NOTES ON STRATEGIES FOR LESS HEALTH-CONTENTIOUS PRODUCTS By: W. D. E. Irwin The Case for Reducing Smoke Dose From epidemiology. lower cigarette consumption correlates with reduced risk of certain diseases. These notes assume ilia contention of a causal basis for the correlation. (I bough this has not been validated. Lower cigarette consumption is equivaler-' lo lower total smoke dose, provided it is not offset by: I . Higher cigarette delivery (machine); 2. Greater human smoking Intensity (compensabon type A). Early epidemiological data were obtained at a time when the current range of deliveries was not available. Therefore the first condition probably held. The second condition probably held as well, but no justification Is given here. Total smoke dose = Unit dose x units consumed Therefore there should be a lower epidemiological riskirom lower total smoke delivery products provided this is not offset by: 1 . Greater smoking Intensity (compensation type A); 2. Gteater unit consumption (compensation type 8). Hence Ilia need for research to understand what people smoke for, e.g.: Nicotine dose (pharmacologicaf); Nicotine impact (sensory): Flavour; 'Sinoke'; Something lo do; Other, or combination. Studies of Ilia affects of such factors on compensation types A and 8 behaviour are -also indicated. I. lowever. smoke is a complex mixture, so when we talk about lower dose of delivery. do we need to reduce everything. or can we be more selective? C) 00 BATCo document for Province of British Columbia 19 April 1999 Three Sliawgies S(ratec jy ldetitity.Ilierisk-c.-tusinqsubstancesititobaccosmokeandref7iovelliemselectively. 'I his has tho ndvaistage of leaving Ilia positive features, what people smoke lut, assuming I I iere is no serious overlap between 'desirable' and 'undesirable' substances or characlefislics. aLaWy- 2 The Opposite of the above. Reduce all deliveries by 'broad spectrums methods, Le. mainly filtration, ventilation and reduction In thewelght of tobacco or similar materials. Build back selectively desirable sensory and other elements. This has the advantage of not identifying risk causes, or finding selective reduction methods. However, it does imply identification of positive elements for add-back. Siratega ('Alternative pr6ducil This recogo@ses some of (lie limitations of I and 2. both of which burn tobacco or Similar to give a higlily complex pyrolysis-based aerosol. Donotburntobacco.'butfindawaytodeliversomeoralloithesensMcharacteristics of tobacco smoke in a simple chemically defined form allowing similar usage patterns to a cigarette. The Three Strategies @ Further Contrasts/Problems etc. In reverse order: Strategy 3 1. It could be labelled a drug delivery system. 2. Added nicotine - new hazards (health Of Political) - limits 10 nicotine quantity and concentration. A non-nicotine option? 3. Other 'now' hazards? 4. Despite above, greatest potential on bio, activity. 5. Greatest now technology requirement. 6. Full tobacco sensory property range unlikely to be rearmed from a relatively simple 'smoke' compositions C:) Qn Co BATCo document for Province of British Columbia 19 April 1999 Sti - I 2 i 'rite evolutionary approach implemented over 20-30 years. 2. Sortio encouragement from lhe epidemiology. 3. But compensation is a continuing issue. A particular problem if consumer Smokes for 'smoke'. see earlier - Smoke a PMWNFI 4. Poinis to more radical efforts In sensory adjustmeni, e.g. GREENDOT. 5. Benefits from some residual tobacco smoke, hence some residual sensory cl unlike Strategy 3. 6. However, residual tobacco smoke means residual biological activity. 7. Less chance of new hazards than Strategy 3. unless sensory adjustment at very low PMWNF introduces Strategy 3 Issues. S. Lower now technology requirement than Stralogy 3, though 'extreme' options may move technology towards Strategy 3. e.g. sensory adjustment. SO aleav I This would be the ideal, indeed the only, option if smokers smoke for 'smoke' and a substitute simple chemically defined aerosol such as glycerol could not be found which would replace tobacco smoke sensory a"utes. However, there are two major and related problem areas - Identifying the risk causes and removing thein -selectively. A. Identification of [tie fisk causes I . Smoke contains thousands of chemicals - weighting their contributions to the risk. 2. Probability that health effects are not addiUve, i.e. interaction. the whole not equal to the sum of the parts. 