Int’l Ass’n v. FCC, 436 F.2d 248 (D.C. Cir. 1970) ..........................................................................................23 Riley v. National Fed’n of the Blind of N.C., Inc., 487 U.S. 781 (1988) ...............................16, 20 Rumsfeld v. Forum for Academic & Institutional Rights, Inc., 547 U.S. 47 (2006).............................................................................................................16 Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011) ......................................................1, 13, 14, 19 Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002)..................................................6, 14 United States v. Playboy Entm’t Group, Inc., 529 U.S. 803 (2000) ............................................20 Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976)...........................................................................................................13 West Virginia State Bd. of Educ. v. Barnette, 319 U.S. 624 (1943) .............................................25 Wooley v. Maynard, 430 U.S. 705 (1977).........................................................................16, 17, 19 iv Yale Broad. Co. v. FCC, 478 F.2d 594 (D.C. Cir. 1973) ..............................................................22 Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) ................................................17 ADMINISTRATIVE CASES Amendment of Part 73 of the Federal Communications Commission Rules With Regard to the Advertisement of Cigarettes, 16 F.C.C.2d 284 (1969) ...............................23 Amendment of Parts 1, 73 and 76 of the Commission’s Rules, ___ FCC Rcd. ___, DA 11-1432 (MMB Aug. 24, 2011) ...............................................24 Complaint by Anthony R. Martin-Trigona, 19 F.C.C.2d 620 (1969) ........................................23 Complaint by Media Access Project, 44 F.C.C.2d 755 (1973) ....................................................23 Complaint by Mrs. Fran Lee, 37 F.C.C.2d 647 (1972) ................................................................23 Complaint by Wilderness Soc’y and Friends of Earth, 30 F.C.C.2d 643 (1971) .........................23 Complaint of Syracuse Peace Council, 2 FCC Rcd. 5043 (1987), aff’d, Syracuse Peace Council v. FCC, 867 F.2d 654 (D.C. Cir. 1989) ....................................24 Fairness Report, 48 F.C.C.2d 1 (1974) ........................................................................................24 WCBS-TV, 8 F.C.C.2d 381, stay and recon. denied, 9 F.C.C.2d 921 (1967) ..............................22 STATUTES Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) ..................................................................................................4, 5, 7 SPEECH Act, Pub. L. No. 111-223, 124 Stat. 2380 (2010) .......................................................25 Sober Truth on Preventing Underage Drinking Act, 42 U.S.C. § 290bb-25b, 120 Stat. 2890, Pub. L. No. 109-422 (2006) ....................................................................21 v FEDERAL REGULATIONS 21 C.F.R. § 1140.10 .........................................................................................................................5 21 C.F.R. § 1140.12 .........................................................................................................................5 21 C.F.R. § 1140.30 .........................................................................................................................6 Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36628 (June 22, 2011) ..................................................................................................2, 6, 8, 9, 10 Required Warnings for Cigarette Packages and Advertisements, 75 Fed. Reg. 69524 (Nov. 12, 2010) ...........................................................................................................6, 8, 9 LAW REVIEW ARTICLES Robert L. Rabin, Tobacco Control Strategies: Efficacy and Future Promise, 41 LOYOLA L. REV. 1721 (Summer 2008) .........................................................................8 Robert L. Rabin, The Tobacco Litigation: A Tentative Assessment, 51 DEPAUL L. REV. 331 (Winter 2001) ............................................................................8 Burt Neuborne, The First Amendment and Government Regulation of Capital Markets, 55 BROOK. L. REV. 5 (1989) .....................................................................................14, 158 MISCELLANEOUS FDA, Tobacco Strategy Announcement (Nov. 10, 2010) (www.fda.gov/TobaccoProducts/NewsEvents/ucm232556.htm) ......................10, 19 Federal Trade Commission, Food & Drug Administration, Centers for Disease Control and U.S. Department of Agriculture, Interagency Working Group on Food Marketed to Children: Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts – Request for Comments (2011) ..........22 vi Kathleen Sebelius, Sec’y of Health & Human Servs., Press Briefing by Press Secretary Jay Carney, Secretary of Health & Human Services Kathleen Sebelius, and FDA Commissioner Margaret Hamburg (June 21, 2011), http://thepage.time.com./2011/06/21/carney-briefs-36) ............................................12 The Smoky Horror Show, THE ECONOMIST, June 21, 2011 (http://www.economist.com/blogs/schumpeter/2011/06/tobaccoregulation?page=2) .........................................................................................................12 The Surgeon General’s Call to Promote Breastfeeding (2011) (www.surgeongeneral.gov/topics/breastfeeding/ calltoactiontosupportbreastfeeding.pdf) .....................................................................21 White House Press Briefing (June 21, 2011) (www.whitehouse.gov/the-press-office/2011/06/21/press-briefing-presssecretary-jay-carney-secretary-health-and-human-ser.) .......................................................11 White House