PHILADELPHIA — The American Association for Cancer Research (AACR) believes the FDA took a major step yesterday to promote and protect the nation’s health by asserting its jurisdiction to regulate all tobacco products, including electronic (e-) cigarettes, cigars, pipe tobacco, and waterpipe tobacco. The regulation also authorizes the Secretary of Health and Human Services to request the FDA to conduct regulatory reviews of all tobacco products that went on sale after Feb. 15, 2007.
“Tobacco is the leading cause of preventable death in the United States and it is associated with 18 different types of cancers,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “Therefore, this action by the FDA is vitally important, especially if we are to protect our nation’s youth from becoming addicted to nicotine. In fact, one of the most encouraging elements of this new rule is that it bans these tobacco products from being sold to anyone under 18, and the products will carry prominent warning labels.”
While the FDA has exercised regulatory authority over some tobacco-based products such as cigarettes and smokeless tobacco, several others, including e-cigarettes and cigars, had remained unregulated until now. In the absence of such regulation, the emergence of e-cigarettes and other electronic nicotine delivery systems (ENDS) has become a major public health concern. While significant research is ongoing regarding their potential merits as smoking cessation tools, the possible popularity of e-cigarettes among the youth and young adult population continues to increase.
“We simply do not know enough about the long-term consequences of e-cigarette use, nor do we know whether they are truly effective as a long-term smoking cessation aid,” said Roy S. Herbst, MD, PhD, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center. “Therefore, in addition to the FDA taking this critical step to regulate these products, it’s going to be extremely important to support research on the health consequences of these products, as well as investigate the potential benefits of e-cigarettes as a cessation tool for those people already addicted to nicotine.”
In addition to e-cigarettes, the smoking of cigars has increased significantly among youth and young adults since the use of flavorings was banned for traditional cigarettes. Today, a similar percentage of high school boys is smoking cigars (10.8 percent) compared to cigarettes (10.6 percent) according to a study by the Centers for Disease Control and Prevention (CDC). When those numbers are combined with the estimated 2.4 million occasional youth users of e-cigarettes, it is clear that the FDA’s extended authority over both products will have a significant impact on the protection of users and those exposed to secondhand smoke or aerosol. With regard to cigars, the AACR commends the FDA for regulating all cigar ingredients, packaging, and labeling in the new deeming rule.
In January 2015, the AACR and the American Society of Clinical Oncology (ASCO) released a joint policy statement detailing recommendations for the regulation of e-cigarettes and other ENDS. The AACR is pleased to see that the FDA’s deeming rule has adopted many of these recommendations by requiring a pre-market review process that will prevent misleading claims by tobacco product manufacturers and require the disclosure of ingredients contained within all tobacco products. This product review process would also give the FDA the authority to review product ingredients, design, and labeling with a specific emphasis on flavors and messaging that appeal to youth and non-users. The joint policy statement specifically recommended that the FDA require health warning and safety labels, including a warning regarding nicotine addiction, and the AACR is extremely pleased to see the full implementation of this recommendation within the deeming rule.