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

R.J. REYNOLDS TOBACCO

COMPANY, al., et

Appellees ADMINISTRATION, &

FOOD DRUG al., Appellants.

et 11-5332,

Nos. 12-5063.

United Court of Appeals, States

District of Columbia Circuit.

Argued April Aug.

Decided Idaho,

State Brett T. DeLange, Deputy General, Attorney Burns, John J. Attorney General, Attorney Office of the General for Alaska, Horns, the State of Tom Attorney General, Office of the Attorney General for Arizona, the State of McDaniel, Dustin Attorney General, of Office the Attorney Arkansas, General for the of State Kamala Harris, General, D. Attorney Office of the Attorney General for the State of Califor- nia, Jepsen, George Attorney General, Of- of fice the Attorney General for the State Connecticut, Kim, of Todd S. Solicitor Gen- eral, of Office the Attorney General for the Columbia, District of Louie, David M. At- torney General, Office of Attorney Hawai'i, General for the State of Lisa Ma- digan, Attorney General, Office of the At- torney General Illinois, for the State of Miller, General, Thomas J. Attorney Office of the Attorney for General the State of Iowa, Schneider, William J. Attorney Gen- eral, of Attorney Office General for the Maine, of Douglas Gansler, State F. Attor- General, ney Office of Attorney for the Maryland, Hood, State of Jim Attorney General, Office of Attorney General for Stern, Attorney, Mark B. Depart- U.S. the State of Mississippi, Bullock, Steve Justice, ment argued of for ap- cause Attorney General, Attorney Office of the pellants. With him on the briefs were Montana, General for the State of Michael West, General, Tony Attorney Assistant Delaney, Attorney General, A. Office of Brinkmann, Beth Deputy S. Assistant At- Attorney General for the of State New torney General, Klein, Alisa Sarong B. V. Hampshire, Gary K. King, Attorney Gen- Damle, Powell, Tenny, Lindsey Daniel eral, of Attorney Office for General Schultz, Attorneys, Acting William B. Gen- Mexico, State of DeWine, New Michael Counsel, eral Department of Health General, Attorney Attorney Office of the Services, and Human Eric M. Blumberg, Ohio, General for the State of Peter F. Deputy Counsel, Chief and Karen E. Kilmartin, General, Attorney of Office Schifter, R. Craig Senior Counsel. Law- Attorney General for the State of Rhode rence, Attorney, Assistant U.S. entered an Island, Marty Jackley, Attorney J. Gener- appearance. al, Attorney Office of the General for the A. Gregory Beck and Allison M. Zieve Dakota, Shurtleff, State South Mark L. were on the brief for amici curiae Ameri- General, Attorney Attorney Office of the Pediatries, Academy can in sup- et al. Utah, General for the State William H. port appellants. Sorrell, General, Attorney Office Wasden, General, Lawrence G. Attorney Attorney General for the State of Ver- mont, Frazier, Office of the Attorney General for the F. Attorney Vincent Gener- BROWN, Judge: Circuit for the Attorney General al, Office of McKenna, At- Islands, M. Robert Virgin and To- Smoking Prevention Family Attorney General, Office torney (“the Act”), No. Act Pub.L. bacco Control Washington, and State for the General (2009), 111-31, directed Stat. General, McGraw, Jr., Attorney Darrell V. Department of Secretary the U.S. for Attorney General Office of regu- Human to issue Health and Services on the brief Virginia, were State of West cigarette packages requiring all lations amici curiae States. or sold in the United States manufactured cause for argued the Francisco Noel J. warnings, one nine new textual to bear the briefs were him on With appellees. depicting the graphics as “color as well Postman, Perry, Jona- Philip J. D. Warren smoking.” consequences Abrams, Hacker, Joel Floyd than D. 201(a). this authori- § Pursuant to See id. A. Barald. Kurtzberg, and Patricia Drug ty, and Administration the Food Rein, Barry, S. E. Robin John Bert W. (“FDA”) rulemaking proceeding initiated Todd, and Conrad, Kathryn Comerford images which it the nine through selected ami- on the brief for Gilbert were Sheldon statutorily-pre- the accompany that would of Commerce cus curiae Chamber companies warnings. Five tobacco scribed support of America United States (“the rule, the al- Companies”) challenged appellees. graphic warn- proposed that FDA’s leging Andrews, Cory L. Popeo, Daniel J. ings the First Amendment. See violated for Samp A. were on the brief Richard The court district Compl. 35-36.1 Washington Legal Founda- amicus curiae sum- granted Companies’ the motion for tion. February mary judgment on 2012.2 appeals, FDA and we affirm. G. Corn-Revere and Ronald

Robert amici curiae on the for London were brief Inc., et of National

Association Advertisers Background appellees. in support al. authority Act gives The FDA the ami- Jeffrey Light was on brief for and sale of to- regulate the manufacture Today Defending Rights Animal cus curiae including cigarettes. products, bacco of neither support party. & Tomorrow in cigarette requiring packages addition to to bear one of nine BROWN, advertisements Circuit Before: ROGERS statements, Act new mandates RANDOLPH, warning Judges, and Senior Circuit warning comprise that the new labels Judge. top percent panels of the front and rear by for the Court Circuit Opinion filed packages percent and 20 cigarette Judge BROWN. Act area of each advertisement. 201(a), The § Stat. at 1842-45. Act Dissenting opinion filed Circuit regula- final Secretary to issue Judge directs ROGERS. originally appealed district court's Companies alleged graphic 2. FDA also warnings Companies’ prelimi- Administrative Proce- grant violated the motion for a ("APA”), specifically 5 U.S.C. dure Act ruling supersed- injunction, was nary but that 553(b)(3) 706(2)(A). Compl. §§ at 37. subsequent ruling ed on the court’s warnings graphic violate we hold the Because merits. Amendment, we not reach the First do Companies’ APA claims. component identifying Required tions of See Warnings for Cigarette 22, 2011, warnings by Packages Advertisements, and pro- June 76 Fed. (June (hereinafter 36,628 2011) Reg. vides that the revised health will Rule). by September take effect 2012. See 15 Final required also each § note. graphic image U.S.C. to bear phone number of the National Cancer Institute’s “Net- directive, statutory Pursuant work of Quitlines,” Tobacco Cessation Proposed seeking FDA issued a Rule com- which the telephone portal uses “1-800- thirty-six potential ment on for the images QUIT-NOW.” Id. new graphic Required labels. Warnings Cigarette Packages and Ad- FDA based its selection of the final im- vertisements, 69,524, 69,534 FecLReg. ages 18,000-person on an internet-based (Nov. 2010) (hereinafter Proposed study consumer it commissioned. The Rule). At the outset of Proposed study respondents divided groups: into two Rule, FDA asserted the government’s a control group that was shown the new in reducing “substantial interest the num- text in of the format the current warnings (located Americans, particularly of ber children and cigarette the side of packages), adolescents, cigarettes separate who use and other and a group treatment that was products in prevent order to proposed shown the graphic warnings, life-threatening consequences health text, asso- which included the new the accompa- 69,525. ciated with tobacco use.” Id. nying graphic image, and the 1-800- ' In requirements QUIT-NOW 36,638. accordance with the of number. Id. Act, proposed expan- FDA a dramatic Each group then questions answered de- warnings, of existing signed assess, sion health which among things, other justified it based on scientific literature graphic whether the warnings, relative to control, (1) and a “strong worldwide consensus”3 re- the text-only increased viewers’ garding graph- the relative of quit effectiveness intention to or refrain from smoking; (2) warnings ic compared text-only to the knowledge increased viewers’ warnings the United States currently smoking re- health risks or secondhand (3) smoke; quires. agency explained “salient,” Id. The and were which FDA “clearly effectively conveying] in part causing defined as viewers to feel consequences smoking,” “depressed,” “discouraged,” or “afraid.” warnings the new discourage would non- Id. smokers, minors, particularly from “initiat- selecting images, these nine use,”

ing cigarette encourage current reviewed and responded to over a thou- 69,526. quit. smokers Id. comments, public joint sand including com-

FDA promulgated the final set nine ments submitted by plaintiffs-appellees RJ images Lorillard, Reynolds, for each statement— and Commonwealth —one by regulations 36,629. issued on June 2011. Brands. See id. at eom- Several Countries/jurisdictions imple- Turkey, Kingdom, Uruguay, that have United and Vene- pictorial warning requirements mented Countries/jurisdictions pending for to- zuela. Australia, France, packaging Belgium, bacco requirements Guernsey, include Canada, Chile, Colombia, include Hon- Brunei, Brazil, duras, Malta, Norway, Philippines, Islands, Djibouti, Hong Egypt, Kong, Spain. noting Cook It is worth constitu- India, Iran, Jordan, Latvia, Malaysia, necessarily Mauriti- tions these countries do not us, Mexico, Zealand, Mongolia, protect stringently New Paki- individual liberties as stan, Panama, Peru, Romania, Paraguay, does United States Constitution. Pro- Switzerland, Taiwan, Thailand, 69,525 Singapore, posed Rule at n. 4. FDA avoided study. Id. from cancer including comments ments— conceding

