What specific steps has the industry as a whole taken to regulate itself?
As the largest trade organization dedicated to the advocacy, education and reputation of the vapor products industry, we support regulation that is appropriate and proportional for these technology products. As a threshold matter, SFATA would like to see carefully tailored regulations that are specific to what these technology products actually are as vaporizers including e-cigs are very distinct from and are not tobacco products. Defining them as tobacco products mistakenly and dangerously defines them as part of the penumbra of public health problems caused by smoking when in fact they very well may be the greatest tool our society has to date in distributing the scourge of preventable tobacco related deaths. Secondly, SFATA believes that standardized regulations geared to ensure consistency among the wide variety of vapor products that exist and continue to emerge is important so that the consumer is assured that there is a high level of product quality and safety. Last for now, SFATA has actively engaged legislators at the state and federal level to help shape laws which prohibit access to vapor products by minors. Vapor products are adult consumer products and not for the use of minors. We actively support child-resistant packaging and proper labeling and discourage youth-oriented nomenclature or infringement on trademarked names to describe flavors being used in the industry.
In June, SFATA launched a national program called Age To Vape™ that is designed to ensure that minors don’t have access to vapor products. The program’s participants must post Age To Vape™ signs, check customer ID’s before making a sale, agree not to sell vapor products to minors and to be part of a public registry of participating outlets -- which is published online – to further ensure that these products are being enjoyed responsibly by smokers of the appropriate age.
What evidence do you have that e-cigarettes are safe? What evidence do you have that e-cigarettes are unsafe?
There are numerous studies from all over the world which speak to various aspects of the safety of vaporizers and many well respected current and former public health officials, public policy experts and physicians have taken the time and continue to take the time to study this issue.
Drexel University published a recent study regarding vapor product safety which concluded:
"In summary, analysis of the current state of knowledge about the chemistry of contaminants in liquids and aerosols associated with electronic cigarettes indicates that there is no evidence that vaping produces inhalable exposures to these contaminants at a level that would prompt measures to reduce exposure by the standards that are used to ensure safety of workplaces. Indeed, there is sufficient evidence to be reassured that there are no such risks from the broad range of the studied products, though the lack of quality control standards means that this cannot be assured for all products on the market. "
Following the Drexel University report, a large contingency of scientists, well respected professors, physicians, public policy experts at major universities such as Johns Hopkins University, the University of Michigan, The University of Buffalo, The University Vermont, and The National Cancer Institute of Aviano in Italy have all joined the former Head of the Tobacco Free Initiative for the World Health Organization (WHO), in signing a letter urging legislators and regulatory agencies across globe, including the WHO to resist “[T]he urge to control and suppress them [vaporizers/e-cigs] as tobacco products…” as doing so wrongfully makes vaporizers part of the problem, when in fact they are a solution to the terrible harms caused by smoking. On, May 26, 2014 a letter from 53 specialists in nicotine science and public health policy was sent to the Director General of WHO, which can be found here.
In this letter to the WHO, these experts called vapor products “among the most significant health innovations of the 21st century - perhaps saving hundreds of millions of lives.”
Additionally, we see evidence that vapers are using vapor technology products to make a switch from using harmful combustible tobacco cigarettes. A recent study published by the Society for the Study of Addiction of 6000, one of the oldest and most respected journals in the world, smokers showed that those attempting to quit cigarettes were more 60 percent likely to be successful when using vapor products as opposed to nicotine patches, gum or other OTC therapies. According to this study's author Dr. Robert West, Director of Tobacco Studies at University College London, the second most widely published journal in all of Europe “more than 5000 lives could be saved for every million smokers who switched to e-cigarettes.”
This important line of thought is echoed by many others including former US Surgeon General Dr. Richard Carmona, former CEO of the American Lung Society Charles D. Connors, and Mitch Zeller, the Director for FDA's Center for Tobacco Products who has stated the Agency is keeping an open mind about whether the devices have a health benefit, such as helping someone stop smoking." Zeller says, "If a current smoker, otherwise unable or unwilling to quit, completely substituted all of the combusting cigarettes that they smoked with an electronic cigarette at the individual level, that person would probably be significantly reducing their risk."
