Sunday, September 25, 2011

Amicus Brief Submitted by Anti-Smoking Groups Undermines Case for Graphic Cigarette Warning Labels

A consortium of anti-smoking and health groups - including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, American Medical Association, and the American Academy of Pediatrics - has submitted an amicus brief with the D.C. District Court to support the FDA's proposed graphic cigarette warning labels, which have been challenged by R.J. Reynolds, Lorillard, and several smaller tobacco companies.

The brief begins by making several strong points. First, it establishes that warning consumers about the health effects of smoking is a legitimate government interest. Second, it establishes that the current warning labels are insufficient for this purpose (there is abundant evidence to support this contention). Third, it provides evidence that the revised, graphic warning labels represent an improvement and that consumers are more likely to pay attention to them.

The Rest of the Story

At this point, however, the brief makes a surprising blunder. Rather than sticking to the argument that the revised warning labels will be more effective by virtue of more effectively delivering information about the adverse health effects of cigarette smoking, the brief essentially shows its hand of cards: it puts forward the argument that including the national quitline number on the cigarette pack will encourage individuals to quit smoking and help them quit by offering them assistance to do so about which they would not otherwise have known.

The brief argues: "Finally, there is also strong scientific evidence demonstrating the value of including the national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers about the availability of assistance if they want to quit. As the Institute of Medicine found, quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence, the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are significantly more successful at quitting than those who get little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that “clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence confirming that by providing a direct and immediate cue for action, quitlines significantly increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev. Med. Supp. S351-363 (2010)."

This argument goes beyond the need to improve the warning message to make it more effective. First, it speaks to a desire not only to warn people about the health effects of smoking, but to encourage then to quit (beyond any desire to quit that might be associated with knowledge of health effects). Second, it demonstrates that the purpose of the revised warning labels is not merely to communicate health information more effectively, but to serve as an anti-smoking advertisement that promotes smoking cessation. Third, the argument acknowledges that an additional purpose of the warning label, beyond informing consumers about the health effects of the product, is to make them aware of a particular smoking cessation quitline service: in essence, to refer them for telephonic smoking cessation counseling. The brief essentially admits that a major purpose of the new warning labels is to "ensure patient access to quitlines and promote quitline use." The warning label is intended to serve as a "direct and immediate cue for action."

These purposes go far beyond the legitimate government interest in effectively communicating to the public a warning about the health effects of cigarette smoking. In the exact words of the interveners, a major purpose of the revised warning labels is to provide an anti-smoking advertisement that will promote smoking cessation by referring potential customers to a smoking cessation hotline number that will provide telephonic counseling as a direct and immediate intervention to try to get the customer to quit smoking.

It is not difficult to see that forcing a tobacco company to put an advertisement on its cigarette package which goes so far as referring a potential customer for a telephonic counseling intervention as a direct intervention to get the customer to discontinue the use of that product goes far beyond the permissible actions of the government under the First Amendment, even as accepted in Commonwealth Brands, Inc. v. United States (678 F. Supp. 2d 512, 528-32 [2010]). The district court in that case merely upheld the legitimacy of the government's interest in improving warnings in order to "convey relevant information in an effective way" (678 F. Supp. 2d at 530-31). However, provision of a referral for telephonic counseling to encourage discontinuation of the use of the product seems far beyond the conveying of "relevant information" to improve the effectiveness of the health warning.

This seems to be a rather strange situation where an intervener's amicus brief actually appears to help the other side. In this case, the anti-smoking groups' brief aids the plaintiffs by helping to establish that the purpose of the revised warning labels goes far beyond the desire to simply improve the effectiveness of the conveying of relevant health information to the consumer. If anything, the brief helps establish that the true underlying motive behind the revised warning labels is to achieve a large-scale, telephonic counseling intervention on cigarette purchasers by using the cigarette pack as a billboard to advertise, promote cessation, and refer the smoker for a telephonic counseling intervention.

To be clear, I am not in any way criticizing the intervention itself or the desire of these anti-smoking groups to aim to reduce smoking prevalence by using the cigarette pack as a form of an anti-smoking advertisement with a direct referral to the smoking cessation hotline. In fact, I applaud them for suggesting such an intervention. The problem, however, is that the intervention is almost certainly not constitutional, as it appears to violate the tobacco companies' free speech rights by compelling them to use their own cigarette packages as a referral system to initiate a process with each customer that is designed to ultimately lead to discontinuation of product use.

That is going to be a tall order for the FDA to defend. And ironically, I think this amicus brief actually makes it more likely that the judge will grant the plaintiff's request for a preliminary injunction.

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