researchers, academics— nonprofits, argument of this substance study design, single exposure criticized on the study “provides insight from noting prevented it of the various warn- relative effectiveness or actual effects long-term assessing the consideration,” not on the “ab- ings under of these warnings. Two proposed warnings general.” solute effects of the FDA conduct recommended comments Id. sur- post-market longitudinal research lack also criticized the Some comments long-term effects. actual veillance to assess FDA’s supporting evidence statistical study conceded the 36,639. FDA Id. at requiring packages “firm” conclu- belief that reach permit did ef- “long-term, real-world reduce graphic warnings about the would sions bear warnings, but proposed fects” of the smoking example, For rates. See id. literature existing scientific claimed the data Companies noted that the Canadian our con- basis for “provides a substantial statistically significant decline revealed no ef- warnings will required clusion that smoking rates for adolescents and fectively the health risks communicate of similar adults after the introduction thereby encouraging smoking, warnings, implied which smoking initi- discouraging cessation and that FDA’s were ineffective Id. Still other comments asserted ation.” well. warnings be ineffective as Id. would study pro- failed to FDA’s research that that summarily disagreed, stating FDA warnings proposed vide evidence satisfy it selected would its images rates, actually smoking signif- would affect goal, effectively which is to con- “primary knowledge of the icantly affect consumers of consequences health vey smoking, bring of or actual risks about smoking and in ad- cigarette packages on 36,640. at But change. behavior See id. vertisements,” help which can “both to dis- again disagreed, relying FDA on “sub- courage initiating ... from nonsmokers showing research” the effective- stantial encourage use and to current cigarette warnings in of health ness similar to smokers consider cessation.” (citing Proposed Rule other countries. Id. 36,633. explained FDA that Rule also 69,531-34).4 Another comment asserted data from Canada did not indicate study’s constituted a selection bias ineffective, warnings had because been methodological Namely, par- serious flaw. warnings studies other showed recruited from an internet ticipants were providing had been “effective par- to panel opportunity and offered the information, making FDA-sponsored smokers with health ticipate an research raising concerns about the lack of 4. Tobacco manufacturers also criticized the ments "study's strong statistically use to behav- significant of intentions measure concern- results change intention, have ioral and stated that FDA should although ing explained FDA showing be- presented data actual effects on study attempt made no to show that increased 36,642. disa- havior.” Final Rule at FDA (let quit alone to translated to actual intention inappropriate an greed that intentions were successful) body quit attempts, "the overall variable, explaining that while intentions do provides literature” sufficient evi- scientific behavior, they perfectly predict are future warnings, “by increasing pub- dence that the “necessary precursor.” Id. FDA cites also thoughts understanding of and about lic shocking the “scientific conclu- literature['s]” smoking, will be effective in health risks of quit to sion “that one's intentions encouraging smoking and discour- cessation be makes the actu- must increased before one aging smoking initiation.” Id. attempt.” response quit al Id. In to com- think views, consumers about health effects of viduals to express certain id. increasing 714-15, smoking, 1428, smokers’ motiva- 97 S.Ct. or to subsidize smoking.” Id. quit speech they tions to which object, see United Foods, Inc., States v. 405, United 533 U.S. After FDA finalized the the Com 410-11, 2334, 121 S.Ct. 150 L.Ed.2d 438 panies court, suit in filed the district claim (2001), subject scrutiny. strict The warnings required under general rule “that speaker has the implementing regula the Act and FDA’s right speech[] to tailor the applies not tions violated the First Amendment. The expressions value, opinion, or granted Companies’ district court mo endorsement, equally but statements preliminary injunction tion for a on No fact speaker would rather avoid.” 7, 2011, subsequently granted vember Hurley Gay, v. Irish-Am. Lesbian & Bi- judgment. their motion summary Bos., Grp. sexual 573-74, 515 U.S. appeals, and we de review novo the (1995). 115 S.Ct. 132 L.Ed.2d 487 grant district court’s summary decision This individuals, holds true whether see W. judgment. v. Davis Pension Benefit Barnette, Va. State Bd. Educ. (D.C.Cir. Guar. Corp., F.3d 624, 642, 63 S.Ct. 87 L.Ed. 1628 2009). (1943), corporations, see Pac. Gas & Comm’n, Scrutiny Elec. Co. v. Pub. Utils. II. Level of 1, 16, (1986) L.Ed.2d Companies dispute do not (plurality opinion), being compelled to Congress’s authority require speak. cigarette packages, nor do they challenge the any substance This case contains compul- elements of nine textual statements mandated sion and forced subsidization. The Com- Act. The question before us is wheth panies that, contend to the extent er promulgation FDA’s of the graphic graphic warnings beyond go the textual incorporate labels—which the tex warnings repulse to shame and smokers warnings, tual a corresponding graphic im and denigrate smoking act, as an antisocial age, “1-800-QUIT-NOW” and the cessa message is ideological and not informa- tion hotline number —violates the First “[B]y tional. effectively shouting well-un- begin Amendment. We our analysis by consumers,” derstood they information to applicable determining level of scruti explain, “FDA is communicating an ideo- ny. logical message, point a on of view how right Both the to speak people and the should live their lives: right to speaking refrain from are “com smoking pleasure risks from outweigh the plementary components of the it, broader that smokers derive from and that concept of individual freedom of mind” decisions, smokers personal make bad and protected by the First Amendment. Woo stop effect, should smoking.” ley 705, 714, v. Maynard, 430 U.S. 97 S.Ct. graphic images are not warnings, but ad- (1977). 1428, 51 Any L.Ed.2d 752 attempt buy monitions: or use this prod- “[D]on’t government either compel to indi- uct”5 government No one doubts can question here is whether the scribe what shall be orthodox commercial warnings actually type do advertising,” constitute the (quoting Dissent at 1226 Zauder- requirements Counsel, disclosure that are Disciplinary reviewable er v. 471 U.S. Office 626, 651, under Zauderer's relaxed standard” —what the 105 S.Ct. L.Ed.2d (1985)) "attempts only pre- dissent characterizes as to they whether are more akin to —or recognized a handful can have Courts programs; cessation smoking promote excep well-understood of “narrow and shame, opprobrium moral and shock, use general to rule that content- tions” becoming from discourage people to speech com regulations including based smokers; taxing regu- use its and can — pelled speech subject strict scruti make economi- latory authority to —are FCC, ny. Sys., Broad. Inc. v. See Turner socially onerous. cally prohibitive 622, 641, 2445, 129 114 S.Ct. certainly require can And (1994). pri There are L.Ed.2d 497 two fully informed about be that consumers speech in the commercial mary exceptions But this products. of hazardous dangers First, un “purely factual and context. scope questions novel about the case raises permissible are controversial” disclosures authority force the government’s they “reasonably if are related to go beyond product of a manufacturer deception of preventing State’s interest in com- and accurate making purely factual consumers,” provided requirements undermine its own mercial disclosures “unjustified unduly are not burden case, making this interest —in economic Zauderer; 651, 105 471 U.S. at some.” in the pack cigarettes “every single Second, on com S.Ct. 2265. restrictions for the country govern- mini billboard” [a] speech subject mercial to less strin anti-smoking message.6 ment’s gent review than restrictions other types burdening For statute speech. Companies’ market- assuming the Even survive, the speech govern commercial other (packaging, branding, and efforts (1) prove must advertisements) affirmatively ment properly be classified can (2) substantial, interest is the re asserted subject to speech, as and thus commercial directly materially striction advances protections, less robust First Amendment (3) interest, the restriction is thorny remains: how much lee- question narrowly tailored. See Hudson Gas Cent. way grant govern- this Court should Comm’n, 447 & Elec. v. Pub. Serv. Corp. compel product’s ment when it seeks 557, 566, 65 L.Ed.2d subjec- convey manufacturer state’s (1980). quite While this test is not ideological perhaps tive—and even —view scrutiny, signifi it is demanding as strict reject that consumers should other- than cantly stringent more Zauderer’s disfavored, product? Nei- legal, wise but standard, akin to which is rational-basis regulation the agency’s ther the Act nor review. squarely question. Howev- addresses er, assume, present we can purposes, for the graphic The district court concluded deciding, compulsion without such is warnings “not type purely were if ac- constitutionally the state’s permissible, uncontroversial” disclosures re- factual and applicable stringent withstand the Zauder- tions must still viewable under the less Reynolds v. scrutiny. er standard. R.J. Tobacco Co. level attempts "prescribe T 2556. to what shall be orthodox obaccoProducts/NewsEvents/ucm23 Zauderer, htm; Briefing by opinion,” see also Press Press Secre- 471 U.S. matters of 651, 2265, Jay Carney, Companies tary Health and Human Services as the Sebelius, Secretary and FDA Com- contend. The dissent overlooks element Kathleen (June argu- compulsion, Margaret Hamburg an which at least creates missioner 2011), scrutiny. applying http://www.whitehouse. ment favor of strict available at gov/the-press-office/2011/06/21/press-briefing- FDA, (Nov. press-secretary-jay-carney-secretary-health- Strategy 6. Tobacco Announcement 10, 2010), http://www.fda.gov/ available at and-human-ser. (D.D.C. FDA, F.Supp.2d 272-73 ments “intended to combat the problem of (hereinafter 2012) Opinion”). Ap “Merits inherently misleading commercial adver- plying scrutiny, strict tisements”). court held that satisfy FDA to failed its burden of demon Supreme Court has never applied strating narrowly that the Rule is tailored Zauderer to requirements disclosure a compelling government to achieve inter designed to correct misleading commercial est. See argues id. at 275-77. FDA speech. argues that le- Zauderer’s in finding the district court erred the Zau nient of scrutiny applies standard regu- inapplicable. derer Alternatively, standard lations that serve a governmental different it contends the district court erred interest: disclosure of the health and safe- failing to apply the intermediate-level scru ty risks associated prod- with commercial tiny generally afforded to commercial ucts. Appellant’s Br. at 26. speech, warnings pass constitutional muster under Central Hud terms, But by its own Zauderer’s hold- son. argument We address each in turn. ing is limited to cases in which disclosure requirements are “reasonably related to Applicability a. the Zauderer the State’s interest in preventing deception Standard consumers.” 471 U.S. at 105 S.Ct. Zauderer, applied Court a lower 2265. Zauderer authority “carries no for a of scrutiny regulations level requiring mandate unrelated to the interest avoid- attorneys fully disclose information or misleading incomplete commercial consequences about the actual cost and messages.” v. Glickman Wileman Bros. 651-52, services. 471 U.S. at 105 S.Ct. Elliott, Inc., 457, 491, & 117 S.Ct. Noting that the First Amendment’s (1997) (Souter, J., 138 L.Ed.2d 585 protection of speech prem- commercial dissenting, joined by Rehnquist, C.J., and ised on its informational value to consum- JJ.) Thomas, Scalia and (explaining why ers, the Court reasoned that an advertis- case).7 Zauderer inapplicable was in that er’s constitutional interest in not providing Foods, In United States ex- United additional factual information was “mini- ample, the Court apply declined to mal.” Id. at Al- Zauderer evaluating standard when a fed- though acknowledged the Court that “un- requiring eral law producers mushroom justified unduly burdensome disclosure an pay assessment support generic ad- requirements might offend the First vertising. distinguished The Court Zau- by chilling Amendment protected commer- derer because there no suggestion was cial speech,” that an “h[e]ld advertiser’s mandatory “that the imposed assessments rights are adequately protected long as require group private one persons to requirements disclosure reasonably are re- speech pay for lated to others are somehow the State’s interest in preventing Id.; deception necessary voluntary to make of consumers.” advertise- see also Milavetz, Milavetz, Gallop non-misleading ments & P.A. v. for Unit- consumers.” — States, -, ed U.S. 130 S.Ct. 533 U.S. 121 S.Ct. 2334. And as (2010) 1340, 176 Gas, L.Ed.2d 79 (applying explained the the Court in Pacific Zauderer require- standard to disclosure “[njothing in ... suggests Zauderer that that, 7. although speech protection” Justice Souter noted only was because it was "our Glickman, government not cited commercial-speech the in a examination of mandate represented Zauderer pass today.” “the closest at au- before 521 U.S. at 117 S.Ct. thority for his limited rationale of commercial 2130. 528(a)(4). § Id. Bankruptcy Code.” require [enti- to the equally free is State par- upheld Court the statute’s disclosure messages of third The carry the to ties] because, Zauderer, in requirement as ties, messages themselves are where “inherently contrary firm’s were to law advertisements expressly or are against biased case, 12, misleading” they n. this because at 15 [entity’s] views.” —in any ... relief without “promis[ed] debt opinion). (plurality filing possibility reference to Department Busi- Florida Ibanez v. bankruptcy, which has inherent costs.” Regulation also ness and Professional Milavetz, One Justice 130 S.Ct. should be con- suggests that Zauderer against interpreting the even cautioned government only apply when strued holding as a en- “presumptive[ ] Court’s that an adver- affirmatively demonstrates requiring use of of] laws dorsement to deceive consumers. tisement threatens in com- government-scripted disclaimers case, the Board of Accountan- In that state noting that Zauderer advertising,” mercial attorney’s of her cy that an use contended that proposition does not stand for the designation in Planner Certified Financial constitutionally compel “can government “potentially mislead- an was advertisement in scripted any of a disclaimer use to re- ing,” and thus entitled Board in pre- its interest circumstance which a include disclaimer. 512 U.S. quire her to might venting deception plausi- consumer 136, 146, 2084, 129 L.Ed.2d 118 114 S.Ct. (Thomas, bly be at stake.” Id. at 1343-44 (1994). apply But the Court declined J., concurring part concurring Zauderer, “given the state of finding that judgment). record,” “to point failed the Board real, pure- any potentially not harm that is Zauderer, Ibanez, and Milavetz simply, gov- Id. Put ly hypothetical.” require that a thus establish disclosure under the ernment could not seek review only appropriate ment if the a show- lenient Zauderer standard absent that, warning, absent a there is a shows at issue would that advertisement “potentially least self-evident—or likely mislead consumers. danger an that advertisement will real”— Ibanez, fact, applica- recent In the Court’s mislead consumers. case, a 114 S.Ct. 2084. In this tion of the Zauderer standard involved requirements disclosure would requirement proposed “share[d] disclosure at issue in apply essential features the rule both advertisements Milavetz, Act cigarette packages. any bans la Zauderer.” Milavetz, beling challenged provision advertising representing any law firm a or a product a risk Bankruptcy “presents Abuse Prevention and tobacco lower (“BAPC- of 2005 disease or is less harmful Consumer Protection Act tobacco-related PA”) required professionals commercially than or more other mar qualifying one agencies “clearly products,” relief and con- keted tobacco “contains re debt any presents level spicuously disclose advertisement of duced substance or substance,” exposure to a or “does bankruptcy assistance services reduced respect or is free of a substance.” 21 services benefits contain § adver bankruptcy relief this title.” 11 U.S.C. 387k. The Act also bans under 528(a)(3). tising descriptors § labeling using also re- U.S.C. BAPCPA “mild,” “low,” descrip or similar quired qualifying professionals “light,” to state restrictions, and agency. light are a debt relief tors. Id. In of these “[w]e We help any congressional absence of find- people bankruptcy file for relief under ings on the misleading nature of cigarette appear deceptive in isolation can constitute packaging itself, there is justification no “part of a continuing deception pub under Zauderer for the graphic warnings. lic” absent highly visible warnings. Id. at 769. But the argument States’ overlooks argument dissent’s that cigarette the broader context of that decision. packages and War other advertisements that ner-Lambert involved a petition fail review prominently display the negative of an FTC order requiring the Warner- consequences of smoking are mis- company Lambert to cease and leading, desist see from Dissent at 1228-29, seems to advertising that product, blame the Listerine industry for by playing gov- mouthwash, prevents, cures, or ernment’s rules. alleviates The Companies have the common cold. Id. at 752. never As a argued that reme no require- disclosure measure, dial the Commission required ments warranted; they merely object Warner-Lambert include the following form and content of specific disclosure in every future requirements advertisement proposed by the FDA. In- for Listerine for a deed, period: defined it seems “Con likely the FDA did not trary to prior advertising, make any Listerine such will claims because the industry not help prevent colds or has sore complied precisely throats or with all of gov- lessen their severity.” Id. at ernment’s previous oth disclosure require- words, er the disclosure ments, and statement was continues to do so. Moreover, required as part of a the Companies corrective order generally acknowledge the which the Commission found need necessary for effective warnings and concede in “dissipate the effects respondent’s their brief that de they would be amenable to ceptive representations.” 769; Id. a number new disclosure requirements, also Novartis Corp. FTC, including F.3d putting the Act’s new text on the (D.C.Cir.2000) 788-89 (upholding side of packages, Com the bottom front pack- mission’s corrective order ages imposing disclo advertisements, or using less sure requirements on manufacturer). drug shocking graphics. Appellees’ Br. at 58.8 The amicus States suggest By contrast, FDA does not frame this graphic warnings be evaluated the con- rule as a remedial measure designed to text of the years of deception that preced- counteract specific deceptive claims made ed them.9 States’ Br. at 7. Citing War- by the Companies, nor did it offer reme FTC, ner-Lambert Co. v. 562 F.2d justification dial for the graphic warnings (D.C.Cir.1977) they claim this Court has during the rulemaking proceeding. While found that even advertisements that do not Companies’ representations about 8. The dissent also claims warnings purport to address the information provided “more than sufficient evidence gaps by identified government. packages and other advertise- ments likely remain to mislead consumers 9. To the extent that there ais concern about notwithstanding existing warnings.” Dis- Companies' past deception, pre- the Act sent at In the Final the FDA cludes them from "portray[ing] the use of found that consumers are uninformed about minors,” as ... healthful to "the see Act nature and extent of the health risks 2(17), § 123 Stat. associated precluding smoking cigarettes,” Companies 36,632, Rule at using "light” from such "the severity other des- magnitude” risks, criptors. See those personal § their U.S.C. 387k. And Con- risks, the smoke, gress's effects of objection secondhand Companies' portrayal highly cigarettes. addictive nature of as "socially acceptable” is like- 36,632-33. id. at But proposed none of the wise remedied the constraints of the Act. literally, interpreted not meant to be have are cigarettes might tar” or “low

