R.J. Reynolds Tobacco Co. v. Food & Drug Admin., 696
F.3d 1205 (D.C. Cir. 2012)
The majority struck down the FDA’s new image-based tobacco
warnings on First Amendment grounds. If the government seeks cert, it will of
course be granted. The case offers another opportunity for the Supreme Court to
muddle around in commercial speech doctrine, with potential implications for
the Lanham Act and the FTC. (Note, however, that simple denial is likely to
protect trademark: trademark
is just different from other commercial speech regulation, somehow, even if the
Justices can’t say why.)
Congress gave the FDA a mandate to create new, large warning
labels for cigarette packages and ads. Relying on part on a strong worldwide
consensus, the FDA proposed a “dramatic expansion” of the existing warnings.
(Over thirty countries require graphic warnings, and more are considering them,
but the majority stated that they don’t necessarily protect “individual
liberties”—for which read “commercial speech”—as strongly as we do.) The aim was to clearly
and effectively convey the negative health consequences of smoking, which would
discourage nonsmokers, especially kids, from starting and encourage current
smokers to quit. The FDA promulgated a regulation specifying nine images, one
for each warning statement, and required each one to include the phone number
for the National Cancer Institute’s Network of Tobacco Cessation Quitlines,
1-800-QUIT-NOW.
The majority was extremely unimpressed with the FDA’s
evidence. The FDA selected the final images based on an 18,000-person internet
study, which looked at whether the graphics increased intention to quit/not
smoke, increased knowledge of the health risks of smoking and second-hand
smoke, and were “salient,” defined in part as causing viewers to feel
“depressed,” “discouraged,” or “afraid”—all compared to control text.
Criticisms of the study—which didn’t just come from the tobacco
companies—included that it didn’t assess long-term effects, only reported
intentions, and some recommended a long-term study. (Too soon to tell?)
Another criticism was that there was selection bias in recruiting an internet
panel for an FDA-sponsored study. The court of appeals snidely described the
FDA’s argument that intention to quit is important on the path to quitting as
“shocking.” The FDA argued that, though this particular study didn’t link
intent to quit with actual quitting, the rest of the scientific literature
provided evidence that increased attention to the health risks of smoking would
work.
The FDA thought the study was good enough, especially given
evidence from similar graphic warnings in other countries. The court of appeals
reiterated that those countries generally don’t have an analogue to the
commercial speech protections conferred by our First Amendment, though why that
would change warning effectiveness was unclear. More directly, the tobacco
companies argued that the Canadian data didn’t show any statistically
significant decline in smoking rates after similar graphic warnings were
introduced. The FDA argued that other studies showed that the Canadian warnings
had been “effective at providing . . . smokers with health information, making
consumers think about the health effects of smoking, and increasing smokers’
motivations to quit smoking.”
The district court granted summary judgment to the tobacco
companies. The FDA appealed. The companies did not (at this time, and probably
not ever because of how invisible they are) challenge the current textual
warnings, only the graphic image and the 1-800-QUIT-NOW requirements.
In what is the most troubling and, I suspect, vulnerable
part of the decision, the majority first held that forcing an individual or a
corporation to express certain views or subsidize speech to which they object
is always subject to strict scrutiny, and this is true whether the forced
speech/subsidization involves an expression of value or a statement of fact.
Just to be clear: this means that the SEC’s registration procedure is subject
to strict scrutiny, and the tax returns on which Uncle Sam tells me to tell it
how much I made last year and what I did with it, not to mention much of the
rest of the regulatory state (nutrition labels, black-box warnings on drugs and
the rest of the drug facts, endorsement disclosures, “typical results are X,”
“equal opportunity housing,” et cetera). But don’t worry—I’m sure we’ll be fine
without those.
Anyway, the majority said this was both compulsion and
forced subsidization. Though factual disclosure is also subject to strict
scrutiny according to the majority, it went on to endorse the companies’
argument that the graphic warnings were designed “to shame and repulse smokers
and denigrate smoking as an antisocial act,” making the message “ideological
and not informational.” People already know smoking is bad, but the companies
argued that this was “‘shouting’” something they already knew, and that
communicated “‘a point of view on how people should live their lives: that the
risks from smoking outweigh the pleasure that smokers derive from it, and that
smokers make bad personal decisions, and should stop smoking.’” These weren’t
warnings, but admonitions not to buy the product.
