Amicus Curiae Brief — R.J. Reynolds Tobacco Company, et al., Petitioners v. Food and Drug Administration, et al.

No. 24-189

In The

Supreme Court of the United States

___________

R.J. REYNOLDS T OBACCO COMPANY, ET AL.,

Petitioners,

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

___________

Respondents.

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Fifth Circuit

___________

BRIEF OF WASHINGTON LEGAL FOUNDATION AS

AMICUS CURIAE SUPPORTING PETITIONERS

___________

Cory L. Andrews

Counsel of Record

John M. Masslon II

WASHINGTON LEGAL FOUNDATION

2009 Massachusetts Ave. NW

Washington, DC 20036

(202) 588-0302

candrews@wlf.org

September 20, 2024

QUESTIONS PRESENTED

1. Whether

provocative

and

misleading

government-mandated graphic warnings on product

packaging and advertising are “purely factual and

uncontroversial” for purposes of applying Zauderer.

2. Whether massive and gratuitous warnings

are “unjustified or unduly burdensome” for purposes

of satisfying Zauderer.

iii

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ................................... ii

TABLE OF AUTHORITIES .................................. iv

INTEREST OF AMICUS CURIAE ........................ 1

INTRODUCTION ................................................... 1

STATEMENT .......................................................... 2

SUMMARY OF ARGUMENT................................. 6

ARGUMENT ........................................................... 9

I.

REVIEW IS NEEDED TO CLARIFY ZAUDERER’S

SCOPE AND SWEEP ............................................. 9

A. This Court should clarify that

Zauderer applies to only deceptive or

misleading advertising ........................ 10

B. This Court should clarify that

Zauderer

applies

to

only

uncontroversial disclosures ................. 14

II. REVIEW IS NEEDED BECAUSE FDA’S

CLAIMED

INFORMATIONAL

INTEREST

CANNOT JUSTIFY THE RULE ............................. 17

A. FDA’s studies are deeply flawed ......... 18

B. Even if reliable, FDA’s own evidence

undercuts its position .......................... 22

CONCLUSION ...................................................... 26

iv

TABLE OF AUTHORITIES

Page(s)

Cases

44 Liquormart, Inc. v. Rhode Island,

517 U.S. 484 (1996) ............................................. 13

Am. Beverage Ass’n v. San Francisco,

916 F.3d 749 (9th Cir. 2019) ........................... 9, 12

Am. Meat Inst. v. U.S. Dep’t of Agric.,

760 F.3d 18 (D.C. Cir. 2014) (en banc).. 3, 9, 14, 15

Borgner v. Fla. Bd. of Dentistry,

537 U.S. 1080 (2002) ........................................... 17

Brown v. Entm’t Merchants Ass’n,

564 U.S. 786 (2011) ............................................. 17

Cent. Hudson Gas & Elec. v. Pub. Serv. Comm’n,

447 U.S. 557 (1980) ........................5, 7, 8, 9, 17, 18

CTIA—The Wireless Ass’n v. Berkeley,

928 F.3d 832 (9th Cir. 2019) ............................... 16

Disc. Tobacco City & Lottery, Inc. v. United States,

674 F.3d 509 (6th Cir. 2012) ................................. 9

Edenfield v. Fane,

507 U.S. 761 (1993) ..................................... 1, 8, 18

Glickman v. Wileman Bros. & Elliott,

521 U.S. 457 (1997) ............................................. 14

Ibanez v. Fla. Dep’t of Bus. & Prof’l Regulation,

512 U.S. 136 (1994) ............................................. 11

Idaho Conservation League v. Wheeler,

930 F.3d 494 (D.C. Cir. 2019) ............................. 20

Mfrs. Ass’n v. Sorrell,

102 F. Supp. 3d 583 (D. Vt. 2015)....................... 14

v

TABLE OF AUTHORITIES

(Continued)

Page(s)

Milavetz, Gallop & Milavetz, P.A. v. United States,

559 U.S. 229 (2010) ................................... 9, 11, 14

Moody v. NetChoice, LLC,

144 S. Ct. 2383 (2024) ......................................... 10

Nat’l Assoc. of Mfrs. v. SEC,

800 F.3d 518 (D.C. Cir. 2015) ....................... 14, 16

Nat’l Ass’n of Wheat Growers v. Becerra,

468 F. Supp. 3d 1247 (E.D. Cal. 2020) ............... 14

Nat’l Inst. of Fam. & Life Advocs. v. Becerra,

585 U.S. 755 (2018) .... 2, 5, 7, 12, 13, 14, 15, 22, 23

NetChoice, LLC v. Paxton,

49 F.4th 439 (5th Cir. 2022) ............................... 11

Pac. Gas & Elec. Co. v. Pub. Utils. Comm’n of Cal.,

475 U.S. 1 (1986) ............................................. 1, 16

Riley v. Nat’l Fed. of Blind,

487 U.S. 781 (1988) ........................................... 2, 9

R.J. Reynolds Tobacco Co. v. FDA,

696 F.3d 1205 (D.C. Cir. 2012) ............. 3, 7, 15, 17

Sorrell v. IMS Health Inc.,

564 U.S. 552 (2011) ............................................. 16

Stuart v. Camnitz,

774 F.3d 238 (4th Cir. 2014) ............................... 16

United States v. United Foods, Inc.,

533 U.S. 405 (2001) .............................................. 1

Va. State Bd. of Pharmacy v. Va. Citizens Consumer

Counc., Inc.,

425 U.S. 748 (1976) ............................................. 13

vi

TABLE OF AUTHORITIES

(Continued)

Page(s)

Video Software Dealers Ass’n v. Schwarzenegger,

556 F.3d 950 (9th Cir. 2009) ............................... 17

Zauderer v. Office of Disciplinary Counsel of the

Supreme Court of Ohio,

471 U.S. 626 (1985) ....... 1, 2, 3, 4, 5, 6, 7, 9, 10, 11,

12, 13, 14, 15, 16, 17, 18

Statutes

Family Smoking Prevention and Tobacco Control

Act of 2009,

Pub. L. No. 111-31, 123 Stat. 1776 ....................... 2

15 U.S.C. § 1333(a)(1) ....................................... 2, 3

§ 1333(b)(2) ........................................... 3

§ 1333(c)(2) ........................................... 3

§ 1333(d) ............................................... 3

21 U.S.C. § 334(a)(2) ................................................ 3

§ 334(g) .................................................... 3

Miscellaneous

21 C.F.R. § 1140.10(c) .............................................. 4

21 C.F.R. § 1140.10(d) .............................................. 4

Comment Letter of RAI Services Co., Docket No.