“light” the textual warn- symbolize rather to v. Phil but United States misleading, see been statements, Inc., provide 1124- which “additional 566 F.3d USA ip Morris (D.C.Cir.2009), Final Rule at prohibits Act now for what shown.” the context by 36,655. images § 387k. chosen many 21 U.S.C. But the See statements. such Warner-Lambert, FDA has not misinterpreted be consum- FDA could Unlike warnings de image were of a man graphic example, For shown ers. misleading any tracheotomy might false or a hole signed smoking through correct cigarette manufacturers that such misinterpreted suggesting claims made as be it that absent consequence did show past.10 Nor common procedure a is a disclosure, likely would be de consumers interpretation logical more smoking—a in the Companies’ packaging by the symbolizes ceived than FDA’s contention that Rather, the warn FDA framed future. cigarettes,” nature of which “the addictive nega disclosures about ings general as extrapolation on the requires significant smoking. The warn tive health effects of Id. part of consumers. effort to represent ongoing an ings thus Moreover, are not buying the discourage consumers from FDA tacitly factual because—as “purely” than, as in rather Companies’ products, they primarily are intended to admits — Warner-Lambert, designed to a measure or, most, response, evoke an emotional deceptive claims. specific combat retaining infor- the viewer into shock Appel- in the See warning. mation text Moreover, do not graphic warnings (citing showing Br. at 33 research lant’s type “purely factual constitute than “pictures are easier remember Zauderer, information, uncontroversial” words”); (citing FDA’s finding id. at 38 105 S.Ct. or “accu- body of scientific litera- substantial statements,” Milavetz, rate 130 S.Ct. responses, ture shows that emotional such may which the Zau&erer standard worry disgust, “reliably predict approved applied. be disclosures that consumers will understand likelihood state- and Milavetz were clear Zauderer warn- appreciate the substance indisputably that were both accu- ments ings”). subject misinterpretation rate and not Zauderer, 471 U.S. at

by consumers. See fact, images do con- many (describing the disci- all, much vey any warning information required any rule that “that adver- plinary an “accurate statement” about less make contingent-fee tisement mentions of a cigarettes. example, images For percentages rates must whether disclos[e] child, crying, and the man a small woman or after computed are before deduction wearing a T-shirt emblazoned with the Milavetz, costs and expenses”); court QUIT” any “I do not offer informa- words (describing BAPCPA disclo- S.Ct. at 1330 of smoking. tion about the health effects alia, a including, inter requirements, sure number, “1-800-QUIT-NOW” And the statement are debt relief “[w]e any explanation presented when without file for relief agency. help people We hotline, provided the services about Code.”). Bankruptcy under the hardly sounds like an unbiased source of inflammatory images information. These images The FDA’s a much different hotline ean- provocatively-named and the images animal. FDA concedes that Companies. Philip pend- against Morris subject 10. Such matters are Inc., litigation ing- entirely separate USA 566 F.3d 1095. —and —line pure rationally attempts not be viewed as reviewed district court requiring order convey They information consumers. defendant manufacturers attempts publish are to evoke emotion corrective statements on unabashed their embarrassment) (and websites, in newspapers, major and brow- and on perhaps quitting. into See Final television networks. 566 beat consumers F.3d 1142-43. (“[R]isk 36,697 began by information is most This Court that noting Rule at “[b]e- conveyed by warnings that elicit cause commercial readily speech receives a lower strong cognitive reac- level of protection emotional and under the First Amend- ”). ment, images it imposed .... While none these burdens on tions receive false, do patently they certainly scrutiny not lower level of from the courts.” factual, accurate, impart purely or un- Id. After acknowledging that “the stan- information to dard for assessing controversial consumers. burdens on commercial images speech varied,” fall Consequently, outside the the Court concluded that Supreme ambit of Zauderer. “the Court’s bottom line is clear: government affirmatively must Applicability b. of Central Hudson demonstrate its narrowly means are tai- lored to achieve a substantial this Because case does not fall goal.” Id. 1143. See also Novartis by within narrow enclave carved out Corp., 223 F.3d at 789 (evaluating a correc- Zauderer, we must next determine which remedy involving tive corrective state- scrutiny level of or intermediate— —strict Hudson). ments under Central Because is The appropriate. district court held this case also compelled involves a com- compelled speech that that falls outside disclosure, mercial we follow lead of subject the Zauderer framework is Philip apply Morris and the intermediate scrutiny. Op. strict See Merits at 274-75. standard set forth in Central Hudson. Lottery, &City also Disc. Tobacco Inc. States, (6th v. United 674 F.3d Evaluating Graphic Warnings III.

Cir.2012) (deciding between applying strict Scrutiny Under Intermediate scrutiny compelled Zauderer to com speech); mercial Entm’t Ass’n v. Software Hudson, Under Central (7th Blagojevich, 469 F.3d Cir. government must first as show 2006) (same). government argues The serted interest is “substantial.” 447 U.S. should the graphic warnings we view so, If 2343.11 the Court speech, restrictions commercial must determine the regulation “whether analyzed rigorous which are under the less directly governmental advances the inter standard established Hudson. Central asserted, and est whether it is not more contrary Despite of other cir views than necessary extensive to serve that cuits, governing precedent our makes clear interest.” Id. party seeking to uphold the appropriate Central Hudson is speech a restriction on commercial bears standard. justifying burden it. Edenfield Fane, recently 761, 770-71, 113 Court This evaluated the consti- S.Ct. (1993). tutionality compelled speech commercial 123 L.Ed.2d 543 Because this case Morris, action, v. Philip challenge agency United States where it involves a to final provides seriously 11. Central Hudson also that com- party 2343. Neither speech only disputes cigarette packaging mercial receives First Amend- ad- protection regulated activity satisfy ment if is a lawful and is vertisements the Act misleading requirement. or fraudulent. 447 U.S.' at threshold 1218 Americans, during particu- the number of governs Administrative Procedure Act

the adolescents, larly record. See 5 U.S.C. and who use children our review 706(2)(B) ap- APA (providing the cigarettes products.” § other tobacco action is agency 69,525. plies allegations to Proposed at And pream- Rule the power, right, “contrary to constitutional Rule ble to the Final reiterates the same re- immunity”). The APA privilege, 36,629.12 Although Rule interest. Final aside unlawful and set quires us to “hold attempted to this interest counsel disclaim action, findings, and conclusions agency argument, at oral the administrative rec- unsupported by substantial found to be objec- primary ord shows otherwise: the 706(2). § evidence.” 5 U.S.C. discourage of Rule was to tive the “both initiating nonsmokers from use review, rational-basis Unlike encourage and to current smokers to con- permit does not Central Hudson standard Id. quitting.” sider inter precise “supplant this to Court sup ests forward with other put [FDA] Assuming FDA’s in re interest 768, Edenfield, 507 U.S. at

