Tobacco Documents Online

NVork.ihops Environmental Tobacco Smoke Introduction The support for public policy ehanges on issues related to envi- ronmental tobacco smoke (E3'S) has changed drantatirallyduring the last decade. By 1986, the scientific and public health commu- nities had reached a consensus thatexposure to ETS was a sigrtifi- cant cause of lung,caneer in nonsmokers. This scientific consensus rapidly expanded to include the regulatory agencies, local governmental jurisdictions, the business community and thee general public. Wath~the release of the EPA risk assessment dassi- fying ETS'as a Group A Carcinogen earlythis year, it is only the representatives of the tobacco industiy who question the validity of the datalinking ET6 exposure to disease. Gutsently,even those groups opposing ehanges in local ordinances generally accept the health evidence: There is no longer significant disagreement that, ETS exposure causes dtsease at the levels of exposure ~that'~occur in everydayilfe in US society, and that separationof smokers an& nonsmokers in the same air space, or filtration of the air with commercially applicable technology, does not:reduce exposure sufficiently to lower the risk below the regulatory threshold!for other occupational~or environmental'caexinogens. The evidence indicating thauEPS is responsible for the deaths of 53,000 Ameri- can nonsmokers each gear from caneer4 beart disease, and other illnesses, a number of deadts substantially larger than that cat>5ed by automobile accidonts,,has fueled efforts to ~restrict smoking in workplaces and public pl9ces to protect nonsmokers. The consequences of Ef5 exposure for children ane partiaulariy severe: In children, EfS exposure causes an increased risk of bronchitis and pneumonia, reduced lung function growth, in- creased prevalence otmiddle ear disease and asthmatic excerbations, and is a risk factor for the develnpmenUof new, cases of asthma This increased vulnerability of children to ~injury from ETS exposure makes!them a high priority for efforts to protect nonsmokers. 7fie widespread acceptance of the health evidence allows afunda- mental shift in the strategy used to prrotect indiMduals firom ECS exposure: Instead of focusing energy on convincing,public poiicy, , makers that the data establish a health risk„efforts can now shih' to persuading them that they need to respond to the risks gener- ated,by ETSexposure using: the same logic and+standards that apply to other occupational!and environmental toxins and car- cinogens. A substantial body of experience and legal precedent already exists to protect individuals from toxic and carcinogenic Julia Carol David Bums, M.D, exposures in the ge.neral environment and especially in worksites. and this experience and precedent can now be applied to ETS exposure. The norms that establiish,roles and responsibilities of'emplorers; levels of acceptable risk, justification for'84vemmental interven- tion; compensation for worker,s injury, and legal liabilityused for other occupational and environmental agents can now be broughtt to bear to reduce exposure to ELS. Once the risks are acknowl- edged and other mitigation strategies are examined,,it,becomes dear thatlasmokefree environment is the only option that does not require a special exemption for ETS from the existing stan- dards for acceptable rislts dtte to environmentaljexposures: The pressures for change generated by the existing ftamework for environmental and occupational protection can be linked with the community based grassroots movement currently driving efforts to protect the ttonsmoker,,and the result would be a more com- prehensiweand effective approach to protection of nonsmokers. By combiningincentives from a variety of directions, inclttding economic benefits and risks, social pressure and the appropriate combination of ordinances and regulation„it is possible to both promote the cutting edge of change in nonsmoker protection and motivate those lagging behind'to catch up:. It is far cheaper and easier for employers to prohibit smoking in the workplace than it is to install several cpmplicated expensive ventilation systetns to segregate the smokers.lfie implementation of smokefree policies is easier when empioymean tell'their customers and employees,that ~thelaw, requires them to be smokefree;,and'worksite policies are more effective in~actuallv protecting nonsmokers from!exposure when diere is also a stronF, local ordinanee: Employees are winning workers' compensauion i cases based upon being forced'to work in a smoky environment For eramplo;,in Sat>5alito; California a nonsmoking, vegetaraan waiter with no (amily history of heart disease was awarded an $85,t)0!Q settlement after suffering a heart attack caused by %cork- ing for five years in a restaurant that permitted smoking., This case represents only the tip of a very large iceberg of potential work- ers' liability in this ar7ea, The current state of scientific data on k`lIS exposure is adequate to define ET6 exposure as a conttibuting factor or exacerbating factor (the operationall'anguage for compensable injury in the workers'' compensation~system) in cardiovascular disease, lung disease and nespirvory, cancers in smokers as wellla5 nonsmokers.lltis creates a potential workers''

