UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
RJ. REYNOLDS TOBACCO COMPANY, )
)
LORILLARD TOBACCO COMPANY, )
)
COMMONWEALTH BRANDS, INC., )
)
LIGGETT GROUP LLC, )
)
and )
)
SANT A FE NATURAL TOBACCO )
COMPANY, INC., )
)
Plaintiffs, )
)
v. ) Civil Case No. 11-1482 (RJL)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRA TION, )
)
MARGARET HAMBURG, Commissioner of the )
United States Food and Drug Administration, )
)
and )
)
KA THLEEN SEBELIUS, Secretary of the )
United States Department of Health )
and Human Services, )
)
Defendants. )
12-
MEMORANDUM OPINION
February~,
2012 [Dkt. #10 and #35]
Plaintiffs in this case ("plaintiffs") are five tobacco companies, which include the
second-, third-, and fourth-largest tobacco manufacturers and the fifth-largest cigarette
manufacturer in the United States. Complaint ("Compl."), Aug. 16, 2011, ~~ 8-12 [Dkt.
#1]. In June 2011, defendant United States Food and Drug Administration ("FDA")
published a Final Rule requiring (among other things) the display of nine new textual
warnings-along with certain graphic images I such as diseased lungs and a cadaver
bearing chest staples on an autopsy table-on the top 50% of the front and back panels of
every cigarette package manufactured and distributed in the United States on or after
September 22,2012. See FDA, Required Warnings for Cigarette Packages and
Advertisements, 76 Fed. Reg. 36,628 (June 22,2011) ("the Rule"); see also Mem. in
Supp. of Pis. , Mot. for Summ. J. and Permanent Inj. ("PIs.' Mot."), Aug. 19,2011, at 3-5
[Dkt. #10]. Alleging that the Rule violates the First Amendment and the Administrative
Procedure Act ("APA"), 5 U.S.C. §§ 553{b)(3), 705, 706(2)(A), see Compi. ~~ 5-6,
plaintiffs moved for a preliminary injunction on August 19,2011, enjoining the
enforcement of the Rule until fifteen months after resolution of plaintiffs' claims on the
merits. See Pis.' Mot. at iii. As such, plaintiffs raised for the first time in our Circuit the
question of whether the FDA's new and mandatory graphic images, when combined with
certain textual warnings on cigarette packaging, are unconstitutional under the First
Amendment. The Court granted plaintiffs' motion on November 7,2011. See R.J.
Reynolds Tobacco Co. v. FDA, No. 11-1482,2011 WL 5307391, at *1, n.l (D.D.C. Nov.
As I previously stated in my Memorandum Opinion granting plaintiffs' Motion for
Preliminary Injunction, although the FDA cOf}veniently refers to these graphic images as
"graphic warnings," characterizing these graphic images as "warnings" is inaccurate and
unfair as they are more about shocking and repelling than warning. See RJ Reynolds
Tobacco Co. v. FDA, No. 11-1482,2011 WL 5307391, at * 1, n.l (D.D.C. Nov. 7, 2011).
Indeed, as discussed fully in Section II.A, these images are not used to warn but rather to
deter individuals from purchasing the package. Accordingly, I will refer to them simply
as graphic images.
2
2
7,2011). Since then both parties have moved for summary judgment on the same issues.
Upon review of the pleadings, oral argument, the entire record, and the applicable law,
the Court concludes that these mandatory graphic images violate the First Amendment by
unconstitutionally compelling speech. For that and the other reasons stated herein, the
Court GRANTS plaintiffs' Motion for Summary Judgment and DENIES the Cross-
3
Motion for Summary Judgment.
4
BACKGROUND
I. Statutory and Regulatory History
A. The Act
The Family Smoking Prevention and Tobacco Control Act ("Act" or "the Act"),
Pub. L. No. 111-31, 123 Stat. 1776 (2009), which President Obama signed into law on
June 22, 2009, gives the FDA the authority to regulate the manufacture and sale of
tobacco products, including cigarettes. Mem. in Support of Defs.' Mot. for Summ. 1. and
in Opp'n to Pis.' Mot. for Summ. J. ("Defs.' Opp'n"), Oct. 21, 2011, at 1 [Dkt. #34].
