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    Tobacco Cos. Revive Packaging Lawsuit Against FDA

    Move is in response to the agency's new guidelines.

    SILVER SPRING, Md. — The big three tobacco companies are once again challenging the Food and Drug Administration's (FDA) efforts to regulate tobacco product packaging.

    In April, Altria Group Inc., Lorillard Inc. and Reynolds American Inc. (RAI), along with subsidiaries, sued over rules for packaging labels they consider too restrictive. 

    Six weeks later, the FDA issued an interim enforcement policy on new tobacco products, signaling its willingness to consider regulatory comments and delay enforcing the initial guidelines. As a result, the tobacco companies called an end to their lawsuit seeking a permanent injunction against the agency to prevent implementation of new packaging guidance.

    The FDA, however, issued new guidelines on Sept. 8, and the tobacco companies say in the revived lawsuit that the new guidelines impose similar restrictions, according to the Winston-Salem Journal.

    In the revival of the lawsuit, ITG Brands LLC has taken the place of Lorillard, which was acquired by RAI this summer.

    The FDA has wanted to broaden its power of prior restraint on the companies' marketing communications, foremost by saying that its approval is required for changes to labeling of tobacco products and the quantities of products within a package. That 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, the news outlet reported.

    According to the lawsuit, "over the past four years, FDA has suggested varying interpretations of the act that would improperly broaden the agency's regulatory authority over tobacco product labels and product quantities."

    "Each time, when challenged, FDA devised a new rationale for the same predetermined conclusion that the changes create a new tobacco product subject to premarket review under the act — a results-oriented approach that is antithetical to proper agency decision-making and inconsistent with the plain language of the act," the news outlet reported, citing the lawsuit.

    The FDA did not comment Wednesday on the revival of the lawsuit, citing a policy of not commenting on pending litigation.

    "Reynolds American's operating companies are in compliance with the act, and believe that FDA does not have the authority to impose the restrictions outlined in the guidance," David Howard, an RAI spokesman, told the Winston-Salem Journal.

    "The act's substantial equivalence provisions regulate the introduction of new tobacco products into the market. These provisions address the characteristics of the product itself, not how the product is described. Congress provided different mechanisms for changes to how the product is described in its packaging and labeling," he said. 

    "FDA is trying to do an end run around these other mechanisms by using the substantial equivalence pathway to regulate packaging and labeling," Howard added.

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