A N I N T E R N A T I O N A L J O U R N A L

Editorial

What should be the elements of any settlement with thetobacco industry?

IntroductionHie epidemic of disease caused by tobacco use has largelybeen a twentieth century phenomenon. As this centurydraws to a close, reaction by both the public and privatesectors has focused on the role of the major tobacco manu-facturers in creating and maintaining demand for anaddictive product marketed to children that kills a largefraction of those who use it as the manufacturersrecommend.

The causal relationship between smoking and disease,and the addictive nature of cigarettes, are widelyrecognised by the general public. The impact of tobaccoadvertising and marketing practices on smoking initiationby children is also a principal concern of the public healthcommunity. Local, state, and federal actions haveincreased the cost of, and decreased adolescent access to,cigarettes; but adolescent tobacco use has recentlyincreased,' reversing a decline over the last two decades.The United States Food and Drug Administration (FDA)has asserted jurisdiction over nicotine as a drug, and overcigarettes and smokeless tobacco products as drug delivery-devices, and they have promulgated regulations to reducetobacco advertising and marketing targeted at children.3

A large number of state attorneys general have suedtobacco companies to obtain reimbursement for stateexpenditures for smoking-attributable disease and toprohibit tobacco marketing to children. Several class actionlawsuits have been filed on behalf of those addicted tocigarette smoking and those exposed to environmentaltobacco smoke.

As a result of these multiple pressures, and mostparticularly the litigation pressure, the tobacco industrymay be willing to moderate its 40-year history of denial andobstruction. Tobacco manufacturers may be willing toaccept a negotiated settlement to address the problemscreated by their behaviour and their products. Representa-tives of several tobacco manufacturers have suggested thatthey might be willing to pay a substantial price, and changea number of their practices,, in exchange for limitation oftheir liability.34

Rumours continue to circulate about the possibility of asettlement with the tobacco industry, mediated by orthrough Congress. These rumours force the questions ofwhether the public health community should support theconcept of a settlement; and if so, what should be the coreprinciples that the public health community define asessential to any agreement?

There are several reasons to be "wary" of a legislativesettlement, including: (a) the public health communitydoes not have a seat at the negotiating table; (b) the otherParties involved have specific interests that are completelycontrary to ours (the tobacco industry) or at least not per-

fectly congruent (the state attorneys general); (c) ongoinglitigation poses a major financial threat to the industry, andprovides a steady stream of incriminating evidence againstthe industry and media coverage about tobacco and health;and (d) in the past, congressional legislative compromisesto secure industry buy-in have diminished or subverted theoriginal policy objective^ Moreover) other questions havebeen raised about the implications of a settlement.6

However, if settlement negotiations or legislation beginto move forward meaningfully and the public health com-munity adopts the position that no solution is acceptable,then it is likely that public health concerns will be peri-pheral rather than central to the resulting legislation oxagreement. Because this may be a once-in-a-generationsituation, the public health community must fight for acomprehensive package of truly effective tobacco policies.5

What are the minimum elements that the public healthcommunity feels are essential to any legislation orsettlement? The relief sought by the tobacco companies iscomprehensive and would limit liability for the damages orinjuries caused by their products or actions to date. There-fore, the appropriate exchange should include both accept-ance of responsibility by the tobacco companies for theproblems they have created, and actions on their part toreduce the death and disability caused by smoking as rapid-ly as possible.

The minimal corporate responsibility expected of acompany manufacturing a product that injures those whouse it is for that company to admit that the risk of injury isreal, to redress existing damage, and to mitigate futuredamage. Any proposed limitation of liability for tobaccomanufacturers must fulfill these criteria. It is useful todefine in some detail what these obligations might generateas terms of an actual agreement.

Acceptance of responsibilityLimiting the industry's liability must be accompanied byan acceptance, publicly and for purposes of formation ofpublic policy that tobacco use is a major cause of deathand disability and that nicotine is an addictive agent. Sim-ple logic mandates that the tobacco companies should onlybe freed of liability for those damages or injuries that theyacknowledge to be real. To absolve tobacco manufacturersof liability for damages, while allowing them to continue todeny that their products cause any damages, would be bothhypocritical and an extremely poor precedent for publicpolicy.

