Tobacco Companies Announce They Won’t Sue FDA Over Product Labels

The three largest U.S. tobacco companies this week announced they will drop their lawsuit against the Food and Drug Administration (FDA), after the agency said it would reconsider rules about the companies’ product labels.

The lawsuit had claimed new guidelines issued by the agency infringed on their commercial speech. The new guidelines were designed to help manufacturers decide which new products require FDA review.

The lawsuit, brought by units of R.J. Reynolds Tobacco, Altria Group Inc. and Lorillard Tobacco, stated the FDA overstepped its authority over labeling and packaging for cigarettes and tobacco products.

In explaining the new guidelines, issued in March, the FDA said certain labeling changes effectively create a new product “if consumers are likely to perceive it as ‘new’ by virtue of the different label.” Examples of such changes include a product’s logo, packaging color or product description.

The tobacco companies said the agency was asserting too much authority over approving or denying labeling changes that would make a product “distinct.” In the lawsuit, the companies argued the FDA only has prior-review authority for tobacco product labels that claim to represent a “modified risk,” meaning they claim to be less harmful than other tobacco products.

In a statement issued last week, the FDA said it will not act against tobacco companies that do not seek pre-approval for label changes that create “distinct” products that are otherwise identical to those already on the market, or where the only change is the quantity in each package, according to Reuters.