Court Blocks FDA Tobacco Warning Labels Appeal

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A federal appeals court on Wednesday rejected the government’s request for the full court to hear a case on the Food and Drug Administration’s graphic tobacco warning labels, setting up a potential Supreme Court showdown with Big Tobacco.

But first, the government has to decide whether it wants to defend the labels it developed or go back to the drawing board.

The Department of Justice has 90 days to appeal the case to the high court. A spokesman declined to comment on whether it would.

Calls from some anti-tobacco groups to do so came quickly.

Wednesday’s decision by the U.S. Court of Appeals for the District of Columbia Circuit “was wrong on the science and wrong on the law, and we urge the government to appeal this ruling to the U.S. Supreme Court,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

In August, a three-member panel of the U.S. District Court of Appeals for the District of Columbia ruled in favor of five tobacco companies, which argued the labels violate the First Amendment rights of corporations. The labels are supposed to take up half of each cigarette package.

That case directly challenged the nine labels FDA developed to implement the Family Smoking Prevention and Tobacco Control Act of 2009. They include graphic images meant to illustrate the consequences of smoking, including an autopsied cadaver and a man smoking through a tracheotomy, a hole in his neck.

The majority argued that the government showed no evidence that the labels would effectively reduce smoking — the science is a matter of debate — and that the government, therefore, could not force the industry to foot the bill for advertising an anti-tobacco message.

In March, the U.S. Court of Appeals for the 6th Circuit upheld the underlying provisions in the law before the labels were created. The tobacco industry has already appealed that ruling to the Supreme Court but asked it not to take action on it before the case was resolved in the D.C. court.

“Now, it’s up to the government to decide if these particular warning labels are actually defensible to the Supreme Court,” said Mary Rouvelas, senior counsel for the American Cancer Society Cancer Action Network, who supports the labels.

Other countries have introduced similar labels. Anti-smoking advocates expect to see mounting evidence that the labels are effective, but the FDA produced limited data to suggest that its labels would work.

One option the FDA could consider, Rouvelas said, would be to adopt labels that are basically the same as labels in other countries. Then the agency could use evidence of their effectiveness to make its case.

“It’s pretty clear that the [D.C. court] had a problem with the scientific studies,” Rouvelas said, adding that First Amendment cases often rise or fall with scientific data that shows any infringement on free speech is narrowly tailored to accomplish a legitimate government goal.

In any event, the labels will not go on cigarette packs anytime soon.

If the government appeals the case and Supreme Court agrees to hear it, the case most likely will be argued next fall and decided spring or winter 2014. Under the law, the labels were supposed to go on packages in October.

The graphic warnings aren’t the only labeling issues the industry is grappling with.

Last month, U.S. District Court Judge Gladys Kessler ruled that tobacco companies will have to publish “corrective statements” about the health effects of cigarettes in package inserts, on corporate websites and in national print and broadcast advertisements — to make amends for decades of misleading the public.

The statements include that tobacco kills an average 1,200 people a day. The industry has not yet said whether it will appeal the ruling.

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