Regulating Electronic Cigarettes and other ENDS
Electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems (ENDS), which are capable of delivering a nicotine solution in aerosolized form, have been suggested as potential tobacco cessation interventions and safer alternatives to cigarettes. At the present time, however, there are insufficient data on the health consequences of e-cigarette use, their value as tobacco cessation aids, and their effects on the use of combustible tobacco products by smokers and nonsmokers.
E-cigarettes may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, they may also be harmful if they increase the likelihood that nonsmokers—particularly children—or former smokers will start smoking or if they discourage smokers from quitting.
UPDATE: On June 30, 2015, the AACR and the American Society of Clinical Oncology (ASCO) submitted joint comments to the FDA Docket, Electronic Cigarettes and the Public Health, which urged the FDA to consider the comments and recommendations from their 2015 joint policy statement on ENDS. Read/download the joint comments.
On Jan. 8, 2015, the AACR and ASCO released a joint statement to guide policy makers in how to best minimize the potential negative consequences of ENDS without undermining their potential use as a smoking cessation tool.
Frequently Asked Questions
- How are e-cigarettes regulated?
- Who uses e-cigarettes?
- What is in “e-liquid?”
- Are e-cigarettes safe?
- Do e-cigarettes help smokers quit?
- How should oncologists address e-cigarette use with cancer patients?
How are e-cigarettes regulated?
Unlike combustible cigarettes, e-cigarettes are not regulated under the FDA’s tobacco regulatory authority, though the FDA has signaled its intent to regulate them. 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. However, there are no federal regulations to this effect, and there is a lack of manufacturing standards and quality controls in place.
Who uses e-cigarettes?
Although e-cigarette use by adults and youth is relatively low, it is increasing. Current data show that e-cigarettes are used primarily by current smokers, and adults tend to report harm-reduction motivations for using them. However, youth who have never smoked are more likely to try e-cigarettes than adults who have never smoked, raising concerns that these products may serve as an introduction to tobacco use among adolescents.
What is in “e-liquid”?
Most e-liquid contains nicotine dissolved in a mixture of propylene glycol and/or glycerin and water. Fruit and candy flavorings are commonly added to the solution, along with sugars, ethyl alcohol, and other compounds.
Are e-cigarettes safe?
The evidence regarding the risks and benefits of e-cigarettes is difficult to interpret, and data on the long-term consequences of e-cigarette use are not yet available. There are more than 460 e-cigarettes brands and more than 7,700 flavors available in the United States, and there is wide variability in design and performance among and within products. The chemical composition of e-cigarette aerosol, its toxicity, and potential addictiveness varies among products, and scientific methods for assessing toxicants in e-cigarettes are not well-validated. The following points summarize the current data on e-cigarette safety.
- Chemicals and ultrafine particles known to be toxic and carcinogenic and/or to cause respiratory and heart distress have been identified in e-cigarettes.
- Studies find the levels of the toxicants in e-cigarette aerosol to be significantly lower than in cigarette smoke and, in many cases, comparable with trace amounts found in a medicinal nicotine inhaler. It is unclear what effects these toxicants might have on e-cigarette users after chronic and frequent use.
- The vast majority of e-cigarette users use products containing nicotine. Nicotine is an addictive chemical, adversely affects maternal and fetal health during pregnancy, has adverse consequences for fetal brain development, and may adversely affect the adolescent brain. It is unclear what effect nicotine intake via e-cigarettes has on health or on the addictiveness of these products.
- Data from the Centers for Disease Control and Prevention showed a significant increase in e-cigarette-related calls to poison centers between 2010 and 2014 as a result of accidental ingestion or absorption of e-cigarette liquid.
- Secondhand exposure to toxicants and nicotine from e-cigarette aerosol has been documented, though there are no current data suggesting that exposure to the aerosol has adverse health effects.
- There are no published studies evaluating thirdhand (i.e., residue that builds up on surfaces over time) exposure to e-cigarette aerosol in indoor environments, although preliminary data suggest that nicotine from e-cigarettes can stick to surfaces.
Do e-cigarettes help smokers quit?
The FDA has not approved e-cigarettes as smoking cessation aids, and current data are inconclusive with regard to their efficacy as quit-smoking products. While some studies show that e-cigarette use by combustible cigarette smokers can reduce the number of cigarettes smoked, this reduction may not be sufficient to confer any health benefits.
How should oncologists address e-cigarette use with cancer patients?
Oncologists would be wise to refrain from recommending e-cigarettes to patients as a first-line therapy for smoking cessation. Oncologists should advise all smokers to quit smoking combustible cigarettes, encourage use of FDA-approved cessation medications, refer patients for smoking cessation counseling, and provide education about the potential risks and lack of known benefits of long-term e-cigarette use.
Additional research will be needed to inform the regulation of e-cigarettes. Nonetheless, there are steps that policy makers can take now to minimize the potential negative public health consequences of these products, and particularly youth initiation of e-cigarette use, without undermining their potential to reduce the harm caused by conventional tobacco products. With these goals in mind, AACR and ASCO make the following policy recommendations:
- The FDA Center for Tobacco Products (CTP) should regulate all ENDS that meet the statutory definition of tobacco products and their component parts. ENDS delivery systems and e-liquids containing tobacco-derived nicotine should be regulated whether they are sold together or separately. ENDS that do not meet the statutory definition of tobacco products (including those containing synthetic nicotine) 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 health warnings and safety labels—including a warning regarding nicotine addiction.
- Youth-oriented ENDS advertising and marketing should be prohibited, including:
- self-service ENDS displays
- the provision of gifts and other giveaways with purchase of ENDS
- the sale and distribution of items such as hats or t-shirts with ENDS brand logos
- brand name sponsorship of social or cultural events, or of any team entry into those events
- youth-oriented advertising of tobacco products.
- 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; to comply with all laws in the purchaser’s state or local jurisdiction; and pay all applicable federal, state, and local taxes.
- Childproof caps should be required for all e-liquid containers.
- ENDS and ENDS liquid containing candy and other youth-friendly flavors should be banned unless there is evidence demonstrating that these products do not encourage youth uptake. Flavors or flavor names that are brand and/or trademarked names for youth-oriented products should also be prohibited.
- ENDS use should be prohibited in places where combustible tobacco product use is prohibited by federal, state, or local law until the safety of second- and thirdhand 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, but 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 independent review as well as to enhance policy decisions for ENDS product regulation.
- Tobacco products should be taxed proportionate to their harm; therefore, ENDS should not be taxed at equal or higher rates than combustible cigarettes.
- State and local governments should implement ENDS regulations within their authorities that are appropriate for protecting the public health, including restricting the sale, distribution, marketing, and advertising of ENDS to youth.
- International cooperation is needed to develop standards for the regulation of ENDS, and these regulations should prioritize protection of the public’s health and draw upon the best available scientific evidence whenever possible.