Ball Now in FDA's Court Over Cigarette Warning Labels

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Ball Now in FDA's Court Over Cigarette Warning Labels


WASHINGTON, D.C. -- One day after a judge struck down the federally mandated new graphic cigarette labels, there is no word from the Food and Drug Administration (FDA) as to what its next step will be.

"As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation," Kara Henschel, a spokesperson for the agency, told CSNews Online.

The litigation in question is a lawsuit brought by Lorillard Inc., R.J. Reynolds Tobacco Co., Commonwealth Brands Inc. and Liggett Group LLC. The legal action, filed in the U.S. District Court for the District of Columbia in August, fought the FDA's nine href="">graphic warning labels mandated to appear on all cigarette packages and advertising effective Sept. 22.

Yesterday afternoon, U.S. District Judge Richard Leon ruled those labels -- a combination of graphic images and text -- are unconstitutional and violate the tobacco companies' First Amendment rights. His ruling was not a complete surprise, since it followed a temporary injunction he issued against the labels in early November, as CSNews Online previously reported.

"The outcome of the constitutionality question -- clearly favorable to the tobacco companies -- was not entirely unexpected, as Judge Leon was supportive of the industry in granting the preliminary injunction," said Bonnie Herzog, managing director of beverage, tobacco and consumer research at Wells Fargo Securities LLC. "Key to Judge Leon's recent opinion were that [one] the FDA did not "demonstrate a compelling interest" (that graphic warning labels would indeed reduce smoking incidence), nor [two] did the FDA demonstrate that the rule is "narrowly tailored" (minimally intrusive) and therefore, the rule was in violation of the companies' First Amendment rights."

The U.S. Court of Appeals for the District of Columbia was slated to hear the Obama administration's appeal of the temporary injunction on April 10. However, yesterday's ruling puts the next move into question. The FDA can either appeal the most recent decision or go back to the drawing board.

"This administration is determined to do everything we can to warn young people about the dangers of smoking, which remains the leading cause of preventable death in America," the U.S. Department of Health & Human Services said in a statement. "This public health initiative will be an effective tool in our efforts to stop teenagers from starting in the first place and taking up this deadly habit. We are confident that efforts to stop these important warnings from going forward will ultimately fail."

As of now, Leon's ruling is good news for tobacco companies.

"We believe governments, public health officials, tobacco manufacturers and others share a responsibility to provide tobacco consumers with accurate information about the various health risks associated with smoking," said Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds. "However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the U.S. Constitution."