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I 0 I 0 US4s9zooZ I PUBLIC HEALTH CIGARETTE, AMENDMENTS OF 1971 '1'VEBDAY, YEHB,IIABY 1, 1972 U.S. SENeTE, COMMn1TF.E, ON COMMERCE, S• URCOMMITTSE FOR CONBUMERa, 1Vashington, D.C. The subcommittee met at 10 a.m. in room 5110, New Senate Office Building, Hon. ; Ffiank E„ Moss (chairman of the subcommittee) presiding. Present : Senators Moss, Pearson, and Cook. OPENIIfti STATEMENT BY SENATOR MOSS ~, Senator Mose. The suubcommittee will come to order. We offer our apologies to you who have been waiting. This morn- ing happened to be the President's Prayer Breakfast at which many Members of the Congress were in attendance and it went on longer than we expected, so we were delayed in getting here and I apolo- gize. gize. Senator Pearson appeared on time at 9:30 and then he had to go to the Senate floor and as_ked to be excused for the early part of the hearing. Senator Cook is here and others of the subcommittee we hop ewill be along eoon. The Consumer Subcommittee is meeting today and on February 3rd and 10th to discuss legislation which I have introduced to amend the Public Health Cigarette Smoking Act to require the Fed- eral Trade Commission to establish maximum levels of tar and nico- tine content of cigarettes. Additionally, during the course of the hearings we will discuss several other aspects of smoking and health which have come to light in recent months. These include : 1. The marketing of little cigars. 2. The status of Federal Trade Commission efforts to require con- s)icuous health warnings in cigarette advertising. The. news last night had something to say on that. 3. The implication in the recent report on the Health Conse- quences of Smoking that confirm the.leg~timacy of complaints by many people of the effects of other people's smoking. Also, we may. diseusa during the_ course of these hearings antismoking commercials in the broadcast media, smoking educational programs and other related matters that may come to light. Back in 1966 the chairman of the Senate Commerce Committee, Senator Warren G. Magnuson, asked the Secretary of the Depart- ment of Health, Education, and Welfare to review the evidence on the hazardous ingredients in cigarette smoke. That review, which was made public in January 1967, stated that : Staff member assigned to these hearings : Edward Merlie. (1)

~ , ~ CONTENTS e Pa Opetyng statement by Senator Moee------------------ ---------- ----- - g 1 COMMITTEE ON COMMERCE Opening statement by Senator Cook-------- -------------------------- Tezt of S. 1464-------------- ----------------------------------------- a 8 ` WARREN O. ][AONUBON, Wa.hington, OAalrwow JOHN 0. PASTURE, Rhode Island VANCE HARTKE, Indiana PHILIP A. HART, Michiglan HOWARD W. CANNON, Nevada RUSSELL B. LONG, Louisiana FRANK E. MOSS, Utah ERNEST F. HOLLINGS, South Carolina DANIEL K. INOUYE. Hawaii WILLIAM B. SPONO, Ja., Virginia NORRIS COTTON. New Hampshire JAMES B. PEARSON, Kansas ROBERT P. ORIFFIN, M1chlgtan HOWARD H. BAKER, Ja., Tennessee MARLOW W. COOK, Kentucky TED STEVENS. Alaska J. GLENN BEALL, Ja., Maryland LOWELL P. WEICKER, Ja., Connecticut FaanaalC[ J. LOaDAN, #taJ Dtrl0tor MICHAaL PaaS/Ca0[, OhteJ OOYIUet S. Lr.a SoTccweel, Oo+urror Ooaree/ Eow.ao MaaLw, ProJeuloxal Staff Yewlwr Aasava PANaorr, Ja., Jtt+wrtty Btay Dtreotor JoHa A. YAaruss, Minority Btaa Ooawoel Coxauxea BU'OOMMT1TiE FRANK E. MOSS, Utah, Cast.raaw ' PHILIP A. HART, Michigan, Y1oe OAa/rwaw JOHN O. PASTORE, Rhode Ialand VANCE HARTKE, Indiana DANIEL K. INOUYE, Hawali WILLIAM B. SPONG, Ja., Virginia MARLOW W. COOK, Ke•ntncky JAMES B. PEARSON, Kansas TED STEVENS, Alaeka J. GLENN BfEALL, Ja., Maryland LOWELL P. WEICKER. Ja, Conneetleat i4s4sqzo6`c CHRONOLOGICAL LI8i1: OF WITNESSES FzzzIIASY 1, 1972 DuVal, Dr. Merlin K., Assistant Secretary for Health and Scientific Af- fairs, Department of Health, Education, and Welfare; accompanied by Dr. John Zapp, Deputy Aseletant Secretary for Legislation ( Health ); Dr. Daniel Horn, Director, National Clearinghouse for Smoking and Health, U.S. Public Health Service; and Dr. Olo Gori, Associate Sci- entific Director for Program, National Cancer Inatitute--------------- 20 Questions of Senator Hartke and Dr. Steinfeld's answers thereto_-__- 46 Questione of the committee and Dr. DdVal'e answers theret,o--------- 47 Ervin, Hon. Sam J., U.S. Senator from North Carolina----------------- 9 Jordan, Hon. B. Everett, U.S. Senator from North Carolina------------- 15 Kornegay, Horace, president, Tobacco Institute, Waehington. D C ____ 71 Letters March 3, 1972-------------------------------------------- , 186 Pitofxky, Robert, Director, Bureau of Consumer Protection, Federal Trade Commission; accompanied by Gerald J. Thain, assistant director for National Advertising; and Allen F. Braunninger, attorney, Division of National Advertleing--------------------------.,------------------ 49 - Prepared statement of-------------------------------------------- , 67 FcsatrAaY S, 1972 , Opening statement by Senator $pong---------------------------------- Oarbo, Paul W., scientific consultant and director, Oeneral Cigar Co., InS. ;' accompanied by George $. Relchart, vice preeident, marketing divieion-_ 168_ Hind, James F., product manager, R. J. Reynolds Tobacco Co., Winston, Salem, N.C. •, accompanied by Max H. Crohn, Jr., associate counee128 Hockett, Robert C., Ph. D., acting eclentiHc director, The Council for To- bacco Research-U.S.A., New York, N.Y..--------------------------- 97,140 Article ------------------------------------ --------------------- 108 Kelley, F• W., chairman of the board, Consolidated Cigar Corp., New York, N.Y.; accompanied by Jack Moguleecu, senior vice president; and Carl J. Carlson, vice president for special proJecta---------------- 182 Sommers, Dr. Sheldon C., chairman, Scientific Advisory Board to the Coun-_ cll for Tobacco Research-U.S.A., New York, N.Y------------------- 88,140 Stephano, Conxtantine, president, IMCAP Corp., Washington, D.C-------- 137 Tiggelbeck, Donald, manager, er, market development, Pittsburgh Activated Carbon Division, Calgon Corp., Pittsburgh, Pa------------------------ ,149 (III) . . ,

