Case 6:20-cv-00176-JCB Document 1 Filed 04/03/20 Page 1 of 52 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`TYLER DIVISION
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`CIVIL ACTION NO. __
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`R.J. REYNOLDS TOBACCO COMPANY;
`SANTA FE NATURAL TOBACCO
`COMPANY, INC.; ITG BRANDS, LLC;
`LIGGETT GROUP LLC; NEOCOM, INC.;
`RANGILA ENTERPRISES INC.; RANGILA
`LLC; SAHIL ISMAIL, INC.; and IS LIKE
`YOU INC.;
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`Plaintiffs,
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`
`v.
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`UNITED STATES FOOD AND DRUG
`ADMINISTRATION;
`
`UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES;
`
`STEPHEN M. HAHN,
`in his official capacity as Commissioner of the
`United States Food and Drug Administration;
`and
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`ALEX M. AZAR II,
`in his official capacity as Secretary of the United
`States Department of Health and Human
`Services;
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`
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`
`
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`Defendants.
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`COMPLAINT
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`

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`INTRODUCTION
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`1.
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`For nearly fifty-five years, cigarette packages have included textual warnings that
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`convey factual, uncontroversial information about the risks of smoking. In 2009, however, Congress
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`sought to replace these factual disclosures with government-created anti-smoking advocacy.
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`Specifically, Congress instructed the Food and Drug Administration (“FDA” or “the Agency”) to
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`issue regulations that require massive “color graphics depicting the negative health consequences of
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`smoking.” Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 201(a), 123
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`Stat. 1776, 1845 (2009) (codified at 15 U.S.C. § 1333(d)[1]).1 In 2011, FDA did so, but before the
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`regulation took effect, the D.C. Circuit held that it violated the First Amendment. FDA has now issued
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`a second graphic-warnings regulation. Tobacco Products; Required Warnings for Cigarette Packages and
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`Advertisements, 85 Fed. Reg. 15,638 (Mar. 18, 2020) (to be codified at 21 C.F.R. pt. 1141) (“the Rule”)
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`(attached as Ex. 6). It too is invalid.
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`2.
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`The Rule requires the use of eleven new textual warnings, accompanied by eleven
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`graphic images—such as images of a specimen cup filled with bloody urine and a pair of diseased feet
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`with several amputated toes—that are designed to frighten, shock, and disgust adult cigarette
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`consumers. In addition, these “warnings” must occupy the top 50% of the front and back of cigarette
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`packages and the top 20% of cigarette advertising. These requirements cross the line into
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`governmental anti-smoking advocacy.
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`3.
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`Such “warnings” are unprecedented. Never before in the United States have producers
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`of a lawful product been required to use their own packages and advertising to convey an emotionally
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`charged government message urging adult consumers to shun their product. These requirements force
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`1 Two separate provisions of the Tobacco Control Act were codified as 15 U.S.C. § 1333(d).
`To avoid confusion, this Complaint will refer to those provisions as Sections 201(a) and 202(b) of the
`Tobacco Control Act and will cite to those provisions as § 1333(d)[1] and § 1333(d)[2], based on the
`order in which they appear in the statute.
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`– 1 –
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`Plaintiffs not to convey purely factual and uncontroversial statements about the risks of smoking, but
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`to become a mouthpiece for the government’s anti-smoking advocacy.
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`4.
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`This is precisely the type of compelled speech that the First Amendment prohibits. As
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`the Supreme Court has explained, the government may not compel Plaintiffs to “use their private
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`property as a ‘mobile billboard’ for the State’s ideological message.” Wooley v. Maynard, 430 U.S. 705,
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`715 (1977). Nor may the government use compelled disclosures to drown out commercial speech
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`regarding lawful products that it does not like. “The State can express [its] view through its own
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`speech. But a State’s failure to persuade does not allow it to hamstring the opposition. The State may
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`not burden the speech of others in order to tilt public debate in a preferred direction.” Sorrell v. IMS
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`Health, Inc., 564 U.S. 552, 578–79 (2011).
