FDA Issues Rule Restricting Children's Access to Tobacco

Last Friday, the US Food and Drug Administration issued a final rule titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” The rule is intended to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents. It will become effective on June 22, 2010.

The new rule includes a set of federal requirements that restrict the sale, distribution, and promotion of tobacco products. For example, 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 the distribution of free samples of cigarettes, restricts the distribution of free samples of smokeless tobacco, and prohibits tobacco brand-name sponsorship of athletic, musical, or other social or cultural events.

During the next few months, FDA will educate the retail community about the new requirements and advise them about how to comply. When the rule becomes effective, FDA will collaborate with states and territories to monitor retailers’ compliance. Manufacturers and retailers that do not comply with the rule may be subject to enforcement actions.

“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 Kathleen Sebelius, secretary of the US Department of Health and Human Services, in a press release. “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.”

“Every day, nearly 4000 kids under 18 try their first cigarette and 1000 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 Margaret A. Hamburg, commissioner of FDA, in the press release. “Putting these restrictions in place is necessary to protect the health of those we care most about: our children.”

FDA first drafted the rule in the 1990s. The Supreme Court set it aside, but the rule later was included as a key provision of the “2009 Family Smoking Prevention and Tobacco Control Act,” which gave FDA the authority to regulate tobacco products.

Months after President Obama signed the Act, FDA created a Center for Tobacco Products to set standards and enforce restrictions on the products. The agency chose Lawrence Deyton, an expert on veterans’ health issues, public health, and tobacco use, as director of the Center. In February 2010, FDA asked for a 23% increase in funding in its fiscal year 2011 budget request. FDA’s total request was $4.03 billion, some of which would be earmarked for tobacco regulation.

See related Pharm Tech articles:

FDA Opens Center for Tobacco Products (ePT)

New Leadership Seeks to Transform FDA (Pharmaceutical Technology)

FDA Requests Another Major Budget Increase (ePT)