Jerry E. Smith, Circuit Judge

Appeal from the United States District Court for the Eastern District of Texas, USDC No. 6:20-CV-176, John Campbell Barker, U.S. District Judge Ryan Jeffrey Watson, Alex Potapov, Christian George Vergonis, Jones Day, Washington, DC, for Plaintiffs—Appellees R J Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Incorporated, Neocom, Incorporated, Rangila Enterprises, Incorporated, Rangila LLC, Sahil Ismail, Incorporated, Is Like You, Incorporated. Philip J. Perry, Andrew D. Prins, Latham & Watkins, L.L.P., Washington, DC, Nicholas L. Schlossman, Latham & Watkins, L.L.P., Austin, TX, for Plaintiff-Appellee ITG Brands LLC. Constantine Z. Pamphilis, Kasowitz, Benson, Torres, L.L.P., Houston, TX, Deva Roberts, Kasowitz, Benson, Torres, L.L.P., New York, NY, Meaghan McLaine VerGow, O'Melveny & Myers, L.L.P., Washington, DC, for Plaintiff—Appellee Liggett Group LLC. Lindsey E. Powell, Esq., U.S. Department of Justice, Washington, DC, Catherine Meredith Padhi, Mark Bernard Stern, Esq., U.S. Department of Justice, Civil Division, Appellate Section, Washington, DC, Stephen Michael Pezzi, U.S. Department of Justice, Civil Division, Washington, DC, for Defendants—Appellants. Agatha M. Cole, Beverly, P.L.L.C., New York, NY, for Amicus Curiae Public Health Law Center. Nandan M. Joshi, Counsel, Allison M. Zieve, Public Citizen Litigation Group, Washington, DC, for Amicus Curiae Public Citizen, Incorporated. Scott P. Lewis, Austin Paganelli Anderson, Anderson & Kreiger, L.L.P., Boston, MA, for Amici Curiae American Academy of Family Physicians, American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Medical Association, Campaign for Tobacco-Free Kids, Texas Medical Association, Truth Initiative. Cory L. Andrews, Washington Legal Foundation, Washington, DC, for Amicus Curiae Washington Legal Foundation. James C. Grant, Caesar D. Kalinowski, Davis Wright Tremaine, L.L.P., Seattle, WA, for Amici Curiae Association of National Advertisers, Summus 2, L.L.C. Sarah M. Harris, Rohit Pranav Asirvatham, Lisa Schiavo Blatt, Williams & Connolly, L.L.P., Washington, DC, Whitney D. Hermandorfer, Tennessee Attorney General's Office, Nashville, TN, for Amicus Curiae Altria Group, Incorporated. 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 warnings each cigarette manufacturer must place on its packages and advertisements. 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 statements (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. 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. 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 manufacturers 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 judgment without reaching the remaining claims. But we disagree—the warnings are both factual and uncontroversial, so Zauderer scrutiny applies, and the rule passes constitutional muster. Therefore, we reverse and remand the remaining claims for initial consideration by the district court.

I.

A. The TCA and Its Antecedents

In 1965, Congress passed the Federal Cigarette Labeling and Advertising Act. For the first time, all cigarettes manufactured, imported, or packaged for sale or distribution within the United States had to display "CAUTION: Cigarette Smoking May Be Hazardous to Your Health."

Four years later, Congress revised that warning to state, "WARNING: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous To Your Health." Then, in 1984, Congress again updated the warnings with the Comprehensive Smoking Education Act. Under that act, the warnings now read,

SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.

SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.

SURGEON GENERAL'S WARNING: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.

SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.

Between 1984 and 2009, though, Congress found that "efforts to restrict advertising and marketing of tobacco products," including the warnings, had "failed adequately to curb tobacco use by adolescents, [so] comprehensive restrictions on the sale, promotion, and distribution of such products [were] needed." TCA § 2(6). Thus, it enacted the TCA.

In the TCA, Congress made extensive and significant legislative findings, including that (1) minors still often see and are exposed to tobacco product advertising; (2) the "overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18"; and (3) "[r]educing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today's children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease[s]" and would "result in approximately $75,000,000,000 in savings attributable to reduced health care costs."

In light of those findings, Congress believed it necessary to update the 1984 Surgeon General's Warnings with new ones. It chose nine new warnings that would rotate regularly, stating,

WARNING: Cigarettes are addictive.

WARNING: Tobacco smoke can harm your children.

WARNING: Cigarettes cause fatal lung disease.

WARNING: Cigarettes cause cancer.

WARNING: Cigarettes cause strokes and heart disease.

WARNING: Smoking during pregnancy can harm your baby.

WARNING: Smoking can kill you.

WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.

WARNING: Quitting smoking now greatly reduces serious risks to your health.

But updating the text and the font size of the warnings was not enough—Congress also wanted images with the textual warnings. So, it instructed the Secretary of Health and Human Services to "issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements." Id. § 1333(d). And Congress gave the Secretary the authority to "adjust the type size, text and format of the label statements" for clarity, conspicuousness, and legibility. Id. Recognizing the difficulty manufacturers may have in updating their packaging, though, Congress delayed enforcement of the regulations for fifteen months after their issuance. Id. § 1333 note.