Task Force on Childhood Obesity Report to the President, Solving the Problem of Childhood Obesity Within a Generation (May 2010) ..............................22 vii INTRODUCTION The Food and Drug Administration (“FDA”) rules being challenged here exemplify the Nanny State. They require producers of tobacco products to carry government-mandated graphic images and textual warnings to proselytize the public with the government’s preferred message in an effort to change behavior, not to prevent deception or to convey product information about which consumers are unaware. As such, these unprecedented rules confiscate plaintiffs’ property for the purpose of skewing the marketplace of ideas. The required graphic warnings do not just fail to survive First Amendment scrutiny – the effort to control public discourse for fear people might otherwise make bad choices is not even a legitimate purpose. The government has numerous nonregulatory means at its disposal to persuade the public to change its ways, and the United States Supreme Court has emphatically rejected the proposition that the state may regulate private speech “in order to tilt public debate in a preferred direction.” Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2671-72 (2011). This principle applies regardless whether the subject of the regulation is a political idea or a product, because the First Amendment’s general command is that “the speaker and the audience, not the government, assess the value of the information presented.” Id. (quoting Edenfield v. Fane, 507 U.S. 761, 767 (1993)). 1 Amici Association of National Advertisers (“ANA”) and the American Advertising Federation (“AAF”) (collectively, the “Advertising Associations”) hereby submit this brief in support of plaintiffs’ motion for a preliminary injunction because of their grave concern over the fundamental constitutional principles at stake. 1 The important issues in this case are not limited to tobacco products. Rather, they affect a wide range of products and services about which some may believe the government knows “best.” If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things – and history shows it will not hesitate to do so. Fortunately, the law is quite clear that such a purpose is illegitimate, and the plaintiffs are likely to succeed on the merits. Accordingly, Amici urge this Court to enjoin the Graphic Warnings Rule. INTEREST OF AMICI Amici Curiae Advertising Associations respectfully submit that the FDA’s Final Rule implementing Section 201 of the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (the “Tobacco Control Act” or “Act”) violates the First Amendment. See Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36628 (June 22, 2011) (the “Graphic Warnings Rule”). The The interests of Amici are also set forth in the concurrently filed Unopposed Motion for Leave to File Brief of Amici Curiae that accompanies this submission. 1 2 ANA leads the marketing community by providing insights, collaboration and advocacy on behalf of a membership of 400 companies with 9,000 brands that collectively spend over $250 billion annually in U.S. marketing communications and advertising. The ANA strives to communicate marketing best practices, lead industry initiatives, influence industry practices, manage industry affairs, and advance, promote, and protect advertisers and marketers. The AAF is the Washington, D.C. trade association that represents 50,000 professionals in the advertising industry, with 130 corporate members that are advertisers, agencies, and media companies representing the nation’s leading brands and corporations. The Advertising Associations participated as amici in litigation challenging certain of the marketing provisions in the Tobacco Control Act that repudiate core principles of commercial speech doctrine developed over several decades. 2 As in that case, the Advertising Associations’ concerns here focus on our nation’s commitment to the First Amendment and, particularly, the commercial speech doctrine. See Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N.Y., 447 U.S. 557 (1980). See Brief of Amici Curiae ANA et al., Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512 (W.D. Ky. 2010) (No. 1:09-cv-117, filed Nov. 30, 2009); Brief of Amici Curiae ANA et al., Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir. filed June 4, 2010). 2 3 BACKGROUND The FDA’s Graphic Warnings Rule implements one of the Tobacco Control Act’s many restrictions and requirements that target advertising, marketing, and promotion. While the Act states that it intends to “continue to permit the sale of tobacco [ ] to adults,” one of its overarching goals is “to promote cessation” of use generally. Compare Pub. L. No. 111-31, § 3(7), with id. §§ 2(33)-(34), 3(9). The principal tools it adopts to curtail tobacco use involve an assortment of broad restrictions on advertising and marketing. These include prohibitions on the use of color and images in most tobacco ads and displays; the brand-name sponsorship by tobacco providers of athletic, musical, artistic, or other social or cultural events; the distribution of cigarette samples, or even of branded non-tobacco promotional items; and the joint marketing of tobacco and certain non-tobacco goods. 3 The specific rules at issue here implement a section of the Act that mandated changes to the content of the warnings that must appear on all cigarette packages and in Id. §§ 101(a)-(b), 102(a)(2). Some of these restrictions were challenged in the U.S. District Court for the Western District of Kentucky, which invalidated the ban on color and imagery in tobacco ads (and one other provision) but rejected other challenges – including to the Act’s mandate for tobacco ads and packages to display graphic warnings – in a decision that both sides appealed. See Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512 (W.D. Ky. 2010), appeal docketed sub nom., Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir. Mar. 9, 2010). However, Commonwealth Brands did not include a challenge to the particular requirements of the Graphic Warnings Rule, because the FDA had not yet promulgated it. Accordingly, this case involves issues not available, litigated, or considered in Commonwealth Brands or on appeal in Discount Tobacco. 