Makers of cigarettes and smokeless tobacco products sued the Food and Drug Administration over guidelines issued in March on obtaining pre-approval from FDA for changes to labels and quantities, Reuters reported.

FDA issued the guidelines to clarify what changes require regulatory approval under the 2009 Tobacco Control Act, according to Reuters. Reynolds American companies RJ Reynolds Tobacco, American Snuff and Altria Group subsidiaries Philip Morris USA and US Smokeless Tobacco are named in the complaint filed with US District Court in Washington D.C. Lorillard also is party to the suit, Reuters said.
Although the guidelines were framed as recommendations to obtain FDA approval before changing product labeling or, for example, the number of cigarettes in a pack, Reuters reported tobacco companies say the guidance creates legal obligations that could subject them to stiff penalties. FDA overstepped its legal authority in restricting the free speech of tobacco companies, the suit reportedly states.