Finally, acknowledging the likelihood of judicial review, Congress included a severability clause: If a court finds any part of the Act unlawful and invalid, that court should keep "the remainder" enforceable "to the fullest extent possible." TCA § 5. B. The TCA's Implementation and Litigation History

1. Pre-Rule Litigation

Before the FDA could issue a rule under the TCA's graphics requirement, several manufacturers and sellers of tobacco products—including RJR—sued the United States, alleging, inter alia, that the Act violated their First Amendment rights. See Discount Tobacco, 674 F.3d at 520-21; see also id. at 553. The district court granted summary judgment to the government on the First Amendment claim, and the Sixth Circuit, reviewing the plaintiffs' claims as a facial challenge to the Act, affirmed. Id. at 551-52.

The Sixth Circuit first determined the applicable standard of review, framing it as a choice between Zauderer and strict scrutiny. See id. at 554. It began with Zauderer. The court noted that "[t]he factual content of the textual warnings [wa]s undisputed." Id. at 558. So, for Zauderer not to apply, "[p]laintiffs would have to establish that a graphic warning cannot convey the negative health consequences of smoking accurately, a position tantamount to concluding that pictures can never be factually accurate, only written statements can be." Id. at 559. The court rejected that position, offering instead several examples of the "many graphic warnings that would constitute factual disclosures under Zauderer." Id. Those included

a picture or drawing of a nonsmoker's and smoker's lungs displayed side by side; a picture of a doctor looking at an x-ray of either a smoker's cancerous lungs or some other part of the body presenting a smoking-related condition; a picture or drawing of the internal anatomy of a person suffering from a smoking-related medical condition; a picture or drawing of a person suffering from a smoking-related medical condition; and any number of pictures consisting of text and simple graphic images.

Applying Zauderer's very deferential test, the Sixth Circuit held that "graphic and textual warnings that convey factual information about the health risks of tobacco use are reasonably related to the purpose of preventing consumer deception." Id. at 562. That deception, the court explained, arose inherently from the past decades of false advertising and misleading research by the companies that were proclaiming that tobacco had no health risks and was not addictive. Further, the court found that the warnings were not unduly burdensome, despite the 50%-coverage requirement. Id. at 567. Finally, the court rejected "the underlying premise [of the dissent] that a disclosure that provokes a visceral response must fall outside Zauderer's ambit. Facts can disconcert, displease, provoke an emotional response, spark controversy, and even overwhelm reason, but that does not magically turn such facts into opinions." Id. at 569. Instead, "whether a disclosure is scrutinized under Zauderer turns on whether the disclosure conveys factual information or an opinion, not on whether the disclosure emotionally affects its audience or incites controversy." Id. (citing Zauderer, 471 U.S. at 650-51, 105 S.Ct. 2265).

2. The First Rule's Litigation

While the Discount Tobacco litigation was pending, FDA issued a Final Rule implementing the Act's graphics requirements. The warnings used the exact language of the Act and included graphics of side-by-side healthy and damaged lungs, a dead body, and a crying woman. Each warning also showed the phone number 1-800-QUIT-NOW.

Five companies—now led by RJR—challenged the 2011 Rule, asserting the warnings violated the First Amendment. The district court granted the companies' motion for summary judgment, and the D.C. Circuit affirmed. See R.J. Reynolds, 696 F.3d at 1208. That court held that the warnings were not "a remedial measure designed to counteract specific deceptive claims made by the [c]ompanies" as required by Zauderer. Id. at 1215. Further, it ruled the chosen graphics were not " 'purely factual and uncontroversial' information" because the images "could be misinterpreted by consumers" and "are primarily intended to evoke an emotional response, or, at most, shock the viewer into retaining the information in the text warning." Id. at 1216 (quoting Zauderer, 471 U.S. at 651, 105 S.Ct. 2265). So, by its reasoning, Zauderer scrutiny did not apply. Id. at 1217.

Applying instead Central Hudson's more stringent scrutiny, the court struck down the rule as violative of the First Amendment. Id. at 1221-22 (citing Cent. Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N.Y., 447 U.S. 557, 566, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980)). "Assuming FDA's interest in reducing smoking rates is substantial," the D.C. Circuit explained that the 2011 Rule nonetheless failed Central Hudson scrutiny because it lacked even "a shred of evidence . . . showing that the graphic warnings will 'directly advance' [FDA's] interest in reducing the number of Americans who smoke." Id. at 1218-19.

3. The Current Rule's Litigation

Eight years later, in 2020, the FDA finally issued this Rule. The FDA asserted that the Rule—and its eleven new warnings, reproduced below—were justified by "the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking." FDA also claimed that the Rule "dissipat[es] the possibility of consumer confusion or deception," thereby advancing the government's interest in preventing "consumer misperceptions regarding the risks presented by cigarettes." 85 Fed. Reg. at 15645 (quoting Zauderer, 471 U.S. at 651, 105 S.Ct. 2265).

Image materials not available for display.

The Warnings do not precisely match the warnings required by the TCA—FDA kept one, split one of the TCA's warnings into two, updated three others, and replaced the remaining four with five new warnings. The FDA claims that the authority to make those changes derives from § 201 of the TCA, which allows the agency to "adjust the . . . text . . . of the cigarette health warnings . . . ." 85 Fed. Reg. at 15641-42 (quoting 15 U.S.C. § 1333(d)). As the FDA explained, the Surgeon General's 2014 report newly attributed eleven diseases to smoking, and the Warnings better reflected those findings.

The Rule also included its own severability provision. There, the FDA explained,

[T]he individual aspects of this rule are workable on their own and should go forward in the event that some are invalidated . . . . FDA has determined that severability both is consistent with Congressional intent and would best advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking . . . . [I]n a circumstance where some but not all of the rule's provisions are invalidated, FDA's intent is for the other provisions to go into effect . . . [because] each other portion of the rule would 'function sensibly' on its own . . . .