FDA-2019-N-3065 (Oct. 11, 2019) .............. 21, 22

FDA, Preliminary Regulatory Impact Analysis

(Aug. 2019), https://perma.cc/JWU5-5AH7 .. 20, 22

vii

TABLE OF AUTHORITIES

(Continued)

Page(s)

FDA, Required Warnings for Cigarette Packages

and Advertisements, 76 Fed. Reg. 36,628

(June 22, 2011) ...................................................... 3

FDA, Required Warnings for Cigarette Packaging

and Advertisements, 85 Fed. Reg. 15,638

(Mar. 18, 2020) ...................................3, 4, 6, 10, 24

Ellen P. Goodman, Visual Gut Punch:

Persuasion, Emotion, and the Constitutional

Meaning of Graphic Disclosure, 99 Cornell L.

Rev. 513 (2014) .................................................... 15

Dannielle E. Kelley et al., Effective Message

Elements for Disclosures About Chemicals in

Cigarette Smoke, 20 Nicotine & Tobacco Rsch.

1047 (2018) .......................................................... 22

Note, Repackaging Zauderer, 130 Harv. L. Rev.

972 (2017) ................................................................ 9

OMB, Notice of Office of Management and Budget

Action, Experimental Study on Warning

Statements for Cigarette Graphic Health

Warnings, Ref. No. 201708-0910-011

(Jan. 29, 2018), https://perma.cc/8S84-SEKW ..... 19

RTI Int’l, Experimental Study of Cigarette Warnings:

Study 2 Report (May 2019),

https://perma.cc/A9HX-4ELW .................. 19, 24, 25

viii

TABLE OF AUTHORITIES

(Continued)

Page(s)

RTI Int’l, Experimental Study on Warning

Statements for Cigarette Graphic Health

Warnings: Study 1 Report (Apr. 2018),

https://perma. cc/9FZM-AZPV ................ 19, 23, 25

RTI Int’l, Qualitative Study on Cigarettes and

Smoking: Knowledge, Beliefs, and Misperceptions

(July 2015),

https://perma.cc/45WX-P86H.................. 19, 22, 24

RTI Int’l, Qualitative Study on Consumer

Perceptions of Cigarettes Health Warning

Images (Apr. 2018),

https://perma.cc/6RM9-LDGR ............................ 19

Siegel+Gale, FDA Graphic Health Warning Image

Concept Testing (June 2016),

https://perma.cc/NHW8-JR8H ............................ 19

Versar, Final Summary Report: External Letter

Peer Review of FDA’s Quantitative Consumer

Research on Cigarette Health Warnings Required

by the Family Smoking Prevention and Tobacco

Control Act (Nov. 19, 2019),

https://perma.cc/JVM9-Q4B7.............................. 23

1

INTEREST OF AMICUS CURIAE *

Washington Legal Foundation is a nonprofit,

public-interest law firm and policy center with

supporters nationwide. WLF promotes free

enterprise, individual rights, limited government,

and the rule of law. It often appears as an amicus

curiae in important compelled-speech cases. See, e.g.,

United States v. United Foods, Inc., 533 U.S. 405

(2001); Pac. Gas & Elec. Co. v. Pub. Utils. Comm’n of

Cal., 475 U.S. 1 (1986).

INTRODUCTION

“The commercial marketplace, like other

spheres of our social and cultural life, provides a

forum where ideas and information flourish.”

Edenfield v. Fane, 507 U.S. 761, 767 (1993). Yet if the

decision below stands, the government will enjoy

largely unchecked power to compel any business to

parrot the government’s viewpoint, no matter how

misleading or controversial a message it conveys.

None of this Court’s First Amendment precedents

blesses so sweeping a governmental power. Among

other defects, the Fifth Circuit’s decision badly

misreads Zauderer v. Office of Disciplinary Counsel of

the Supreme Court of Ohio, 471 U.S. 626 (1985). That

misreading flouts the constitutional protections this

Court has long granted all speakers, including

businesses.

* No party’s counsel authored any part of this brief. No

person or entity, other than WLF and its counsel, paid for the

brief’s preparation or submission. WLF timely notified all

counsel of record of its intent to file this brief.

2

The Fifth Circuit relied on Zauderer to justify

FDA’s forcing cigarette makers and retailers to

disseminate the government’s anti-smoking messages

and sensational images. But Zauderer does not hold,

and this Court has never suggested, that a

commercial speaker’s First Amendment rights are

minimal any time the government wants to force it to

echo the government’s views.

On the contrary, a law compelling speech is no

less pernicious than one banning it; the State as

ventriloquist is no better than the State as censor. By

forcing Plaintiffs “to speak a particular message”

against their will, FDA’s compelled warnings “alte[r]

the content of [their] speech.” Nat’l Inst. of Fam. &

Life Advocs. (NIFLA) v. Becerra, 585 U.S. 755, 766

(2018) (quoting Riley, 487 U.S. at 795). Nothing in

Zauderer remotely suggests that the government may

commandeer a business into serving as an

involuntary mouthpiece for controversial viewpoints

it opposes—much less for discouraging consumers

from buying its goods. Because that is a grave

constitutional violation under any level of

constitutional scrutiny, this Court should intervene

and set things right.

STATEMENT

The Family Smoking Prevention and Tobacco

Control Act of 2009, Pub. L. No. 111-31, 123 Stat.

1776, grants FDA limited authority to regulate

tobacco products and marketing. Among other things,

the TCA amends § 4 of the Fair Packaging and

Labeling Act to require nine new textual warnings, or

“label statements,” that must be displayed on a

rotating basis with the same frequency. 15 U.S.C.

