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NCAB REC~,'-t1ML`MDATIONS FOR FEDERAL GOVERNMIENT REGULATION 0rr' MAXIMOM, CIGARETTE YIELDS OF „OXIOUS St?O1KE CDt•iPONENTS APPROVED AT THE ~~:O~d;•iBER 19, 1974 MEETING WHEREAS: 1. A v-ery l ow, i nci derrce of primary l ung cancer i s observed by non-smokers, but- the-overti•rhelming majority of the nearly 80,000 current annual deaths in the United States alone is observed-among habitual cigarette _smokers. A dose-response rel ati or.sh i p be tti•reen the number of c i garettes smoked and inciderice of cancer of the lung has been established beyond doubt by.' nume.rous_ ep i demi oi og-: cal studi es i nman . (Notabl e- exampl es--are :- A study by Hammond -and Horn - s-ea Appendix 1-Reference =1i= -Where, compared to non-smokers, the _r-isk--of dying-of lung cancer-is 8 times more for habitual smokers of less than 10 cigarettes a:day, 10.5 times for 10 to 20 cigarettes, and 23.4 tim:es for smokers of over 2(3 cigarettes dai ly: S imi larl~r, - Dol l a-nd- H il l-- see Appendix 1- Refere~-cQ $4 - found that in England the same risk is- 18.4-t:mes higher for -habitual srokers_of-1 to.14 cigarettes daily, 19.86 tires for 15 to 24 cigarettes, and 23.4-3-times-- higher for smokers of over 25 cigarettes daily. The differences among these and other studies-are to be found in the different populations studied, difr"erent ciga,r-ettes consumed and different survey times, but a similar dose-response trend is confirmed by the scientific evidence available, as summarized and highlighted in Appendix 1.) 2. Carcinoma of the larynx and oral cavity, and certain respiratory and ci,diovascular diseases also have shown a dose-response relationship with smoking of cigarettes, and evidence for less- pronounced cigarette smoking of dependence has also been found for cancer of th2-esophagus, of the bladder, of the pancreas, and other forms of disease. (See_Appendix 1) 3. Epidemiological studies in ex-smokers indicate that a diminution of risk of lung cancer takes place after cessation of the habit, and continues to diminish with time. (A notable example of evidence is the study by Doll and - Hill - see Appendix l Reference 04 - where, compared to non-smokers,-the risk of dying of lung cancer for continuing

-smokers is 18.29 times, decreasing to 9.57 times for - those"that have quit smoking fo_r over 5 years, 7 times for those between- 7 and 9 years, -2.57 -times between 10 and 20 years and 2.75 times for over 20.years-after cessat-idr-`of smoking. Other pertinent- references- are - given in Appendix 2.) Toxic components are found in both the condensate and-=e the gas phase of ci=garette s-:oke_ But the primary sources of toxicity so-far identified are tar and n-*cotine and -probably carbon monoxide, nitrogen oxides-and.hydrogen- cyanide.- (See- Appendix 3) 5. The=2xperience of the last 20 years indi-cates t~at the consumer can-be accustomed to the usz of milder cigarettes without causing appreciable marketing changes. The sales- weighted approximate averace cigarette yield of coirmerciai cigarettes marketed in the United States during 1973 was 19.2 milligrams of tar and 1.3-miiligrams of nicotine- - (FTC standards), reflecting current consumer demand and - acceptability. Ho,,rever, se•-reral popular brands are still being marketed wri th tar content of 28 to 30.5 milligrams and nicotine content as hic^ as 2.2 milligrams according to FTC reports. ;See Appendix 4) THEREFORE:- The NCAB recommends legislative and/oi regulatory action by the Federal Government as follows: 1. -A Government agency should be empowered to set maximum cigarette levels of tar and nicotine that will become - progressively lower than 'the 1973 averages of 19.2 milligrams and 1.3-miliigra-s respectively. Such decreases should be underta.k•en slowly enough to insure that no important increase in the number of cigarettes consumed does occur. These actions should insure that a range of cigarettes including sime wfth very low tar and nicotine contents continue to be-available. P

