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AACR, ASCO, Two Leading U.S. Cancer Organizations, Call for Regulation of E-cigarettes and Other Electronic Nicotine Delivery Systems

Recommendations also focus on efforts to protect minors
1/8/2015

PHILADELPHIA — The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (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 (ENDS) without undermining their potential to reduce harm as a smoking cessation tool. The two organizations’ recommendations were published in the AACR’s Clinical Cancer Research and ASCO’s Journal of Clinical Oncology.

“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 ENDS 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, Tennessee. “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.”

“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 Peter Paul Yu, MD, FACP, FASCO, ASCO president. “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.”

According to the statement, tobacco use 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 percent of all cancer deaths and is associated with increased risk for at least 18 types of cancer. E-cigarettes and other ENDS, which are capable of delivering a nicotine solution in aerosolized form, have been promoted as potential tobacco cessation products and safer alternatives to combustible cigarettes. At the present time, however, insufficient data exist on the health consequences of ENDS use and their value as tobacco cessation aids.

Unlike combustible cigarettes and many other tobacco products, e-cigarettes and other ENDS 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. The statement calls on federal policymakers to immediately implement these recommendations, most specifically the ones that are aimed at restricting the sale, distribution, marketing, and advertising of ENDS to youth.

Noting that additional research is needed to inform the regulation of e-cigarettes and other ENDS, 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 ENDS that meet the statutory definition of tobacco products. ENDS that do not meet the statutory definition of tobacco products should be regulated by the FDA through other appropriate authorities.
  • ENDS manufacturers should be required to register with the FDA and report all product and ingredient listings, as well as the nicotine concentration in the ENDS solution.
  • ENDS packaging and advertising should be required to carry safety labels that include a warning regarding nicotine addiction.
  • All youth-oriented ENDS advertising and marketing should be prohibited.
  • Internet and other mail-order sellers of ENDS 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.
  • ENDS and ENDS liquid-containing candy and other youth-friendly/youth-oriented flavors should be banned unless there is evidence demonstrating these products do not encourage youth uptake.
  • ENDS 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 ENDS, should be used to help support research on ENDS and other tobacco products, and should not preclude the allocation of federal funding for this research.
  • All data related to ENDS composition, use, and health effects should be disclosed for dissemination and should inform policy decisions for ENDS product regulation.
  • State and local governments should implement ENDS regulations appropriate for protecting the public’s health, including restricting the sale, distribution, marketing, and advertising of ENDS 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 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.”

For more information on this subject from the AACR, visit www.AACR.org/e-cigs. Additional information on ENDS, as well as oncologist-approved tobacco cessation resources can be found on ASCO’s patient information website, Cancer.Net, at www.cancer.net/tobacco.