R.J. Reynolds Tobacco Company et al v. United States Food And Drug Administration et al
Filing
106
OPINION AND ORDER granting in part 34 Motion for Summary Judgment; denying 36 Motion to Dismiss; and denying 37 Motion for Summary Judgment. All other pending motions are denied as moot. Signed by District Judge J. Campbell Barker on 12/7/2022. (ndc)
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No. 6:20-cv-00176
R.J. Reynolds Tobacco Co. et al.,
Plaintiffs,
v.
U.S. Food & Drug Administration et al.,
Defendants.
OPINION AND ORDER
Several motions are ready for resolution in this challenge to an
FDA rule. First, the government asks the court to dismiss one
plaintiff for lack of subject-matter jurisdiction and to then dismiss
or transfer the case for improper venue in this district. For the
reasons explained below, the government’s argument as to jurisdiction is unpersuasive, and the government’s argument as to
venue is forfeited. Accordingly, the government’s motion to dismiss or transfer (Doc. 36) is denied.
Second, both sides move for summary judgment and agree
that no factual disputes require trial. As explained below, plaintiffs
are entitled to judgment on their claim that the challenged rule is
invalid under the First Amendment. Accordingly, the court denies defendants’ motion for summary judgment (Doc. 37) and
grants in part plaintiffs’ motion for summary judgment (Doc. 34).
Background
1. Plaintiffs sue to challenge an FDA rule on cigarette health
warnings. Such warnings have a long history. For over 50 years,
Congress has required health warnings on cigarette packages and
advertising. 1 Section 4 of the Labeling Act of 1965 is the precursor
of today’s regime. It required that cigarette packages state: “Caution: Cigarette Smoking May Be Hazardous to Your Health.”
1
Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92,
§ 4, 79 Stat. 282, 283 (1965) (codified at 15 U.S.C. § 1333 (1970)).
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Two decades later, Congress amended § 4 of the Labeling Act
to require that cigarette packages and advertising include, on a rotating basis, one of four “Surgeon General’s warnings”:
•
“SURGEON GENERAL’S WARNING: Smoking Causes
Lung Cancer, Heart Disease, Emphysema, [a]nd May
Complicate Pregnancy.”
•
“SURGEON GENERAL’S WARNING: Quitting Smoking
Now Greatly Reduces Serious Risks to Your Health.”
•
“SURGEON GENERAL’S WARNING: Smoking [b]y
Pregnant Women May Result in Fetal Injury, Premature
Birth, and Low Birth Weight.”
•
“SURGEON GENERAL’S WARNING: Cigarette Smoke
Contains Carbon Monoxide.” 2
Those warnings typically appear on the side panel of cigarette
packages, as shown in the image below: 3
In the 1990s, the FDA tried to impose additional restrictions
on cigarette sales under its existing statutory authority. The Supreme Court, however, read those statutes as withholding authority for such regulations. 4 In response, Congress passed the Family
Smoking Prevention and Tobacco Control Act of 2009, 5 which
gives the FDA limited authority to regulate tobacco products. The
2
Comprehensive Smoking Education Act, Pub. L. No. 98-474, § 4,
98 Stat. 2200, 2201–02 (1984) (codified at 15 U.S.C. § 1333 (1988)).
3
Institute of Medicine of the National Academies, Ending the Tobacco
Problem: A Blueprint for the Nation 290 (2007) (Fig. 6-1), available at
https://www.nap.edu/catalog/11795/ending-the-tobacco-problem-ablueprint-for-the-nation.
4
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137 (2000).
5
Pub. L. No. 111-31, 123 Stat. 1776.
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Tobacco Control Act recites Congress’s understanding that “tobacco products are inherently dangerous and cause cancer, heart
disease, and other serious adverse health effects.” 6 Congress expressed particular concern that more limited efforts to regulate
tobacco products had “failed adequately to curb tobacco use by
adolescents.” 7
Rather than banning tobacco products—which could foster a
black market—the Tobacco Control Act creates measures aimed
at reducing the usage and dangers of tobacco products. Among
other things, the Act approves the FDA’s 1990s restrictions on
cigarette marketing, finding them “substantially related to accomplishing the public health goals” of the Act. 8 Specifically, Congress found that “[r]educing the use of tobacco by minors” by half
would save over three million children from premature deaths, 9
and that advertising “often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors.” 10
The Tobacco Control Act also amends § 4 of the Labeling Act
to replace the Surgeon General’s warnings with new warnings that
have both a textual and a graphic component. 11 Congress set out
nine textual warnings—called “label statements” 12—that must be
displayed with equal frequency on a rotating basis. 13 Congress
then directed the Secretary of Health and Human Services to require, by rulemaking, that the label statements be accompanied by
color graphics depicting the negative health consequences of
smoking. 14
Congress directed that the label statements must occupy the
top half of the front and rear panels of cigarette packages. 15 And
6
Id. § 2(2), 123 Stat. at 1777.
Id. § 2(6), 123 Stat. at 1777.
8
Id. § 2(30), 123 Stat. at 1778–79.
9
Id. § 2(14), 123 Stat. at 1777.
10
Id. § 2(17), 123 Stat. at 1778.
11
See id. § 201 (codified at 15 U.S.C. § 1333).
12
15 U.S.C. § 1333(a)(1), (b)(2).
13
Id. § 1333(c)(2).
14
Id. §§ 1332(9), 1333(d) (first of two subsections (d)).
15
Id. § 1333(a)(2).
7
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Congress directed that the label statements must occupy at least
20 percent of the area of cigarette advertising. 16
Congress also specified type-size, format, and color requirements for the label statements. 17 But the type-size and format requirements—although not the color requirements—were made
subject to adjustment by mandatory and optional rulemaking. 18
Congress separately gave the Secretary authority to issue rules
adjusting the type size, format, color graphics, and text of any label requirements “if the Secretary finds that such a change would
promote greater public understanding of the risks associated with
the use of tobacco products.” 19
Those amendments to § 4 of the Labeling Act were made in
subsection (a) of § 201 of the Tobacco Control Act. 20 But those
amendments were not effective immediately. Rather, Congress directed that the amendments “shall take effect 15 months after the
issuance of the regulations required by subsection (a)” of § 201. 21
Read literally, that provision creates a circularity. There are no
regulations required by § 201(a) until § 201(a) takes effect as law.
But the parties agree that “required by” should be read as meaning something like “required by § 201(a) were it in effect.” The
court agrees and adopts that reading to avoid an absurdity.
The parties also agree to another implied qualification: the 15month countdown clock to the effectiveness of § 201(a)’s statutory amendments runs only if the contemplated regulations are
not just issued but also keep their effectiveness throughout the
countdown period. Thus, the parties agree that the Act’s additional labeling requirements are “tied to the effective date of the
16
Id. § 1333(b)(2).
Id. § 1333(a)(2), (b)(2).
18
Id. § 1333(b)(4) (directing the Secretary to provide for certain adjustments and allowing the Secretary to provide for further adjustments).
19
Id. § 1333(d) (second of two subsections (d)).
20
Pub. L. No. 111-31, § 201(a), 123 Stat. at 1845.
21
Id. § 201(b), 123 Stat. at 1845.
17
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graphic-warnings Rule.” 22 On that view, a court’s postponement
of the effective date of the FDA’s regulations also postpones the
15-months-after-rulemaking effective date of (i) the Tobacco Control Act’s amendment to § 4 of the Labeling Act and (ii) related
Tobacco Control Act provisions. 23 The court accepts the parties’
shared understanding of the effective date of the statutory provisions.
2. On June 22, 2011, the FDA issued a final rule specifying
graphic health warnings. 24 The rule required that the Act’s nine
textual warnings be accompanied by graphics on the top half of
the front and back panels of cigarette packs and the top fifth of
advertisements. 25 As shown, the required graphics 26 included disembodied organs, a distressed baby, and a sutured corpse:
FDA’s 2011 Graphics
22
Doc. 30 at 4 n.1 (citations omitted; emphasis added). Citations to
an ECF document (“Doc.”) are to the page number added by ECF, not
to the parties’ assigned numbering.
23
See id.
24
Required Warnings for Cigarette Packages and Advertisements, 76 Fed.
Reg. 36,628 ( June 22, 2011).
25
Id. at 36,674.
26
Id. at 36,629, 36,696; Complaint [Doc. 1] at 23–26, R.J. Reynolds
Tobacco Co. v. FDA, 845 F. Supp. 2d 266 (D.D.C. 2012) (No. 1:11-cv01482) (showing images).
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FDA’s 2011 Graphics
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The FDA justified those graphics as reducing the consumption of cigarettes and thus improving public health:
The warnings currently in use in the United States also fail
to include any graphic component, despite the evidence in
the scientific literature that larger, graphic health warnings
promote greater understanding of the health risks of smoking and would help to reduce consumption. In proposing
this regulation and preparing this final rule, we found substantial evidence indicating that larger cigarette health
warnings including a graphic component, like those being
required in this rule, would offer significant health benefits
over the existing warnings. 27
That regulatory approach follows the path of countries like Australia and Canada, which require cigarette packages to carry large
warnings with stark graphic and textual components. 28
3. Before the FDA’s final rule issued in 2011, five cigarette
manufacturers—including R.J. Reynolds—and one cigarette retailer sued the government to enjoin enforcement of some provisions of the Tobacco Control Act, including its requirement of
graphic and textual health warnings. 29 The district court rejected
those plaintiffs’ argument that the Act’s requirement was facially
invalid as an unconstitutional compulsion of and burden on private speech. 30 Graphics for the health warnings had not yet been
specified by the FDA. But the court reasoned that a graphic component would not alter the neutral and uncontroversial nature of
the required warnings, “at least as a general rule.” 31
27
76 Fed. Reg. at 36,629 (citations omitted).
Institute of Medicine of the National Academies, supra note 3, at
292 (describing global approaches).
