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AACR, ASCO recommend regulation of e-cigarettes, other electronic nicotine delivery systems
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A joint statement issued today by the American Association for Cancer Research and ASCO calls for the regulation of electronic cigarettes and other electronic nicotine delivery systems.
The statement — in which the organizations emphasize the need for additional research into the potential adverse health effects of the devices, as well as safety measures intended to protect minors — is intended to help policymakers as they consider ways to ensure public health while still acknowledging the potential roles of these devices in smoking cessation.
“Certainly, we agree that smoking [electronic cigarettes] is not the same as a tobacco cigarette, and that there are many more carcinogens in tobacco,” Roy S. Herbst, MD, PhD, Ensign professor of medicine at Yale Cancer Center, chief of medical oncology at Smilow Cancer Hospital at Yale-New Haven and chair of the AACR/ASCO committee that delivered the statement, told HemOnc Today. “But we don’t know about the long-term consequences that these vapors might have on the pulmonary epithelium and on patients’ lungs.”
E-cigarettes and other electronic nicotine delivery systems (ENDS), which deliver nicotine in an aerosol form, are used by some smokers as a smoking cessation tool. Although there are some restrictions on the sale of ENDS at the local and state levels, there is no federal regulation in place and no manufacturing or quality-control standards exist.
In addition, because use of ENDS is fairly new, safety data are limited and no information is available with regard to their long-term effects.
The use of ENDS is on the rise, especially among minors, and the statement’s authors expressed concern that use of ENDS could encourage minors to try other forms of tobacco.
This is particularly concerning given that tobacco is the top preventable cause of disease, disability and death in the United States. Smoking causes 18 forms of cancer and accounts for 30% of cancer deaths in the country, according to the AACR/ASCO statement.
“We are concerned that e-cigarettes may encourage non-smokers, particularly children, to start smoking and develop nicotine addiction,” Peter Paul Yu, MD, FACP, FASCO, president of ASCO, said in a press release. “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. 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.”
In an effort to deter minors from using ENDS, AACR and ASCO called for the FDA Center for Tobacco Products to regulate all ENDS that meet the statutory definition of tobacco products. Devices that do not meet that definition should be regulated by the FDA through “other appropriate authorities,” according to the organizations.
Other recommendations include:
- A requirement that all ENDS manufacturers register with the FDA and report all product and ingredient listings, as well as nicotine concentrations in the devices’ solutions.
- A requirement that packaging and advertising carry safety labels that include a warning about nicotine addiction.
- A ban on the sale of these devices to anyone aged younger than 18 years, as well as a ban on youth-oriented advertising and marketing.
- A requirement that online and mail-order sellers of these devices verify the identity and age of customers at the point of purchase and delivery.
- A ban on use of ENDS in areas where use of tobacco products is prohibited, at least until the safety of second-hand aerosol exposure is established.
AACR and ASCO recommend placement of child safety caps on ENDS liquids, as well as a ban on ENDS that contain candy or other youth-friendly/youth-oriented flavors.
The organizations also encourage oncologists to recommend FDA-approved smoking cessation methods to their patients.
“The effects of [electronic cigarettes] on the lungs are still unknown and the long-term effect of these high doses of nicotine are not known,” Herbst told HemOnc Today. “There aren’t data at this point to suggest that electronic cigarettes are an approved and legitimate form of smoking cessation.” – by Lauren Frisby
Perspective
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Michael B. Steinberg, MD, MPH, FACP
As e-cigarettes have exploded onto the tobacco market, the FDA has been scrambling to decide how to effectively regulate these novel products. Many organizations, including AACR and ASCO, have released policy statements on this topic.The regulation of these “tobacco” products is not such an easy issue. In the past, health care professionals and tobacco control experts have operated under the relatively simple concept that all tobacco products are harmful, and the public’s health would benefit from their elimination or reduced use. However, a newer concept of “harm reduction” has emerged. Are some tobacco products less harmful than others and, if so, is there an overall public health benefit in cigarette smokers switching to these less harmful products? The challenge for policymakers is the balance between regulating a potentially harmful product while not favoring more harmful products. Although more scientific evidence is needed, many experts believe that electronic cigarettes — by virtue of their absence of combusted tobacco — may represent a less harmful alternative to combusted tobacco. However, less harmful does not equate to safe.
The AARC/ASCO statement does a very good job of supporting some “common-sense” regulatory steps that most reasonable people would want implemented for the public’s well-being. For example, few would deny that additional research is needed on the patterns of use and health impact of these products. Most people would also agree that some basic regulation is needed, such as manufacturers’ disclosure of ingredients, childproof packaging, and prohibition of sales and marketing to youth. Would many rational people oppose consumers wanting to know what they are consuming or oppose protecting children? Additionally, banning e-cigarette use in public places where cigarette smoking is prohibited makes sense until we can demonstrate that second-hand vapor is not harmful.
Some of the recommendations are a bit more controversial, such as warning labels and banning of flavors. How should the warning labels be stated in a way not to drive potential users back to combusted tobacco? We have seen this phenomenon occur with nicotine replacement medications. Although the banning of flavors may prevent youth initiation, could it also reduce appeal for current cigarette smokers who would have considered switching products?
The final issue is taxation. Tax increases do reduce consumption of tobacco products. However, do we want a tobacco tax system in place that taxes all tobacco products equally, or should we implement a tax structure that taxes the most harmful products with the highest tax and less harmful products with a lower tax? By simply recommending an increase in the e-cigarette tax, will we be driving current cigarette smokers back to combusted products? AACR/ASCO recognizes this and currently opposes taxing e-cigarettes at equal or higher rates than combusted tobacco.
Many of these decisions are complex. It seems reasonable to start with the most common-sense regulations, such as ingredient disclosure, product testing for harm, and child protections regarding sales, advertising and packaging. Then, as we gain more scientific data, we can make a more informed decision as to regulations that will take into consideration the relative harm of these new tobacco products, including warning labels, flavorings and tax rates. What we still do not have enough evidence for — beyond self-report and limited, sub-optimally designed trials — is the use of these products for tobacco cessation. In order to begin recommending e-cigarettes for cessation, health care providers will certainly need more data.
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