A federal district court judge today issued a preliminary injunction against the FDA's graphic cigarette warning label requirements, which were scheduled to go into effect next September. Unless overturned on appeal, this means that the FDA will not be able to implement this graphic warning label requirement pending the outcome of the lawsuit, which was filed on First Amendment grounds by R.J. Reynolds, Lorillard, and three smaller tobacco companies.
The primary argument of the tobacco company plaintiffs was that while requiring factual and uncontroversial information on cigarette packs is permissible, the large graphic warnings which are intended to solicit an emotional response along with a telephone hotline number for smoking cessation service go beyond this and essentially require the tobacco companies to place an anti-smoking billboard on their packages.
Judge Richard Leon of the District Court of the D.C. Circuit agreed with the plaintiffs, finding that the graphic warning labels are intended and designed not to convey factual information about smoking and health, but to discourage people from smoking.
Leon writes: "Unfortunately for the Government, the evidence here overwhelmingly suggests 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. Indeed, 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." That the images were unquestionably designed to evoke emotion - or, at the very least, that their efficacy was measured by their "salience," which the FDA defines in large part as a viewer's emotional reaction ... further undercuts the Government's argument that the images are purely factual and not controversial ... . Moreover, it is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start, smoking: an objective wholly apart from disseminating purely factual and uncontroversial information."
Judge Leon then analyzes the graphic warning label requirement under strict scrutiny and fails to find that the government has either demonstrated that it will advance a legitimate and significant government interest or that it is tailored as narrowly as possible to advance that interest.
Leon writes: "In short, the Government has neither carried its burden of demonstrating a compelling interest, nor demonstrated how the Rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech."
Because he finds that the tobacco companies are likely to prevail on the merits of their First Amendment challenge and because they are likely to suffer irreparable harm if the requirement is implemented, Judge Leon issued a preliminary injunction, barring implementation and enforcement of the requirement while the Court considers and decides the case.
The Rest of the Story
I predicted in an August post that Judge Leon would rule in favor of the plaintiffs on two major grounds. As I wrote:
"There are two problems with the required graphic warning labels that I believe renders them subject to potential violation of the First Amendment. First, as the tobacco companies argue, it is going to be difficult for the FDA to assert that requiring tobacco companies to put the smoking cessation hot line number on their packs is merely a health warning, rather than a smoking cessation message."
"Second, it is going to be difficult for the FDA to argue that the required warnings are the least restrictive interference with free speech that could accomplish the government's intended purpose in requiring that tobacco companies warn their consumers of the health hazards of smoking."
Each of these points played a central role in Judge Leon's ruling.
First, Leon found that the requirement for a smoking cessation hotline number on the cigarette pack made it abundantly clear that the purpose of the warning label requirement was not merely to provide factual information on health risks, but to advocate for smoking cessation.
As he writes: "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 - where these emotion-provoking images are coupled with text extolling consumers to call the phone number "1-800-QUIT" - the line seems quite clear."
Second, Leon found that the graphic warning labels are not even close to being narrowly tailored to advance the government's purpose: "it is quite clear that the Rule's graphic-image requirements in no way suggest the slightest attempt to narrowly tailor the display or presentation of the graphic images Congress mandated."
Also, as I noted in more recent commentaries, the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups actually undermined the government's case. While the FDA tried to achieve a lesser degree of scrutiny by arguing that the purpose of the graphic images was to more effectively communicate health information, the amicus brief makes it eminently clear that the real purpose of the labels is to create a tobacco industry-funded anti-smoking campaign on the cigarette packs.
Indeed, the fact that Judge Leon had difficulty discerning and articulating the government's primary interest in his opinion is a testament to the sneaky tactics of the FDA in trying to design a smoking cessation campaign under the guise of an information campaign. Had the FDA simply been honest and stated that its purpose was to save lives by deterring smoking, it would have at least been able to meet one of the prongs of the Central Hudson test. Sure, it would have had to give up on lesser scrutiny, but at least it could have tried to make a compelling case for why the government has a substantial interest in lowering smoking rates, something it failed to do in its arguments because it was unwilling to admit that the purpose of the warning labels was to deter smoking.
Predictably, the Campaign for Tobacco-Free Kids responded to the ruling by issuing a press release calling the decision "wrong on the science" and "wrong on the law" but failing to point out either how the ruling is wrong on the science or how it is wrong on the law. In fact, the press release fails to address any of the relevant legal issues involved in the case.
Professor Stanton Glantz responded to the ruling by issuing an email entitled "Bush appointed judge rules against FDA graphic warning labels." This implies that the decision was a purely political one and like the Campaign's response, fails to address any of the substantive issues of the case, or even to admit that it involves any substantive legal issues.
Despite the anti-smoking groups' apparent confidence that this ruling will be overturned on appeal, I do not share that confidence. I do think there is a valid First Amendment issue of whether the government can compel speech by a company which is not purely factual but which is instead primarily intended to discourage sales of that company's own products.
It would be one thing to require the Clorox company to place a warning on Clorox bleach that says: "Corrosive. Do not allow to touch your skin." It would be quite another, however, to require that 50% of a Clorox bottle contain a picture of a dead fish and urge consumers to call a hotline that promotes the use of natural products instead of household chemicals.