Tobacco Companies’ Lawsuit Claims FDA Guidelines Infringe on Commercial Speech

The three largest tobacco companies are suing the Food and Drug Administration (FDA), claiming new guidelines issued by the agency infringe on their commercial speech. The new guidelines are 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, states the FDA is overstepping its authority over labeling and packaging for cigarettes and tobacco products, the Associated Press reports.

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 say the agency is asserting too much authority over approving or denying labeling changes that would make a product “distinct.” In the lawsuit, the companies argue 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.