The government can use “shock, shame, and moral opprobrium”
to discourage smoking and make smoking “economically prohibitive and socially
onerous.” And it can require consumers to be fully informed about the dangers
of hazardous products. But this regulation raised “novel” questions” about the
government’s authority to force a manufacturer to go beyond “purely factual and
accurate commercial disclosures and undermine its own economic interest” by
making every single pack a “mini billboard” for the government’s message. As it
turns out, some disclosure requirements are reviewed under Zauderer’s relaxed standard for ads, which turns on whether they
attempt “only to prescribe what shall be orthodox in commercial advertising” or
to “prescribe what shall be orthodox in … matters of opinion.” The “element of
compulsion” creates an argument for using strict scrutiny.
(1) Okay, so certain disclosure requirements aren’t subject to strict scrutiny? Good
to know; would have been nice to say so in the holding. (2) This won’t be the
last time I’ll say this: the question is only “novel” if you completely ignore
abortion restrictions, which you have to do to avoid embarrassing
contradictions—which, admittedly, are likely to exist on both sides of the
political divide. (3) Wow, “element of compulsion” is a truly bad distinction.
We are evaluating disclosure requirements,
which is why both descriptions of the ok and the not-ok use the same word,
“prescribe.” Plainly, Zauderer
involved compulsion. Most likely, the majority means ideology v. fact, except that it can’t full-on say that
because the line between the two is … rather malleable. The alternative
reading—tobacco warnings are extra compulsory because anyone who sells
cigarettes has to use them regardless of what other factual claims their ads
make or don’t make—is also dumb; anyone who sells tobacco creates the same
health risks and the same need for disclosure, the same way anyone who made the
affirmative claim at issue in Zauderer
(that clients wouldn’t need to pay “fees” unless they won) created the same
need for disclosure.
Laying another mine, the majority “assum[ed]” that
marketing—“packaging, branding, and other advertisements”—could properly be
classified as commercial speech. There is nothing to assume here. As long as
there’s a commercial speech doctrine, those things are commercial speech. Not
for nothing, that’s the basis of the Lanham Act. The question remained: “how
much leeway should this Court grant the government when it seeks to compel a
product’s manufacturer to convey the state’s subjective—and perhaps even
ideological—view that consumers should reject this otherwise legal, but
disfavored, product?” Assuming, without deciding, that such compulsion is
constitutionally permissible, it still had to withstand the appropriate level
of scrutiny.
According to the majority, there are two primary exceptions
to strict scrutiny “in the commercial speech context.” Most obviously (though
the majority puts it second), commercial
speech regulation isn’t subject to strict scrutiny under Central Hudson, though the majority
described the Central Hudson standard
as demanding nonetheless. How this is an “exception” to strict scrutiny “in the
commercial speech context” is left as an exercise for the reader. (Some ad
regulation could be subject to strict scrutiny, if we took Justice Stevens’s
approach—regulations designed to preserve the fairness of the bargaining
process are reviewed with great leniency, and everything else gets strict
scrutiny.) The second exception is that, under Zauderer, “purely factual and uncontroversial” disclosures are permissible
if they are “reasonably related to the State’s interest in preventing deception
of consumers,” provided the requirements are not “unjustified or unduly
burdensome.” This is close to rational basis review.
First, the government argued that Zauderer applied. In that case, the Court reasoned that an
advertiser’s constitutional interest in not providing additional factual
information was “minimal,” given that commercial speech is constitutionally
protected because of its informational benefits to the audience. Zauderer
said that an advertiser’s rights were adequately protected as long as
disclosure requirements were reasonably related to the state’s interest in
preventing deception. The FDA argued
that Zauderer’s lenient standard
applied to disclosures of health and safety risks, but the court of appeals
disagreed: it’s only for preventing deception.
(What about the evidence that consumers don’t fully understand just how dangerous
smoking is? Why aren’t health and safety
regulations anti-deception regulations?)
Zauderer didn’t apply in United Foods, which was about an
assessment on mushroom producers to support generic advertising. Ibanez also
suggests that Zauderer only applies
when the government “affirmatively demonstrates” a threat of deception, since
it found that the state hadn’t shown that use of an attorney’s Certified
Financial Planner designation was “potentially misleading”; the state’s posited
harm was “purely hypothetical.” Zauderer only applies when the
government shows that an ad will likely mislead consumers. (This conveniently ignores the actual record
in Zauderer, which was hardly that
robust—it was common sense to the Court at the time.) Milavetz,
the most recent pronouncement, upheld a disclosure requirement for ads that
were “inherently misleading” because they “promis[ed] . . . debt relief without
any reference to the possibility of filing for bankruptcy, which has inherent
costs.” Justice Thomas’s concurrence
cautioned against reading Milavetz
broadly to endorse disclosure requirements just because consumer deception
might “plausibly” be at stake. The
government must show that, absent a warning “there is a self-evident—or at
least ‘potentially real’—danger that an advertisement will mislead consumers.”