29
Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512
(W.D. Ky. 2010).
30
Id. at 528–32.
31
Id. at 532.
28
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The Sixth Circuit affirmed that aspect of the judgment. 32 It
held that the Act’s textual warnings should be judged under the
free-speech standards set out by the Supreme Court in Zauderer
v. Office of Disciplinary Counsel. 33 The textual warnings complied
with those standards, the court held, because they were factual,
uncontroversial, and reasonably related to preventing consumer
deception (from past tobacco-industry deception). 34
The Sixth Circuit then held that the Act’s requirement of a
graphic component to the warnings was not facially invalid. The
court could imagine some set of graphics that might satisfy Zauderer, such as an illustration merely showing the warnings’ text in
a child’s handwriting. 35 At the same time, the court noted that it
was resolving only a facial challenge and that, by the time of its
decision, specific images had been chosen by the FDA and were
“under review elsewhere.” 36
4. That separate review of the FDA’s 2011 graphics took
place in the District of Columbia. There, a group of tobacco companies sued and obtained on appeal a judgment vacating the 2011
rule. 37
The vacatur of the 2011 rule, the parties agree, also postponed
the effective date of the Tobacco Control Act’s statutory amendments tied to that rulemaking. 38 That understanding leaves the
Surgeon General’s warnings applicable today, pursuant to the preTobacco Control Act version of the Labeling Act.
The D.C. Circuit’s vacatur of the FDA’s 2011 rule rests on the
First Amendment right to refrain from speaking. 39 That right
32
Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509
(6th Cir. 2012).
33
471 U.S. 626 (1985).
34
Discount Tobacco, 674 F.3d at 558, 562.
35
Id. at 559–60, 564–66.
36
Id. at 558.
37
R.J. Reynolds Tobacco Co. v. FDA, Doc. 1391187, No. 11-5332, 696
F.3d 1205 (D.C. Cir. Aug. 24, 2012) (judgment).
38
See supra notes 22–23 and accompanying text.
39
R.J. Reynolds, 696 F.3d at 1211 (citing Wooley v. Maynard, 430 U.S.
705, 714 (1977)).
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requires scrutiny of state efforts to compel private speech or private subsidization of speech. 40 The FDA rule was such an effort,
the D.C. Circuit held, as the FDA itself claimed to be making the
top half of every cigarette package into “[a] mini billboard for the
government’s anti-smoking message.” 41
The parties disputed what standard of review applies to state
action compelling a product’s manufacturer to carry the government’s speech. The agency argued for use of the less-stringent
standard set out in Zauderer. But the D.C. Circuit viewed that
standard as limited to disclosure requirements that are reasonably
related to preventing consumer deception. On that view, the Zauderer standard was inapplicable to warnings based on public
health. 42
The D.C. Circuit also held that the FDA rule failed a second
requirement for Zauderer treatment: that it compels only “purely
factual and uncontroversial” information. 43 The court reasoned
that many of the FDA’s nine images could be misinterpreted as
showing a common consequence of smoking, even though the government justified the images as symbolic rather than showing the
nine most common consequences of smoking. 44 The court further
held that the graphic warnings were not “purely” factual because
they were primarily intended to evoke an emotional response or
because they offered advocacy rather than factual information
about health effects. 45
After holding that the FDA rule did not qualify for Zauderer
review, the D.C. Circuit turned to the general standard of review
40
Id. at 1212.
Id.
42
Id. at 1213. The D.C. Circuit has since overruled that aspect of its
reasoning and held that Zauderer review applies to “factual and uncontroversial” compelled disclosures that serve government interests other
than preventing consumer deception. Am. Meat Inst. v. USDA, 760 F.3d
18, 21–23 (D.C. Cir. 2014) (en banc) (overruling R.J. Reynolds on that
point).
43
R.J. Reynolds, 696 F.3d at 1216.
44
Id.
45
Id.
41
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for commercial-speech restrictions, which the Supreme Court set
forth in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York. 46 That standard requires the state to show
that a regulation is narrowly tailored to achieve a substantial interest. 47
The D.C. Circuit held that the FDA had to rely on the single
interest asserted in the challenged rule: reducing the number of
Americans, and particularly adolescents, who use tobacco products. 48 Yet no substantial evidence supported the government’s
argument that causing increased thoughts about quitting smoking
would directly lead to an actual, material reduction in smoking. 49
It could just as well be true that causing more thoughts about quitting smoking would not actually overcome smoking’s addictiveness. 50 The court apparently relied on the same reasoning about
the resilience of the impulse to start smoking despite widespread
knowledge of its health risks.
The D.C. Circuit dismissed the government’s resort to an interest in “effectively communicating health information,” standing alone. 51 A purely informational interest in education, the court
reasoned, could not qualify as a substantial interest under Central
Hudson because such an abstract interest can always be said to be
directly advanced by more and more compelled disclosure. 52
The D.C. Circuit thus held unconstitutional the FDA’s attempt to force private companies to spread the government’s antismoking message. 53 Relying on circuit precedent, the D.C. Circuit
vacated the rule and remanded the rulemaking to the agency. 54
46
447 U.S. 557 (1980).
Id. at 564–65.
48
R.J. Reynolds, 696 F.3d at 1218.
49
Id. at 1219–21.
50
See id.
51
Id. at 1221.
52
Id.
53
Id. at 1221–22.
54
Id. at 1222.
47
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5. On remand to the agency, the FDA spent years contemplating its future course of action. In 2016, several nonprofit organizations sued, claiming that the agency was unreasonably delaying the issuance of a new graphic-warning rule. A district court
ordered the FDA to issue a final rule by March 15, 2020. 55
On March 18, 2020, after receiving public comment on its proposed rule, the FDA issued a new final rule on cigarette health
warnings. The rule requires that cigarette packaging and advertising display, with even frequency on a rotating basis, one of these
eleven warnings: 56
FDA’s 2020 Graphics
55
See Am. Acad. of Pediatrics v. FDA, No. 1:16-cv-11985, 2019 WL
1047149, at *3 (D. Mass. 2019).
56
85 Fed. Reg. at 15,690–91; FDA, Required Cigarette Health Warnings, 2020, https://www.fda.gov/media/136157/download.
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FDA’s 2020 Graphics
In adopting those eleven warnings, the rule does not simply
provide graphics for the nine textual warnings in the Act. 57 The
57
See 85 Fed. Reg. at 15,641–42 (asserting authority to do so).
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rule omits two of the Act’s warnings (“Cigarettes are addictive”
and “Quitting smoking now greatly reduces serious risks to your
health”). 58 The rule then rephrases other warnings from the Act
and splits one of the Act’s warnings (on cancer) into two.
The rule also includes new warnings, not required by the Act,
about three health outcomes (amputation, blindness, and erectile
dysfunction). 59 Those additions are based in part on the intervening 2014 Surgeon General’s report on smoking. 60 That report
identified additional health conditions whose causal link to smoking was reported as established at the highest level of evidence. 61
Regarding the D.C. Circuit’s decision on the prior rule, the
new rule disclaims that the government’s “one true interest lies
in reducing smoking rates.” 62 Rather, the government justifies the
new rule on an interest “in promoting greater public understanding of the negative health consequences of smoking.” 63 That interest flows from the Tobacco Control Act, which allows changes
to the graphic warnings to “promote greater public understanding
of the risks associated with the use of tobacco products.” 64
The rule then attempts to tie the chosen graphics to the government’s interest in increasing public understanding. The rule
contends that the new warnings will be noticed whereas the Surgeon General’s warnings are not: “[T]here is considerable evidence that the Surgeon General’s warnings go largely unnoticed
and unconsidered by both smokers and nonsmokers . . . [and] have
been described as ʻinvisible’ . . . .” 65
58
See 15 U.S.C. § 1333(a).
See 85 Fed. Reg. at 15,680–84.
60
Id. at 15,640.
61
See id.; U.S. Dept. of Health & Human Servs., The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon
General (2014).
62
85 Fed. Reg. at 15,644.
63
Id. at 15,650.
64
15 U.S.C. § 1333(d) (second of two subsections (d)).
65
85 Fed. Reg. at 15,640.
59
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The warnings required by the new rule must occupy the top
50 percent of the front and rear panels of cigarette packages and
the top 20 percent of cigarette advertisements. 66 That would result in an appearance as follows: 67
6. The new rule applies to manufacturers and retailers alike.
The rule deems it unlawful conduct to make, package, sell, advertise, or offer for sale cigarettes without the specified warnings.68
Retailers and manufacturers alike engage in activities on that list.
Manufacturers make, package, and advertise cigarettes and sell
them to retailers. Retailers too advertise and sell cigarettes.
Retailers may be penalized for their unlawful conduct if they
fall outside an enforcement safe harbor in the rule. If a retailer
sells or advertises cigarettes without a required warning, the retailer may face a term of imprisonment, a fine, and an injunction
if either (i) the retailer materially altered the supplied packaging
or advertising or (ii) the supplier did not hold a license or permit. 69
66
Id.