3 4 ads. Section 201(a) specified nine new textual messages, including statements that cigarettes can kill, that they cause cancer, fatal lung disease, strokes and heart disease, and that “quitting now” reduces health risks. Pub. L. No. 111-31, § 201(a). These new warnings must appear in large-font, accompanied by color graphics that occupy the top 50 percent of both sides of cigarette packages. Id. The Act also requires tobacco companies to further stigmatize their products by requiring the top 20 percent of ad space be used for the new anti-tobacco “warnings” along with the color graphics. Id. §§ 201(a), 204(a). Implementing this statutory mandate, the FDA’s new Graphic Warnings Rule requires tobacco companies to use disturbing, emotionally charged images and accompanying warnings on all cigarette ads and packaging as of October 22, 2012. 21 C.F.R. § 1141.10. These stark graphics, which appear at pp. 4-5 of Plaintiffs’ Memorandum in Support of their Motion for Preliminary Injunction, include an image of a man smoking through what appears to be his tracheostomy opening to accompany the warning “cigarettes are addictive.” 21 C.F.R. § 1141.12; http://www.fda.gov/cigarettewarningfile. For “cigarettes cause fatal lung disease,” the Graphic Warning Rule requires a picture of traumatized lungs. Id. There is also a “lesion on lip” photo for the “cigarettes cause cancer” warning, an image of a crying “baby in incubator” for the “smoking during pregnancy” warning and, for “smoking can kill you,” a cadaver with chest staples. Id. In addition to being emblazoned atop all 5 cigarette packs and cartons, the graphics must appear on all advertisements, including magazine and newspaper ads, pamphlets, leaflets, brochures, point of sale displays, posters, billboards, direct mailers, and Internet advertising. Required Warnings for Cigarette Packages and Advertisements, 75 Fed. Reg. 69524, 69537 (Nov. 12, 2010) (the “Graphic Warnings Notice”). See Graphic Warnings Rule, 76 Fed. Reg. 36679, 36676-78; 21 C.F.R. § 1140.30. ARGUMENT This Court should grant injunctive relief where plaintiffs are likely to succeed on the merits of their challenge to the rules, particularly where regulations threaten freedom of expression. Davis v. Pension Benefit Guarantee Corp., 571 F.3d 1288, 1291 (D.C. Cir. 2009); People for the Ethical Treatment of Animals v. Gittens, 215 F. Supp. 2d 120, 134 (D.D.C. 2002). In this case, the FDA’s rules implementing the Tobacco Control Act’s graphic warnings requirement ignore core limits on government authority to regulate commercial speech. These include the principles that “the power to prohibit or to regulate particular conduct does not necessarily include the power to … regulate speech” about it, Greater New Orleans Broadcasting Ass’n v. United States, 527 U.S. 173, 193 (1999), and that, when government seeks to further interests in the commercial arena, “regulating speech must be a last – not first – resort.” Thompson v. Western States Med. Ctr., 535 U.S. 357, 373 (2002). For purposes of the instant motion, however, Amici focus on one overriding flaw of the rules – the government’s commandeering of space 6 on commercial products and advertisements for the paternalistic purpose of controlling public debate and altering individual behavior. Such a governmental purpose is foreign to the First Amendment. See, e.g., 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 510, 516 (1986). I. THE GRAPHIC WARNINGS RULE IS AN ILLEGITIMATE EFFORT TO DEPUTIZE PRODUCT PRODUCERS AND ADVERTISERS TO PROMOTE THE GOVERNMENT’S MESSAGE A. The Government’s Goal is to Change Behavior, Not to Inform The proposed options for graphics combined with the new cigarette warnings are expressly designed to be propagandistic rather than informative. The government’s purpose for requiring use of these graphics is clear from the face of the Act and from the FDA’s Graphic Warnings Rule. It is to dissuade consumers from purchasing the lawful products on which the warnings appear. The Tobacco Control Act explicitly states that its “purposes” include promoting cessation. 4 It seeks to achieve that purpose largely by restricting the speech of tobacco companies while simultaneously mandating carriage of the government’s message. 5 See supra at 4 (quoting Pub. L. No. 111-31, § 3(9)). The Act is premised on the assumption that “[c]omprehensive advertising restrictions will have a positive effect on the smoking rates of young people.” Id. § 2(22), (25). Its marketing restrictions are based on the proposition that “advertising regulations that are stringent and comprehensive have a greater impact on overall tobacco use.” Id. § 2(27). 4 The FDA may claim that its goal is merely to educate or inform consumers, but the Supreme Court has found that review of statutory language, the regulations at issue, and statements by the regulators can reveal that the true purpose is 5 7 The FDA’s protests notwithstanding, 6 there can be no serious doubt tobacco users already know smoking poses serious health risks. Indeed, as one academic in the forefront of tobacco cessation has noted, “[i]n recent years, public opinion polls have consistently indicated that the public, including the smoking public, is well aware of the health risks of smoking.” Robert L. Rabin, Tobacco Control Strategies: Efficacy and Future Promise, 41 LOYOLA L. REV. 1721, 1748 & nn.a1 & 106 (Summer 2008); id. at 1726. See also Robert L. Rabin, The Tobacco Litigation: A Tentative Assessment, 51 DEPAUL L. REV. 331, 352 (Winter 2001) (same). Cf., e.g., Glassner v. R.J. Reynolds Tobacco Co., 223 F.3d 343, 35051 (6th Cir. 2000) (collecting tobacco cases applying “common knowledge” doctrine). The problem is not that people do not know that smoking entails health risks; it is that too few – in the government’s estimation – act on this knowledge. The FDA openly embraced the purpose of persuading people to change their ways in adopting the Graphic Warnings Rule. It acknowledged that the “primary goal” is to have the graphic warnings appear on cigarette packages and advertisements “both to discourage nonsmokers … from initiating cigarette use and to encourage current smokers to consider cessation.” 