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FDA proposes new health warnings on cigarette packages, most significant change in over 35 years

By Tom Latek
Kentucky Today

The U.S. Food and Drug Administration has issued a proposed rule, requiring new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. 

The new warnings, which contain images depicting some lesser-known but serious health risks of cigarette smoking, would be the most significant change to cigarette labels in more than 35 years.

When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act.

“As a cancer doctor and researcher, I am well aware of the staggering toll inflicted on the public health by tobacco products, which cause cancer, heart disease, stroke, emphysema and other medical problems,” said Acting FDA Commissioner Dr. Ned Sharpless. 

Label warning

“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.”

According to the FDA, 34.3 million U.S. adults and nearly 1.4 million U.S. youth (aged 12-17 years) currently smoke cigarettes.

Despite years of progress in tackling the leading cause of preventable disease and death in the United States, tobacco use kills about 480,000 Americans a year. 

They say smoking kills more people each year than alcohol, HIV, car accidents, illegal drugs, murders, and suicides combined, and over 16 million Americans alive today live with disease caused by cigarette smoking.

Tobacco use also costs more than $300 billion a year in direct health care costs and lost productivity.

Health warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984 to include the Surgeon General’s warnings that appear on packages and in advertisements today. However, research shows that these warnings have become virtually invisible to both smokers and nonsmokers, not attracting much attention and not leaving a very memorable impression of the risks.

As a result, the FDA undertook a science-based approach to develop and evaluate the new proposed cigarette health warnings. 

They focus on serious health risks such as bladder cancer, diabetes, erectile dysfunction and conditions that can cause blindness; that are lesser known by the public as being negative health consequences of smoking. 

For example, current smokers have been found to have almost four times the risk of bladder cancer as never smokers, and it has been estimated that smoking is responsible for 5,000 bladder cancer deaths in the United States each year. Yet research shows the public has limited awareness of bladder cancer due to smoking. 

New cigarette health warnings, once finalized, would appear prominently on cigarette packages and in advertisements, occupying the top half of the area of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements. The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.

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