Monday, August 27, 2012

U.S. Court of Appeals Upholds District Court's Invalidation of FDA's Proposed Graphic Cigarette Warning Labels

On Friday, the U.S. Court of Appeals for the District of Columbia upheld the District Court's decision that overturned the FDA's proposed graphic warning labels for cigarettes on the grounds that these warnings violate the First Amendment.

Although the appeals court applied a different standard than the district court, it still found that under that less stringent standard, the proposed warning labels do not pass constitutional muster as they do not satisfy the third prong of the Central Hudson criteria for commercial speech: that the restriction of free speech must directly advance the government's stated interest (and the government must provide substantial evidence to support this contention). In this case, that interest is in promoting smoking cessation. The appeals court found that the FDA did not provide sufficient evidence to support the contention that the graphic warning labels will cause smokers to quit.

The Rest of the Story

There are two key findings in the decision. The first relates to the appropriate level of scrutiny to evaluate the First Amendment claims, and the second relates to whether the warning labels pass muster under that level of scrutiny.

The FDA argued that a very lenient level of scrutiny is appropriate (a level defined in the Zauderer case) because the proposed warning labels are merely an uncontroversial statement of the facts regarding the effects of smoking. The district court ruled that a high level of scrutiny (sometimes called "strict scrutiny") was the appropriate standard, and under that high level of scrutiny, the warning labels do not even come close to passing constitutional muster.

Interestingly, the appeals court took the middle ground, ruling that an intermediate level of scrutiny is appropriate because:

1. The case involves commercial speech, and is not subject to strict scrutiny that might be required of non-commercial speech; and

2. The warning labels go far beyond disclosing uncontroversial, factual information and therefore the low Zauderer level of scrutiny is not appropriate.

The Court writes: "this case raises novel questions about the scope of the government's authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest - in this case, by making 'every single pack of cigarettes in the country a mini-billboard' for the government's anti-smoking message. ... the graphic warnings do not constitute the type of 'purely factual and uncontroversial' information ... to which the Zauderer standard may be applied. ... the graphic warnings are 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." ...

"In fact, many of the images do not convey any 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. ... While none of the images are patently false, they certainly do not impart purely factual, accurate, or uncontroversial information to consumers. Consequently, the images fall outside the ambit of Zauderer.

The appeals court thus decides that the appropriate standard of scrutiny in this case is an intermediate level of scrutiny, as set forth in Central Hudson. Under Central Hudson, the government must demonstrate (with substantial, scientific evidence) that the graphic warning labels will advance the government's stated interest in reducing smoking by encouraging smokers to quit and thus reducing smoking rates.

After reviewing the scientific evidence put forward by the FDA, the Court finds that the evidence is not at all compelling (the FDA does not even provide a "shred of evidence" to support its position), and therefore, the regulations do not pass muster under Central Hudson.

The Court writes: "FDA has not provided a shred of evidence - much less the 'substantial evidence' required by the APA - showing that the graphic warnings will 'directly advance' its interest in reducing the number of Americans who smoke. FDA makes much of the 'international consensus' surrounding the effectiveness of large graphic warnings, but offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them. ... FDA's Regulatory Impact Analysis (RIA) essentially concedes the agency lacks any evidence showing that the graphic warnings are likely to reduce smoking rates. ... The Rule thus cannot pass muster under Central Hudson."

In a dissenting opinion, Judge Rogers rules that only the "1-800-QUIT-NOW" aspect of the warning labels is unconstitutional. That aspect of the warning, he argues, falls outside of the reach of Zauderer, thus forcing a stricter level of scrutiny under Central Hudson. And under that intermediate level of scrutiny, the warning label fails because the "1-800-QUIT-NOW" requirement has not been shown to be the least stringent requirement necessary to advance the government's interest in reducing smoking (the fourth prong of the Central Hudson test).

Putting it All Together

What does this all mean?

What it means is that the anti-smoking movement's use of shoddy science has finally caught up to it. While the lack of rigor in its recent use of science to support its policy positions may be good enough to convince policy makers, it is not good enough to convince the courts.

The Court did not fall for the argument that studies have demonstrated an effect of graphic warning labels on smokers' attitudes about quitting. The Court wanted to see studies showing that these labels actually led to smokers quitting, but such evidence was not forthcoming. The Court essentially laid bare the lack of scientific evidence behind the "international consensus" that graphic warning labels are effective.

The Court agreed with the argument I have advanced for some time that the FDA's own evidence, as well as evidence from a host of other studies, does not support its case.

These previous posts lay out my argument:

Even the FDA Itself Concludes that Graphic Warning Labels Will Have Minimal Impact, and Perhaps No Impact, on Cigarette Smoking - August 29, 2011

FDA Analysis Shows that Graphic Cigarette Warning Labels Increased Cigarette Smoking in Canada from 2001-2008 - August 30, 2011

New Study Shows No Effect of Graphic Warning Labels in England on Smoking Behavior - August 22, 2011

Yet Another New Study Suggests Likely Ineffectiveness of Graphic Cigarette Warning Labels - April 25, 2012

Data from Other Countries Show No Effect of Graphic Warning Labels on Cigarette Consumption - August 14, 2011

Research Firm Report Estimates that Graphic Warning Labels Will Reduce Cigarette Consumption by No More than 1% - July 11, 2011

Experimental Study Demonstrates that Graphic Cigarette Warning Messages Invoke Defense Response; May Explain Observed Lack of Effect of Warning Labels - August 23, 2011

Study Shows Carotid Artery Plaque Screening Does Not Promote Smoking Cessation; Provides Further Evidence that Graphic Warning Labels Will Not Work - February 1, 2012

More New Research Suggests that Graphic Cigarette Warning Labels Will Not Be Effective in Deterring Smokers - July 13, 2011

This story also exposes the gross distortions of the scientific evidence by the FDA and the Department of Health and Human Services in over-hyping the significance of the graphic warning labels:

Health Agencies Boast of Dramatic Impact of New Cigarette Warning Labels - November 15, 2010

Finally, the story shows that the FDA and the health groups which filed an amicus brief in the case undermined the FDA's position by making it very clear that the intended purpose of the warning labels was to reduce smoking, not merely to warn smokers of the health effects. Because of this, the agency had to provide evidence that the warning labels would reduce smoking, rather than merely provide evidence that the warning labels would warn smokers. In addition, these arguments made it more difficult to argue that Zauderer was the correct standard. Thus, the arguments put forward by the FDA and the health groups undermined the government's case both for the Zauderer standard and for validity under the Central Hudson standard:

FDA and DHHS Harm their Own Case by Pushing Political Propaganda and Over-hyping Significance of Graphic Warning Labels on Cigarettes - March 5, 2012

Amicus Brief Submitted by Anti-Smoking Groups Undermines Case for Graphic Cigarette Warning Labels - September 25, 2011

The rest of the story is that the loss of scientific rigor in the anti-smoking movement - the lack of a clear link between science and policy - has now come back to hurt the movement. While anti-smoking groups may have pulled the wool over the eyes of politicians and policy makers in convincing them that regulating the "safety" of tobacco products and instituting graphic warning labels were effective methods of standing up to Big Tobacco, their weak scientific support for this agenda did not fool the D.C. Appeals Court.

In my view, the graphic warning labels are now dead in the water. Even if the FDA appeals to the Supreme Court, it is not going to be successful. In fact, such an appeal will likely result in even more of an embarrassment for the agency.

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