7 This, in turn, reflects a view that “health warnings that unconstitutional. See Arizona Free Enterprise Club‘s Freedom Club PAC v. Bennett, 131 S. Ct. 2806, 2825 & n.10 (2011). 6 E.g., Graphic Warnings Notice, 75 Fed. Reg. at 69525, 69529-30, 69533. Graphic Warnings Rule, 76 Fed. Reg. at 36634. See also id. at 36640 (“The purpose of graphic health warnings is to effectively communicate [ ] negative 7 8 evoke strong emotional responses” ultimately are “reasonably likely” to foster “healthier behaviors, such as trying to quit smoking or deciding not to start.” Id. at 36641. Similarly, in its rulemaking notice, the FDA observed that the Graphic Warnings Rule is intended to support smokers’ intentions “to quit or decrease [ ] consumption, and to discourage nonsmokers, particularly youth, from initiating cigarette use.” Graphic Warnings Notice, 75 Fed. Reg. at 69535. In adopting the final rule, the FDA specifically measured whether the graphic warnings under consideration made respondents feel “depressed,” “discouraged,” or “afraid,” and selected the final images based on their ability to provoke strong emotional reactions. Graphic Warnings Rule, 76 Fed. Reg. at 36638. Clearly, the focus of this effort was to choose shocking visual images, rather than finding warnings that could impart neutral factual information. Its rulemaking notice acknowledged that such warnings differ from “disclosure requirements that apply to other products that FDA regulates,” which “have a different purpose.” Graphic Warnings Notice, 75 Fed. Reg. at 69539. Specifically, while medical products like drugs and devices, for example, “require that … labeling and advertising disclose all material risk information” to facilitate safety in use and/or prescription, id. at 69539-40, the graphic warnings here seek to “encourage cessation and discourage initiation.” Id. at 69540. health consequences … to smokers and nonsmokers” with the expectation that a supposed “greater understanding” thereof “will motivate some smokers to stop smoking and prevent some nonsmokers from starting[.]”). 9 The FDA acknowledges that its purpose is to elicit “strong emotional and cognitive reactions to graphic warnings,” but argues that doing so more effectively and graphically communicates “the very real, scientifically established adverse health consequences of smoking.” This, in turn, changes “attitudes and beliefs,” and eventually can lead to “changes in intentions to quit or to start smoking and then later can lead to lower likelihood of smoking initiation and greater likelihood of successful cessation.” Graphic Warnings Rule, 76 Fed. Reg. at 36641. Existing warnings fail to achieve the same purpose, the FDA claims, because textual warnings have grown “unnoticed and stale,” while graphic warnings on product packaging is the most “efficient” way of reaching smokers. Def.’s Opp. to Pls.’ Mot. for Prelim. Inj. at 15, 19 [Dkt. 18]. Such claims are beside the point. The reference to “scientifically established” evidence hardly means that the purpose of the rules is just to educate and inform the public. Virtually all arguments include some fact, but here, the clear purpose of the Graphic Warnings Rule is to require tobacco companies to publish the government’s arguments against smoking. FDA Commissioner Margaret Hamburg was quite clear about this purpose when she stated that the warnings will ensure that “every single pack of cigarettes in our country will in effect become a mini-billboard” for the government’s anti-smoking message. 8 8 FDA, Tobacco HHS Secretary Kathleen Sebelius likewise Strategy Announcement 10 (Nov. 10, 2010) explained that the rule will have the effect of “rebranding our cigarette packs.” White House Press Briefing (June 21, 2011) (www.whitehouse.gov/the-press- office/2011/06/21/press-briefing-press-secretary-jay-carney-secretary-health-andhuman-ser.). Any claim that the government’s “mini-billboards” are just presenting “facts” is absurd. To begin with, this argument flatly contradicts the government’s own rationale for banning color and graphics in cigarette marketing, a restriction it said was necessary because young people “are particularly ‘susceptible to peripheral cues such as color and imagery.’” Reply Br. for Defendants-Appellees/Cross Appellants, Discount Tobacco City & Lottery, Inc. v. United States, Nos. 10-5234 & 10-5235 (6th Cir.) at 8 (quoting 61 Fed. Reg. 44468). The government cannot argue in one breath that the use of any color or imagery in tobacco marketing is an unfair persuasive technique that must be banned, and in the next assert that a government mandate requiring lurid and frightening fullcolor images on product packaging and advertising is presenting “just the facts, ma’am.” But one needn’t explore the illogic of the government’s contradictory arguments to understand the true purpose of the Graphic Warnings Rule. The regulators freely admit that their purpose is advocacy, not education. Secretary Sebelius was quite clear about the FDA’s intent when she announced the required labels: (www.fda.gov/TobaccoProducts/NewsEvents/ucm232556.htm). 11 Somebody said when they first saw the warnings, ‘These are really gross.’ And they are. We want kids to understand smoking is gross, not cool, and there’s really nothing pretty about having mouth cancer or making your baby sick if you smoke. So some of these are very driven to dispelling the notion that somehow this is cool and makes you cool. 9 Commissioner Hamburg likewise stressed that those “who are under the impression that smoking is cool or glamorous will be confronted by a very different reality when they’re tempted to pick up a cigarette pack 15 months from now.” June 21 Press Briefing. The FDA’s intended message is clear: “If you smoke, you will become a gruesome pariah with Dickensian teeth who abuses children and dies early and alone.” The Smoky Horror Show, THE ECONOMIST, June 21, 2011 (http://www.economist.com/blogs/schumpeter/2011/06/tobacco-regulation?page=2). “Such is the message conveyed by graphic new cigarette labels, unveiled by America’s Food and Drug Administration,” THE ECONOMIST noted, describing the warnings as “the latest attempt by a government to nauseate and petrify its citizenry.” Id. The World Health Organization acknowledges that such images are designed to “elicit strong emotions, such as fear.” Id. Clearly, the intent of the HHS and FDA was to Kathleen Sebelius, Sec’y of Health & Human Servs., Press Briefing by Press Secretary Jay Carney, Secretary of Health and Human Services Kathleen Sebelius, and FDA Commissioner Margaret Hamburg (June 21, 2011), http://thepage.time.com/2011/06/21/carney-briefs-36/ (“June 21 Press Briefing”). 9 12 choose graphic warnings that are provocative, visually confrontational, and propagandistic, rather than to seek factual and neutral information. B. The Graphic Warnings Rule’s Purpose is Illegitimate Whether or not such tactics are effective, regulating speech and forcing companies to highlight the government’s message in order to scare people into “improving” their behavior is antithetical to the First Amendment. The Supreme Court recently rejected an analogous state effort to “balance” the marketplace of ideas, finding that “the law’s express purpose and practical effect are to diminish the effectiveness of marketing.” Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2663 (2011). Here, the FDA’s rules are premised on the idea that tobacco company marketing efforts will be too persuasive unless the government can restrict commercial appeals and replace them with its own messages. But, as the Court made clear in Sorrell, “the fear that speech might persuade provides no lawful basis for quieting it.” Id. at 2670. The Court repeatedly has rejected such a “highly paternalistic approach,” Linmark Assocs, Inc. v. Township of Willingboro, 431 U.S. 85, 97 (1977), as “incompatible with the First Amendment.” Id. at 2671. See Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 770 (1976) (“It is precisely this kind of choice, between the dangers of suppressing information, and the dangers of its misuse if it is freely available, that the First Amendment makes for us.”). As in this case, those “who seek to censor or burden free expression often assert that disfavored speech has adverse 13 effects. But the ‘fear that people would make bad decisions if given truthful information’ cannot justify content-based burdens on speech.” Sorrell, 131 S. Ct. at 267071 (quoting Thompson, 535 U.S. at 374). Indeed, the First Amendment “directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, 517 U.S. at 503. See also Linmark Assocs., 431 U.S. at 96-97 (constitutional defect “is far more basic” where regulation of commercial speech is premised on the belief that people will act “irrationally” unless the government intervenes). The bottom line is that the government lacks any legitimate interest either in suppressing truthful commercial information or in controlling debate about it “in order to prevent members of the public from making bad decisions with the information.” Thompson, 535 U.S. at 374. As constitutional scholar Burt Neuborne put it: When society provides its members with lawful choices, respect for individual dignity compels that the choices be the autonomous expression of individual preference. It is impossible to respect individual autonomy with the left hand while selectively controlling the information available to the individual with the right hand. A purportedly free individual choice premised on a government controlled information flow is a basic affront to human dignity. 10 The Supreme Court in Sorrell reaffirmed that the government lacks any interest in regulating speech “to reverse a disfavored trend in public opinion.” 131 S. Ct. at Burt Neuborne, The First Amendment and Government Regulation of Capital Markets, 55 BROOK. L. REV. 5, 37 (1989). 10 14 2671. It certainly may use its own resources to persuade the public to choose a different course of action, but it could not “ban campaigning with slogans, picketing with signs, or marching during the daytime” to achieve the same result. Id. Likewise, the government cannot “seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.” Id. Nor may the government require private parties to vilify their own products. Congress has no authority “to license one side of a debate to fight freestyle, while requiring the other to follow Marquis of Queensberry rules.” RAV v. City of St. Paul, 505 U.S. 377, 392 (1992). The FDA’s claim that existing health warnings have grown “stale” or that people pay insufficient attention to the textual statements does not legitimize the government’s purpose. Its measure of success boils down to the notion that people would be better off if they could be persuaded to follow the government’s health recommendations. Perhaps so. Such a purpose may call for a public education campaign or governmentsponsored public service announcements, but it cannot justify broad restrictions on commercial speech or drafting private speakers to deliver the government’s message. 