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FDA Seeks Reconsideration of U.S. Cigarette Label Ruling

The U.S. Food and Drug Administration asked for a full-court review of a decision by a three-judge appeals panel that threw out rules forcing cigarette packaging and advertising to display images such as diseased lungs.

The agency in a filing today in the U.S Court of Appeals in Washington said the court’s 2-1 ruling finding the regulations violated the free speech rights of tobacco companies under the First Amendment of the U.S. Constitution was wrong and conflicts with a ruling by a federal appeals court in Cincinnati.

The majority on the three-judge panel said in August that the government failed to present any data showing the warnings would cut smoking rates.

“The First Amendment does not require statistical proof of the extent to which the decline in smoking rates resulted ‘directly’ from the new health warnings,” the FDA said in today’s filing.

The eight active judges on the Washington-based appeals court heard only one so-called en banc case last term, according to the court’s docket.

R.J. Reynolds, a unit of Reynolds American Inc. (RAI), Lorillard Tobacco Co., Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Co. sued the FDA last year, claiming the mandates for cigarette packages, cartons and ads, passed as part of the Family Smoking Prevention and Control Act, violated the First Amendment because the government was using “threats and fear” to motivate people to stop using a lawful product.

‘Browbeat Consumers’

The Washington court on Aug. 24 ruled that FDA regulations mandating visual-image warnings of smoking’s health risks, along with the phone number 1-800-QUIT-NOW, are “unabashed attempts to evoke emotion” and “browbeat consumers” to stop buying the companies’ products.

David Howard, a spokesman for Winston Salem, North Carolina-based Reynolds American, declined to comment on the filing.

The case is R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, 11-5332, U.S. Court of Appeals for the District of Columbia (Washington).

To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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