positions.” substantial,13 ducing smoking rates is we begin identifying 1792. We thus S.Ct. FDA next evaluate whether has offered interests. FDA’s asserted showing substantial evidence A of statute the adminis- review graphic warning requirements “directly clear record makes that the trative governmental as interest advance[] to cur- encourage are intended serted,” Hudson, 566, Cent. U.S. at quit rent and dissuade other smokers 2343, to a degree,” 100 S.Ct. “material Fl. buying cigarettes. consumers from ever It, Inc., 618, 626, Bar v. For Went many purposes One the Act’s stated is (1995). 2371, 132 115 S.Ct. L.Ed.2d 541 “promot[ing] cessation reduce disease government justi bears the burden of risk and the social costs associated fying attempt its restrict commercial § tobacco-related diseases.” Act 3.9. The 770, speech, Edenfield, 507 U.S. in only explicitly asserted interest either 1792, its is not A light. S.Ct. burden or Final Rule an interest Proposed is “provides restriction that ineffective reducing smoking Proposed rates. The gov- support government’s or remote for the preamble Rule its that the states purposes,” has a re- is not ernment “substantial interest id. Moreover, designed promote objective.” Re- be the Institute Medicine must port, which relies for some Id. unequiv- supporting evidence states primary objective ocally that “the of tobacco court, skeptical Like district we are regulation promote informed choice government that the can assert substantial discourage consumption to- but rather to discouraging pur- interest consumers from reducing products ... as a bacco means chasing product, even a lawful one that has Institute tobacco-related death disease.” conclusively been linked to adverse health Medicine, Ending the Tobacco Problem: A Nonetheless, consequences. Supreme (2007), Blueprint Nation 291 available govern- implied Court at least http://www.nap.edu/catalog.phpPrecord_ ment could have substantial interest in re- Report goes id= 11795. The on to state that ducing smoking smoking poses rates because though products legally “[e]ven "perhaps single significant most threat to adults, public paramount available to public in the States.” FDA v. United people is to health aim reduce number Corp., Brown & Williamson Tobacco prod- who use and become addicted to these ucts, L.Ed.2d 121 through on children and a focus (2000). "warnings youths,” recommends sufficient, and sat- cannot Some Canadian and Australian studies in- “by speculation or isfy large graphic its burden mere dicated that warnings might Co., conjecture.” Brewing Rubin v. Coors induce individual smokers reduce con- 476, 487, S.Ct. sumption, persons or to help who have (1995). requirement that L.Ed.2d 532 already quit smoking remain abstinent. directly a restriction advance the asserted But again, study pur- See id. the did not “critical,” it, interest is because without port implementation to show that the government [interfere with] the “could large graphic warnings actually led to speech in the service of commercial other a in smoking reduction rates. that objectives justify could not themselves questionable FDA’s reliance on this so expression.” on Id. burden commercial cial science is unsurprising when we con provided FDA has not a shred evi- sider the raw data regarding smoking dence—much less the “substantial evi- rates in countries that have enacted required by showing dence” the APA— graphic warnings. FDA claims that Cana graphic warnings “directly will survey dian national data suggest reducing advance” its interest in the num- graphic warnings may smoking reduce ber of Americans who smoke. FDA But the strength rates. is evidence makes much of the “international consen- underwhelming, making claim FDA’s surrounding large sus” the effectiveness of In misleading. year prior somewhat graphic warnings, but offers no evidence introduction graphic warnings, warnings directly that such showing have survey the Canadian national showed that smoking a material in caused decrease percent aged Canadians 15 or older any in rates the countries that now cigarettes. smoked year require them. While studies Canadian introduced, warnings were the national youth Australian smokers showed rate to 22 smoking dropped percent, and it warnings packs on cigarette caused dropped percent further to 21 in 2002. Id. survey substantial number of participants 69,532. But the raw numbers don’t tell to think —or think more—about quitting the whole tale. FDA it cannot concedes 69,532, smoking, Proposed Rule at directly any attribute decrease in Ca might FDA be correct that intentions are smoking nadian to the graphic rate warn precursor” “necessary change, to behavior ings because Canadian 36,642, speculation Rule it is mere implemented smoking other initia control suggest that respondents report who tives, including an in increase thoughts quitting smoking increased about tax public and new restrictions on smok actually

will through follow on their inten- ing, during the period. Although same Id. And at point tions. no did these studies FDA maintains suggestive” the data “are attempt to evaluate whether increased large graphic warnings “may” reduce thoughts about smoking par- cessation led id., smoking consumption, satisfy it cannot ticipants actually quit. Another Austra- Amendment burden First with “mere study reported lian quit increased at- Rubin, speculation conjecture.” tempts by survey participants after that 487, 115 U.S. at country large warnings, enacted graphic but found “no Regulatory Impact Analysis association short-term FDA’s (“RIA”)14 quit Proposed essentially agency success.” Rule concedes the 30, 1993), analysis required agencies 14. Such an under Execu- which all directs to assess 51,735 Fed.Reg. (Sept. regulatory tive Order al- costs and benefits of available presented FDA has thus us with graph- that the any showing lacks evidence directly the im- likely smoking two studies that evaluate warnings reduce ic graphic warnings RIA ana- on actual smok- pact in which the way rates. One rates, benefits of Rule and neither set of data shows expected lyzed warnings “directly” of similar impact will by comparing was smoking reducing introduced Canada its interest advance (1) 36,719-20. Rubin, It ana- degree.” Final Rule “to a material rates trends in change lyzed 115 S.Ct. 1585. And one of (2) 2000; as- after Canada before principal- researchers whom post-2000 in the any sumed difference recently surveyed the relevant liter- relies and the United change between Canada way and conceded that is no “[t]here ature to the intro- solely attributable States was smoking] [in ... declines to attribute (3) as- warnings; of graphic duction Ham- warnings.” the new health David have an warnings sumed similar would mond, on To- Warnings Messages Health smoking on U.S. rates. impact identical Review, Products: A 20 Tobacco bacco 36,755. Describing approach its See id. (2011), http:// available Control acknowledged FDA that “rudimentary,” as tobaccocontrol.bmj.com/content/20/5/327. taxes, apart cigarette from differences foreign full.pdf light of the number of potential RIA not account for “d[id] large jurisdictions that have enacted variables,” 36,720-21, id. at confounding labels, the dearth of data stringent introduction of more such reflecting smoking rates decreased smoking advertising bans and restrictions surprising, these countries is somewhat period, time during in Canada relevant warnings strongly implies that such prices the fact that Canadian or very promoting are not effective at cessa- prices. generally higher than U.S. discouraging initiation. While tion Proposed Plaintiffs’ Letter on Comment agency APA review of final action is defer- (Jan. 2010) Rule Statement of Rob- ential, surely require it does not us to ert S. Maness. accept interpretation flawed Canadian survey agency’s projected data own procedural

Logic dictates these would, rate if lead to an 0.088% decrease the U.S. anything, shortcuts efficacy warnings evidence” that its overly optimistic prediction of the as “substantial warnings. Not so. advance stated proposed graphic will its interest. The RIA the new estimated by attempts downplay FDA smoking rates

would reduce U.S. 0.088%, 36,721, significance explaining a num- the RIA mere Final Rule at is “must be in all rule- general ber the FDA concedes “in not it included federal distinguishable making manage zero.” statistically improve from internal Government,” 36,776. Indeed, it had ac- Id. at because ment the Federal sets,” second-guess FDA it “was intended to “very cess to small data could that Congress’s regarding the value reject possibility judgment not even statistical Br. warnings.” Reply on Pet. impact the Rule would have no of new attempts FDA to rehabilitate smoking rates. Id. at 15-16.15 and, necessary, Congress’s regulation urges FDA us to defer to when is also ternatives graph judgment regarding efficacy approach net select that maximizes warnings. Sys., Turner Broad. Inc. ic See benefits. FCC. 520 U.S. 180. analysis only made would not findings noting its render Central Hudson’s point” that it requirement the “unremarkable is “substantial interest” a com- plete nullity, “difficult determine statistical but it [to] would also eviscerate precision impact relative causal of the requirement any restriction “di- factors,” contributing particularly relevant rectly advance” that interest.

given very small data sets which U.S. at case, S.Ct. 2343. In this FDA had access. 16. But FDA Id. both the statute and the Rule offer a ba- get cannot around the First Amendment rometer assessing the effectiveness of futility. by pleading incompetence or Be- the graphic warnings degree to which —the justifying cause FDA bears the burden of they encourage quit current smokers to speech, on it proposed restraint cannot and dissuade would-be smokers from tak- perversely claim—rather its own ing up 36,630, the habit. See Final Rule at —that analysis was irrelevant because lacked 36,707-08. such, As FDA’s interest “ef- precision and was based insufficient fectively communicating” the health risks requires data. Central Hudson of smoking merely description find present supporting data its claims by means it plans which to accomplish its prior imposing to on commercial burden goal reducing rates, of smoking and not an speech. independent capable interest of sustaining the Rule.16

Alternatively, FDA asserts an interest “effectively communicating health infor- IY. Conclusion regarding negative mation” the of effects Proposed In the FDA lamented cigarettes. Appellant’s Br. at 28. But as that their previous efforts to concedes, combat the FDA this “interest” purported companies’ tobacco advertising campaigns only by describes the means which is have been like bringing butter knife to a attempting to reduce rates: smoking gun fight. According FTC, the to effectively goal communicating of “[t]he companies spent approximately bil- is, course, $12.49 the smoking risks of on advertising promotion lion in 2006 quit, related to the decision viewer’s to alone, employing marketing start, and advertis- smoking.” never to Id. at The ing experts to incorporate current government’s to trends attempt reformulate its target their messages toward certain purely interest as informational is uncon- demographics. Proposed an Rule at vincing, as interest “effective” com- The graphic warnings represent FDA’s at- vague munication is too to stand on its Indeed, field, tempt playing only own. to the government’s the chosen level not buzzwords, through limiting Companies’ ability which it reiterates the to adver- tise, rulemaking, prompt question: an but forcing Companies obvious also to Allowing “effective” what sense? FDA bear the cost of disseminating an anti- to define however it sees fit smoking message. Supreme “effectiveness” But (1997). L.Ed.2d 369 But deference is disease risk the social costs associated Congress warranted where its "base[s] con- § with tobacco-related diseases.” Act. 3.9. id., evidence,” upon clusions substantial predictive Congress’s judgments are not “in- "choosing 16. The us of dissent accuses judicial meaningful sulated from Turner, review.” interest, ignore” thereby ignoring our ex- 512 U.S. at 114 S.Ct. 2445. Def- planation government's that the inter- stated here, appropriate not erence is because we "effectively” communicating est in informa- showing graphic find little evidence illusory tion is absent some barometer for

warnings purpose will advance stated assessing that effectiveness. "promoting] reduce cessation to statute — us, scrutiny the correct level of applied recently “[t]hat reminded Court persua- expression too [government] finds companies’ the tobacco First addressing quiet speech it to permit sive does challenge requirement to the Amendment v. messengers.” its Sorrell or to burden they health con- disclose —Inc., U.S.-, IMS Health cigarette pack- sequences smoking (2011). 2653, 2671, The 180 L.Ed.2d The ages and other advertisements.1 requires govern- Amendment First proposing cig- the sale of speech issue— inter- only to a substantial ment not state indisputably arettes —is commercial on commercial justifying regulation est contrary speech. Consequently, regulation also show speech, but application of strict district court’s scruti- goal. FDA failed directly advances that whether, ny, question is under the less substan- present any data —much adopted by traditional standards the Su- APA— required under the tial evidence Court, government’s warning preme enacting proposed their showing subject requirement label the “less accomplish agen- will exacting scrutiny” of v. Zauderer objective cy’s reducing stated Office pass The Rule thus cannot muster Disciplinary Supreme rates. Counsel under Hudson. APA directs Central Ohio, 626, 650-51, Court agency set aside [the] we “shall (1985), 85 L.Ed.2d 652 or to constitu- contrary action ... found to be scrutiny intermediate under Central Hud- 706(2). § right.” 5 U.S.C. We tional Corp. son Gas & Electric Public Service warning re- vacate the therefore York, 557, New 447 Commission U.S. agency. and In quirements remand the (1980). 566, 2343, 100 65 L.Ed.2d 341 S.Ct. doing, permanent so we also vacate the affirming grant summary judg- In the court, injunction issued the district in companies, ment the tobacco the court obligation of our to “set aside” furtherance applies wrong scrutiny, the level of disre- See, regulation. N. Air e.g., the unlawful garding companies’ history tobacco the Serv., Cargo v. United States Postal 674 the deceptive advertising govern- and (D.C.Cir.2012) (“It 852, quite F.3d 861 was “primary goal, ment’s which is to stated anomalous the district to issue [for court] effectively convey con- an re- injunction. When district court sequences pack- on and agency verses action determines that unlawfully, advertisements,” ordinarily acted agency ages Required in and identify legal course is to appropriate Warnings Cigarette Packages Ad- then be- agency, error and remand vertisements, 36,628, 36,633 Fed.Reg. 76 in cause the role the district court such (June (“Final 22, 2011) Rule”). an appellate situations is act as tribu- warning present labels fac- Because nal.”).