(3) 2.--Se^aus°_-smoking has_a severe impact on cardiovascular and respiratory diseases, the Government agency_empower.ed to regulate maximum emission of undesirable smoke components .should get appropriate tecignical advice frem the National Hearti_and Lung Institute: 3. Pending the accompli_shment_of =the foregoing recommendations -through changes in the existing law; the-President of the United States might consider making a public persbnal appeal to the tobacco and ci-aarette industry for volu~tary; and rapid effort totirards preferential marketing of low tar and -loW nicotine c1garFttes, and towards reduction of other smoke componcnts that may be recognized-as hazardous. The public must be informed tFiat_there is currently n~- knotivn formula -for a safe cicarette, and that t;e restrictions here suggested are likely to produce, but cannot guarantee -a-reduction of hazards *rcm snoking: For health protection, the safest course-is not to smoke at all.- It is particularly inportant that education-in the schools be continued and improved to prevent future generations from acquiring smoking-related diseases. In maicing these recommendations the NCAB also recognizes that total- cigarette banning in the current cultjral, economic and political setting is impractical. The regulation of maximum yields of noxious -cigarett=e components in a gradual way would-permit the cigarette industry a reasonable tfime for utilization and modification of existing_inventories, and development of less-hazardous products.- The-NCRB also notes that other factors, notably asbestos inhalation and uran i um mi ni ng cond i ti ons , have been sho:•.n to i ricrease the susceptibility-_of-cigarette smokers to lung cancer. 0

REFEREPCE APPENDI.. The-scienti_fic 1_iteratur-e-in smoking and_health_ca-nnot be_ reported -hera-in-detail,-because of its vastness.-. This_document offers- guidance td sel-ected_puhl;cations giving critical ana':ysis of the scjentific literature, prominent among which are the Annual Reports to Congress by the United States Sdrgeon-General on the Health Consequences of-Smoking, as compiled by the National-Clearinghouse for_ Smoki ng--and -Heal th.- The additional listing of specific scientific references does not imply that-other stadies-are less important or valid,_but simply offers_selected examples. Some of the-latest information on consumer statistics-and trends in .disease incidence is still unpublished, but it can be described and defended byt expert wi tnesses should .heari ngs become necessary. APPENDIX 1 The 1971 Report to Congress of the L'.S._ Surgeon General on the Health Consequences of Smokin-g-is the most complete compilation of scientific evidence published through the year 1970. Studies published since then have been listed in the 1972, 1973-and 1974 Reports to C-or,7ress.- In the 197j_Report, the references on cancer of the lung are summarized at pages 239 to 276 and tables 1 to 19; references on cancer of the -larynx are summarized at pages 277 to 281 and tables 20, A21, A22, A23, A24, 25-and 26;.references on cancer of the oral cavity on pages 284 to 289 and tables 27, A28, and A29; references on cancer- of the esophagus on pages-239 ~o 293 and tables A29, 30, A31, A31a-, A32 and A33; references on_cancer of the bladder on pages 293 to-299 and tables 34, A35, and A35a. The scientific evidence on respiratory disease is-summarized in _ Chapter 3, pages 139 to 176 and tables 1 to 17. The sci_entific- evidence on cardiovascular diseas-e is summarized in Chapter 2, - pages 21 to 75, tables 1 to- 30. The supplementary reports in 1972, _ 1973 and 1974 review more recent studies-under-the appropriate- - 0 chapter headings. .A G8 Scientific reference highlights are:_ ~ A. Human Data ~ Mortality Ratios for Death from all-Causes 1. H.A. Kahn: The Dorn study of smoking and mortality among- U.S. veterans: Report on eight and one-half years of observation.-tJatl. Cancer Inst. Monogr., 19: _ 1-125, 1966.

