On November 7, 2011, U.S. District Court Judge Richard Leon issued an order granting five tobacco manufacturers a preliminary injunction and a stay against the implementation of the FDA's new text and graphic image warnings for cigarette packages, cartons and advertisements. The five major tobacco manufacturers that brought the lawsuit against the FDA include R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company, Inc.
This past June, the FDA published a Final Rule requiring nine new text warnings, nine graphic images and a smoking cessation toll-free number to be printed on a rotating basis on the top 50 percent of the front and back of cigarette packages, the left 50 percent of the front and back of cigarette cartons, and the top 20 percent of all printed cigarette advertisements. The new text and graphic image warning labels were to take effect 15 months after the publication of the Final Rule, which would be September 22, 2012.
However, in his opinion, Judge Leon ruled that the manufacturers demonstrated a substantial likelihood that they will prevail on "the merits of their position that these mandatory graphic images unconstitutionally compel speech, and that they will suffer irreparable harm absent injunctive relief pending a judicial review of the constitutionality of the FDA's rule."
Judge Leon determined that the tobacco manufacturers would likely prevail in the lawsuit for several reasons. The main reason is that the First Amendment to the U.S. Constitution protects free speech, including commercial speech such as advertising. This constitutional protection extends to both the right to speak freely and the right to not speak at all. When the government mandates that a person or company make a statement that the individual or business would not otherwise make if they had a choice, this type of speech is known as "compelled speech" and is presumptively unconstitutional. In this case, the judge found that the new text and graphic warning images were designed to compel the manufacturers to "speak" to consumers so that they would quit or never start smoking, rather than to just simply provide factual health information.
Images Overly Broad
Besides the mandate of compelled speech, the judge determined that the size of the cigarette health warnings on packages, cartons and advertisements was overly broad and not narrow enough to achieve the government's purpose. Specifically, the judge held that the size of the health warnings alone strongly suggests that the government was seeking to rebrand cigarette packs as a "mini-billboard" for "its obvious anti-smoking agenda."
The judge also found that the manufacturers would suffer irreparable harm as a result of the FDA’s mandate for the graphic image warnings. This would occur because the companies would be required to spend approximately $20 million to redesign existing packaging and incur thousands of employee hours to comply with the new warning requirements. Most important, the judge noted that the U.S. Supreme Court has ruled that the loss of First Amendment free speech rights, even for a short period of time, constitutes irreparable harm.
On November 29, 2011, the FDA appealed Judge Richard Leon's ruling granting a temporary injunction against the FDA's graphic cigarette health warning images to the U.S. Circuit Court of Appeals. Generally, the appeals process for the U.S. Circuit Court of Appeals will involve the FDA and the tobacco manufacturers submitting appellate briefs arguing their respective sides of the case. Then, the U.S. Circuit Court of Appeals will schedule an oral argument for both sides to present their case in front of a panel of Circuit Court judges. This appeals process at the U.S. Circuit Court of Appeals level may take up to eighteen to twenty-four months.
This means that there will be a delay in the scheduled implementation date of September 22, 2012 for the FDA's graphic cigarette labels.