Less than a month after FDA promulgated the Rule, plaintiffs sued. They decried the Warnings as "unprecedented" and "precisely the type of compelled speech that the First Amendment prohibits." They alleged that each of the Warnings "misrepresent[s] or exaggerate[s] the potential effects of smoking." Further, they complained that "[c]ontrary to FDA's characterization, the peer reviewers raised serious, substantive concerns about FDA's studies" used to support the selected Warnings. Thus, plaintiffs contended, (1) the Rule violates the First Amendment, (2) the Act violates the First Amendment, and (3) the Rule violates the APA and the Act. Additionally, they urged the court to delay the implementation of the warning requirement until fifteen months after FDA issued a legally valid new rule.

Reviewing cross-motions for summary judgment, the district court began and ended with the First Amendment challenge to the Rule. It found that Zauderer did not apply because the Warnings were "not inherently 'accurate,' and 'purely factual and uncontroversial.' " Rather, the imagery is fundamentally so "prone to ambiguous interpretation" that "it is unclear how a court would go about determining whether it[ ] . . . is 'accurate' and 'factual' in nature." 2022 WL 17489170, at *13-14. In other words, the court reasoned that no photorealistic image could ever be purely factual and uncontroversial because different viewers will ascribe to it different meanings. The inherent ambiguity in any graphic warning—e.g., that viewers may interpret the heart disease warning to suggest that open-heart surgery "is the most common treatment for heart disease" or the best—means that the Warnings cannot be " 'purely factual and uncontroversial' and objectively accurate as required to allow relaxed Zauderer review." Id. at *14-15. Further, the court found that the graphic portions of the Warnings fell beyond Zauderer's reach because they are inherently "provocative." Id.

The district court then turned to Central Hudson. Id. at *15. The court acknowledged that it is unsettled whether Central Hudson intermediate scrutiny, or instead strict scrutiny, applies to compelled speech. Id. But the government failed to satisfy Central Hudson's narrow-tailoring requirement, so it a fortiori failed strict scrutiny. Id. at *17. The Rule was more extensive than necessary because the government had not increased funding for anti-smoking advertisements, increased its own anti-smoking communications, or "test[ed] the efficacy of 'smaller or differently placed warnings.' " Id. (quoting 85 Fed. Reg. at 13650).

The district court concluded by declining to sever the Warnings, even though it had considered only three of the eleven in detail. Id. That, the court ruled, was because "[t]he Act . . . does not allow the court to 'sever' the FDA's warnings by simply deleting their graphical component[s]." Id. at *18.

Relying on the preceding analysis, the district court declared that enforcing any part of the Rule against the plaintiffs would violate the First Amendment; it then vacated the entire Rule. FDA appeals.

II.

FDA raises four issues on appeal: whether (1) the Warnings violate the First Amendment, (2) the Rule survives APA review, (3) the district court should have considered each Warning individually and severed the unconstitutional from the constitutional, and (4) vacatur was a proper remedy. Before turning to those issues, though, we first must assure ourselves we even need to. A. Preclusion

This is the second TCA-related case styled R.J. Reynolds v. FDA, and we are the third circuit to consider a challenge to that Act. In all three cases, RJR has been a party, and in all three, the plaintiffs have challenged the validity of the same provisions of the Act under the First Amendment. Yet the FDA has not asserted any form of preclusion.

Because they are affirmative defenses, the defendant must typically "plead and prove" res judicata or collateral estoppel for us to consider them. When proper, though, we may raise preclusion sua sponte. Yet we rarely do so, for it is a "drastic step" to "invok[e] res judicata for the first time on appeal and revers[e] the district court below as a consequence." United Home Rentals, Inc. v. Tex. Real Est. Comm'n, 716 F.2d 324, 330 (5th Cir. 1983).

We deem it unnecessary to take that drastic step here. Although this case meets the requirements for a district court to consider preclusion sua sponte—"all of the relevant facts are contained in the record and are uncontroverted"—we could not resolve the entire case on preclusion alone. Even if we dismissed RJR's First Amendment challenge to the TCA as precluded, we would still need to resolve its challenge to the Rule. So, we turn to the merits. B. First Amendment

We begin by addressing FDA's contention that the Warnings do not violate the First Amendment. We usually do not turn first to a constitutional issue where a challenge presents multiple pathways for review. But "federal courts have emphasized the importance of resolving First Amendment cases at the earliest possible junction." Green v. Miss U.S.A., LLC, 52 F.4th 773, 800 (9th Cir. 2022). Further, the district court resolved only the constitutional issue. Thus, we will do the same.

The outcome-determinative question for the First Amendment issue is whether the district court properly found that the Warnings do not receive Zauderer's deferential scrutiny. The district court erred. The Warnings are both factual and uncontroversial, despite the emotional impact the graphics may have. Therefore, we reverse.

1. Zauderer and Central Hudson

The Warnings are government-compelled speech—not speech restrictions. Because of that, the many cases plaintiffs and their amici cite regarding prohibitions or restrictions on speech provide, at best, merely persuasive authority. That said, government-compelled speech inherently regulates speech on the basis of its content. And, as plaintiffs point out, we generally review content-based regulations of speech under strict scrutiny unless they come within an exception such as the commercial speech exceptions of Zauderer or Central Hudson.

For decades, the Supreme Court has consistently applied Central Hudson and Zauderer to cases implicating regulation of commercial speech. We, too, are no strangers to those frameworks.

