FDA Ends Legal Battle Over Cigarette Warning Labels

The FDA will go back to the drawing board and amend its requirements for cigarette warning labels, abandoning its legal battle to require cigarette packs to carry one of a set of nine large, graphic warning labels depicting the dangers and harms of smoking to encourage smokers to quit.

A number of the largest tobacco companies in the U.S. filed suit to block the mandate to include warnings on cigarette packs as part of  the 2009 Family Smoking Prevention and Tobacco Control Act (the Act), which, for the first time, gave the federal government authority to regulate tobacco. The Act also specified the text of the nine warnings and directed the FDA to adopt graphic images to accompany them.  The FDA’s nine warning labels would have been one of the biggest changes to the appearance of cigarette packs in 25 years. The graphic images proposed by the FDA included a man exhaling cigarette smoke through a tracheotomy hole in his throat, and a plume  of cigarette smoke enveloping an infant receiving a mother’s kiss. The  warnings were to cover the entire upper half of cigarette packs, front and back,  and include the phone number for a stop-smoking hotline.

The government had until early last week to ask the Supreme Court to review an appellate decision from the D.C. Circuit upholding a ruling that the graphic label warnings violated First Amendment free speech protections. The prior district court ruling held that the proposed FDA requirements went too far and were not designed to protect consumers from confusion or deception. More importantly, the judge noted that the labels would not increase consumer awareness of risks associated with smoking, because the labels were intended to evoke an emotional response.

In a letter dated March 15, 2013 to the Speaker of the House, Attorney General Eric Holder wrote that the Department of Justice would not be filing a petition for writ of certiorari on the matter. Instead, the FDA will look to propose new labels that would not run afoul of First Amendment claims.

Tobacco companies had complained of the labels as impeding one of the few remaining advertising avenues, namely the pack itself, after government curbs were placed on advertisement presence in magazines, billboards and television. The companies argued that the labels went beyond factual recitation into anti-smoking advocacy. The government had countered that the images were part of the conveyance of the dangers of tobacco, responsible for over 400,000 deaths a year in the U.S.