Iv Fr®svAsi 106 1972 Pao Opening statement by Senator Mo.s----------------------------------- 108 Banzhaf, John F., III, executive director, Action on Smoking and Health, Washington, D.C--------------------------------------------------- 253 Cooper, Hon. John Sherman, U.S. Senator from Kentucky______________ 198 Edwards, _ dwards, Dr. Charles C., Commissloner, Food and Drug Administration • accompanied by Peter B. Hutt, Assistant General counsel for Food, Drugs, and Product Safety Divislon--------------------------------- 289 Letter ----------------------------------- ---------------------- 246 Furet, Dr. Arthur, director, Institute of Chemical Blology, University of San Francisco, San Francisco, Calf--------------------------------- 208 Biographical sketch---------------------------------------------- 207 Mouhtouris, Charles J., secretary-treasurer, Little Cigar Council--------- 278 Okun, Dr. Ronald, director of clinical pharmacology, Cedars-Sinai Medi- cal Center, Los Angeles, Calif--------------------------------------- 229 Biographical eketch---------------------------------------------- 288 Thurmond, Hon. Strom, U.S. Senator from South Carollna______________ 217 Wilson, Bruce B., Deputy Assistant Attorney General, Antitrust Division, Department of Juetice -_ _ ________________________ 219 Prepared statement---------------------------------------------- 220 Wynder, Dr. Ernest L., president, American Health Foundation, New York, N.Y --------------------------------------- ---------------------- 174 ADDITIONAL ARTICLES, LETTERB, AND STATEMENTS _ ` - - -_ American Health Foundation, division of epidemiology, Health Research _- _ Institute, New York, N.Y., report------------------------------------ 845 Auerbach, Stuart, article ln the Washington Poat______________________ 594 Baker, Hon. Howard H., U.S. Representative from Tennessee__________ 178 Banzhaf, John F., III, executive director, Action on Smoking and Health, letters of : January 25, 1972------------------------------------------------- 604 January 20,1972------------------------------------------------- 814 BeRinger, Dr. Ing. Jan, Totiacco Bmoking Research, letter of February 21, 1972 -------------------------------------------------------------- 828 Berger, Carl O., R. Q. Dun Cigar Corp., letter of February 28, 1972____ 889 ____________________________ 1972_ _ Bromberg Louls letter of April 10 600 _ _ , , , Carter, Hon. Tim Lee, U.S. Representative from Kentucky, statement____ Cigarette Smoking Shows Sharp Drop After British Study, article______ eui 594 Cook, lion. Marlow W., U.S. Senator from Kentucky, statement________ 284 Cooper, Dr. Philip, and Dr. James B. Knight, Jr., article in the New Eng- la ml Journal of ilfediclne--------------------- --_------------------- 784 _ Crohn, Max H., Jr., secretary, R. J. Reynolds Tobacco Co., letter of March 29, 1972-------------------------------------------------=-- 715 Culiman, Joseph F., 111, Philip Morris, Inc., letter of April 18, 1971_____ 598 Curlln, Hon. William P., Jr., U.S. Representative from Kentucky, state- ment -----------------------------------------=------------------- 169 Davis, Rex D., Director, Alcohol, Tobacco, and Firearms Division, In- ternal Revenue Service, Department of the Treasury, letter of January 28, 1972----------------------------------------------------------- 604 Department of Health, Education, and Welfare : Letter ofDecember 1,1972---------------------------------------- 849 Couference Report on Harmful Substances In Cigarette Smoke_______ 857 Evaluation of the 1909 Supplement to the 1967 Public Health Service Review-The Health Consequences of 8moking______________________ 862 Federal Trade Commission, Report to Congrese, Pursuant to the Public Health Cigarette Smoking Act, December 81, 1971---------------- ..__ 888 Graham, James A., Commissioner of Agriculture, State of North Carolina, statement -- - --- - --- - ---- - - ------------------- 80B Herink, Relnhard, P. E., doctoral studlee program, Falrlelgh Dickinson University, letter of February 7, 1972_______________________________ 890 Hockett, Robert C., Ph. D., acting scientific director, The Council for Tobacco Research-U.S.A., Inc., letters of: March 9 1972 ----- 718 , ---------------------------------------------- - ----- btarch 81, 1972-------------------------------------------------- 777 Hoilings, Hon. Ernest F., i1.S. Senator from South Carolina, statement__ 86 C.MS4U.7ZUUT v t Infant Weight and Parental Smoking Habits, arttcle------.............. - Kloepfer, William, Jr., letter of January 81, 1972______________________ Kornegay, Horace R., president and executive director, the 7bbacco In- stitute, Inc., letters of : Paae 297 860 1+'ebruary 8,1972------------------------------------------------- M March 8, 1972------- -------------- ------ --------------------- an Long, Hon. Russell B., U.S. Senator from LonSsiana, letter of May 17, 1972 ------------------------------------- --.--------- --- 844 Morris, John D., article In the New York Times------------------------ ------ Moes, Hon. Frank E., U.S. Senator from Utah, statement________________ 283 Perkins, Hon. Carl D., U.S. Representative from Kentucky, statement____ 170 'Report of "Tar" and Nicotine Content of the 6moke of 121 Varieties of Cigarettes : August, 1971----------------------------------------------------- 813 October 21, 1970------------------------------------------------- 828 Response to Senator Moss concerning Article by J. Cornfield, W. Haeneael, E. C. Hammond, A. M. Lillenfeld, M. B. 8himkin and E. L. Wynder_-__ 461 8nyder, Hon. M. Gene, U.S. Representative from Kentucky, etatement____ 168 8ommers, Dr. Sheldon C., research director, the Council for Tobacco Re- search-U.$.A., Inc., letter of March 80, 1972------------------------ 725 Stewart, Dr., William H., chancellor, Louisiana 9tate University Medical Center. letter------ ------- ------ --- _ 184 The Epidemlotogy of Lung Cancer, artfcle_____________ -- 289 Whiteside, Thomas, article In the New Republic________________________ 247

