FDA rules take on different hue

| August 18, 2016

Tobacco companies notched a partial victory in a lawsuit challenging the US Food and Drug Administration’s authority in requiring them to obtain clearance before selling tobacco products with changed pack designs or content-quantities, according to a story by Jessica Dye for Reuters.

US district judge Amit Mehta sitting in Washington, DC, on Tuesday, apparently vacated part of the FDA directive stating that tobacco companies might need the agency’s approval 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 in its pack.

The ruling came in a lawsuit filed last year by subsidiaries of Imperial Brands, Reynolds American and Altria.

The tobacco companies argued in part that the FDA’s interpretation was not what Congress intended in the Tobacco Control Act, but the FDA said that 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 the omission was purposeful,’ he wrote.

Category: Breaking News

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