15 C. The Graphic Warnings Rule Unconstitutionally Compels Speech Not only is the purpose of the Graphic Warnings Rule constitutionally deficient, its mandate imposes excessive burdens on free expression. Compelling tobacco companies to display government-prescribed graphic images and accompanying warnings violates the First Amendment, which secures “both the right to speak [ ] and … to refrain from speaking at all.” Wooley v. Maynard, 430 U.S. 705, 714 (1977). Except for purely factual and non-controversial disclosures, the government may not compel private entities to publish messages selected or dictated by the government. Id. at 715. This is because, where regulations “[m]andat[e] speech that a speaker would not otherwise make,” they “necessarily alter[ ] the content of the speech.” Riley v. National Fed'n of the Blind of N.C., Inc., 487 U.S. 781, 795 (1988). The Supreme Court has noted that some of its “leading First Amendment precedents have established … that freedom of speech prohibits the government from telling people what they must say.” Rumsfeld v. Forum for Academic & Institutional Rights, Inc., 547 U.S. 47, 61 (2006). This is as true for “corporations as for individuals,” Pacific Gas & Elec. Co. v. Public Utils. Comm’n, 475 U.S. 1, 16 (1986) (plurality op.), and that includes tobacco companies as much as any other advertiser or other company. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 571 (2001). The lurid images of the Graphic Warnings Rule cannot be justified under the narrow constitutional exception permitting disclosure requirements for noncontroversial information. Under Zauderer and its progeny, compelled disclosure may 16 be permissible to convey “purely factual” information. Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985). E.g., New York State Restaurant Ass’n v. New York City Bd. of Health, 556 F.3d 114, 131-34 (2d Cir. 2009); National Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d 104, 113-14 (2d Cir. 2001). However, such disclosures may be required only if they are “uncontroversial” and apply to commercial messages that may otherwise mislead or deceive. E.g., Zauderer, 471 U.S. at 651. See Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324, 1339-40 (2010). If government seeks to compel overly bur- densome disclosures or to co-opt a speaker’s message, its regulation is unconstitutional, and courts consistently reject efforts to compel private entities to sponsor government propaganda. E.g., Pacific Gas & Elec. Co., 475 U.S. at 15; Wooley, 430 U.S. at 714. Compelling tobacco companies to devote half their cigarette packages and 20 percent of their advertising space to the government’s prescribed warnings “both penalizes the expression of particular points of view and forces speakers to alter their speech to conform with an agenda they do not set.” Pacific Gas & Elec. Co., 475 U.S. at 9. Such requirements are particularly offensive constitutionally where they require a speaker to foster views that are contrary to its interests. Thus, notwithstanding Zauderer, no Supreme Court decision suggests that the government may require corporations to carry messages “where the messages themselves are biased against or are expressly contrary to the corporation’s views.” Id. at 16 n.12. Moreover, the Court has expressly rejected the argument that compelling such expression furthers the 17 constitutional goal of providing “more speech,” because “the State cannot advance some points of view by burdening the expression of others.” Id. at 20. Rather, “[t]hat kind of forced response is antithetical to the free discussion that the First Amendment seeks to foster.” Id. at 16. Additionally, the Supreme Court has stressed that the fact that a product “poses some threat to public health or public morals” does not justify commercial speech regulation “by the simple expedient of placing the ‘vice’ label on selected lawful activities.” 44 Liquormart, 517 U.S. at 514. The decision in Entertainment Software Association v. Blagojevich, 469 F.3d 641 (7th Cir. 2006), well illustrates this point. In that case, the Seventh Circuit invalidated mandatory stickers on “violent” and “sexually explicit” video games – even though they comprised no more than a four-inch square sticker with the number “18,” indicating that the games could not be sold to minors. The court explained that the mandatory labeling requirement could not be upheld for the same reason “we would not condone a health [ ] requirement that half of the space on a restaurant menu be consumed by [a] raw shellfish warning.” Id. at 652. If a stark numeral 18 could not clear the hurdle of being “uncontroversial” and an innocuous (hypothetical) shellfish warning could not stand if it was merely too big, it is impossible to see how the writlarge, lurid imagery the FDA has adopted survives constitutional scrutiny. The graphics proposed here far exceed current, eminently noticeable textual warnings, which also are proposed to become more prominent and emphatic. Taken 18 together, purposefully disturbing imagery combined with large text warnings will turn cigarette packs into “mobile billboards” for the government’s “ideological messages” about smoking. Wooley, 430 U.S. at 715. Cf., Hamburg Tobacco Strategy Announcement, supra note 8 (new warnings are “mini-billboards”). The graphics are intended to be “controversial,” to draw attention, and to repel consumers from buying a legal product. The warnings far exceed the court’s assumption in Commonwealth Brands, that the graphics do not “alter the substance of [the] message,” and that the warnings are “objective” and “ha[ve] not been controversial for many decades.” 