tually accurate information and address ROGERS, Judge, dissenting: Circuit misleading speech, commercial as defined Supreme in precedent, Court Zauderer govern- question The threshold this scrutiny appeal applies, ment whether district court need court, ruling companies applying scrutiny the district strict sought injunctive challenged requirement relief violated label the First warning requirement label under the First did Amendment. The district court not reach Amendment and the Proce- Administrative Reynolds the APA claims. See R.J. Tobacco ("APA”). granted Act The district court dure FDA, (D.D.C.2012). F.Supp.2d Co. v. 266 injunctive summary upon judgment relief and show that the warning require- label & Williamson Tobacco Corp., 529 U.S. ment is reasonably related to its 120, stated 135, 120 146 L.Ed.2d 121 and substantial in effectively interest con- (2000). They are highly also addictive. veying this information to consumers. See Consequently, use, “tobacco particularly Milavetz, Milavetz, Gallop & P.A. v. Unit- among children and adolescents, poses — States, -, ed U.S. 130 S.Ct. perhaps the single significant most threat 1339-40, (2010); Zauderer, L.Ed.2d 79 to public health in the United States.” Id. 650-51, 2265; U.S. Spirit Thus, S.Ct. 1291. the govern- Airlines, Inc. v. Dep’t Transp., 687 ment’s informational interest “take[s] (D.C.Cir.2012). F.3d Even treat- importance,” added Pearson, 164 F.3d at ing Zauderer’s “less exacting scrutiny” as 656, and independent merits consideration. limited to requirements disclosure serving Upon consideration of interest, governmental interest in preventing con- government appears to have met its bur- deception, sumer findings voluminous den under Central Hudson well as Zau- courts, of our own cited and supplemented derer, except with regard to the additional by Congress in the Family Smoking Pre- inclusion of “1-800-QUIT-NOW” num- (“Tobac- vention and Tobacco Control Act ber each label. “Act”), co Control Act” or Pub.L. No. Ill— Accordingly, because the district (2009), court Stat. 1776 and the Federal erred in applying Drug (“FDA”) strict scrutiny Administration the Final commercial issue, disclosures more than adequate to substanti- be- cause disclosures, ate that those interest. except as dis- below, cussed appear to survive lev- either Regardless of which level of scrutiny el scrutiny under traditional commercial applies, the court in failing errs to examine speech precedent, I would reverse the both of government’s stated interests. grant of summary judgment, and I re- In the rulemaking, the FDA articulated spectfully dissent. complementary, distinct, but interests effectively conveying information about the negative health consequences smoking of I.

to consumers and in decreasing smoking The of context the See, challenged warning e.g., rates. 76 Fed.Reg. at requirement label can be The summarized court dismisses the former First, briefly. it is beyond dispute interest “too vague,” Maj. Op. 1221, the textual thereby statements in the sidestepping warning much of la- the substan- required tial bels evidence under supporting Tobacco warning label Control requirement. convey Act factually Yet this court accurate “recog- information. government’s nize[d] that Tobacco use is the leading in preventable interest preventing consumer cause of in death may United It fraud/confusion States. well take on added causes or importance in the con- contributes to least sixteen text product of a cancer, kinds of can affect the as well as heart and cere- public’s Shalala, health.” disease, Pearson v. brovascular bronchitis, chronic (D.C.Cir.1999). F.3d emphysema, and Tobacco thereby “killing] more products necessarily 400,000 affect public than every year Americans —more health, significant and to a degree. AIDS, Unlike than alcohol, deaths from car acci- other products, consumer dents, prod- murders, “tobacco suicides, fires, drugs, and ucts are ‘dangerous health’ to when used combined.” Panel, President’s Cancer prescribed.” manner FDA v. Brown Promoting Healthy (2007) Lifestyles 61 sup- products, of their addictive nature at 61- see id.

(hereinafter Report”); “PCP the addictive- revealing is research pressed in tobacco contained nicotine 62. to nicotine, their efforts and denied used of substances ness addictive most of the “one delivery,” all Medicine, End nicotine levels of control Institute by humans.” around Blueprint products A their “engineer[ing] Problem: while Tobacco ing the (hereinafter Re (2007) sustaining “IOM addic- [nicotine] creating Nation 5 public aware company Despite increasing 1107. The tobacco tion.” Id. at port”). to dangerous one’s falsity” of their the[ ] ness that “knew of executives complete “a still lack health, people time” “made most “at the statements dis many serious understanding of deceive.” Id. the intent to statements with true nature smoking, the caused eases addiction, be like would or what un- Beginning or addic those either diseases experience health of the consumers dertook warn Mor Philip States United

tion itself.” smoking by requiring risks associated Inc., USA, F.Supp.2d ris warning on the of a health the inclusion (D.D.C.2006). particular Adolescents Federal packages. See side or be uninformed “to underestimate tend Advertising Act of Labeling and Cigarette smoking,” difficulty of stopping about (1965). 89-92, 79 Stat. 282 Pub.L. No. result, E-8; “they as a Report at IOM and for- the content Congress revised last risk of addic likely believe less 1984. See labels mat of these apply consequences tion and related Smoking Act Education Comprehensive eighty percent them,” at E-13. Over id. 98-474, 98 Stat. No. Pub.L. to became addicted of adult smokers (1984). then, regarding “evidence Since age eighteen; below bacco at or warn- prescribed the ineffectiveness smokers, prematurely half will die these accumulate,” sup- continued to ings has Re PCP disease. from a tobacco-related these porting conclusion facts, view these port at 64. stale, they fail to “are unnoticed that “to has recognized Supreme Court in an effective convey relevant information use, among children and particularly bacco Report at way.” IOM adolescents, single perhaps the most poses in 2009 background, health in Con- public In view this significant threat Williamson, Act. Brown & the Tobacco Control gress States.” United enacted 161, 120S.Ct. 1291. exists U.S. at consensus Congress “[a] found and medical communi- the within scientific dispute Second, beyond that it is also inherently are products ties that tobacco in engaged companies the have tobacco disease, cancer, heart cause dangerous and to consum- decades-long campaign deceive effects,” other adverse health and serious knowledge Despite facts. ers about these drug.” an addictive and “[n]icotine of consequences health negative “the 2(2), (3), § 123 Stat. Act Tobacco Control manipu- and smoking, the addictiveness (codified § Note at 21 U.S.C. at 1777 nicotine, harmfulness of lation of [and] (2011)). found that Additionally, Congress smoke,” company ex- secondhand “spent more companies in 2005 the tobacco made, “made, caused ecutives to be users, new to attract than [billion] contrary $13 statements approved public users, con- current increase retain current Philip States v. knowledge.” United long- generate favorable sumption, and Inc., 566 F.3d Morris USA smoking and tobac- toward term (D.C.Cir.2009). attitudes they “publicly Specifically, 2(16), misleadingly use,” § “often co id. the truth about the distorted denied and 2010) posed Rule”), portray[ing] socially (“Proposed the use tobacco as Nov. minors,” the FDA relied on the results of a id. consum- acceptable and healthful conducted, er study part, “to 2(17). quantita- § Based on these and other find- tively efficacy evaluate the of the [relative] relevant, ings, Congress required, as required proposed warnings in communi- one display of of nine textual rotating cating smoking the health harms of by graphics “color warnings,2 accompanied ..., ..., young adults adults youth” consequences depicting negative (“FDA study”). Rule, Final Fed.Reg. smoking” by to be selected the Secre- 36,635; 36,637-39. id. at In particu- see Services, Human tary of Health and on lar, the FDA focused on the meas- salience cigarette packages and other advertise- reported thirty-six ures for each of the 201(a), § ments. Tobacco Act Control images graphic study; considered (codified at 15 Stat. at 1842-45 U.S.C. these measures “[e]motional included reac- (2011))(hereinafter § 1333 Note “Section tions, reactions, cognitive and [reactions as 201”). requirements These become effec- to] whether the was difficult to tive months from the fifteen issuance 36,696. look at.” Echoing Id. the Insti- regulations. implementing See id. tute of in justifying Medicine its reliance 201(b). § measures, on these use of which “is Rule, FDA, acting In Final on well-established in the scientific litera- Secretary,3 behalf of the stated ture,” 36,696-97, id. at FDA explained “primary goal” selecting that “the literature suggests that risk in- images pursuant to Section 201 was “to readily formation is most communicated convey negative health con- effectively messages reactions, that arouse emotional pack- sequences report greater neg- that smokers who ages advertisements.” ative in response emotional reactions Fed.Reg. 36,633; see also id. at cigarette warnings significantly more 36,641. explained also “this likely thought to have read and about help effective communication can both to 36,639; warnings____” Id. at see Re- IOM nonsmokers, discourage including minor port considering at C-3. After the results children, initiating cigarette from use and study of the FDA “and a number of other encourage current smokers to consider factors,” FDA “concluded that the nine greatly reduce serious cessation required warnings effectively selected smoking poses risks that to their health.” health conse- communicate id.; 36,640. selecting see also id. at quences smoking.” Id. thirty-six graphic images pre- nine of the II. rule, proposed Required

sented in the Cigarette Warnings Packages Ad- degree protection “Because the af- vertisements, 69,524 Fed.Reg. (pro- depends forded the First Amendment precedes Congress contemplated 2. “WARNING" each textual the selection of statements, following: which consist of the images by the be would made the addictive”; “Cigarettes are “Tobacco smoke expertise of ... in view its "scientific to children”; your "Cigarettes can harm cause labels, impact labeling, and evaluate the disease”; lung "Cigarettes fatal cause can- advertising on behavior in to consumer order cer”; "Cigarettes cause strokes and heart dis- promote reduce risk of and under- harm ease”; "Smoking during pregnancy can harm standing impact product of the on your baby”; "Smoking you”; can kill and 2(44), § health.” Tobacco Act 21 Control lung smoke fatal “Tobacco causes disease in § U.S.C. 387 Note. 201, § nonsmokers.” Tobacco Control Act 15 § 1333 U.S.C. Note. 1226 “eommonsense” dis- regu has reasserted this sought to be activity

on whether speech, or noncom compelled commercial in the context of constitutes tinction lated determine we must speech, differentiating attempts “pre- mercial between first [speech] of the at classification proper politics, what shall be orthodox scribe Drug Youngs Bolger v. here.” issue nationalism, religion, or other matters of 65, 60, 103 S.Ct. Corp., 463 U.S. Prods. force to confess opinion or citizens word (1983) add (emphasis 2875, L.Ed.2d 469 77 attempts their or act faith therein” dis ed). ‘eommonsense’ “the Recognizing be “only prescribe shall orthodox what a com speech proposing tinction between Zauderer, 471 advertising.” in commercial transaction, occurs an which mercial (citations 651, at 105 2265 U.S. S.Ct. traditionally subject area omitted).5 quotation marks internal speech,” and other varieties regulation, Indeed, in view of “material differences in repeatedly has Supreme Court requirements between disclosure and out that the “Constitution accords structed id. 650, right prohibitions speech,” speech to commercial protection lesser 2265, Court Supreme 105 S.Ct. has constitutionally guaranteed to other than step Hudson, 447 U.S. at taken this distinction a further. Central expression,” (citations in the context of noncommercial 562-63, and inter Whereas 100 S.Ct. 2343 omitted).4 may speech, “compulsion speak marks Court be quotation nal transaction, Notwithstanding may speech. commercial any constituted 4. intimations Monis, Philip as Sorrell v. IMS F.3d at made in cases such See 566 1143-44. In- have - -, 2653, Inc., stead, companies U.S. 131 S.Ct. Health tobacco maintain (2011), Supreme Court L.Ed.2d 544 180 the character of the labels them- apply continued to the more deferential triggers application selves of strict scruti- Central to commercial framework of Hudson Appellees' ny. Turning See at 35-36. Br. 2667-68, speech restrictions. See id. holding premise Supreme Court's acknowledges, Maj. Op. court As the head, they Zauderer on its assert that "at- 1217-18, it therefore remains incumbent on regulate tempts to 'what shall be orthodox in distinguish this court to between commercial opinion' i.e., whether ... matters individ- — purposes speech noncommercial buy product— a lawful uals should and use degree determining protection afforded subject scrutiny.” Appellees' be must to strict companies' speech under the First tobacco Zauderer, 651, (quoting U.S. Br. at 31 and, consequently, the level of Amendment 2265). contrary, To because Morris, scrutiny apply. Philip See 566 F.3d opinion matters of over whether individuals event, Supreme any at 1142-43. buy product should use lawful fall rationale in “the Court's Sorrell—that 'fear squarely within the domain of commercial given people if would make bad decisions Court, recognized advertising Supreme justify information' cannot content- truthful not, regulation as the thereof is district Sorrell, speech,” 131 S.Ct. based burdens on ruled, scrutiny. subject court to strict (quoting Thompson v. W. at 2670-71 States Zauderer, 651, 2265; 105 S.Ct. U.S. at 374, Ctr., 357, 1497, U.S. 122 S.Ct. Med. Hudson, Central 447 U.S. at 100 S.Ct. (2002))- apply 152 L.Ed.2d 563 —does 2343; Morris, Philip 566 F.3d 1142-44. here, companies where it is the reason, For the court's invocation of non- suppress truthful information. seek speech compelled commercial cases like Woo- ley Maynard, v. 97 S.Ct. companies argu- advance no The tobacco (1977), Virginia L.Ed.2d 752 West State cigarette packaging their and ad- ment that Barnette, Board Education propose than anything other vertisements (1943), 87 L.Ed. they, could commercial transaction. Nor & v. Public Gas Electric Co. Utilities part of this determination that because court’s Pacific 1, California, Commission 475 106 companies' attempts persuade the to 903, (1986), Maj. Op. 89 L.Ed.2d 1 see purchase cigarettes, S.Ct. public to even in formats 1210-11, unavailing. is explicitly a propose that did not commercial

