Monday, November 7, 2011

Court Enjoins FDA Tobacco Labels

Judge Richard J. Leon (D.D.C.) today issued a preliminary injunction in R.J. Reynolds v. U.S. FDA prohibiting the FDA from enforcing its rules requiring new graphic labels on cigarette cartons.  In an opinion rife with disdain for the labels, frustration with the government's position, and a disjointed approach to strict scrutiny, the court concluded that the FDA requirements and the new labels violate the First Amendment Speech Clause. 

Ucm233072The court wrote that the labels are a form of compelled commercial speech that do not involve "purely factual and uncontroversial information" designed to protect consumers from "confusion or deception."  Thus the labels do not get the lower standard in Zauderer v. Office of Disciplinary Counsel.  Instead, the court wrote, the label requirement must meet strict scrutiny.

The court concluded that the government had trouble under both parts of the strict scrutiny analysis--the end and the means.  As to the end, it wrote that government's stated objective to inform consumers about the dangers of tobacco was undermined by evidence that the government evaluated the relative impact of different warning labels.  The court said that this suggests that the government's true objective was to change consumer behavior (and not merely to inform them).  But it didn't say whether this was a "compelling" interest; instead, it concluded that the label requirement wasn't narrowly tailored.

On narrow tailoring, the court wrote that sheer size of the labels--50% of the front and back of cigarette packs and the top 20% of printed advertising--renders them "anything but narrowly tailored":

Appropriating the top 50% of the front and back of all cigarette packages manufactured and distributed in the United States is hardly a directive narrowly designed to achieve the Government's purpose (whatever it might be).  To the contrary, the dimensions alone strongly suggest that the Rule was designed to achieve the very objective articulated by the Secretary of Health and Human Services: to "rebrand[] our cigarette packs," treating (as the FDA Commissioner announced last year) "every single pack of cigarettes in our country" as a "mini-billboard."  A "mini-billboard," indeed, for its obvious anti-smoking agenda!

Ucm233090Op. at 20 (emphasis in original).  But the court didn't explain why the sheer size of the labels alone renders them inappropriately tailored to meet an objective to inform consumers, or an objective to change behavior.  Indeed, by its own reasoning, it seems that the labels are well designed to do both--all too well.  After all, a mini-billboard on a cigarette pack seems an ideal way to promote an anti-smoking agenda to consumers of tobacco.  It seems that that's exactly what the Commissioner said, and what the court acknowledged--a mini-billboard for its anti-smoking agenda.  (There's nothing to prohibit government from taking an anti-smoking position, or, for that matter, a pro-smoking position.  This is a matter of policy.)

The court's analysis of the graphic images is moderately clearer.  Here it wrote that the graphic images aren't necessary to achieve the government's objective to inform consumers--that the FDA could achieve this objective in a different way, e.g.: "they could publish a graph demonstrating the difficulty of quitting smoking by showing the correlation between the number of people who try to quit and the percentage who actually do."  Op. at 21.  Maybe.  But that seems to depend on what the government's objective is--information, or changing behavior, or something else--and the court passed on that question, and on the related question whether the objective is "compelling."  The court itself acknowledged that the government conducted studies to determine which labels created the greatest impact on consumers.  If changing behavior is the government's goal, and if that goal is "compelling," then the court has to wrestle with whether these particular labels are narrowly tailored to achieve that end.  It didn't.

In the end, the court held that there's the plaintiffs demonstrated a likelihood of success on the merits (free speech) and that they demonstrated irreperable harm absent an injunction.  The court issued an injunction against enforcement of the label requirement for 15 months after a final ruling by the court--in order to give the plaintiffs enough lead time to impement the requirements should the final judgment go the other way.

We previously posted on the labels here.

SDS

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