Acceptance of the risks caused by tobacco smoke expo-sure must include those risks produced by exposure toenvironmental tobacco smoke. One demonstration of thisacceptance would be a withdrawal of opposition to cleanindoor air laws and support for final promulgation and

34 Pauly, Stegmeier3 Mayer, Lessesi Sireck

if we did not control the individuals' normalsmoking behaviour. We know of no other pub-lished studies that have used human subjects totest cigarette filter integrity or defects.

MethodsSUBJECTSAll protocols and procedures used in the humansmoking study were approved by the clinicalinvestigations committee of the Roswell ParkCancer Institute. Subjects were adult (5* 25years of age) long term smokers who weresmoking currently at least 20 cigarettes per day.The volunteers were informed verbally of thepurpose and scope of this study. Thereafter, asigned and witnessed consent was obtained. Allparticipants were compensated financially.

CIGARETTES USEDCigarettes analysed were Lark cigarettes. Larkcigarettes are manufactured by Liggett Group.Lark cigarettes have a triple granular filtercomposed of cellulose acetate fibres andactivated charcoal and have been described indetail elsewhere.3 3'fi A recently published bookprovided a historical overview of the origin ofcharcoal filters and the development of the fil-ter on the^Lark cigarettes.9 An exploded view ofa triple granular filter is illustrated in fig 1.

ANALYSIS OF FILTERS FOR CHARCOAL GRANULESMany of the tests reported here wereperformed with 20 packs of Lark cigaretteswhich had been purchased locally (two packsfrom each of 10 vendors). Each pack of Larkcigarettes received a code number, and wasthen opened carefully in the laboratory. Thetop wrapper of each pack was cut off with scis-sors. Without removing the cigarettes from thepack, the filter surfaces of the non-smokedcigarettes were examined with a stereo zoommicroscope (Stereomaster; Fisher Scientific).

In our initial examinations, the filters of ran-domly selected cigarettes, with and withoutcharcoal filters, were inspected for the presenceof charcoal granules and the integrity of thewrapping papers. For quantitative analysis, thestereo zoom microscope was adjusted topermit viewing of the whole cut surface of thecigarette filter (15-fold magnification; xl.5objective and xlO ocular). At x8 magnification,the resolution was about 13.7 (im; at x40, theresolution was about 7.4 |im (personalcommunication, Carton Optical Industries,Tokyo, Japan).

Charcoal granules observed on the filter sur-face were counted by each of threeinvestigators. The three readers examined theentire filter and then counted the number ofwell defined conspicuous carbon particles ineach of the four filter quadrants. The numberof particles was then scored as: 0 (nil), 1-5(low), 6-10 (medium), >10 particles (high).

Thereafter, the tipping papers—the wrap-ping papers that surround the filter (fig

gap, no charcoal (low); >1 gap, no charcoal(medium); and >1 gap, with charcoal in thegap (high).

For ail tests, a formal measure of the degreeof association (for example, agreement) of thecounts recorded by three independent observ-ers was computed using the K test.10

For comparison, other cigarettes of variouspopular American brands were included ascontrols. These control cigarettes had filtersthat did not contain charcoal.

MODIFIED CIGARETTE HOLDERWith the safeguards against contamination(see below), a cigarette holder was used tomeasure the release of charcoal granules fromcharcoal filter cigarettes during humansmoking. The efficiency of the holder andentrapment device was qualified initially inrepeated trials in which Lark and other brandsof cigarettes fixed to the holder were smokedmechanically.

A conventional cigarette holder (Denicotea;Denicotea Co (Germany^ distributed byLane), purchased from a local retail shop, wasfirst removed from its cardboard packaging.The cartridge of Denicotea crystals wasremoved and discarded. The cigarette holderwas then soaked in 20% bleach for 30 minutesand rinsed with deionised water. This was fol-lowed by a second wash with Palmolive deter-gent (Colgate-Palmolive Company, New YorkCity) and repeated rinsing in deionised water.

After the cigarette holder had been dried inan oven at 56°C, an entrapment device wasadded. This device consisted of an 85x250 mmpolyurethane sponge cylinder (product Nc1030; 1.016 density; 30 ILD; Foamax, ArcadeNew York). Positioned on the upstream end othe cylinder was a white, fine mesh, polyestescreen (FN 5720-010; cut off- 0.1 |im; Poly)ite).