Pursuant to that authority, Congress directed the Secretary of the U.S. Department of
Health and Human Services ("the Secretary") to "issue regulations that require color
Plaintiffs filed their Motion for Summary Judgment [Dkt. # 10] on the same day
they filed their Motion for Preliminary Injunction [Okt. # 11].
Plaintiffs bring both First Amendment and AP A claims. At the September 21,
2011 hearing, however, all parties agreed that if plaintiffs prevailed on their First
Amendment claim, resolution of the APA claim would be superfluous. See PI Tr. 68:10-
19 (Government), 71:17-22 (plaintiffs). Because plaintiffs prevail on their First
Amendment claim, an analysis of the AP A claim is unnecessary.
4 The full facts of this case have been amply described in my earlier opinion
granting the preliminary injunction. See R.J Reynolds, 2011 WL 5307391 at * 1-3.
3
graphics depicting the negative health consequences of smoking. ,,5 See Pub. L. No. 111-
31, § 201(a) (amending 15 U.S.C. § 1333(d»; CompI. ~ 31; Defs.' Opp'n at 1. In
addition, Congress required all cigarette packages manufactured, packaged, sold,
distributed, or imported for sale or distribution within the United States to bear one of the
following nine textual warnings:
"WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your
health." Act § 201(a) (amending 15 U.S.C. § 1333(a)(l».
Congress required that these new textual warnings and graphic images occupy the
top 50% of the front and back panels of all cigarette packages, Act § 201(a) (amending
15 U.S.C. § 1333(a)(2», and the top 20% of all printed cigarette advertising, id.
(amending 15 U.S.c. § 1333(b)(2». It gave the FDA "24 months after the date of
The statute also vests a certain amount of discretion in the Secretary, who "may
adjust the type size, text and format of the label statements specified in subsections (a)(2)
and (b )(2) as the Secretary determines appropriate so that both the graphics and the
accompanying label statements are clear, conspicuous, legible and appear within the
specified area." Pub. L. No. 111-31, § 201 (amending 15 U.S.C. § 1333(d».
4
enactment" of the Act to issue regulations implementing the requirements of Section 201.
Act § 201(a) (amending 15 U.S.c. § 1333(d)); Compl. ~ 33. Finally, under the Act, the
new textual warnings and graphic-image labels (and the related requirements) were
scheduled to take effect 15 months after issuance of the Rule. Act § 201(b) (note on
amending 15 U.S.C. § l333).
B. The Rule
1. Proposed Rule
On November 12,2010, the FDA submitted for public comment a Proposed Rule
unveiling 36 graphic color images that could be displayed with the 9 new textual
6
warnings created by Congress. Required Warnings for Cigarette Packages and
Advertisements, 75 Fed. Reg. 69,524; 69,534-69,535 (Nov. 12,2010) (to be codified at
21 C.F.R. Part 1141); Compl. ~~ 36,38; Defs.' Opp'n at 10-11. In addition, the Proposed
Rule required cigarette packaging and advertising to include "a reference to a smoking
cessation assistance resource" and set forth related requirements for what that resource
must provide. 75 Fed. Reg. 69,564 (proposing 21 C.F.R. § 1141.16(a)); Compl. ~ 39.
Finally, as part of its preliminary benefits analysis, the FDA estimated that "the U.S.
smoking rate will decrease by 0.212 percentage points" as a result of the Proposed Rule,
75 Fed. Reg. 69,543 (emphasis added), a statistic the FDA admits is "in general not
,'
I~, I
The proposed images were not only in color, but some were also cartoon images,
as opposed to staged photographs; and some were enhanced using either actors or
technological augmentation to achieve the desired effect. See CompI. ~ 38; Defs.' Opp'n
at 36.
5
statistically distinguishable from zero.,,7 Jd. at 69,546; see also CompI. ~ 41.