U.S. Food & Drug Admin., FDA Proposes New Health Warnings for
Cigarette Packs and Ads (May 1, 2020), https://www.fda.gov/tobaccoproducts/labeling-and-warning-statements-tobacco-products/fda-proposes-new-health-warnings-cigarette-packs-and-ads.
68
85 Fed. Reg. at 15,709 (21 C.F.R § 1140.10(c), (d)).
69
Id. (21 C.F.R § 1141.1(c)–(d)); see 15 U.S.C. §§ 1338–39; 18 U.S.C.
§ 3581(b).
67
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In addition to that enforcement mechanism, a noncompliant
retailer may have its personal property seized and destroyed regardless of the safe harbor from other penalties. Failure to display
the warnings makes cigarettes “misbranded” under the rule,
which allows the government to seize and condemn them. 70
7. Plaintiffs in this case are four cigarette manufacturers and
five cigarette retailers. One of the retailer plaintiffs is Neocom,
which resides in and sells cigarettes in this district. One of the
manufacturer plaintiffs is R.J. Reynolds, which is bound by the res
judicata effect of the Sixth Circuit’s judgment on its facial challenge to the Tobacco Control Act. 71 The other plaintiffs are not.
Plaintiffs claim that (i) the rule and the Act’s requirements for
compelled warnings violate the First Amendment; (ii) the rule violates the Administrative Procedure Act; and (iii) the rule violates
the Tobacco Control Act’s own requirements for both the text and
the graphics of the health warnings.
Early in the case, the parties jointly moved for a postponement
of the rule’s effective date, which the court granted. The court
has extended that postponement while it considered pending motions. Three motions are now ripe for resolution:
(1) the government moves to dismiss plaintiff Neocom for
lack of Article III standing;
(2) the government moves to dismiss or transfer the case
based on improper venue; and
(3) each side moves for summary judgment, with plaintiffs
seeking a declaratory judgment, an injunction, and vacatur
of the rule.
Analysis
For the reasons set forth below, the court denies the government’s motion to dismiss plaintiff Neocom. See infra Part I. The
court also denies the government’s motion to dismiss or transfer
70
85 Fed. Reg. at 15,709 (21 C.F.R § 1141.12) (citing 21 U.S.C.
§ 387c); 21 U.S.C. § 334(a)(2)(E), (g).
71
See supra note 35.
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the case based on venue. See infra Part II. Finally, the court denies
the government’s motion for summary judgment and grants plaintiffs’ motion for summary judgment as to their First Amendment
challenge to the rule. See infra Part III.
I. The court has jurisdiction to resolve Neocom’s claims because they track the manufacturer plaintiffs’ claims.
The government contends that “Neocom lacks Article III
standing, and the Court lacks subject-matter jurisdiction over its
claim.” 72 At oral argument, the government confirmed that it
seeks Neocom’s dismissal on standing grounds regardless of how
the government’s defense of improper venue is resolved.
Because the government asserts the defense of lack of subjectmatter jurisdiction, its motion to dismiss is governed by Federal
Rule of Civil Procedure 12(b)(1), although its motion strangely
fails to cite that rule. Such a motion should be granted “only if it
appears certain that the plaintiff cannot prove any set of facts in
support of his claim that would entitle [the] plaintiff to relief.” 73
The government admits that the manufacturer plaintiffs have
Article III standing to bring their claims and that their claims arise
under the Constitution and laws of the United States. 74 The court
agrees that it has constitutional and statutory subject-matter jurisdiction over the manufacturers’ claims. 75
The five retailer plaintiffs allege the same legal defects in the
same statute and same rule as do the manufacturer plaintiffs
whose standing is established. Does that end the analysis?
The Supreme Court, for its part, has repeatedly ended its
standing analysis there. In Rumsfeld v. FAIR, for instance, the
Court stated that it could “limit its discussion” to the one plaintiff
whose standing was established. 76 In Watt v. Energy Action Educational Foundation, the presence of one plaintiff with standing
72
Doc. 36 at 17.
Ramming v. United States, 281 F.3d 158, 161 (5th Cir. 2001).
74
Doc. 36 at 6.
75
U.S. Const. art. III, § 1; 28 U.S.C. § 1331.
76
547 U.S. 47, 52 n.2 (2006).
73
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allowed the Court to “not consider the standing of the other
plaintiffs.” 77 Several other Supreme Court decisions follow such
a “need not consider” approach after finding one plaintiff with
standing to raise a particular legal argument. 78
Explaining that approach, the Supreme Court in Doe v. Bolton
stated that “nothing is gained or lost by the presence or absence
of” additional plaintiffs past the first with standing. 79 Of course,
that statement is not true in its broadest sense. An additional
plaintiff’s presence in a case will, under res judicata, bind that
plaintiff to the judgment in that case. That is a very important
thing “gained or lost” by being in court or not. Its importance is
shown by the frequent litigation over using a class action to bind
many plaintiffs to a single judgment.
The presence or absence of an additional plaintiff can also affect defenses such as improper venue. And it can affect discretionary transfer decisions based on the location of parties, witnesses, and evidence. All to say, at least some things are gained or
lost by the presence or absence of additional plaintiffs.
So perhaps the Supreme Court’s reasoning should be understood as limited to a tribunal that can decide legal questions on
which it grants review, as opposed to entire cases. 80 In deciding
legal questions, truly nothing may be gained or lost by the presence in the case of additional plaintiffs. But a district court enters
77
454 U.S. 151, 160 (1981).
Horne v. Flores, 557 U.S. 433, 446 (2009) (when one plaintiff has
standing, “we need not consider whether the Legislators also have standing”); Bowsher v. Synar, 478 U.S. 714, 721 (1986) (holding that the Court
“need not consider the standing issue as to” other plaintiffs when one
plaintiff has Article III standing) (citing Sec’y of the Interior v. California,
464 U.S. 312, 319 n.3 (1984) (“Since the State of California clearly does
have standing, we need not address the standing of the other respondents, whose position here is identical to the State’s.”)); Vill. of Arlington
Heights v. Metro. Hous. Dev. Corp., 429 U.S. 252, 264 n.9 (1977) (noting
that, because at least one plaintiff had standing, the Court “need not consider whether other . . . plaintiffs have standing”).
79
410 U.S. 179, 189 (1973).
80
See generally Ben Johnson, The Origins of Supreme Court Question
Selection, 122 Colum. L. Rev. 793 (2022).
78
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judgments adjudicating whether specific parties are entitled to
specific types of relief. 81 So it does seem strange to contemplate a
district court issuing a judgment awarding (or denying) relief to a
party that does not have a cognizable legal stake in the case that
gives it standing to sue.
The Supreme Court’s approach may also reflect the fact that
its holdings on matters of federal law bind all parties nationwide—
if not as a matter of res judicata, then as a matter of stare decisis.
So perhaps the Supreme Court’s one-good-plaintiff approach to
standing should not apply in the different setting of a circuit court
(whose rulings do not have nationwide precedential effect) or a
district court (whose rulings do not have even local precedential
effect).
Whatever the merits of that debate, this court is bound by the
rulings of the Fifth Circuit, which has not attached significance to
those unique aspects of the Supreme Court. The Fifth Circuit
holds that the presence of one party with standing is sufficient to
authorize judicial relief as to all parties challenging the same defendant’s action on the same legal theory—what the Fifth Circuit
calls the same “claim.” 82
That rule controls here. The manufacturer plaintiffs undeniably have standing to raise each of their challenges to the Tobacco
Control Act and the FDA rule. And plaintiff Neocom challenges
the same statute and rule on the same legal theories. Under binding circuit precedent, those facts confirm that awarding Neocom
relief on its claims is within the Article III “case or controversy”
81
See Fed. R. Civ. P. 8(b) (directing that a party’s pleading must contain a “demand for the relief sought”); Fed. R. Civ. P. 54(c) (directing
that judgments must grant the “relief to which each party is entitled”).
82
Brackeen v. Haaland, 994 F.3d 249, 291 (5th Cir. 2021), cert. granted,
142 S. Ct. 1205 (Feb. 28, 2022); Texas v. United States, 50 F.4th 498, 514
(5th Cir. 2022). This court was aware of those cases in waiting for an
opportunity for the Fifth Circuit and the Supreme Court to clarify the
law on this matter and the matter discussed below in Part III.F.2, which
might work to the FDA’s advantage. But the FDA has indicated its desire
for a ruling at this time. Doc. 101.
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entrusted to this court’s jurisdiction. So the court need not consider Neocom’s standing.
II. The government’s venue defense is waived.
The government moves for dismissal of this action based on
the defense of improper venue. But, prior to that request, the government made a substantive motion that failed to object to venue. 83
Plaintiffs argue that the government’s litigation conduct waived
or forfeited any venue defense. 84 The court agrees.
In response to plaintiffs’ waiver argument, the government
counters only that its venue defense was raised in a Rule 12(b)(3)
motion to dismiss filed by the deadline for an answer to the complaint. 85 Such a motion does indeed avoid a deemed waiver under
Rule 12(h). But application of Rule 12(h) is not the only way that
a venue defense can be waived.
