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C. SOU1"HaMP1ON ~D BRITISH- AMERICAN TOBACCO COMPANY LIMITED i h=.~ canfidlmill ~ = t~ =mlmrty of Briti~-Amuncan Tobacco E.ompan? Lzrmlld. and rnusl not be copied ar shown to Urlluth(]mld I:m~. ,m==,41~ ~/~T Co LTD - MINNESOTA TOBACCO LITIGATION

EXAMINATION OF A CONCEPT PROPOSED BY GORI FOR ~ATING CIGARETTES REPOET NO. KDo 1789 ~ESTRICTED 25.3,1981 ~THOK; S.R. Hassey ZSSUED BY: D.E. Conway PROG. REF. 26.01.002 26.O1.003 DZSTEIBUTION : Dr. L.C.F. B~claaan Dr. T.',J. ~uL;hes Dr. K.A. Sanfocd K.M. G£bb, Esq. K.S. Wade, Esq. R.G. Nlcholl$, Esq. Herr E. R/tcershaus Dr. F. Seehofer Dr. C.J.P. de Siqueira Mr. W. Van Pucten H. Tudor, Esq. Dr. D.C. FeLcon Library Copy No. 1, 2, 3, II II " " 6, 7 It II 8 " " 9, 10, 11 " " 12, 13 " " 14 " " 15 " " 16 " " 17 .... 18 .... 19 " " 20, 21 COPY NO. t~T Co LTD - MINNESOTA TOBACCO LITIGATION IO ~ I~

Croup P~zsearcb & Deve%opm~uc Centre, Brtc~sh-American Tobacco Co. Ltd., SOUTHAMPTON. 25ch March, 1981 EXAMINATION OF A CONCEPT PROPOSED BY GORI FOR RATING CIGARETTES (Report No. RE.1789 Restricted) SUMMARY Dr. G.B. Gorl, formerly of che U.S. National Cancer Institute, introduced the Idma of 'critical levels' for smokers daily exposure to six constituents of cigarette smoke. Ic was araued, on the basis of opidem/olosical evidence relating co typical pro-1960 U.S. cigarettes, thac £f cercaln 'crlClcal levelst were noC exceeded, then smokers would show no SEnator risk of disease or mortality than non-smokers. These IcriUlcal levels' can be used as • basis for calculaulnE uhe number of cigarettes/day, for any given existing commercial brand, which could be smoked without increased risk over Chat of a non-smoker. Consumer research was undertaken in cite U.K. using a cigarotte raced sccordinS to the Gorl approach at |0 cigarettes/day. The essential finding was chat smokers, especlally low tar smokers, can understand and are interested in Che basic proposition, but are hi6hly sceptical of manufacturer's claims. Third party endorsement from an authoritative, Independent and objective body would, however, be more likely to influence choir attitudes. t-',,',T Co LTD - MINNESOTA TOBACCO LITIGATION ~ O 5~>~ Z'~¢:~/'-~

t -2- Direct comnunlcatloa through brand advertising of any themes typified by "these products are safe to smoke at X cigarettes/day" would have severe legal implications. A possible approach would be to base a claim co the fact that the total deliveries from X clgarettes/day do not exceed those of the six smoke constituents associated with two pre-1960 ~ype cigarettes. It is recomended that Operating Companies should discuss wLth their Public Affairs departments ways of developing third party/medla interest in the Gorl proposition. Consideration ~Lght also be given to ~ne launching of a 'sleeper' brand, albeit on a different platform, with the potential of Kalnln~ sales impetus from any eventual publi=ation of talrd party findings. Iechnical Summary Cigarette design work, covering Virginia and U.S. blended style cigarettes, to aseess the feasibility of produclnS c~garettes with a specific target "Daily Eating" is described. The problem in designing s~=h clgarettes is in achievin~ selective contro~ over the delivery of certain smoke constituents. In the =ase of Virginia cigaretues, deliveries ~ nicotine and carbon monoxide tend to exert control over the "Daily RAting" - number of cigarettes that =an be smoked per day. With blended cigarettes, nicotine end nitric oxide deliveries conuro~ the "Daily A survey of "Daily Ratings" for U.K. low delivery brands over a six =on~h period is also discussed. This survey reveals tba~ if cigarettes ~ers marketed on this basis, problems could be encountered in maintaining t~e "Daily Rating", particularly if this was in excess of I0 cigarettes/day. I';,,~T Co LTD MINNESOTA TOBACCO LITIGATION

