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The Family Smoking Prevention and Tobacco Control Act: 7 years of tobacco product regulation
Story Date: 7/1/2016
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Source: FDA, 6/30/16
This month marks seven years since the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law, empowering FDA to take these types of actions to protect Americans, and particularly youth, from tobacco-related disease and death. Thanks to the Tobacco Control Act, CTP has a strong track record of public health protection through its comprehensive actions in support of tobacco product regulation.
The seventh anniversary of the Tobacco Control Act follows closely on the heels of a defining moment for this youngest FDA Center: the finalization in May of the “deeming rule.” The rule extends FDA’s application of the Tobacco Control Act—previously implemented only for cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco—to all products that meet the definition of a tobacco product in the Tobacco Control Act. Examples of these products are e-cigarettes, cigars, and hookah and pipe tobacco. Among other things, the deeming rule restricts sales to minors; requires health warnings on additional products; and requires manufacturers to receive marketing authorization from FDA before selling new tobacco products. The regulation serves as a foundation for investigating and understanding the potential benefits and risks of e-cigarettes and ensuring science-based oversight of all newly regulated tobacco products, which were previously sold without any review of their ingredients, how they were made, and their possible dangers.
But finalizing the deeming rule is only one milestone among many. These are just a few examples of CTP’s accomplishments over the last couple of years:
• Announced a set of strategic priorities to guide the Center’s work;
• Initiated the first no-tobacco-sale order actions for repeated violations of restrictions on the sale and distribution of tobacco products, including sales to minors;
• Issued the first warning letters to cigarette manufacturers making “additive free” or “natural” claims without an FDA order to make these claims;
• Launched multiple national public education campaigns to educate youth and young adults about the risks associated with tobacco products;
• Following a rigorous, science-based review, authorized for the first time the marketing of new tobacco products through the premarket tobacco application pathway because they met the standard set forth in the law.
As we look to the future, CTP will continue to build on the last seven years of work to reduce the death and disease caused by tobacco use. This includes continuing to work on the Center’s priorities to explore and develop product standards; working with our colleagues across the agency on a comprehensive nicotine regulatory policy; strengthening pre- and post-market controls through product application evaluations, guidances, and regulations; expanding compliance and enforcement activities; and continuing to develop and implement public education campaigns.
More information about CTP’s regulatory and public health efforts is available online: http://www.fda.gov/TobaccoProducts/default.htm.
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