11 The government in this case relies heavily on Commonwealth Brands despite the fact that it is not binding on this Court and that it predated both the FDA’s Graphic Warnings Rule and the Supreme Court’s reaffirmation that “a State’s failure to persuade does not allow it to hamstring the opposition.” Sorrell, 131 S. Ct. at 2671. Such reliance, however, cannot overcome the serious constitutional deficiencies of the rule. In this respect, the government’s argument that tobacco companies have little reason to complain because “half of cigarette packs, . . . and 80% of advertisements remain available for their speech,” Def.’s Opp. at 18 (quoting Commonwealth Brands, 678 F. Supp. 2d at 531), is reminiscent of the Beatle’s song Taxman: “Should five percent Commonwealth Brands, 678 F. Supp. 2d at 531-32. However, the court in Commonwealth Brands reached its conclusion without seeing the images in question, as the FDA had yet to unveil them. Now that they have been revealed, images like “hole in throat,” “crying baby in incubator,” “lesion on lip,” and a cadaver with chest staples can hardly be called purely “informational” or “uncontroversial.” 11 19 appear too small, be thankful I don’t take it all.” But it is no defense for the government to argue that it refrained from taking over all of the tobacco companies’ modes of communication. The “distinction between laws burdening and laws banning speech is but a matter of degree.” Sorrell, 131 S. Ct. at 2664 (quoting United States v. Playboy Entm’t Group, Inc., 529 U.S. 803, 812 (2000)). Ultimately, the FDA relies on the claim that “there is no more efficient method of reaching smokers than through the use of graphic and highly visible warning labels.” Def.’s Opp. at 19 (citation omitted). But this runs headlong into the constitutional command, recently reaffirmed by the Supreme Court, that “the First Amendment does not permit the State to sacrifice speech for efficiency.” Arizona Free Enterprise, 131 S. Ct. at 2824 (quoting Riley, 487 U.S. at 795). Accordingly, the Graphic Warnings Rule is unconstitutional and should be enjoined. II. THE CONSTITUTIONAL ISSUES AT STAKE EXPRESSION REGARDING TOBACCO PRODUCTS TRANSCEND FREE Amici Advertising Associations are very concerned with the outcome of this case because the First Amendment principles involved extend far beyond the rights of tobacco companies. If the government prevails with the novel argument that companies may be compelled to devote space on their packaging and in advertisements for government-mandated messages of this type, then no product is safe from such regulation. Once such a paternalistic notion gains a legal foothold, demands to apply similar requirements in other contexts will soon follow – as history well shows. 20 The government operates numerous product-related programs designed to educate consumers and that otherwise make the government a participant in the marketplace of ideas. For example, the Surgeon General promotes breastfeeding by encouraging hospitals to refuse advertisements for infant formulas. 12 The Environmental Protection Agency promotes “Energy Star” guidelines to advocate energy efficiency. 13 Congress has authorized a media campaign designed to reduce underage drinking. 14 The Department of Agriculture issues nutritional guidelines. 15 Such programs do not raise constitutional concerns to the extent they are solely informational and do not attempt to use the express or implied coercive force of the government to skew the marketplace of ideas. But it is important to recognize the inherent temptation in such programs to use government authority to get members of the public to make “correct” decisions. 16 If this Court were to uphold the FDA’s The Surgeon General’s Call to Promote Breastfeeding (2011) at 43 (www.surgeongeneral.gov/topics/breastfeeding/calltoactiontosupportbreastfeeding.pdf). 12 13 See U.S. Environmental Protection Agency (www.energystar.gov). See Sober Truth on Preventing Underage Drinking Act, 42 U.S.C. § 290bb-25b, 120 Stat. 2890, Pub. L. No. 109-422 (2006). 14 15 See U.S. Department of Agriculture (www.choosemyplate.gov). This risk is illustrated by the federal Interagency Working Group on Food Marketed to Children, authorized by the Omnibus Appropriations Act of 2009. H.R. 1105, 111th Cong. (2009). Implementing this mandate, the Federal Trade Commission, the FDA, the Centers for Disease Control, and the U.S. Department of Agriculture have proposed “voluntary guidelines” to control the marketing of food to children or adolescents. See Interagency Working Group on Food Marketed to Children: 16 21 constitutional authority to convert products into platforms for government messages, there is no doubt the practice would spread to other products beyond tobacco. In this regard, the FCC’s experience in applying its now-defunct Fairness Doctrine to tobacco products provides a cautionary tale. In the late 1960s, the Commission interpreted its rule to require broadcasters to air counter-advertising for cigarette product advertising on the theory that such advertising was needed to provide the public with a “balanced” presentation of views on a controversial issue. WCBS-TV, 8 F.C.C.2d 381, stay and recon. denied, 9 F.C.C.2d 921 (1967). At the time, the Commission expressly rejected as a “parade of horribles” the claim that “if governmental and private reports on the possible hazard of a product are a sufficient basis” for requiring counteradvertising, “the ruling would apply to a host of other products, such as: automobiles, food with high cholesterol count, alcoholic beverages, fluoride in toothpaste, pesticide residue in food, aspirin, detergents, candy, gum, soft drinks, girdles, and even common table salt.” WCBS-TV, 9 F.C.C.2d at 942-43. Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts – Request for Comments (2011). However, even where such efforts are characterized as “voluntary,” they often are backed by the threat of regulation. See, e.g., White House Task Force on Childhood Obesity Report to the President, Solving the Problem of Childhood Obesity Within a Generation at 32 (May 2010) (“If voluntary efforts to limit the marketing of less healthy foods and beverages to children do not yield substantial results, the FCC could consider revisiting and modernizing rules on commercial time during children’s programming.”). Cf. Yale Broad. Co. v. FCC, 478 F.2d 594, 606 n.22 (D.C. Cir. 1973) (Bazelon, C.J., dissenting) (“The main value of the sword of Damocles is that it hangs, not that it drops.”). 