FDA Issues Final Rule Restricting Access and Marketing of Cigarettes and Smokeless Tobacco Products to Youth

FDA Issues Final Rule Restricting Access and Marketing of Cigarettes and Smokeless Tobacco Products to Youth

The U.S. Food and Drug Administration issued a final rule containing a broad set of federal requirements designed to significantly curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States. Published March 19, 2010, the new rule becomes effective June 22, 2010, and has the force and effect of law.

Titled Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, the new rule restricts the sale, distribution, and promotion of these products to make them less accessible and less attractive to kids. Among other things, the rule prohibits the sale of cigarettes or smokeless tobacco to people younger than 18, prohibits the sale of cigarette packages with less than 20 cigarettes, prohibits distribution of free samples of cigarettes, restricts distribution of free samples of smokeless tobacco, and prohibits tobacco brand name sponsorship of any athletic, musical or other social or cultural events. The entire rule can be found at www.fda.gov/protectingkidsfromtobacco.

“This ruling is a critical piece of a coordinated effort to save lives, lower costs, and reduce suffering from heart disease, cancer and other tobacco-related illness,” said HHS Secretary Kathleen Sebelius. “Today, we’re addressing a larger public health effort to prevent our children from becoming the next generation of Americans to die early from tobacco-related disease. This is a great step toward a healthier America.”

“Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young. This is an avoidable personal tragedy for those kids and their families as well as a preventable public health disaster for our country,” said FDA Commissioner Margaret A. Hamburg, M.D. “Putting these restrictions in place is necessary to protect the health of those we care most about: our children.”

Enforcement of the new rule will begin once it becomes effective on June 22, 2010. FDA will work closely with States and Territories to ensure that retailers comply with the rule. FDA will also work with the retail community over the coming months to educate them about the new requirements and assist them in understanding how to comply with them and help protect our children and adolescents from these addictive products.

Manufacturers and retailers who do not comply with the rule may be subject to enforcement action.

The rule was originally crafted in the 1990s by the Food and Drug Administration. After being set aside by the Supreme Court, it was included as a key provision of the 2009 Family Smoking Prevention and Tobacco Control Act.

For additional information, including a copy of the final rule, fact sheets, and a set of general questions and answers, please go to www.fda.gov/protectingkidsfromtobacco. This site will be updated to reflect the latest information on the rule.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last revised: March 19, 2010