Worksliops compensation claim for approximately two-tbitds of;the disease that occurs in the US:. As this body of'legal precedent develops it will create a powerfuf economic incentive to become smokefree in all areas of'employ- ment. In addition, as employers acknowledge the risks or can be shown to have been informed of the risks and'do noutake action to eliminate ETS exposure;,they mayalso.incur liabiliry based on claims of~ negligence. Public places such as restaurants are also workplaces for many people. In fact, according,to Smoking and Restattrants: A Guide for Policy-Niakets, published by the Universityof'California; restaurant workers are exposed to three to five times more E15 than other workers, and consequently have about four times the expected lung cancer mortality and two-and-a-half times the expected heart disease mortaiity rate. The perception of what is acceptable protet:tion for nonsmokers in a restaurant changes dramatically when the restaurant is considered as a worksite exposing employees as opposed to a public place exposing only the patrons. Actions Taken to Protect Nonsmokers- State and Local Although some states restrict smoking in public places, the vast majority of this protection occurs at the loeal level. To date, over 540ciUes and counties throughout the country have enacted! ordinances to:protect nonsmokers. In the 11980's, these ordinances provided for smoking and non- smoking areas in workplaces and restaurants, while eliminating smoking inmost other public places. It is interesting,to note that the tobacco industry, opposed the creation of separate sections and warned businesses of economic disaster if these sections wereput in, to effect. In 1986, then-SutgeonGeneral C.. Everett Koop acknowledged that these ordinances provided onlypartial protection when~he declared that "the simple sepanation,of smok; ers and nonsmokers within the same air space may reduce, but does not eliminate: the exposure of nonsmokers to environmental tobacco smoke." This declarstion led to a1sh&in the proposed protection of nonsmokers toward a smoke free work environment insteadlof separate sections. After the EPA's drafU risk assessment was released in,199U; a number of cities and counties began to adopt complete elimina- tion of srnoking in workplaces and restaurants, Four cities efimi- nated!smoking in restaurants in late 1996;,another seventeen did' so in 1991, with most of the new ones also eliminating smoking in all!workplaces: To date; 13 cities.eliminate smoking inirestau- rants, i l eliminate smoking in workplaces, and 24 aties or counties eliminate smoking in both-a total of 48 smokeftree ordinances. The tobacco industry is ~now supporting separate sections, and maintaining that instituting a smoke free environ- ment will lead'to economic disaster. The shift from ordinances restricting smoking to ordinances completely eliminating smoking represents the most dramatic and significant change over the Ihst fewvears: This shift is possible Tp1JaGcof *SE' .-lrt.~?mP+,C.In crsi'S because of the strong support from nonsmokers and smokers alike for these ordinances. Smokefiee ordinances have been upheld by voters in communities throughout ~ the country despite attempts by the tobacco industry to repeal them. In November of ' 1'992; voters upheld five different local smokefree restaurant ordinances bv an average margin of victory of 21 percent: The heated, public campaigns to enact these ordinanees aree important to their effectiveness because diey raise the entire communitys awareness of the dangers of secondhand smoke and of the changes being mandated by the ordinance. As a result, these communities know about the existence and importance ofl these ord'utances;,and''by forgittg,a consensus become invested in their success. This process helps ensure compliance with the new law in ~a manrter ttiat istate and federal regulations often cannot aecomplisli. In addition, it is easier to develop a consensus within local communities on the appropriate extent of restrictions nn smoking,to be applied, and this consensus is critical to sustaining the ordinance and promoting effective peer enforcement. The extent of'restriction that can be sustained on a local level in individual communities is generally greater than that sustainable byastatewide consensus which must include bothithose commu- nities who are supportive of restrictions and those which have not yet 1 reached thatievel of consensus, The result is that statewide laws are likely, to be less comprehensive in their protection of nonsmokers and less effective in their implementation. The devell opment of'a national consensus to supportilegislation protecting nonsmokers on the federal level would be even more dill'icult and would be likely to lead