2 1. The preponderance of scientific evidence strongly euggeets that the lower the tar and nicotine content of cigarette smoke the less harmful would be the effect, and, 2. We recommend to the Surgeon General that action be encouraged which wilt result in the progressive reduction of the tar and nicotine content of ciga- rette smoke. Subsednently, this Consumer Subcommittee held 3 days of hear- ings during the summer of 1967 to review progress made toward the development and the marketing of a less hazardous cigarette. As an outgrowth of those heariugs, Chairman 1ltagnuson requested that the FTC periodically test and report the tar and nicotine content of the various cigarettes sold in the United States. The first of these reports was made public in November 1967. Several cigarette market- ers as well as the Public Health Service have made significant efforts to promote low tar and nicotine content. That activity is to be commended since much of it has been done in a fairly responsible - manner. The next chapter of this sa¢a consists of a request from Chair- man Magnuson to the Public Health Service to prepare an authori- tative report on other hazardous ingredients in cigarette smoke, par- ticularly those that might be present in the gas phase. Prior to the issuance of that report, I appeared in .Tanuary 1971 on the CBS program "The Advocates", to discuss whether or not the Federal Government should establish mandatory limits on tar and nicotine content. Although the most traditional way for the Govern- ment to deal with product hazards is to ban the hazard, this is impractical and undesirable in the case of cigarettes. The alternative remains, however, to set standards to eliminate the most hazardous aspects of the product. Followinq the broadcast of that program I reviewed the literature which had come to my attention and decided that it was an appropriate time to introduce lelvislatiou to establish just such limits.. Chairman Magnuson has authorized me to state that he joins in calling for such legislation. We now move to January 1972, and the release of this year's report on the health consequences of smoking. Chapter 9 which con- stitutes the Secretary's response to the chairman s request for an authoritative review of the knowledge concerning the significance of hazardous ingredients in cigarette smoke unequivically confirms my conviction that the next logical step is the setting of maximum limits for tar and nicotine and other hazardous ingredients. At the present time carbou monoxide is one of those other hazardous ln;aredients. Thus, we meet today to discuss with several representatives of Government aFencies involved as well as with the Tobacco Institute both the legislation at hand and other matters which may arise in the course of our discussions. (The bill follows:) vitS4s9MOT 11 I 021/rCPNaGoxSS , ". .. I , ; M THE BENA~E OF THE'UNITEb STATFB ~ ; Aaau. 1, 1971 Atr. Mor iqtrqduoed the following bill ; which waa tead twice.aad nlerted to the Committee on Commerce 3 So 1454 ' I A- BILL ' 1'o nmend the Federal Cigarette Iobeling and Advertising Act to require • bhe. Fe_ deral Trade Cormmissiap to e.tablish aoo- ' ceptable levela of tarr and nicodiae oanteat gf cigaretter.. ~ ], . &•it, oaqcFrd by tAe ,4eaate and Aow of RepreseHta-•, 21 eivee of tlus Urtitad 3talea of Atneriait in Congrese paaernbled; ~ 3.,ThM. section 3 of the Federal Cigarette Labeling and Adver-.' • 4;. tising Acy is smentied : by - adding..,t the end .t>tereof the b., ,1Q#ov1'in8•new paraB'raph; 6~; :i.!i ~i(7),; ~e tpstt~ `.iUCriqniplated ag0qt' t~tAlAS astty.pupstlt- 7,! ,pent ejetpeut nf Ciganette.nminsream smoke:whic!h fs.presenf#:' 8 in quantities eufiicient to be a health .htsord:' ,.t,,,, 9, i,! .. Seution 7 qf the Federal 0'igaret.te Lsheling and . 10 Advertisittg Act is amended by redesignatjag gubeoctinni)l- 11 • ! Q :0. G 'I I , 4; '1 1 ~IE ~: ; f; ii , s d G~E li ,; i I!IE ,,. 1 i i rG

26 this may affect driving performance in a poorly ventilated, smoke- filled car. I am proud of the leadership which Secretary Richardson has iven to this problem within the Department of HEW. As you may ~now, we are setting up procedures so that supervisors may establish separate work areas for nonsmokers where this is possible; we have established no-smoking areas in our cafeterias; and we are now asking employees and -visitors alike not to smoke in our conference rooms and auditoriums. It is my hope that these steps taken by my Department may serve as an example to other branches and levels of government and to private industry. Irn summary, it is our opinion that all cigarette smoking is dan- gerous and poses an unreasonable health hazard to both th smokers and nonsmokers. Nevertheless, the Department endorses the approach taken in this bill and subject to the qualifications we have suggested, we believe S. 1454 to be a realistic effort to minimize the health risk of smoking in a manner acceptable to the consuming public, which avoids the pit- falls of outright prohibition. Thank you, Mr. Chairman. Senator Moss. Thank you very much, Dr. DuVal, for that very fine statement. Your summary paragraph expressed what I was trying to stress in the first place, but really the best way to improve the public health is to have no smoking at all. But since that is not practical, then we ought ught to move to the next higher level of protection of the public health, which is looking toward the control of the tar and nicotine content and other hazard- ous substances in cigarettes. Throughout your testimony you have made references to new evi- dence, and one of the criticisms in the past has been that there is nothing new since 1964. Are you saying that there_ is new evidenceY And is this clinical, or is it statistical Y Dr. 1)uVAr.. There is new evidence, of course, being recorded each year, Mr. Chairman. One of the first purposes of the annual report we publish is to bring the American public up to date on the evidence that exists. Thie evidence is both clinical and experimental and, as I said, it is compiled and monitored and reported duly once a year through our report. A complete compilation is now in that report. But it is new evidence. Senator Moss. As part of this collection of new evidence, do you also monitor the work that is being done in other countries Y I made reference to the fact that many other countries, Britain and others, are making similar kinds of studies. Dr. DuVet.. Mr. Chairman, we not only monitor the reports from other countries, but we do it through two separate devices so they can be collated to make sure that we get it all. Senator Moss. This bill provides for a definition of tar and nico- tine levels in cigarettes, and whether or not you believe that we can define that now, one, is there sufficient evidence to select acceptable levels of tar and nicotine and other hazardous ingredients 4 And, 9e81!1s9z00Z 27 two, is there adequate technology for the manufacturers to design their products so the, can meet these levelsp .' I) r r. DuVAr.. It is the position of our De artment-and I hope it is appropriately reflected in our testimony-that the