Conclusions and recommendations from 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
addiction.
- The safety and extent of nicotine uptake from ENDS products have not been established. Although ENDS may cause and sustain addiction, evidence
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 evidence
sufficient to establish their actual nicotine dosing capabilities, their efficacy as smoking cessation aids and safety of use is not yet available.
- There is concern that nicotine delivery to the lung might result in stronger toxicological, physiological and addictive effects, and this concern must
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 marketing
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 restrictions
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 the
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 authorities
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 intended, is
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 scientifically
proven to the satisfaction of regulatory authorities.

2.13 Recommendations for clinical trials and other research required
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 regulators
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 implications
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.