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U.S. Department of Health and Human Services

For Industry

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Why is FDA requiring graphic health warnings for cigarette packages and advertisements?

Graphic health warnings are required under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act); a bipartisan law passed by Congress in June 2009. Tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year, according to the Centers for Disease Control and Prevention (CDC) and costs our economy nearly $200 billion every year in medical costs and lost productivity.

Scientific evidence, outlined in the final rule, shows that the content and format of the current warnings have failed to successfully draw and hold consumer attention.  More specifically, a 2007 Institute of Medicine (IOM) report concluded that the available scientific evidence indicates that larger graphic health warnings would promote greater public knowledge of the health risks of using tobacco and would help reduce consumption.

In addition, there are a number of studies and evidence from international experience to show the positive impact of graphic health warnings on effectively conveying the health risks of smoking, and on increased cessation and decreased initiation.

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