setting of a level of tar and nicotine and other incriminated agents is properly the province of the FTC and not HEW, since to take any other position would le to acknowledge that there is such a thing as a safe ciga- rette. We believe that the FTC, with arpropriate advice and counsel, can find levels that would be acceptable to those growmg as well as consumins tobacco. This is confirmed by the fact that in less than 10 years the concentrations of nicotine and tar has been brought down substantially in cigarettes and, at the same time, we apparently have evidence, strong evidence, that there is good consumer acceptability of the milder cigarettes among those who are afflicted with the habit. We know, for example, at this time among females, 76 percent of all females smoking are smoking tobacco that has less than 1.2 milli- grams of nicotine and less than 20 milligrams of tar. In this cate- gory 66 per cent would be true for males. This is quite different than the profile 10 years ago and indicates to me that a level of public acceptability can be achieved. Senator Moss. Would there be an appreciable time lag for the tobacco manufacturers to meet a new level of tar and nicotine con- tent? What time does it take them to do thatY Dr. DuVer.. I think that answer would have to come from those in the industry. And as I recall, the language of the bill does not spell out such a time lag. It would be the position of the Department that any time lag that was necessary to achieve the objective would be acceptable, since in principle this wo_ uld in effect be a type of important legislation worth achieving, and the penalty, so to speak, of the time lag seems to us to be minor. Senator Moss. Now that there is going to be a health warning in all cigarette advertisements, what additional in€ormation be pro- vided to_ the public Y I am thinking about point of purchase displays featuring tar and nicotine information and things of that sort. Do you ou visualize that t Dr. DvVnr.. I do not believe that I could amplify further on the imprimatur of Congress, which has already taken its own position on this matter. We-would go with the viewpoint that you already have expressed apropos the display of appropriate warnings. Senator Moss. In your opinion, do the advertisements for Win- chester little cigars, which are extremely similar to cigarette adver- tisements, undermine the Public Health Cigarette Smoking Act g I have a pack of Winchesters hero. This is the individual Win- cliestis with the filter tip on it. As far as I can tell, it is precisely the same sir.e as a cigarette. And it has shredded tobacco inside. lir. 1)u_ Vni.. Mr. Chairman, I am tempted to answer 66yesf0 but it seems to me that this belongs somewhat more in the jurisdiction of the FT C. And I hope you will address that question to them. Senator Moss. I sha1L In your 1972 Report on the Health Consequences of Smoking Act, there is an entire section devoted to the effect of cigarette smoking 7r-o1+-72--3 I

34 Senator Moss. Is any research being done on drugs that might be used to assist people who are smoking, and want to quit 4 Dr. Goxr. The current pharmacological knowledge in this area is very primitive, and drugs that are currently used do not have a demonstrated pharmacological activity. The National Cancer Institute is sponsoring in the next 2 or 3 months a conference on this particular subject; and we hope to pin- point, avenues of research in this area. Senato- r Moss. On what basis are you now developing a less haz- ardous cigarette Y I)r. Goac. The clues come from two ways. One, the epidemiological studies showing a dose/response relationship in the development of smoking related diseases, namely, if one smokes more, there is a higher risk of develo p- ing disease. The other is the large, experimen- taY evidence that we have in laboratory animals to support the same conclusion. Therefore, we are trying to develop a cigarette that, while main- taining a degree of consumer acceptability, would deliver tar and nic-. otine that would be less objectionable from a healthpo int of view. The approaches used so far have been mostly formulated with the cooperation of the tobacco industry, and by studying the parallel re- search that is being conducted in other countries, particularly Eng- land and Germany. We have been testing several modifications of cigarettes, several parameters that could be changed, with the aim of reducing the haz- ard connected. We have tested the paper porosity, the additives to the paper, the size of the tobacco shredding, the possibility of adding nitrates to the cigarette to improve its combustibility, modifications of the blend, the use of reconstituted tobacco sheets, and other methods of Vocessing tobacco, such as dry-freezing, artifical tobacco substitutes, ~ow-nicotine tobacco, tobaccos that are dewaxed, and, of course, the use of selective filtration. This is the general technical approach we are exploring at this particular moment. Senator Moss. How can you tell that a cigarette is less hazardous 4 In what way do you determine that4 Dr. Goar. The assessments of these experimental cigarettes would be based, eventually on epidemiological evaluations in man. The premise on which we are working is that less tar, less nico- tine, will result in less hazard for the smoker. On studies by Wyn- der, and Bross, it is clearly indicated that people smoking filtered cigai~et.tes have an appreciable degree of risk, but it is as much as 40 percent less than those who smoke nonfiltered cigarettes. This would imply considerable benefits to public health if we would introduce widespread use of filtered cigarettes at this time. For the immediate evaluation of the cigarette, we are using a bat- ter,y of tests in animals which have been recommended by the to- baceo working group, and represent the joint understanding of sci- entists in the Federal Government, the academic world, and the tobacco industry. Senator Moss. Well, what cigarette do you recommend right now as the least hazardous4 What typeY ls it the low tar and nicotine 35 cigarette, or any other type of cigarette that you have experimented with4 1)r. Goat. Our programs started about 3 yearsago , and this type of ~rsearch takes lota of time. We are just now in the process of fin- ishing our first experiments. I do not think that we_ are ready to in- dicate any particular solution for a less hazardous cigarette beyond statinri that it