Philip Morris USA and three units of Reynolds American sued the U.S. Food and Drug Administration, claiming the agency lacks authority to regulate labeling on new tobacco products.
An FDA rule issued 4 March requiring pre-approval of label changes involving new tobacco products violates laws limiting that power to a few narrow circumstances, according to a complaint filed Tuesday in federal court in Washington.
The FDA directive, while presented as “guidance,” sets forth “final agency conclusions and creates specific, binding legal obligations that plaintiffs must either follow or face severe consequences,” the companies said, claiming the rule violates their free speech and due process rights.
Two other companies, US Smokeless Tobacco and Lorillard Tobacco, joined the case.
“The FDA does not comment on possible, pending or ongoing litigation,” Michael Felberbaum, an agency spokesman, said in an e-mail.
According to the complaint, the guidance obligates “manufacturers to obtain FDA preauthorization before making any change to a label that would render a tobacco product ‘distinct’ -- as defined under FDA’s vague standards -- from the predecessor version of the product, even though there is no change to the tobacco product itself.”
Bloomberg News, edited by ESM
