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North American Quitline Consortium
Implementation of Graphic Health Warnings for Cigarettes Halted in the U.S.! 

Dear Colleagues:
We are disappointed to learn that the U.S. Department of Justice will not ask the Supreme Court to review the ruling on the constitutionality of the Food and Drug Administration’s proposed graphic health warnings. For now, implementation of the FDA’s stellar rule to make smokers, especially young smokers, more aware of the dangers of smoking through graphic health warning has been halted. However, there are two positive notes in the government’s announcement – first, it is noteworthy that the Department of Justice vigorously defended the constitutionality of the graphic warnings in lawsuits filed by the tobacco industry; and second, the FDA has made a commitment to “go back to the drawing board to develop the warnings as required by legislation passed by Congress in 2009.”
NAQC will support the FDA in its efforts to develop new warning labels and encourages its members and partners to do the same. The use of graphic health warnings in countries throughout the world has been an effective strategy for communicating the dangers of tobacco use to smokers. We hope that FDA will make every effort to expedite this work, thereby making more effective health warnings available to smokers in the U.S.
For more information, please read:
Reuters article
AP News article 
CTFK statement 
Blog posted by Dr. Howard Koh, Assistant Secretary of Health, USDHHS


Linda A. Bailey, JD, MHS
President and CEO
North American Quitline Consortium

By David Ingram Reuters
7:39 p.m. CDT, March 19, 2013

WASHINGTON (Reuters) - The government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.

In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.

Half the space on the front and back of each cigarette pack must be taken up by anti-smoking warnings and a large share of other printed ads should have similar discouraging messages, according to the legislation.

Cigarette manufacturers, however, sued to prevent the ads from appearing on the packaging for their products, saying such a move would curtail free speech rights. In August, a federal court struck down the requirement as unconstitutional.

The Justice Department was facing a deadline on whether to ask the Supreme Court to review that ruling.

"The Department of Justice in this case has vigorously defended the constitutionality of the graphic warnings," Holder wrote in the letter notifying Boehner, who is a smoker. Holder said the deadline for an appeal prompted the new approach.

Many other nations have for years used graphic images to try to deter smokers.

The FDA has argued that the images of rotting teeth and diseased lungs are accurate and necessary to warn consumers - especially teenagers - about the risks of smoking.

On Tuesday, the FDA used a blog posting to say the agency "will undertake research to support a new rulemaking consistent with the (2009) Tobacco Control Act."

(Additional reporting by Toni Clarke; Editing by Paul Simao)

APNewsBreak: US won't appeal ruling blocking graphic cigarette warnings, FDA to revise labels
AP Tobacco Writer
19 March 2013
(c) 2013. The Associated Press. All Rights Reserved.

RICHMOND, Va. (AP) - The U.S. government is abandoning a legal battle to require that cigarette packs carry a set of large and often macabre warning labels depicting the dangers of smoking and encouraging smokers to quit.

Instead, the Food and Drug Administration will go back to the drawing board and create labels to replace those that included images of diseased lungs and the sewn-up corpse of a smoker, according to a letter from Attorney General Eric Holder obtained by The Associated Press. The government had until Monday to ask the U.S. Supreme Court to review an appeals court decision upholding a ruling that the requirement violated First Amendment free speech protections.

"In light of these circumstances, the Solicitor General has determined ... not to seek Supreme Court review of the First Amendment issues at the present time," Holder wrote in a Friday letter to House Speaker John Boehner notifying him of the decision.

Some of the nation's largest tobacco companies, including R.J. Reynolds Tobacco Co., sued to block the mandate to include warnings on cigarette packs as part of the 2009 Family Smoking Prevention and Tobacco Control Act that, for the first time, gave the federal government authority to regulate tobacco. The nine labels originally set to appear on store shelves last year would've represented the biggest change in cigarette packs in the U.S. in 25 years.

Tobacco companies increasingly rely on their packaging to build brand loyalty and grab consumers -- one of the few advertising levers left to them after the government curbed their presence in magazines, billboards and TV. They had argued that the proposed warnings went beyond factual information into anti-smoking advocacy.

The government, however, argued the images were factual in conveying the dangers of tobacco, which is responsible for about 443,000 deaths in the U.S. a year.

The nine graphic warnings proposed by the FDA included color images of a man exhaling cigarette smoke through a tracheotomy hole in his throat, and a plume of cigarette smoke enveloping an infant receiving a mother's kiss. These were accompanied by assertions that smoking causes cancer and can harm fetuses. The warnings were to cover the entire top half of cigarette packs, front and back, and include the phone number for a stop-smoking hotline, 1-800-QUIT-

In a statement on Tuesday, the FDA said it would "undertake research to support a new rulemaking consistent with the Tobacco Control Act." The FDA did not provide a timeline for the revised labels.

"Although we pushed forcefully ... (the) ruling against the warning labels won't deter the FDA from seeking an effective and sound way to implement the law," Dr. Howard Koh, assistant secretary of the Department of Health and Human Services, wrote in an blog post Tuesday afternoon.

Floyd Abrams, a noted First Amendment lawyer who represented Lorillard Tobacco Co. in the challenge said he wasn't surprised by the Justice Department's decision not to appeal.