1227 prohi governs violative of the First Amendment as [a court’s] review.” 130 S.Ct. at speech” trigger 1339; bitions on and thus Spirit Airlines, see 687 F.3d at 412. id., scrutiny, same level of the context of requirement label meets compulsion speak speech, commercial to both of these criteria.

may be Amend less violative First First, government need show prohibitions speech ment than on and thus targeted speech commercial pres- a trigger scrutiny, loiver level see id. “possibility ents deception” or a 650-51, 105 2265. the ex S.Ct. “Because Milavetz, to “tendency mislead.” 130 tension of Amendment protection First (citation 1340 S.Ct. at internal quota- justified commercial is speech principally omitted). tion speech marks If the is actu- by the value to consumers of the informa ally misleading, it enjoys First no Amend- speech tion such provides,” the Court ex ment protection. Thompson See v. W. plained, requirements “disclosure trench Ctr., 357, States 367, Med. 535 U.S. 122 narrowly much more on an advertiser’s 1497, (2002); S.Ct. 152 L.Ed.2d 563 Cen- prohibitions interests than flat do Hudson, 566, tral 447 U.S. at 100 S.Ct. 651, speech....” Id. at 2265 S.Ct. (citations “the Where likelihood of deception” omitted); 14, 105 see id. at 651 n. one,” is a “hardly speculative 2265; govern- Va. Bd. v. Pharmacy Va. ment Council, Inc., produce need “evidence that Citizens Consumer 425 U.S. 748, 770, 1817, [the] advertisements are misleading,” 96 S.Ct. 48 L.Ed.2d 346 as (1976). may rely the court Consequently, “unjustified while on experience instead or unduly require Airlines, and common burdensome disclosure sense. Spirit (alteration might ments offend First Amendment original) F.3d at 413 (quoting by chilling protected (internal speech[,] Milavetz, 1340) commercial 130 S.Ct. at quo- ... an rights advertiser’s are adequately omitted). Milavetz, tation marks In protected long require as disclosure Supreme Court concluded that law firm’s reasonably ments are related to the State’s “inherently advertisements were mislead- in preventing interest deception of con ing” they “promisefd] because ... debt Zauderer, sumers.” 471 U.S. at 105 relief any without to the possibil- reference Milavetz, 2265; 5.Ct. 130 S.Ct. ity filing for bankruptcy, which in- 1339-40.6 Milavetz, herent costs.” S.Ct. at Thus, any evidence, absent additional

As Supreme explained Court in Mi- lavetz, Court considered the omission of a refer- challenged where the requirements possible ence to a outcome “inherent misleading “directed at commercial costs” be speech,” sufficiently they “impose misleading and where as to a disclo- requirement sure rather warrant review than an affirma- under Zauderer. Even tive speech, limitation on ex- the less advertisements that all display the costs of acting scrutiny may described in Zauderer a service remain misleading. Spir- In Health, recognized, 6. As other have circuits in Zau- State City Rest. Ass’n v. N.Y. Bd. of (2d Supreme appears simply Cir.2009); derer the Court 556 F.3d 133 & n. 21 Rowe, government pro- have held Mgmt. that a interest Pharm. Care Ass’n v. 429 F.3d tecting (1st possible Cir.2005); deception consumers from n. Nat’l Elec. Mfrs. Sorrell, support require- (2d disclosure Ass’n v. 272 F.3d Cir. sufficient particular 2001). ment —not that is nec- interest view of the likelihood of consumer essary here, requirement. such support deception confusion shown there is Zauderer, 650-51, 2265; scope no need determine whether City Lottery encompasses Discount & United Tobacco Zauderer other in States, (6th Cir.2012); 674 F.3d N.Y. terests. 1228 existing warnings. notwithstanding the Depart- ers Airlines, addressed this court

it (“DOT”) City Lottery & v. Tobacco rule re- Discount See Transportation ment (6th States, number F.3d 562-63 prominent 674 the most United quiring that Cir.2012). further, be the dem- goes advertisements even in airfare Yet displayed Spirit Air- of taxes. warnings actually inclusive price, these onstrating total Notwithstanding lines, at 408-09. F.3d 687 cru- convey appropriately “have failed preexisting compliance the airlines’ as the nature and information such cial advertisements requiring regulations associated with the health risks extent of well as cost as ticket the entire display Rule, 76 Final Fed. smoking cigarettes.” tax, accepted the court any amount of Rule, 36,632; Proposed at see Reg. determination, on common based DOT’S studies); 69,530-31 (citing see Fed.Reg. at “that it was deceitful experience, and sense Tobacco, at 674 F.3d 563-64. Discount also prominent the most misleading when understand though “most smokers Even anything other an by airline price listed certain statistical risks smoking poses travel.” total, price of air final than the health,” noted the FDA studies to their pro- court Accordingly, the 413. Id. at “many appreciate fail to show rule under Zauderer. ceeded to review of those risks.” severity magnitude at 413-14. See id. 36,632. Rule, at More- Fed.Reg. Final affirmatively mislead- any Even absent over, underestimate their “many smokers 1214-15, at statements, Maj. Op. see (noting, example, risks.” Id. personal other advertise- cigarette packages minority of in studies which display the final costs of that fail to ments they were at believed increased smokers manner are at prominent in a disease). Many cancer and heart risk for advertise- misleading as the airline least the effects of also people are unaware Existing warn- Spirit in ments Airlines. others. See id. secondhand smoke 1984, appear on one ings, last revised in 36,633. particular fail And adolescents percent occupy only four panel side nature of highly addictive appreciate Rule, packages. See id.; Philip also see Mor- cigarettes. sense, expe- Common Fed.Reg. ris, F.Supp.2d at 578. rience, and scientific evidence substantial Furthermore, (contrary to if Su- even that these support the conclusion precedent) court’s preme Court and this example,” “For are ineffective. to establish findings inadequate were these “concluded that the Institute of Medicine mislead,” court “tendency to has warnings are both ‘unnoticed package ” advertisements, that certain recognized Reg. Proposed stale.’ alone,” if taken “although misleading 291); 69,530 Report see (quoting IOM misleading” when “consid- “become[] can thus generally id. light past advertisements.” ered than sufficient evidence provided more FTC, 562 F.2d Co. and other adver- Warner-Lambert cigarette packages (D.C.Cir.1977); id. at n. 57.7 likely to mislead consum- remain tisements requisite Congress provide the "fram- distinguish could attempts Warner- The court high Especially ing.” view of level ground that the FDA on the "does Lambert Congress crafted the specificity with which as a remedial measure not frame this rule requirement, it was not incum- deceptive label specific designed to counteract supplement the upon the con- Maj. Op. bent Companies.” made claims findings already supporting the re- gressional reasoning Even if Warner-Lambert’s Nonetheless, measures, did the FDA frame quirement. surely were limited remedial

1229 words, “tendency object mislead” companies other that “mo on may through “capitalize nopolize prominent arise efforts to all the space ciga on by continuing ... ad- rette prior deceptions packages, thereby make it im in that possible vertise a manner builds on consum- for manufacturers to communicate misperceptions.” Philip existing messages ers’ their own and their own view Morris, at (citing points 566 F.3d 1144-45 War- in prominently packaging,” Joint 769). ner-Lambert, Co., F.2d at This court Reynolds 562 Comments R.J. Tobacco acknowledged tendency already Lorillard Tobacco Co. & Commonwealth (Jan. 2010) (J.A. 216) cigarette marketing Brands, 9 mislead consumers Inc. companies’ added), decep- (emphasis objection based on the decades of rings their regarding tion each of the risks identified in the any hollow absence of evidence of Morris, in in warning Philip difficulty labels. See conveying their desired mes 1144; supra sages 566 F.3d at Part I.8 Consis- notwithstanding experi a decade of decision, Congress tent with that found ence warning under similar label re “[tjobaceo product quirement Rule, often in advertising Canada. 76 36,633, misleadingly portrays Fed.Reg. 36,698; use of tobacco as Appellants’ Br. socially 6-12; to mi- acceptable and healthful at Add. v. Fla. Dep’t Ibanez cf. 2(17), § nors.” Control Act 21 Regulation, Tobacco Bus. & Prof'l findings 146-47, § U.S.C. Note. These 129 L.Ed.2d 118 (1994). “adequate more than Consequently, establish fail they to show deception likelihood of this case ‘is hard- warning label requirement is “an ” Milavetz, ly a speculative one.’ S.Ct. affirmative limitation on speech.” Mila 1340; Tobacco, vetz, 1339; see 674 F.3d at Airlines, Discount Spirit see 687 F.3d 413-14. To the extent labels warning factually disclose accurate Second, warning label requirement information about the cigarettes being ad “an impose does not affirmative limitation vertised, then, appro Zauderer offers the Milavetz, 1339; speech,” 130 S.Ct. at priate of scrutiny. level rather, warning labels infor- disclose mation about the conse- companies The tobacco not challenge do (The quences smoking. exception accuracy one the factual of the textual state- infra.) provisions discussed Unlike other ments included labels. See Act, of the Tobacco Control 201 Appellees’ Section Br. at 54-55. they Nor could conveyed so, does not restrict information do reasonably given the scientific con- consumers, requires in- products but additional sensus “that tobacco are inher- conveyed ently cancer, formation to be with aid of dangerous and cause heart graphic images. Although disease, the tobacco and other serious adverse health designed its rule as a measure to counteract tobacco companies would commit specific gaps knowledge violations, in consumers’ Philip future RICO United States v. smoking, health risks of see Final Inc., (D.C.Cir. Morris USA 686 F.3d Fed.Reg. 36,632-33 gaps align 2012), — past where their RICO violations con specific deceptive claims made the tobacco proven sisted "misstatements acts of Morris, companies, Philip 566 F.3d at deception concealment and made ... inten 1106-07, 1118-19. tionally part deliberately of mul ti-faceted, defraud,” sophisticated scheme to Indeed, addressing injunction, a RICO 834; Philip id. at see United States v. Monis recently acknowledged this court the "reason- Inc., USA, (D.D.C. F.Supp.2d 74-75 notwithstanding able restric- likelihood”-— imposed tions Act— Tobacco Control 2011). 2(2), Final smoking,” § 21 and disease caused Control Act Tobacco

effects.” 36,696, Rule, Note; Rule, 76 at and the tobac- Fed.Reg. 76 § see Final 387 U.S.C. Rule, companies suggest not Proposed 75 co do otherwise. 36,641; FecLReg. at That are not com- 69,527-29. images invariably The for such question Fed.Reg. at forting necessarily at does not analysis, to look First Amendment purposes of the As the then, make them inaccurate. FDA went graphic images select- whether the is fact, severe, explain “the accompany factually on obvious ed FDA to life-threatening disfiguring and sometimes statements render accurate textual conveyed smoking in the or controversial. To effects of nonfactual warnings required warnings disturbing and the the court must— question, answer this not, Maj. Op. images appropriately ... selected re- court does see although [it] Rule, Fed.Reg. flect this Final 76 at images in connection fact.” at 1216-17—view 36,696. they warnings accompany. with the textual See, Transp., Am. Inc. v. e.g., S. Air companies object The tobacco further Inc., 1010, Cos., F.2d 1015 877