would have to have the least tar and the least nicotine compatible with consumer acceptability at this moment. Senator Moss. Thank you. One final question, perhaps. f n approachin~ the smoking and health problem, why do you put so much emphasls on cancer, and not so much on cardiovascular and respiratory diseasese I)r. Gosr. We nre considering both aspects at this particular time. Our research is coordinated with the Heart and Lung ung Institute. With cooperation between the Cancer Institute and the Heart and Lung Institute, we should be able to provide a comprehensive ap- proach or understanding the problems posed by cigarette smoking in both cancer problem, and the cardiovascular, and respiratory fields. Senator Moss. Thank you. Dr. DuVal, over the past 20 years, the average tar and nicotine has decreased substantially in cigarettes. When may we expect to find a decline in morbidity and mortality, if the cigarette is indeed less hazardous with lower tar and nicotine i Dr. DUVei.. It is very difficult from a purely scientific viewpoint to give you a date. I would suspect that the lag period in terms of catching up on the statistics on consumption from milder cigarettes would probably be between 10 and 20 years. It might be less. But the statistical analysis itself is awkward, because people change their habits, obviously, enroute. So it would require very large numbers to make the case. Senator Moss. Putting that somewhat in reverse, for a long time- because women seemed to be less afflicted • with Iung cancer and these other diseases-it was said it was because they- had not taken up smoking until the last 20 years, in an appreciable degree-and is there a similar lag there that you can see ~ I)r. DuVnr.. Yes, sir; there is a similar lag. And as a matter of fact, the full impact of that change on the national scene has proba- bly not yet become evident. Senator Moss. Thank you very much, gentlemen. My colleague, Senator Cook, will have some questions, I'm sure. Dr. DuVer» Mr. Chairman, could uld I intrude for one moment 4 Senator Moss. All right. Dr. DuVnr.. You asked in my judgment a singularly important question which should have further documentation in the record, and it relates to a question Senator Cook has also touched upon, and that is the evidence that shows, so to speak, that there is a definable dose illness, as it were, curve or relationship. That word, while it can be found in many differentpo ints in the medical literature, is very nicely summarizec~ in the JAMA Volume 213, Issue No. 13, September 28, 1970, in an article entitled "The Epidemiology of Lung Cancer," and I would be pleased to submit a copy of this for appropriate inclusion in the record. 068469?:00Z

22 have higher rates for peptic ulcers than nonsmokers, and, in addi- tion, that their continued smoking appeared to reduce the effective- ness of standard ulcer treatment and to. slow the rate of healing. New experimental studies suggest mechanisms through which ciga- rette smoking may produce this adverse effect. A third chapter of the 1972 report deals with chronic obstructive bronchopulmonary disease, primarily chronic bronchitis and pulmo- nary emphysema. Cigarette smoking is the most important known cause of this group of diseases, having a greater overall effect than either air pollution or occupational exposure. Men and women ciga- rette smokers have an increased prevalence of respiratory symptoms and diminished pulmonary function compared to nonsmokers. Other investigations, and especially those involving high school students, have demonstrated that abnormal pulmonary function and pulmo- nal;v symptoms are more common in young smokers than in non- smokers of comparable age. The chapter in the 1972 report that is most pertinent to this hear- ing deals with the harmful constituents found in cigarette smoke. An array of compounds is listed and an estimation of their hazard is made. The first compounds listed are those judged most likely to contrib- ute to the health hazards of smoking; they are carbon monoxide, nicotine, and tar, the last named being the particulate matter col- lected from smoke after nicotine, and moisture have been removed. The second series comprise a total of six substances judged as proba- ble contributors to the health hazards of smoking: these are acrolein, cresol, hydrocyanic acid, nitric oxide, nitrogen dioxide, and phenol. A final, third series, comprises a larger number of compounds judged as suspected contributors to the health hazards of smoking. This chapter on harmful ingredients is more than a "state of the art" review. It bears directly on the public health challenge of pro- tcctingr cigarette smokers from at least some of the harmful effects of their smoking. This is, of course, the purpose of S. 1454. In 1966, the Public Health Service prepared a technical report on tar and nicotine. This stated what has become me the Public Health Service's position that "the preponderance of scientific evidence strongly suggests that the lower the 'tar' and nicotine content of cig- arette smoke, the less harmful would be the effect." - Among the studies cited in this technical report were several which showed that tar caused skin cancer in mice; and that the tumor-producing capacity of cigarette smoke could uld be reduced by reducing the tar and nicotine content. Since that time, additional studies have been made which give fur- ther evidence that reducing tar and nicotine in cigarette smoke reduces its harmful effects. One of these is the Hammond-Auerbach dog study, which demonstrated that cigarettes with filter tips capa- ble of making substantial reductions in inhaled tar and nicotine were less harmful than nonfilter cigarettes. Studies of lung cancer patients showed there was a lower risk of lung cancer for those patients who had smoked filter cigarettes for 10 years after switching from nonfilter cigarettes than those who continued to smoke unfiltered cigarettes. This sug_ tceste that this lower risk may be due to the lower tar content in filter cigarettes smoked by those patients. 