The entrapment device was positioned in thproximal segment of the two piece holdeiWhen a cigarette was positioned in the holdeithe end of the cigarette filter was approximate!3 to 5 mm from the entrapment screen. Thcigarette filter was not permitted to contact thscreen. The assembled smoking apparatus wstransported in a capped Falcon polystyrertube (17x100 mm; No 2051; BectoiDickinson, Franklin Lakes, New Jersey).

SAFEGUARD AGAINST AIRBORNE CONTAMINANTSTo prevent the contamination of screens another materials used in the study by airborfibres and debris, the following precautiowere implemented. All glass slides, co*glasses, instruments, and other items usedthe study were precleaned and—immediaRbefore using—flamed with 100% etha*1

Inspection of the slides and cover glabefore use showed that they contained no cbon particles or fibres. Other than actsmoking, all procedures were performed uiK

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expeditious implementation of the Occupational Safetyand Health Administration's proposed regulations onsmoking in the work environment.7

Redress the damage that has been createdThe simplest form of redress, and the most common pro-vided through the court system, is monetary compensationfor the damages caused. However, monetary compensationcannot be the sole basis of any agreement for release ofliability from tobacco, because the damages created exceedthe resources of tobacco industry. Tobacco is a $45 billionindustry,8 and estimates of just the direct, smoking-attributable healthcare costs for 1993 in the United Statesare $50 billion9 with another $50 billion in indirect costs.Clearly any monetary redress would have to be provided ata discount. The sums currently being suggested3" as abasis of settlement ($6-12 billion per year) translate into alicence for the tobacco companies to continue to kill morethan 400 000 Americans per year10 for a payment of SI5-25 000 per death. A yardstick for the monetary damagesthe industry could pay is the $32 billion that might be gen-erated through monopoly profit-maximising pricing ofcigarettes."

Absolving the tobacco industry of its liability for400 000 deaths each year, while allowing them to continueto market freely an addictive product that causes thosedeaths, is morally repugnant, as well as contrary to our tra-ditions of justice and protection of public health. As aresult, any agreement to limit the liability of the tobaccoindustry for the damages caused by its products mustinclude modifications to tobacco products that reducetheir capacity to continue to cause damage.

The disease burden created by tobacco results from rwocharacteristics of tobacco use. Tobacco, and tobaccosmoke, contain a variety of toxic and carcinogeniccompounds that cause disease when ingested over aprolonged period of time. Also, the nicotine in tobaccocauses addiction, and it is addiction which maintains therepetitive ingestion of these toxic and carcinogenicsubstances. Addiction robs many individuals of a freechoice about whether to continue to be exposed to the risksof smoking.

The FDA has asserted jurisdiction over nicotine as anaddictive agent, and there is no question that maintainingan addictive agent in a formulation as hazardous as thecigarette is contrary to both the public health and themandate of the FDA. However, there has been concernthat, if nicotine levels were reduced in cigarettes, smokersmight compensate by smoking more cigarettes per day,puffing more frequently, or inhaling more deeply, and suchcompensatory behaviour might actually increase theirrisks. Removal of nicotine from cigarettes is possible, butsudden elimination of nicotine might precipitatewithdrawal in many smokers, most of whom are addicted,also an unacceptable alternative. Nicotine replacementtherapy is available over the counter as a cessation aid, andthese formulations provide substantial relief of thewithdrawal syndrome.

Experimental formulations of nicotine more closelymimicking the pattern of nicotine delivery available fromcigarettes are being examined,12 including nasal sprays andinhalers as well as other formulations.l3 M Theseformulations rapidly deliver nicotine to the circulation in apattern similar to that provided by a cigarette, raising theexpectation that they, or other formulations, may be muchmore acceptable to addicted smokers; and they may also bemuch better substitutes for cigarettes in avoidingwithdrawal and breaking addiction. In addition, these andother newer formulations offer the promise of acceptable

long-term pharmacological substitutes for addicted smok-ers as part of a harm reduction strategy.15

It is likely that the immediate future will provideproducts with cigarette-like satisfaction of the nicotineneeds of addicted smokers through formulations of purenicotine that do not contain the other toxic andcarcinogenic constituents present in cigarette smoke.These formulations could allow the FDA to mandateremoval of nicotine from all cigarettes, removing theiraddictive potential, without creating a black-marketdemand for nicotine-containing cigarettes. Those who areaddicted to nicotine could satisfy their addiction throughingestion of formulations of pure nicotine, withoutexposure to other toxic and carcinogenic compounds.Smokers of nicotine-free cigarettes would have a free, non-addicted choice about continuing their exposure to therisks of smoking, and most would likely quit.

