electronic nicotine delivery devices challenges and opportunities

1All Rights Reserved Health Sciences Authority

Dr Liu Yan Ping Regulatory Consultant

Pharmaceuticals & Biologics Branch Health Products Regulation Group

Health Sciences Authority, Singapore

Electronic Nicotine Delivery DevicesChallenges and Opportunities

14th ICDRA 3 December 2010


WHO Regulatory Consultation on the Safety of Electronic Nicotine Delivery Devices

6-7 May 2010Participants:

– Delegates of WHO Member States*– Experts– WHO Study Group on Tobacco Product

Regulation (TobReg)– the Convention Secretariat and WHO staff

*Australia, Brazil, Canada, European Commission, Saudi Arabia, Serbia, Singapore, South Africa, Switzerland, Thailand, Turkey, Ukraine and United States


OVERVIEW• What are ENDS?

• WHO Study Group on Tobacco Product Regulation Report (January 2010)

• WHO Regulatory Consultation on the Safety of ENDS (May 2010)– Recommendations

• Summary


WHAT ARE ENDS?Electronic Nicotine Delivery Devices (ENDS) :

– Battery powered devices– Designed to deliver nicotine to the lungs– Contain tobacco-derived substances, but not

tobacco– Variety of brand names and descriptors – e.g.,

“electronic cigarettes”, “e-cigs”


Three main components:– Nicotine cartridge– Atomization chamber– Smart chip + lithium ion battery

5

BASIC DESIGN


MODELS AND BRANDING

BASIC DESIGN


MARKETING OF ENDS

• First marketed in 2004• Significant increase in global distribution and

sales• The increase coincides with the implementation

of Article 8 of the WHO Framework Convention on Tobacco Control (FCTC) that is leading to the introduction of smoke-free environments in many countries


WHO FCTC• Article 1(f) defines tobacco products

as:“those products entirely or partly

made of the leaf tobacco as raw material which are manufactured to be used for smoking, sucking, chewing or snuffing.”

• ENDS are not tobacco products under this definition.

• ENDS are technically not under the reach of this global treaty against the tobacco epidemic.


WHO TobReg and ENDS

• The fifth meeting of the WHO TobReg addressed regulation of ENDS (Nov 2008)

• Recommendation on ENDS to the WHO126th Executive Board meeting (Jan 2010)


Recommendations for Regulatory Policy1. ENDS products should be regulated as combination drugs

and medical devices and not as tobacco products;

2. If ENDS are regulated under tobacco control laws, ENDS should be subject to the same regulation as tobacco control;

3. Regulators should weigh the theoretical benefits of ENDS and the risks that the products will appeal to nonsmokers;

4. Regulatory authority to confirm the evidence before approving these products for sale and marketing;

5. Claims implying health benefits or less harm than cigarettes should be prohibited;

6. Claims that ENDS assist smoking cessation should be prohibited.


WHO Regulatory Consultation on the Safety of ENDS

• Meeting was held in May 2010• The purpose:

– share national regulatory experiences;– raise awareness of potential safety concerns

related to ENDS;– consider current and future approaches to

regulation;– map out means of promoting and protecting

public health through research and the development of clear regulatory guidelines.


Concerns identified:• Lack of understanding of the chemicals used in

ENDS and absence of any published studies demonstrating their efficacy and safety

• Lack of data to confer the claimed cigarette mimicking sensory characteristics when heated and delivered to the lung

• The precise nature and the quantity of constituents in the emissions are unknown

WHO Regulatory Consultation on the Safety of ENDS


Recommendations (1)1. Nicotine is a highly toxic and addictive substance that

poses a serious risk to health. Nicotine and nicotine products for human use should be regulated.

2. ENDS products may be used to deliver other potentially toxic chemicals and drug ingredients. These products are often accompanied by inaccurate information. Regulators are concerned that the quality and safety of these products has not been established.

3. Regulators of medical and tobacco products should collaborate in assessing the regulatory framework within their own countries to determine the most effective means of regulating (or possibly banning) ENDS to protect public health.


Recommendations (2)

4. Where health and/or therapeutic claims are being made or implied, quality, safety and efficacy data substantiating those claims should be presented to the regulator.

5. National regulators are encouraged to inform the public and other interested parties about concerns related to these products, including their safety and misleading marketing, and to share information among themselves about these products, including research findings and related policies.

6. National regulators encourage WHO to facilitate information exchange between tobacco control and medical products regulators.


7. Decided to establish two informal working groups:– A Regulators' Information Document Working Group

to put together an informational document for regulators.

– A Consumer Information Document, addressing the consumer.

Recommendations (3)


Consumer Information Document

Working group led by Health Canada: for consumers and public

- What are ENDS- Perceived benefits of ENDS are not supported - Risks of ENDS and nicotine- No regulatory agency has granted marketing

authorization for ENDS- Advised not to purchase or use these products


• Significant increase in global distribution and sales of ENDS

• No data to support the quality, safety and efficacy of ENDS

• Regulatory gap exists for ENDS• Regulators should assess the regulatory

framework to determine the most effective means of regulating ENDS to protect public health.

Summary


Thank youAcknowledgement:Tobacco Free InitiativeQuality Assurance and Safety: MedicinesWHO

electronic nicotine delivery devices challenges and opportunities

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