to even less comprehensive andleffective policy change. Although local laws have become stronger and more numerous at the local' level, the tobacco ihdustty has been able to prevent strong, effective laws from passing at the state level; and'the general population is often isolated from the debate surrounding passage of state laws. These laws often go into effectwithotu the communitys awareness of the need for the law; the details of its provisionsi,or the process for its enforrement The tobacco industry knows thatlocal!laws tendito be stronger, and more effective than state laws;,and their primary strategy is to strip cities and counties ofxheit power to : restrict smoking by passing weak ineffective state laws that preempt,local'control. Eight.states partially or completely preempt local smoking restric- tions, Even when state laws do not include preemption, they c:ui have a chilling eHect on local action. Fxperienee in the U.S. has shown that dte recipe for succecs is a combination of education and legislation; both are needed to ensure support for and1eompl'iattce with strong. comprehensivee smoking control legislation. The public debate over dte enactment of local tobacco control ordinances is one of dte best public education campaigns available:. Federaf! Legislative and Regulatory Actions In 1989, Congress enacted!an amendment offered by [Reprcsenta- uve Dick Durbin (Dlti:) and Senator Frank Lautenberg (D-v.1) eliminating,smoking onvictuall~°all domestic airline flis;ltts: Thr 202419ss5s

tiri'clrishops law strengthened and made permanenta 1987 amendment that eliminated smoking on domestic flights of two bottrs or less. The airtine smoking;ban remains the most significant federal action protecting nonsmokers. Mthough the airline smoking bandoes.not extend to international flights,,the United States representative to the Intemational.civili AviationOrgan'v.ation supported a resolution encouraging mem- bership nations to prohibit smoking on their international flights. Other federal measures to protect nonsmokers were defeated, however. andlpresident Bush failed to respond to a proposal from Louis Sulliwan, Secretary of Healdi & Human Serviees, for an executive order requiring federal agertcies to be smokefree. In late 1992, Senator Gautenberg successfully, amended an appro+ priations bill to require programs receiving federal funds that serve children under the age of five to be smokebree: A similar proposal introduced by Representative Durbin was not consid- ered in the House; and the Lautenberg amendment died in confer- ence committee. Over the objections of the Secretary of Veterans Affairs, Edward Derwinski: the House voted to overturn the veterans' hospitals smokefree policy, which had been established'to comply with new standards estabiished.by the JointiCommission oaAccreditation of Healthcare Organizations. Congress subsequently approved legis- lation that may jeopardize the VA policy. To date, the only significant federal law protecting nonsmokers remains the airiitte smoking ban. Policy Questions Federal, state, and local!governments have all provided important protection for nonsmokers, and each level of!government can make unique contributions to this protectim For example;,smok- ing restrictions on aircraft could not be enacted on a state-by, state basis. Airlines needed to be covered'by a federal law. Similarly, federal agencies are exempt ftom state and lbcal laws, andlederal action is needed toproteehemplores and4he publicc in these facilities. The goal of regulation at any level is to change the behavior of smokers in order to reduce or eliminate the exposure of non- smokers to E1'S;,and it is the effectivertess of agiven regulatory approach in actually changing smokers' behavior„ratherthan simply the comprehensiveness of,the regulations enacted, that determines the extent of~protection provided to nonsmokers. The effectiveness of an ordinance in changing the behavior of smokers is heavily influenced by the norms for expected behavior among smokers and nonsmokers; by the support and peer enforcement within the community;,and by the awareness o0smokers and nonsmokers that the rides have changed. For these reasons; the federal government may not always be the most appropriate jurisdiction for regulating smoking.lfie federal government may have the authority and responsibility to regulate worksites and other environments uniformly across the nation, but tharauthority does not automaticaily translate into a protection of.nonsmokets un le~s there is compliance with the ~riegulations by individuall smokers and enforcement ofthe regulation by individual nott- smo kers and i individual employers. Local jurisdictions have been able to respond more rapidly to the changing understanding ofthe risks ofETS exposure because it is easier to develbp a consensus to supportithese changes in a single locality as compared to nationally. Similarly, local workplace and public places laws are often stronger and more effective than federal'laws because