United States Court of Appeals United States Court of Appeals

for the Fifth Circuit Fifth Circuit

FILED ____________ March 21, 2024

No. 23-40076 Lyle W. Cayce ____________ Clerk R J Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Incorporated; ITG Brands LLC; Liggett Group LLC; Neocom, Incorporated; Rangila Enterprises, Incorporated; Rangila LLC; Sahil Ismail, Incorporated; Is Like You, Incorporated,

Plaintiffs—Appellees,

versus Food & Drug Administration; United States Department of Health and Human Services; Robert M. Califf, Commissioner of Food and Drugs; Xavier Becerra, Secretary, U.S. Department of Health and Human Services,

Defendants—Appellants. ______________________________

Appeal from the United States District Court for the Eastern District of Texas USDC No. 6:20-CV-176 ______________________________ Before Smith, Elrod, and Graves, Circuit Judges. Jerry E. Smith, Circuit Judge: In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”), which revised the required warn- ings each cigarette manufacturer must place on its packages and advertise- Case: 23-40076 Document: 140-1 Page: 2 Date Filed: 03/21/2024

No. 23-40076

ments.1 Modernizing the ubiquitous text of the Surgeon General’s current warnings, the Act requires cigarette packages to include “color graphics depicting the negative health consequences of smoking to accompany the [updated] label statements.” 15 U.S.C. § 1333(d). Those graphics and state- ments (together “Warnings”) “shall comprise the top 50 percent of the front and rear panels of the package” of cigarettes and “at least 20 percent of the area of [any] advertisement . . . .” Id. § 1333(a)(2), (b)(2). Tobacco companies quickly brought a facial challenge to the TCA’s constitutionality, but the Sixth Circuit upheld it in 2012.2 The FDA’s first attempt at a rule interpreting and applying the Act fared less well, as the FDA failed to rebut an as-applied First Amendment challenge before the D.C. Circuit in 2014.3 Now, ten years later, the FDA has tried again, so we are the third circuit to weigh in. R.J. Reynolds Tobacco Company (“RJR”) and other cigarette manu- facturers and retailers claim that the FDA’s newest attempt at implementing the Act’s warning-label requirement violates the First Amendment, the Administrative Procedure Act (“APA”), and the requirements of the TCA itself. On cross-motions for summary judgment, the district court agreed with the plaintiffs’ First Amendment challenge and granted summary judg- ment without reaching the remaining claims. But we disagree—the warnings are both factual and uncontroversial, so Zauderer4 scrutiny applies, and the

_____________________ 1 Pub. L. No. 111-31, div. A, title II, §§ 201(a), 202(b), 206, 123 Stat. 1776, 1842–50 (2009) (codified as amended in scattered sections of Titles 15 and 21 U.S.C.). 2 See Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 552 (6th Cir. 2012) (controlling opinion by Stranch, J.). 3 See R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012), overruled by Am. Meat Inst. v. USDA, 760 F.3d 18 (D.C. Cir. 2014) (en banc). 4 Zauderer v. Off. of Disciplinary Couns. of Su