Kahn presents extens i ve i nformati on- abou-t- the - relationship bet%•reen smoking and mortality: -- studyinc 293,658-U-.S. veterans, he found that mdrtali-ty ratios of current cigarette smokers compared to those whc-had never- smoked ere 1.7 for death from ala, causes; 10.9 for lung cancer-, 12.2 for errphysema wi tbaut brdnchi ti s, and 1.6 for_coronary heart dYsease. For all categories of current sm:okers, risk was related to amount -smAked and a reduced ri sk was e~r : uenced as duration of di-scontinued smoking increased. . E.W.R. Best- -A_Canadian study of smoking and-health. Uttawa, Canadian:Dept4-of National Heaith_and- - ' Welfare, p.- 137, 1966 Large study of both men and women where it was found that current cigarette smokers had a death rate fQr- overal l rriortal i ty 54`2 hi gher than non-smokers., and ex-cigarette smokers had a comparatively lower rate, which was still 36:~ above the rate for non-smokers. Overal l mortal i ty was e1 Evated after 5 years of ~-smoking and remained elevated as long as smoking continued, and mortal ity was 52% h-igher in-those who inhaled the smoke compared to non-inhalers. Lung Cancer 3: E.C. Hammond: Smoking in relation to the death rates of- one million r^en-and women. Natl. Cancer Inst. Monogr., 19, 127-204; 1966. - Young smokers (i.e.,- between 45 and 54) have the highest mortality ratios -- three times as-great for men, and twice as-great for women if they smoke 10 or more- cigarettes a.day, as compared to non-inhalers. 4. R. Doll and A.B. Hill: Mortality in relation to smoking: Terv years observation in British Doctors. Brit. Med. J., 1, 1399-141G, 1964. _ This study showed that for non-smokers, the death rate from lung cancer was 7 per 100,000. For smokers of 1-14 cigarettes per day, it was.57, for smokers of- 15-24 cigarettes, it was 129, and for smokers of over 25 cigarettes,-223. ~

5. T.A. -Hi r-ayama : A prospecti ve -study- oo the i nfl penc of Ligarette smoking and-alcohol drinking on-the death rates for total and selected causes of death in_Japan.- Smoke Signal-s 16(7), 1--8,_1970. Study_of the 142,857 Japanese women aged_40 and over inciuded- 94 deaths _frorn lung can=cer and showed that the mortal i t~~ *rom lung cancer was 2.44 times_gxeatcr for smokers than nvn=smokers. Women sToki ng- 10-24 -oi garettes- a day showed . a-morta i i ty rati o of -33._14 S-compared wi th 2. 65--women who sr.oked 1-9 cigarettes, a day._ 6: I.®.J. Bross:- Effect of filter=ci_^yarettes_on the-risk of lung- oaocer. - Nati. Cancer Inst. tdonogr ., 28, 35-40 - 1968. Risk of developing lung cancer is reduced about 60% when the smoker switches from non=fi-lter,to filter oigarettes (although risk remains about 4-tfimes that of a non-smoker.l. Smokers for less than-30 years have relative risk 3 times that of non-smokers; smokers for 30-50 years have a relative risk 5.6 that of a_non-smoker,_ smo't:ers of more -than a pack a day for more=than 30 years have a?2-times greater risk of lung-cancer than-non-smokers. E.L. Wynder, K. .labuc-hi, and E.J. Beattie, Jr.: The-- epidemiplogy-of lung-cancer. Recent Trends. -J. Amer. Med. Assoc., 213, 2221-2228, 1970. In a retrospective st::dy, of_21t~ lung cancer men and 420 controls,-it was found that men who smoked-only cigarettrs, had a relative ri-sk of 12.4 and men who smoked pipes and cigars had a relative risk cf 2.0 of developing lung cancer as compared to-the non-smokers. Increased risk was- evi_denced as the number of cigarettes smoked increased.- It was shown that there is a reduction in relative risk of lung cancer 10 years after switching to filter cigarettes. 8. I.T.T: Higgins: _Trends in respiratory cancer mortality in - , the U.S. and in EnglaRd and Wales.- Archiv. Env-iron: Health, 28, 121-129, 1974. In the U.S., male age-specific death-rates due to respiratory cancer have-increased at a declining rate while female rates have increased dramatically since around 195D: both changes reflecting changes- in- smoking -habits -- i.e., more men are smoking less and more women are smoking more. In England - and Wales, male rates have declined under 55, have flattened A O ~ 4

