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Entries in Warning Labels (5)

Wednesday
Nov302011

FDA Appeals Block on Cigarette Warning Labels

A proposed graphic health warning for cigarette packages. U.S. Department of Health and Human Services(WASHINGTON) -- The U.S. Food and Drug Administration has appealed a federal judge's order that blocked graphic warnings about the dangers of smoking on cigarette packages.

In November, U.S. District Judge Richard Leon ruled that cigarette companies would likely win their battle against the FDA's mandatory requirement that graphic images of cigarette-induced diseases and death by smoking would be displayed on the top half of the pack. Leon said the images went too far.

In June, the FDA unveiled the final nine graphics that were scheduled appear on cigarette packs by 2012, including images of a man smoking from a tracheotomy hole, and rotting teeth with short one-line facts such as "cigarettes cause cancer."

"We want to make a difference and help people who are smoking stop smoking and discourage people who haven't taken up the habit yet," FDA commissioner Margaret Hamburg told ABC News.

Leon blocked the labels until after the lawsuit was resolved between cigarette companies and the FDA.

The images mark the most dramatic change a single pack has undergone in more than 25 years. The agency will require all manufacturers to use the labels on all U.S. sold cigarettes by Oct. 22, 2012. The Obama administration submitted its appeal Tuesday.

Although intended to warn smokers of the fatal consequences of cigarette smoking, the images created by the FDA are arguably tame in comparison to other countries such as Canada or Australia, said Dr. Eden Evins, associate professor of psychiatry at Harvard Medical School.

Previous studies suggest that graphic health warnings displayed in other countries worked better than text warnings to motivate smokers to quit and non-smokers not to start.

The United States was the first country to require health warnings on tobacco products. But it is now playing catchup to more than 30 countries that already require large, graphic cigarette warnings. Images used on cigarette packs in countries such as Canada are so disturbing that some smokers buy covers for their cigarette packs to block out the images.

While "the stronger the better" when it comes to motivating smokers to quit, according to Dr. Mary O'Sullivan, director of the smoking cessation program at St. Luke's-Roosevelt in New York, the images do offer straightforward messages of the fatal consequences.

Since many Americans are not used to seeing jarring images on their labels, the new campaign may prove comparable to other countries that display more gruesome images, O'Sullivan said.

While some experts such as Evins and Sullivan believe the images will pack a heavier punch to smokers than the current warning labels, some health communication experts wonder how long the proposed fear-based messages will work.

"The point of putting these pictures is the shock value and research tells us shock value on its own rarely works," said Timothy Edgar, associate professor and graduate program director of health communication at Emerson College in Boston.

Most Americans already know that smoking is dangerous; the message that the FDA is trying to convey, Edgar said. But visualizing the harms associated with smoking will inform many who might find it hard to quit.

The new package warnings are part of an FDA proposal under the Family Smoking Prevention and Tobacco Control Act, which requires that cigarette packages and advertisements have larger and more visible graphic health warnings. While the graphics might dissuade some smokers at the start of the campaign, the communication tactic might not spur many to kick the habit for good, if at all, Edgar said.

"I think people are still going to have a hard time saying, 'Yes, that's me on that label,'" he said. "There's a physical addiction involved in this as well. It's not an absolute choice for many who smoke."

Leading cancer groups, including the American Cancer Society, approached the FDA early on in the development of the labels and "were adamant about including the 800-Quit-Now number," said Thomas Glynn, director of cancer science and trends at the American Cancer Society.

"To be most effective, these labels need to be paired with an action," Glynn said.

The FDA indicated that the number would be included in the label design.

Although smoking rates have declined overall since the 1960s, health officials noted, that rates have leveled off in the past decade. About 21 percent of U.S. adults and nearly 20 percent of high school students smoke cigarettes, according to the Centers for Disease Control and Prevention.

Copyright 2011 ABC News Radio

Tuesday
Nov082011

Judge Blocks Graphic Photos from Appearing on Cigarette Packs

Jupiterimages/Thinkstock(WASHINGTON) -- A federal judge's ruling on graphic photos that were to be displayed on cigarette packs delivered a punch that the Food and Drug Administration didn't see coming.