2. Final Rule
After a period of notice and comment in which the FDA reviewed more than 1,700
comments, it published a Final Rule on June 22, 2011. See 76 Fed. Reg. 36,628-36,629;
CompI. ~ 57. Of the 36 graphic images originally proposed, the FDA chose 9 for
pUblication. Compi. ~ 57. The new graphic images, which will rotate according to an
agency-approved plan, Act § 201(a) (amending 15 U.S.C. § 1333(c)(2»; Compi. ~ 30,
include color images of a man exhaling cigarette smoke through a tracheotomy hole in
his throat; a plume of cigarette smoke enveloping an infant receiving a kiss from his or
her mother; a pair of diseased lungs next to a pair of healthy lungs; a diseased mouth
afflicted with what appears to be cancerous lesions; a man breathing into an oxygen
mask; a bare-chested male cadaver lying on a table, and featuring what appears to be
post-autopsy chest staples down the middle· of his torso; a woman weeping
uncontrollably; and a man wearing a t-shirt that features a "no smoking" symbol and the
words "I QUIT." See Compi. ~~ 57, 59. An additional graphic image appears to be a
stylized cartoon (as opposed to a staged photograph) of a premature baby in an incubator.
Jd. Plaintiffs allege, on information and belief, that many of these images are
Indeed, the FDA's estimated reduction in U.S. smoking rates decreased from
.212% in the Proposed Rule to .088% in the Final Rule. Compare 75 Fed Reg. 69,543
with 76 Fed. Reg. 36,721. See also 76 Fed. Reg. 36,724 (further explaining the "FDA's
f
estimate of a 0.088 percentage point reduction in the U.S. smoking rate"). Plaintiffs
suggest that the decrease could be attributed to the FDA considering (for the first time) a
confounding factor-the difference between Canadian and U.S. cigarette tax rates-in
the Final Rule analysis. See Compi. ~ 62.
6
technologically manipulated, 8 enhanced, or animated, or that they depict actors to achieve
the desired image. See id. ~ 59. And indeed, the FDA cited these nine images'
"salience"-defined as a warning's ability to evoke emotion-as a primary selection
criterion. 9 76 Fed. Reg. 36,639.
In addition to being paired with one of the nine new textual warnings introduced
by Congress, each of the graphic images prominently displays "1-800-QUIT-NOW": a
telephone number the FDA selected to fulfill its own regulatory obligation to offer
smoking cessation assistance on each package. 76 Fed. Reg. 36,686-36,687, 36,754-
36,755; see also CompI. ~~ 57, 60. Based on the 15-month implementation period set out
by Congress, see Act § 201(a) (amending 15 U.S.C. § 1333), the new textual warnings
and graphic images are scheduled to take effect for all cigarette packages manufactured
on or after September 22, 2012, and for all cigarette packages introduced into commerce
The FDA does not dispute that "some of the photographs were technologically
modified to depict the negative health consequences of smoking," although it insists that
"the effects shown in the photographs are, in fact, accurate depictions of the effects of
sickness and disease caused by smoking." Defs.' Opp'n at 36 (quoting 76 Fed. Reg. at
36,696).
9
The Rule reads, in pertinent part: "First, many of the proposed required warnings
elicited significant impacts on the salience measures (emotional and cognitive measures),
which the research literature suggests are likely to be related to behavior change (Ref.
51). For example, the literature suggests that risk information is most readily
communicated by messages that arouse emotional reactions (see Ref. 45), and that
smokers who report greater negative emotional reactions in response to cigarette
warnings are significantly more likely to have read and thought about the warnings and
more likely to reduce the amount they smoke and to quit or make an attempt to quit (Ref.
44). The research literature also suggests that warnings that generate an immediate
emotional response from viewers can result in viewers attaching a negative affect [sic] to
smoking (i.e., feel bad about smoking), thus undermining the appeal and attractiveness of
smoking (Ref. 45 and Ref. 40 at pp. 37-38)." 76 Fed. Reg. at 36,639 (emphasis added).
7
on or after October 22,2012. See Act § 201(b) (note on amending 15 U.S.C. § 1333). In
response to the Final Rule, plaintiffs filed a Motion for Preliminary Injunction, which this
Court granted on November 7,2011. Plaintiffs also filed a Motion for Summary
Judgment and Permanent Injunction on August 19, 2011; defendants responded and filed
a Cross-Motion for Summary Judgment on October 21, 2011; and oral argument was held
on February 1,2012.
