Big Tobacco Companies Drop Legal Challenge to FDA Over Product Labeling

This week, some of the country’s biggest tobacco companies dropped a federal lawsuit against the Food and Drug Administration (FDA), it its effort to assert authority over labels on tobacco products.

Tobacco subsidiaries of Altria Group Inc., Reynolds American Inc., and Lorillard Inc. said they were dropping the suit because the FDA has said it will announced last week that it will review a proposed policy to require tobacco companies to secure federal approval for tobacco products if they made packaging changes. Even such changes as a new background color, an altered logo, or the addition of such words as “premium tobacco” to a label would have subjected the product to the approval requirements, the Wall Street Journal reports.

The FDA said the policy will not be enforced until it decides whether to revise it or preserve it as is. The lawsuit was filed in April in U.S. District Court in Washington, DC, challenging the policy. The tobacco companies claimed the 2009 Tobacco Control Act, which gives 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 see fit, the WSJ reports. The companies argued the policy inflicts harm by “restricting [their] ability to modify their product labels without FDA preauthorization and by chilling and restricting” free speech. But the companies did not challenge the surgeon general’s warnings on cigarette labels; these are required by law to warn the public about the health risks of smoking.

The tobacco companies asked the FDA to use the “notice-and-comment rule making” process before issuing new rules. The FDA would accept and review comments from tobacco companies, health experts, and others, before making a new rule final, the WSJ reports.

Tobacco companies have been engaged in a decades-long battle with the FDA and other government agencies over the regulation of tobacco products. Recently, attention has focused on e-cigarettes, which many public health experts say should be regulated just as traditional tobacco products are. Last year, under the authority of the 2009 tobacco law, the FDA proposed new regulations for e-cigarettes but has not made these final. The regulations would prohibit the sale of e-cigarettes to minors and would require the devices to carry health warning labels. In May 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 said, “the process has already taken far too long.” The organizations claim that e-cigarette makers are using marketing tactics designed to appeal specifically to young people. The devices come in a variety of candy and fruit flavors with catchy names drawn from pop culture. The letter writers argue, “We cannot afford more delays that allow tobacco companies to target our kids with a new generation of tobacco products.” Though e-cigarettes are often promoted as an aid to smoking cessation, many health experts say they are instead a way to introduce a new generation to nicotine, which is highly addictive.



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