D.C. District Court Strikes Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages

By Ricardo Carvajal - 

Last November, we noted that FDA’s regulation requiring the display on cigarette packages of graphic warnings intended to dissuade would-be smokers appeared in jeopardy at the hands of U.S. District Judge Richard Leon in R.J. Reynolds et al v. FDA et al.  In an opinion hewing closely to his earlier analysis, Judge Leon has now granted plaintiffs’ motion for summary judgment and held that FDA’s regulation violates the First Amendment.  (In our discussion below, we refer to the graphic warnings as “graphic images,” in deference to the court’s conclusion that the characterization of the graphics as warnings “is inaccurate and unfair as they are more about shocking and repelling than warning.”)

Citing numerous statements made by FDA, the court concluded that the graphic images required by the regulation were not “purely factual and uncontroversial information” intended to prevent consumer confusion or deception.  Rather, the court found that the images “were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.”  The regulation was therefore subject to strict scrutiny, which required FDA to show that the regulation was “narrowly tailored to achieve a compelling government interest.”  

The court allowed that “an interest in informing or educating the public about the dangers of smoking might be compelling” (emphasis in original).  However, advocating a change in consumer behavior (i.e., “advocating that the public not purchase a legal product”) is not.  Further, the court held that the regulation was not narrowly tailored, citing “the sheer size and display requirements for the graphic images,” and the existence of “several alternatives that are easily less restrictive and burdensome for plaintiffs.”

Although the ruling is important from a legal perspective, it’s not clear what the public health impact of the ruling would be if it stands.  As noted by the court, FDA’s analysis of the benefits of the regulation estimated that it would have a negligible impact on smoking rates (an estimated reduction of .088% – “not statistically distinguishable from zero”).  Nevertheless, in a brief statement issued shortly after the decision, HHS signaled its intent to fight: “We are confident that efforts to stop these important warnings from going forward will ultimately fail.”