ANALYSIS
I. Standard of Review
Summary judgment is appropriate when the movant demonstrates that there is no
genuine issue of material fact in dispute and that the moving party is entitled to judgment
as a matter oflaw. Fed. R. Civ. P. 56(a). The moving party bears the burden, and the
court will draw "all justifiable inferences" in the favor of the non-moving party.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242,255 (1986). Nevertheless, the non-
moving party "may not rest upon the mere allegations or denials of his pleading, but ...
must set forth specific facts showing that there is a genuine issue for trial." [d. at 248
(internal quotations omitted). Factual assertions in the moving party's affidavits may be
accepted as true unless the opposing party submits its own affidavits, declarations, or
documentary evidence to the contrary. Neal v. Kelly, 963 F .2d 453, 456 (D.C. Cir. 1992).
II. First Amendment Claim
Plaintiffs oppose the placement of the Government-mandated warnings on the top
8
50% of the front and back portions of their cigarette packaging. lo Pis.' Mot. at 1. In
particular, plaintiffs argue that the new Rule unconstitutionally compels speech, see
Hurley v. Irish-Am. Gay, Lesbian & Bisexual Grp. o/Boston, Inc., 515 U.S. 557, 573-74
(1995); Wooley v. Maynard, 430 U.S. 705, 714 (1977), and that such speech does not tit
within the "commercial speech" exception under which certain types of Government-
mandated, informational disclosures are evaluated under a less restrictive standard, see
Zauderer v. Office o/Disciplinary Counsel o/Sup. Ct. o/Ohio, 471 U.S. 626,651 (1985);
see also PIs.' Mot. at 17-20. As a result, they argue, the Government's conduct must be
analyzed under the strict scrutiny standard. I I PIs.' Mot. at 17-24. I agree.
A. Applicable Level of Scrutiny
A fundamental tenant of constitutional jurisprudence is that the First Amendment
protects "both the right to speak freely and the right to refrain from speaking at all."
Wooley, 430 U.S. at 714. A speaker typically "has the autonomy to choose the content of
his own message." Hurley, 515 U.S. at 573. And, in fact, "[fjor corporations as for
individuals, the choice to speak includes within it the choice of what not to say." Pac.
Gas & Elec. Co. v. Pub. Uti/so Comm'n o/Cal., 475 U.S. 1, 16 (1986) (plurality opinion).
10 Plaintiffs do not challenge the substance of the nine new textual messages
Congress created by statute. SJ Tr. 12:10-12.
II
The parties continue to disagree fundamentally on the applicable level of scrutiny.
While plaintiffs advocate for an application of strict scrutiny, they also argue that the
Rule/ails under any constitutional standard. PIs.' Mot. at 3. And as defendants contend
that the Rule is subject to no more than intermediate scrutiny, see Cent. Hudson Gas &
Elec. Corp. V. Pub. Servo Comm'n o/N.Y, 447 U.S. 557, 573 (1980), they also continue
to insist that the Rule withstands any level of scrutiny. Defs.' Opp'n at 13-14.
9
As plaintiffs so aptly stated, although "the Government may engage in [ ] advocacy using
its own voice[,] ... it may not force others, such as Plaintiffs, to serve as its unwilling
mouthpiece." Reply in SUpp. of Pis.' Mot. ("PIs.' Reply"), Nov. 18,2011, at 1 [Dkt.
