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Tobacco Companies Drop Lawsuit against FDA Over Product Labeling

Jun 4, 2015

On Tuesday, the biggest U.S. tobacco companies dropped a legal challenge to the Food and Drug Administration (FDA)'s effort to assert authority over labels on tobacco products.

In a court filing, tobacco subsidiaries of Altria Group Inc., Reynolds American Inc., and Lorillard Inc. said they were dropping the suit because the FDA announced last week that it will review a policy that would have required companies to secure federal approval for tobacco products if they made packaging changes—even such changes as switching a background color, altering a logo or adding such words as "premium tobacco," the Wall Street Journal reports.

The FDA said it will not enforce the policy until it decides whether to revise or preserve it. The tobacco companies filed the lawsuit in April in U.S. District Court in Washington, DC, challenging the policy. The companies claimed the 2009 Tobacco Control Act, giving the FDA authority to regulate tobacco, restricted the FDA from pre-approving labels for Marlboro, Camel and Newport cigarettes. The manufacturers said they should be able to change the color or look of tobacco packaging as they chose. According to the WSJ, the companies argued that the policy harmed them by "restricting [their] ability to modify their product labels without FDA preauthorization and by chilling and restricting" free speech.

The lawsuit did not, however, challenge the surgeon general's warning labels, which are required by law and warn the public about the health risks of smoking.

The tobacco companies called on the FDA to undertake a "notice-and-comment rule making" process before issuing new rules. In evaluating the policy, the FDA will review comments from tobacco companies and others, a spokesman said.

Tobacco companies have long sparred with the FDA and other government agencies over the regulation of tobacco products. The newest front in this battle is e-cigarettes, which many public health experts say should be regulated in the same way traditional tobacco products are. The FDA has proposed, but not finalized, new regulations for e-cigarettes that would, among other things, prohibit their sale to minors and require health warning labels. The new rules have not yet gone into effect and last month 31 health and medical groups including the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Heart Association wrote to President Obama urging the federal government to finalize the "long-overdue" regulation. The letter writers say e-cigarette makers are using marketing tactics that seem designed to appeal directly to young people. The letter contends that "the process has already taken far too long . . .We cannot afford more delays that allow tobacco companies to target our kids with a new generation of tobacco products." Though some say e-cigarettes are an aid to smoking cessation and help save lives, others say they are a way to introduce a new generation to nicotine, which is highly addictive.

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