No. 12-521 In the Supreme Court of the United States AMERICAN SNUFF COMPANY, LLC, ET AL., PETITIONERS v. UNITED STATES OF AMERICA, ET AL. ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT BRIEF FOR THE RESPONDENTS IN OPPOSITION DONALD B. VERRILLI, JR. Solicitor General Counsel of Record STUART F. DELERY Principal Deputy Assistant Attorney General MARK B. STERN ALISA B. KLEIN Attorneys Department of Justice Washington, D.C. 20530-0001 [email protected] (202) 514-2217 QUESTIONS PRESENTED 1. Whether the court of appeals correctly upheld against a facial First Amendment challenge warning- label requirements in the Family Smoking Prevention and Tobacco Control Act (Act) for the packaging of and advertisements for cigarettes, 15 U.S.C. 1333 note (Supp. V 2011), and smokeless tobacco, 15 U.S.C. 4402 (Supp. V 2011). 2. Whether the court of appeals correctly upheld against a facial First Amendment challenge the Act’s requirement that a manufacturer establish the health benefits of a tobacco product before marketing it as a modified-risk tobacco product, 21 U.S.C. 387k (Supp. V 2011). 3. Whether the court of appeals correctly upheld against a facial First Amendment challenge regulations that— a. prohibit using the brand name of a cigarette or smokeless-tobacco brand on merchandise or to sponsor certain public events, 21 C.F.R. 1140.34(a) and (c), and b. generally prohibit the distribution of free samples of tobacco products, 21 C.F.R. 1140.16(d); see 21 U.S.C. 387a­1(a)(2)(G) (Supp. V 2011). (I) TABLE OF CONTENTS Page Opinions below ................................................................................ 1 Jurisdiction ...................................................................................... 1 Statement ......................................................................................... 2 Argument ....................................................................................... 13 A. Warning labels .............................................................. 13 B. Modified-risk tobacco products .................................. 20 C. Branded merchandise, event sponsorship, and free samples ................................................................... 30 Conclusion ...................................................................................... 36 TABLE OF AUTHORITIES Cases: Alexander v. Cahill, 598 F.3d 79 (2d Cir.), cert. denied, 131 S. Ct. 820 (2010) .............................................. 24 Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557 (1980) .................................. 12, 15, 26 Desert Outdoor Adver., Inc. v. City of Moreno Val- ley, 103 F.3d 814 (9th Cir. 1996), cert. denied, 522 U.S. 912 (1997) ............................................................... 27 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) ................................................. 2, 9, 10, 28 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996) ...................................................................................... 26 Freedman v. Maryland, 380 U.S. 51 (1965) ........................ 26 International Dairy Foods Ass’n v. Boggs, 622 F.3d 628 (6th Cir. 2010) ................................................ 18 Kordel v. United States, 335 U.S. 345 (1948)....................... 22 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001) .................................................................... 30, 31, 34, 35 Nebraska Press Ass’n v. Stuart, 427 U.S. 539 (1976)......... 26 (III) IV Cases—Continued: Page New York Magazine v. Metropolitan Transp. Auth., 136 F.3d 123 (2d Cir.), cert. denied, 525 U.S. 824 (1998) ................................................................................ 26, 27 Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir.), cert. denied, 525 U.S. 1040 (1998)...................... 27 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ....... 23, 24 Public Citizen, Inc. v. Louisiana Attorney Discipli- nary Bd., 632 F.3d 212 (5th Cir. 2012)............................... 24 R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) ..................................................... 9, 13, 15, 16 Rubin v. Coors Brewing Co., 514 U.S. 476 (1995)............... 35 Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011) ............. 26 Southeastern Promotions, Ltd. v. Conrad, 420 U.S. 546 (1975) ............................................................................... 26 Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) ...................................................................................... 25 United States v. Article … Consisting of 216 Cartoned Bottles, More or Less, Sudden Change, 409 F.2d 734 (2d Cir. 1969).................................................. 