In Central Hudson, the Public Service Commission of New York had banned all advertising promoting the use of electricity, and Central Hudson Gas & Electric Corporation challenged the ban as a violation of its First Amendment rights. 447 U.S. at 558-59, 100 S.Ct. 2343. The Court acknowledged that "[t]he First Amendment . . . protects commercial speech" because it "furthers the societal interest in the fullest possible dissemination of information." Id. at 561-62, 100 S.Ct. 2343 (citing Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 761-62, 96 S.Ct. 1817, 48 L.Ed.2d 346 (1976)). But the government may still regulate commercial speech more than it does "other constitutionally guaranteed expression." Id. at 563, 100 S.Ct. 2343 (citing Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447, 456, 98 S.Ct. 1912, 56 L.Ed.2d 444 (1978)). So, the Court applied a form of intermediate scrutiny—requiring narrow tailoring and a substantial government interest—to the Commission's rule and struck it down. Id. at 569-72, 100 S.Ct. 2343.

Five years later, in Zauderer, the Court created a carve-out to Central Hudson's rule for government-compelled commercial speech. The Court reviewed the discipline of an Ohio attorney who had published two newspaper advertisements. The Court began by explaining that "advertising . . . falls within those bounds" of commercial speech that "is entitled to the protection of the First Amendment, albeit to protection somewhat less extensive than that afforded 'noncommercial speech.' " Zauderer, 471 U.S. at 637, 105 S.Ct. 2265 (citations omitted). And the Court applied Central Hudson to the speech restrictions. Id. at 638, 105 S.Ct. 2265.

The Court applied a different standard, however, to compelled disclosures in advertising. It acknowledged that "in some instances[,] compulsion to speak may be as violative of the First Amendment as prohibitions on speech" and that no State may "prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein." Yet speakers have no protected interests in false statements, and Ohio had "prescribe[d] what shall be orthodox [only] in commercial advertising," not all speech. Id. at 651, 105 S.Ct. 2265 (emphasis added). Further, the "prescription ha[d only] taken the form of a requirement that [Zauderer] include . . . purely factual and uncontroversial information . . . ." Id. Thus, his limited rights in commercial advertising were "adequately protected" because his "interest in not providing any particular factual information in his advertising [wa]s minimal." Id. And the disclosure requirements were neither (1) "unjustified or unduly burdensome" nor (2) "[un]related to the State's interest in preventing deception of cosumers." Id.; see also id. at 651 & n.14, 105 S.Ct. 2265.

Then, in Milavetz, 559 U.S. at 249-50, 130 S.Ct. 1324, the Court applied Zauderer to uphold the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005. The Bankruptcy Code's disclosure requirement was "directed at misleading commercial speech"; "the challenged provisions impose[d] a disclosure requirement rather than an affirmative limitation on speech"; and "the disclosures entail[ed] only an accurate statement . . . ." Id. (emphasis omitted). Therefore, the law did not violate the First Amendment.

Most recently in NIFLA in 2018, the Court distinguished Zauderer. It struck down a California law that required crisis-pregnancy centers to provide notices related to, among other things, the availability of state-sponsored abortion services. 585 U.S. 760-62, 765, 138 S.Ct. 2361. Describing Zauderer, the Court did not refer to any requisite claimed state interest in preventing misleading speech. Id. at 768-69, 776-77, 96 S.Ct. 1817. Instead, the Court distinguished Zauderer by focusing on the controversial nature of abortion as well as the fact that the disclosures discussed state-provided services rather than compelled-speaker-provided services. Id. at 768-69, 96 S.Ct. 1817.

Four years after NIFLA, we applied Zauderer in NetChoice. Describing our pre-enforcement review of a law requiring social media companies to publish three censorship disclosures as "controlled by . . . Zauderer," we declared the disclosures to be factual and noncontroversial. 49 F.4th at 485. Then, we held that the state's interest in "enabling users to make an informed choice regarding whether to use [social media] Platforms" was sufficient to survive review under Zauderer. Id. (cleaned up).

Finally, just a few months ago, in Chamber of Commerce, we reviewed the SEC's ability to compel speech by publicly traded companies related to share buybacks. 85 F.4th at 766-67. Applying Zauderer and NetChoice, we ruled that the disclosure of a company's rationale for a stock buyback was purely factual and uncontroversial commercial speech. Id. at 768-72 (citing NetChoice, 49 F.4th at 485-88).

Distilling that precedent, Zauderer applies where the compelled speech is (1) purely factual and (2) uncontroversial. To survive Zauderer scrutiny, the warnings must (3) be justified by a legitimate state interest and (4) not unduly burdensome. FDA's Warnings meet all four requirements.

a. The Warnings Are Purely Factual.

Despite the myriad applications of Zauderer, neither the Supreme Court nor this court has expressly defined "purely factual . . . information." Zauderer, 471 U.S. at 651, 105 S.Ct. 2265. The closest comes from the distinction between a statement of fact that "expresses certainty about a thing," and "a statement of opinion . . . [that] does not." We have similarly described " 'explain[ing] the reason' for [a company's] actions [as] a purely factual disclosure." Chamber of Comm., 85 F.4th at 769 (quoting NetChoice, 49 F.4th at 446, 485). But, we have cautioned, the government may not demand a private party "undertake contextual analyses, weighing and balancing many factors . . . that depend on community standards," to determine the speech it must parrot. Book People, Inc. v. Wong, 91 F.4th 318, 340 (5th Cir. 2024).