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`5.
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`When FDA first tried to transform cigarette packages and advertising into billboards
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`for the government’s anti-smoking message, the D.C. Circuit had no difficulty holding that the rule
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`violated the First Amendment. See R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012),
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`overruled in part by Am. Meat Inst. v. U.S. Dep’t of Agric., 760 F.3d 18, 31 (D.C. Cir. 2014) (en banc). The
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`court recognized that FDA’s warnings were not “factual” disclosures; rather, they were “unabashed
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`attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting.” Id.
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`at 1217. The court also recognized that the warnings were not “uncontroversial”; instead, “many of
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`the images chosen by FDA could be misinterpreted by consumers.” Id. at 1216. And the court held
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`that “FDA has not provided a shred of evidence … showing that the graphic warnings will ‘directly
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`advance’ its interest in reducing the number of Americans who smoke.” Id. at 1219.
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`6.
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`FDA’s new rule fares no better. Once again, the Rule is an unconstitutional attempt
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`to compel Plaintiffs to disparage their own products, frighten and shame their own customers, and
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`proclaim the government’s anti-smoking message. Once again, the warnings would mislead consumers
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`– 2 –
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`about the risks of smoking. And once again, FDA cannot show that the Rule would meaningfully
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`affect consumers’ smoking behaviors or beliefs.
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`7.
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`FDA’s back-to-back failures to develop a constitutional rule point to a larger problem:
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`the Tobacco Control Act’s graphic-warnings mandate itself is an unconstitutional attempt “to remove
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`a popular but disfavored product from the marketplace.” Sorrell, 564 U.S. at 577. Given the Act’s
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`directive, FDA will undoubtedly make a third attempt to develop a graphic-warnings rule after this
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`one is invalidated, and the resulting rule will inevitably suffer from the same constitutional problems.
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`The Court should break this cycle by striking down both the Rule and the Act’s graphic-warnings
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`requirement.
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`8.
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`The Rule has yet more flaws. For example, in issuing the Rule, FDA contravened
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`several core requirements of the Administrative Procedure Act (“APA”), 5 U.S.C. § 500 et seq. In
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`addition, FDA lacked statutory authority for its revisions to the textual warnings in the Tobacco
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`Control Act.
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`9.
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`In light of these problems, Plaintiffs respectfully request that this Court (1) declare
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`that the Rule and the Act’s graphic-warnings requirement violate the First Amendment to the United
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`States Constitution, (2) declare that the Rule violates the APA and the Tobacco Control Act,
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`(3) preliminarily and permanently enjoin Defendants from enforcing either the Rule or the Act’s
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`graphic-warnings requirement, and (4) vacate the Rule in its entirety.
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`PARTIES
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`10.
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`Plaintiff R.J. Reynolds Tobacco Company is a North Carolina corporation
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`headquartered in Winston-Salem, North Carolina. Reynolds manufactures, sells, distributes, and
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`advertises cigarettes nationwide, including in this district.
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`– 3 –
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`11.
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`Plaintiff Santa Fe Natural Tobacco Company, Inc., is a New Mexico corporation
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`headquartered in Oxford, North Carolina. Santa Fe manufactures, sells, distributes, and advertises
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`cigarettes nationwide, including in this district.
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`12.
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`Plaintiff ITG Brands, LLC is a Texas limited liability company headquartered in
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`Greensboro, North Carolina. ITG Brands manufactures, sells, distributes, and advertises cigarettes
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`nationwide, including in this district.
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`13.
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`Plaintiff Liggett Group LLC is a Delaware limited liability company headquartered in
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`Mebane, Alamance County, North Carolina. Liggett manufactures cigarettes and, through an affiliate,
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`sells, distributes, and advertises them nationwide, including in this district.
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`14.
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`Plaintiff Neocom, Inc., is a Texas corporation headquartered in Tyler, Texas. Neocom,
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`Inc. operates three convenience stores in Tyler that sell cigarettes in this district.