3. Part of (lie risk may not be chemically based. e.g. physical Irritation by smoke in a more holistic sense. 4. Al least 3 disease types. 5. Problem of proof Mat selective reduction of certain substances or substance classes lessens risk. EpidemioiogymaybotheniostdefiniOve.bu(woufdagres that bio tests offer some measure of progress, some method of 'weighting'. B. Selective ren loyal, it large( substances Idendried I lot I crises there we multiple tobacco sources of a given noxa, e.g. . catechol probably front polyphenols, sugar, cellulose and others. lt@b CD U1 co Ln BATCo document for Province of British Columbia 19 April 1999 2. in rimi)y cases there are multiple smoke components from a given tobacco source. e.g. calechol. CO and aldphydes frorn sugar. Some of these smoke Components will be desirable as well as undesirable. 3. Flom I and 2, as Ilienumberof target noxae increases. II ie numberol precursor substances for removal or modification will Increase rapidly with probable rapid effect on desirable smoke components as well. Indeed. the ability to reduce noxae relative to tar (r. smoke) will decrease because some of the precursors (nay be major tar producers. e.g. cellulose. Limits to specificity in tobacco modification. 5. The above points explain why Strategy 2 has been adopted so far. Some Conclusions on Programmes Related to Strategy I The selective reduction of 4 finite group of substances will not attract a strong consistent scientific or political consensus that it Is 'safer' than Strategy 2 products Which give non-selective reduction of all components and therefore must reduce the dose of other unknown risk-causing variables, provided compensation Is controlled. However. there will continue to be scientilidpolitical hypotheses creating pressures for the reduction of certain smoke components. even though it cannot be proved that such reductions give a safer smoke. An example might be the numerous papers from the Hoffmann school pressing the case for nitrosamine reduction, even though certain epidemiology based considerations may suggest no measurable contribution of these to the epidemiological risk. The hypothesised smoke components will change from time to time, In part due to the changing research interests of influential workers. making prediction difficult and literature awareness Important. However, to allow any focused research activity, some guestimate must be made of the likely substances In terms of current and potential interest. e.g. the SRG list. Potential "Other Noxae" Goals I . Maintain a Company knowledge base. supported by our own research. on the health-contentious substances In smoke and the factors which Influence their levels. This is part of a wider activity to maintain a knowledge bass on the smoking and health part of the environment in which the Company must operate. and to interact with it as necessary. Another aspect of this goal may be 'due diligence' in understanding the properties o(the product we sell. 2. As an extension of 1. to provide background research information on the opportunities for, and limitations to, the selective reduction of smoke levels of health-contentious substances. C:) L.n CO Lrl Ln BATCo document for Province of British Columbia 19 April 1999 5 3. As an extension of 2, to develop products giving selective reductions In target substances. Further Notes A particular Regulatory Authority whim to 'league table' one specific substance. e.g. nitricoxide. or one specificbiologicalpararrieter. e.-g. Ames activity, may offer product opportunities. but is quite different to a 'GRAS' (generally recognised as safer) product. The feasibility of meeting a paMcutar whim will depend on wheMarthe noxa has finite. preferably one, main source (e.g. nitric oxide) or Ls mulbsourced (e.g. aldehydes). For many vapour phase noxao, the simple vapour phase selective property of carbon filters should not be forgotten. This represents 'cure'. removal after formation. -whereas the other noxas programme concentrates on 'prevention', by tobacco modificit0on. The sensory and process cost/noxa benefit raUo Is likely to favour carbon filtration (existing technohW) for substances such as acrolein. If our research goal is to effect addWonal reductions beyond current technology, which it is. then the carbon argument can be Ignored, though not it there were a product development need now. However, this is getting a bit detailed and I rest my case. I hope it provides food for thought. W.D.E. Irwin C) Ln CD Ln L^1 O\ BATCo document for Province of British Columbia 19 April 1999