see also: Int. Union Against Lung Disease 2013
California Department of Public Health 2015
Deutsche Gesellschaft für Pneumologie 2015
the "Report on the Scientific Basis of Tobacco Product Regulation"
prepared by the WHO Study Group on Tobacco Product Regulation
(publication date: 2010)
2.11 Conclusions (page 10)
- ENDS (Electronic Nicotine Delivery
Systems) products claim to deliver nicotine, an addictive
chemical, via the respiratory
system with the purpose of facilitating and perpetuating nicotine
- The safety and extent of nicotine
from ENDS products have not
been established. Although ENDS may cause and sustain addiction,
for potential addiction and the frequency with which addiction occurs
does not currently exist.
- Manufacturers have marketed ENDS as smoking cessation aids, and these
products might be effective in this respect; however, scientific
sufficient to establish their actual nicotine dosing capabilities,
their efficacy as smoking cessation aids and safety of use is not yet
- There is concern that nicotine delivery to the lung might result in
stronger toxicological, physiological and addictive effects, and this
be addressed in scientific studies.
- Lung delivery of medications, independent of the effects of nicotine,
is of global importance and must be addressed in scientific studies.
2.12 Recommendations for regulatory policy
- ENDS products should be regulated as combination drugs and medical
devices and not as tobacco products. Notwithstanding the various
strategies, ENDS might facilitate and perpetuate nicotine addiction.
- If ENDS products are regulated under tobacco control laws, the
manufacture, sale or importation of these products should be subject to
regulation of the contents and labelling (Articles 9–11), prohibition
of public use that might expose others to emissions (Article 8) and
on advertising, promotion and sponsorship that appeal to adolescents
(Article 13). Countries might consider granting exemption and
concurrent jurisdiction with drug regulatory authorities only if ENDS
products are proven to be safe and effective as smoking cessation aids.
- Regulators should weigh the theoretical benefits of ENDS as smoking
cessation aids against those of current NRT products and the risk that
10 products will appeal to nonsmokers, that is, the risk that
nonsmokers will be drawn into nicotine addiction.
- Manufacturers and retailers must provide evidence to define the
appropriate uses of, exposure to, and safety of ENDS, and regulatory
should confirm the accuracy of this evidence before approving these
products for sale and marketing.
- Claims implying health benefits or less harm than cigarettes should
be prohibited, unless the safety of these devices, when used as
scientifically proven to the satisfaction of regulatory authorities.
- Claims that ENDS assist smoking cessation should be prohibited,
unless the efficacy of these devices, when used as intended, is
proven to the satisfaction of regulatory authorities.
2.13 Recommendations for clinical trials and other research
for regulatory approval
- Research should be conducted on the delivery and absorption of
nicotine from ENDS use, in both the short and the long term, to enable
to establish the dosage and formulation for regulatory approval.
- Research should be conducted on the behavioural and physiological
consequences of using ENDS.
- The dependence potential (also known as ‘abuse liability’) relative
to cigarettes and NRTs should be studied.
- Short- and long-term effects of human exposure should be monitored to
determine potential harm.
- Post-marketing studies should be conducted to determine patterns of
use, such as dual use, to monitor adverse effects and to determine the
for initiation and cessation at individual and population level.
The Study Group intends this new set of
recommendations to be useful to WHO Member States and national
policymakers and regulators in shaping tobacco control policy.