they can be developed and enforced based on the locally derived consensus. The federal regulatory structure must recognize the limitations of~develbping,and!implementing regulations protecting nonsmokers; andj in the process of!fulfill- ing its mandate to provide a safo environment, it should nott restrict the freedom of the states and cities to enact strong, effec- tivemeasttres tailored to the needs of their own communities. Regulatory agencies like the Occupational Safety & Healih Admin- istration (IOSHA) must recognize the critical role played by local ordinances in ertsuring the control and enforcement.thatprovide effective protection for nonsmokers,. In determitting where to direct efforts to regulate smoking,,thee following issues must;be considered 1. Each jurisdiction should take action to eliminate e:xposure to environmental tobacco smoke: 2. Each jurisdiction should take care to provide the most effectivee enforcement ofthe elimination of exposure to environmental tobacco smoke. Recormnendaiions The following list of recommendations is in order of priority:. 1. All'jurisdictions should!take action to protect children from exposure to environmental tobacco smoke. For example, we endorse the legislation proposed bylfwngressman Dick Durbin and Senator Frank lautenberg which ~would require all feder- aily.funded'children'S programs to establish and make,a good faithi effort to enforce a nonsmokirtg'policy that protects chil- dren from exposure to environmental tobacco smoke. !n, addition: A. f.ocal and State governments should enact legislation requir- ing that agencies receivittg government funds for providing services to children be 100 percent smokefree. B. State legislatures and!local school boards should enact regulations requiring allipublic elementary and secondary schools to be 100 percent smokefree in all areasof the ctmpus. C. The Congress should enact legislation requiring allcollOcs andI universities thatireceive federal'funds to be 1011percent0 smokefree in all enclosed areas, 2. All jurisdictions should take action to protect workm and other people from exposure to environmental tobacco smoke. A. The local governments should establish ordinances requir- ing the elimination of environmental tobacco smoke in all restaurants and other worksites.

Wcrrksltops B, The State governments sbouldlestabli.sh atlean Indoor Aii law without preemption of local tnandates. C. The Presidentishoutd sign an executive order making en- dosed federal workplaces, including all branches ofthe mili, tary, and the veteransAdministration ,hospital.s; 100 percent smokefree to ensure that,affemployees are prrotected from exposure to envinonmental tobacco smoke. The Congress should'institutionalize this policy by enacting legislation to protect employees from the hazards of environmeatalitobacco smoke and should~ extend this policy to cover all buildings in the Legislktive andjudicialBranches. D. The Congress should enact legislation requitang all!internay tional airline flights by, American carriers originating from or landing in ahe United States or its territories to be 100 percent smokefree, and the Department of'Ttansportation shouidd support and aggressively pursue international standards to make all international airlines 1IDO peticent smokefrae. E: OSHA should develop regulations covering smoking in the workplace, and shoul&aonsider the irnportaace of'local norms in the effective enfoncement of policies to protect nonsmokers. 3. Economic incentives for businesses tu go smoke hee should be developed A. Tobacco conttol ieommittee.s should work with insurers to acquaint them with the liabidtty implications of environmental tobacco smoke exposure and encourage them to differentially rate worksites by their smoking policies for purposes of work- ers' compensatdon insurance. B. Members of the scientific and legal communities should support the development of legal precedent that indltdes, diseases secondary to ETS exposure under those conditions covered by the workers' compensation system for, both,smok< ers and nonsmokers. Tobacco t"se .-1n .3mericnn Crisis ` l

WWrlcshctlts Whio's Minding~ the Tobacco Store.? It's T'une to Level the Regulatory Playing Field "We accept an interest in people'sbea!!b as a basic responsibility, paramount to every ot,ber consideration in our business. " Tobacco Industry Advertisement to the American Public. The New YorkTimea, January, 1954 I. Introduction As the Food and Drug Administration continues to use its authori- ties to protect the health and welfare of'the Mterican~public from misbranded, adulterated, dangerous products, there still~remains one product that in spite of the fact that it kills over 430,000 Americans each year remains, as columnist Ellen Goodman noted, the "Missing Entree in the Regulatory Menu." Thatprodirct iss tobacco. Its absence from specific:regtilatory controls is not an accident but rather a tribute to the tobacco industr}rs long,time strangle hold over the Congness and the Executive branch. What other