#42]; see Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2671 (2011) ("The State can
express [its] views through its own speech. But a State's failure to persuade does not
allow it to hamstring the opposition. The State may not burden the speech of others in
order to tilt public debate in a preferred direction."). Thus, where a statute "'mandates
speech that a speaker would not otherwise make,' that statute 'necessarily alters the
content of the speech. '" Entm 't Software Ass 'n v. Blagojevich, 469 F .3d 641, 651 (7th
Cir. 2006) (quoting Riley v. Nat 'I Fed'n of the Blind ofN.C., Inc., 487 U.S. 781, 795
(1988)). As the Supreme Court itself has noted, this type of compelled speech is
"presumptively unconstitutional." Rosenberger v. Rector & Visitors of the Univ. of Va.,
515 U.S. 819, 830 (1995).
In the arena of compelled commercial speech, however, narrow exceptions do
exist and allow the Government to require certain disclosures to protect consumers from
"confusion or deception:' Zauderer,471 U.S. at 651. Indeed, courts apply a lesser
standard of scrutiny to this narrow category of compelled speech through which the
Government may require disclosure only of "purely factual and uncontroversial
infonnation." Id. Even under this paradigm, however, compelled disclosures containing
"purely factual and un controversial infonnation" may still violate the First Amendment if
they are "unjustified or unduly burdensome." Id. Unfortunately for the defendants, the
images here neither meet the Zauderer standard, nor are narrowly tailored to avoid an
10
undue burden to the plaintiffs' speech. How so?
First, after reviewing the evidence here it is clear that the Rule's graphic-image
requirements are not the type of purely factual and uncontroversial disclosures that are
reviewable under this less stringent standard. 12 To the contrary, the graphic images here
were neither designed to protect the consumer from confusion or deception, nor to
increase consumer awareness of smoking risks; rather, they were crafted to evoke a
strong emotional response calculated to provoke the viewer to quit or never start
smoking. Indeed, a report by the Institute of Medicine-an authority chiefly relied upon
by the Government-very frankly acknowledges this very purpose. See Defs.' Opp'n at
vi; Institution of Medicine, "Ending the Tobacco Problem: A Blueprint for the Nation"
(Richard J. Bonnie ed. 2007) ("10M Report") at 290-91. According to the 10M Report,
"[i]t is time to state unequivocally that the primary objective of tobacco regulation is not
to promote informed choice but rather to discourage consumption of tobacco products,
especially by children and youths, as a means of reducing tobacco-related death and
disease." 10M Report at 291. Further, "[e]ven though tobacco products are legally
available to adults, the paramount health aim is to reduce the number of people who use
and become addicted to these products, through a focus on children and youths," and,
therefore, the "warnings must be designed to promote this objective." Jd.
Not surprisingly the use of the graphic images accomplishes just that: an objective
12 As this Court previously stated, "the fact alone that some of the graphic images
here appear to be cartoons, and others appear to be digitally enhanced or manipulated,
would seem to contravene the very definition of 'purely factual. '" R.J. Reynolds, 2011
WL 5307391 at *5.
11
wholly apart from disseminating purely factual and uncontroversial information. That
Dr. David Hammond-a researcher upon whom the Government relies-recommended
that the graphic warnings should "elicit negative emotional reactions" to convince
smokers to quit undercuts any argument that the images are purely factual. See David
Hammond, Health Warnings Messages on Tobacco Products: A Review, 20 Tobacco
Control 327, 331-32 (2011) ("Hammond Review"); Defs.' Opp'n at vi. Indeed, the FDA
measured the efficacy of the graphic images by their "salience," which the FDA defines
in large part as a viewer's emotional reaction. See Compl. ,-; 58 (citing 76 Fed. Reg.
36,638-36,639).
Further, the graphic images are neither factual nor accurate. For example, the
image of the body on an autopsy table suggests that smoking leads to autopsies; but the
Government provides no support to show that autopsies are a common consequence of
smoking. Indeed, it makes no attempt to do so. Instead, it contends that the image
symbolizes that "smoking kills 443,000 Americans each year." Defs.' Opp'n at 42. The
image, however, does not provide that factual information. Similarly, the image of a man
exhaling cigarette smoke through a tracheotomy hole in his throat is not being used to
show a usual consequence of smoking. Instead, it is used to symbolize "the addictive
nature ofsmoking"-a fact that is not accurately conveyed by the image. Id. at 37. Put
simply, the Government fails to convey any factual information supported by evidence
about the actual health consequences of smoking through its use of these graphic
12
lInages. 13
•
The images, coupled with the placement of the toll free number, do not "promote
informed choice" but instead advocate to consumers that they should "QUIT NOW." A
telling example is the image depicting a man wearing a t-shirt that features a "no
smoking" symbol and the words "I QUIT" next to the "1-800-QUIT-NOW" phone
number. This image contains no factual information, and even the Government concedes
this image "encourag[es] cessation." Defs.' Opp'n at 43 (quoting 76 Fed. Reg. 36,656).