3

§§ 1333(a)(1), (b)(2), (c)(2). A label statement must

occupy the top 50 percent of the front and back panels

of all cigarette packaging and at least the top 20

percent of all cigarette advertising. Id. § 1333(b)(2).

The TCA also directs the Secretary of Health and

Human Services to promulgate rules requiring every

label statement to include “color graphics depicting

the negative health consequences of smoking.” Id.

§ 1333(d).

In 2011, FDA issued a final rule specifying nine

graphic warnings to accompany the label statements.

See FDA, Required Warnings for Cigarette Packages

and Advertisements, 76 Fed. Reg. 36,628 (June 22,

2011). The graphic warnings featured sensational

images ostensibly depicting the consequences of

smoking, such as diseased lungs or a cadaver on an

autopsy table. Id. Five tobacco companies challenged

the rule on First Amendment grounds. Finding not a

“shred of evidence” that the new warnings would

further FDA’s stated interest in reducing smoking,

the D.C. Circuit in 2012 vacated that rule as an

unconstitutional

compulsion

of

the

tobacco

companies’ speech. R.J. Reynolds Tobacco Co. v. FDA,

696 F.3d 1205, 1221–22 (D.C. Cir. 2012), overruled in

part by Am. Meat Inst. v. U.S. Dep’t of Agric., 760 F.3d

18 (D.C. Cir. 2014) (en banc).

Years later, in March 2020, FDA issued the

new Rule. See FDA, Required Warnings for Cigarette

Packaging and Advertisements, 85 Fed. Reg. 15,638

(Mar. 18, 2020). The Rule omits seven of the TCA’s

textual warnings, adds nine FDA-created label

statements, and imposes eleven corresponding

graphic images. Pet. App. 66a–67a. Aimed at

manufacturers and retailers alike, the Rule makes it

4

a crime to make, package, sell, advertise, or offer for

sale cigarettes without the mandated warnings. 21

C.F.R. §§ 1140.10(c), (d). Failure to include the

warnings on all cigarette packaging and advertising

renders cigarettes “misbranded” under the Rule,

which permits the government to seize them. 21

U.S.C. § 334(a)(2), (g); 85 Fed. Reg. at 15,709;

To justify the new Rule, FDA has abandoned

its earlier interest in reducing smoking. Unable to

prove that graphic warnings will have any real-world

impact on smoking behavior, FDA now asserts a

purely informational interest—fostering “greater

public understanding” of the risks of smoking—as its

sole justification for commandeering private speech.

85 Fed. Reg. at 15,650.

Plaintiffs—four cigarette manufacturers and

five cigarette retailers—challenged the Rule’s

compelled-warnings on First Amendment grounds.

After granting the parties’ joint motion to postpone

the Rule’s effective date, the District Court ultimately

granted summary judgment for Plaintiffs on their

First Amendment claim.

First, the District Court concluded that the

Rule’s warnings do not qualify for relaxed First

Amendment scrutiny under Zauderer because they

are not purely factual and uncontroversial. FDA

presented no evidence that “each image-and-text

pairing conveys only one, unambiguous meaning that

is factually correct.” Pet. App. 90a. Given their

“capacity for multiple reasonable interpretations,” the

Rule’s warnings were not “objectively ‘accurate’” as

Zauderer requires. Id. at 92a.

5

Second, the District Court held that the Rule’s

warnings cannot survive intermediate scrutiny under

Central Hudson Gas & Electric v. Public Service

Commission, 447 U.S. 557 (1980), because they are

not narrowly tailored. Pet. App. 95a. FDA failed to

show that “compelling these large, graphic warnings

is necessary in light of other options.” Id. Other

measures, such as increased government funding for

anti-smoking education, would be more narrowly

tailored to achieve the Rule’s stated aim without

abridging Plaintiffs’ freedom of speech. Id.

The Fifth Circuit reversed. In the Fifth

Circuit’s view, Zauderer applies anytime the

government

compels

purely

factual

and

uncontroversial speech, no matter the government’s

interest. Pet. App. 3a, 24a. The panel cited this

Court’s decision in NIFLA to justify its holding that

FDA’s informational interest sufficed. Id. at 23a

Because NIFLA, struck down a California-mandated

disclosure for crisis-pregnancy centers but “did not

refer to any requisite claimed state interest in

preventing misleading speech,” the Fifth Circuit saw

no need for FDA to show that the new graphic

warnings are necessary to correct misleading or

deceptive commercial speech. Id. (citing NIFLA, 585

U.S. 768–69, 776–77). Instead, the court held that

FDA’s graphic warnings easily satisfy Zauderer

“despite the emotional impact the graphics may

have.” Pet. App. 19a.

The Fifth Circuit denied rehearing en banc.

Pet. App. 111a.

6

SUMMARY OF ARGUMENT

I. Zauderer clarified that “free flow of

commercial information is valuable enough to justify

imposing on would-be regulators the costs of

distinguishing * * * the harmless from the harmful.”

471 U.S. at 646. Yet the Fifth Circuit badly mangles

Zauderer, ignoring just how much the Court’s modest

compelled-speech holding hinged on the case’s unique

facts. At bottom, commandeering private speakers to

spread the government’s message allows the

government to promote its own agenda at the expense

of First Amendment rights. The Fifth Circuit’s

watered-down take on Zauderer ignores this threat to

free speech. This Court should grant review and

clarify Zauderer’s narrow scope once and for all.

A. Thirteen times in Zauderer, this Court

emphasized that the test it announced applies only to

government efforts to correct misleading or deceptive

commercial advertising. Two subsequent decisions

from the Court reaffirm that principle. Yet the lower

courts are hopelessly divided on whether this Court

meant what it said. If anything, Zauderer further

exposes the constitutional defect in FDA’s position

here. To advance a purely informational interest in

“fostering greater public understanding” of smoking

risks, 85 Fed. Reg. at 15,650, FDA invokes Zauderer

to justify compelling manufacturer and retailer

speech. But this Court has never sustained a speech

mandate under Zauderer outside the narrow confines

of requiring a business to prevent consumer deception

by curing false or misleading advertisements. None

exist here. By expanding Zauderer’s scope and sweep,

the decision below drastically erodes the First

Amendment’s prohibition against compelled speech.

