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The FDA’s New and Improved Cigarette Warning Labels

Posted in FDA, Tobacco with tags , , , , , on November 8, 2011 by saynsumthn

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UPDATE 2-U.S. judge blocks graphic cigarette warnings
Mon Nov 7, 2011 2:51pm EST

* Judge sides with tobacco companies in free speech fight
* Finds them likely to prevail against FDA
* Companies argue new graphic labels unconstitutional

By Alina Selyukh and Jeremy Pelofsky

WASHINGTON, Nov 7 (Reuters) – A federal judge blocked a U.S. rule requiring tobacco companies to display graphic images on cigarette packs, such as a man exhaling cigarette smoke through a hole in his throat.

U.S. District Judge Richard Leon sided on Monday with tobacco companies and granted a temporary injunction, saying they would likely prevail in their lawsuit challenging the requirement as unconstitutional because it compels speech in violation of the First Amendment.

The Food and Drug Administration in June released nine new warnings to go into effect in September of 2012, the first change in U.S. cigarette warning labels in 25 years. Cigarette packs already carry text warnings from the U.S. Surgeon General.

The new warnings must cover the top half of the front and back of cigarette packs and 20 percent of printed advertisements and must contain color graphics depicting the health consequences of smoking, including diseased lungs, dead bodies and rotting teeth.

Congress instructed FDA to impose the new labels as part of 2009 legislation making the agency responsible for regulating tobacco products.

“The sheer size and display requirements for the graphic images are anything but narrowly tailored,” Leon wrote in a 29-page opinion.

Just because Congress ordered the size and placement of the new warnings before charging the FDA with carrying out the mandate, “doing so does not enable this requirement to somehow automatically pass constitutional muster,” he said.

The content of the images would also not likely survive constitutional muster because the FDA did not attempt to narrowly tailor those either, the judge said.

The tobacco lawsuit is the latest effort by corporations to assert a right to free speech, a high-profile legal battle that could end up before the U.S. Supreme Court.

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 , sued the FDA in August.
They argued the new graphic warnings force them to “engage in anti-smoking advocacy” on the government’s behalf, breaching their right to free speech.

The Obama administration’s options include appealing Leon’s ruling or the FDA could try to rewrite the rules.

FDA spokeswoman Stephanie Yao said the agency did not comment on proposed, pending or ongoing litigation. Justice Department spokesman Charles Miller said the department was aware of the decision and was reviewing it.

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