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`15.
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`Plaintiff Rangila Enterprises Inc. is a Texas corporation headquartered in Fort Worth,
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`Texas. Rangila Enterprises Inc. operates five convenience stores in Fort Worth that sell cigarettes.
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`16.
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`Plaintiff Rangila LLC is a Texas limited liability company headquartered in Fort Worth,
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`Texas. Rangila LLC operates convenience stores in Fort Worth, Hurst, and Terrell that sell cigarettes.
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`17.
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`Plaintiff Sahil Ismail, Inc. is a Texas corporation headquartered in Grapevine, Texas.
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`Sahil Ismail, Inc. operates a convenience store in Grapevine that sells cigarettes.
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`18.
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`Plaintiff Is Like You Inc. is a Texas corporation headquartered in Fort Worth, Texas.
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`Is Like You Inc. operates a convenience store in Fort Worth that sells cigarettes.
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`19.
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`Defendant United States Department of Health and Human Services (“HHS”) is a
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`federal agency of the United States. Under the Food, Drug, and Cosmetic Act and the Tobacco
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`Control Act, HHS is responsible for regulating cigarettes marketed in the United States. 21 U.S.C.
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`§§ 321(d), 387a(a). HHS is headquartered in Washington, D.C.
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`– 4 –
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`20.
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`Defendant FDA is a federal agency of the United States within HHS. FDA regulates
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`cigarettes marketed in the United States using authority delegated to it by HHS. Id. § 387a(e). FDA is
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`headquartered in Silver Spring, Maryland.
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`21.
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`Defendant Alex M. Azar II is the Secretary of HHS. Secretary Azar oversees FDA’s
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`activities and is responsible for the implementation and enforcement of the Tobacco Control Act and
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`the Rule. Secretary Azar is sued in his official capacity.
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`22.
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`Defendant Dr. Stephen M. Hahn is the Commissioner of FDA. Commissioner Hahn
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`oversees the implementation and day-to-day enforcement of the Tobacco Control Act and the Rule.
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`Commissioner Hahn is sued in his official capacity.
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`JURISDICTION AND VENUE
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`23.
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`This Court has subject-matter jurisdiction under 28 U.S.C. § 1331, 28 U.S.C. § 2201,
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`and 5 U.S.C. § 701 et seq.
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`24.
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`Venue is proper in this district under 28 U.S.C. § 1391(e) because it is where one of
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`the Plaintiffs resides.
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`BACKGROUND
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`A.
`25.
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`The Government’s Historical Approach To Reducing Smoking
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`For decades, the government has used a multi-pronged approach to reducing smoking.
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`The government has promulgated messages about the dangers of smoking; it has severely restricted
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`the speech of tobacco manufacturers; and it has otherwise regulated the advertising, sale, and use of
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`cigarettes.
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`26.
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`First, the government has required that cigarette packages and advertising display
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`factual warnings about the risks of smoking. In 1965, Congress “establish[ed] a comprehensive Federal
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`program to deal with cigarette labeling and advertising with respect to any relationship between
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`smoking and health.” Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 282,
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`– 5 –
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`282 (1965) (the “Labeling Act”). Specifically, the Labeling Act mandated that cigarette packages
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`include the following warning: “CAUTION: Cigarette Smoking May Be Hazardous to Your Health.”
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`Id. at 283.
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`27.
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`In 1984, Congress amended the Labeling Act to require that all cigarette packages and
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`advertising include a series of rotating warnings that cover a variety of smoking risks:
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`• “SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart
`Disease, Emphysema, And May Complicate Pregnancy.”
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`• “SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces
`Serious Risks to Your Health.”
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`• “SURGEON GENERAL’S WARNING: Smoking By Pregnant Women May Result
`in Fetal Injury, Premature Birth, And Low Birth Weight.”
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`• “SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon
`Monoxide.”