As noted in the treatise Federal Practice & Procedure, “Even in
situations in which a motion under Rule 12(b)(3) would be appropriate, the defendant may waive his right to obtain a dismissal for
lack of venue [when] the defendant interposes a pre-answer motion that fails to object to venue.” 86 Numerous decisions of the
Fifth Circuit and other circuits have so held with respect to the
defenses of improper venue and lack of personal jurisdiction. 87
83
The parties relied (Doc. 30 at 2) on 5 U.S.C. § 705, which authorizes “the reviewing court” to issue “appropriate process” to prevent irreparable injury and preserve the status quo during judicial review of
agency action.
84
Doc. 48 at 19.
85
Doc. 70 at 106.
86
5B Charles Alan Wright et al., Fed. Prac. & Proc. Improper Venue
§ 1352 (3d ed.).
87
See, e.g., Heyward v. Pub. Hous. Admin., 238 F.2d 689, 695 (5th Cir.
1956) (“[The defendant] by filing the motion for summary judgment and
thus putting at issue the merits of the case effectively waived whatever
objection to venue as it may have had.”); Rubens v. Ellis, 202 F.2d 415,
417 (5th Cir. 1953) (“Even if the venue was improperly laid . . . , that irregularity . . . could be, and was, waived . . . because [the defendant] . . .
sought the aid of the New Mexico court.”); Bel-Ray Co. v. Chemrite (Pty)
Ltd., 181 F.3d 435, 443 (3d Cir. 1999) (“In particular, where a party seeks
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That waiver principle was applied on remarkably similar facts
in Marquest Medical Products, Inc. v. EMDE Corp. 88 There, the defendants objected to venue and personal jurisdiction after waiting
six to ten weeks from service of the complaint and after they had
“submitted to an order of th[e] court by their stipulation which
restrains them from acting as was requested by [the plaintiff ].” 89
Although the defendants “avoided actual argument on the probability of success or failure of the merits” by stipulating to an injunction, the motion for that relief still called on the court to assess the likely merits of the controversy:
[I]n adopting the stipulated agreement I considered the
propriety of the mutual injunctions in light of the facts and
law in this case, albeit not determining the ultimate resolution of the litigation. Preliminary matters such as personal jurisdiction or venue should be raised and disposed
of before a court considers the merits or quasi-merits of
a controversy. 90
The defendants could not simply raise a venue challenge and
“walk away” from the court’s order that considered likelihood of
merits success after stipulating to that very order and thus gaining
“the presumed advantages which they obtained.” 91
affirmative relief from a court, it normally submits itself to the jurisdiction of the court with respect to the adjudication of claims arising from
the same subject matter.”); Peterson v. Highland Music, Inc., 140 F.3d
1313, 1318 (9th Cir. 1998) (“Rule 12(h)(1) specifies the minimum steps
that a party must take in order to preserve a defense. It does not follow,
however, that a party’s failure to satisfy those minimum steps constitutes
the only circumstance under which the party will be deemed to have
waived a defense.”); Manchester Knitted Fashions, Inc. v. Amalgamated
Cotton Garment & Allied Indus. Fund, 967 F.2d 688, 692 (1st Cir. 1992)
(“[I]f a defendant interposes a pre-answer motion that fails to object to
venue . . . he effectively has waived his right to obtain a dismissal on the
ground of lack of venue.”) (citations omitted).
88
496 F. Supp. 1242 (D. Colo. 1980).
89
Id. at 1245.
90
Id. at 1246 (citations omitted).
91
Id.
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Likewise here. The government joined in a motion for injunctive relief, gaining thereby some perceived advantage such as
avoiding potential accelerated consideration of a temporary restraining order. 92 Granting that injunctive relief required this
court to consider whether plaintiffs presented a substantial case
on the merits. 93 The court did so. It found relief appropriate considering the likelihood of success on the merits, irreparable injury,
and the other equitable factors bearing on a stay. 94
To be sure, a defendant need not raise a venue defense at the
earliest conceivable moment in a case, such as the day of its filing
or service of process. But the government here had ample time
92
The FDA might have itself acted to postpone the rule’s effective
date. Had it done so, however, that agency action might then have been
challenged in court. See, e.g., Sierra Club v. Jackson, 833 F. Supp. 2d 11,
21 (D.D.C. 2012) (invalidating an agency’s stay of a rule’s effectiveness
when the agency failed to apply the four-part equitable test for a stay).
Here, the FDA avoided such potential litigation by joining plaintiffs in
moving the court to postpone the rule’s effectiveness. In doing so, the
FDA was not merely memorializing an internal agency action. Rather, it
was seeking judicial relief that would not be subject to challenge in separate litigation.
93
The judicial process “appropriate” under 5 U.S.C. § 705 is determined by the traditional “balancing process which attends the grant of
injunctive relief.” Sampson v. Murray, 415 U.S. 61, 80 (1974); id. at 68 n.15
(citing Scripps-Howard Radio v. FCC, 316 U.S. 4, 9–17 (1942)). As explained in Scripps-Howard: “A stay is not a matter of right, even if irreparable injury might otherwise result to the appellant. It is an exercise of
judicial discretion.” 316 U.S. at 10 (quoting Virginia Railway v. United
States, 272 U.S. 658, 672 (1926)). The Fifth Circuit, citing the same Virginia Railway passage, has confirmed that a stay of agency action pending
judicial review “is not a matter of right.” Texas v. EPA, 829 F.3d 405, 424
(citing Virginia Railway, 272 U.S. at 672). A stay “appropriate” under
§ 705 requires satisfaction of the well-known test that considers the likelihood of success on the merits, injury to the plaintiff, injury to the defendant, and the public interest. Id. at 424, 435 (citing 5 U.S.C. § 705).
Accord, e.g., Ohio ex rel. Celebrezze v. Nuclear Reg. Comm’n, 812 F.2d 288,
290 (6th Cir. 1987) (holding that a § 705 stay is based on a balancing of
the traditional four factors relevant to injunctive relief ); D.C. v. USDA,
444 F. Supp. 3d 1, 15 (D.D.C. 2020) (“The factors governing issuance of
a preliminary injunction also govern issuance of a § 705 stay.”).
94
Doc. 33 at 1–2. The court also adopted the parties’ requested briefing schedule. Id. at 3–4.
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and resources to assess venue before it joined plaintiffs in moving
to postpone the rule’s effectiveness and proposing that the court
move directly to cross-motions for summary judgment. Indeed,
the government relied on a statute authorizing a stay by “the reviewing court” 95—again intimating that this court’s review is authorized. The reasoning of Marquest Medical Products thus has
substantial persuasive force here.
Also persuasive is Manchester Knitted Fashions, Inc. v. Amalgamated Cotton Garment and Allied Industries Fund. 96 There, the defendants objected to venue for the first time almost nine weeks
after service of the complaint and almost four weeks after they
stipulated to a court order enjoining their conduct. 97 The court
noted that the defendants had over one month to assess venue
before entering into their stipulation to injunctive relief, which
was “certainly adequate time to sufficiently apprise them of any
question as to venue.” 98 The court also explained that the defendants “submitted to the jurisdiction of the court by twice requesting hearings on the plaintiff’s motions for a temporary restraining
order and for a preliminary injunction.” 99 The First Circuit then
“agree[d] fully” with the district court’s waiver ruling, reasoning
that the defendant, by stipulating to a temporary injunction pending litigation and then requesting a hearing on further injunctive
relief sought by the plaintiff, waived the venue defense. 100
The same reasoning applies here. The government first objected to venue over 12 weeks after service of the complaint 101 and
over 8 weeks after it stipulated to a court order staying the rule’s
effectiveness. 102 Both delays are longer than in Manchester Knitted. The government had adequate time to apprise itself of any
95
Doc. 30 at 2 (citing 5 U.S.C. § 705).
1990 WL 383798 (D.N.H. Nov. 30, 1990).
97
Id. at *3.
98
Id.
99
Id.
100
Manchester Knitted Fashions, 967 F.2d at 692.
101
See Docs. 21–25.
102
See Doc. 30.
96
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question as to venue before requesting § 705 relief from this court.
And, similar to Manchester Knitted, the government here not only
moved for injunctive relief but also asked for a hearing on its forthcoming motion for summary judgment.
The court has the duty and discretion to manage the adjudicative process to conserve judicial resources, and that end is advanced when venue issues are raised and disposed of before the
court considers the merits of the controversy. 103 Applying those
principles here, the court holds that the government’s venue defense is waived.
III. Plaintiffs are entitled to summary judgment on their First
Amendment challenge to the FDA rule.
The parties agree that no issues of fact require a trial and that
the case is ripe for resolution on the cross-motions for summary
judgment. The court concludes that the label statements required
by the FDA rule do not qualify for First Amendment scrutiny under Zauderer because they are not purely factual and uncontroversial. The court then concludes that the compelled labels do not
survive scrutiny under Central Hudson’s test for commercialspeech regulations generally.
A. Zauderer is a limited relaxation of Central Hudson’s
framework for commercial-speech regulations.
A requirement to include warnings on a product’s package or
advertisements regulates commercial speech—speech inextricable from the commercial transaction that it proposes. 104 In Central
Hudson, 105 the Supreme Court laid out a four-part framework for
First Amendment review of commercial-speech regulations:
103
See United States v. Ziegler Bolt & Parts Co., 111 F.3d 878, 882 (Fed.
Cir. 1997) (explaining abuse-of-discretion appellate review on this issue:
“This court places waiver within the discretion of the trial court, consistent with its broad duties in managing the conduct of cases pending
before it.”).