-$- .at ages=55 to 64, and have risen only in=those 65-and over; female-rates have=increased-markedly since_atrout 1957..- Res_pi-rato-ry cancer--death-rates=qf-men__in=England and Wales_have_levelled.off, whereas-in the U.S.,-they continue- to rise even though cigarette consumption - -appears higher in the U.K._- Oral Cancer 9. K_. Rothman-and A. Keller: -The effect of joint exposure to alcohol and tobacco on risk of cancer of the mouth 4nd pharynx. J. Chron. Diseases, 25, 711-716, 1972. The effect of-joint exposure to smoktng and drinking was-:studied in 4883 men ;•iith `squamous*cell carcinoma of -the mouth and ptiarynx, and 447 controls matched-for sex and -age. findividual effects of the two -_exposur es- as wel l as the synergistzc effect were oemonstrated thus indicati-ng that both drinking and smoking are causes of oral cancer. Larynx Cancer 10. E.L. Wgmder,_ I.J. Eross,-& E. Day: A study of environmental factors in cancer of the larynx. Cancer, 9, 389-413, 1956. Of 209 male patients with-larynx cancer, only one was_a- non-smoker compared to 22 among the controls. Estimated relative risks of larynx cancer compared to non-smokers were about 8 for smokers o' 1-15 cigarettes per day, 14 for 16-34 cigarettes per day, 30_for over 35 cigarettes, and 15 for cigar and pipe users. In the 16-34 group examined, risk is markedly increased for those consuming over 7 units of alcohol. - 11. E.C. Hammond, and D. Horn: Smoking and death rates -_Report of 44 months of follo-a-up of 187,783 men. J. P.m. Med. Assoc., 166! 1159-1172 and 1294-1308, 1958. This study included data-cn 24 proved larynx cancer cases. Of these, no cases were non-smokers, 17 were cigarette - -smokers, 3 were cigar smokers, and- 4 used more than one-- type of tobacco product.

Pancreas=Cancer- - 12. E.L. Wynder, K._Mabuchi,_N. '1taruchi a-nd J.G. Fortner: Epidemiology-cf-_ cancer of the Fancreae.-- Journal of -ha-tl . -Cancer=-Inst. , 1973._ The data from this retrospective_study of 163 patients with carc-inom3 of the pancreas indicated that tiis-cancer -predominated among ^aies-, particularly at ages under 50. and was significanyiy associated with cigarette smoking. A suggestive association with cigar smoking was also repor ted. . , _ Cancer of the Urinary Bladder 13. -E.L. Wynder, J. Onderdonk, and N. Mantel: An Epidemiological inves_tigation of cancer_of the bladder.- Cancer, Vol. 16-, 1963. In a strady-of 300 bladder cancer patients and 300 controls, the relative risks of bladder cancer compared to non-smokers- were found to be 1.6 for smokers of 1-15 cigarettes per day, - 3.4 for smokers of 10-34 cigarettes,-5.4 for over 35 per day,-and 1.0 for cigar and pipe-smokers. 14. P. Cole, R.R. Monson, H. Haning and G. Friedell: Smoking -and -cancer of the lower urinary--tract. New Eng. J. Med. - 284, 129-134, 1971. Study= of 470 patients ti•litfi- trans itional or squamous cell carcinoma of the lo,rer uri.ary tract, and 500 age--and sex-stratified controls i-ndicated that: 1) among men, cigarette smokers have a relative risk of bladder_-cancer of 1.89 as compared to non-smolsers ; 2) among women 20 years old and older, the relative risk was 2_00; 3) for both sexes risk increases with heavy smoking and with inbalation practices._ No significant risk was found to be associated with pipe or cigar smoking.- Emphysema -15. 0. Auerbach, E.C. Ha=:nond-, L. Garfinkel and C. 8enante: Relation of smoking- and age of emphysema. New England Journal of hied., 286, 853-357, 1972. 9 O r In this study, a dose-response relationship was-found for the number of cigarettes s.noked per day and the severity of emphysema. Of 1,443 men studied, 90% of the 146 men