22 United States v. Caronia, 703 F.3d 149 (2d Cir. 2012)....... 23 United States v. Philip Morris USA Inc.: 449 F. Supp. 2d 1 (D.D.C. 2006), aff’d in part and vacated in part on other grounds, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010)......................................... passim 556 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010)...................................... 4, 5, 6, 11 686 F.3d 832 (D.C. Cir. 2012)....................................... 7, 25 Washington State Grange v. Washington State Republican Party, 552 U.S. 442 (2008) ................. 16, 17, 33 Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir.), cert. denied, 543 U.S. 925 (2004)......................................... 23 V Case—Continued: Page Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) ................................................... 11, 14, 18 Constitution, statutes, regulations and rule: U.S. Const. Amend. I ..................................................... passim Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111­31, Div. A, 123 Stat. 1776 ....................................................................... 2, 8, 9, 13, 23 § 2, 123 Stat. 1777-1781 (21 U.S.C. 387 note (Supp. V 2011)).................................................... passim 15 U.S.C. 1333 note (Supp. V 2011) ...................... 8, 11, 13 15 U.S.C. 1333(a)(1) note (Supp. V 2011) .........................8 15 U.S.C. 1333(a)(2) note (Supp. V 2011) .........................8 15 U.S.C. 1333(b)(1) note (Supp. V 2011) .........................8 15 U.S.C. 1333(b)(2) note (Supp. V 2011) .........................8 15 U.S.C. 1333(d) note (Supp. V 2011) ........... 8, 11, 16, 20 15 U.S.C. 4402 (Supp. V 2011) ............................... 8, 11, 13 15 U.S.C. 4402 note (Supp. V 2011) ................................19 15 U.S.C. 4402(a)(1) (Supp. V 2011) ..................................8 15 U.S.C. 4402(a)(2) (Supp. V 2011) ..................................8 15 U.S.C. 4402(b)(1) (Supp. V 2011) .................................8 15 U.S.C. 4402(b)(2) (Supp. V 2011) .................................8 15 U.S.C. 4402(d) (Supp. V 2011) ......................................8 21 U.S.C. 321(g)(1)(B) .......................................................22 21 U.S.C. 321(m) ................................................................22 21 U.S.C. 321(p) .................................................................22 21 U.S.C. 355(a) .................................................................22 21 U.S.C. 355(d) .................................................................22 21 U.S.C. 387 note (Supp. V 2011) ....................................2 21 U.S.C. 387a (Supp. V 2011) .........................................10 21 U.S.C. 387a-1(a) (Supp. V 2011) .................................10 VI Statutes, regulations and rule—Continued: Page 21 U.S.C. 387a­1(a)(2)(G) (Supp. V 2011) .......................10 21 U.S.C. 387k (Supp. V 2011) ....................... 12, 20, 21, 28 21 U.S.C. 387k(a) (Supp. V 2011) ......................................9 21 U.S.C. 387k(b) (Supp. V 2011) ....................................23 21 U.S.C. 387k(b)(1) (Supp. V 2011) .................................9 21 U.S.C. 387k(b)(2)(A) (Supp. V 2011) ............................9 21 U.S.C. 387k(d) (Supp. V 2011) ......................................9 21 U.S.C. 387k(g) (Supp. V 2011) ......................................9 21 U.S.C. 387k(g)(1)(B) (Supp. V 2011) ..........................27 21 U.S.C. 387k(g)(4) (Supp. V 2011) ...............................27 21 C.F.R.: Pt. 897 (1997) .......................................................................9 Pt. 1140 ...............................................................................10 Section 1140.16(d)............................................ 10, 13, 30 Section 1140.16(d)(1) ...................................................10 Section 1140.16(d)(2) ...................................................10 Section 1140.34 ............................................................10 Section 1140.34(a) ............................................ 10, 13, 30 Section 1140.34(c) ............................................ 10, 13, 30 Sup. Ct. R. 10 ...........................................................................31 Miscellaneous: 146 Cong. Rec. 4571 (2000) .......................................................4 150 Cong. Rec. 10,527 (2004) ....................................................6 155 Cong. Rec. (2009): p. 13,654 ..............................................................................29 p. 13,655 ............................................................................ 2, 6 pp.