-3- INTRODUCTION In the main, league tables tend to be constructed from tar (PMkR4F) a~d nicoClne deliveries alone. Several attempts have been made to rank ,:Lgare~ces on a basis which takes Into account deliveries of addlclonal stroke constituents; notably vapour phase constituents. Such rar~ngs have often led to confusion in the minds of concerned consumers. With a ~Lew to overcoming this confusion, Dr. G.B. Gori proposed a system of ~ ltinE cigarettes by relating their deliveries of selected smoke constituents ~ ) a set of "critical levels" derived from delivery data for pre-1960 ,:~garettes. Thia concept was introduced by Gori durinE his time as deputy director of [he Division of Cancer Cause and Prevenclon at the N,ational Cancer Inscltuce where he had a ~Jor involvement in the Smoking ~d Health Program. A publication of "Daily Ratings" for low tar U.S. brands injected s£gnlflcant lapetus, albait by chance, into the salts of Carlton. It was ~:herafore considered worthwhile investigating the feaslbillty of designing ,=Lgsrettes aimed at achlevlnE specific target "Daily Ra~Ings". Thls report ,:i,~als with several aspects associated with the concept, as veil as d~scrlblni the cigarette design work carried out. The discussion is set ,:),It under the following main headings: Development of the Concept. Calculation of Daily Ratings'. Validity of the Concept. Deslgn of Cigarettes Co Achieve Specific Daily RatinKs. Problems of Maintainlns a Daily Rating for a Brand on the Market. Market Research into the Acceptability of the Concept. t;,,~T Co LTD - MINNESOTA TOBACCO LITIGATION

-4- v DZSCUSSlON 1, Development of the Concept Gorl started by conducttnE a deta£1ed st~tlst£cA1 analysis o£ epide~tologlcal data which associated daily cigarette consumption with increases in risk of mortality from 11 specific disuses (I). 'I1)..e ep£de.Ltolo&tcal data was dravn from published stud£es conducted durin8 the 1950s. Gorl concluded from his analysis sharp compared co non-smokers, apidemdolo81cal studies do not reveal a significantly increased risk o£ disease or mortality for smokers who consumed only 2 pre-1960 cisarettes per day. The averase dellverles of six selected smoke constltuenCs frnm pre- 1960 c£$aretCes were used by Gorl (I) to assisn "crlClcal levels" for smokers daily exposure. The "critical levels" are simply obcalned by multiplylng the £ndfvldual averaEe deliveries by 2. These data are shown below together with the six smoke constituents and the average deliveries. Smoke Constituent Avera6e OeliverT/cix "Critical Level" (pre-1960) Tar (P~F) (mS) 43 86 ~Ltcocine (mS) 3,0 6.0 Carbon Honoxide (m~) Z3 &6 Nitric Oxide (ug) 270 540 Hydrogen Cyanide (u£,) 410 810 Acrolatn (~&) 130 250 Gori's selection o£ the smoke constituents appears to be based on the assertion that these constituents are the ones most frequently cited as contributors to cancer, chronlc pulmonary d£seases and cardiovascular impairment in smokers. The averase deliveries £or pre-[960 cisarettes. I.~ ~T Co LTD - NtlNNESOTA TOBACCO LITIGATION m L..r'l CI;) r',o ,,.c) "--,4