Siding with five tobacco companies, U.S. District Judge Richard J. Leon issued a preliminary injunction that stops the government from putting enhanced warnings on cigarette packages, cartons and advertisements that some have found repulsive.  The photos of diseased lungs, a disfigured lip and a man smoking from a hole in his throat, among others, were supposed to appear next June.

Lawyers for the cigarette makers successfully argued that a court must first decide if the FDA's new rules violate their constitutional right to free speech before the graphic pictures can find their way onto their products.

Meanwhile, Matthew L. Myers of the Campaign for Tobacco-Free Kids said in a statement, "Judge Leon’s ruling ignores the overwhelming scientific evidence about the need for the new cigarette warnings and their effectiveness."

The FDA said it would turn the case over to the Justice Department, which could appeal Leon's ruling.

Copyright 2011 ABC News Radio

Wednesday
Aug172011

Tobacco Companies Sue FDA over Graphic Cigarette Warning Labels

U.S. Food and Drug Administration(WASHINGTON) -- For years, the tobacco industry has put up with anti-smoking ads and having to put warnings labels on packs of cigarettes.

But now, several big tobacco companies are fighting back against new requirements imposed by the U.S. Food and Drug Administration to put hard-hitting anti-smoking images on packs of cigarettes.

In a 41-page lawsuit filed on Tuesday, five tobacco companies argue that the labels step on their freedom of speech and serve as an advertisement to push the government's anti-smoking agenda.

"The government can require warnings which are straightforward and essentially uncontroversial, but they can't require a cigarette pack to serve as a mini-billboard for the government's anti-smoking campaign," Floyd Abrams, a lawyer for the companies, said in a statement.

Beginning in September 2012, the labels -- which include images of a man smoking from a tracheotomy hole and rotting teeth -- will be required on all cigarette packing in the U.S.

The FDA has not yet issued a response to the lawsuit.

Copyright 2011 ABC News Radio

Tuesday
Jun212011

FDA Unveils Final Nine Cigarette Warning Labels

U.S. Food and Drug Administration(WASHINGTON) -- The modest one-line warnings on the dangers of smoking now featured on cigarette packs, will soon turn into graphic images and messages that cover nearly half the pack.

The U.S. Food and Drug Administration unveiled the final nine graphics that will appear on cigarette packs, including images of a man smoking from a tracheotomy hole, and rotting teeth.  The images mark the most dramatic change a single pack has undergone in more than 25 years.  The agency will require all manufacturers to use the labels on all U.S. sold cigarettes by Oct. 22, 2012.

The FDA first introduced 36 jarring labels in November 2010, which were aimed at escalating efforts to warn smokers of the fatal consequences of cigarette smoking.  The labels represented the agency's exercise of its new authority over tobacco products and the most significant change in cigarette warnings since companies were forced to add the mandatory Surgeon General's warning in 1965.

Previous studies suggest that graphic health warnings displayed in other countries worked better than text warnings to motivate smokers to quit, and nonsmokers not to start.

The United States was the first country to require health warnings on tobacco products.  But it is now playing catchup to more than 30 countries that already require large, graphic cigarette warnings.

Images used on cigarette packs in countries such as Canada are so disturbing that some smokers buy covers for their cigarette packs to block out the images.

The images created by the FDA are arguably tame in comparison, said Dr. Eden Evins, associate professor of psychiatry at Harvard Medical School.

While some experts think the images will pack a heavier punch to smokers than the current warning labels, some health communication experts wonder how long the proposed fear-based messages will work.

Copyright 2011 ABC News Radio

Tuesday
Dec142010

FDA Warns Prescription Cough Capsules Can Kill Children

Photo Courtesy - Getty Images(NEW YORK) -- The FDA is requiring that label warnings on prescription cough medication benzonatate (Tessalon) be changed to caution parents to keep it out of reach of children, reports MedPage Today

"Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, director of the FDA's Division of Medication Error Prevention and Analysis.

There have been reports of 31 overdoses and five toddler deaths related to the gelcaps, which look like candy.  Data included in the reports prompted action by the FDA.

The product, approved in 1958 for cough treatment in patients 10 and older, will remain on the market after the new label information is added.

Copyright 2010 ABC News Radio 







ABC News Radio