0 It is against this_ background that the current report states : A progressive_ and simultaneous reduction of all substances considered likely to be Involved In the health hazards of smoking should be encouraged as the most promising step available at the present time towards the devetopment of a less hazardous cigarette. Primary emphasls should be given to the reduction of the three substances (carbon monoxide, "tar," and nicotine) named In the first table, and as a sec- ond priority to the reduction of these substances or classes of substances fn the second tsble. . . S. 1454, the bill now before your committee, would require the FTC to promulgate standards establishing the maximum acceptable levels of tar, nicotine, and other incriminated agents that may be present in cigarettes. These maximum levels must be such as not to pose an unreasonable health hazard, and may be reduced (not more than once each year) whenever the commission determines that lower levels are necessary to avoid unreasonable health hazards. Nevertheless, the bill places an important limitation on the setting of these levels. Standards established by the commission may not lower the content of tar, nicotine, or other incriminated agents in cigarettes below the level of consumer acceptability. Specifically, the standards may not require a level of these agents that is so low as to give rise to an illicit market in noncomplying cigarettes. We do not question the practical need for thls limitation. If maxi- mum levels were to be established on the basis of health hazard alone, we would find ourselves banning cigarettes entirely because there is no such thing as safe levels of these agents. Although we recognize that the banning of cigarettes would not meet with public acceptance, there is good evidence that the.public is willing to accept lower levels of tar, nicotine, and other incriminated agents. The keyt perhaps, is to do this gradually. A very considerable reduction has already taken place in this country; the public today accepts a prodiict that it might not have fonnd acceptable a generation ago. We believe that further reduc- tions can and should be made in protection n of the smoker's health, and that S. 1454 will help achieve this. Nevertheless, we would recommend that the bill be amended in several respects. We have pointed out that there are no safe levels of tar, nicotine, or other incriminated agents. Therefore, successive reductions in the permissible levels of these agents, under this bill, should not be made solely dependent upon the avoidance of "unreasonable" health hazards. Necessarily, any given reduction of these levels must emerge from a balancing of con- sumer acceptability of a reduced level against the relative reduction that the level would effect in the hazard to the public health. Or, to cast the point somewhat differently, if a level is to be reduced, as the bill now provides, because it presents_ an "unreasona- ble" health hazard, the bill should make clear that a health hazard may be considered "unreasonable" if the public will accept a lower level, and that lower level, although admittedly not safe, will meas- urably diminish the dangers of smoking. In this regard, we would also recommend that the bill provide that, prior to establishing a given level, the FTC consult with the Secretar•v of HEW with respect to the health implications of the new level. I I I V88469%00Z

28 on other persons. What do you think can and should be done about the problems of air pollution from other pc~ple's smoking4 Should f,•encral regulations be issued on this4 Or should it be left-voluntar- cly as ,you describe it as is being done by the Secretary of IIealth, Ldueaction, and Welfare? I)r. DuVnr.. I would submit that at this time this is an area of individual rights where we are not comfortable in coming down with a firm conclusion. I have spoken publicly in the past about the right of one person to smoke and the right of another person to breathe clean air and observed that there is, in fact, a contradiction between those two rights when they are exerted simultaneouyl,y. It would seem to me that there is no way in which there could be a proper governmental intrusion into that particular confrontation. Aicl 1 would do everything I could until snch time as we reach that point (if indeed we do), to encourage private and local efforts to undertake programs to create awareness of the problem locally and control it even inside individual buildings and rooms. Senator Moss. Well, I can well remember when all public trans- portation used to have an absolute bar against smoking in the vehi- cle, which was the streetcar, mostly, when I was a boy. And that has now been relaxed or almost forgotten. Do you think we ought to move back to that 4 Dr. DuVAz.. If we were able to go back to the days in which we used to ride on the "smoker" railroad car, we might find that the levels of carbon monoxide in those cars was past the point of good judgment to have taken place, had we been able to prevent it. I would prefer that we try to find a way to use our expertise, our thoughtfulness, our technology, to change the rate at which air is turned over in a room; to change the allocation of seat positions in airplanes, or whatever is necessary to try to find some_ b_etter way to accommodate to what is clearly an insoluble problem. Senator Moss. The thing t,hat strikes me is a sort of change in attitude. It seems to me tliat, well, 30 years ago it was generally thought that the smoker was intruding somewhat on the nonsmoker and, in fact, it was customary to ask permission to smoke in a par- ticular place. Now it seems to me it is just the other way; it is pre- sumed that anybody can smoke anywhere he wants, whether it is a movie theater, or aiiy lace else; and the nonsmoker really has no protection anymore. That has come about in the last 20 or 30 years, has it not I Dr. DuVnL. Yes, I think it has come about in 30 years or less. But I think we have reached a point in our own growth and development when, in point of fact, we are becoming more sensitive to the individual ri g-hts of all people, and we are a little less certain as to how they should be exerted. It is possible also that the type of material smoked 30 years ago as an average is different than it is today. There are many people, for example,-who do find tobacco, such as perhaps cigar smoke, some- what more offensive than cigarette smoke. Under those circum- stances, it might be more normal to ask permission to light a cigar than a cigarette. I think the explanation of the observation you have recorded may be a very complex one. 44S84,6( 9?'00Z 2!) Senator Moss. Dr. Horn, I would like to ask a question or two of you. I)r. Horn, a smoker chanes from, say, a 20 milligram tar ciga- rette to a 10 milligram