104
Edenfield v. Fane, 507 U.S. 761, 767 (1993).
105
447 U.S. at 561–66.
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(1) The commercial speech must be protected constitutionally, as opposed to “forms of communication more likely
to deceive the public than to inform it” and “commercial
speech related to illegal activity.” 106
(2) The state “must assert a substantial interest” to be
achieved by a regulation. 107
(3) The restriction must “directly advance” the state interest,
as opposed to providing only “remote” support. 108
(4) The restriction must be “narrowly drawn” 109 in that “it is
not more extensive than is necessary.” 110
As an example of a “narrower restriction” that could serve a given
state interest, Central Hudson noted the potential to require “limited supplementation” of commercial speech, as “by way of warning.” 111
Five years later, in Zauderer, the Supreme Court confronted
“three separate forms of regulation” of commercial speech: two
prohibitions and one disclosure requirement for certain types of
attorney advertising. 112 The Court reviewed the two prohibitory
regulations under the Central Hudson test, confirming along the
way that images in advertisements “are entitled to the First
Amendment protections afforded verbal commercial speech.” 113
Turning to the third regulation, which required disclosures,
Zauderer rejected the call for “precisely the same inquiry” as for
the prohibitions of speech. 114 Zauderer acknowledged that a disclosure rule may require speakers to “provide somewhat more
106
Id. at 563–64.
Id.
108
Id. (giving the example that a restriction on advertising has only a
remote connection to deterring shoddy professional work).
109
Id.
110
Id. at 566.
111
Id. at 565.
112
471 U.S. at 638.
113
Id. at 647.
114
Id. at 650.
107
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information than they might otherwise be inclined to present.” 115
But Zauderer viewed that requirement as materially different than
a rule that wholly prevents commercial speakers “from conveying
information to the public” because one type of regulation keeps
information out of the marketplace, whereas the other adds information to the marketplace. 116
At the same time, Zauderer recognized First Amendment principles that limit the state’s power to compel disclosures. Specifically, the Court cited its compelled-speech decisions such as
Wooley v. Maynard 117 and West Virginia State Board of Education v.
Barnette, 118 which reject the idea “that a Bill of Rights which
guards the individual’s right to speak his own mind, left it open to
public authorities to compel him to utter what is not in his
mind.” 119 That principle applied, but had lesser force, for two reasons:
(1) the speech compelled in Zauderer was “in commercial advertising,” 120 which is more susceptible to restrictions
than is personal or political speech, and
(2) the state in Zauderer required the advertising to contain
“accurate,” “purely factual,” and “uncontroversial information about the terms under which [the advertiser’s] services will be available.” 121
If those two requirements are met, Zauderer provides a standard of review more lenient than Central Hudson’s. Specifically,
Zauderer rejects a “strict ʻleast restrictive means’ analysis” under
which disclosure rules “must be struck down if there are other
means by which the State’s purposes may be served.” 122 Zauderer
requires only a “less exacting” tailoring inquiry that asks whether
115
Id.
Id.
117
430 U.S. 705 (1977).
118
319 U.S. 624 (1943).
119
Id. at 633.
120
471 U.S. at 651.
121
Id. at 651 & n.14.
122
Id. at 651 n.14.
116
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disclosure requirements are “reasonably related” to the state’s interest. 123 Zauderer also requires that a disclosure requirement is
not “unjustified or unduly burdensome.” 124 In contrast, “[u]njustified or unduly burdensome disclosure requirements offend the
First Amendment by chilling protected speech.” 125
This court need not decide whether a third prerequisite for
Zauderer review exists: that the state’s interest in a compelled disclosure is to prevent consumer deception. Zauderer recognized
that the government’s interest there was preventing potential consumer deception. 126 And Zauderer stated its holding in those
terms, ruling “that an advertiser’s rights are adequately protected
as long as disclosure requirements are reasonably related to the
State’s interest in preventing deception of consumers.” 127
But parts of Zauderer’s reasoning focused generally on the
constitutional value of a freedom not to disclose facts in commercial advertising. 128 So several courts of appeals have held that Zauderer review is available for commercial disclosure requirements
that advance state interests other than preventing consumer deception. 129 The Fifth Circuit has not decided that issue. Neither
must this court decide that issue to resolve this case, as Zauderer
review is unavailable for the independent reason explained below.
123
Milavetz, Gallop & Milavetz, P.A. v. United States, 559 U.S. 229,
249 (2010).
124
Id.
125
Id. at 250. Because failing this test makes a government regulation
“offend the First Amendment,” id., as opposed to just making it ineligible for a relaxed standard of review, the court has classified this requirement as part of the Zauderer standard of review itself, not just a prerequisite for that standard of review.
126
471 U.S. at 651.
127
Id. (emphasis added).
128
Id. at 650–52.
129
CTIA-The Wireless Ass’n v. City of Berkeley, 928 F.3d 832, 844 (9th
Cir. 2019); Discount Tobacco, 674 F.3d at 556–57; Am. Meat Inst., 760 F.3d
at 22; Nat’l Elec. Mfrs. Ass’n v. Sorrell, 272 F.3d 104, 114–15 (2d Cir. 2001)
(Walker, J.). See also Pharm. Care Mgmt. Ass’n v. Rowe, 429 F.3d 294, 310
(1st Cir. 2005).
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B. The rule’s graphics are not inherently “accurate” and
“purely factual and uncontroversial.”
The parties agree that the disclosures required by the FDA
rule would occur in commercial speech. So the first requirement
for Zauderer review is met. But to allow Zauderer review, a compelled disclosure must also be of “accurate,” “purely factual,”
and “uncontroversial” information. 130 That second requirement
is not met here.
For expression to be “purely factual,” it must be information
with an objective truth or existence. 131 That is how the law understands a “factual” assertion in general. 132 And only if a message is
uncontroversial and objectively accurate can its compulsion fall
within Zauderer’s carve out for disclosures that do not “prescribe
what shall be orthodox” in matters of controversy. 133
Verbal statements can usually be classified by courts as either
purely factual or as value-laden opinion. Courts have thus found
Zauderer applicable to many verbal disclosures, such as those stating what services are provided and their cost, 134 what country food
comes from, 135 and how much of a chemical is in a product. 136
130
Zauderer, 471 U.S. at 651 & n.14.
See Lawrence Solum, Legal Theory Lexicon: Fact and Value,
https://lsolum.typepad.com/legaltheory/2019/07/legal-theory-lexiconfact-and-value.html ( July 7, 2019) (noting that, in “popular culture, the
idea is that factual assertions or beliefs are, in principle, demonstrably
true or false,” although the “relationship between fact and value is a deep
and complex topic” in philosophy).
132
E.g., Fed. R. Evid. 104(b) (referring to whether “a fact exists” or
not); Fed. R. Evid. 401(a) (referring to whether the existence of “a fact”
is “more or less probable” in light of given evidence than without it); Fed.
R. Evid. 1008 (assigning a court the role of finding whether “the factual
conditions” of admissibility are established or not).
133
Zauderer, 471 U.S. at 651 (quoting Barnette, 319 U.S. at 642); accord
Entm’t Software Ass’n v. Blagojevich, 469 F.3d 641, 652 (7th Cir. 2006)
(rejecting Zauderer review where an image’s message was “non-factual”
and “opinion-based”).
134
Milavetz, 559 U.S. at 233; Zauderer, 471 U.S. at 652.
135
Am. Meat Inst., 760 F.3d at 21–26.
136
Sorrell, 272 F.3d at 107, 113–16.
131
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But imagery can be more prone to ambiguous interpretation.
Sometimes, that is even its artistic value. 137 This reality can make
it harder for courts to ascertain whether an image has a single,
objective meaning that could make it “purely factual.”
That is the case here. Take, for instance, this warning required
by the FDA rule:
Its verbal aspect makes a falsifiable claim—that smoking causes
head and neck cancer. But it is unclear how a court would go about
determining whether its graphic aspect is “accurate” and “factual” in nature. The image may convey one thing to one person
and a different thing to another. One person might view the image
as showing a typical representation of the sort of neck cancer
caused by smoking before a person could seek medical treatment.
Another person might view the image as showing a stylized, exaggerated representation of neck cancer, perhaps in an effort to provoke repulsion. Others might interpret the depicted person’s
gaze, in conjunction with the text, as expressing regret at her
choice to smoke or the message that smoking is a mistake. All of
those interpretations would be at least reasonable.
The imagery in the warnings here is provocative. As to each
warning, it is not beyond reasonable probability that consumers
would take from it a value-laden message that smoking is a
137
Cf. Hurley v. Irish-American Gay, Lesbian and Bisexual Group of
Boston, 515 U.S. 557, 569 (1995) (noting the painting of Jackson Pollock
as an example of expression without a “narrow, succinctly articulable
message”).
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mistake. 138 For that reason alone, the graphics make all of the
warnings here not “purely factual” and “uncontroversial” within
the meaning of Zauderer. 139
But that is just one possible interpretation of the graphic warnings. This highlights a broader problem. It is not apparent—and
the FDA has not made a record-based showing—that each imageand-text pairing conveys only one, unambiguous meaning that is
factually correct. For example, take the heart-disease warning:
Consumers may reasonably interpret the image in this warning as
indicating that open-heart surgery, whose scars are shown, is the
most common treatment for heart disease. But the court has no
evidence of that assertion’s truth. Indeed, commenters notified
that FDA that in-patient interventions for heart disease are 2.5
times more common than open-heart surgery. 140 The FDA did not
disagree. It responded only that open-heart surgery is a “common” and “typical[]” treatment, without disagreeing that non-
138
The court does not hold that all conceivable imagery in a disclosure is necessarily value-laden. For example, a map showing on which
continent food was farmed, next to a disclosure naming that continent,
would seem purely factual. And perhaps a stylized icon could be mere
shorthand for factual information, such as a symbol denoting the presence of a given chemical in a product.
