Judge halts graphic warnings on cigarette packages

An FDA regulation requiring tobacco companies to put the images and text on their products was supposed to take effect in September 2012.

By Alicia Gallegos — Posted Nov. 18, 2011

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A federal judge has temporarily blocked a new rule requiring graphic warning labels on cigarette packages. The decision was a victory for tobacco companies who say the warnings are unfair and would cost millions of dollars to produce.

The Food and Drug Administration in June said the nine text and graphic health warnings would be required in an effort to curb tobacco use and encourage users to quit smoking. The labels -- scheduled to appear on packages and cartons by September 2012 -- include images of a man smoking through a tracheotomy hole and a dead person with a surgery-scarred chest.

In his Nov. 7 opinion, Judge Richard J. Leon of the U.S. District Court for the District of Columbia said the tobacco companies showed they probably will prevail on their claim that the mandatory graphic images unconstitutionally force commercial speech (link).

"This case poses a constitutional challenge to a bold new tack by the Congress and the FDA, in their obvious and continuing efforts to minimize, if not eradicate, tobacco use in the United States," Leon said. "Notwithstanding the potential legal and financial ramifications of this challenge, the government, for reasons known only to itself, is unwilling to voluntarily stay the effective date of this rule until the judicial branch can appropriately review the constitutionality of the government's novel and costly approach to regulating tobacco packaging and advertising."

Tobacco industry applauds ruling

Tobacco companies, including plaintiff R.J. Reynolds Tobacco Co., were satisfied with the decision.

"We're pleased with the judge's ruling, and we look forward to the court's final resolution in this case," said Brian Hatchell, an R.J. Reynolds spokesman.

An FDA spokeswoman said the agency does not comment on ongoing litigation. The U.S. Justice Dept. is reviewing the ruling and has not made a determination on its next step, said department spokesman Charles Miller.

Oral arguments have not been scheduled, but Hatchell said the case probably will be heard in 2012.

The American Lung Assn. urged the Justice Dept. to appeal the ruling, calling the decision a blow to the FDA's authority to regulate tobacco products as required in the Family Smoking Prevention and Tobacco Control Act.

"This ruling presents a direct and immediate threat to public health," said Charles D. Conner, president and CEO of the association. "The tobacco industry's efforts to halt the replacement of cigarette warning labels that are 25 years old, ineffective and hidden on the side of packages will result in more lives lost to tobacco."

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