A minimum requirement for providing limitation ofliability is the acceptance by tobacco manufacturers ofFDA jurisdiction over the nicotine content of tobaccoproducts, with a mandate for the FDA to require removalof nicotine from these products as soon as it is feasible.Research funding, provided by the agreement should bededicated to the discovery of the most effective nicotinereplacement strategies and the development of ways thatwould help addicted smokers change to these nicotinedelivery approaches. As soon as reasonable alternatives forconverting nicotine-addicted smokers are available, theFDA should mandate the removal of nicotine from alltobacco products provided in the American market.

As part of FDA jurisdiction, tobacco manufacturersshould be required to publicly disclose the additives intheir tobacco products and any research performed toevaluate the safety of these additives. The manufacturing,labelling, and marketing of tobacco products, includinguse of additives, should be subject to FDA jurisdiction, asare all other forms of nicotine delivery currently on themarket.

Mitigation of future damagePerhaps the most objectionable current behaviour oftobacco manufacturers is continued advertising andpromotion of tobacco products, particularly to children.There is substantial public concern and outrage over use ofcartoon characters in tobacco advertising, and even thetobacco manufacturers claim to agree that marketingapproaches targeting children are unacceptable.

Once the enormous magnitude of disease risks isacknowledged, it is unclear what legitimate justificationexists for encouraging anyone of any age to start smoking,or for discouraging anyone of any age from stopping. Evenmarketing practices directed at brand loyalty and brandswitching lose their legitimacy, as it is hardly ethical toattempt to increase the burden of the death and disabilityfor which an individual company is responsible.

A core element of the mitigation of future damage isavoidance of any influence that might encouragenon-smokers to begin smoking or smokers to continue.One way these influences can be avoided with certainty isto eliminate all tobacco advertising and promotional activ-ity, other than FDA-approved activities for pure nicotinereplacement. This could be done by limiting liability forpast promotional activity, while explicitly defining liabilityfor any future promotional activity judged to encourageinitiation, discourage cessation, or promote use-Elimination of advertising and -promotional activity has the

additional benefit of allowing transfer of the approximately$5-6 billion per year spent by the tobacco industry onthese activities"5" to an account used to repair thedamages done by their products.

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Monetary compensationFinancial reparation by the tobacco companies could bestructured in two parts: a fixed sum and a per-pack charge.An annual sum of $5-6 billion would be available if alladvertising and promotional expenditures were aban-doned. This sum equals the 1993/1994 advertising andpromotional expenditures by the tobacco manu-facturers16 '7 and could be paid without increasing the netexpenditures by each company. It should be adjustedannually for inflation and paid proportionate to each com-pany's current market share. Using the 1993 expenditureof $6 billion, $5 billion of this sum could be paid to thestates to compensate them for their smoking-attributableMedicaid expenditures, and $1 billion could be allocatedto tobacco control programmes and research. Eighty percent of the tobacco control funds could be allocateddirectly to the states with 20% retained for allocation bythe federal government.

The fixed payment described above would not necessar-ily increase the cost of cigarettes because it is a transfer ofadvertising and promotional expenditures. However, it isappropriate that the cost of cigarettes be increased both todecrease consumption and to compensate society for thedisease burden and social costs caused by tobacco compa-nies and their products. The monopoly profit-maximisingprice of cigarettes (54.08 per pack, compared with the cur-rent price of $1.88) would yield more than $32 billionannually for liability payments or pre-tax profits."Therefore, an additional payment per pack of cigarettescould be required. Payment of an additional %l per packinitially, increasing to $2 per pack once the FDA mandatesremoval of nicotine from tobacco products, would providepartial compensation for the societal burdens resultingfrom smoking. A fraction of these payments would covercessation assistance for addicted smokers, transitional aidfor tobacco farmers, and whatever compensation is judgedappropriate for individual smokers. Additionally, asubstantial, professionally designed and implemented,national anti-tobacco broadcast media campaign should befunded to help correct the results of decades of tobaccoadvertising. The remainder of the funding could be usedfor national priorities such as funding the Medicareprogramme and solving the indigent healthcare problem.