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`Comprehensive Smoking Education Act, Pub. L. No. 98-474, 98 Stat. 2200, 2201–02 (1984). These
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`warnings have become known as the “Surgeon General’s warnings,” and they are in effect today.
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`28.
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`Second, the government has systematically limited the avenues through which Plaintiffs
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`can advertise their lawful products. For example, federal law prohibits Plaintiffs from advertising
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`cigarettes in television and radio advertisements, see 15 U.S.C. § 1335, media that are well-suited to
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`reach a large number of consumers.
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`29.
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`Federal law also prohibits Plaintiffs from doing the following:
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`a.
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`sponsoring “any athletic, musical, artistic, or other social or cultural event, or
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`any entry or team in any event, in the brand name … , logo, symbol, motto,
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`selling message, recognizable color or pattern of colors, or any other indicia of
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`product identification identical or similar to, or identifiable with, those used
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`for any brand of cigarettes,” 21 U.S.C. § 387a-1(a)(2); 21 C.F.R. § 1140.34(c);
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`– 6 –
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`b.
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`marketing, licensing, distributing, or selling any promotional item (such as hats
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`and t-shirts) bearing the “brand name … , symbol, motto, selling message,
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`recognizable color or pattern of colors, or any other indicia of product
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`identification identical or similar to, or identifiable with, those used for any
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`brand of cigarettes,” 21 U.S.C. § 387a-1(a)(2); 21 C.F.R. § 1140.34(a); and
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`c.
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`“distribut[ing] or caus[ing] to be distributed any free samples of cigarettes,” 21
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`U.S.C. § 387a-1(a)(2)(G); 21 C.F.R.§ 1140.16(d).
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`30.
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`Federal law also provides that federal agencies, states and subdivisions, and Indian
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`tribes may “enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with
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`respect to tobacco products that is in addition to, or more stringent than” certain aspects of the Act,
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`including with respect to “advertising and promotion,” 21 U.S.C. § 387p, and that states or localities
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`may enact statutes and promulgate regulations that impose “specific bans or restrictions on the time,
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`place, and manner, but not content, of the advertising or promotion of any cigarettes,” 15 U.S.C.
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`§ 1334(c).
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`31. Many cigarette manufacturers (including Reynolds and Santa Fe) are also subject to
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`the Master Settlement Agreement (“MSA”), which settled litigation brought by forty-six states. Under
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`this agreement, the participating manufacturers are subject to additional restrictions on cigarette
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`advertising, including prohibitions on using billboard and transit advertising, paid product placement,
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`event sponsorships, and advertising
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`in sports stadiums and arenas. See MSA § III(d),
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`https://tinyurl.com/y6te8olv.
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`32.
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`Together, these advertising restrictions leave Plaintiffs with few avenues through
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`which they can effectively communicate truthful information about their lawful products to adult
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`cigarette consumers.
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`– 7 –
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`33.
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`Third, the government has imposed numerous non-speech restrictions on the
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`advertising, sale, and use of cigarettes. For example, federal law prohibits the sale of cigarettes to
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`anyone under the age of twenty-one, see Further Consolidated Appropriations Act, 2020, Pub. L. No.
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`116-94, 133 Stat. 2534 (2019), and imposes taxes on cigarettes that are designed to deter cigarette use,
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`see, e.g., 27 C.F.R. § 40.1 et seq. See also Centers for Disease Control and Prevention (“CDC”), State and
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`Territorial Laws Prohibiting Sales of Tobacco Products to Persons Aged < 21 Years (Feb. 21, 2020),
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`https://tinyurl.com/socswzw (explaining that such strategies can “help prevent and reduce youth
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`tobacco product use”). In addition, state and local governments across the country have regulated
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`who may sell cigarettes, who may use cigarettes, and where cigarettes may be used.
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`34.
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`Fourth, the government has run multiple public-education campaigns urging smokers
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`to quit. For example, between 2009 and 2014, FDA spent more than $500 million on such campaigns.