7

This Court’s recent NIFLA decision created

confusion about Zauderer’s reach when it restated the

test without a requirement that the disclosure be

necessary to correct deception. Some judges have

interpreted that restatement of the Zauderer test as

a change, while others have said that this Court does

not overturn precedent implicitly. This question—

about when Zauderer applies—is fairly encompassed

by the first question presented. The Court should

reaffirm that Zauderer applies only when a disclosure

is necessary to correct deception.

B. This Court’s recent commercial-speech cases

show that Zauderer applies only when the compelled

speech is uncontroversial. Far from being “purely

factual and uncontroversial,” as both Zauderer and

NIFLA require, the FDA’s graphic warnings

themselves are misleading. At best, the warnings

seek to dramatically exaggerate the health harms of

smoking by suggesting that very rare consequences of

smoking are in fact common. At worst, the warnings

are an “unabashed attempt[] to * * * browbeat

consumers into quitting.” R.J. Reynolds, 696 F.3d at

1216–17. Neither goal offers a valid governmental

justification for compelling speech. This is yet another

reason the Fifth Circuit erred by applying Zauderer.

II. Although the Rule’s warnings are

impermissible compelled speech subject to strict

scrutiny, the Rule also fails to satisfy the

government’s evidentiary burden under either

Zauderer or Central Hudson. First, even if Zauderer

applies, FDA may not mandate a disclosure if it is

“unjustified.” Zauderer, 471 U.S. at 651. Here the

Rule is unjustified because FDA has not shown that

it will materially improve the public’s understanding

8

of the risks of smoking. Likewise, under Central

Hudson, the Rule “must directly advance” FDA’s

stated interest in improving public understanding of

the risks of smoking “in a material way.” Cent.

Hudson, 477 U.S. at 566; Edenfield, 507 U.S. at 774.

Yet again, FDA’s shaky record evidence cannot meet

this burden.

A. FDA’s studies are deeply flawed. As the

Office of Management and Budget concluded, FDA

selectively recruited its study participants using

convenience sampling whose outcomes are not

nationally representative. Even worse, FDA’s costbenefit analysis failed even to quantify the Rule’s

supposed benefits. No surprise, then, that FDA hid

crucial data from the public, which had no

opportunity to comment on its peer-review report or

FDA’s response to it. And without explanation, FDA

failed to seriously consider several alternatives.

B. Even if taken at face value, however, FDA’s

studies undercut the Rule’s effectiveness. The main

takeaway from FDA’s data is that the public

overwhelmingly understands that smoking is

harmful. As FDA’s own PATH survey shows, 99.5% of

individuals believe that cigarette smoking endangers

health, with 91% believing that it is “very or

extremely harmful.” What’s more, FDA ignored its

own study’s findings that participants simply did not

believe FDA’s sensational new warnings. And FDA

ignored, downplayed, and misrepresented its own

peer-review feedback, which identified core defects in

FDA’s studies.

9

ARGUMENT

I.

REVIEW IS NEEDED TO CLARIFY ZAUDERER’S

SCOPE AND SWEEP.

Laws that compel speech are subject to strict

scrutiny or, at a minimum, intermediate scrutiny. See

Riley v. Nat’l Fed. of Blind, 487 U.S. 781, 797–98

(1988). But the Fifth Circuit applied the relaxed

Zauderer

standard

when

analyzing

the

constitutionality of the Rule’s new graphic warnings

scheme. When it applies, Zauderer requires only that

a law not be “unduly burdensome.” 471 U.S. at 651.

But “a close examination of courts’ treatment of

Zauderer reveals a doctrine at odds with itself.” Note,

Repackaging Zauderer, 130 Harv. L. Rev. 972, 986

(2017).

Lower courts are sharply divided about when

(and how) Zauderer governs. Repackaging, 130 Har.

L. Rev. at 973. Some courts don’t even think this

Court meant to create a separate test for compelled

speech in Zauderer. See Disc. Tobacco City & Lottery,

Inc. v. United States, 674 F.3d 509, 559 n.8 (6th Cir.

2012). The D.C. Circuit has suggested that Zauderer

and Central Hudson both apply the same level of

intermediate

scrutiny

to

commercial-speech

regulations. Am. Meat Inst., 760 F.3d at 26–27.

Members of this Court have questioned Zauderer’s

reasoning and have called for it to be reexamined.

Milavetz, Gallop & Milavetz, P.A. v. United States,

559 U.S. 229, 254 (2010) (Thomas, J., concurring); see

also Am. Beverage Ass’n v. San Francisco, 916 F.3d

749, 762 (9th Cir. 2019) (Ikuta, J., concurring)

(discussing how this Court has taken a more

originalist approach to compelled commercial speech

10

since Zauderer was decided). This state of confusion

cries out for this Court’s review.

A.

This Court should clarify that

Zauderer applies to only deceptive

or misleading advertising.

FDA insists, and the Fifth Circuit agrees, that

Zauderer allows it to commandeer private speech to

further its interest in “fostering greater public

understanding,” 85 Fed. Reg. at 15,650. But Zauderer

strictly limits its holding to curing speech that is

“false or deceptive.” Zauderer, 471 U.S. at 638. The

government may mandate speech only “to dissipate

the possibility of consumer confusion or deception.”

Id. at 651. Indeed, this Court upheld the state’s

advertising disclaimer only after finding that the

possibility of deception was “self-evident” and that

“substantial numbers of potential clients would be so

misled” without Ohio’s disclosure rule. Id. at 652.

Despite

its

commercial-speech

context,

Zauderer recognizes that “an advertiser’s rights are

adequately protected” only so long as “disclosure

requirements are reasonably related to the State’s

interest in preventing deception of consumers.” Id.

at 651. Outside that narrow context of supplementing

misleading ads with disclosures to prevent consumer

deception, Zauderer simply does not apply. The Court

has never disclaimed this rule. True, this Court

recently applied Zauderer when reviewing preenforcement facial relief from Florida- and Texasmandated disclosures aimed at regulating the speech

of social media platforms. Moody v. NetChoice, LLC,

144 S. Ct. 2383 (2024). But no party there disputed

the adequacy of the States’ interests, so this Court

11

never considered the question. Id. at 2439 n.57

(Barrett, J., concurring) (“NetChoice did not contest—

and accordingly forfeited—whether Zauderer applies

here.”); see also NetChoice, LLC v. Paxton, 49 F.4th

439, 485 (5th Cir. 2022) (noting that “the Platforms do

not dispute” the adequacy of Texas’s interest in

“enabl[ing] users to make an informed choice”).