In light of other restrictions on cigarette ads barring them
from making health claims and banning “light,” “mild,” “low,” or similar
descriptors, along with the absence of any congressional findings on the
misleading nature of cigarette packaging itself, there was no Zauderer justification for the graphic
warnings. The companies didn’t argue
that no disclosure requirements were warranted; they objected to these proposed
disclosures.
The dissent argued that consumers were still being misled
about the nature and extent of the risks of smoking, secondhand smoke, and
addiction. “But none of the proposed
warnings purport to address the information gaps identified by the government.” And the broader context of years of deception
preceding these warnings was only relevant as part of a corrective order
necessary to “dissipate the effects of respondent’s deceptive representations,”
whereas the FDA didn’t frame the graphic warnings as remedial measures designed
to counteract specific deceptive claims that would keep going forever.
Plus, the graphic warnings weren’t “purely factual and
uncontroversial” information, Zauderer,
or “accurate statement[s],” Milavetz.
Those disclosures “were both indisputably accurate and not subject to
misinterpretation by consumers. The FDA’s images are a much different
animal.” The FDA argued that the images
were not meant to be interpreted literally, but symbolized the textual
warnings, which provided context for the images. But consumers might misinterpret the images:
“the image of a man smoking through a tracheotomy hole might be misinterpreted
as suggesting that such a procedure is a common consequence of smoking—a more
logical interpretation than FDA’s contention that it symbolizes ‘the addictive
nature of cigarettes,’ which requires significant extrapolation on the part of
the consumers.” (Once again, courts’
confidence in words as bearers of singular meaning does damage—words can be
misinterpreted too, and images can predictably convey important messages without
conveying universality. Compare, for example, the FTC’s new Guides on
Endorsement, which now disfavors “results not typical” when an image of a
particularly successful product user is shown—that guideline is clearly at risk
from this decision.)
Anyway, the graphic warnings were not “purely” factual
“because—as FDA tacitly admits— they are primarily intended to evoke an
emotional response, or, at most, shock the viewer into retaining the
information in the text warning.” See,
there is reason, and there is emotion, and they can be easily distinguished
(despite all the evidence we have that this is not so; people who cannot feel,
it turns out, cannot think). The court
of appeals interpreted the FDA’s citation of research showing that pictures are
easier to remember than words as being about “shocking”—why can’t it be about
“remembering, which we know is aided by emotional cues”? Likewise, the court didn’t like the FDA’s
reliance on a “substantial body” of scientific literature showing that
emotional responses “such as worry and disgust, ‘reliably predict the
likelihood that consumers will understand and appreciate the substance of the
warnings.’” Apparently the government is
not allowed to use a warning that works if the mechanism travels through the
emotions—as in fact words/symbols do too (for example, research shows that
price signals, similar to the required disclosure in Zauderer and Milavetz,
trigger negative emotional reactions that mitigate consumers’ desires for the
advertised products), but why worry about that difficulty?
The court didn’t like that many of the images didn’t convey
typical “warning” information at all,
much less make an “accurate
statement” about cigarettes. For example, the images of a woman crying, a small
child, and the man wearing a T-shirt emblazoned with the words “I QUIT” do not
offer any information about the health effects of smoking. And the
“1-800-QUIT-NOW” number, when presented without any explanation about the
services provided on the hotline, hardly sounds like an unbiased source of
information. These inflammatory images and the provocatively-named hotline
cannot rationally be viewed as pure attempts to convey information to
consumers. They are unabashed attempts to evoke emotion (and perhaps
embarrassment) and browbeat consumers into quitting.
These images weren’t “patently false,” but they didn’t
“impart purely factual, accurate, or uncontroversial information to consumers.”
Without Zauderer,
the question was whether strict or intermediate scrutiny was appropriate. Central
Hudson was the answer for mandatory disclosures applied to commercial
speech, despite conflicting precedent from other circuits. The test: a substantial government interest
directly advanced by the regulation that isn’t more extensive than necessary,
with the government bearing the burden of justification.