Those interpretations closely mirror common usage as seen in several dictionaries. As a grammatical matter, both "purely" and "factual" describe "information." Therefore, we set our baseline understanding by defining "information"; and then we narrow it.

The Oxford English Dictionary ("OED") defines "information" as "[f]acts provided or learned about something" and as "[w]hat is conveyed or represented by a particular arrangement or sequence of things." Similarly, Garner's Dictionary of Legal Usage ("Garner's") defines "information" through "knowledge," but as "a broader term, covering the full gamut ranging from all that is meant by knowledge to putative facts, unverified and unverifiable facts, and a collection of falsehoods." Therefore, we define "information" quite broadly.

Zauderer narrows that baseline by requiring that the information be factual. Garner's defines "factual" as "of or involving facts" or as "true." OED similarly explains that "factual" means (1) "[c]oncerned with what is actually the case rather than interpretations of or reactions to it" and (1.a) "actually occurring." Applying those definitions, we understand "factual" to limit "information" to falsifiable material and inferences fairly drawn from it, rather than one's non-falsifiable "interpretations[,] . . . reactions," or opinions.

To reach this understanding, we reject the construction that plaintiffs and the district court proffer—that, to be factual, the information must be true. Despite that such a reading matches Garner's second definition, were we to adopt that interpretation, we would create surplusage: The adverb "purely" becomes entirely redundant in the phrase "purely factual information" if "factual information" already excludes any information that is not true and objective. Therefore, instead of reading surplusage into the phrase, we adopt the more natural reading.

Guided by that understanding of Zauderer, we must determine whether the Warnings are (1) statements composed of only (a) information supported by facts and (b) conclusions driven by those facts, and (2) not akin to unfalsifiable statements of opinion.

Because plaintiffs challenge each component of the Warnings as well as the Warnings as a whole, we begin with the text. The Surgeon General's 2014 report found that cigarette smoking causes the negative health consequences identified in the textual warnings. Without contesting the Surgeon General's report, plaintiffs allege that the updated textual warnings create Warnings that "misleadingly exaggerate smoking risks" and improperly "focus on conditions that less frequently arise from smoking." Yet they acknowledge that the 1984 (and currently used) "Surgeon General's warnings are purely factual[ and] uncontroversial."

We cannot square those contentions. Consequences supported by scientific findings, even if exaggerated or non-modal, are still, by definition, factual. Thus, though the Rule does not use the TCA's exact language, we, like the Sixth Circuit, hold that the "factual content of the textual warnings is undisputed." So, the crux of the dispute must center on the images.

We agree with the Sixth Circuit's reasoning and its examples of images that might be factual. The Warnings fall well within the ambit of those examples. The addition of images to the textual warnings makes no difference to the constitutional analysis of factuality.

In Discount Tobacco, the Sixth Circuit read Zauderer's depiction of an IUD to "demonstrate[ ] that a picture can be accurate and factual." 674 F.3d at 560 (citing Zauderer, 471 U.S. at 647-49, 105 S.Ct. 2265). It then suggested several examples of images that it would consider factual. For this Rule, "FDA used a certified medical illustrator to design images that depicted common visual presentations of the health conditions and/or showed disease states and symptoms as they are typically experienced, and that present the health conditions in a realistic and objective format devoid of non-essential elements." 85 Fed. Reg. at 15646. As one of the amici explained it, each of the images provides "a straightforward, science-based, objectively truthful depiction of the accompanying text." The images are no different from those a medical student might see in a textbook, and several are of exactly the type described by the Sixth Circuit as purely factual. We see no reason to split from our sister circuit.

Plaintiffs then claim the Rule is unlawful because it conveys an ideological or provocative message. They imply a requirement that is absent, and we join the Sixth Circuit in rejecting their imaginative, novel limitation. See Discount Tobacco, 674 F.3d at 569.

A fact does not become "value-laden" merely because the fact drives a reaction. But even if it did, ideological baggage has no relevance to the first Zauderer prong. Any number of factual messages are, of course, ideological. Similarly, emotional response to a statement is irrelevant to its truth. That someone may have to declare bankruptcy is likely to engender strong emotions. But the Court never even discussed that aspect of the mandatory disclosures of Milavetz. See 559 U.S. at 249-50, 130 S.Ct. 1324.

Further, unlike the images before the D.C. Circuit in R.J. Reynolds, these images are "meant to be interpreted literally." 696 F.3d at 1216. They are not "primarily intended to evoke an emotional response" but instead to draw attention to the warning and depict a possible medical consequence of smoking. Id. Thus, at most, the emotional response of viewers is incidental to their retention of information about the health risks. Consequently, even if we adopted the D.C. Circuit's reasoning, the emotional impact of the Warnings does not abrogate their factual nature.

Plaintiffs and the district court next suggest that because the images may be subject to several interpretations, they cannot possibly have one factual meaning. Plaintiffs take further issue with the FDA's lack of "testing to ensure the warnings have only one meaning." But when each image is paired with a fact-based, textual warning, any reasonable viewer interprets the image in light of the words. Each image emphasizes the factual meaning of the words it accompanies; it does not impart distinct, novel meaning. In other words, it provides context.

In its analysis, the district court considered the possible different interpretations of the image bereft of the text. That was error. Consumers will see not just the image, but the image with the text. That context matters.