139
Notably, in rejecting a facial challenge to the Tobacco Control
Act’s requirement of a graphic component to health warnings, the Sixth
Circuit reasoned that the graphics could “merely be[] words” and offered
the example of “handwriting”—not provocative, photorealistic images.
Discount Tobacco, 674 F.3d at 559. Thus, as to plaintiff R.J. Reynolds, preclusion principles do not bar the court’s ruling as to the different graphic
warnings at issue here.
140
85 Fed. Reg. at 15,677.
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surgical treatment is 2.5 times more common or typical. 141 Neither does the FDA’s cited source disprove that statistic. 142
Alternatively, the image could be reasonably understood as
conveying that open-heart surgery is the best treatment for heart
disease, even if not the most common. But that message would
seem opinion-based, as opposed to a purely factual disclosure
about an advertiser’s product. At the least, nothing in the administrative record establishes the objective truth of that claim.
The same point about consumer misinterpretation applies, for
example, to the cataracts warning:
For one, the warning does not indicate whether it shows cataracts
or blindness, both of which are mentioned. That alone creates a
reasonable possibility of misinterpretation by some consumers.
Moreover, even if the warning’s text were limited to cataracts,
without mentioning blindness, some consumers may reasonably
interpret the image as depicting the most common result of cataracts. But the court has no evidence of that depiction being accurate. To the contrary, commenters told the FDA that cataracts in
the United States are typically treated long before they progress
to the stage shown. 143 The FDA did not disagree. It responded
only that “underserved populations may face barriers to receiving
cataract surgery.” 144 That may be. But it does not establish the
141
Id. at 15,678.
Manesh R. Patel et al., ACC/AATS/AHA/ASE/ASNC/SCAI/
SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization
in Patients with Stable Ischemic Heart Disease, 69:17 J. of the Am. College
of Cardiology 2212 (2017), https://doi.org/10.1016/j.jacc.2017.02.001.
143
85 Fed. Reg. at 15,684; accord Doc. 1-5 at 327.
144
85 Fed. Reg. at 15,684.
142
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accuracy of this reasonable interpretation of the warning as depicting the most common result of cataracts. 145
Those two examples show a problem that exists with each of
the graphic warnings required by the FDA rule. Because of their
capacity for multiple reasonable interpretations, consumers may
perceive expression whose truth has not been established by the
record. So the court cannot deem the warnings “purely factual
and uncontroversial” and objectively “accurate” as required to allow relaxed Zauderer review. 146 Accordingly, the court need not
reach plaintiffs’ alternative argument that, even if Zauderer review
applies, the warnings would fail that review as unjustified and unduly burdensome.
C. The FDA rule does not meet Central Hudson’s narrowtailoring requirement.
The parties dispute whether intermediate scrutiny or strict
scrutiny applies to a compelled advertising disclosure that does
not qualify for relaxed Zauderer review. Central Hudson addressed
only a “prohibition” of speech, not an involuntary conveyance of
speech. 147 And Zauderer itself recognized the Court’s earlier suggestion that “involuntary affirmation could be commanded only
on even more immediate and urgent grounds than silence.” 148
The Fifth Circuit has not decided which standard applies. But
a commercial compelled disclosure outside Zauderer’s ambit must
at least satisfy intermediate scrutiny, even if more is required. So
the court turns now to that standard.
Central Hudson review first asks if a regulation serves a substantial state interest. The Tobacco Control Act’s stated purpose
145
The FDA also justified its warnings based on the tobacco industry’s “decades of deception” and concerted attempt to “misl[ead] its
own customers.” Doc. 37 at 6 (citing United States v. Phillip Morris USA,
Inc., 449 F. Supp. 2d 1 (D.D.C. 2006)). But that is not an argument about
whether the warnings here are “purely factual and uncontroversial” for
purposes of Zauderer.
146
Zauderer, 471 U.S. at 651 & n.14.
147
447 U.S. at 540.
148
471 U.S. at 650 (quoting Barnette, 319 U.S. at 633).
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for its health warnings is that “the public may be adequately informed about any adverse health effects of cigarette smoking.” 149
The FDA likewise relies on “the Government’s interest in promoting greater public understanding of the negative health consequences of cigarette smoking” 150 and cites evidence that consumer awareness of the health risks of smoking is a substantial
problem. 151
Promoting public understanding of the dangers of smoking is
also the state interest behind the current regime of “Surgeon General’s Warnings,” 152 which plaintiffs do not question under Central Hudson. So one might assume that the same interest qualifies
as substantial here. Because the FDA rule fails Central Hudson review for an independent reason, however, the court need not decide the parties’ arguments about (i) whether the conceptual nature of that interest is disqualifying or (ii) the extent of record evidence needed to qualify that interest as substantial.
As noted, Central Hudson review requires not only a substantial state interest, but also that a commercial-speech regulation is
“ʻnarrowly drawn’” 153 to that interest, in that “it is not more extensive than is necessary.” 154 That formulation has similarities to
the test set out in Wooley v. Maynard for review of government
compulsion of speech: “even though the governmental purpose
be legitimate and substantial, that purpose cannot be pursued by
means that broadly stifle fundamental personal liberties when the
end can be more narrowly achieved.” 155 Both ask whether a narrower alternative would achieve the government’s interest.
149
15 U.S.C. § 1331(1).
85 Fed. Reg. at 15,638.
151
85 Fed. Reg. at 15,655.
152
Comprehensive Smoking Education Act, Pub. L. No. 98-474, § 2,
98 Stat. at 2202 (1984) (stating Congress’s purpose to make “Americans
more aware of any adverse health effects of smoking” and “enable individuals to make informed decisions about smoking”).
153
447 U.S. at 565 (quoting In re Primus, 436 U.S. 412, 438 (1978)).
154
Id. at 566.
155
430 U.S. at 716 (quotation marks omitted).
150
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Here, the government has not shown that compelling these
large, graphic warnings is necessary in light of other options. Rather than taking over half of a package’s face, the government may
take advantage of other strategies such as increasing funding for
anti-smoking advertisements in various forms of media, increasing funding for speakers and school instruction, and increasing
anti-smoking resources in the government’s own communications. Deeming those alternatives as more narrowly drawn means
to achieve the government’s interest follows from the Supreme
Court’s recent decision in NIFLA, which held that a compelled
disclosure failed this requirement because the state could have informed people of the desired information with a “public-information campaign” involving steps such as postings on public
property and in private advertisements. 156
Increasing resources for such a public-information campaign
not only is less burdensome of private speech but also offers the
ability to target particular groups in different channels of communication with different messages. Indeed, the FDA has touted
such public-information campaigns as highly successful in educating youth about the dangers of smoking. 157
Notwithstanding those campaigns, the FDA argues that “millions of Americans may pick up smoking, or continue to smoke,
without knowing many of the serious risks to which they are
exposing themselves and their loved ones.” 158 That is legitimate
cause for concern. But NIFLA held that, “regardless, a tepid response does not prove that an advertising campaign is not a
156
Nat’l Inst. of Family and Life Advocates v. Becerra, 138 S. Ct. 2361,
2376 (2018).
157
In 2019, for example, the Acting Commissioner of Food and Drugs
issued a press release describing the FDA’s “highly successful” publicinformation campaigns, which “are yielding tremendous results.” Norman E. “Ned” Sharpless, Statement on New Results Demonstrating Continued Success of the Agency’s Youth Smoking Prevention Efforts and Significant Public Health Cost Savings (Aug. 20, 2019), www.fda.gov/newsevents/press-announcements/statement-new-results-demonstratingcontinued-success-agencys-youth-smoking-prevention-efforts-and.
158
Doc. 37 at 60.
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sufficient alternative” as a First Amendment matter. 159 NIFLA
reasoned that the constitutional line is principled, not pragmatic:
“The First Amendment does not permit the State to sacrifice
speech for efficiency.” 160 That reasoning controls today.
The FDA also cannot argue that less burdensome warnings on
cigarette packages and advertisements would not achieve the government’s interest, for the FDA did not test the efficacy of
“smaller or differently placed warnings.” 161 The FDA explains
that it did not consider such warnings because “the statute sets
forth the requirements with regard to size and placement of the
warnings.” 162 But the First Amendment limits congressional action as much as agency action. So the lack of any such consideration in the record counts against the government. 163
For all of those reasons, Central Hudson’s narrow-tailoring
requirement is not met here. Accordingly, the FDA rule exceeds
First Amendment limits. That holding “in no way disparages the
national interest” 164 in reducing smoking, particularly among
youth. But when that goal is pursued by mandating commercial
disclosures that are not purely factual and uncontroversial, the
First Amendment requires at least that such a regulation “be no
more extensive than is necessary to serve the state interest.” 165 In
this case, as in Central Hudson, that requirement is not met.
159
Id. (quotation marks omitted).