producrcan boast that it is a major cause of caneer4 heart disease, emphysema, stroke, premature births and other ai.finents and still be allowed on the tnarket? What other addictive drug (nicotine) can be sold on the markerwith virtually no federal advertising, promotion and distribution constraints except for so- called industry'woluntary efforts,', which have not protected the public, for nearfy 34 years. Aitd'whatlother product can make, unsubstantiated implied health claims about itself (Le. low tar, low nicotine and weight control), contain dozens of untested and undisclosed chemical additives, as well as undisclosed harmful constituents, and still remain on the market-2 It is now almost thirmy years since the first SarggoniGeneral'.s Report was released!implicxring cigarettes as aleause of'cancer- almost thirty years since Surgeon General Luther Terry,,MD:fiist indicated that any voluntary efforts by the tobacco industry didbot "obviate the desirabiliry of enacting specific regulatory authority to express those minimum standards that protection of the publicc interestirequires." in 1964, when the first Surgeon General's Report on cigat ette. smoking andlcancer was first released, numerous bills were introduced in Congress that would have resulted in specific au- thorities being vested in the Federal Trade Gommissioner and!the FoodI and Drug Administration designed to ensure the proper reyulationiof this dangerous consumer product Unfortunately; the tobacco ind'ustrs was quick to develop: leqislative and public John S1adb, hiD : Scott Ralfin, JD relations strategies that were designed to ensure that no such lawss were ettacted As a4ormer Y'ice President of the Tobacco Institute, Frederick R: Pattzer, was to later aclmowledge in a 1'972 confi- dential memorandum to then~Tobaoco institute president, Horace Kornegay;,the holding strategy was °brilliiantlyconceived and exeauted," and imofved: •"creating doubt about the health charge without actually deny- ing it" •"advocatittg the public's right to smoke without actually urgin& them to 1 take up the practice." •"encottragipg objective scientific research as the only way to resolve the questionof health harrrd." The strategy according to ~Panzer involved particular attention : to issues in the areas of'litigatlon, legislation, and public relkt9ons; In July 1992, a Goalition of national health organizations (includ- ing the American Cancer Society, the Ameri:can Heart Association, the American tutttg,Association, the American Public Health :1.s.so~ ciation; the American Academy of'Pediatncs, the American t:ol- lege ofGardiology„the American Association for Respicatory Gare, the Association of State and Territorial Health Offcials, and the American Society of Internal Medicine) senra letter to Congress- man John Dingell, Chairman of the House Energy and Commerce Committee, asking that he open a thorough imestigation into whether representatives of the tobacco industry and the Tobacco Institute sought on i nttmerotu occasions to defraud the House Energy and Commerce Gommittee and its subcommittees as well as the public by repeatedly stating that the tobacco industry was engaged in an objective, independent scientifie inquiryas to the link between tobacco and disease. In its closing,paragraphs the Coalition asked that Chairman Dingell "explore the need to once and for all bring this addictive drug in Line with the way other legalj dangerous products are regulated. It is time, after 25 years of patience, to do what Surgeon General Luther Terry; MD and FTC Chairman Paul Rand'Dixon and a number of other Congres- sional members believed crucial to the protection of the public health -thatis to regulate the manufacture, distribution, sale: labeling, advertising and promotion ~of this nation's leading cause of death." It'is a natlonal health travestythat an inherentl.y dangerous prtxl- uct; that is by far the number one cause of preventable death inn the nation, should'go virtually unregulated': The few fcdcrall;uid

Workshops st7te lmvs and'regulations that do exist ane a patchwork of incom+ plete and ineHective eontrols. To date only the Congress has had any specific authonity toregulate these products for health and safety, p,urposes: Unfortunately for the health of the Americart public, tobacco has been exempted!fcom every major federal' health and safety lawenacted by Congress including the Constuner. Product Safety Act,,the Fair Gabeling and Packaging Act, the Toxic Substances Act and the Federal Harardous Substances :Act: Be- cause the-Congress has failed to deal~with the tobacco issue, millions of people have needlessly died or been disabled!frlom~ cardiovascular disease, cancer, emphysema, stroke and a host of other diseases. With health care costs eontintting,to skqrooketj with,preventive health measures finally being viewed as critical to health care reform, many national health organizations as well as many members of Congress believe it is timelor a change: FDA Commissioner David Kessler has on many