tar cigarette, is there any indication that ho wi Il be smoking more because of that change I Dr. Hortx. We do not have any precise information on the ques- tion as you posed it. The best information we have came from an analysis of data collected on approximately 1,500 cigarette smokers in 1904, who were then requestioned in 1966. The comparison was made of bhe number of cigarettes smoked in both periods of time, and com p- ared for those who had reduced the tar intake and the nicotine intalke of their cigarettes during that interval. What we found was that for those who stayed at the same level of tar and nicotine intake in 1966 as they had been in 1964, 46.5 percent stayed at the same level of consumption, 27 percent decreased their level of consumption, and 26 percent went up. I have got those reversed. It is 26 percent who wont down and 27 percent w -o went up. Among those who changed to a lower tar and nicotine cigarette, the figures were almost identical, 45,5 percent stayed the same; 27.8 perceutt went up; and 27.3 percent went down. 1'he only conclusion I can draw from that is that the factors that make for changing the number of cigarettes that are consumed appear to be independent of whether or not you change the tar and nicotine level of the cigarette. Senator Moss. So from the rather limited sample that you have, it would indicate that people do not smoke more cigarettes yust because they have less tar in them Y Dr. IIoxx. Yes, sir. y pe Senator Coox. Can ou say that from the conclusions and reent- ages you just ~•ave us a -Dr. Honx. Let me amend it a' little bit: We have some new data which are not yet analyzed, and we are in the.process of analyzing them, which represent a more recent period of time. That is, changes that have taken place between 1966 and 1970. We are in the proeess of analyzing these the same way. And since we have more cases-we have approximately 4,000 reinterviews in the case-we should be in a position to look more carefully at people and quite precise catego- ries of tar and nicotine content. So I would like to_ withhold a€nal judgment on this until those data are available. But on the basis of what little data we do have, I would say we have no evidence that a reduction in tar and nicotine plays a signifi- cant role in the number of cigarettes one consumes. Senator Coox. On the contrary, you do not have any evidence thaf~• it does not; or that it doesY You say you have no evidence, but you cannot say at this time, at this stage of the game, that it is to the contraryl And it is because you have not even begun to make an analysis of your new reports t Dr. HORN. That is right. Senator Coox. All right. Senator Moss. My question, of course, was on the old limited sample you had. It does not seem to make any difference in that.

2 1. The preponderance of scientific evidence strongly euggeets that the lower the tar and nicotine content of cigarette smoke the less harmful would be the effect, and, 2. We recommend to the Surgeon General that action be encouraged which wilt result in the progressive reduction of the tar and nicotine content of ciga- rette smoke. Subsednently, this Consumer Subcommittee held 3 days of hear- ings during the summer of 1967 to review progress made toward the development and the marketing of a less hazardous cigarette. As an outgrowth of those heariugs, Chairman 1ltagnuson requested that the FTC periodically test and report the tar and nicotine content of the various cigarettes sold in the United States. The first of these reports was made public in November 1967. Several cigarette market- ers as well as the Public Health Service have made significant efforts to promote low tar and nicotine content. That activity is to be commended since much of it has been done in a fairly responsible - manner. The next chapter of this sa¢a consists of a request from Chair- man Magnuson to the Public Health Service to prepare an authori- tative report on other hazardous ingredients in cigarette smoke, par- ticularly those that might be present in the gas phase. Prior to the issuance of that report, I appeared in .Tanuary 1971 on the CBS program "The Advocates", to discuss whether or not the Federal Government should establish mandatory limits on tar and nicotine content. Although the most traditional way for the Govern- ment to deal with product hazards is to ban the hazard, this is impractical and undesirable in the case of cigarettes. The alternative remains, however, to set standards to eliminate the most hazardous aspects of the product. Followinq the broadcast of that program I reviewed the literature which had come to my attention and decided that it was an appropriate time to introduce lelvislatiou to establish just such limits.. Chairman Magnuson has authorized me to state that he joins in calling for such legislation. We now move to January 1972, and the release of this year's report on the health consequences of smoking. Chapter 9 which con- stitutes the Secretary's response to the chairman s request for an authoritative review of the knowledge concerning the significance of hazardous ingredients in cigarette smoke unequivically confirms my conviction that the next logical step is the setting of maximum limits for tar and nicotine and other hazardous ingredients. At the present time carbou monoxide is one of those other hazardous ln;aredients. Thus, we meet today to discuss with several representatives of Government aFencies involved as well as with the Tobacco Institute both the legislation at hand and other matters which may arise in the course of our discussions. (The bill follows:) vitS4s9MOT 11 I 021/rCPNaGoxSS , ". .. I , ; M THE BENA~E OF THE'UNITEb STATFB ~ ; Aaau. 1, 1971 Atr. Mor iqtrqduoed the following bill ; which waa tead twice.aad nlerted to the Committee on Commerce 3 So 1454 ' I A- BILL ' 1'o nmend the Federal Cigarette Iobeling and Advertising Act to require • bhe. Fe_ deral Trade Cormmissiap to e.tablish aoo- ' ceptable levela of tarr and nicodiae oanteat gf cigaretter.. ~ ], . &•it, oaqcFrd by tAe ,4eaate and Aow of RepreseHta-•, 21 eivee of tlus Urtitad 3talea of Atneriait in Congrese paaernbled; ~ 3.,ThM. section 3 of the Federal Cigarette Labeling and Adver-.' • 4;. tising Acy is smentied : by - adding..,t the end .t>tereof the b., ,1Q#ov1'in8•new paraB'raph; 6~; :i.!i ~i(7),; ~e tpstt~ `.iUCriqniplated ag0qt' t~tAlAS astty.pupstlt- 7,! ,pent ejetpeut nf Ciganette.nminsream smoke:whic!h fs.presenf#:' 8 in quantities eufiicient to be a health .htsord:' ,.t,,,, 9, i,! .. Seution 7 qf the Federal 0'igaret.te Lsheling and . 10 Advertisittg Act is amended by redesignatjag gubeoctinni)l- 11 • ! Q :0. G 'I I , 4; '1 1 ~IE ~: ; f; ii , s d G~E li ,; i I!IE ,,. 1 i i rG

