U.S. Tobacco Companies File Suit Against FDA Over Label Regulations

By Tripp Mickle 

The biggest U.S. tobacco companies filed a lawsuit against the U.S. Food and Drug Administration Tuesday, challenging its effort to assert authority over labels on tobacco products.

The suit follows a document the FDA issued in March that tobacco subsidiaries of Altria Group Inc., Reynolds-American Inc. and Lorillard Inc. argue violates the Tobacco Control Act by requiring them to submit labels for approval.

The makers of Marlboro, Camel and Newport cigarettes argue the Tobacco Control Act, which gave the FDA authority to regulate tobacco, limited the agency's authority over labels to tobacco products that make a "modified risk" claim. Otherwise, they should be able to change the color or look of their packaging as they wish.

"We disagree that FDA's new requirements that manufacturers must obtain agency authorization before changing certain product labels when the actual physical tobacco product remains exactly the same," said Brian May, an Altria spokesman. "We're asking the court to resolve these issues so that we and other manufacturers know how to proceed."

The FDA said it doesn't comment on litigation.

Write to Tripp Mickle at [e-mail]

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