The government’s interest was in decreasing smoking rates
both through preventing initiation and through encouraging quitting. In a footnote, the court suggested that this
wasn’t actually a substantial interest: “we are skeptical that the government
can assert a substantial interest in discouraging consumers from purchasing a
lawful product, even one that has been conclusively linked to adverse health
consequences.” Comment: I bet Planned Parenthood would be super, super
surprised to hear that. Also, even
assuming that the rules for abortion weren’t directly contrary, this is
ridiculous. We do not live in a world in
which that which is not permitted is required, or that which is allowed is therefore
okay. If “smoking kills people” isn’t
enough to create a substantial interest in decreasing smoking, then what would
be? (Note that this factor is supposedly
about the government’s interest, not about the mechanism of
regulation.) We know that the interest
in protecting children from molestation is substantial, but molestation is less
serious than death. Even the court,
though, had to admit that “the Supreme Court has at least implied that the
government could have a substantial interest in reducing smoking rates because
smoking poses ‘perhaps the single most significant threat to public health in
the United States.’” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120
(2000).
Okay, that assumption out of the way, the next question was
whether the FDA had offered substantial evidence showing that the warnings
directly advanced the asserted governmental interest. Ineffective or remote support for the
government interest wasn’t enough, nor was mere speculation or conjecture. And the FDA hadn’t provided “a shred of
evidence” showing that the graphic warnings would directly advance its interest
in reducing smoking. Despite the
international consensus on the effectiveness of graphic warnings, there was no
evidence that such warnings
directly caused a material decrease
in smoking rates in any of the countries that now require them. While studies
of Canadian and Australian youth smokers showed that the warnings on cigarette
packs caused a substantial number of survey participants to think— or think
more—about quitting smoking, and FDA might be correct that intentions are a
“necessary precursor” to behavior change, it is mere speculation to suggest
that respondents who report increased thoughts about quitting smoking will
actually follow through on their intentions. And at no point did these studies
attempt to evaluate whether the increased thoughts about smoking cessation led
participants to actually quit.
One Australian study found increased quit attempts after the
enactment of large graphic warnings but “no association with short-term quit
success.” Some Canadian and Australian studies suggested that the warnings
induced reduced consumption and helped former smokers stay away, but didn’t
purport to show an actual reduction in smoking rates. True, Canadian smoking rates dropped after
graphic warnings were introduced, but the FDA couldn’t directly attribute any decrease to the warnings because Canada
implemented other smoking control initiatives too during the same period. Thus, the FDA’s evidence was mere speculation
and conjecture. The regulatory impact
assessment, despite favorable assumptions, estimated that the new warnings
would reduce smoking rates by “a mere 0.088%, a number the FDA concedes is ‘in
general not statistically distinguishable from zero.’” And one of the principal
researchers on whom FDA relies recently surveyed the relevant literature and
conceded that “[t]here
is no way to attribute . . . declines [in smoking] to the new health warnings.”
“In light of the number of foreign jurisdictions that have
enacted large graphic warning labels, the dearth of data reflecting decreased
smoking rates in these countries is somewhat surprising, and strongly implies
that such warnings are not very effective at promoting cessation and
discouraging initiation.” Even deferential review couldn’t defer to this. The FDA argued that the studies only made the
unremarkable point that it’s difficult to determine with precision the relative
causal impact of multiple contributing factors, especially given small data
sets. “But FDA cannot get around the
First Amendment by pleading incompetence or futility.” It failed to meet its burden.
The FDA also argued that the court should defer to
Congress’s judgment about the effectiveness of graphic warnings, per Turner, but deference is only warranted
when Congress bases its conclusions on substantial evidence. (Ah, Eldred,
the lost cause.)
Nor could the FDA assert a separate interest in effectively
communicating health information, which is just a redescription of the means by
which it was trying to reduce smoking rates.
Anyway, that just begs the question of what “effectively” means. If effectively isn’t cashed out in reductions
in smoking rates, then it’s a meaningless constraint on government regulation.
In conclusion, the court noted the FDA’s position that
“previous efforts to combat the tobacco companies’ advertising campaigns have
been like bringing a butter knife to a gun fight. According to the FTC, tobacco
companies spent approximately $12.49 billion on advertising and promotion in
2006 alone, employing marketing and advertising experts to incorporate current
trends and target their messages toward certain demographics.” The graphic warnings were the FDA’s attempt
to level the playing field, but the fact that the government finds expression
too persuasive doesn’t permit it to silence the speech or burden its
messengers.
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