Broad. images were graphic chosen (D.C.Cir.1989). information, nega- but to convey evoke thereby sug discourage tive and

Contrary companies’ to the tobacco emotions 24, smoking. Br. Appellees’ Br. at the use of at 26-27. gestion, Appellees’ however, enhanced, if digitally explained, even that “con- images, illustrated, symbolic, does not necessari evidence shows that siderable scientific warnings strong The health that elicit ly warnings nonfactual. emotion- make reactions,” al and Supreme recognized cognitive in Zauderer reflected Court measures, pro- their “are pictures use of illustrations or salience better “[t]he effectively cessed important serves com and more communicate advertisements it functions: attracts the atten information about the health con- municative Rule, sequences to the smoking.” tion audience advertiser’s 76 of the Fed.Reg. 36,642; 36,639, at may impart also serve to at see id. message, and 46; Zauderer, Thus, directly.” 471 IOM FDA’s Report information C-3. 2265; see N.Y. Times Co. reliance measures in the on salience was (D.C.Cir. NASA, v. F.2d service inconsistent 1005 of—not with—the (2011) 1990); see, § warnings’ purpose. e.g., 16 C.F.R. 1500.14 informational More- over, accurate, emotive, (requiring factually per- skull-and-crossbones and poisonous mutually products). descrip- the Final suasive are not exclusive tions; quality FDA concluded “the effects the emotive the selected “are, fact, images necessarily accu undermine the images shown” in the does not warnings’ accuracy.9 rate depictions Comprehend- effects of sickness factual Supreme explained, court relied on tual. Court later The district Entertainment As Blagojevich, games F.3d because video "communicate ideas— Association Software (7th Cir.2006), messages,” they proposition enjoy full even social requirements "ultimately protection, guards First label communi- Amendment which subjective highly against government expres "to cat[ing] a controversial efforts restrict ideas, message, message” scope "purely sion fall outside because of its its sub matter, ject per- or its content.” Brown v. Entm't factual and uncontroversial” disclosures — U.S.-, Ass’n, Reynolds, R.J. Merchs. mitted under Zauderer. (2011) (citation (quoting Blagojevich, F.Supp.2d at 274 180 L.Ed.2d 708 omitted). 652) (internal quotation quotation F.3d internal marks The labels marks omit- ted). represented Blagojevich exactly Blagojevich involved that were issue in But labels challenged provision necessarily subjective exclusively such an effort: the re- nonfac- re- convey the facts about the actual harms no information about conse- smoking likely sulting provoke quences from whatsoever. See Ap- discourage emotional reactions also to pellees’ objec- Br. 25-26. All of these Rule, 76 cigarettes. the use of See Final pertain tions to the images divorced from compa- Fed.Reg. at The tobacco accompanying their text and thus fail to argument nies’ to the counterintui- leads address the relevant question —whether concerning the more tive conclusion that images render the overall message particular health effects of a conveyed by the warning labels nonfactual. product, govern- the more constrained the they with accompany, Viewed the text mandating ment is in disclosures of those images none of these that effect. Unsurprisingly, compa- facts. the tobacco image accompanying the textual point any sup- nies neither to case law warning “Cigarettes are depicts addictive” port any legally nor to argument this smoking a man a through tracheotomy significant distinction between fact and opening in his throat. Viewed with the Appellees’ emotion. See Br. at 24-25. text, image accompanying conveys this Rather, public greater the harms to health, tenacity nicotine addiction: even greater government’s inter- after undergoing cancer, est those under informing surgery consumers of for one Pearson, harms. 656. F.3d at might be unable to abstain from smoking. especially great This interest is view of Indeed, government represented counsel companies’ the tobacco extensive advertis- situation is not extreme so or ing Congress found was “often mis- unusual as court the tobacco and com- designed leading! to attract adoles- ]” suggest. panies Compare Arg. Oral Tr. at users, expand cents retain and new (stating fifty percent of neck and consumption, “generate favorable smoke) patients head cancer continue long-term attitudes toward 1216-17; Maj. Op. Appellees’ Br. Tobacco Act use.” Control This representation support finds 2(16X18), § § 387 Note. U.S.C. from the President’s Cancer Panel. (includ- among “Smoking cancer survivors general objections Aside from their with, diagnosed being individuals treat- graphic images inclusion of for, cancer),” ed surviving the Panel reasons, spe- companies above the tobacco an reported, underappreciated “is and un- cifically object to five of the nine selected problem.” Report at derstudied PCP images. images of They maintain that the “[Sjmoking prevalence population in this a man smoking through tracheotomy a approximately equivalent people with no hole in his throat and a man with chest cancer,” history “mounting despite evi- staples autopsy convey on an table mis- confirm[ing] dence the adverse effects of leading messages consequences about the smoking on man continued cancer treatment smoking, images and that the of a regardless wearing reading QUIT,” baby a t-shirt “I a outcomes of treatment modali- smoke, enveloped crying ty.” image and a woman Id.10 This serves to un- thus quired games placed to be no the label nonfactual because there were facts to convey. explicit," "sexually deemed defini- the state’s opinion-based tion of “far which was more Cong. S6021 10. See also 155 (daily Rec. ed. question particular than the of whether a 3, 2009) (statement Lautenberg) June of Sen. any given product.” Bla- chemical is within who, (sharing testimony "despite of woman gojevich, at 652. were 469 F.3d These labels essentially she had lost her fact that voice significant. Secondhand sequences are factual, uncontrover- and now

derline as a cause of “has been established highly smoke are sial, cigarettes statement 3,000 lung cancer deaths approximately addictive. in the Unit- among nonsmokers year each a man with sta- image of Similarly, the States”; contrib- significant a also “is ed autopsy an table lying on in his chest ples cardiac, and other dis- respiratory, utor to textual warn- with, against, the works exposed to it.” PCP eases in individuals Assuming you.” kill can ing “Smoking 95; As a see id. 95-96. Report consequence a common are not “autopsies result, exposure secondhand smoke 25, neither Br. at Appellees’ smoking,” 38,000 approximately the lives of “claims yet the status gravestones; coffins or at 95. Ad- annually.” Id. nonsmokers autopsy-scarred an images of evoked cigarettes, purchasers dressing potential man, coffin, gravestone —death—is convey the mes- warning labels these two smoking. See consequence of common smoking poses risks sage 69,526; Rule, at Fed.Reg. 75 Proposed them, family members but also to their might 64. The Report at PCP and others. image decaying of a for an opted have pile portray a of ashes cadaver or of image is the Initially problematic more smoking, consequences of likely physical “I wearing a t-shirt that reads of a man in images limited to such it was not but companies QUIT,” which the tobacco An consequences. those representation of no information about “provides maintain merely way one of commu- autopsy scar is (or quit- of smoking risks even the benefits dead; in image that the man nicating But the to- ting).” Appellees’ Br. with the textual viewed in connection objection, companies overstate bacco image conveys message warning, the image does address the benefits for the can result in death. smoking image, the FDA viewed this quitting. As warning in the textual connection with in baby enveloped images The smoking greatly now reduces “Quitting crying depict both smoke and woman health,” conveys it your serious risks to smoke. significant harms secondhand I message quit, “I am alive and accompany the textual warn- images These healthy.” message comports This with your can chil- ings smoke harm “Tobacco “[sjmoking cessa- showing fatal evidence smoke causes dren” and “Tobacco conse- nonsmokers,” tion decreases the risk of the health respectively. lung disease Rule, smoking.” Proposed 75 image, quences commenters Regarding the former 69,529. example, per- “For Fed.Reg. at “clearly parents noted that it would inform have quit smoking age before they presence in the sons who that when smoke children, dying the risk of the next 15 their children will also be one-half their years compared continuing smokers.” Fed.Reg. inhaling toxins.” any Nothing image, in this or other 36,650. image, as the FDA Id. The latter FDA, non- by the renders image the “emotional suffer- selected explained, highlights controversial the textual warn- lung fatal disease and factual or ing” dimension of warning accompanies. The labels consequences ing health “negative other accurate, factually uncontr- qualify as exposure.” smoke thus caused secondhand con- oversial disclosures. negative Id. at Those health unbreakable"). box, through people is almost the hole in her ... still smoked throat,” explaining hold on "[t]he warning consequences labels are Because the “direct- consumers these (espe- speech,” and misleading commercial cially ed against companies’ histo- require- they “impose disclosure because ry deception), of consumer the expert ment rather than an affirmative limitation judgment exercised FDA in by the select- speech, exacting scrutiny less graphic images, and the absence of gov- should described Zauderer” have any evidence that similar restrictions else- the district court’s review. Mila- erned where have hindered the tobacco compa- vetz, 130 While mindful that S.Ct. ability get nies’ their message own “unjustified unduly burdensome disclo- n consumers, the burden on the tobacco requirements might offend the First sure companies’ rights First ap- Amendment by chilling protected Amendment commer- pears unjustified. undue neither nor court have cial the district should speech,” warning requirement appears label thus whether the re- determined label Zauderer, constitutional. See 471 U.S. at “reasonably to the quirement was related” S.Ct.-2265; Tobacco, Discount cf. con- government’s effectively interest at 569. F.3d veying consequences Zauderer, consumers. Zauderer, Attempting to distinguish 2265; Milavetz, adopts court the view that the warning 130 S.Ct. at 1339-40. requirement label involves “elements of exacting scrutiny,” Under this “less the compulsion and forced subsidization.” warning requirement appears pass label Maj. Op. at 1211. Commercial disclosure muster. The government only justify need requirements can involuntary involve requirement the the on basis of substantial See, compliance statements and e.g., costs. on evidence the record. See Nat’l &Cable Milavetz, 1340-41; 130 at S.Ct. Meese v. FCC, 996, v. Telecomms. Ass’n 555 F.3d Keene, 465, 467, 481-82, U.S. 481 107 S.Ct. (D.C.Cir.2009). 1002 In view of the scien- (1987). 1862, Nonetheless, L.Ed.2d 95 415 supporting tific literature the reli- FDA’s Supreme the Court has reviewed such re on reported ance the salience measures quirements under a different level of scru Rule, study, Fed.Reg. its see Final 76 at tiny than compelled noncommercial 36,638, 36,642, 36,649-57, the label warning speech, Pac. Gas & Elec. Co. v. Pub. cf. requirement reasonably is related to the Cal., 1, 8-9, Utils. Comm’n 475 U.S. 106 government’s effectively interest com- 903, (1986), S.Ct. 89 L.Ed.2d 1 and under a municating about information the different set of than considerations com consequences smoking. And in pelled private speech, subsidies of cf. literature, view extensive scientific see Foods, Inc., United States United 533 (cit- Rule, Proposed 69,531 Fed.Reg. at 405, 2334, 150 L.Ed.2d 438 C-3-4), Report IOM at international (2001). Contrary to the court’s conclusion experience, 69,531-32, see id. domestic case questions “this raises novel about Rule, experience, Fed.Reg. see Final scope government’s the of the authority,” 36,632, sense, and common the size 1212, Maj. atOp. given congressional placement warning of the labels is also findings regulatory supporting record reasonably Al- related interest. the government’s effectively interest in in though graphic images may some evoke forming negative, consumers of the indeed reactions, it is undisputed emotional lethal, potentially consequences of smok smoking can cause health conse- ing, warning quences they depict. requirement Given label falls magnitude government informing scope Supreme interest within Court’s (3) est; regulation directly Amendment treatment “whether traditional First (4) interest; whether advances” that commercial disclosures. regulation not more extensive than “is images envisioned in the graphic Unlike necessary that interest.” Cen- is to serve however, inclu- additional Section Hudson, 447 U.S. 100 S.Ct. tral number “1-800- telephone sion of prong to the third regard 2343. With label does warning each QUIT-NOW” on test, Court has clarified Supreme this information directly factual disclose that, government “must dem- although smoking. consequences of the health about it onstrate that the harms recites are real pur- requirement, imposed and that its will in fact restriction alleviate authority, separate statutory suant degree,” may to a it do them material so Rule, 387f(d), Final 76 Fed. § U.S.C. and, “by reference to studies anecdotes 36,681, provide place “to Reg. at in order altogether, locales pertaining to different other members where smokers and solely history, even con- based infor- can cessation public obtain sensus, and common Loril- simple sense.” specifically from trained mation staff Reilly, lard Tobacco Co. v. by delivering unbiased help quit smokers (2001) 150 L.Ed.2d 532 advice, information, and evidence-based (citations quotation and internal marks Rule, Fed.Reg. support,” Proposed omitted). regard And with to the fourth view, inclusion of In the FDA’s does not have prong, “[t]he the effec- the number also enhance would adopted show that it has least restric- tiveness of the labels. See bringing regulato- tive means about 36,681. To the ex- Fed.Reg. objective; ry it does not have to demon- directed toward reduc- purpose tent fit; perfect strate means —ends rates, constitutionality the of ing satisfy not a it does have to court that mandatory in the inclusion the number’s the option.” chosen best conceivable Nat’l under warning requires labels examination Cable, 555 at 1002. condi- F.3d “The Zauderer, to a different standard than tion is that regulation proportionate the be I which now turn. advanced,” sought to the interests be “a fit id.—that there be reasonable be- III. the regulato- tween means and ends of the scrutiny inapplicable Where Zauderer is Lorillard, scheme,” 561, ry 533 at 121 U.S. speech regulation, “the commercial 2404; 556, at S.Ct. see id. 121 S.Ct. 2404. clear: Supreme Court’s bottom line is the government affirmatively assuming images, demon- Even that the graphic must ‘narrowly by depicting negative strate means are tailored’ the actual conse- thereby government goal.” quences cigarette smoking achieve substantial Morris, reactions, Philip evoking beyond (quoting “go 566 F.3d at 1143 emotional Fox, 469, 480, Trs. 109 ... purely Bd. factual and accurate commer- 3028, (1989)); disclosures,” 1212, Maj. Op. see S.Ct. 106 L.Ed.2d 388 cial at there Milavetz, applying exception, 130 would still with appear, S.Ct. one no scrutiny, warning this level of intermediate the basis to label conclude the (1) requirement compa- court must determine whether the violates the tobacco rights. speech activity lawful nies’ First Amendment The court “concernís] [is] enjoys ... misleading,” opposite such that reaches conclusion dismiss- (2) protection; ing government First whether one of the Amendment two interests rulemaking. analysis inter- in asserts substantial stated Its