Finally, contrary to the district court's reasoning, we uncover no caselaw requiring the government to choose only the most common side-effect or consequence of the disease or injury discussed in a warning. Indeed, Milavetz forecloses the "single, objective meaning" approach to determining whether a compelled disclosure is factual. People may interpret "debt relief agency" in many ways, but disclosing that a business is one is still purely factual. See 559 U.S. at 251-52, 130 S.Ct. 1324. Similarly, there is no requirement that cigarette manufacturers "undertake contextual analyses, weighing and balancing many factors to determine" the warning—the FDA did that for them. Book People, 91 F.4th at 339. Therefore, the Warnings are factual so long as FDA's claims are inferable from scientific observation.

Thus, the Warnings are factual under Zauderer.

b. The Warnings Are Uncontroversial.

Plaintiffs claim that the Warnings are not uncontroversial for the same reasons they are not factual. We review the cases discussed above and disagree.

In NIFLA, the Court found that the abortion-services notifications were controversial, 585 U.S. at 769, 138 S.Ct. 2361, but, in NetChoice, we found that disclosures of social media censorship decisions were not controversial, 49 F.4th at 485. From these disparate results, we distill the following: A factual statement is "controversial" under Zauderer where the truth of the statement is not settled or is overwhelmingly disproven or where the inherent nature of the subject raises a live, contentious political dispute. In other words, that the speaker does not like the message does not make it controversial; there must be something more. See Chamber of Com., 85 F.4th at 770 (weighing the level of political controversy). If mere dislike sufficed, Zauderer would have prevailed, as he certainly did not want to drive away potential clients by telling them they might still be liable for costs. Similarly, if mere connection to a live, contentious, political issue sufficed, NetChoice would have prevailed.

Yet, plaintiffs never suggest any good-faith debate that the Warnings are not truthful. As discussed in the section above, we evaluate the compelled speech's truthfulness as a matter of "controversy." But where, as here, neither party disputes the Warnings' claims and amici offer even more support for their factualness, any controversy must derive from the subject matter or the presentation of the Warnings.

Nevertheless, the assertion of controversy fails here too. Plaintiffs contend only that the Warnings are emotion-inducing and ideological. They do not assert that cigarette warnings are an inherent part of a national political debate. Instead, plaintiffs merely dislike the nature of the warnings. Yet, just as bankruptcy warnings, disclosure of stock buyback rationales, and explanations of social media censorship decisions may induce emotions or be related to ideological and political issues while remaining uncontroversial, so too the Warnings.

Thus, the Warnings are uncontroversial under Zauderer.

2. The Rule Satisfies Zauderer.

Assured that the Warnings are both factual and uncontroversial, we now apply Zauderer's deferential standard of review, under which the Warnings must be "reasonably related to the State's interest" and not "unjustified or unduly burdensome." Zauderer, 471 U.S. at 651, 105 S.Ct. 2265.

Plaintiffs aver that the warnings are unjustified for two reasons. First, that FDA does not claim an interest in preventing deception, which plaintiffs contend Zauderer requires. Second, that even if Zauderer does not require an anti-deception interest, FDA still has not proven its informational interest sufficient or the Warnings effective.

a. FDA's Interest Is of the Type Subject to Zauderer Scrutiny.

Plaintiffs claim that, because Zauderer upheld the compelled speech as "reasonably related to the State's interest in preventing deception of consumers[,]" only that interest suffices. 471 U.S. at 651, 105 S.Ct. 2265. In other words, anti-deception is a necessary interest, and that interest must independently justify the entire rule on Zauderer review. Yet, mirroring the TCA, the FDA justifies the Rule by claiming primarily that the government has an interest in "greater public understanding" of the risks of smoking. 85 Fed. Reg. at 15650; see TCA § 3(6). So, in plaintiffs' view, the government's interest is not cognizable under Zauderer. Once again, we conclude otherwise: Zauderer does not require the state to assert an anti-deception interest.

Plaintiffs' primary contention is that "the Supreme Court has never held that Zauderer applies outside the consumer-deception context." So, it must not apply in any other context. Our sister circuits have read Zauderer differently, though. As the D.C. Circuit explained in American Meat Institute, "the principles articulated in Zauderer apply more broadly to factual and uncontroversial disclosures required to serve other government interests" than the prevention of deception. 760 F.3d at 21-23. The First, Second, Sixth, and Ninth Circuits have also taken that approach.

Chamber of Commerce and NetChoice also endorse that broader application of Zauderer. In Chamber of Commerce, we upheld the buyback disclosure law on the ground that the "SEC has a legitimate interest in promoting the free flow of commercial information"; we ruled that was "more than enough to satisfy this prong of Zauderer." 85 F.4th at 771. That analysis pointedly dropped the deception-of-consumers rationale from its description of Zauderer. In NetChoice, we similarly described Zauderer as mandating that "disclosure requirements . . . be reasonably related to a legitimate state interest, like preventing deception of consumers." 49 F.4th at 485 (emphasis added).

Further, the Supreme Court implicitly adopted that reasoning in NIFLA when it declined to "decide what type of state interest is sufficient to sustain a disclosure requirement . . . ." 585 U.S. at 776, 138 S.Ct. 2361. Therefore, we follow the Supreme Court, finish the job started by NetChoice and Chamber of Commerce, and join our sister circuits' interpretation.

