The nation's two largest organizations of cancer specialists have urged the FDA to develop and implement regulations as soon as possible for electronic nicotine delivery systems (ENDS), including e-cigarettes.
Although ENDS offer potential smoking-cessation benefits, the devices "may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or if they discourage smokers from quitting," according to a report from the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO).
AACR and ASCO "recognize the potential ENDS have to alter patterns of tobacco use and affect the public's health; however, definitive data are lacking."
"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," AACR president Carlos L. Arteaga, MD, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a statement.
"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."
Added ASCO president Peter Paul Yu, MD, of the Palo Alto Medical Foundation in California, "The FDA has signaled its willingness to regulate e-cigarettes and other electronic nicotine delivery systems, and we urge the agency to follow through with this intention."
In the joint report, AACR and ASCO make almost a dozen recommendations for FDA regulation of ENDS products, including:
- Regulation of all ENDS products that meet the statutory definition of tobacco products and regulation of products that do not meet the definition by "appropriate authorities"
- Require ENDS manufacturers to register with the FDA and provide complete lists of products and ingredients, as well as the nicotine concentration
- Require safety labels warning against nicotine addiction
- Prohibition of all ENDS advertising directed toward youth
- Require Internet and mail-order merchants that sell ENDS products to check the age and identification of all customers at the point of purchase and delivery
- Child-proof caps for all e-liquid containers
- A ban on sale and use of ENDS and ENDS liquid-containing candy and other "youth-friendly/youth-oriented flavors," in the absence of evidence demonstrating the products' safety
- Funding of ENDS-related research from taxes generated by sale of tobacco products and potential taxes on ENDS products
- Implementation of state and local regulations to protect the public health, particularly the sale, distribution, marketing, and advertising of ENDS to youth
Noting that tobacco use remains the leading preventable cause of death and disability in developed countries, authors of the report said that "rapid elimination of combustible tobacco products would dramatically reduce the burden of tobacco-related death and disease.
"The AACR and ASCO support every effort to reduce the use of combustible tobacco, and we support careful consideration of ENDS as potentially harmful, and potentially beneficial products in this regard. The benefits and harms must be evaluated with respect to the population as a whole, taking into account the effect on youth, adults, nonsmokers, and smokers."
One or more authors of the report disclosed relevant relationships with Pfizer, Voxiva, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, NovaRX, Genentech/Roche, Biothera, DiaTech Oncology, Kolltan Pharmaceuticals, and N-of-Ones.
American Association for Cancer ResearchSource Reference: 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 2015; DOI: 10.1158/1078-0432.CCR-14-2544.