1235 Co., herring of cre- Coors Brewing to a red its own Rubin v. 514 directed in Although there are statements ation. 131 L.Ed.2d 532 gov- (1995)). rulemaking regarding record This court has previously “recog in reducing smoking ernment’s interest government’s nize[d] interest in rates, see, Rule, Fed.Reg. 76 e.g., Final preventing consumer may fraud/confusion Rule, 36,629; Fed.Reg. at Proposed 75 importance well take added in the con record, 69.525, less nothing much product text of a that can affect the press briefing House cited the White public’s use, health.” And Id. “tobacco court, Maj. Op. sug- see at 1212 n. particularly among children and adoles these were gests statements intended cents, poses perhaps single sig most ef- clearly stated interest override public nificant threat health the Unit fectively communicating about information Williamson, ed States.” Brown & consequences smok- 161, 120 1291. Congress U.S. at (Nor does ing consumers. the Institute agreed. 2(29), § See Tobacco Act Control objec- characterization of the of Medicine’s § The government U.S.C. Note. Maj. Op. at regulation, tives of tobacco see effectively conveying interest the nega from 1218 n. detract the FDA’s own consequences tive health of smoking takes government’s “primary” statement greater importance on even in view of the interest.) contrary, in To the the rulemak- highly addictive nature of and the that, the FDA repeatedly stated fact that “the most harmful serious conse “[cjonsistent Act, the Tobacco Control cumulative, quences smoking are purpose required warnings is of these occur in the distant Philip future.” Mor effectively graphically to communicate ris, F.Supp.2d at 577. real, very scientifically ad- established requirement appears label consequences smoking.” verse health Rule, prongs to meet third and fourth 36,641; Fed.Reg. id. see 36,630, 36,633-42, 36,646-47, 36,696-97, rulemaking Central Hudson as well. The Rule, 36,699; Fed.Reg. at includes Proposed record substantial evidence from 69.526, 69,531-35. Even under experience, Proposed Central international scrutiny, court 69,531-32, Hudson intermediate Fed.Reg. and the fully have both Rule, should examined of Study, see Final 76 Fed.Reg. at interests. government’s stated 36,637-42, supporting government’s warnings reasoned determination that the government’s informational interest “directly would advance” its informational effectively conveying in interest, by “ensuring] not least that the consequences smoking clearly qualifies message[s] actually health risk seen [are] “substantial” under second prong in by consumers instance.” first Com Supreme Hudson. “The Court Central Brands, States, monwealth Inc. v. United question said ‘there no [the has is that 512, F.Supp.2d (W.D.Ky.2010), 678 530 in ac government’s] ensuring interest Tobacco, part, relevant Discount curacy of commercial information in the aff'd ” Pearson, govern 674 at 569. “The harms substantial,’ [the F.3d marketplace 164 is Fane, in part by recites real”—caused ment] at (quoting 656 F.3d Edenfield 761, 769, 1792, misleading” advertising the “often that 113 123 507 U.S. S.Ct. (alteration (1993)) part healthy lifestyle is with L.Ed.2d 543 in original), consequences out is there substantial government “and substantial —and health, safety, support government’s evidence con ‘promoting interest ” citizens,’ warning requirement label (quoting and welfare of its id. clusion that 1236 Final relapse,” on their own try quit to a harms] [those alleviate in fact

“will 36,681. compari- Rule, Fed.Reg. at Lorillard, at 533 U.S. degree.” material counseling interven- consensus, or no to minimal “[H]istory, son 555,121 ” tions, “signifi- have been found quitlines sense,’ (quoting id. common ‘simple Id. at abstinence rates.” It, Inc., cantly increase For 515 U.S. Bar v. Went Florida Human 36,687 Health & (citing Dep’t 2371, L.Ed.2d 541 115 S.Ct. Serv., Servs., Treating To- Health Public warning (1995)), as well demonstrate Update Dependence: bacco Use prong the fourth meets requirement label 2008)); Report at (May see also IOM The failures test. Hudson of the Central experience referenced International convey C-7. efforts to previous Rule, Final 76 Fed. small, rulemaking, see in the through the relevant information 36,682, the com- supports further Reg. at on the side textual informing proposition Rule, mon sense Fed.Reg. Final see packages, likely is resources Rule, smokers of cessation Fed.Reg. 36,631-32; Proposed attempts. quit of successful increase rates 69,530-31, the alternatives similar suggest, Appel- now companies the “1- inclusion of But the additional 58-59, to show are sufficient lees’ Br. at warning 800-QUIT-NOW” number on the labels, im- warning prong the fourth labels does not meet extensive than neces- ages, are “not more promi- The number is Hudson. Central government’s substan- sary to serve” terms, imperative di- nently presented conveying in effectively interest tial “QUIT NOW.” That recting consumers to information to consumers. the tobacco directly contradicts command message point at the desired “1-800-QUIT- companies’ exception is the The one mentioned, sale, significant burden thereby imposing As telephone number. NOW” “In speech. commercial protected con- on their directly to inform designed it is not addressing prong final previous [the] cases .consequences of of the health sumers test,” the Supreme Hudson in their of the Central to assist smokers smoking, but if the has “made clear that Govern- 76 Fed. Court cessation efforts. in a man- achieve its interests Hudson ment could Under Central Reg. at speech, or that that does not restrict scrutiny, government’s ner intermediate speech, the Government must restricts less reducing smoking rates interest Lorillard, See, Thompson, 535 U.S. e.g., do so.” substantial. doubtless re- label 2404; & S.Ct. 1497. Unlike 121 S.Ct. Brown 533 U.S. to Section Williamson, quirement imposed pursuant fail- response 201 in to the demonstrated evidence to 1291. There also is substantial attempted, less burden- previously ures of FDA’s determination support the the inclusion warning requirements, “1-800-QUIT-NOW” num- some display of the fol- “1-800-QUIT-NOW” number interest. of the directly advance this ber will of the consideration upon apparent lows no psychological effects of biological of con- alternative means effectiveness of smoking cessation ex- nicotine “can make resources, 62; necting to cessation difficult,” smokers tremely Report PCP an insert.11 Absent try package such as a quit” smokers percent “about 40 of would why alternatives explanation such percent “95 of those who year, each but See, www.lorillard.com/?s=quit+smoking and the 30(citing e.g., Appellants’ Reply atBr. another, http://www.sfntc.com/ subsidiary displayed information cessation resource Quit-Smoking/Overview.aspx). company, http:// the websites of one tobacco inadequate, government showing has failed and the be such information. In fit,” view of Lor- the record evidence—as requisite to show the “reasonable well as illard, experience and common support- 2404. See S.Ct. sense— ing power the communicative 535 U.S. at Thompson, images accompanying textual warnings, 1497.12

no such appears distinction to exist. IV. demonstrating Given the evidence tenacity addiction, of nicotine the young Finally, noting it bears that the court’s age at which the vast majority of smokers understanding precedent governing begin smoking cigarettes, these smokers’ scrutiny, level of as well appropriate “incomplete understanding of the addictive of a well as its dismissal established and related, nature of tobacco use that interest, government is incon- substantial part, to their inaccurate assessment of the Supreme “princi- sistent with Court’s smoking risks and their they belief that justification pal” “extending] for quit can at any time and therefore avoid protection First Amendment to commer- addiction,” IOM Report at and the speech” cial value to consumers of —“the significant negative health consequences of speech provides.” the information such smoking, government an interest Zauderer, 471 U.S. at paramount importance effectively Supreme 2265. The Court has reiterated conveying information about the health justification in this the tobacco context. risks of smoking to adolescent would-be Addressing “substantial” restrictions on smokers and other consumers. The tobac- advertising imposed by Massa- companies’ co decades of deception regard- chusetts, the Court identified as the risks, ing these especially the risk of addic- “countervailing First Amendment inter- tion, buttress Contrary this interest. companies’ ests” the tobacco “interest arguments, their nothing in the Supreme conveying truthful information about their Court’s commercial speech precedent products to adults” and adults’ “corre- would restrict convey- sponding interest in in- receiving truthful ing ways these risks in already that have products.” formation about tobacco Lor- proved prohibit ineffective or would illard, S.Ct. 2404. government from employing the communi- justification, view the Court cation tools tobacco companies have wield- requirements has treated disclosure “as great years. ed to effect over the constitutionally preferable outright Pearson, suppression.” reasons, 164 F.3d at 657 For these the district court cases). Here, (citing recent govern- erred in applying scrutiny strict in sustain- required companies ment has the tobacco companies’ the tobacco as-applied First state, show, but also to challenge Amendment to the Tobacco Con- significant negative consequences trol Act issuing and the and in using product injunction. their as intended. The permanent Because the distinction, (absent principled court identifies no requirement label “1- number) purposes determining 800-QUIT-NOW” applica- appears scrutiny, stating ble level of between the challenge survive the First Amendment labels, companies Neither the tobacco nor the struck from and it can be 12. rulemaking suggests EPA, record the FDA severed. North Carolina v. 531 F.3d promulgated would not have the Final Rule (D.C.Cir.2008). "1-800-QUIT-NOW” had the number been Hudson, or Central either Zauderer under remain for the It would reverse.

I would remand to address court on

district under the challenges companies’ Act, supra Procedure

Administrative 1.

note HAMDAN, Petitioner Ahmed

Salim America,

UNITED STATES

Respondent.

No. 11-1257. Appeals, Court of

United States

District of Columbia Circuit. 3,May

Argued

Decided Oct.

Case Details

Case Name: R.J. Reynolds Tobacco Co. v. Food & Drug Administration

Court Name: Court of Appeals for the D.C. Circuit

Date Published: Aug 24, 2012

Citation: 696 F.3d 1205

Docket Number: 11-5332, 12-5063

Court Abbreviation: D.C. Cir.