Menthol and Tobacco Regulation

A Global PerspectiveMichelle Dowle International Scientific Affairs Manager (Product

Regulatory Science)

September 11th 2013

Key Facts

Menthol cigarettes are:

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

1. Toxicity: Are they harmful?

It is generally accepted by Regulators that Menthol does not increase the harm caused by cigarettes

2. Addictiveness: Do they get you hooked?

Smoking is addictive with or without ingredients

3. Attractiveness: Do they encourage use?

.

What is attractiveness?

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

InitiationSmoking

behaviourNicotine and dependence Cessation

Note: Of the above studies, more than 90% are independent researchers

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)

NicotineWith menthol -

Decreased intake (2)

No effect or inconclusive (23)Increased intake

(10)Carbon Monoxide

With menthol - No effect or

inconclusive (10)Increased (6)

CessationWith menthol -

No effect or evidence (22)

Harder to quit (14)

Harm/cancer With menthol -No difference

(54)No effect or

evidence (19)Increased (9)

Harm

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

Conclusion: The weight of evidence does not support the hypothesis that Menthol increases toxicity, addiction or attractiveness

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