I was saying it is an honour to be able to present testimony to this committee on electronic nicotine delivery systems, ENDS, of which electronic cigarettes are the better known type. My testimony is presented on behalf of the World Health Organization, based on its report on ENDS, which was prepared in response to the request made by the Conference of the Parties of the WHO Framework Convention on Tobacco Control. This report was presented at the sixth session of the COP, Conference of the Parties, which just took place two weeks ago. A copy of this report in English and French has been provided to the committee. My testimony will refer also to the decision adopted by the sixth session of the COP on ENDS, also provided to the committee.
ENDS are the subject of a health debate among bona fide tobacco-control advocates. Whereas some experts welcome ENDS as a pathway to the reduction of tobacco smoking, others characterize them as products that could undermine efforts to denormalize tobacco use. ENDS, therefore, represent an evolving frontier, filled with promise and threat for tobacco control. ENDS deliver an aerosol by heating a solution that users inhale. The main constituents of the solution by volume, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents.
The global ENDS market is presently formed by about 500 brands, which use liquids presented in close to 8,000 flavours. Transnational companies have entered the ENDS market and are increasingly dominating it. Questions related to the use of ENDS as reflected in the WHO report have been articulated in three groups include whether ENDS pose health risks to users and non-users, whether they are efficacious in helping smokers to quit smoking and ultimately nicotine dependence, and whether they interfere with existing tobacco-control efforts and implementation of the WHO FCTC.
When talking about the health risk of ENDS it is important to know that the battery voltage, unit circuitry differences, and the type of solvent used in the liquid result in considerable variability of the level of nicotine and other constituents they deliver, including the formation of toxicants in the emissions.
In the area of risks to health I would like to say three things.
In terms of risks from nicotine inhalation, a key concern with nicotine is its capacity to affect the brain development of foetuses, children, and adolescents; hence, our recommendation to regulate ENDS in a way that avoids initiation of ENDS by these groups.
In terms of health risks resulting from chronic inhalation of toxicants from ENDS, conclusive evidence about the association of ENDS use with specific diseases will not be available for years or even decades, given the relatively recent entry of ENDS into the market and the lengthy lag time for onset of some diseases of interest such as cancer. However, evidence based on the assessment of the chemical compounds in the liquids used and in aerosol produced by ENDS indicate that average ENDS use produces lower exposures to toxicants than combustible tobacco products, although some ENDS can produce levels of some carcinogens that are similar to that produced by cigarettes. Hence our recommendation is to regulate ENDS in a way that minimizes risks for users and avoids the initiation of ENDS use by non-smokers.
In terms of risks to bystanders, they are exposed to the aerosol exhaled by ENDS users, which increases the background level of some toxicants, nicotine as well as fine and ultrafine particles in the air, although at levels lower than that of conventional cigarette emissions. It is not clear if these lower levels in exhaled aerosol translate into lower exposure, as demonstrated in the case of nicotine. Despite having lower levels of nicotine than in second-hand smoke, the exhaled ENDS aerosol results in similar uptake as shown by similar serum cotinine levels. It is unknown if the increased exposure to toxicants and particles in exhaled aerosol will lead to an increased risk of disease and death among bystanders as does the exposure to tobacco smoke.
However, epidemiological evidence from environmental studies shows adverse effects of particulate matter from any source following both short-term and long-term exposures. The low end of the range of concentrations at which adverse health effects have been demonstrated is not greatly above the background concentration, which means that there is no threshold for harm and that public health measures should aim at achieving the lowest concentrations possible. Hence, our recommendation is to protect non-users in indoor public places.
In terms of ENDS as an aid to quit smoking, although anecdotal reports indicate that an undetermined proportion of ENDS users have quit smoking using these products, the evidence for the effectiveness of ENDS as a method for quitting tobacco smoking is limited and does not allow us to reach conclusions at this point. Hence, our recommendation is to impede unproven health claims about ENDS.
From the point of view of the impact of ENDS on existing tobacco-control effort there are several concerns.
One is that ENDS could be a gateway to nicotine dependence and smoking for youth. The likelihood and significance of this effect occurring will be the result of a complex interplay of individual, market, and regulatory factors and is very difficult to predict. They can only be assessed with empirical data which at present are limited. These data show that young, never smoker users of ENDS is about 1% in the few countries which have data. In some countries this figure does not seem to grow while in at least one country, Poland, ever use of ENDS among never smokers between 15-19 years-old has gone up from 1.6% to 7.1% in three years and current use has gone up from 0.6% to 2% coupled with a significant increase of smoking in this age group.
Another concern is the aggressive marketing of ENDS by some tobacco companies to be used in smoke-free environments as a way to break the enforcement of smoke-free policies.
A third and final concern is the role of the tobacco industry that is at the same time marketing conventional and electronic cigarettes in order to dominate the ENDS market and to preserve the status quo in favour of cigarettes for as long as possible. The industry’s historic interest in smokeless tobacco products outside some Nordic countries, for which similar benefits to ENDS were made, was because they could be used, as declared in their own documents, in smoke-free environments and could be promoted to young, non-tobacco users to create new forms of tobacco use. All of this is while they were simultaneously pretending to be part of the solution to the smoking epidemic because they present ENDS as the solution to the epidemic that they themselves have created.
After consideration of the report and extensive deliberations of the COP of the WHO FCTC during the week of October 13, 2014, the 179 parties to the WHO FCTC decided unanimously to welcome the WHO report, invite parties to take careful note of it, and request WHO for an update to be presented in two years. They also decided to invite parties to consider taking measures to at least achieve the following objectives in accordance with national law: first, prevent the initiation of ENDS by non-smokers and youth with special attention to vulnerable groups; second, minimize as far as possible potential health risks to ENDS users and to protect non-users from exposure to their emissions; third, prevent unproven health claims from being made about ENDS; and fourth, protect tobacco control activities from all commercial and other vested interests related to ENDS including the interests of the tobacco industry. It was also going to invite parties to consider prohibiting or regulating ENDS, including as tobacco products, medicinal products, consumer products, or any other categories, as appropriate, taking into account a high level of protection for human health. Finally, they urged parties to consider banning or restricting advertising, promotion, and sponsorship of ENDS, as well as to comprehensively monitor the use of ENDS.
Thank you for your attention.
I'll be glad to respond to any questions you may have about issues pertaining to...[Inaudible--Editor].
Thank you.