One of the amici suggests that in Test Masters Educational Services, Inc. v. Robin Singh Educational Services, Inc., this court based its holding on the interest of eschewing the "deception of consumers." Thus, amicus contends, we are limited to applying Zauderer only to that interest. But no analysis accompanied our statement in Test Masters. Instead, like Zauderer, we merely concluded the government's interest in preventing deception sufficed, not that that interest was necessary. The same can be said for Public Citizen, where we again accepted the interest in preventing deception as sufficient without deciding it was necessary. 632 F.3d at 227. Further, we see no way to adopt the amicus's reading of Public Citizen without disregarding our acknowledgment that the government also had a "substantial interest in promoting the ethical integrity of the legal profession" as we upheld that case's disclaimer requirement. Id. at 228.

In other words, our review uncovers both (1) in-circuit applications of Zauderer with non-consumer deception interests claimed by the state and (2) persuasive out-of-circuit applications. Joining our sister circuits, we hold that Zauderer applies even when the government's claimed primary interest is not the prevention of consumer deception. The standard is not that only anti-deception interests suffice, but that any legitimate state interest suffices, and anti-deception is a legitimate state interest. See Chamber of Com., 85 F.4th at 768. Increasing public understanding of the risks of smoking, particularly given the "long history of deception concerning consumer health risks in the cigarette industry," is a legitimate state interest, meeting that standard.

b. FDA's Claimed Interest Justifies the Warnings.

Plaintiffs compare the Warnings to the disclosures struck down in NIFLA and claim that the Warnings are unjustified because (1) the interest is insufficient or too amorphous and (2) FDA has not proven the Warnings effective. We conclude otherwise.

We begin with the claimed interest in the images. FDA asserts that the images serve an informational interest. In Zauderer, the Court explained that "[t]he use of illustrations or pictures in advertisements serves important communicative functions: it attracts the attention of the audience to the advertiser's message, and it may also serve to impart information directly." 471 U.S. at 647, 105 S.Ct. 2265. The Warnings do exactly that—they "attract attention" and "impart information."

Indeed, FDA justified the Warnings through an informational interest, specifically focusing on raising consumer awareness: the agency tested the Warnings' effectiveness in raising consumer awareness and then refined them based on those results. See 84 Fed. Reg. 42768-69. Consequently, the informational interest suffices under Zauderer, and FDA's selection of images in the Warnings serves that interest.

Next, we turn to the breadth of the claimed interest. In NIFLA, the Court explained that a compelled disclosure is justified only if it will "remedy a harm that is 'potentially real[,] not purely hypothetical,' and . . . 'extend[s] no broader than reasonably necessary.' " Plaintiffs challenge that the current Surgeon General's warnings are sufficient, so the imposition of the new Warnings must inherently "extend" the First Amendment harm more "than reasonably necessary."

Not only did the Sixth Circuit reject that position in Discount Tobacco, see 674 F.3d at 563-64, but that claim also ignores FDA's significant evidence that consumers do not notice, much less internalize, the text-only warnings in the status quo. The updated warnings serve to remedy the harm that buyers might (1) not know about tobacco's harms or (2) ignore the existing Surgeon General's warnings. In other words, FDA and Congress have well justified the extent of the new warnings.

Finally, we consider the effectiveness of the Warnings. Plaintiffs assert that alleged flaws in the FDA's studies should be reason to discount their results. At the current stage, though, we search only for the regulation's reasonable relation to the legitimate state interest. Whether FDA's use of the studies survives APA review is a question we consider separately from our Zauderer review. FDA has sufficiently proven that the Warnings reasonably relate to and further its legitimate, and substantial, interest.

Thus, for purposes of Zauderer, the legitimate state interest justifies the Warnings.

c. The Warnings Are Not Unduly Burdensome.

Plaintiffs challenge the Warnings as an undue burden by claiming that the size and content of the Warnings will make it nearly impossible to convey information to potential customers. Three fatally erroneous assumptions underlie plaintiffs' assertion:

First, plaintiffs conflate Zauderer and Central Hudson, describing Zauderer as merely an application of Central Hudson. But those are different tests. That some speech fails Central Hudson does not mean that speech automatically fails Zauderer. Indeed, the Court applied Central Hudson in Zauderer when it addressed speech restrictions, but it then declined expressly to adopt Central Hudson in its analysis of compelled speech. See Zauderer, 471 U.S. at 651 & n.14, 105 S.Ct. 2265. Further, the Supreme Court treats the two as distinct. Thus we decline to merge these distinct tests into one.

Second, plaintiffs focus their claim of burden solely on the size of the warnings. Yet these Warnings are no larger than those upheld by the Sixth Circuit when it reviewed the TCA. See Discount Tobacco, 674 F.3d at 567. Even though FDA updated the Warnings from those Congress selected in the TCA, they have not changed the size of the Warnings. We decline to give RJR a new chance to relitigate this issue without any factual distinctions.

Third, and most fundamentally, we reject plaintiffs' claim that any burden is inherently undue. True, the Warnings impose a burden on plaintiffs. But that alone does not offend the Constitution. Instead, we must inquire whether that burden is undue. In other words, the regulation cannot impose a burden excessive or disproportionate to the benefits gained.

We draw that balancing requirement both from the plain meaning of "undue" and from precedent. In NIFLA, the Court weighed the disclosure requirement and found it lacking. The requirements (1) were "wholly disconnected from California's informational interest"; (2) allowed for no consideration of "what the facilities say on site or in their advertisements"; and (3) "cover[ed] a curiously narrow subset of speakers." 585 U.S. at 777, 138 S.Ct. 2361; see also id. at 777-79, 138 S.Ct. 2361. Therefore, the burden outweighed any possible benefit.

