Our Global Harm Reduction Programme TMA 2009 David O’Reilly, PhD Head of Public Health & Scientific Affairs © British-American Tobacco (Holdings) Limited 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 Low HighLow Toxicants:nicotine Conventional Cigarettes Heat-not-Burn Cigarette-like Devices Low Toxicant Smokeless Tobacco Non-tobacco Nicotine Products Combustible PREPs

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 Africa with new products

First clinical studies on modified combustible prototypes underway in Germany 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 Selective filter

‘Alternative’ Nicotine Products

E-cigarettes

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 mg 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 Yearly worldwide sales volume 2007, USD millions ESTIMATES ANP categoryElectronic cigarettes Nicotine / tobacco gum Nicotine / tobacco pills Nicotine / tobacco inhalators Nicotine / tobacco gel Nicotine drinks and food Nicotine film and others Number of brands Number of manufacturers Major marketsChina USA EU states Japan Sweden USA UK USA EU states Worldwide online USANot 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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