This post was authored by O’Neill Institute research assistant and third-year Georgetown University Law Center student Mirona Dragnea.
Proposed New Warning Label by FDA
On November 7, 2011, District Judge Richard J. Leon of the D.C. District Court sided with five tobacco companies in granting a preliminary injunction in R.J. Reynolds v. U.S. FDA. The decision prohibits the United States Food and Drug Administration (“FDA”) from enforcing its rules requiring new graphic labels on cigarette packages.
The Family Smoking Prevention and Tobacco Control Act was signed into law by President Obama on June 22, 2009, and gives FDA the authority to regulate the manufacture and sale of tobacco products. As part of this Act, in June 2011, FDA published a final rule, which requires, among other things, that all cigarette packages manufactured and distributed in the United States after September 22, 2012 display cigarette warning labels. These warning labels are comprised of nine rotating textual warnings accompanied by graphic images, and must cover the top 50% of both the front and back panels of all cigarette packages. In their complaint, the tobacco companies alleged that the rule violates the First Amendment right to free speech by unconstitutionally compelling speech in the form of graphic images, and by hampering tobacco companies’ ability to convey their own messages on cigarette packages. In its opinion, the court analyzed the rule under the strict scrutiny standard and sided with the tobacco companies in concluding that the FDA requirements and the new labels are unconstitutional.
The court found that the First Amendment protects “both the right to speak freely and the right to refrain from speaking at all,” and 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,” as required by the strict scrutiny standard. The court concluded that the graphic images were meant to elicit an emotional response and change consumer behavior, rather than simply convey information on the harmful effects of smoking. Moreover, the court went so far as to determine that, due to the size of the images and the “emotional response they were crafted to induce,” the graphic warning labels are meant to turn every package of cigarettes into a “mini-billboard” for the FDA’s “obvious anti-smoking agenda,” thereby crossing the line into advocacy. The court then went on to say that the graphic images are not necessary to achieve the government’s objective to inform consumers, and that the FDA could instead “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.”
The court held that the tobacco companies had demonstrated a likelihood of success on the merits (free speech) and that they would suffer irreparable harm absent injunctive relief pending a judicial review of the constitutionality of the FDA’s rule. The court thus issued an injunction against enforcement of the label requirement for 15 months after a final ruling on the merits of the case by the court. The 15 months are designed to provide the tobacco companies with enough time to implement the requirements should the final judgment be in favor of the FDA’s new tobacco control law.
Tobacco control advocates reacted strongly against the ruling. Mathew L. Myers, president of the Campaign for Tobacco-Free Kids, released a statement declaring, “Judge Leon’s ruling ignores the overwhelming scientific evidence about the need for the new cigarette warnings and their effectiveness. It also ignores decades of First Amendment precedent that support the right of the government to require strong warning labels to protect the public health.” Myers concludes his statement by suggesting that “the Justice Department must now immediately appeal Judge Leon’s ruling, so that implementation of the warning label requirement can go forward without delay.”
The issue of cigarette warnings and their effectiveness in curbing tobacco consumption and informing consumers has also been addressed in two previous O’Neill blog posts:
In August, Sam Halabi discussed what it means to inform. Halabi suggested that “Congress intended to inform consumers about risks cigarette manufacturers are extensively trained to distort, shape and minimize. Information – in its broader and more meaningful sense – is the larger interest that should enjoy protection in U.S. courts.”
In July, Juan Carballo generally commented on the approved regulation. Carballo compared the U.S. regulation with others in the world and cited evidence that shows that these types of warning labels increase knowledge about the risks associated with smoking and can influence future decisions about smoking. Consequently, Carballo argued that warning labels are an effective way to curb the tobacco epidemic.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.