SFATA is particularly pleased that the American Heart Association also recognized the magnitude of benefits vaporizers such as e-cigs offer to the population as tools used in domestic public health intervention capable of reducing cigarette induced disease. While SFATA nor its members make any cessation claims, we do believe that AHA's guidance to physicians and counselors in this report are worth highlighting to the extent AHA states: "If a patient has failed initial treatment, has been intolerant to or refused to use conventional smoking cessation medication, and wishes to use e-cigarettes to aid quitting, it is reasonable to support the attempt."
“Electronic cigarettes also have the benefit of eliminating exposure to toxic secondhand smoke. They are helping to reduce disease among smokers and nonsmokers alike,” says Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health – a leading tobacco expert with over 25 years of experience in the field of tobacco control, including two years at the Office on Smoking and Health at CDC.
Arian Saffari, lead author of Journal of Environmental Science, Processes and Impacts noted in his study that the “analysis of secondhand emissions from a popular and widely used e-cigarette brand indicated a very large reduction of particle-phase emissions compared to normal tobacco-containing cigarettes in a real-life setting.” Saffari went on to report that, “emission rates of organic compounds (including alkanes and organic acids) as well as total emission of inorganic elements and metals were also significantly reduced (more than 100 times for organics and 10 times for elements) in e-cigarettes compared to normal cigarettes.”
Recent studies also confirm that there is no comparable risk between tobacco smoke and vapor when it comes to serious adverse health effects and that there is no so-called secondhand vapor from vaporizers and therefore vaporizers pose no discernible risk to the public health (based on the October 2012 indoor air quality study Comparison of the Effects of E-cigarette Vapor and Cigarette Smoke on Indoor Air Quality conducted by CHANGE, LLC at the Center for Air Resources Engineering and Science at Clarkson University in Potsdam, NY).
Vaporizers that feature open-tank systems allow users to customize their experience by selecting their own e-liquid, which contains highly diluted nicotine, or no nicotine at all, meaning users can tailor the level of nicotine to meet their specific needs – which is beneficial to those who want to wean themselves off nicotine. Flavors in e-liquid flavors are necessary among vapers leaving behind harmful tobacco products; according to a recent study by Dr. Konstantinos E. Farsalinos published by The International Journal of Environmental Research and Public Health. Dr. Farsalinos believes that e-liquids are important contributors in reducing the number of people smoking combustible cigarettes.
What is your response to the FDA’s intent to regulate e-cigarettes?
SFATA and its members believe there should be proportionate and appropriate, carefully drafted and narrowly tailored regulations to ensure safety and quality of the products as they continue to evolve and to the extent we believe innovation in this segment of the technology market should be encouraged not stifled.
Unlike the tobacco industry, the vapor products industry is comprised of thousands of young, small, technology companies and entrepreneurs. These companies, including SFATA members located in various parts of the United States, are creating jobs and economic opportunity for thousands of employees. The regulatory and financial burden imposed by being treated like tobacco under the Tobacco Act will crush these companies and destroy their businesses. In the last five to six years, the industry has grown to more than $5 billion globally, and regulations that classify vapor products as tobacco will have drastic economic consequences for the category. Ironically, the proposed regulation would just cede the industry to Big Tobacco, since only those large tobacco companies will be able to afford to comply with onerous rules.
SFATA believes appropriate regulation would include:
· Establishing 18 as the minimum age to purchase vaporizers and e-liquids.
· Establishing proper health warnings, which would be required for certain product packages and advertisements.
· Requiring submission of ingredient listing.
· Establish proper GMP’s for e-liquid manufacture.
· Enforcement against products determined to be adulterated and misbranded, possibly including provision and enforcement of good manufacturing practices, if appropriately tailored to address manufacturing of vapor products.
· Require child-resistant caps and seals for e-liquid containers
Further, any regulations applied to vapor products should be tailored to mitigate the economic impact on small and medium-sized businesses, which comprise a majority of SFATA’s members as well as a significant segment of the nascent vaping industry.