a~e sales vtiihted sverqes in the case of tar and ctcot~s, while the .... sapour phase deliveries are derived from those of the University of ~,ntucky IRI Reference Cigarette. Yn essence, the hypothesis 4s that if smokers exposure to the various sr=oke constituenCs was 1LmLted to the "critical Zevels"s then their risk ,~ disease and mortality would not be substantially above that of non- ~,~okers. It is these "critical levels" that form the basis of the Daily ~cings for cigarettes. Calculation of Daily Katin[~s In 1978 Gorl published a report (2) in which he applied his hypothesis o: "critical levels" to a survey of some 27 low tar U.S. brands. This ~-eport gave detaL1s of the maximum n~bers of cigarettes per day for each h~and Chat a person could smoke without exceeding any of the smoke ,~+nsclCuenC "crlClcal levels". Calculation of the number of cigarettes/day :~ most readily explained by reference co an example; the one discussed below is for a branded product ex U.S. market. Smoke Co~t Icuent Tar (u~) Nicotine (mg) Brand Deliveries (per cig) 2.3 0.38 "Critical Levels" (per day) 86 Calulatlon of Cig/Day 86÷2.3 =37 6÷0.38-16 CO (rag) NO (t~S) HCN (~g) Acrolein (t~g) 3.0 50 21 14 46 540 810 260 46 ÷ 3.0 - 14 540 + 50 = II* 810 - 21 - 39 260- 14 - 19 Daily RatinE (cig/day) 11 I~/,T Co LTD - MINNESOTA TOBACCO LITIGATION c.m (_r'l Co r,o ',,.O Oo

-6- The ealcu~acion simply involves dividing the appropriate "critical level" by the maasur~d delivery of the corresponding smoke consc£cuenc, T~e lowest number obtained £s whac has been termed the Dally Rac£uS. In c~Lls particular example it ts 11 cigarettes/day and the £accor which controls this is the delivery of nitric oxide, Viability of the Concept IC is important to point ouc that while the philosophy behind the Corl concept has certain merlcs iC was not ac all well received. ~ndeed, :tt was the subject of severe public criticism (3, 4), most o£ which emanated from Gori's colleagues and a£fillates in the NCI, who were afraid chat their seneral pollcy and anC£-smok£ng e£forcs would be seriously undermined. Their crlci=Isms tended to be centred upon the assIEnment of the "crlt£cal levels'" and a sumauary o£ chelr main obJecclons is Eiveu below. (a) It was claimed chat many of the assumptions made in the scaclsclcal analysls used co obcaln ch~ dace were invalid or ac the very lease quesclonable. (b) The validity o£ the "crlclcal levels" and the £1Gures for the number of cigarsctas/day was quescloned since they are based on • machine smoked cigarettes. As such, ic was argued, they did not take account of smoking compensation and inhalation and consequently did not reflect the sNuokers' exposure. (c) There was enraged concern that consumers would Interpret the "critical levels" and gigures for the number of cisaretces/day as safe llmlts which imply no risk. IC was argued Chac while epldemlologlcsl sCudles may show no scaclsClca~ly siEnlflcant B,\T Co LTD - MINNESOTA TOBACCO LITIGATION

-7- Increase in risk ic was misleading in the extreme to equate this with a zero risk. ~t is not the p~ace of-this report to coment upon these criticisms, but merely to remark that they are characteristic of those which punctuate the whole debate on smoking and health. It is of more significance to w~ comment upon the company's potential use of the concept as a marketing platform. Essentially this is somewhat limited. Adoption of the concept withln a markeclng framework tends to infer automatically thac average consumpclon of s significant proportion o£ the company's brands worldwide places consumers at risk. LeGal Department in Millbank tended to concur with ~his general view. ~ndeed, they were unvil~ing to •auction any overt use of the concept or reference to safe/safer cigarettes wlchin a marketlnE context. This, however, does not necessarily preclude ca~tlonad reference to the concept within discussions on smoking and health, particularly since the publications by Gori (I, 2) highlight two luportant points. First, Gorl recognises that present day conm~erclal cigarettes have much lower yields of smoke constituents than pie-1960 ci&aretces. Secondly, there is evidence to support a dose response relationship between the ~mounts of smoke constituents inhaled and disease incidence. These points are important since they illustrate the efforts made by the tobacco industry to overcome the adverse assertions regarding smoking and health. 4. Design of CtgRrettes to Achieve S?eclflc Daily RatSn~s The aim of carrying out this work was to assess if there are any particular problems in producin8 cigarettes to achieve a specific Dnily Rating, as opposed to the sore normal situation of desiEulng for a target t~,~T Co LTD - MINNESOTA TOBACCO LITIGATION c~