ASCO, AACR Call for Regulation of Electronic Nicotine Delivery Systems

By ASCO
February 25, 2015

ASCO and the American Association for Cancer Research (AACR) released a joint statement in January to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems.

Tobacco use, according to the statement, constitutes the largest preventable cause of death and disability in developed countries and is a rapidly growing health problem in developing nations. It is responsible for 30% of all cancer deaths and is associated with increased risk for at least 18 types of cancer. E-cigarettes and other electronic nicotine delivery systems, which are capable of delivering a nicotine solution in aerosolized form, have been promoted as safer alternatives to combustible cigarettes and potential tobacco cessation products. At the present time, however, insufficient data exist on the health consequences of electronic nicotine delivery systems use and their value as tobacco cessation aids.

Federal Regulations Needed

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.

“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.”

The statement’s recommendations also focus on efforts to protect minors. “We cannot afford to wait to take prudent steps to stop those under 18 from using e-cigarettes,” said AACR President Carlos L. Arteaga, MD. “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.”

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.
• Packaging and advertising of these products should be required to carry safety labels that include a warning regarding nicotine addiction.
• 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 systems composition, use, and health effects should be disclosed for dissemination and should inform policy decisions for electronic nicotine delivery systems product regulation.
• State and local governments should implement related regulations appropriate for protecting the public’s 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 in or trying to quit smoking combustible cigarettes.

The joint statement was published in ASCO’s Journal of Clinical Oncology¹ and the AACR’s Clinical Cancer Research.²

Additional information on electronic nicotine delivery systems, as well as oncologist-approved tobacco cessation resources, can be found on ASCO’s patient information website at www.cancer
.net/tobacco and on AACR’s website at www.aacr.org/e-cigs. ■

References

1. Brandon TH, Goniewicz ML, Hanna NH, 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).

2. Brandon TH, Goniewicz ML, Hanna NH, 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 21:514-525, 2015.

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