Tuesday, September 27, 2011

Hearing on Cigarette Warnings Reveals Key Issue: Are Proposed Labels Warnings or Advocacy Statements?

I have been writing for the past several weeks about what I see as a key issue in the lawsuit regarding the FDA's proposed cigarette warning labels: whether the proposed labels represent merely warnings about the health effects of smoking or whether they are really anti-smoking advertisements designed primarily to promote smoking cessation. According to an Associated Press article regarding last week's hearing before the District Court judge, this does appear to be a key issue in the case and Judge Richard Leon directly questioned the government attorney about this.

According to the article: "A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether the nine graphic images proposed by the FDA convey just the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. ... Lawyers for the tobacco companies argued that the government is free to tell people how to live — through steps such as enacting smoking bans on teenagers and by requiring written, factual warnings on the sides of cigarette packages from the surgeon general about the effects of smoking. But what the government cannot do is "conscript" the companies "into an anti-smoking brigade," noted First Amendment lawyer Floyd Abrams told the judge. The judge questioned Stern about why the images did not amount to advocacy. "What do you say is the line" between advocacy and fact? he asked Stern. "This is not an ordinary product" and the images coupled with written warnings are designed to communicate the dangers to the public — including youngsters as well as adults, Stern replied."

The Rest of the Story

You can see why I argued yesterday that the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups hurts the government's case. In the hearing, government lawyer Mark Stern was very careful to insist that the purpose of the graphic warning labels is to "communicate the dangers to the public." He apparently argued that the graphic nature of the warnings is necessary in order to effectively communicate the dangers, as evidence shows that the current warnings are not effectively doing so.

In contrast, the amicus brief argues that the purpose of the graphic warnings is to send an anti-smoking message, encouraging smokers to quit by referring them to a telephonic counseling service, which the groups assert has proven effective in promoting smoking cessation.

Now, the FDA is in the awkward position of having to counter the amicus brief and convince the judge that the reasons for the graphic warning labels set forward in the brief by the anti-smoking groups are not the real reasons that the FDA has proposed these warnings.

While it is true that tobacco is not an ordinary product and that the type of warning that might be sufficient for a typical consumer product may not be effective for cigarettes, this would still not seem to explain why the 1-800-QUIT-NOW message needs to be included on the label. To me, the inclusion of that requirement is the chief legal problem with the proposed labels, as it appears difficult to assert that the inclusion of the smoking cessation number is intended and necessary to effectively convey a health warning, rather than intended to promote smoking cessation and help smokers quit by referring them for telephonic counseling.

According to the AP, Judge Leon indicated that he hopes to issue a ruling by the end of October.

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