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`Comment Letter of RAI Services Co. at 32, Docket No. FDA-2019-N-3065 (Oct. 11, 2019) (the
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`“Reynolds Comments”) (citing U.S. Gov’t Accountability Office, No. 14-561, Most FDA Spending
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`Funded Public Education, Regulatory Science, and Compliance and Enforcement Activities at 16–17 (June 2014),
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`https://tinyurl.com/y93gktex) (attached as Ex. 2). And since 2014, FDA has run multiple public-
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`education campaigns, including The Real Cost, Fresh Empire, This Free Life, and Every Try Counts. Id. FDA
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`has touted these campaigns as “highly successful” and as “yielding tremendous results.” Id. at 33
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`(quoting Norman E. Sharpless, Press Announcement (Aug. 20, 2019), https://tinyurl.com/y3kmouoa).
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`Indeed, FDA alleged that The Real Cost had “prevented up to 587,000 youth nationwide from initiating
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`smoking between the campaign’s launch in February 2014 and November 2016, half of whom might
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`have gone on to become established smokers.” Id. (quotation marks omitted).
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`35.
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`Other government agencies have run similar campaigns. For example, the CDC
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`regularly runs public-education campaigns, and the Surgeon General has issued more than thirty
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`reports about the health risks of smoking. Id. at 13; see also CDC’s Successful Tips From Former Smokers
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`– 8 –
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`Campaign
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`Returns
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`on
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`March
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`23,
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`CDC
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`(Mar.
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`23,
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`2020),
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`https://www.cdc.gov/media/releases/2020/p0323-smoker-tips-return.html.
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`36.
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`This multi-pronged approach—factual warnings, advertising restrictions, non-speech
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`restrictions, and public-education campaigns—coincided with effectively universal public awareness
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`of the risks of smoking. Over the past several decades, the public has widely understood that smoking
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`is harmful. For example, data from FDA’s own Population Assessment of Tobacco and Health
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`(“PATH”) survey shows that 99.5% of individuals believe that cigarette smoking is harmful to health,
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`including 91% who believe that it is “very or extremely harmful,” 7% who believe it is “somewhat
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`harmful,” and 1.5% who believe it is “slightly harmful.” Reynolds Comments at 14.
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`37.
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`It would be difficult, if not impossible, to improve these numbers. Experts generally
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`agree that, “as a practical matter, getting to awareness levels above 80 or 90 percent is unrealistic.”
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`Reynolds Comments at 14 (brackets and quotation marks omitted). Indeed, the percentage of
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`Americans who know that smoking is harmful to health is higher than the percentage of Americans
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`who know that the Earth revolves around the sun (74%), or the percentage of young Americans who
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`know where the United States is on a map (94%). Id.
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`38.
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`At the same time, smoking prevalence and cigarette consumption have fallen
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`dramatically. For example:
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`a.
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`Between 1965 and 2017, the percentage of adults who smoked cigarettes fell
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`from 42.4% to 14%. Id. at 23; see also CDC, Current Cigarette Smoking Among
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`Adults
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`in
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`the United
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`States
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`(last
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`updated Nov.
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`18,
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`2019),
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`https://tinyurl.com/jdqoxrq (explaining that, in 2018, the percentage of adults
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`who smoked cigarettes fell to 13.7%).
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`b.
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`Between 1981 and 2017, the number of cigarettes purchased annually in the
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`United States dropped from 640 billion to 249 billion—a decline of more than
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`60% despite an increase in the U.S. population of more than 100 million.
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`Reynolds Comments at 23.
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`c.
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`Between 1997 and 2017, the percentage of high school students who smoked
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`fell from 36.4% to 8.1%. Id.; see also CDC, Youth and Tobacco Use (last updated
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`Dec. 10, 2019), https://tinyurl.com/jvsmmen (explaining that, in 2019, the
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`percentage of high school students who smoked fell to 5.8%).
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`39.
