Responding to a lawsuit filed by five of the nation's largest cigarette manufacturers, the U.S. Food and Drug Administration filed Friday to block any delay to new regulations requiring graphic warning labels on cigarette packages.
The tobacco companies are suing the agency in U.S. District Court for the District of Columbia, claiming that the new labels cross the line from factual warnings to unconstitutionally compelled speech. The companies want a preliminary injunction postponing the date the new rules go into effect.
In its opposition brief (PDF), the FDA is pushing back against the companies’ claim that they would suffer “economic harm” by spending several million dollars to produce the new labels in the meantime. The new regulations are set to go into effect in September 2012.
“Even taking plaintiffs’ untested allegations at face value, their alleged cost of preparing the revised warnings represents approximately one-tenth of one percent of their annual net sales, which is not sufficient to establish an entitlement to preliminary relief,” the agency argues in its brief.
The companies – R.J. Reynolds Tobacco Co., Lorillard Inc., Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company – accuse the agency of overstepping by requiring the new warning labels, which show graphic images depicting the risks associated with smoking, such as a picture of a diseased lung or a body lying on an autopsy table. The labels also include the phone number for a quitting hotline.
Lead counsel for the tobacco companies is First Amendment veteran Floyd Abrams of New York’s Cahill, Gordon & Reindel. Abrams could not immediately be reached. An FDA spokeswoman has said the agency does not comment on pending litigation.
The agency is arguing that the tobacco companies haven’t proven that they’re likely to succeed on the merits, since the government has flexibility to regulate commercial speech, especially in cases where there’s a public interest. Previous studies have shown that the written warning labels haven’t been as effective as the agency might like, the FDA argues in its brief, and there is new proof that the graphic labels are better at conveying the health risks associated with smoking.
In the brief, the agency also points to a ruling from the U.S. District Court for the Western District of Kentucky rejecting a similar constitutional claim made by several tobacco companies after Congress passed the Family Smoking Prevention and Tobacco Control Act. That case is now on appeal to the U.S. Court of Appeals for the Sixth Circuit.
A preliminary injunction hearing is set for Sept. 21 before U.S. District Judge Richard Leon.