Judge Rules Tobacco Label Change Does Not Create New Product

If a tobacco company changes a label for a product, the Food and Drug Administration (FDA) cannot consider it a new product for regulatory purposes, a federal judge ruled this week.

U.S. District Judge Amit Mehta said changing the quantity of a product in packaging does make it a new tobacco product, and requires FDA approval, according to the Winton-Salem Journal.

The three biggest tobacco manufacturers, Altria, Lorillard and Reynolds-American, sued the FDA and the Department of Health and Human Services in 2015 over new packaging rules.

Mehta wrote that under the Tobacco Control Act of 2009, “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.”

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