The FDA said in a statement Tuesday that it will go back to the drawing board and “undertake research to support a new rulemaking consistent with the Tobacco Control Act,” the 2009 law that requires the agency to find ways to reduce the estimated 440,000 annual deaths attributable to tobacco use.
Shortly after the FDA rolled out the new requirements in 2011, some of the country’s largest cigarette makers, including R.J. Reynolds Tobacco and Lorillard, sued the agency, arguing that the labels were too broad and violated the companies’ First Amendment rights. The Justice Department countered that the images merely contained factual information about the health risks of smoking.
Richard J. Leon, a federal district court judge, granted a temporary injunction in late 2011, and in February 2012 he ruled in favor of the tobacco companies, a group that did not include Richmond-based Altria, parent company of the nation’s largest cigarette maker, Philip Morris USA.
In a 19-page opinion, Leon ruled that the proposed requirements went too far because they were “neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks.” Rather, he wrote, they were intended to evoke emotional responses that would provoke people to quit smoking or never start.
“Although an interest in informing or educating the public about the dangers of smoking might be compelling,” Leon wrote, “an interest in simply advocating that the public not purchase a legal product is not.”
Last August, the U.S. Court of Appeals for the D.C. Circuit upheld the D.C. District Court’s decision, finding that the requirement indeed ran afoul of the First Amendment.
Facing a deadline to appeal to the Supreme Court, the Justice Department declined, Attorney General Eric H. Holder Jr. said in a letter to House Speaker John A. Boehner (R-Ohio) dated March 15. “In these circumstances, the Solicitor General has determined, after consultation with [the Department of Health and Human Services] and FDA, not to seek Supreme Court review of the First Amendment issues at the present time,” the letter said.
Warnings on cigarette packs and in advertising first appeared in the mid-1960s, and smoking rates fell steadily for decades. Since 2004, the numbers have largely stayed level at about 45 million U.S. adult smokers.
Dozens of countries already require graphic warning labels similar to those proposed by the FDA, and a survey by the World Health Organization found that they were more effective than text-only labels in deterring smoking.