Introducing Tobacco Harm Reduction Policy into Korea Jaewook Choi, MD, Ph.D Professor and Director, Institute for Environmental Health, Korea University Korean Harm Reduction Association(KHRA)

Agenda

1. Recent Scientific Evidences related to THR

- FDA, USA

- Heat-not-burn tobacco products: A systematic literature review

2. Policy Updates on Harm Reduction Policy Towards e-Cigarettes

3. Conclusions and Recommendations

FDA Permits HnB Through PMTA Following Science-based Review

• Thorough scientific review was conducted, and came to a conclusion that permitting IQOS is fitting as a means to

protect public health because IQOS generates smaller amount of toxins than those by manufactured cigarettes

• Carbon monoxide exposure by HnB aerosol is within the normal range of average environment, while acrolein and

formaldehyde exposure rate is lower than that of manufactured cigarettes by 85% to 95%, 66% to 91% respectively.

• E-cigarettes provide similar amount of nicotine as general manufactured cigarettes, suggesting the possibility of

solely relying on HnB for nicotine intake

• 5 major health impacts (cancer, cardiovascular diseases, respiratory diseases, and reproductive dysfunction, and

addiction) and 18 among 93 (Harmful and Potentially Harmful Constituents (HPHCs) are contained in vapes

Heat-not-Burn Tobacco Products: A Systematic Literature Review

(Ref : Simonavicius E, et al. Tob Control 2018;0:1–13. doi:10.1136/tobaccocontrol-2018-054419)

Key Research Findings

• Separate analysis is conducted between independent study and manufacturer-sponsored research

• Nicotine levels in HnB tobacco sticks

• Nicotine levels in mainstream HnB emissions

• Particulate matter and HPHCs in sidestream and secondhand HnB emissions

• HnB smoking research with human subjects

• Total of 15 researches (5 independent, 10 manufacturer-sponsored) were HnB intake research with human subjects, while 5

among them are RCTs; 5, cross-over; 1 case report; and 3 were epidemiologic investigation.

• Nicotine delivery

• HPHCs exposure level

• Epidemiologic investigation regarding HnB smoking

• Among the three independently-conducted surveys, two were conducted in Japan (n=8,420),

while another one was done in UK (n=12,696)

Global State of Tobacco Harm Reduction

National Academies of Sciences, Engineering, and Medicine (NASEM), USA Public Health Consequences of E-Cigarette (2018.01)

Case : THR Policies in US

Policy Changes Related to THR

• US FDA, since 1995, assumed the role as central responsible government agency regarding tobacco-related regulation,

and successfully formed legal foundation via TCA mainly because policy priority in the US has been shifted to recognizing

public health impact

• FDA’s announcement of its Comprehensive Plan on Tobacco and Nicotine in 2017, prompted dual approaches which

focused on reducing conventional usage of manufactured cigarettes, and determining the role of less harmful products in

the context of public health promotion

Issues among Gateway effects for young adults, alternative effect, and abstinence efficacy

• Gateway effects for young adults: position that views vaping increases the possibility of smoking for youth gains support

via substantial evidence: more studies are necessary to come to firm conclusion

• Gateway is generally used term, however, it has gotten more attention due to the launching of JUUL and its fast growth

in the market: the criticism begins with the notion that JUUL usage will ultimately result in smoking cigarettes. Another

criticism cites FDA’s hands-off policy triggered the growing usage of JUUL by youth

Case : THR Policies in US

Key Learnings

1. PRO THR

In the perspective harm reduction by vaping, excessive regulation against vaping limits smokers’ access to less harmful alternative, thus

leading to conversion of good intention into bad consequences

2. Against THR / More tight regulations

THR is the result of industry adapting to its past lessons of regulatory restriction for profiteering

Large focus is placed on the uncertainty of efficacy of vaping as harm reduction means, greater interest is placed on its gateway effect

Case : THR Policies in UK

Expert and Government Towards THR

• Cochrane Review in 2016

• House on Commons, Science and Technology Committee publishes policy report regarding vapes on August 17, 2018

Vapes, when compared to conventional manufactured cigarettes is proven to be less harmful—by around 95%—than

conventional cigarettes, and noted that the amount of known toxins such as tar and carbon monoxide is almost none.

Although smokers should be encouraged to reach abstinence in principle, however, should they have challenges to do

so, they should be offered to switch to e-cigarettes as a considerably less harmful alternative

Although the health impact evaluation for the long-term use of vapes is not sufficient, the ultimate decision on harm

should factor the comparative risk assessment of the risk between the continual use of conventional manufactured

cigarettes and usage of vaping

• Public Health England(PHE) and the Committee on Toxicity of Chemicals in Food, Consumer Products and the

Environment have collectively continued researches on evidence on the relative risks between conventional

manufactured cigarettes and vapes in their annual ‘evidence review

Case : THR Policies in UK

E-cigarettes are encouraged as abstinence supplements

• In case of UK, it has been concluded that e-cigarettes is significantly less harmful than manufactured cigarettes and is

recommending vaping as part of nicotine replacement therapy, NRT

Accurate information generation that extends public’s right to know

• Message should be clearly communicated on harm reduction through preexisting experience on tobacco harm reduction,

and limited research on HnB

• Ethical issues which address teen smoke barrier policies and diminished smokers’ right to heath

• Long-term health impact evaluation is being conducted

Conclusion

Challenges of Korea’s Smoke-free Policy

1. Dual regulation which causes redundant restrictions

• ”Tobacco Business Act” of the Ministry of Economy and Finance and

“Public Health Promotion Act” of the Ministry of Health and Welfare

2. Excessively uniformed regulation forces either ’smoking’ or ’quitting’

• Current tobacco policy is uniformly designed to promote ‘quitting＇

3. Policies designed to manage or reduce harmful aspects of cigarettes are found lacking

Smoking Rate (Korea)

Conclusion

Paradigm shift in baseline tobacco policy is critical in ushering positive changes

1. Harm reduction, which is supposed to adopt tailored approaches per those who need such support, should start with

the notion that abstinence is not the sole objective of all harm reduction policies, but are more effective when

minimization and reduction become central goal, while recognizing the human rights and societal rights of the users

of harmful substance or patients

2. Two track approaches that promote both prevention of smoking and leading smokers to abstinence are

recommended

3. Domestic smoke-free policies are heavily geared towards leading them to abstinence, and its efficacy indicates low

success rate in reducing the number of smokers

4. In consideration for public health, supplementary policies that encourages smokers who are either unwilling to quit or

those with repeated failed attempts for abstinence to transition into less harmful cigarettes

5. More open platform that welcomes public discussion on utilizing e-cigarettes by introducing the new paradigm of

harm reduction

Conclusion

Policy Insights

1. In order to ensure smoking-related policies to be based on scientific findings, it is necessary to unify those policies

with the Ministry of Food and Drug Safety as done in the U.S. where FDA is responsible for such role and function

2. Policies that not only deals with pricing policy (hike in excise), but also regards smokers’ right to their health should

be reflected in the policies via harm reduction policy adoption

3. Policy adaptation of MRTP done in advanced nations with the purpose of reducing harmful substance generation is

recommended

4. Informing the public on accurate information on Vapes and HnB and substances in the products is fitting approach to

meet the expectation of citizens’ right to know

5. Refinement and updates are required on statistical research on smoking rate and smoking behavior and patterns