U.S. Department of Health and Human Services unveiled a new comprehensive tobacco control strategy that includes proposed new bolder health warnings on cigarette packages and advertisements. Once final, these health warnings on cigarettes and in cigarette advertisements will be the most significant change in more than 25 years. These actions are part of a broader strategy that will help tobacco users quit and prevent children from starting.

Tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year. Thirty percent of all cancer deaths are due to tobacco. Each day 1,200 lives of current and former smokers are lost prematurely due to tobacco-related diseases.

"Every day, almost 4,000 youth try a cigarette for the first time and 1,000 youth become regular, daily smokers," said HHS Secretary Kathleen Sebelius. "Today marks an important milestone in protecting our children and the health of the American public."

The strategy includes a proposal issued by the Food and Drug Administration titled Required Warnings for Cigarette Packages and Advertisements. Specifically, the proposed rule details a requirement of the Family Smoking Prevention and Tobacco Control Act that nine new larger and more noticeable textual warning statements and color graphic images depicting the negative health consequences of smoking appear on cigarette packages and in cigarette advertisements. The public has an opportunity to comment on 36 proposed images through Jan. 9, 2011.

By June 22, 2011, FDA will select the final nine graphic and textual warning statements after a comprehensive review of the relevant scientific literature, the public comments, and results from an 18,000 person study. Implementation of the final rule (September 22, 2012) will ultimately prohibit companies from manufacturing cigarettes without new graphic health warnings on their packages for sale or distribution in the United States. In addition, manufacturers, importers, distributors and retailers will no longer be allowed to advertise cigarettes without the new graphic health warnings in the United States. By Oct. 22, 2012, manufacturers can no longer distribute cigarettes for sale in the United States that do not display the new graphic health warnings.

"Today, FDA takes a crucial step toward reducing the tremendous toll of illness and death caused by tobacco use by proposing to dramatically change how cigarette packages and advertising look in this country. When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes," said FDA Commissioner Dr. Margaret A. Hamburg. "This is a concrete example of how FDA’s new responsibilities for tobacco product regulation can benefit the public’s health."

The FDA action is part of a broad department-wide strategy that was announced by Assistant Secretary for Health Howard K. Koh, M.D., MPH. While progress has been made, smoking remains particularly high with low-income and within certain racial/ethnic groups and in certainpopulations, including people with mental illnesses and substance abuse disorders. Ending the Tobacco Epidemic: A Tobacco Control strategic Action Plan outlines specific, evidence-based actions that will help create a society free of tobacco-related death and disease.

"We are at an unprecedented time in our nation’s history to protect the public’s health from tobacco use, the leading cause of preventable, premature death in the United States," said Dr. Koh. "It will take renewed commitment from every sector of society to end the tobacco epidemic."

In addition to the announcements made today, other recent tobacco control and prevention efforts include:

The Affordable Care Act is giving Americans in private and public health plans access to recommended preventive care, like tobacco use cessation, at no additional cost.

The American Recovery and Reinvestment Act (ARRA) invested $225 million to support local, state and national efforts to promote comprehensive tobacco control and expand tobacco quitlines.

The Prevent All Cigarette Trafficking Act (PACT) aims to stop the illegal sale of tobacco products over the Internet and through mail order, including the illegal sale to youth.

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) gives FDA the authority to regulate the manufacture, marketing and distribution of tobacco products. Significant progress has already been made by restricting the use of the terms "light," "low," and "mild," banning characterizing fruit, candy, and spice, flavors from cigarettes, and putting in place restrictions on the sale and distribution of cigarettes and smokeless tobacco products to youth.

The Children’s Health Insurance Program Reauthorization Act (CHIPRA) raised the federal cigarette tax by 62 cents per pack. Raising the price of tobacco products is a proven way to reduce tobacco use, especially among price-sensitive populations such as youth.

For more about the announcement, visit www.hhs.gov.