FDA Announces New Comprehensive Plan for Tobacco and Nicotine Regulation

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Recently, the U.S. Food and Drug Administration (FDA) announced a new strategy to address tobacco-related disease and death. The agency seeks to develop a plan to reduce the nicotine levels in combustible cigarettes to nonaddictive levels. However, as part of the strategy, the FDA also announced it will delay the regulation of e-cigarettes for several years. This regulation was part of the implementation of the Deeming Rule 2021/2022, which was issued this past year.

In the absence of clear data on e-cigarettes and other electronic nicotine delivery systems (ENDS) products to aid cessation, ASCO recommends the continued use of proven smoking cessation medications such as nicotine replacement therapies, bupropion, and varenicline. ASCO advocates for continuing the progress that has been made in reducing and preventing tobacco-related cancers through regulations and tobacco-use control measures, without delaying the implementation of regulations.

Though tobacco use is the leading preventable cause of cancer, people throughout the nation are still dying from cancers caused by tobacco use. Each year, 660,000 people in the United States are diagnosed with, and 343,000 people die of, cancers related to tobacco use.

In the announcement, the FDA stated a key piece of its approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk. It is most harmful when delivered through smoke particles in combustible cigarettes. The agency’s focus will be on strategies to reduce the nicotine levels in combustible cigarettes. 

The FDA will also seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and understanding patterns of use of premium cigars.

The Society welcomes the prospect of looking at the reduction of nicotine levels and the role of flavors in youth addiction as part of its efforts; limiting the sale of cigarettes and other tobacco products; and increasing smoking cessation to reduce the overall public health impact of tobacco, including tobacco-related morbidity and mortality.

ASCO will continue to closely monitor the agency’s progress on this comprehensive tobacco plan. Read the Society’s full recommendations on ENDS products in the Journal of Clinical Oncology at http://ascopubs.org/doi/full/10.1200/JCO.2014.59.4465. ■

© 2017. American Society of Clinical Oncology. All rights reserved.




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