Thursday, March 18, 2010

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

"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

"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

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.

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