In Ibanez v. Florida Department of Business &

Professional Regulation, 512 U.S. 136, 146 (1994), for

example, the Court relied on Zauderer to invalidate a

Florida regulation mandating a disclaimer on any ad

that (truthfully) held out a professional as a Certified

Financial Planner. Because Zauderer applies only to

“an appropriately tailored check against deception or

confusion,” the Court held that Florida’s compelledspeech mandate could not survive First Amendment

scrutiny without evidence of “potentially real, not

purely hypothetical” consumer deception. Id. If the

“protections afforded commercial speech are to retain

their force,” Ibanez explained, courts “cannot allow

rote invocation of the words ‘potentially misleading’ to

supplant the [government’s] burden.” Id. (quoting

Zauderer, 471 U.S. at 648–49). Had the Court shared

the Fifth Circuit’s elastic view of Zauderer, Ibanez

would have upheld Florida’s compelled-speech

mandate despite no evidence of consumer deception.

Likewise, in Milavetz, the Court considered a

First Amendment challenge to a federal law requiring

attorneys and other debt-relief professionals to

include disclosures in their advertisements. 559 U.S.

at 232–33. Congress required those disclosures to

prevent consumers from being misled about the

services being offered. Id. Deciding that Zauderer

supplied the proper First Amendment test, the Court

12

reiterated that the “essential feature[]” of the

disclosures upheld in Zauderer was that they were

aimed at “inherently misleading commercial

advertisements.” Id. at 250 (quoting Zauderer, 471

U.S. at 651). Because that prong was satisfied—a

showing FDA has not made here—the Court upheld

the disclosure under Zauderer.

As the decision below confirms, this Court’s

recent precedent in NIFLA has become a source of

confusion about whether Zauderer’s deception prong

remains. When setting forth the Zauderer test in

NIFLA, this Court omitted any mention of a

“correction of deception” requirement. Many lower

court judges correctly believe that the correction of

deception requirement is still part of Zauderer. For

example, Judge Nguyen objected to the Ninth

Circuit’s “expansion” of the Zauderer test “to

commercial speech that is not false, deceptive, or

misleading.” Am. Beverage Ass’n, 916 F.3d at 767

(Nguyen, J., concurring). Judge Nguyen correctly

believes that mere informational interests fall outside

of Zauderer’s scope. Rather, Zauderer applies only

when there are doubts about a “commercial message’s

accuracy”—“not its completeness.” Id. at 767–68. Like

the Fifth Circuit, however, Judge Ikuta evidently

disagrees with Judge Nguyen. In her view, NIFLA

“broke new ground” for the Zauderer test so that it no

longer contains a correction-of-deception element. Id.

at 758–67.

By expanding the universe of acceptable

justifications for government-compelled speech, the

decision below undermines this Court’s historical

rationale for giving commercial advertising somewhat

reduced, but still considerable, First Amendment

13

protection. The “greater ‘objectivity’ of commercial

speech,” the Court has said, “justifies affording the

State

more

freedom

to

distinguish

false

advertisements from true ones.” 44 Liquormart, Inc.

v. Rhode Island, 517 U.S. 484, 499–500 (1996)

(quoting Va. State Bd. of Pharmacy v. Va. Citizens

Consumer Counc., Inc., 425 U.S. 748, 771 n.24

(1976)). Put differently, truthful commercial speech

receives greater constitutional protection than false

or misleading commercial speech.

But that rationale collapses as a justification

for compelling speech when, as here, the mandatory

disclosure is not aimed at preventing consumer

deception. When, as here, the government seeks to

compel speech for some other reason, “the greater

objectivity of commercial speech” simply cannot

justify treating commercial and noncommercial

speakers differently. As the Court reiterated in

NIFLA, Philip Zauderer’s incomplete statements

“would have been ‘fully protected’ if they were made

in a context other than advertising.” NIFLA, 585 U.S.

at 771 (quoting Zauderer, 471 U.S. at 637 n.7).

This doctrinal confusion was “outcome

determinative” here. Pet. App. 19a. FDA disclaims

any interest in preventing consumers from being

deceived by Plaintiffs’ speech. And it is undisputed

that Plaintiffs’ relevant commercial speech is neither

false nor misleading. After all, Plaintiffs are

prohibited by law from making false or misleading

claims through cigarette packaging or advertising.

That alone suffices to disqualify Zauderer as the

appropriate standard of First Amendment review. Yet

the Fifth Circuit mistakenly relied on NIFLA to

relieve FDA from any showing of consumer deception.

14

As Justice Souter noted more than twenty-five

years ago, “however long the pedigree of [compelledspeech] mandates may be, and however broad the

government’s authority to impose them, Zauderer

carries no authority for a mandate unrelated to the

interest in avoiding misleading or incomplete

commercial messages.” Glickman v. Wileman Bros. &

Elliott, 521 U.S. 457, 490 (1997) (Souter, J.,

dissenting); see Milavetz, 559 U.S. at 257 (Thomas, J.,

concurring). The decision below jettisons this crucial

limit on Zauderer’s scope; this Court should grant

review and vindicate it.

B.

This Court should clarify that

Zauderer

applies

to

only

uncontroversial disclosures

Zauderer applies only when a required

disclosure is “uncontroversial.” NIFLA, 585 U.S. at

768 (quoting Zauderer, 471 U.S. at 651). Again, the

lower courts desperately need guidance on this

requirement. “It is unclear how we should assess and

what we should examine to determine whether a

mandatory disclosure is controversial.” Nat’l Assoc. of

Mfrs. v. SEC, 800 F.3d 518, 528 (D.C. Cir. 2015)

(“NAM”) (quoting Am. Meat Inst., 760 F.3d at 34

(Kavanaugh, J., concurring in the judgment)); see also

Mfrs. Ass’n v. Sorrell, 102 F. Supp. 3d 583, 628 (D. Vt.

