Wednesday, April 15, 2015

Tobacco companies sue FDA over label approvals

An ash tray with cigarette butts is pictured in Hinzenbach By Jessica Dye NEW YORK (Reuters) - A group of tobacco companies sued the U.S. Food and Drug Administration on Tuesday over recent guidance they say violates their free-speech rights by mandating pre-approval of labeling changes. Plaintiffs including R.J. Reynolds Co, Lorillard Tobacco Co and Altria Group Inc's Philip Morris USA Inc filed the lawsuit in the U.S. District Court for the District of Columbia to try to block the directive, which was issued in March. If the guidance is left intact, the companies say, they could be exposed to substantial financial and legal penalties if they make changes to how they package or market already-approved tobacco products without the FDA's permission. The FDA issued the guidelines to help clarify what changes require regulatory approval under the 2009 Tobacco Control Act.








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