our global harm reduction programme tma 2009 david o’reilly, phd head of public health &...
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Our Global Harm ReductionProgrammeTMA 2009
David O’Reilly, PhD
Head of Public Health & Scientific Affairs
© British-American Tobacco (Holdings) Limited 2009. All rights reserved. No part of these materials may be reproduced in any form or by any means without the prior written consent of British American Tobacco Holdings Limited, and no responsibility or liability is accepted for any third party reliance on any data contained herein. The data and information used in these materials has been compiled from a number of sources.
A long-term commitment
Our pivotal question
What do we need to do to bring commercially viable,
consumer acceptable reduced risk products to
market?
The Product/Risk Continuum
Risk to user
High
LowHigh LowToxicants:nicotine
Con
vent
iona
l Cig
aret
tes
Hea
t-no
t-B
urn
Cig
aret
te-li
ke D
evic
es
Low
Tox
ican
t S
mok
eles
s T
obac
co
Non
-tob
acco
Nic
otin
e P
rodu
cts
Com
bust
ible
PR
EP
s
Consumer acceptance of
smokeless
PREP development &
assessment
Public Health, Scientific &
Regulatory support
Our Global Harm Reduction Programme- Progress over the last year
Snus test market expansion in South Africawith new products
First clinical studies on modified combustible prototypes underway in Germany
http://www.controlled-trials.com/ISRCTN72157335
To compare the exposure levels of selected smoke constituents as determined by biomarkers of exposure, filter analysis, sensory perception and other parameters when smokers using commercial cigarettes are switched to novel cigarettes
Tobacco diluent Treated tobacco
Opti cal Mi crograph (× 73)
Opti cal Mi crograph (× 73)
Selective filter
‘Alternative’ Nicotine Products
E-cigarettes
0
0.002
0.004
0.006
0.008
0.01
0.012
(0mg) (6mg) (11mg) (16mg)
Claimed Nicotine Loading of Cartridge
Nic
oti
ne
/ p
uff
(m
g)
ISO (E-Cigarette) Intense (E-Cigarette)
ISO regime = 35mL puff/ 2secs duration / 60 secs interval
Intense regime = 55 mL puff/ 2secs duration / 30 secs interval
Analysis of Ruyan Classic E-Cigarette
•The cartridge nicotine loadings claimed by Ruyan were similar to that measured by BAT, with the exception of the 0mg cartridge which was measured in the range of 0.4-2.9mg nicotine
•Nicotine yields per puff were similar irrespective of the cartridge nicotine loading or puffing regime
•All Hoffmann analyte yields were below the BAT analytical Limit of Quantification (LOQ)
•The E-Cigarette does not generate Carbon Monoxide
•The vapour & particulate phases from the e-cigarette contained less compounds than those from conventional cigarettes, however the presence of plasticisers, PG derivatives, flavour compounds and nicotine derivatives was confirmed
Figure 1. Nicotine yields per puff
Electronic cigarettes are currently the biggest business in ANP
~20
N/a<0.5~2 <0.50.5 - 1
>100Yearly worldwide sales volume
2007, USD millions
ESTIMATES
ANP category Electronic cigarettes
Nicotine / tobacco gum
Nicotine / tobacco pills
Nicotine / tobacco inhalators
Nicotine / tobacco gel
Nicotine drinks and food
Nicotine film and others
Number of brands 20+ 1 2 2 2 1 0
Number of manufacturers
50+ 1 1 2 2 1 0
Major markets • China
• USA
• EU states
• Japan
• Sweden
• USA • USA
• UK
• USA
• EU states
• Worldwide online
• USA • Not available yet (some brands failed)
The biggest worldwide ANP market is for electronic cigarettes, which only started up
less than 3-4 years ago. Other ANP categories, although being longer on the market
don’t show signs of rapid expansion
The traditional boundaries of tobacco / nicotine products are starting to blur
* Or nicotine substitute** Pfizer, Johnson & Johnson, GSK, Novartis
Tobacco (and nicotine) Nicotine only*
Combustion (or heat) Smoke-free
•Cigarettes• Machine made• Hand made (roll-your-own)
•Cigars• Large• Little
•Pipe tobacco
•Nasal tobacco• Moist• Dry
•Oral tobacco• Loose leaf• Plug• Twist, roll• Other traditional (e.g. Guthka, Toombak, Ipco Creamy Snuff, etc.)
• “Smokeless” inhalation (Heat-not-burn)
•Nicotine gums•Nicotine lozenges•Nicotine aerosols (sprays, inhalators, etc.)
•Nicotine patches
•Nicotine gel (with tobacco)•Nicotine film (with tobacco) •Nicotine pills/lozenges (with tobacco)
•Nicotine gums (with tobacco)•Nicotine water (with tobacco)
•Electronic cigarettes •Nicotine drinks•Nicotine food •Nicotine snus (tobacco free)•Nicotine film•Nicotine water (tobacco free)
Traditional tobacco space
• Big tobacco companies (BAT, PMI, IT, JT, etc.)
• Long-standing smokeless tobacco companies (Swedish Match, UST, etc.)
• Small producers of traditional local tobacco products
Nicotine replacement therapies (NRT)
• Regulated as pharma-ceuticals or medical devices
• Marketed by big pharmaceutical companies** often with the involvement of generic producers
• On the market for 10+ years (in different shapes and forms)
Alternative nicotine products (ANP)
• Newly emerging small companies with one or few products
• Alternative, non-traditional nicotine delivery technologies
‘Quit or Die’ continues to dominate public health policy for tobacco….
The answer to our pivotal question….?
POLICY
SCIENCE
CONSUMER
PRODUCT
Integrated approach
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