Judge Rules Label Changes Don't Require FDA Pre-Clearance

WASHINGTON, D.C. — A federal judge has ruled tobacco companies do not have to get the OK from the Food and Drug Administration (FDA) to change their product's labeling.

On Aug. 16, U.S. District Judge Amit Mehta in Washington, D.C., vacated part of a FDA directive stating tobacco companies may need the agency's clearance to market products with significant labeling modifications, such as a change in color or logo.

In a split victory, however, Mehta said the agency may require clearance for marketing a tobacco product with a different quantity. This would apply to an increase in the number of cigarettes per pack, as Reuters reported.

Last year, Reynolds American Inc., Altria Group Inc. and ITG Brands LLC filed suit against the FDA over guidelines clarifying what changes to a tobacco product require regulatory approval under the 2009 Family Smoking Prevention and Tobacco Control Act. The guidance is not binding, but does indicate the agency's thinking about what constitutes a "new tobacco product" requiring companies to seek approval or face potential enforcement action, the news report explained.

Among other things, the FDA directive said significant modifications to a product's label that make it distinct from the original version, or changes to the quantity sold in each package, could require authorization.

The tobacco companies argued, in part, that the agency's interpretation was not what Congress intended in the Tobacco Control Act. The FDA, meanwhile, said its guidance was supported by federal law.

Ruling on motions put forth from both sides, Mehta said Congress could have explicitly stated a labeling modification triggered a regulatory approval requirement, but did not. "The court must presume that that omission was purposeful," he wrote.

Mehta did rule, though, that changing the quantity of tobacco product "necessarily entails a change in the amount of constituent ingredients and additives," and does represent a modification to the product.

Altria spokesman Brian May told Reuters the company is pleased with the decision on the labeling changes, calling it the "principle focus of our lawsuit." He said Altria is still considering whether to appeal the quantity-change decision.

Representatives for Reynolds and the FDA declined to comment, while ITG Brands did not immediately return a request for comment.

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