Menthol and Tobacco Regulation A Global Perspective Michelle Dowle International Scientific Affairs Manager (Product Regulatory Science) September 11th 2013

Key Facts Everybody has tasted Menthol Derived from two botanical species and predominantly grown in India and China Used as a flavour

Menthol cigarettes are: Globally available But, represent a small market share (5%) Under regulatory review Science is not always the key driver

What’s happening globally right now? Varied approaches to science-based policy-making

1. WHO: Science Really Matters The Framework Convention on Tobacco Control (FCTC) sets out several binding obligations 177 parties Hold a conference every two years Menthol is one of a number of flavours referred to in the Guidelines to Articles 9 &10 (Product Regulation) Partial Guidelines to Articles 9 & 10 adopted in 2010 state: “Mindful of the provisional nature of the guidelines and the need for periodical reassessment in light of the scientific evidence and country experience…” “The Guidelines drawing on the best available scientific evidence…” “Parties should consider scientific evidence, other evidence and experience of other countries when determining new measures on ingredients of tobacco products…”

2. EU: Science is getting lost Revision of the Tobacco Products Directive (TPD) Binding on all 28 Member States 500+ million population impacted EU TPD2 is still under review Includes a proposal to prohibit characterising flavours, which would include menthol Unclear what scientific evidence, if any, the EU has used to establish its proposal to prohibit menthol Next vote at which menthol is being considered under Article 6 - October 8th

3. Brazil: What Science? In March 2012, a Brazilian regulator (ANVISA) became the first in the world to regulate to prohibit Menthol in tobacco products Implementation was due in autumn 2013 However, implementation has been postponed ANVISA is expected to issue a new regulation

4. Canada: But… October 2009 Bill C-32 was enacted to amend the 1989 Tobacco Act. It prohibits the use of all flavours but MPs made a decision not to prohibit Menthol. In the third meeting of the Standing Committee on Health an amendment was proposed to ban menthol as well. During debate of the amendment a Health Canada representative stated the following: The research we have done indicates that menthol use is actually declining. It is not something that youth view as attractive. When presented with it, they actually refuse it and prefer something else. We do not feel that it is a product that needs to be acted upon, and therefore we are not proposing action. In fact, it goes counter to some of the evidence we have. According to our information, the use of menthol is decreasing. We believe the amendment is not in the spirit of the bill.”

What’s influencing the menthol debate right now? Policy-Maker misperceptions continue to colour regulatory debate

Menthol Cigarette Debate: 3 Concerns Dominate Thinking Increased Toxicity? Increased Addiction? Increased Attractiveness?

1. Toxicity: Are they harmful? Issue Does Menthol increase the harm caused by cigarettes? Example 1 Cigarettes with Menthol are especially harmful to health – German Cancer Research Centre (DKFZ) Germany, Heidelberg, 2012 Example 2 Mentholation of cigarettes has no significant impact on the exposure to smoke toxicants, smoking behaviour and overall cancer rates compared to non-mentholated cigarettes – Kabat et al 2012 It is generally accepted by Regulators that Menthol does not increase the harm caused by cigarettes

2. Addictiveness: Do they get you hooked? Issue Do Menthol cigarettes discourage smoking cessation - are they more addictive? Example 1 Menthol smokers have greater exposure to nicotine and tar, leading to increased nicotine dependence – Henningfield J.E. et al, 2003 Example 2 The results do not support the hypothesis that Menthol smokers initiate earlier, smoke more or have a harder time quitting compared with non-Menthol smokers. – Cubbin et al 2010 Smoking is addictive with or without ingredients

3. Attractiveness: Do they encourage use? Issue Does Menthol in cigarettes facilitate smoking initiation and increase smoking prevalence? Example 1 Menthol Cigarettes are a starter product for youth – Hersey et al, 2006 Example 2 Reactions to initial smoking experiences do not differ between Menthol and non-Menthol smokers - Difranza J.R et al, 2004 What is attractiveness? .

Nicotine and dependence What does the weight of evidence tell us? In 2012 BAT R&D carried out a preliminary review of 240 published research papers dealing with menthol cigarettes Smoking behaviour Nicotine and dependence Harm Initiation Cessation Harm/cancer With menthol -No difference (54) No effect or evidence (19) Increased (9) With menthol- No evidence (6) Inconclusive (9) Contribution (6) With menthol - “Cooling” effect (34) Decreased puff intensity (4) No effect or inconclusive (14) Increased puff intensity (1) Nicotine With menthol - Decreased intake (2) No effect or inconclusive (23) Increased intake (10) Carbon Monoxide No effect or inconclusive (10) Increased (6) Cessation With menthol - No effect or evidence (22) Harder to quit (14) Note: Of the above studies, more than 90% are independent researchers

Conclusion: The weight of evidence does not support the hypothesis that Menthol increases toxicity, addiction or attractiveness But more must be done to: Complete a scientific review Facilitate scientific research to help debunk common misperceptions Evaluate the quality of the science – the BAT Review includes all research papers irrespective of the quality of the science

Thanks for your attention! Feel free to contact me Michelle Dowle: michelle_dowle@bat.com To learn more about our science: www.bat-science.com September 11th 2013