2015) (claiming that courts do not “affix[] the

‘controversial’ label lightly”), with Nat’l Ass’n of

Wheat Growers v. Becerra, 468 F. Supp. 3d 1247, 1258

(E.D. Cal. 2020) (acknowledging that “what * * *

‘uncontroversial’ means has not been completely

explained by the Supreme Court”).

15

True, in some cases “determining whether a

disclosure is ‘uncontroversial’ may be difficult.” Am.

Meat Inst., 760 F.3d at 34 (Kavanaugh, J., concurring

in the judgment). This is not one of those cases. Under

any plausible interpretation, FDA’s latest graphic

warnings are misleading and thus highly

controversial.

Far from being “purely factual and

uncontroversial,” as both Zauderer and NIFLA

require, the FDA’s graphic warnings themselves are

misleading. While no image “has a single, objective

meaning that could make it ‘purely factual,’” many

reasonable interpretations are medically inaccurate

and thus misleading. Pet. App. 88a–92a. At best, the

warnings seek to dramatically exaggerate the health

harms of smoking by suggesting that very rare

consequences of smoking are in fact common. At

worst, the warnings are an “unabashed attempt[] to

* * * browbeat consumers into quitting.” R.J.

Reynolds, 696 F.3d at 1216–17. Neither goal offers a

valid governmental justification for compelling

speech.

“Where the government orders disclosures as a

way to advance its side in a controversial matter,”

then “the disclosure mandate” should “bear[] greater

constitutional scrutiny.” Ellen P. Goodman, Visual

Gut Punch: Persuasion, Emotion, and the

Constitutional Meaning of Graphic Disclosure, 99

Cornell L. Rev. 513, 552 (2014). Here the Fifth Circuit

implied that it would consider the warnings’ factual

accuracy under the “uncontroversial” prong. Pet. App.

27a n.48 (“We expressly refrain from suggesting that

a factual statement is necessarily an accurate one.”).

Yet as part of its analysis, the Fifth Circuit never

16

addressed whether the warnings themselves are

misleading.

The D.C. Circuit, however, holds that

“uncontroversial” must refer to whether “a message

* * * is controversial for some reason other than a

dispute about simple factual accuracy.” NAM, 800

F.3d at 527–30 & n.28. This makes sense, of course,

because Zauderer requires that a disclosure be both

“purely factual” and “uncontroversial.” Besides

conflicting with this Court’s and the D.C. Circuit’s

precedent, the Fifth Circuit’s decision also conflicts

with the Ninth Circuit, which holds that even

“literally true” statements may “nonetheless [be]

misleading, and, in that sense, untrue” under

Zauderer. CTIA—The Wireless Ass’n v. Berkeley, 928

F.3d 832, 847 (9th Cir. 2019).

Under the First Amendment, FDA cannot

require companies to spread its idiosyncratic

viewpoint, particularly “where the messages

themselves are biased against or are expressly

contrary to the corporation’s views.” Pac. Gas & Elec.,

475 U.S. at 15 n.12 (plurality opinion). On the

contrary, when it comes to a controversial issue of

public debate, “the general rule is that the speaker

and the audience, not the government, assess the

value of the information.” Sorrell v. IMS Health Inc.,

564 U.S. 552, 578 (2011) (cleaned up) (emphasis

added).

Of course, even if FDA’s new graphic warnings

were purely factual—they aren’t—that would not

“divorce the speech from its moral or ideological

implications.” Stuart v. Camnitz, 774 F.3d 238, 246

(4th Cir. 2014). “If the disclaimer creates confusion,

17

rather than eliminating it, the only possible

constitutional justification for [the] speech regulation

is defeated.” Borgner v. Fla. Bd. of Dentistry, 537 U.S.

1080, 1080 (2002) (Thomas and Ginsburg, JJ.,

dissenting from denial of certiorari).

Above all, the government never has a

legitimate reason to force companies to deliver

misleading information about their products to their

own consumers. See Video Software Dealers Ass’n v.

Schwarzenegger, 556 F.3d 950, 967 (9th Cir. 2009),

aff’d sub nom. Brown v. Entm’t Merchants Ass’n, 564

U.S. 786 (2011); see also R.J. Reynolds, 696 F.3d at

1216 (a compelled disclosure fails First Amendment

scrutiny if it “could be misinterpreted by consumers”).

Misleading disclosures are inherently controversial.

It would be ironic if FDA could transform

Zauderer, a First Amendment test created to require

advertisers to correct or clarify false or misleading

speech, into a justification for foisting false or

misleading speech onto the public. But that is

precisely what the Fifth Circuit allowed FDA to do.

The Court should end this confusion among the lower

courts by reviewing the Fifth Circuit’s decision to

apply Zauderer here.

II.

REVIEW IS NEEDED BECAUSE FDA’S CLAIMED

INFORMATIONAL INTEREST CANNOT JUSTIFY

THE RULE.

Review is also warranted because FDA’s own

evidence confirms that its mere “informational

interest” in educating the public is inadequate to

justify the rule. In other words, the Rule fails to

satisfy either Zauderer’s or Central Hudson’s

18

required evidentiary showing. First, even if Zauderer

supplies the right test, FDA may not mandate a

disclosure if it is “unjustified.” Zauderer, 471 U.S.

at 651. Here the Rule is unjustified because it will not

materially improve the public’s understanding of the

risks of smoking, which is FDA’s only stated goal.

Likewise, under Central Hudson, the Rule

“must directly advance” FDA’s stated interest in

improving public understanding of the risks of

smoking “in a material way.” Edenfield, 507 U.S.

at 774. FDA’s record evidence simply cannot clear

that hurdle. It is not enough that the Rule “provides

only ineffective or remote support for the

government’s purposes,” or that it has “little chance”

of advancing the FDA’s goal. Id. at 770–71.

