U.S. FDA Proposes Graphic Warnings On Cigarette Packs, Advertisements

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The FDA is also accepting proposals for graphics, text and scientific facts about smokers that may be appropriate to put on the new required graphics to increase public understanding of the dangers of smoking.

The FDA has shared images showing the types of labels that may be featured on cigarette packages under this proposed rule, including one showing someone's chest after having open heart surgery, another showing a pale child with an oxygen mask, and another showing a container containing bloody urine meant to represent bladder cancer.

The move would mark the first revisal since the Surgeon General's warning was introduced to cigarette packaging and advertisements in 1984. Our lawsuit sought to force the FDA to comply with provisions of the 2009 Family Smoking Prevention and Tobacco Control Act, which required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising.

FDA will accept comments on the proposed rule through October 15.

Smoking and secondhand smoke exposure account for 480,000 deaths in the USA each year, the FDA reported, totaling more fatalities than alcohol, HIV, auto accidents, illegal drugs, murders and suicides combined.

The lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative and several individual pediatricians.

Editor's Note: Of course, Australians will be familiar with similar warnings and graphic imagery on cigarette packets already.

According to the FDA, about 34.3 million adults and nearly 1.4 million youth in the US smoke cigarettes. When the FDA first proposed its version of these labels in 2011, tobacco companies sued, saying that they were scare tactics.

Earlier this year and following a lawsuit filed by several public health groups, a judge in the U.S. District Court for the District of MA issued an order directing the FDA to finalize the warnings by March of next year.

R.J. Reynolds Tobacco Company, which is among the tobacco companies that would be impacted by this FDA rule, said in a statement on Thursday that the company is reviewing the FDA's latest proposal for graphic warnings. That court found the graphic warnings "are reasonably related to the government's interest in preventing consumer deception and are therefore constitutional".

The administration proposed 13 new warning labels for cigarette packs. A federal court ruled in favor of the group in March.

"[It] is important for FDA to focus on providing information that can produce health benefits for the public, not merely reiterating well-known messages that smoking is risky, which the public already understands", Hollon added.

"The Tobacco Control Act gives the FDA the authority they need to protect the public health", the ALA's Erika Sward says. As outlined in the proposed rule today, the unchanged content of these health warnings, as well as their small size, location and lack of an image, severely impairs their ability to convey relevant information about the negative health consequences of cigarette smoking in an effective way to the public. The tobacco industry can not be allowed to further delay these necessary warnings that show and tell the truth about the deadly consequences of smoking.

"We firmly support the public awareness of the harms of smoking cigarettes", she said in a statement.

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