occxsions ex- pressed, hisstrong,belief about the role hesees#ordte FDAincarrying out its statutory, responsibilities, eapet•ially for high rosk . products which ltave the greatest impact on health. As he said in aa speech published in the iVovember 1991 edition of the Food.Drug Cosmetic Law, journal; "I have sev a range of goals to make the agencymore credible, more eEficient and better equipped to serve the country in the future: But ifiyvu ask whauia the essence of my program I'would answer quite simply thatit is to enforce the law:'- Settaag aside the historical, political, or economic circumstances surrounding the tobacco issue, it is obvious that this product should have and wouldhave beenIremoved from the marketplace a long time ago. Instead, today we find ourselves at the other exteeme-faced with the manufgeturing, distribution, sale, L1beh ing and advertising of a widely used, addictive product that is subject to minima!'and ineffective regulation. What follows is a three pronged proposal to correet this;national travesty. • The Executive Branch at both federal'and state levels should use every, available means to make the regulation of tobacco products a central feature of health policy and practice. • The FDA and the analogous existing authorities within states should'regttlate tobacco products which make health claims (implied or direct) or which seek to alter the structure or func- tion of'the body and therefore fallsquarebyunder the definitional requirements for "drugs". • The Food, Drug and Cosmetic Act (iFDC Act) should be amended through legislation to specifically and unequivocally bring tobacco in dine with the ways and means other products (parricularly ttiosepresenting;health rnsks to the public) are regulated. IL. What can the FDA and states do under existing authorities to regulate tobacco products Legislative and Legal Actions Defining "Drugs" In 1906, Congress enacted the firstI federal food and drug law: The primary purpose of the Acrwas to ensure safety of products sold as foods and drugs. The Act defined "drug" very narrowlyto include onlythose ar<icfoswhich were litted in the US !Phamna- copeia. Manufactured tobacco proI including cigarettes, were not listed at thatItime. Since 1906 the authority of the FDA has been expartdedito include, cosmetics and medical devices as well as food and dtugs. All!of the products covered by the Act are products that are either ingested by man, are applied to the skin,,or implanted into the body, FDA regulation of these products not onlycovers the com- position of the products, but in most cases their labeling, sale; dist„ibutinn; adirrristng and promotim In the 1930s, Congress, concerned with an increasing number ob ineffective, unsafe and dangerous products and devices appearing on the market, expanded the definition of"drug" ttnderthe Act. 1fie Senate.Cotttmittee Report accompanyjrtg dte 1935 Act noted: "Thedefinition of'dnug` has beert exp,nded'to inciude, first, substances and prep'drations recognized ia the Homeopathia Pharmacopeia ofthe United States;,second„devices lntended fpr use in tbe cure, mitigution, tteatment'olprectention of dis- ease; third, substances, preparationsand'devines intended for diagnostic purposes; and fourth, such articles other thxn foodIand cosmetics intended to affect the structure or function.of the body. Such expansion of the definitibn of the term 'diug!'i.s essen, tial'if the consumer is to be protected against a multiplicity of devices and such preparations as 'Mendedzers,' many of'which, are worthless acbesrand some of which are distinctly dangcrous; to health." (Emphasis added.) Congress was also very dear that product definitions am notI and should not be mutually exclusive. As the Senate Report furifier noted:' "The use to which the product is to be put will determine the category into-whiiih it will fall. If it is used only as;a food it will come under the definition of food ornotte other. lfiit contains nutritive ingredients but is sold for dtug use only, as shown by Meling and advertising; it will come under the de9nition of dnig but not that of'food. If it is sold to be tued both as a food and for the prevention or treaunent of disezse tl,would satisfy both de6ni+ tions-and be subject to the substantive requirementsof both.l7ie manufacturer of the article, through his representations in con+ nection vith its sale can determine the use to which the article is to be put." (Senate Report 74-361, 74th Congress: Session. l'935p. 4. See also„C/.S: u. Artdcle--,Sudden Change, 409 F.?el 734, 739., 1969)i It is, thus„legall~ arguable that low tar and low nicotine cigareues dearlyfit'within the parameters of what both the Congrctssand the courts and state laws intended when theydefined.drug.c. Tobacco companies manufacture, advertise, promote, and sell low tar and low nicotine with the obvious intention of playing,on the publie's perceptionthat use of these products will mitigate and prevent the onset of disease assoeiatediwith smoking. S3 Tnn,.cco l';e: .1i:r •?rnerican Cris:s . 202419sgGo

