SJG:NW Mm .20!, 5 .5th September 1974 NOTS. ON TM CURRENT STATUS OF SUBSTI=MS AND POLICY Current trends in tobacco pxices gives added incentive to exploring further use of reconstituted tobacco and non-tobacco substitutes.. B.A.T. policy on the use of substitutes has been -stated slime 1962 as follows: "We wil.1 not use substitutes unless there is* a demonstrable adv"tage on health Since that,time our policy has been modified in some respects largely by the interpretatIon of what we mean by 11demonstrabl* advantageO. The present position is that we regard a matexial as having a demonstrable advantage if It gives cigarettes with lower Uz and lower -nicotine and with carbon mon"ide no'higher and shows no increase In biological activity. Tbe Hunter Committee Guidelines have now helped us to clarify what we mean by biological activity: tbi should cover an examination of the 'One, chemistry Of smoke lacludIng materials such as benz-oyx nitrosamines, hydrogencyanide, etc., it should cover tests for tumorigenicity both by skin painting and by inhalation, it should also involve some general imbalation toxicology. Hunter, of course, is developing his Guidetlines further to include clinical and other human - studies. B'.A.T. could go further than HuntQz in one r2spect: we could take cognizance of the initiation/promotion hypothesis and aim to get both a reduction in total tumorigenicity and in promotion activity. A list'Of substitutes and their present status is attached. TO my knowledge only two of th4se are lik21y at present to show a demonstrable advantaga on health ground that would satisfy us: these are CYTREL and NSM. Presumably we would only use tobacco substitutes if they prove to be profitable in the bzoadest sense, i.e. acceptable to the consumer, acceptable to the cigaxette manufacturex, .. available at the right pricep etc. One other condition, of course, is that they, would not contravene the law in the market -for which the use-is intended. Before they are used in any partIculax market careful consideration would also have to Ve given to any change in the legal position with respect to consumers. In my vLew the fact that tobacco substitutes have been accepted for sale by the German Federal Health Minisury' does not necessarily constitute a demonstrable advantage on health grounds or.provide a basis for use in any other country. The test& carried out under the German law by Professor Xrdje .consists onlk of simple pyrolysis tests and benzpyrene detexmin- ation, on this basis BATFLAK3. CYT-MEL and I'M have, all been cleared. Equally although the H=ter Guidelines axe very much more extensive it does not follow that clearance by Hunter would be satisfactory for clearance either by B.A.T. or for use in-another country. Contd. 01 \ 1%0 BATCo document for Province of BritiSh Columbia 27 October 1999 --2 - This raises Important questions. If - as Xor promotion - we regard Hunter Guidelines as inadequate should we do our utmost to get the Guidelines enlarged or should we be grateful for small Mercies. Should we insist an more stringent requirements to satisfy B.A.T. than are required to satisfy V=tex, or for that matter Krdlej, 'In my view we should get the best legal advice we can with regard to potential markets and our responsibili ties as manufacturers. This advice will almost certainly require us to act responsibly and it may be necessary to got independen medical advice. Suggested actions are as Sollowss- 1. We should get legal advice an our position if we use substitutes In the United Kingdom. Perhaps sixtilarly opinions could be sought In U.S.A., Canada and Australia. 2. We have, -promised to proposo to Amexicam. Calanese a draft agreement for the purchase of CYT2SL. This w6uld, if accepted, comdt us to buying a given quantity of CYMML contingent upon CYTREL in substantial quantities in cigarettes on sale in the U.K. This would cover both consumer acceptance and any revision in Hunter requirements. or reversal after testing on human 3. We sbmld ala to got a. similar understanding with IDL for NSM. 4,,- We should continue to prpss on. with BATFLAKM development and a pxopd;sal vrLI-I be but to the Tobacco Board In this respect an the 20th Septemberi... S. We should make an approach to Courtaulds to exploxe the possibility of some co-operation or a phased joint venture. The mai- attraction here is that it is likely that they could quickly engage in large sca2e production.' 6.. We should diligently inform ourselves with. respect to the other materials, particularly E-custa which is being tested by the N.C.I. in America. 7. We will make a point of examining the Bayer material- when it appears in Reentsma's cigarettes and thus becomes available to us, at least for laboratory work. - S. We should continue the development of reconstituted substitutes with lower biological activity. Rne: Q:~ CN BATCo document for Province of BritiSh Columbia 27 October 1999 BATFLAKR N.S.M. -YTRILL SCUSTA COURTAULDS BAYER B & W HELIPM DUPONT SHAW PRODUCT SUrMN RESEARCH SJG:NW 5.9.74 APPENDIX I B.A.T. product based on chalk and sodium carboxymethyl cellulose. or semi-commercial Approaching decision stagef plant. Weak but useful patent position. ProbablyPid per lb. Product of Imperial Developments Ltd. Full scale 20 - 30 million lbs/year plant under construction. Partially oxidised' cellulose. Useful patent protection. Expensive - probably over I/lb- Product of American Celanese Corporation. Full scale 10 million lbs/year plant under construction. Inorganic additives with cellulose bonder probably carboxymethyl cellulose. Useful patent protection - not impregnable. Price at present values about 75 ji/lb. Product of Scusta. Believed at pilot plant scale but probably no problem in production as is essentially cellulose. No patents. Probably 50 g! /lb. No biological claims but under test by N.C.I. No public information. , Probably v1scose. No patents known. Price - not to be offered for sale but cosU is probably around 60 e /lb. Could be produced readily. No inform ation but will be on test in Germany and samples can then be examined. Almost certainly cellulose based. Batflake iype product based on aluminium compounds. Laboratory stage. Vegetable reconstitution. No biological information. May be an sale in U.S.A. in 1974. No knowledge Presumed dead - was reconstituted vegetable waste but effectively flavoured. Turned down by IDLI B&W and SAT. Patented. Cellulose based. C:> Cl\ ON BATCo document for Province of BritiSh Columbia 27 October 1999