US
Tobacco companies won a small victory this August against the Food and Drug Administration (FDA) in a lawsuit challenging FDA’s authority to require pre-clearance for tobacco products with changed labels or quantities.
Part of FDA’s 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 was vacated by US District Judge Amit Mehta in Washington, DC. However, Mehta said that FDA could require clearance for marketing a tobacco product with a different quantity, such as an increase in the number of cigarettes per pack.
Judge Mehta’s ruling came 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 FDA authority to regulate tobacco products. While not binding, the guidance does indicate what FDA considers to be a “new tobacco product” that require companies to seek approval or face potential enforcement action.
The guidelines in the FDA directive included saying 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.
In the lawsuit, tobacco companies argued that FDA’s interpretation was not what Congress intended in the Tobacco Control Act, while FDA said its guidance was supported by federal law.
Mehta ruled that 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. On the other hand, he also wrote that changing the quantity of tobacco products “necessarily entails a change in the amount of constituent ingredients and additives,” and does represent a modification to the product.
Altria’s Brian May said the company was pleased with the decision on labeling changes, calling it the “principle focus of our lawsuit”, and that the company was still considering whether to appeal the quantity-change decision.
Imperial’s US subsidiary, ITG Brands, said the company agreed with the court’s analysis on the labeling issue. Representatives for Reynolds and FDA declined to comment.