Id. (quoting Riley v. Nat’l Fed. of the Blind of N.C., Inc., 487 U.S.
781, 795 (1988)) (quotation and alteration marks omitted).
161
85 Fed. Reg. at 13,650.
162
Id.
163
See, e.g., Ent’mt Software Ass’n, 469 F.3d at 652 & n.13 (noting that
the government “has failed to even explain why a smaller [warning]
would not suffice” and holding that a sticker covering less than 10% of a
package “literally fail[ed] to be narrowly tailored”); Am. Beverage Ass’n v.
City and Cty. of San Francisco, 916 F.3d 749, 756–57 (9th Cir. 2019) (holding that a warning that occupied 20% of advertisements for sugar-sweetened beverages—far less space than here—was “unduly burdensome”).
164
Central Hudson, 447 U.S. at 571.
165
Id.
160
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D. Plaintiffs’ other claims need not be resolved.
Notwithstanding the general doctrine of constitutional avoidance, “federal courts have emphasized the importance of resolving First Amendment cases at the earliest possible junction.” 166
Indeed, the district court that considered the FDA’s first graphicwarnings rule resolved the case on First Amendment grounds
rather than deciding the Administrative Procedure Act claims. 167
So this court will “follow a well-trodden path by reaching and deciding a dispositive First Amendment issue that will avoid forcing
the parties through unnecessary” litigation over statutory issues. 168 The court thus expresses no opinion on plaintiffs’ nonFirst Amendment claims.
E. Severance is inappropriate.
The government argues that, if the court credits plaintiffs’
First Amendment claim, the court should sever and declare invalid only certain aspects of the warnings. But while the Tobacco
Control Act expresses a general preference for severance, the Act
directs that text and graphics be tied together in health warnings.
Section 5 of the Act is the general severability provision. It directs that if “any provision” of the Act or regulations promulgated
under the Act “is held to be invalid,” then the remainder of the
Act or any such regulations “shall not be affected and shall continue to be enforced to the fullest extent possible.” 169 Consistent
with that direction, today’s ruling does not affect many provisions
of the Tobacco Control Act, such as its provisions on agency authority over “tobacco products” 170 or on penalties for regulatory
166
Green v. Miss U.S.A., LLC, 52 F.4th 773, 2022 WL 16628387, at
*57 (9th Cir. 2022) (collecting cases).
167
R.J. Reynolds Tobacco Co. v. FDA, 823 F. Supp. 2d 36, 39–40 n.3
(D.D.C. 2011) (“Because plaintiffs prevail on their First Amendment
claim, an analysis of the APA claim is unnecessary.”); see also id., Mem.
in Supp. of Pls.’ Mot. for Summ. J. and Perm. Inj. at 49–55 (filed Aug. 9,
2011) (argument on the arbitrary-and-capricious and notice-and-comment APA claims).
168
Green, supra note 166, at *57.
169
Tobacco Control Act § 5, 123 Stat. at 1782.
170
E.g., id. § 101, 123 Stat. at 1782–1830.
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violations. 171 Even the Act’s provisions on health warnings are not
held facially invalid but, rather, are held invalid only as applied in
the specific health warnings in the challenged rule and on the administrative record presented here.
The Act, however, does not allow the court to “sever” the
FDA’s warnings by simply deleting their graphical component. To
the contrary, the Act directs that graphics and text must accompany each other in the new warnings. 172 That linkage presumably
underlies Congress’s direction about the size of the warnings.
And the Act directs that its requirement of new warnings will not
go into effect until the accompanying graphics are specified by
rule. 173 “As a fundamental rule of statutory interpretation, specific provisions trump general provisions.” 174 So the Act’s specific direction that health warnings must include both graphics
and text, which become effective only as a whole, controls. The
court thus rules on each warning as a whole.
F. The court issues the remedies of a declaratory judgment and vacatur of the FDA rule.
1. The Declaratory Judgment Act allows a reviewing court to
“declare the rights and other legal relations of any interested
party seeking such declaration.” 175 Any such declaration “shall
have the force and effect of a final judgment or decree.” 176 If necessary, a court may later grant an injunction to enforce its declaratory judgment. 177
The government offers no argument against declaratory relief
if the court credits any of plaintiffs’ claims. 178 And the court finds
171
E.g., id. § 102(q), 123 Stat. at 1839–40.
15 U.S.C. § 1333(d) (first of two subsections (d)).
173
See supra note 21 and accompanying text.
174
Navarro-Miranda v. Ashcroft, 330 F.3d 672, 676 (5th Cir. 2003).
175
28 U.S.C. § 2201(a).
176
Id.
177
Id. § 2202; Powell v. McCormack, 395 U.S. 486, 499 (1969).
178
See Doc. 37 at 83–88; Doc. 67 at 37.
172
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it proper to exercise its discretion to issue such relief. 179 The court
will therefore issue a final judgment declaring that enforcement
against plaintiffs of the FDA rule would be contrary to constitutional right under the First Amendment. It is “anticipated that
[defendants] would respect the declaratory judgment,” 180 so the
court chooses not to issue an injunction at this time. 181 Plaintiffs
may, of course, seek an injunction should defendants threaten to
depart from the declaratory judgment.
2. The next question is whether to vacate the FDA rule. The
court understands vacatur (or vacation 182) of an agency rule as relief beyond just a court order that the defendants not enforce the
rule as to cause irreparable harm to the plaintiffs. Such an order
would simply be an injunction. 183
Rather than operating in personam on defendants by ordering
them not to take action, vacatur operates in rem on the agency rule
itself. Vacatur of an agency rule nullifies and revokes the rule,
179
See Sherwin-Williams Co. v. Holmes Cty., 343 F.3d 383, 388 (5th Cir.
2003).
180
Poe v. Gerstein, 417 U.S. 281, 281 (1974).
181
See Morrow v. Harwell, 768 F.2d 619, 627 (5th Cir. 1985).
182
Some writers prefer “vacation” whereas others prefer “vacatur.”
Both terms appear to be accepted by lexicographers.
183
Preventing irreparable injury to a plaintiff may require enjoining a
rule’s enforcement as to all parties that it governs if those parties’ conduct under the rule causes the plaintiff’s irreparable injury. See, e.g.,
Texas v. United States, 809 F.3d 134, 188 (5th Cir. 2015) (upholding nationwide injunction given freedom of movement across the country of
persons found to impose pocketbook injury on plaintiffs as a result of the
agency action), aff’d by an evenly divided Court, 579 U.S. 547 (2016) (per
curiam). But such a remedy is still an injunction against enforcement of
agency action; the remedy applies nationwide because the irreparable injury to plaintiff would flow from nationwide enforcement of the agency
action. That is not the same as acting on an agency rule itself. And here,
of course, there is no claim that enforcement of the FDA rule as to parties
other than plaintiffs would cause irreparable injury to plaintiffs.
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rendering it devoid of legal effect in the same way that an appellate
vacatur acts on a district-court judgment. 184
The practical effect of vacatur will vary by the nature of the
vacated agency action. When the agency action is adjudication of
a dispute between the government and a private party, 185 vacatur
of an agency ruling for the government affords relief only to the
private party. 186 When the agency action is a rulemaking, 187 vacatur of that action nullifies the rule for all whom it would otherwise
bind. If a rule had nationwide force, the rule’s vacatur would be
nationwide.
The government complains that nullifying a rule’s legal effect
on all whom it binds would deprive the government of the benefit
of any victory in separate lawsuits by different plaintiffs challenging the same rule. That point has some force. As the government
notes, 188 the APA does not answer the question: set aside as to
whom? Indeed, the APA does not mention “vacating” an agency
rule at all. So where is that relief authorized?
The APA does have a provision on the form of judicial review.
That provision, 5 U.S.C. § 703, allows judicial review in either a
special statutory review proceeding (not applicable here) or in
“any applicable form of legal action, including actions for declaratory judgments or writs of prohibitory or mandatory injunction.”
The previous provision of the APA, 5 U.S.C. § 702, requires that
184
See Merrick B. Garland, Deregulation and Judicial Review, 98 Harv.
L. Rev. 505, 574 (1985) (stating that “vacating [an agency] order alone
returns the matter to the status quo ante” by undoing the “effect” of the
agency order); see also, e.g., Jonathan F. Mitchell, The Writ of Erasure Fallacy, 104 Va. L. Rev. 933, 1012 (2018) (contrasting vacatur of a rule with
an injunction against its enforcement: “courts may formally vacate an
agency’s rule or order, rather than merely enjoin officials from enforcing
it”); Ronald M. Levin, “Vacation” at Sea: Judicial Remedies and Equitable
Discretion in Administrative Law, 53 Duke L.J. 291, 299 (2003) (describing
vacation of a rule as “nullification” of the rule).
185
See 5 U.S.C. § 554 (procedure for adjudications).
186
A vacatur in those circumstances would not seem to present the
Article III debate described below.
187
See 5 U.S.C. § 553 (procedure for rulemaking).
188
Doc. 67 at 37 n.30.
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“any mandatory or injunctive decree shall specify the Federal officer or officers (by name or by title), and their successors in office, personally responsible for compliance.” Neither provision
mentions a remedy of vacatur that acts on an agency rule itself.
