Tobacco company lawsuit alleges FDA overstepping authority

The nation’s largest tobacco companies are suing the Food and Drug Administration over recent guidelines that they claim overstep the agency’s authority over labeling and packaging for cigarettes and other tobacco products.

Units of R.J. Reynolds Tobacco, Altria Group Inc. and Lorillard Tobacco filed the lawsuit Tuesday in the U.S. 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, including the power to pre-review new tobacco products that are significantly different from older ones already on the market.

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

But the tobacco makers allege that the FDA is asserting overly broad authority to approve or deny any labeling change that would make a product “distinct.” Their lawsuit argues that the FDA has only prior-review authority for labels on tobacco products claiming to represent a “modified risk,” or to be less harmful than other tobacco products.

FDA guidelines are considered suggestions and are not legally binding. But the tobacco companies say the FDA document “creates specific legal obligations with clear and draconian consequences for violations.”

The FDA said it does not comment on litigation.

This story was originally published April 14, 2015 at 11:42 PM with the headline "Tobacco company lawsuit alleges FDA overstepping authority."