30 Now you are going to have another study that may throw more li litt )r. HORN. Yes. And this would give us additional information. Of course, it is quite possible that some people reduced their tar intake and increased their cigarette consumption. Some people at the same time may reduce their tar intake and reduce their cigarette consumption, whether it is because of lowered satisfaction from the individual cigarette or because they are changing their cigarettes in order to protect themselves. And at the same time that they changed the tar content, they feel they are doing other things to protect themselves by reducing thetr intake. Senator Moss. I)r. Horn, if by regulation we set a maximum level of tar and nicotine in cigarettes at, let's say, 20 milligrams of tar and 1 milligram of nicotine, could you give us a profile of how peo-e ple would be affected by this change, and what this might do for their health 4 Dr. HORN. Our most recent national survey, in which we have col- lected substantial information on a representative sample of the U.S. population, was done in the spring of 1970, and we have figures showing the percentage of people who use cigarettes of various tar levels. In the first place, what you say about the tar level of a ciga- rette is practically identical with what one says about the nicotine level because there is such a high correlation between the level of tar and the level of nicotine in cigarettes as they are actually marketed today. So that when I say high tar, one can make the same statement for high nicotine. And when I say low tar, one can make the same stat,e-t ment for low nicotine. Approximately one-fifth of all cigarette smokers-that is, adult cigarette smokers-use cigarettes that produce 25 or more milligrams of tar; 27 percent of the men and 15 percent of the women. Then below 25 milligrams we have a group of about 6 percent who smoke cigarettes between 21 and 24 milligrams of tar. And then the bulk of the ci arette smokers, two-thirds of them, use cigarettes with tar levels oi~15 to 20 milligrams, with, of course, the most popular cigarettes running around 19 and 20 milligrams of : tar, and representing 41 percent of all the people who smoke. Only 5 percent of adult smokers use low tar cigarettes, defined as under 15 milligrams of tar. This represents 9 percent of women who smoke and 2 percent of men who smoke. These figures airo somewhat different from the ones you would get if you were to analyze sales figures, because sales figures give you the proportion of cigaivttes in the various categories, and I am talk- :ing about the proportion of smokers who smoke cigarettes at these lr,vels. And the distinction comes out rather clearly m some of the fiu•ther comments that I have to make, because the low tar cigarettes tend to be consumed by people who consume fewer cigarettes. The low tar cigarettes comprise a smaller portion of the market that is sold than would be warranted by the percentage of people who use them. + Among men, high tar cigarettes-and I am using "high" as 25 men upr45nto 64,land least by yo ng m n wyho are u der the age of 3~ gro 8884697001 31 They are also used most by the average smoker; that is, the one who smokes about a pack a day; and least by the light smoker, under 15 cil,•arettes a day. 'i'he heavy smoker, t•he one smoking 25 or more ci arettes a day, or over 25 a day, characteristically a pack and a hal~or two packs, is somewhat intermediate. Low tar cigarettes are used more by men over 45, and also are used much more by the very light smokers, those who consume under 15 a day. Among women the pattern of use of high and low tar cigarettes by age and level of smoking is very similar to that of men, al- though, of course, fewer women than men use high tar cigarettes and more women than men use low tar cigarettes. Again, high tar cigarettes are used most by women between the ages of 45 and 64, and least by women under 35. They again are used both by the average smoker and least by the light smoker, with the heavy smoker being intermediate. The low tar cigarettes are clearly used most by the light smokers who smoke under 15 cigarettes a day. And in the case of women, also by the older smoker, women over the age of 55. Senator Moss. I have heard of a number of voluntary efforts going on in other countries to limit tar and nicotine. Can you tell us about efforts in Canada and Germany, and wherever else this is going on Y Dr. Hoxx.. Approximately a year ago, the Canadian Government submitted a bill to its Parliament that would have provided for the setting of a maximum level of tar and nicotine in cigarettes, for their manufacture, and it is my understanding that this bill, al- though it had its first reading, it never went through the necessary second and third readings and debate, but is being reintroduced in this year s session. - Apparently in response to this--and I am simply quoting the t.o-o bacco publications_ as an important source of information-the to- bacco industiy of Canada has voluntarily agreed to set a maximum tar and nicotine level, which was to go in effect-it may be in effect now; I am just not sure of that point. But this was set at 23 milli-s grams of tar. It is also my understanding that there has been a voluntary set- ting of a maximum level of tar and nicotine for filtered cigarettes in Western Germany. Senator Moss. By reducing the tar and nicotine, might we be in- creasing any of the other hazardous substances in cigarettes, such as carbon monoxideY I)r. HORN. This is one of the thorny problems of trying to deal with the harmful ingredients in cigarette smoking. The chapter in the "Health Consequences of Smoking" that deals with this issue was largely the result of a 1-day conference involving a substantial number of people actively engat;ud in research on the question of the in redients of cigarette smoke and its effect on the human budy. ~'liis is one of the most thorny problems at issue. The consensus that is represented in this chapter is that although it is theoretically possible to reduce certain ingredients, and at the same time increase other ingredients, or increase the intake because