Transitional aid for tobacco farmersOne of the groups most likely to be affected by theproposed changes is tobacco farmers. Declining Americancigarette consumption would place financial pressures ontobacco farmers. It can be argued that these changes areinevitable and that tobacco farmers deserve no specialconsideration, but both political and humanitarian motiva-tions support providing assistance to tobacco farmers asthey change to other crops. Several states in the southeastare disproportionately dependent on tobacco as a crop,and much of the investment in equipment and infrastruc-ture for growing tobacco cannot easily be transferred toother crops. Economic dislocation from changes intobacco may be considerable in some counties of thesestates, and assistance could minimise the impact.

Effects on stockholders of tobacco manufacturersIt is apparent that the changes proposed above would leadto a much more rapid decline in tobacco use than wouldoccur otherwise. Indeed, no solution to this problem thatdoes not lead to a more rapid decline in tobacco consump-tion will be acceptable to the public health community. Asuperficial examination of this conflict suggests that share-holders of tobacco companies would be better served by acontinuation of the "scorched earth" slow retreat that hasbeen the tobacco industry's practice for the past 40 years.

Ultimately they would arrive at bankruptcy, but they wouldpreserve profits in the short run.

However, much has changed in the structure of themajor cigarette companies during the past four decades,including diversification into food and other businessesand growth of the international segments of these compa-nies. Stock values for these diversified companies, based ona price/earnings ratio, are depressed by threats of tobaccoregulation and litigation,18 and it is likely that these threatswill inflict real damage on the industry in the next monthsto years, further depressing stock values. Currently thestock values of several of these companies are depressed bylitigation risks by as much as 50%.3

The depression in stock values is large enough that thedomestic tobacco earnings could be eliminated with theresidual company having a price/earnings ratio comparableto that of the stocks of other American companies. Thissuggests that the net value of domestic tobacco earnings tothe stock price is roughly counterbalanced by the declinein stock value produced by the threat of litigation. There-fore, domestic tobacco earnings could be traded for limita-tion of liability without a sharp decline in stock values. Ifone or more of the current actions by the state attorneygeneral are successful, then tobacco stocks are likely to fallsharply; and even a resolution of tobacco liability that sac-rificed all of the domestic tobacco earnings could result instable stock values.

SummaryLitigation and regulatory assaults on the tobaccocompanies may create a willingness among tobacco manu-facturers to bargain resources and acceptance of publicpolicy changes for limitations of liability/ * as has beenseen by the recent settlement with the Liggett Group. i9

Two elements absolutely critical to any plan are the elimi-nation of tobacco advertising and promotion and theremoval of addiction as a reason for tobacco use.

Minimal components of any settlement should include;(a) acceptance by the tobacco manufacturers of the causal

relationship between tobacco use and disease, and theaddictive nature of nicotine;

(b) a total ban on tobacco advertising and promotion;(c) FDA jurisdiction over tobacco products and their

nicotine content, with the intent of removing nicotineas soon as acceptable nicotine substitution productsare available;

(d) reimbursement to the states for Medicaid and otherstate expenditures attributable to smoking, to themaximum extent feasible;

(e) funding for local, state, and federal programmes andresearch in tobacco control;

(f) acceptance of legislation and regulations protecting theright of non-smokers to breathe air free of tobacco

• smoke;(g) funding for a large, national, media-led, anti-tobacco

campaign; and(h) cessation assistance for addicted smokers.

If negotiations toward a settlement proceed, it isessential that the public health community participate indefining the elements of any agreement to ensure thatwhatever agreement develops is focused on reducingtobacco-related disease rather than continuing theprofitability of American tobacco companies. That partici-pation requires articulation of the core elements essentialto an acceptable agreement. If resolution of the publichealth issues surrounding continued sale of tobacco prod-ucts can be reached in the United States, it may provide amodel for similar resolution in other countries.