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`Indeed, youth and adult smoking rates are at historic lows. As Mitch Zeller, the
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`Director of FDA’s Center for Tobacco Products, recently testified before Congress, “[w]e’ve made
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`such progress in reducing the number of kids who smoke cigarettes. The numbers that are coming
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`out will report historically low rates of kids smoking cigarettes.” The Federal Response to the Epidemic of
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`E-Cigarette Use, Especially Among Children, and the Food and Drug Administration’s Compliance Policy: Hearing
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`Before the Subcomm. on Econ. and Consumer Policy of the H. Comm. on Oversight and Reform, 116th Cong. (2019)
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`(statement of Mitch Zeller, Director, Center for Tobacco Products, Food and Drug Administration);
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`see also CDC, Cigarette Smoking Among U.S. Adults Lowest Ever Recorded (Nov. 8, 2018),
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`https://tinyurl.com/y5wcor58.
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`B.
`40.
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`The Tobacco Control Act
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`In 2009, Congress changed the government’s approach to cigarette warnings by
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`enacting the Tobacco Control Act. Pub. L. No. 111-31, § 201 (amending section 4 of the Labeling
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`Act, 15 U.S.C. § 1333). Specifically, Congress transformed the factual and uncontroversial warnings
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`on cigarette packages and advertising into government-created anti-smoking advocacy.
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`41.
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`The Tobacco Control Act requires that cigarette packages and advertising bear one of
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`nine textual warnings:
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`• “WARNING: Cigarettes are addictive.”
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`• “WARNING: Tobacco smoke can harm your children.”
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`• “WARNING: Cigarettes cause fatal lung disease.”
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`• “WARNING: Cigarettes cause cancer.”
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`• “WARNING: Cigarettes cause strokes and heart disease.”
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`• “WARNING: Smoking during pregnancy can harm your baby.”
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`• “WARNING: Smoking can kill you.”
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`• “WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.”
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`• “WARNING: Quitting smoking now greatly reduces serious risks to your health.”
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`15 U.S.C. § 1333(a)(1), (b)(1).
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`42.
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`The Act also directs FDA to “issue regulations that require color graphics depicting
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`the negative health consequences of smoking to accompany” these textual warnings. Id. § 1333(d)[1].
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`43.
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`Together, the textual warnings and color graphics must occupy the top 50% of the
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`front and back of cigarette packages and the top 20% of cigarette advertising. Id. § 1333(a)(2), (b)(2).
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`The Act does not explain why Congress believed such large warnings were necessary.
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`44.
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`The Act gives FDA a limited ability to adjust the textual warnings as part of its
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`rulemaking to require graphic warnings. Specifically, FDA can “adjust the type size, text and format
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`of the label statements specified in subsections (a)(2) and (b)(2) as the Secretary determines
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`appropriate so that both the graphics and the accompanying label statements are clear, conspicuous,
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`legible and appear within the specified area.” Id. § 1333(d)[1].
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`45.
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`After the graphic warnings take effect, FDA has a greater ability to adjust them.
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`Specifically, FDA may, via rulemaking, “adjust the format, type size, color graphics, and text of any of
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`the label requirements … if the Secretary finds that such a change would promote greater public
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`understanding of the risks associated with the use of tobacco products.” Id. § 1333(d)[2].
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`46.
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`In addition to adopting new textual warnings and directing FDA to issue a regulation
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`adopting graphic images, the Tobacco Control Act imposes a related set of labeling requirements.
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`These requirements (the “related requirements”) require that cigarette packages display:
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`• “the name and place of business of the tobacco product manufacturer, packer, or
`distributor,” 21 U.S.C. § 387c(a)(2)(A);
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`• “an accurate statement of the quantity of the contents in terms of weight, measure, or
`numerical count,” id. § 387c(a)(2)(B);
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`• “an accurate statement of the percentage of the tobacco used in the product that is
`domestically grown tobacco and the percentage that is foreign grown tobacco,” id.
`§ 387c(a)(2)(C); and
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`• where applicable, “the statement ‘Sale only allowed in the United States,’” id. § 387t(a).
