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FDA Sued By Cigarette Companies Over Labeling Regulations

August 17, 2011

Four of the largest cigarette makers have filed suit against the Food and Drug Administration (FDA), seeking to void as unconstitutional the recent graphic labels and advertising requirement warning consumers about the risks of smoking in hopes of inducing them to quit, Reuters is reporting.

The lawsuit by Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC and Commonwealth Brands Inc, owned by Britain’s Imperial Tobacco Group Plc, said the warnings required no later than September 22, 2012 would force cigarette makers to “engage in anti-smoking advocacy” on the government’s behalf.

Under recently announced FDA regulations, cigarette packs, cartons and all cigarette advertising must display graphic warnings by September 22, 2012, AFP reports. “The regulations violate the First Amendment,” said Floyd Abrams, a partner at Cahill Gordon & Reindel, the law firm representing Lorillard.

Dead bodies, diseased lungs and rotting teeth are among the images expected to appear, in the first change to US cigarette warnings in 25 years.

“Certain provisions of the final rule raise constitutional concerns,” Altria Group Inc, spokesman Bill Phelps said. “We continue to work constructively with the FDA, and reserve our rights and options to protect the company.”

Altria brands include Marlboro, which is not part of the case, had previously supported the 2009 law.

A smaller cigarette maker, Santa Fe Natural Tobacco, is also a plaintiff in the lawsuit, which also seeks to delay enforcement of other parts of the FDA regulations.

Kathleen Sebelius, Secretary of the Department of Health & Human Services, in June said the new warnings would ensure that “every person who picks up a pack of cigarettes is going to know exactly what risks they are taking.”

She said the goal was to stop children from starting to smoke, and to give adult smokers a new incentive to quit.

The lawsuit claims the images were manipulated to be especially emotional. The tobacco companies said the corpse photo is actually an actor with a fake scar, and the healthy lungs were sanitized to make the diseased organ look worse.

The companies also said the new labels will cost them millions of dollars for new equipment so they can frequently change from warning to warning and designers to make sure the labels meet federal requirements while maintaining some distinction among brands.

The FDA, which routinely declines discussing pending litigation, could not be reached for comment.

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