Likewise, the Secretary and the Commissioner of the FDA ("the Commissioner") have
acknowledged that the graphic images convey an anti-smoking message-specifically,
the images were designed to: convey that "smoking is gross"; help "encourage smokers
to quit"; "rebrand[ ] our cigarette packs"; and "dispel[ ] the notion that somehow [tobacco
use] is cool." Graphic Health Warning u.s. Food & Drug Admin. Announcement, (Nov.
10, 2010), available at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm232556.
htm; Press Briefing, Press Sec'y Jay Carney, Sec'y of Health and Human Servs. Kathleen
Sebelius, & FDA Comm'r Margaret Hamburg (June 21,2011), available at
http://www .whitehouse.gov/the-press-office/20 11/06/21 Ipress-briefing-press-secretary-
jay-carney-secretary-health-and-human-ser; News Release, U.S. Dep't of Health &
Human Servs., FDA Unveils Final Cigarette Warning Labels (June 21, 2011), available
13 Indeed, at oral argument, the plaintiffs proffered an analogy that exposes the
weakness in the Government's contention that these images are purely factual and
uncontroversial. After reciting an account of a 117 -year-old woman who smoked her
entire adult life, plaintiffs asked rhetorically: "Would it be purely factual and
uncontroversial if we were to take a picture of one of these people [like the lifelong
smoker], put [her] on our advertisements, and say 115 years old and still smoking?" [SJ
Tr.46:2-12J. Of course not!
13
at http://www.hhs.gov/news/pressI2011pres/06/20110621 a.html. Thus, while the line
between the constitutionally permissible dissemination of factual information and the
impermissible expropriation of a company's advertising space for Government advocacy
can be frustratingly blurry, here the line seems quite clear.
Rather than fit the Zauderer paradigm, "the disclosures mandated in this case are
much more similar in form and function to those at issue in Blagojevich, 469 F.3d at 643,
652." R.J. Reynolds, 2011 WL 5307391 at *6. There, the Seventh Circuit refused to
apply the Zauderer standard of scrutiny to a state law that required video game retailers
to affix a four-square-inch sticker with the number "18" (representing age 18) on any
game deemed "sexually explicit" under the statute. 469 F.3d at 643, 652. "Just as the
Seventh Circuit recognized that a compelled video-game label based on what the state
deemed to be 'sexually explicit' was 'far more opinion-based than the question of
whether a particular chemical is within any given product,' Blagojevich, 469 F.3d at 652
(referencing Sorrell), so too are the graphic images promulgated as part of the FDA's rule
a more subjective vision of the horrors of tobacco addiction." R.J. Reynolds, 2011 WL
5307391 at *6. Indeed, like the stickers in Blagojevich, the graphic images "ultimately
communicate[ ] a subjective and highly controversial message." Blagojevich, 469 F.3d at
652. The Rule, therefore, does not fit into the ,zauderer exception for purely factual and
uncontroversial information. See Pac. Gas & Elec., 475 U.S. at 15 n.l2 ("Nothing in
Zauderer suggests ... that the State is equally free to require corporations to carry the
message of third parties, where the messages themselves are biased against or are
expressly contrary to the corporation's views."). Thus, these images must withstand the
14
strict scrutiny analysis the Supreme Court imposes on Government regulations which
compel commercial speech.
B. Analysis Under Strict Scrutiny
I'
To withstand strict scrutiny, the Government carries the burden of demonstrating
that the FDA's Rule is narrowly tailored to achieve a compelling government interest.
See, e.g., A.N.S. W.E.R. Coal. v. Kempthorne, 537 F. Supp. 2d 183, 195 (D.D.C. 2008)
(citing Boos v. Barry, 485 U.S. 312, 322 (1988) and Rosenberger v. Rector & Visitors 01
the Univ. 01 Va. , 515 U.S. 819, 829 (1995)). Unfortunately for the Government, it fails to
satisfy this burden.
