WINSTON-SALEM, N.C. – This week, a federal judge said that the U.S. Food and Drug Administration (FDA) could not look at a label revision for a tobacco product as a new product, the Winston-Salem Journal reports. Judge Amit Mehta ordered the agency to eliminate its proposed label changes guidance. The judge also said that if a product changes the quantity in the package, that would make it a new tobacco product and thus require FDA approval.

The Altria Group Inc., Lorillard Inc. and Reynolds American Inc. filed suit against the FDA and the U.S. Department of Health and Human Services just over two years ago, claiming the new rules restricted their First Amendment rights. Mehta’s ruling stated 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.”

However, the judge found that changing the quantity or size of a tobacco product did make it fall under the FDA’s stringent review process: “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.”

According to Altria spokesman Brian May, the company “is pleased the court struck down FDA’s requirement that manufacturers obtain pre-approval from the agency before modifying product labels, which was the principal focus on our lawsuit. … Specifically, the court ruled that changing labels does not change the tobacco product itself, and therefore cannot be part of FDA's process for approving new tobacco products.”