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 sciencebased policy-making
1. WHO: Science Really Matters
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•
•
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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
Example 1
Example 2
• Does Menthol increase the
harm caused by cigarettes?
• Cigarettes with Menthol are
especially harmful to health
– German Cancer
Research Centre (DKFZ)
Germany, Heidelberg, 2012
• 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
Example 2
• Menthol smokers have
greater exposure to
nicotine and tar, leading
to increased nicotine
dependence –
Henningfield J.E. et al,
2003
• 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
What is attractiveness?
.
Example 2
• Reactions to initial
smoking experiences
do not differ between
Menthol and nonMenthol smokers Difranza J.R et al, 2004
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
Harm
Harm/cancer
With menthol No difference
(54)
No effect or
evidence (19)
Increased (9)
Initiation
With mentholNo evidence (6)
Inconclusive (9)
Contribution (6)
Smoking
behaviour
With menthol “Cooling” effect
(34)
Decreased puff
intensity (4)
No effect or
inconclusive
(14)
Increased puff
intensity (1)
Nicotine and
dependence
Nicotine
With menthol Decreased intake
(2)
No effect or
inconclusive (23)
Increased intake
(10)
Carbon Monoxide
With menthol No effect or
inconclusive (10)
Increased (6)
Cessation
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.batscience.com
September 11th 2013