First, although the Government contends that it has a compelling interest-
"conveying to consumers generally, and adolescents in particular, the devastating
consequences of smoking and nicotine addiction," see Defs.' Opp'n at 23-its "stated
'.
purpose does not seem to comport with the thrust of its arguments, or with the evidence it
offers to support the Rule." R.J Reynolds, 2011 WL 5307391 at *7. To the contrary, it
is clear that the Government's actual purpose is not to inform or educate, but rather to
advocate a change in behavior-specifically to encourage smoking cessation and to
discourage potential new smokers from starting. See 10M Report at 290-91 ("It is time to
state unequivocally that the primary objective of tobacco regulation is not to promote
informed choice but rather to discourage consumption of tobacco products, especially by
children and youths, as a means of reducing tobacco-related death and disease.");
Hammond Review at 331-32 (recommending that the graphic warnings should "elicit
negative emotional reactions" to convince smokers to quit); 76 Fed. Reg. 36,633 (the
15
purpose of the graphic warnings is to "discourage nonsmokers ... from initiating
cigarette use and to encourage current smokers to consider cessation"); Act § 3.9 (the
purpose of the Act is "to promote cessation to reduce disease risk and the social costs
associated with tobacco-related diseases"). The Government's reliance on the graphic
images-which were chosen based on their ability to provoke emotion, a criterion that
does not address whether the graphic images'affect consumers' knowledge of smoking
risks-coupled with the toll free number, further supports the conclusion that the
Government's actual purpose is to convince consumers that they should "QUIT NOW.,,14
Indeed, at oral argument, the Government effectively conceded this purpose when it
acknowledged: "Now, it's no secret that the Government wants people to stop smoking."
SJ Tr. 26: 17-18. Although an interest in infonning or educating the public about the
dangers of smoking might be compelling, an interest in simply advocating that the public
not purchase a legal product is not. 15 However, even if the Government's interest is in
14 The Government's interest in adv9cating a message cannot and does not outweigh
plaintiffs' First Amendment right to not be the Government's messenger. See Wooley v.
Maynard, 430 U.S. 705, 717 (1977) C'[W]here the State's interest is to disseminate an
ideology, no matter how acceptable to some, such interest cannot outweigh an
individual's First Amendment right to avoid becoming the courier for such message.").
This Court is acutely aware of the health risks of smoking. And although the
Government may want to convince consumers to stop smoking to protect their health,
plaintiffs are correct in stating that their industry should not "serve as the government's
unwilling spokesman in that paternalistic endeavor." SJ Tr. 6: 18-19.
15 Even assuming that the interest is compelling, the Rule does not achieve or further
this interest. According to the plaintiffs, the Jamieson & Romer study "demonstrates that
consumers are overwhelmingly aware of the risks of smoking and indeed overestimate
those risks, which is why the introduction of graphic warnings does not move the needle
either in terms of behavior or in terms of knowledge of the risks that the warnings
address." SJ Tr. 21:5-13; see Jamieson & Romer, What Do Young People Think They
16
fact "compelling," the Rule is clearly not narrowly tailored to achieve the Government's
purpose. How so?
As I noted previously, "the sheer size and display requirements for the graphic
images are anything but narrowly tailored." R.J Reynolds, 2011 WL 5307391 at *7.
Under the Rule, plaintiffs are forced to act as the Government's mouthpiece by
dedicating the top 50% of the front and back of all cigarette packages manufactured and
distributed in the United States to display the Government's anti-smoking message: not
to purchase this product. These dimensions alone clearly demonstrate "that the Rule was
designed to achieve the very objective articulated by the Secretary of Health and Human
Services: to 'rebrand[] our cigarette packs,' treating (as the FDA Commissioner
announced last year) 'every single pack of cigarettes in our country' as a 'mini-billboard.'
