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    Tobacco's Big Three Drop Packaging Lawsuit Against FDA

    Agency releases interim policy for labeling rules.

    SILVER SPRING, Md. — Six weeks after taking legal action, tobacco companies have called an end to their lawsuit seeking a permanent injunction against the Food and Drug Administration (FDA) to prevent implementation of new packaging guidance.

    According to the Winston-Salem Journal, the FDA issued an interim enforcement policy May 29 on new tobacco products, which appears to be a response to the manufacturers' lawsuit filed April 14.

    Altria Group Inc., Lorillard Inc. and Reynolds American Inc. (RAI), along with several of their subsidiaries, sued over rules for packaging labels they consider too restrictive, the news outlet reported.

    "Our perspective is in light of FDA's interim enforcement policy announced last week. There is no need to move forward with the lawsuit at this time," Altria spokesman Brian May said. 

    RAI declined comment to the newspaper and Lorillard could not be reached for comment. The lawsuit was dismissed without prejudice, meaning it can be refiled.

    According to the news report, the FDA wanted to broaden its power of prior restraint on the companies' marketing communications, notably requiring FDA approval for changes to labeling of tobacco products and the quantities of products within a package. This includes being able to declare any tobacco product whose label is modified as a new "distinct" product even if the product's ingredients and characteristics are not changed. 

    However, the interim policy issued by the agency now puts a halt to that initiative until at least 30 days after the FDA issues a revised guidance or announces its intention to not issue one.

    The agency said the policy covers new tobacco products in which the only modification is a label change that creates a distinct product with identical characteristics to the predicate product, or new tobacco products in which the only modification is a change in product quantity, the Winston-Salem Journal reported.

    "FDA does not intend to issue any warning letters or take steps to initiate any judicial or administrative adversarial proceedings for these tobacco products that are marketed without required pre-market authorization," the agency said. "FDA does not intend to issue any 'not substantially equivalent' orders or preliminary finding letters for reasons of failing to provide sufficient information."

    The policy covers products introduced from Feb. 16, 2007 through the end of the interim period.

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