• April 25, 2024

Tobacco firms challenge FDA’s authority over packs

The US’s biggest tobacco companies are suing the Food and Drug Administration over recent guidelines that they claim overstep the agency’s authority in respect of tobacco-products packaging, according to an associated press story.

Lorillard and units of Reynolds American and Altria filed the lawsuit on Tuesday in the US District Court for the District of Columbia, claiming the FDA’s guidance infringes on their commercial speech.

The FDA gained authority to regulate tobacco in 2009 with the passing of the Tobacco Control Act, which handed it the power to pre-review new tobacco products that were significantly different from products already on the market.

Last month, the agency issued guidelines intended to help manufacturers determine which new products require FDA review.

But the tobacco manufacturers allege that the FDA is asserting overly-broad authority to approve or deny any labeling change that would make a product ‘distinct’.

The company lawsuit argues that the FDA only has prior review of tobacco labels claiming a ‘modified risk’.

The FDA said in a statement that it did not comment on litigation.