A 'mini-billboard,' indeed, for its obvious anti-smoking agenda!" Id. (internal citations
omitted). The FDA's contention that neither it nor this Court has the authority to second-
guess Congress, see R.J Reynolds, 2011 WL 5307391 at *7 n.25, even if the
congressional mandate violates the First Amendment, is an oh-too-convenient dodge.
See SJ Tr. 36:22-25; 37:13-17. As the parties have conceded, there is no evidence that
Congress even considered the First Amendment implications when drafting the Act. See
SJ Tr. 30:10-13 (defendants); 42:3-13 (plaintiffs). To say the least, implementing a Final
Rule consistent with a congressional mandate does not require a Court to hold that the
Know About the Risks o/Smoking (2001),28-30. Indeed, the Rule itself makes clear that
the warnings may cause smoking rates in the United States to decrease by O.088ro--a
rate which is "not statistically distinguishable from zero." 76 Fed. Reg. 36,721; 36,724;
36,776. The Government "therefore cannot reject, in a statistical sense, the possibility
that the rule will not change the U.S. smoking rate." Id. at 37,776.
17
Rule automatically passes constitutional muster. Congress must pass laws, and the FDA
must implement final rules, that are consistent with the requirements of the Constitution.
Thus, just as the four-square-inch sticker "literally fail [ed] to be narrowly tailored"
because it "cover[ ed] a substantial portion of the box," in Blagojevich, so too must these
graphic images fail to meet the narrowly tailored requirement the Government must
demonstrate. 469 F.3d at 652.
Finally, with respect to the content of the graphic images, it is curious to note that
plaintiffs have offered several alternatives that are easily less restrictive and burdensome
for plaintiffs, yet would still allow the Government to educate the public on the health
risks of smoking without unconstitutionally compelling speech. First, the Government
could disseminate its anti-smoking message itself, for example, by increasing its anti-
smoking advertisements or issuing additional statements in the press urging consumers to
quit smoking or both. Pis.' Mot. at 28. Although doing so might impose costs on the
Government, see Defs.' Opp'n at 22, "[c]itizens may not be compelled to forgo their
[First Amendment] rights because officials ... desire to save money." Palmer v.
Thompson, 403 U.S. 217, 226 (1971). Of course, by now it is clear that the
Government's actual concern is not the potential for added cost as the FDA recently
announced that it will be spending $600 million on a new-presumably believed to be
effective-anti-smoking multimedia campaign. See Pis.' Reply at 47. Second, the
Government could change the display requirements. Specifically, the Government could
reduce the space appropriated for the proposed "warnings" to 20% of the packaging or
require "warnings" only on the front or back of the packaging. Pis.' Mot. at 29-30.
18
Third, the Government could change the content by selecting graphics that conveyed only
purely factual and uncontroversial information rather than gruesome images designed to
disgust the consumer. Id. at 30. Fourth, the Government could increase cigarette taxes.
Id. at 29. And lastly, the Government could improve efforts to prevent the unlawful sale
of cigarettes to minors. Id. Anyone of these suggestions would be less restrictive than
'.
the Rule's current requirements. Unfortunately, because Congress did not consider the
First Amendment implications of this legislation, it did not concern itself with how the
regulations could be narrowly tailored to avoid unintentionally compelling commercial
speech.
Therefore, because the Government has failed to carry both its burden of
demonstrating a compelling interest and its burden of demonstrating that the Rule is
narrowly tailored to achieve a constitutionally permissible form of compelled commercial
speech, the Rule violates the First Amendment and plaintiffs' Motion for Summary
Judgment must be, and is, GRANTED.
;.1
CONCLUSION
For all the foregoing reasons, plaintiffs' Motion for Summary Judgment [Okt.
#10] is GRANTED, and defendants' Cross-Motion for Summary Judgment [Dkt. #35] is
DENIED. An order consistent with this decision is attached herewith.
United States District Judge
19
R.J. Reynolds Tobacco Company v. United States Food and Drug Administration
Court: District Court, District of Columbia
Date filed: 2012-02-29
Citations: 845 F. Supp. 2d 266, 40 Media L. Rep. (BNA) 1473, 2012 U.S. Dist. LEXIS 26257
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