WASHINGTON -- A federal district court judge struck down a Food and Drug Administration (FDA) rule that would have considered a tobacco product new if it underwent a label change, thus subjecting it to a complicated FDA approval process.
However, Judge Amit Mehta of the U.S. District Court for the District of Columbia declared in the same ruling that changing the quantity of the product in packaging does qualify for status as a new tobacco product.
Following his decision, Mehta ordered the FDA to vacate its proposed guidance on label changes, according to the Winston-Salem Journal.
The action stems from a 2015 lawsuit filed on behalf of Altria Group, Richmond, Va.; Lorillard Tobacco Co., Greensboro, N.C.; and Reynolds American, Winston-Salem, N.C., against the FDA and the U.S. Department of Health and Human Services. Calling the rules too restrictive under the federal Tobacco Control Act of 2009 and the First Amendment, the manufacturers requested a permanent injunction to stop implementation of the packaging guidelines.
Mehta wrote in his ruling that under the act, “a modification to an existing product’s label does not result in a new tobacco product, and therefore such a label change does not give rise to the act’s substantial equivalence review process.”
When it comes to changing the volume of a tobacco product in new packaging, Mehta ruled that “does trigger the act’s substantial equivalence review process.” He said, “The court harbors no doubt that the FDA would have adopted the product-quantity interpretation set for in the guidance separate and apart from the labeling-change interpretation.”
Altria spokesperson Brian May told the Journal that the company was pleased with the court’s decision, saying the labeling question was a “principal focus” of its lawsuit.
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