22 Despite the FCC’s confidence about its ability to draw the line with cigarettes as “a unique situation and product,” 17 it soon was overrun by calls for mandatory counteradvertising in a wide variety of situations. Demands for time arose from retail store advertising during a labor dispute, automobile advertisements, gasoline advertising, institutional advertising praising commercial television, advertisements advocating oil exploration, institutional advertisements for a power company, army recruiting advertisements, advertisements for snowmobiles, and even advertisements for dog food. 18 While the FCC rejected some demands for counter-advertising (army recruiting, gasoline additives, snowmobiles, etc.), it accepted others (oil exploration, utility rates, retail advertising). Even in a case where the FCC did not mandate responsive ads, the Court of Appeals did, rejecting the FCC’s claim that cigarettes were a “unique” product Amendment of Part 73 of the Federal Communications Commission Rules With Regard to the Advertisement of Cigarettes, 16 F.C.C.2d 284, 292 (1969). 17 Public Interest Research Group v. FCC, 522 F.2d 1060 (1st Cir. 1975) (ads about snowmobiles); Neckritz v. FCC, 502 F.2d 411 (D.C. Cir. 1974) (ads about particular brand of gasoline); Friends of Earth v. FCC, 449 F.2d 1164 (D.C. Cir. 1971) (ads about high powered automobiles and high-test gasoline); Green v. FCC, 447 F.2d 323 (D.C. Cir. 1971) (ads about military service); Retail Store Employee’s Union, Local 880 Retail Clerks Int’l Ass’n v. FCC, 436 F.2d 248 (D.C. Cir. 1970) (ads for department store picketed by union); Complaint by Media Access Project, 44 F.C.C.2d 755 (1973) (ads by power company about need for rate increases, expansion, etc.); Complaint by Mrs. Fran Lee, 37 F.C.C.2d 647 (1972) (ads about dog food and pet products); Complaint by Wilderness Soc’y and Friends of Earth, 30 F.C.C.2d 643 (1971) (ads about particular brand of gasoline); Complaint by Anthony R. Martin-Trigona, 19 F.C.C.2d 620 (1969) (ads about broadcast network and the free television industry). 18 23 and not understanding how the Commission could “plausibly differentiate the case presently before us.” 19 Ultimately, the FCC was forced to admit it had been a “great mistake” to impose counter-advertising requirements and it expressly declined to do so in the future. Fairness Report, 48 F.C.C.2d 1, 26 (1974). In particular, the Commission found that the policy had become “particularly troublesome” because it could not be limited to cigarette advertising as originally promised. Id. at 25. The D.C. Circuit agreed that the agency had “great difficulties” in fashioning a coherent policy regarding counteradvertisements and found that “if anything, [the FCC] understated the problem.” National Citizens Comm. for Broad. v. FCC, 567 F.2d 1095, 1100 (D.C. Cir. 1977). Eventually, the Commission abandoned the Fairness Doctrine altogether after concluding it was inconsistent with First Amendment principles. Complaint of Syracuse Peace Council, 2 FCC Rcd. 5043 (1987), aff’d, Syracuse Peace Council v. FCC, 867 F.2d 654 (D.C. Cir. 1989). As often is the case, however, these legacy regulations lingered on the FCC’s books long after their demise, and only very recently were deleted. Amendment of Parts 1, 73 and 76 of the Commission’s Rules, __ FCC Rcd. ____, DA 11-1432 (MMB Aug. 24, 2011). It is rare that federal agencies voluntarily relinquish grants of authority, and it is highly doubtful that any such thing would occur here. If this Court were to approve the 19 Friends of Earth, 449 F.2d at 1170 (advertisements for high-powered cars). 24 FDA’s extraordinary rule, it certainly would become the model for the government’s next effort to control commercial speech to ensure consumers make the “right” choices. Before taking a step with such potentially far-reaching consequences, Amici ask this Court to preserve the status quo so that the issues may be fully considered. Where such significant constitutional risks are at stake, it bears recalling that “the First Amendment to our Constitution was designed to avoid these ends by avoiding these beginnings.” West Virginia State Bd. of Educ. v. Barnette, 319 U.S. 624, 641 (1943). CONCLUSION The FDA’s Graphic Warning Rule represents an unjustified incursion into First Amendment protections for commercial speech. The FDA plays down free expression concerns by pointing out that the requirements “closely resemble those adopted by Canada in late 2000,” and the specific graphics set forth in the rule are like those required by Canada and other nations such as the United Kingdom and Australia. Def.’s Opp. at 13. Such an assurance is cold comfort, since none of those countries enjoys the same level of protections for free speech as are provided by our First Amendment. Indeed, such differences prompted Congress to enact a law to prevent “libel tourism” because other countries, including the U.K., have inadequate protections for free expression. SPEECH Act, Pub. L. No. 111-223, 124 Stat. 2380 (2010). This Court should not permit the dilution of American freedoms by reference to the regulatory 25 regimes of foreign governments. For the foregoing reasons, the Court should grant the preliminary injunction sought by Plaintiffs. Respectfully submitted, /s/ Robert Corn-Revere Robert Corn-Revere (D.C. Bar No. 375415) Ronald G. London (D.C. Bar No. 456284) DAVIS WRIGHT TREMAINE LLP 1919 Pennsylvania Avenue, N.W., Suite 800 Washington, D.C. 20006-3401 Tel: (202) 973-4200 Fax: (202) 973-4499 COUNSEL FOR AMICI CURIAE ASSOCIATION OF NATIONAL ADVERTISERS AMERICAN ADVERTISING FEDERATION September 16, 2011 26

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