The APA also has a provision, 5 U.S.C. § 705, on judicial relief
pending review. That provision allows a court to postpone the
effective date of agency action “to the extent necessary to prevent
irreparable injury.” Similarly, under circuit precedent, such relief
turns on the extent of any irreparable injury to the plaintiff absent
a stay pending review and the extent of any injury to the defendant
from a stay pending review. 189 So this provision seems to allow judicial relief only as needed to prevent irreparable injury shown by
a party in litigation, as opposed to postponing a rule’s legal effect
on all parties regardless of their likelihood of irreparable injury.
That leaves a textual analysis of the APA with its provision on
the scope of judicial review. That provision, 5 U.S.C. § 706, directs
a reviewing court to issue two forms of relief: (1) compel agency
action if certain criteria are met and (2) “hold unlawful and set
aside agency action, findings, and conclusions” that meet other
criteria like, as relevant here, infringing constitutional rights.
This provision too does not mention “vacatur.” But it does direct a court to “set aside” the specified agency actions. That term
could mean two things—a rule of decision or a form of relief. Does
it simply mean setting aside the agency action in deciding a claimant’s case? That is what courts do in the analogous context of
holding a statute unconstitutional; courts simply refuse to enforce
the statute in the case at hand. 190 Or does that term mean setting
aside the agency action from legal effectiveness in any case or controversy, involving any party? That is the effect of vacatur.
In favor of the former view, researchers have argued that the
remedy of vacatur was unknown to Congress and to the courts at
189
See supra note 93 (discussing this provision).
Mitchell, supra note 184, at 972 (“[A] federal court has no authority to render a duly enacted statute invalid or ʻvoid’; its powers extend
only to resolving the cases and controversies described in Article III.”).
190
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the time of the APA’s enactment and that universally nullifying a
rule’s legal effect exceeds Article III limits. 191 A leading treatise,
moreover, refers to the APA’s direction that a court “set aside”
agency action as “functionally similar” to an injunction. 192
Moreover, if “set aside” were to have its broader meaning, one
might expect to see courts vacating agency rules not only in preenforcement challenges like this one but also in civil and criminal
enforcement actions brought by the government. After all, § 706
does not distinguish between pre- and post-enforcement judicial
review of agency action. Yet attention has not been called here to
that practice, which would seem inconsistent with the government’s traditional choice not to appeal some losses as to preserve
its ability to litigate the same legal issue in another case.
But arguments for the broader understanding of “set aside”
also have force. First, that is a linguistically plausible reading of
the term. 193 Second, in some circumstances, a pragmatic argument might be made for that broader view. For some types of
rules, it might be unadministrable or counterproductive to allow a
rule’s enforcement as to some parties but enjoin it as to others.
Third, the APA’s provision on the scope of judicial review allows courts to compel agency action, including rulemaking, if unreasonably delayed. 194 That is understood to allow a court to compel rulemaking that will bind nationwide, even on persons not
191
See John C. Harrison, Vacatur of Rules Under the Administrative Procedure Act, Yale J. on Reg. Bull. (forthcoming 2022), available at
https://ssrn.com/abstract=4247173; John C. Harrison, Section 706 of the
Administrative Procedure Act Does Not Call for Universal Injunctions or
Other Universal Remedies, 38 Yale J. on Reg. Bull. 1, 6–9 (2020); Samuel
L. Bray, Multiple Chancellors: Reforming the National Injunction, 131 Harv.
L. Rev. 417, 420–21, 451–52 (2017).
192
33 Charles Alan Wright et al., Fed. Prac. & Proc. Judicial Review
§ 8307 (2d ed.).
193
See, e.g., Set Aside, Black’s Law Dictionary (11th ed. 2019) (giving
a definition of “set aside” that refers to vacatur, at least of a court order:
“(Of a court) to annul or vacate (a judgment, order, etc.)”).
194
5 U.S.C. § 706(1).
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represented in that court. That scope, in turn, may suggest a similarly broad meaning of “set aside” in the same APA provision.
Fourth, other areas of the law feature federal courts vacating
legal commands as such, rather than just enjoining their enforcement by named parties. Most analogously, federal appellate courts
vacate judgments, injunctive orders, and consent decrees entered
by federal district courts. That analogy breaks down somewhat because, unlike district courts, agencies are not acting under Article
III’s power to resolve cases and controversies between identified
parties. The federal courts’ Article III power may not allow them
to nullify a rule that an agency issues outside the constraints of
Article III. But perhaps Article III is not the only source of federal
courts’ power to vacate agency rules. If Congress can delegate its
Article I lawmaking authority to Article II agencies, unmentioned
in the Constitution and staffed by unelected officials, then perhaps Congress can delegate to the Article III judiciary the authority to veto agency rules that violate §706’s standards. 195
195
Congress has occasionally conscripted the federal judiciary into
functions outside traditional Article III dispute resolution. For example,
in the Invalid Pensions Act of 1792, Congress instructed the federal circuit courts to review claims for pensions by veterans of the Revolutionary
War. To address the concerns of some Justices of the Supreme Court that
such a duty was unconstitutional, Chief Justice Jay and Justice Cushing
adjourned court and then “regard[ed] themselves as being . . . commissioners, to execute the business of this act in the same court room, or
chamber.” Hayburn’s Case, 2 U.S. (2 Dall.) 409, 414 (1792); see also
United States v. Ferreira, 54 U.S. (13 How.) 40, 53 (1851).
Another example may be judicial approval of funding requests under
the Criminal Justice Act. Judges perform that function, using the dockets
used for Article III cases. But a federal judge’s funding decision may be
susceptible to veto by a non-judicial officer, which may provide another
example of Congress entrusting the judiciary with tasks outside traditional Article III dispute resolution. See 18 U.S.C. § 3006A(i); Ayestas v.
Davis, 138 S. Ct. 1080, 1091 (2018) (collecting cases interpreting the CJA
that way); see, e.g., United States v. Gast, 297 F. Supp. 620, 621–22 (D.
Del. 1969) (noting that a Comptroller General’s Opinion prevented CJA
funding that district judges approved); Subcomm. on Constitutional
Rights, S. Comm. on the Judiciary, The Criminal Justice Act in the Federal
District Courts 213, 90th Cong. (Comm. Print 1968) (detailing Administrative Office rejections of judge-approved funding).
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In any event, even if it is idiosyncratic in the law for judicial
relief to operate on a thing (such as an agency rule) as opposed to
a party’s actions (such as enforcement of a rule), that does not
make it altogether unique. In an in rem action, jurisdiction and
remedies proceed on the legal fiction that a court is imposing liability on a thing. 196 And judicial relief that operates on an offending rule may have some common-law analogues, such as the
quashing order in U.K. practice, which invalidates administrative
measures that are ultra vires or suffer from a facial error of law. 197
Finally, the D.C. Circuit has held for decades that vacatur of
an agency rule is authorized by § 706 of the APA: “When a reviewing court determines that agency regulations are unlawful, the ordinary result is that the rules are vacated—not that their application to the individual petitioners is proscribed.” 198 Of course,
even the remedial practice of circuit courts that routinely hear
certain types of cases does not always carry the day. 199 But that is
precisely the relief awarded by the D.C. Circuit upon review of
the FDA’s prior rule on cigarette health warnings. 200
Ultimately, the debate is resolved at this stage by Fifth Circuit
precedent, which is binding here. That precedent treats “set
aside” in § 706 of the APA as meaning the remedy of vacatur. For
example, in Chamber of Commerce v. Department of Labor, 201 the
Fifth Circuit relied on the APA’s “set aside” language to vacate
an agency rule in toto. Likewise, in Community Financial Services
196
See, e.g., Cargill B.V. v. S/S Ocean Traveller, 726 F. Supp. 56, 61
(S.D.N.Y. 1989).
197
See Her Majesty’s Treasury v. Ahmed and Others [2010] UKSC 5
(noting that a quashing order indicates that the offending measure is ultra
vires and “of no effect in law”).
198
Harmon v. Thornburgh, 878 F.2d 484, 495 n.21 (D.C. Cir. 1989);
see also Nat’l Mining Ass’n v. U.S. Army Corps of Eng’rs, 145 F.3d 1399,
1409 (D.C. Cir. 1998).
199
See eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391–94 (2006)
(reversing the Federal Circuit’s rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances).
200
See supra note 37.
201
885 F.3d 360, 388 (5th Cir. 2018).
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Association v. CFPB, 202 the court rendered judgment vacating a
rule that exceeded the agency’s authority. Similarly, in Southwestern Electric Power Co. v. EPA, 203 the Fifth Circuit vacated portions
of a rule held to be unlawful. Consistent with that circuit precedent, this court will vacate the challenged rule.
Conclusion
For the reasons explained above, plaintiffs’ motion for summary judgment on their First Amendment claim is granted. The
court will grant plaintiffs (1) a declaratory judgment and (2) vacatur of the FDA rule. Vacatur of the rule resolves all of plaintiffs’
pleaded injuries given defendants’ agreement that the relevant
Tobacco Control Act provisions do not take effect if the rule is
vacated. So this court need not consider plaintiffs’ other claims.
The court denies defendants’ motion to dismiss and crossmotion for summary judgment. All other pending motions are denied as moot. A final judgment will issue forthwith.
So ordered by the court on December 7, 2022.
J. C AMPBELL B ARKER
United States District Judge
202
51 F.4th 616, 643–44 (5th Cir. 2022), petition for cert. filed, No. 22448 (filed Nov. 14, 2022).
203
920 F.3d 999, 1033 (5th Cir. 2019).
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