ASCO and AACR Call for Regulation of E-Cigarettes and Other Electronic Nicotine Delivery Systems


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While e-cigarettes may reduce smoking rates and attendant adverse health rates, we will not know for sure until these products are researched and regulated.

—Peter Paul Yu, MD, FACP, FASCO

The American Association for Cancer Research (AACR) and ASCO have outlined steps in a joint statement to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems without undermining their potential to reduce harm as a smoking cessation tool. The two organizations’ recommendations were published in ASCO’s Journal of Clinical Oncology1 and the AACR’s Clinical Cancer Research.2

Prudent Steps Needed

“We are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction. While e-cigarettes may reduce smoking rates and attendant adverse health risks, we will not know for sure until these products are researched and regulated,” said ASCO President Peter Paul Yu, MD, FACP, FASCO. “The FDA has signaled its willingness to regulate e-cigarettes and other electronic nicotine delivery systems, and we urge the agency to follow through on this intention.”

“As a physician scientist who treats patients with cancer, I am concerned about the delayed time course that’s needed to assess the adverse impacts of [electronic nicotine delivery systems] use,” said ­Carlos L. Arteaga, MD, AACR President, and Professor of Medicine and Cancer Biology and Director of the Center for Cancer Targeted Therapies and the Breast Cancer Program at the Vanderbilt-Ingram Cancer Center of Vanderbilt University in Nashville. “Therefore, although we call for additional research to determine with certainty the potential negative public health consequences of these products, particularly in youth, we cannot afford to wait to take prudent steps to stop those under 18 from using e-cigarettes. This is especially important since e-cigarette use is growing fast among this age group, as reported in the most recent National Youth Tobacco Survey.”

Unlike combustible cigarettes and many other tobacco products, e-cigarettes and other electronic nicotine delivery systems are not currently regulated by the U.S. Food and Drug Administration (FDA). Some state and local governments have enacted e-cigarette regulations, including imposing restrictions on the sale of e-cigarettes to minors and prohibiting use of e-cigarettes in public places. Federal regulations have yet to be adopted, and manufacturing standards and quality controls on e-cigarettes are also absent.

Policy Recommendations

Noting that additional research is needed to inform the regulation of e-cigarettes and other electronic nicotine delivery systems, the AACR and ASCO statement outlines steps that can be taken now in the interest of public health. Specifically, the policy recommendations include the following:

  • The FDA Center for Tobacco Products should regulate all electronic nicotine delivery systems that meet the statutory definition of tobacco products. Those that do not meet the statutory definition of tobacco products should be regulated by the FDA through other appropriate authorities.
  • Manufacturers of these products should be required to register with the FDA and report all ingredient listings, including nicotine concentration.
  • Packaging and advertising for these products should be required to carry safety labels that include a warning regarding nicotine addiction.
  • All youth-oriented electronic nicotine delivery systems advertising and marketing should be prohibited.
  • Internet and mail-order sellers of these products should be required to check the age and identification of customers at the point of purchase and delivery.
  • Childproof caps should be required for all e-liquid containers.
  • Electronic nicotine delivery systems and liquid-containing candy and other youth-friendly flavors should be banned unless there is evidence demonstrating these products do not encourage youth uptake.
  • Electronic nicotine delivery systems use should be prohibited in places where combustible tobacco product use is prohibited by federal, state, or local law until the safety of secondhand aerosol exposure is established.
  • Funding generated through tobacco product taxes, including any potential taxes levied on electronic nicotine delivery systems, should be used to help support research on electronic nicotine delivery systems and other tobacco products, and should not preclude the allocation of federal funding for this research.
  • All data related to electronic nicotine delivery system composition, use, and health effects should be disclosed for dissemination and should inform policy decisions for product regulation.
  • State and local governments should implement related regulations to protect public health, including restricting the sale, distribution, marketing, and advertising of electronic nicotine delivery systems to youth.

In addition, the AACR and ASCO encourage all oncologists to recommend FDA-approved cessation medications instead of e-cigarettes to individuals who are interested or trying to quit smoking combustible cigarettes.

Further Research Required

“Further research and regulation are needed to determine if e-cigarettes can help people stop smoking combustible cigarettes,” said Roy S. Herbst, MD, PhD, Ensign Professor of Medicine, Professor of Pharmacology, and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, who served as Chair of the joint AACR/ASCO committee that developed the statement. “In the meantime, oncologists should encourage patients to use FDA-approved cessation medications, refer them for smoking cessation counseling, and provide education about the potential risks and lack of known benefits of long-term e-cigarette use.” ■

References

1. Brandon TH, et al: Electronic nicotine delivery systems: A policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. Clin Cancer Res. January 8, 2015 (early release online).

2. Brandon TH, et al: Electronic nicotine delivery systems: A policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. J Clin Oncol. January 8, 2015 (early release online).



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