"The graphic warnings imposed by the FDA were constitutionally indefensible," he wrote in an email.

Warning labels first appeared on U.S. cigarette packs in 1965, and current warning labels that feature a small box with text were put on cigarette packs in the mid-1980s.

The share of Americans who smoke has fallen dramatically since 1970, from nearly 40 percent to about 19 percent. But the rate has stalled since about 2004, with about 45 million adults in the U.S. smoking cigarettes. It's unclear why it hasn't budged, but some market watchers have cited tobacco company discount coupons on cigarettes and lack of funding for programs to discourage smoking or to help smokers quit.

In recent years, more than 40 countries or jurisdictions have introduced labels similar to those created by the FDA. The World Health Organization said in a survey done in countries with graphic labels that a majority of smokers noticed the warnings and more than 25 percent said the warnings led them to consider quitting.

Joining North Carolina-based R.J. Reynolds, owned by Reynolds American Inc., and Lorillard Tobacco, owned by Lorillard Inc., in the lawsuit were Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc.

Richmond, Va.-based Altria Group Inc., parent company of the nation's largest cigarette maker, Philip Morris USA, which makes the top-selling Marlboro brand, was not a part of the lawsuit.

The case is separate from a lawsuit by several of the same tobacco companies over other marketing restrictions in the 2009 law. Last March, a federal appeals court in Cincinnati ruled that the law was constitutional. The companies in October petitioned the U.S. Supreme Court to review that case.
FOR IMMEDIATE RELEASE:    March 19, 2013
CONTACT:  Peter Hamm, 202-296-5469
Government’s Decision Not to Appeal Cigarette Warning Ruling Is Disappointing;
FDA Should Quickly Develop New Set of Graphic Warnings
Statement of Matthew L. Myers
President, Campaign for Tobacco-Free Kids
WASHINGTON, DC – We are disappointed that the government will not seek Supreme Court review of an appellate court ruling that blocked graphic cigarette warnings proposed by the Food and Drug Administration (FDA).  However, we welcome the FDA’s announcement that it will begin development of new warnings that comply both with legal rulings and the 2009 law that required large, graphic cigarette warnings.  The FDA should move quickly to require strong warnings that are based on the best available science and fully inform Americans about the deadly consequences of smoking.
While the court ruling at issue today blocked the specific warnings developed by the FDA, a separate appellate court ruling upheld the law’s underlying requirement for the graphic warnings.  The law requires cigarette warnings that contain color graphics depicting the health consequences of smoking and cover the top half of the front and back of cigarette packs, as well as 20 percent of cigarette ads.
Tobacco companies filed two lawsuits challenging the warnings.
In March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s warning labels requirement, finding that the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.”  It found that the warnings “do not impose any restriction on Plaintiff’s dissemination of speech, nor do they touch on Plaintiffs’ core speech. Instead, the labels serve as disclaimers to the public regarding the incontestable health consequences of using tobacco.”  Tobacco companies have appealed this ruling to the Supreme Court, which has not decided whether to accept the case.
In August 2012, the U.S. Court of Appeals for the D.C. Circuit struck down the specific warnings proposed by the FDA.  We believe this ruling was wrong on the science and the law.
Tobacco companies are fighting the graphic warnings because they know such warnings are effective.  As a federal judge found in a 2006 civil racketeering judgment against cigarette manufacturers, these companies have spent decades deceiving the American people and downplaying the health risks of smoking.  Even today, they continue to spend billions to glamorize smoking.  The graphic warnings would counter the industry’s deception and tell the truth about how deadly and unglamorous smoking truly is.
The graphic warnings were mandated by a large, bipartisan majority of Congress, which relied on an extensive scientific record demonstrating both the need for the new warnings and their effectiveness.  That record shows that the current, text-only warnings – which are printed on the side of cigarette packs and haven’t been updated since 1984 – are stale and unnoticed.
Studies around the world and evidence presented to the FDA show that large, graphic warnings are most effective at informing consumers about the health risks of smoking. The warnings discourage children and other nonsmokers from starting to smoke and also motivate smokers to quit (see our fact sheet at: http://www.tobaccofreekids.org/research/factsheets/pdf/0325.pdf). Because of that evidence, more than 60 countries now require large, graphic cigarette warnings.
As the Sixth Circuit decision concluded, “Faced with evidence that the current warnings ineffectively convey the risks of tobacco use and that most people do not understand the full risks, the Act’s new warnings are reasonably related to promoting greater public understanding of the risks.  A warning that is not noticed, read, or understood by consumers does not serve its function.  The new warnings rationally address these problems by being larger and including graphics.”
We call on the FDA to act as quickly as possible to propose new warning labels to address the continuing harm caused by tobacco, the nation’s number one preventable cause of death and disease.

Blog Post by Howard K. Koh

“Although we pushed forcefully for Graphic Health Warning Labels to appear on cigarette packages, the D.C. Circuit's ruling against the warning labels won't deter the FDA from seeking an effective and sound way to implement the law. The FDA has announced it will undertake research to support new rulemaking on graphic warning labels consistent with the Family Smoking Prevention and Tobacco Control Act.”

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