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Mr Shopland contributed to this work in his private capacity. The viewsexpressed here are his own and no official support or endorsement by theNational Cancer Institute or the Departmeni of Health and Human Services isintended or implied.

Dr Connolly contributed to this work in his private capacity. The viewsexpressed here are his own and no official support or endorsement by the Mas-sachusetts Department of Public Health is intended or implied.

We are grateful to Richard Daynard, Matthew Myers, and Charles L Gruder,who provided critical comments on earlier versions of this editorial.

DAVID BURNSUCSD Medical Center, 200 West Arbor Drive,San Diego, California 92103, USA;email; dburns@ucsd.edu

NEAL BENOWITZUniversity of California at San Francisco,San Francisco, California, USA;email; nbeno@hsa. ucsf. edu

GREGORY N CONNOLLYMassachusetts Tobacco Control Program,Massachusetts Department of Public Health,Boston, Massachusetts, USA;email; gr£gconn@ix.netcom. com

K MICHAEL CUMMINGSRoswell Park Cancer Institute,Buffalo, New York, USA;email: mcummings@sc3102.med.buffah.edu

Editor

Johns Hopkins University,Baltimore, Maryland, USA;email: fhenning@ckarm. net

National Cancer Institute,Rockville, Maryland, USA;email: shopland@dcpcepn.nd.nih.gov

RONALD M DAVIS

JACK E HENNINGFIELD

DONALD R SHOPLAND

KENNETH E WARNERSchool of Public Health, University of Michigan,Ann Arbor, Michigan, USA;email: kwarner@umich.edu

1 Cigarette smoking among American teens rises again in 1995 (pressrelease). Ann Arbor, Michigan: University of Michigan Stuvey ResearchCenter, 15 December 1995.

2 US Food and Drug Administration. Regulations restricting the sale and dis-tribution of cigarettes and smokeless tobacco to protect children andadolescents; final rule. Federal Register I9963<51:44395-638.

3 France M3 Bongiorno L. Big tobacco may be ready to deal? Business Week1996 Oct 7.

4 Ingersol B, Frisby M. Smoke signals: Omens of tobacco truce are in the air.Wall Street Journal 1996 Dec 19:A16.

5 Warner KB. Dealing with tobacco (editorial). Am J Public Health 1997. Inpress.

6 Glantz SA, Fox BJ, Ughtwood JM. Tobacco litigation: Issues for publichealth and public policy. JAMA 1997;277:751~3.

7 US Occupational Safety and Health Administration. Notice of proposed1 i J d / ^ l 9 2 9 5 9 6 8 68 US Department of Agriculture. Tobacco outlook and situation report.

Washington, DC: US Department of Agriculture, April 1996.9 US Centers for Disease Control, Medical care expenditures attributable to

smoking—United States. MMWR l993;43:469-72.10 US Centers for Disease Control. Cigarette smoking—attributable mortality

and years of potential life \ost~-United States 1990. MMWR 1993;42:645-9.

11 Harris J. American cigarette manufacturers' ability to pay damages:overview and a rough calculation. Tobacco Control I996;5:292-4.

12 Gorodetzky CW. Implications of alternative treatment goals: product impli-cations. Tobacco Control 1995;4 Suppl 2:S57-9.

13 Sutherland G, Stapleton JA, Russell MA, et al. Randomized controlled trialof nasal nicotine spray in smoking cessation. Lancet 1992;340; 324-9,

14 Tonnenesen P, Norregaard J, jVlikkelsen K, Jorgensen S, Nilsson F. Adouble-biind trial of a nicotine inhaler for smoking cessation. JAMA 1993;269:1268-71.

15 Hughes JR. Applying harm reduction to smoking. Tobacco Control 1995;4Swppl 2;S33~8.

16 US Federal Trade Commission. Report to Congress for 1993. Pursuant to theFederal Cigarette Labeling and Advertising Act. Washington, DC; FederalTrade Commission, 1995.

I? US Federal Trade Commission, Report to Congress for 1994. Pursuant to theFederal Cigarette Labeling and Advertising Act. Washington, DC: FederalTrade Commission, 1996.

18 France M. Is Big Tobacco ready to deal? Business Week 1996 Dec 23.19 Broder JM. Cigarette maker concedes smoking can cause cancer. New Vork

Times 1997 Mar 21: Al, A12.

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