who never smoked-regu-larly had no emphysema, 10ZA; had moder--ate-emphyse^:a, and none were advanced cases. Of i81 subjects who s.,~oked -1-19 cigarettes per day; 13% had no emphyse-;a -and 12 9 were advanced cases. ~ Of 658-v:hQ -smoked,- 20 or more per day, only 0.3100 did-not have some-emphysema, and 1_2%-.~ere advanced.- 16. I.1".T. Higgins: The epide~riology of=chronic respiratory -disease. Preventive t~ted., 2, 14-33, 1973: -_ Review article-of pertinent data which concludes that smoking (particularly cigarette smoking) has been related-to the cadsation of Chronic r.espiratory Disease (CRD; more consistently than -anl other environmental factor. in addition to the _dir_cr affect cigarette smoking has on the= body, data sua:.est that srr:oking may act indirectly _ to modify the effect produced-by other environmental` pollutants as ~rell. Coronary lleart-Disease 17. W. _ D. Kannel, 1J. F. Castelli, and P.M. McNamara. Cigarette -_ smoking-and-risc o+ coronary heart-disease. Epidemiological clues to pathogenesis. -The Framingham Study. Natl. Cancer Insti tu: e;:znogr.,, 28: 9-20, _1968. ingham experience indicated that the Data based on the Fram risk of CHD was prc~crti-onal to the intensity of the smoking , habit but not to its duration which strongly suggests-a transient, non-cum:,-lative effort. The adverse effect of smoking was less prc^cunced in women,- but giving up_the habit was shown_ to -prcduc? a p.ro;»pt loss of the adverse effects - in both men and women. _ 1$.--J. Staml•er and F.H. Epstein: Coronary heart disease: Risk factors as guices to preventive action. Preventive Medicine, 1, 27-43. 1972. An extensive review article relating CHD to various risk factors indicating shat the most effective combination-of variables _knowm for the identification of persons -prone to develop manifest coronary heart disease in-5-10-years are: hypercholesterolemia;_ hypertension;-and cigarette smoking. It has been proved that there is a steady incren:ent in risk as the level of the variables rises; moreover, - cigarette smoking consistently makes-an independent and additive contributicri to risk of sudden-death, coronary death, and death from all causes.

/ L Experimental Data 19. E.L. Wynder, -P. -Kopf, and H. .Ziegler--_-A study of tobacco ca:^cinogencsis._ II. Dose-respdnse.-s-tudies. Cancer,- - 10, 1193-1200,-1957. -There is an optimum as we;1-_as a minimum concentration of tobaccQ tar that wi l lproduce papil loma}- ar,d cancers of __ -the skin in mice. Optimum dose is in part dependent on the toxicity of the tobacco tar. Mihimuc^ dose of tar capable-of producing papillomas in mice is aoout-Qne-tfii.rd that of the optiru.r, dose;- a--nd, of producing cancer, one-half : of that dose. 20. _-F.G. Bock and_-G.E_ MorA: The sigri=ificance- of mouse ski-n tests of cigarette smoke condensate. In=T_abacco and Heaith (G. James and-~l-. Rosenthal, eds.), Charles Thomas, Springfielc, I11., 72=-86,' 1962. Study of the-dev-el_opment of mouse skin_tumors and cigarette "tar" showed that nearly linear dose-response dependence.- - This dependence see:-ed to be the rule whenever moderate levels of dosage-wer-e used. 21. -E.L. Wynder and D. Hoffmann: Reduction of tumorigenicity of cigarette smoke. J. Am. Med. Assoc., 192, 88-94, 1965.- Study reviewed various approaches to the modifications-in the make-up of cigarettes. The-investigators demonstrated- that reduction of total smoke condensate yield,' selective reduction of-tuToricer,ic-agents, and selective-reduction - of ciliotoxic acents, can significantly iower-the tumorigenic as well as the ciliotoxic activity of cigarette smoke condensate applied to a variety of animais and-animal tissue. 22. T.D. Day: Carcinogenic action of cigarette smoke condensate on mouse skin.- Brit.- J. Cancer, 31, 56-81, 1967. Large-scale study using approximately 8,000 mice in England demonstrated that cigarette smoke condensate causes skin tumors when applied topically. 23. W.- Dontenwill, J.J. Chevalier, H.P. Harke, U. Lafrenz,-G. Reckzeh, and B. Schneider: Investigations on the effects of chronic cigarette-smoke inhalation in Syrian golden hamsters. J. Iaat1. Cancer Inst. t 51, 1781-1832,_ 1973. -