`
`47.
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`The Act provides that the new textual and graphic warnings, and each of the related
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`requirements, will become effective “15 months after the issuance of [a graphic-warnings rule].” Pub.
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`L. No. 111-31, § 201(b) (setting the effective date for the amendments to 15 U.S.C. § 1333); id.
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`§ 103(q)(5) (using identical text to set the effective date for the related requirements in 21 U.S.C.
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`§ 387c(a)(2)); id. § 301 (using identical text to set the effective date for the related requirement in 21
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`U.S.C. § 387t(a)).
`
`C.
`48.
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`FDA’s First Graphic-Warnings Rule
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`On June 22, 2011, FDA issued a rule implementing the Act’s graphic-warnings
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`requirement. Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,629 (June 22,
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`2011) (the “2011 Rule”). The 2011 Rule required that all cigarette packages and advertising bear one
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`of nine disturbing images, such as images of a body on an autopsy table, diseased body parts, and a
`
`wailing baby.
`
`49.
`
`FDA freely admitted that these images were designed to make consumers “depressed,
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`discouraged, and afraid” to buy cigarettes. Id. at 36,638 (quotation marks omitted). FDA also admitted
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`that these images were designed to convey the government’s anti-smoking message. FDA said that
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`
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`that these images were designed to “rebrand[] our cigarette packs”; convey that “smoking is gross”;
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`“dispel[] the notion that somehow [smoking] is cool”; and “encourage smokers to quit.” Press Briefing
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`by Press Secretary Jay Carney, Secretary of Health and Human Services Kathleen Sebelius, and FDA
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`Commissioner Margaret Hamburg (June 21, 2011), https://tinyurl.com/yyxc8x88. Indeed, FDA
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`admitted that graphic warnings were designed to make “‘every single pack of cigarettes in the country
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`[a] mini billboard’ for the government’s anti-smoking message.” R.J. Reynolds, 696 F.3d at 1212
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`(quoting FDA, Tobacco Strategy Announcement (Nov. 10, 2010)).
`
`50.
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`FDA claimed that the 2011 Rule was designed to further the government’s interest in
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`“reducing the number of Americans, particularly children and adolescents, who use cigarettes.”
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`76 Fed. Reg. at 36,629. But FDA’s own study determined that the warnings would not advance that
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`interest. The study concluded that the warnings would reduce smoking rates by a mere 0.088%, a
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`number that FDA conceded was statistically indistinguishable from zero. Id. at 36,775–76. As FDA
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`explained: “our effectiveness estimates are in general not statistically distinguishable from zero; we
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`therefore cannot reject, in a statistical sense, the possibility that the rule will not change the U.S.
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`smoking rate. Therefore, the appropriate lower bound on benefits is zero.” Id. at 36,776.
`
`D. R.J. Reynolds Tobacco Co. v. FDA
`51.
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`A federal district court enjoined the 2011 Rule before it went into effect and, in 2012,
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`the D.C. Circuit held that it violated the First Amendment. See R.J. Reynolds, 696 F.3d 1205.
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`52.
`
`The court began by analyzing whether the 2011 Rule was subject to the standard of
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`scrutiny set forth in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985), which holds that “purely
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`factual and uncontroversial disclosures are permissible if they are reasonably related to the State’s
`
`interest in preventing deception of consumers, provided the requirements are not unjustified or unduly
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`burdensome.” R.J. Reynolds, 696 F.3d at 1212 (quotation marks omitted). The court held that the
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`Zauderer standard did not apply for three reasons.
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`
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`53.
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`First, the graphic warnings were not “reasonably related to the State’s interest in
`
`preventing deception of consumers.” The court explained that the Tobacco Control Act already
`
`prohibited misleading statements on cigarette packages and advertising. Id. at 1214. In addition, neither
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`Congress nor FDA had found that graphic warnings were necessary to prevent consumers from being
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`deceived. Id. at 1214–15.2
`
`54.