In NetChoice, after deciding that Zauderer applied, we similarly turned to whether the disclosure requirements were unduly burdensome. 49 F.4th at 485. Our analysis focused on the possibility of chilling protected commercial speech. Id. at 486 (citing Zauderer, 471 U.S. at 651, 105 S.Ct. 2265). We found that the one-and-done and the biannual transparency disclosure requirements would not possibly "burden the Platforms' protected speech," so they both survived Zauderer review. Id. Then, we upheld the complaint-and-appeal disclosure requirement because the burden of the disclosure was not so significant in the context of the "statute's plainly legitimate sweep" that it reached the level of an undue burden. Id. at 487 (quoting Ams. for Prosperity Found. v. Bonta, 594 U.S. —, 141 S. Ct. 2373, 2387, 210 L.Ed.2d 716 (2021)). In other words, we balanced the harm and the benefit, found the harm was minimal and the benefit significant, and ruled the burden was constitutional.

Finally, in Chamber of Commerce, we similarly balanced the interests. We explained that the compelled disclosures were not unduly burdensome because they "neither burden[ ] issuers' protected speech nor drown[ ] out their message." 85 F.4th at 772. We found the balance tilted toward the SEC because it had imposed additional speech only "within the narrow confines of SEC filings . . . ." Id. (citing NetChoice, 49 F.4th at 486).

As explained earlier, FDA claims the Warnings directly alleviate information asymmetry regarding the harms tobacco causes and consumers' sub-optimal awareness of and response to those harms. And the government has shown a significant benefit from the resultant reduction in those harms. See TCA § 2; see also 84 Fed. Reg. at 42,779; supra part II.B.2.b.

On the other hand, plaintiffs claim two large burdens—that the government is infringing on their First Amendment rights and that they will suffer financial harm.

The scale tilts toward the benefits for two reasons.

First, plaintiffs can still speak on 80% of their advertisements, and they still control more than 50% of the total surface area of their cigarette packages. See 15 U.S.C. § 1333(a)(2), (b)(2). The remaining portions offer "ample room for manufacturers to distinguish their products from other products." 85 Fed. Reg. at 15647. Thus, we are not concerned that the brands will be "drown[ed] out" by the warnings such that plaintiffs would have no reason to speak at all. Contra NIFLA, 585 U.S. at 778, 138 S.Ct. 2361. Though the Warnings will not produce "additional speech" in the same way the novel disclosures did in NetChoice or Chamber of Commerce, they also do not impose a disproportionate requirement that would " 'effectively rule[ ] out' the possibility of having [an advertisement] in the first place." NIFLA, 585 U.S. at 778, 138 S.Ct. 2361 (quoting Ibanez, 512 U.S. at 146, 114 S.Ct. 2084). So, it is extremely unlikely that the Warnings will chill protected commercial speech. See NetChoice, 49 F.4th at 485.

Second, as mentioned earlier, plaintiffs have, at most, a minimal interest in not withholding useful and factual information from their customers. See Zauderer, 471 U.S. at 651, 105 S.Ct. 2265. Any harm suffered purely because of an infringement on that minimal interest is limited.

Thus, the Warnings are not unduly burdensome under Zauderer.

* * * * *

In sum, because the Warnings are (1) purely factual and (2) uncontroversial, Zauderer scrutiny applies. Then, because the Warnings address a legitimate state interest, are justified, and are not unduly burdensome in light of that interest and justification, the Warnings survive Zauderer scrutiny. C. APA Claim

We turn to plaintiffs' contention that FDA issued the Rule in violation of the APA. The district court never reached the issue, granting summary judgment for plaintiffs solely on its finding that the Rule violated the First Amendment. We generally prefer not to resolve a complicated fact-intensive dispute without the benefit of the district court's reasoning, and the instant case is no exception. So we remand for consideration in the first instance.

Plaintiffs are right that "this Court may affirm . . . on any ground supported by the record and presented to the district court." Wantou v. WalMart Stores Tex., L.L.C., 23 F.4th 422, 430 (5th Cir. 2022). But we generally "will not reach the merits of an issue not considered by the district court" and we see no reason to stretch for them here.

We recognize that an exception to that well-established rule arises where there are "special circumstances." PHH, 80 F.4th at 563 (citing Man Roland, Inc. v. Kreitz Motor Exp., Inc., 438 F.3d 476, 483 (5th Cir. 2006)). But those circumstances are not present here. The extensive dispute in the district court, and the limited briefing on appeal, repudiate any suggestion that the "proper resolution is beyond any doubt."Id. (quoting Baker v. Bell, 630 F.2d 1046, 1056 (5th Cir. 1980)). Further, after an adverse APA ruling by the district court, either party may still appeal, without any concern that "injustice might otherwise result." Thus, the case does not present the necessary "special circumstances" for us to resolve an issue "not passed on below." Id. Consequently, we remand for the district court to conduct an initial analysis of the APA claims.

* * * * *

We summarize our conclusions as follows:

When determining whether Zauderer applies, (1) images can be factual; (2) ideological or emotion-inducing statements are not per se controversial or non-factual; (3) "uncontroversial" means not subject to good-faith dispute about the accuracy of the factual statement; and (4) legitimate state interests other than the prevention of consumer deception are cognizable under Zauderer. For the reasons detailed above, the district court erred by finding Zauderer inapplicable to the FDA's newest Warnings.

Applying Zauderer, the Warnings survive constitutional muster against the First Amendment challenge. We REVERSE and REMAND with direction for the district court to consider the merits of the APA challenge.