Because no credible empirical evidence links

the Rule’s mandated warnings to FDA’s only stated

goal, FDA’s informational is interest particularly

inadequate here. See Pet. 40. This Court’s review is

thus needed to clarify that the Rule cannot survive

any level of First Amendment scrutiny.

A.

FDA’s studies are deeply flawed.

Facts are stubborn things, but studies are

pliable. Bent on reaching its predetermined

conclusions no matter what, FDA placed a heavy

thumb on the scales for its various studies. These

methodological flaws make FDA’s underlying studies

unreliable.

FDA relied on two quantitative studies to

justify the Rule. The first study tested whether the

Rule’s textual warnings produced a statistically

significant change in participants’ beliefs about

19

smoking risks. See RTI Int’l, Experimental Study on

Warning Statements for Cigarette Graphic Health

Warnings: Study 1 Report (Apr. 2018), https://perma.

cc/9FZM-AZPV. The second study tested whether the

Rule’s graphic warnings had that same effect. See RTI

Int’l, Experimental Study of Cigarette Warnings:

Study 2 Report (May 2019), https://perma.cc/A9HX4ELW. Both studies were deeply flawed.

According to the Office of Management and

Budget, FDA selectively recruited the participants for

both studies “using convenience sampling methods”

with no “known probability of selection.” OMB, Notice

of Office of Management and Budget Action,

Experimental Study on Warning Statements for

Cigarette Graphic Health Warnings, Ref. No. 2017080910-011 (Jan. 29, 2018), https://perma.cc/8S84SEKW. As a result, FDA’s quantitative studies are

“not intended to generate nationally representative

outcomes.” Id. As the saying goes: garbage in, garbage

out.

FDA also relied on three qualitative studies.

But FDA did not design those studies to test the

accuracy of the Rule’s warnings or the messages they

convey to consumers. Rather, FDA focused merely on

whether the warnings conveyed new information,

grabbed participants’ attention, or were believed or

understood by participants. See RTI Int’l, Qualitative

Study on Cigarettes and Smoking: Knowledge, Beliefs,

and Misperceptions at 6–7 (July 2015), https://perma.

cc/45WX-P86H; Siegel+Gale, FDA Graphic Health

Warning Image Concept Testing at 11–13 (June

2016), https://perma.cc/NHW8-JR8H; RTI Int’l,

Qualitative Study on Consumer Perceptions of

Cigarettes Health Warning Images at 3 (Apr. 2018),

https://perma.cc/6RM9-LDGR. But none of those

20

variables fairly measures the Rule’s effectiveness at

improving the public’s understanding of the true risks

of smoking.

Nor is that all. “[W]hen an agency decides to

rely on a cost-benefit analysis as part of its

rulemaking, a serious flaw undermining that analysis

can render the rule unreasonable.” Idaho

Conservation League v. Wheeler, 930 F.3d 494, 507

(D.C. Cir. 2019) (cleaned up). Here, FDA’s cost-benefit

analysis failed even to quantify the Rule’s benefits.

See FDA, Preliminary Regulatory Impact Analysis

at 2 (Aug. 2019), https://perma.cc/JWU5-5AH7

(“[T]here is a high level of uncertainty around

quantitative economic benefits at this time, so we

describe them qualitatively.”); FDA, Final Regulatory

Impact Analysis at 17 (Mar. 2020), https://perma.

cc/ZN2S-BUC4 (“[T]here is a high level of uncertainty

around quantified economic benefits at this time[,]

and we therefore apply a break-even analysis.”).

Even worse, FDA hid crucial data from the

public during the rulemaking. “[S]tudies upon which

an agency relies in promulgating a rule must be made

available during the rulemaking in order to afford

interested persons meaningful notice and an

opportunity for comment.” Am. Radio Relay League,

Inc. v. FCC, 524 F.3d 227, 237 (D.C. Cir. 2008).

Despite repeated requests, FDA refused to release the

final data sets from its two quantitative studies. See,

e.g., Letter from A. Klingler, Docket No. FDA-2019-N3065-0001 (Sept. 9, 2019); Letter from Altria Client

Services, Docket No. FDA-2019-N-3065-0001 (Sept. 5,

2019).

FDA also failed at first to release the

underlying data, or even the study reports, for its

21

three qualitative studies. 84 Fed. Reg. at 42,767,

42,771. When—nearly a month after the comment

period closed—FDA finally placed the qualitative

study reports on the docket, it gave the public only

fifteen days to comment. See Tobacco Products;

Required Warnings for Cigarette Packages and

Advertisements; Additional Materials; Reopening of

the Comment Period, 84 Fed. Reg. 60,966 (Nov. 12,

2019).

This Court need not guess why FDA hid its

data from stakeholders during the rulemaking. In a

revealing “Memo to File” included in the

administrative record, FDA openly worried that

disclosure would “allow third party attempts to

analyze the data in different and potentially selective,

biased or misleading ways other than what FDA prespecified in the statistical analysis plan.” E.D. Tex.

Dkt. 59–3 at 11 (administrative record excerpts). But

the core assumption behind rulemaking is that FDA’s

“pre-specified” methodological assumptions will be

scrutinized, challenged, and even criticized by

stakeholders. FDA has no right to obstruct that

process.

FDA also failed to seriously consider

alternative approaches. It ignored several lessrestrictive alternatives suggested by stakeholders—

public-education campaigns, differently placed and

differently sized warnings, and revised textual

warnings. See C.A. ROA 1266–67, 1586–87, 1593–

1615, 1630–31, 1698; Comment Letter of RAI Services

Co. at 31–32, Docket No. FDA-2019-N-3065 (Oct. 11,

2019). Even when it considered more cost-effective

alternatives, FDA supplied no rational explanation

for rejecting them. For example, when FDA

considered mandating only nine warnings instead of

22

eleven, it concluded that nine warnings would be less

costly. FDA, Preliminary Regulatory Impact Analysis,

supra, at 51–54. Even so, FDA stuck with eleven

warnings and never showed that the greater costs

imposed by two more warnings are offset by greater

benefits. The Fifth Circuit ignored these evidentiary

flaws, but this Court should grant review and

scrutinize them.

B.