`
`Second, the graphic warnings were not “purely factual.” As “FDA tacitly admit[ted],”
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`the warnings were “primarily intended to evoke an emotional response, or, at most, shock the viewer
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`into retaining the information in the text warning.” Id. at 1216. Because the warnings were “unabashed
`
`attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting,” the
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`court had no trouble concluding that they were not purely factual. Id. at 1217.
`
`55.
`
`Third, the warnings were not “uncontroversial.” On the contrary, “many of the images
`
`chosen by FDA could be misinterpreted by consumers.” Id. at 1216.
`
`56.
`
`Having held Zauderer inapplicable, the court then turned to analyzing whether the 2011
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`Rule satisfied the standard of scrutiny set forth in Central Hudson Gas & Electric Corp. v. Public Service
`
`Commission, 447 U.S. 557 (1980), which governs certain restrictions on commercial speech. Under the
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`Central Hudson standard, the government had the burden to prove (among other things) that it had a
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`“substantial” interest and that the 2011 Rule “directly advances” that interest. Id. at 1217 (quotation
`
`marks omitted). But FDA had utterly failed to meet its burden.
`
`57.
`
`The court first held that the 2011 Rule would not advance the government’s interest
`
`in reducing smoking. As the court explained, “FDA has not provided a shred of evidence—much less
`
`
`2 The D.C. Circuit later held that, under Zauderer, a compelled disclosure need not be
`reasonably related to preventing consumer deception. Am. Meat Inst., 760 F.3d at 31. But this Circuit
`has taken the opposite view, noting that Zauderer applies to compelled disclosures that are “directed at
`deceptive or misleading commercial speech.” Test Masters Educ. Servs., Inc. v. Robin Singh Educ. Servs.,
`Inc., 799 F.3d 437, 453 (5th Cir. 2015), modified on other grounds, No. 13-20250, 2015 WL 13768849 (5th
`Cir. Oct. 22, 2015).
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`
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`the ‘substantial evidence’ required by the APA—showing that the graphic warnings will ‘directly
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`advance’ its interest in reducing the number of Americans who smoke.” Id. at 1219.
`
`58.
`
`The court then rejected FDA’s argument that the government had a substantial
`
`interest in “effectively communicating health information regarding the negative effects of cigarettes.”
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`Id. at 1221 (quotation marks omitted). As “FDA concede[d], this purported ‘interest’ describes only
`
`the means by which FDA is attempting to reduce smoking rates.” Id. at 1221. This “purely
`
`informational” interest was therefore “too vague to stand on its own” and was “not an independent
`
`interest capable of sustaining the Rule.” Id.
`
`59.
`
`Because the 2011 Rule failed to satisfy either Zauderer or Central Hudson, the court
`
`vacated it and remanded to FDA. Id. at 1222.
`
`E.
`60.
`
`FDA’s New Proposed Rule
`
`On August 16, 2019—almost seven years after the D.C. Circuit vacated the 2011
`
`Rule—FDA issued a proposed rule that again implemented the Tobacco Control Act’s graphic-
`
`warnings requirement. Tobacco Products; Required Warnings for Cigarette Packages and Advertisements, 84 Fed.
`
`Reg. 42,754 (Aug. 16, 2019) (the “Proposed Rule”) (attached as Ex. 1). In the Proposed Rule, FDA
`
`abandoned its previously asserted interest of “reducing the number of Americans … who use
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`cigarettes.” 76 Fed. Reg. at 36,629. Instead, FDA said that the Rule would “promote greater public
`
`understanding of the negative health consequences of cigarette smoking.” 84 Fed. Reg. at 42,755. In
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`particular, FDA said that it wanted to advance this interest by focusing on “less-known health
`
`consequences of smoking.” Id. at 42,757.
`
`61.
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`The Proposed Rule deleted all but two of the textual warnings prescribed by the
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`Tobacco Control Act, and added ten FDA-created textual warnings. Id. at 42,772–77. Thus, the
`
`Pr