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FDA Proposes Graphic Health Warnings On Cigarette Packages

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The U.S. Food and Drug Administration has proposed a rule that requires tobacco manufacturing companies to display new health warnings with color images on cigarette packets and in advertisements to promote greater public understanding of the negative health consequences of smoking.

If implemented, it will be the most significant change to cigarette labels in the UNited States in more than 35 years.

The color images, depicting some of the lesser-known, but serious health risks of cigarette smoking, will have to be printed prominently on the cigarette packets. FDA has proposed 13 cigarette health warnings.

The proposed rule will be published in the Federal Register on Friday. The public have time to comment on it until October 15.

When finalized, the proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements on the cover of cigarette packets.

The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.

The agency estimates that the U.S. tobacco industry will incur an additional expense of about $1.6 billion to make changes in the current format and provide the proposed health warning on cigarette packages.

According to FDA, cigarette smoking remains the leading cause of preventable disease and death in the United States. It estimates that cigarette smoking is responsible for more than 480,000 deaths per year in the country.

About 34.3 million U.S. adults and nearly 1.4 million U.S. youth, aged 12-17 years, currently smoke cigarettes.

FDA also noted that the Surgeon General's warnings currently displayed in advertisements have been shown to go unnoticed and be "invisible."

"While most people assume the public knows all they need to understand about the harms of cigarette smoking, there's a surprising number of lesser-known risks that both youth and adult smokers and nonsmokers may simply not be aware of, such as bladder cancer, diabetes and conditions that can cause blindness," said Acting FDA Commissioner Ned Sharpless.

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