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 U.S. District Judge Amit Mehta in Washington, D.C., on Tuesday
vacated part of an 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.
However, Mehta said that the agency could require clearance for
marketing a tobacco product with a different quantity – for
instance, an increase in the number of cigarettes per pack.
The ruling comes in a lawsuit filed last year by subsidiaries of
Imperial Brands, Reynolds American Inc and Altria Group over FDA
guidelines clarifying what changes to a tobacco product require
regulatory approval under the 2009 Tobacco Control Act, which gave
the FDA authority to regulate tobacco products.
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.
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.
Tobacco companies argued in part that the FDA's interpretation was
not what Congress intended in the Tobacco Control Act. The FDA said
its guidance was supported by federal law.
Ruling on motions from both sides, Mehta said Congress could have
explicitly stated that a labeling modification triggered a
regulatory approval requirement, but did not. "The court must
presume that that omission was purposeful," he wrote.
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On the other hand, 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, the judge wrote.
Altria spokesman Brian May said the company was pleased with the
decision on labeling changes, calling it the "principle focus of our
lawsuit." He said the company was still considering whether to
appeal the quantity-change decision.
A representative for Imperial's U.S. subsidiary ITG Brands said the
company agreed with the court's analysis on the labeling issue.
Representatives for Reynolds and the FDA declined to comment.
The case is Philip Morris USA v. U.S. FDA, U.S. District Court for
the District of Columbia, No. 15-1590.
(Reporting by Jessica Dye; Editing by Anthony Lin and Alan Crosby)
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