FDA Facts: Building on Three Years of Accomplishments in Tobacco


 The Tobacco Control Act gave FDA the authority to regulate the manufacturing, marketing, and distribution of tobacco products, which are responsible for more than 443,000 deaths in the United States each year. FDA now has a powerful new regulatory tool to make tobacco-related disease and death part of America’s past, not its future—and to ensure a healthier life for every family.

In three years, FDA has moved science-based, tobacco-related regulation forward and started a rigorous tobacco research program to enhance the science already available. FDA focuses on three strategic priorities: preventing initiation, particularly among youth; decreasing the harms of tobacco product use; and encouraging cessation.

What FDA is Doing

Protecting Youth:

• Issuing and enforcing regulations that restrict youth access to cigarettes, cigarette tobacco, and smokeless tobacco, such as the national minimum age of 18 for purchases of cigarettes and smokeless tobacco;

• Removing cigarettes with characterizing flavors, such as candy and fruit, from the market, making cigarettes less appealing to kids;

• Enforcing the ban on brand-name sponsorship of sporting events and concerts; and

• Issuing and enforcing new restrictions on marketing and promotion, such as the minimum pack size of 20 cigarettes.

Providing Information to Help Educate Consumers:

• Enforcing prohibitions on misleading labeling and advertising claims and claims that imply that products are safe or safer without evidence to support those claims;

• Implementing provisions that require tobacco companies to report to FDA on the quantities of a list of harmful or potentially harmful constituents in tobacco products;

• Enforcing new smokeless tobacco warning requirements; and

• Requiring new graphic warning labels for cigarette packages and advertisements to effectively communicate the health risks of smoking.

Ensuring Compliance with the Law:

• Conducting more than 78,400 inspections of tobacco product retailers across the United States to ensure that they comply with the law (as of July 1, 2012);

• Issuing more than 3,380 warning letters and more than 240 civil money penalties (as of July 1, 2012); and

• Publishing guidance for industry to help them meet their obligations under the law (ongoing).

Leading Cutting-Edge Research:

• Establishing a world-class testing laboratory in partnership with the Centers for Disease Control (CDC) with capacity to analyze tobacco products and increase our understanding of their health risks; and

• Partnering in research with the National Institutes of Health (NIH) to dramatically increase regulatory science capabilities. Projects underway include:

• The first-ever longitudinal study to understand patterns of tobacco use over time with the Population Assessment on Tobacco Health Study (PATH);

• Innovative research on how altering nicotine levels in tobacco products to assess how such changes could affect the way people might use tobacco products and become addicted; and

• Adding questions to CDC-sponsored surveillance surveys to acquire data important to FDA.

Created: July 2012

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