Even if reliable, FDA’s own evidence

undercuts its position.

Even if FDA’s evidence is accepted as reliable,

it still undermines any notion that the Rule

effectively enhances the public’s understanding of

smoking risks. Simply put, a compelled disclosure

does not remedy an informational harm by telling

people things they “already know.” NIFLA, 585 U.S.

at 777. And that is precisely what FDA’s evidence

shows the Rule does here.

FDA’s own studies reveal that most of the

Rule’s warnings describe already well-known

smoking risks. See C.A. ROA 1581, 1597–98, 1602–06;

RTI Int’l, Qualitative Study on Cigarettes and

Smoking, supra, at 20, 33, 35; Comment Letter of RAI

Services Co., supra, Ex. C, Stmt. of J. Klick ¶¶ 5.43,

5.45, 5.48, 5.50, 5.58, 5.59, 5.60; Dannielle E. Kelley

et al., Effective Message Elements for Disclosures

About Chemicals in Cigarette Smoke, 20 Nicotine &

Tobacco Rsch. 1047, 1051 (2018). Indeed, Americans

overwhelmingly understand that smoking is harmful.

As FDA’s own PATH survey shows, 99.5% of

individuals believe that cigarette smoking harms

health, with 91% believing that it is “very or

extremely harmful.” C.A. ROA 1597–98. Comment

Letter of RAI Services Co., supra, Stmt. of J. Klick

23

¶ 5.20. FDA cannot “educate” the public by merely

repeating information the public already knows.

NIFLA, 585 U.S. at 777.

Again, FDA’s first quantitative study tested

whether the textual warnings led to a statistically

significant change in participants’ beliefs about

smoking risks. But when compared to the TCA’s

textual warnings, seven of the nine FDA-created

warnings—for “head-and-neck cancer,” “bladder

cancer,”

“erectile

dysfunction,”

“amputation,”

“diabetes,” “macular degeneration,” and “cataracts”—

did not increase the participants’ belief that smoking

has the negative health outcome tied to that warning.

See C.A. ROA 1471–72; 1485–87; RTI Int’l, Study 1

Report, supra, at 40–42. On the contrary, participants

found that the FDA-created statements were “less

believable.” Id. at 40. Rather than address these

defects, FDA nixed questions on “believability” from

its second quantitative study. As FDA’s own peerreview report pointedly asked, “What happened to

believability?” Versar, Final Summary Report:

External Letter Peer Review of FDA’s Quantitative

Consumer Research on Cigarette Health Warnings

Required by the Family Smoking Prevention and

Tobacco Control Act at 34 (Nov. 19, 2019),

https://perma.cc/JVM9-Q4B7.

FDA

has

never

answered that question. The Fifth Circuit showed no

interest in answering it either.

Likewise, FDA’s second quantitative study

tested whether the Rule’s graphic warnings led to any

statistically significant change in views about

smoking risks. Yet it showed that five of the Rule’s

eleven graphic warnings had no significant effect on

participants’ views, and that five more had only a

small effect that quickly dissipated. C.A. ROA 1482–

24

92, 1485–87; RTI Int’l, Study 2 Report, supra, at 42–

45.

What’s more, FDA ignored its own study’s

findings that participants simply did not believe the

FDA-created textual warnings. Indeed, the first

qualitative study’s “most prevalent” finding was that

participants had a “widespread negative reaction” to

warnings that smoking “causes” a disease, rather

than “can cause,” “may cause,” or “increases the risk

of” a disease. RTI Int’l, Qualitative Study on

Cigarettes and Smoking, supra, at 7, 52; see also id.

at 15, 17, 19, 26, 27, 31, 33, 34, 35, 36, 38, 45, 46.

Despite these valid concerns, nearly all the Rule’s

FDA-created warnings say that smoking “causes” the

specific negative health outcome. FDA simply ignored

its own study participants’ feedback.

FDA’s study participants also “expressed a

desire for more information about the relationship

between the amount and duration of smoking . . . to

the health effects of smoking.” Id. at 7; see also id.

at 38, 52. Although this was among the study’s “key

findings,” FDA never included this clarifying

information on the warnings. Participants also were

dubious of warnings about certain smoking risks—

like erectile dysfunction or diabetes—without more

detail about how smoking “causes” them. See id.

at 23–24, 45, 53. Yet FDA, despite its supposed goal

of fostering “greater public understanding” of the

risks of smoking, 85 Fed. Reg. at 15,650, ignored this

finding in the final Rule.

FDA has also ignored, downplayed, and

misrepresented its own peer-review feedback. FDA

portrayed its peer-review report as overwhelmingly

favorable. See 85 Fed. Reg. at 15,661. Yet peer

25

reviewers identified core weaknesses with FDA’s

studies because they were based on an “undetermined

and never clearly defined” conceptual model. Final

Summary Report, supra, at 14. FDA’s sole reliance on

“self-reported learning” and “new information,” for

example, lacked “convincing validity” as measures of

the Rule’s effectiveness. Id. at 14; see also 27–28, 33.

As peer reviewers explained, neither

criterion—“self-reported

learning”

nor

“new

information”—can tell us whether the Rule’s

warnings would improve public understanding of

smoking risks; they are non-standard measures of

questionable validity. Id. at 14, 18, 28. No surprise,

then, that FDA deprived the public of the chance to

comment on the peer-review report or FDA’s response

to it. See RTI Int’l, Study 1 Report, supra, at 4–5; RTI

Int’l, Study 2 Report, supra, at 1–2. This is typical for

FDA, which displayed a curious tendency to downplay

and even hide the underlying data for its own studies

throughout the rulemaking.

FDA bears the burden of proving that its

drastic compelled-speech remedy solves a real-world

problem. Yet none of FDA’s evidence supports FDA’s

flimsy justification for the Rule. This is just one more

reason, among many, to grant the petition.

26

CONCLUSION

The Court should grant the petition.

Respectfully submitted,

Cory L. Andrews

Counsel of Record

John M. Masslon II

WASHINGTON LEGAL FOUNDATION

2009 Massachusetts Ave. NW

Washington, DC 20036

(202) 588-0302

candrews@wlf.org

September 20, 2024