Wor. 6itttyps . Court Rulings Find Tobacco Products to be "Di:ugx" Under the FDC Act The expanded definition of~"drugs" was applied against cigarettes in two FDA related courticases in the 1950s. The courts found!tfuat conventional cigarettes could be "drugs" under certain circum- stances. In the court's view;,the question of whetheror not the FDA could assert jurisdiction over tobacco hinged on whetfier or not the prodttcts were being sold as articles intended toleither mitigate or prevent disease or intended to affectthe function or structure of, the body and thus were not sold just for "smoking, pleasure only." As the court noted in U.S: v. 46 Cartons Fairfax Cigorettesr. "lfIclaimanCs libeling was such that it created in the mind of the public the idea that these cigarettes could be used for the mitiga- tion or preventionof the various named diseases,,claimartt cannot now be heard to say that it is selling only cigarettes and not drugs... The ultimate impressionuponihe mind o[the reader arises from the sum total of not only what is said'; but also all that is reasonably implied if claimant wisbes to rmp the reuvrd of sucb claims let'it bear the responsibility as Congrez, bas seen fst to impose on it:"' This was the first time that cigarettes were found to ~besubject~to the FDA's jurisdiction because they; were nousold""tnerely for smoking pleasure" but had other intended purposes. Because those cigarettes could not meet the statutory and regulatury re- quirements of the FDC Act;,they were removed from the market- place. The idea of classifying cigarettes as drugs has been reaffirmed by the FDA in testimony before Congress on~ntunerous occasions and' again more recently bythe courts. In 1977, for esample;,ia at- tempting to further cfarify FDA's jurisdiction, A'ction~on Smoking and Health, (ASH) and others filed a petition with EDA seeking to classifiy all'ciganettes as drugs under Section 201 (g) (C) as ar- ticles "intended to affect the structure or any funcflon of the body of man ~or other animals." The premise onwhich the petition was filed was that because all cigarettes contain nicotine "they fall easily and squarel j+wvitttin the broad'langttage of the act" FDA denied the petition-a decision upheld in c.otut in 1980. Then FDA Commissioner ponald'Ketutedy and the Court held thai'the petitioners had failed to establish an "intenP' on the part of the manufacturer to sell a product which "affected tttesiructure or function of the body" Specifically,,the Commissioner wrote: "Statements by the petitioners and!citations in the petition that cigarettes are used by smokers to affect the structure or functions of their bodies are not evidence of such intentbythe manufactur- ers or vendors as requiied;under provisions of the FDC Act." However~ in denying the petition„the case gave further clarifica- tion as to the requirements needed to be satis6ed before FDA would assert jurisdiction under Sec. 201. The FDA said that inithe case of cigarettes in general, petitioners f9iled to provide suffi- cient eidence to establish that manufacturers sell cigarettes with an intention of affecting the structure or function of the body. The issue of whether tobacco was coatained in the products was and is not pertinent to a determimtioo asto whether or, not a tobacco product is a'.tirug„ifit meets the statutory and court requirements. Consumer intent alone (absent a showing ofI ven- dor interest), said the Court;,was evidence, but was notsuffieient by itself to bring the cigarettes under the definition of~"d ivg" under the Acti In 1988, with this decision dearly in mind, the Coalition on Smokirtg OR Health (American Cancer Soeiety, American Lung Association, and the American Heart Association) filed.a petition with FDA seeking:to classify all so-called "low.tar"'and "low- nicotine"'cigarettes as "drugs" under the FDC Act The Coalition's petition is based!on a thorough review of the advertising and marketing strategies of'these products by the inditstny as well as evidonce relea.sed as a result of the 1988 CipoQone v. Liggett Group Inc. liabitity case. In that case;,for example;,[7S District Court Judge Sarokin noted that the tobacco companies: "were well aware of the extreme difficulty smokers had and have in quitting smoking. Tfiey knew based upon sophisticated re- search that a smoker who found!it difficult to quit, particularly faced with claims of hazards of risks, would4ocus on any rational- ization to justifr his or her continued smoking;."and "plaintiff ~ offered expert testimony which demonstrated that evenafter the companies erased ma}dng,specific health claims, the vast adver- tising of the industry created a consistent message of purity, health, safety; reduced tars and nicotine, etc This campaign served to create doubt in the minds of the consumer as to smok- ingd9rtgers, and played on the wealmess of'those who were either addicted andror deaendent" The Coalition's petition concludes that there is a clear indication that the tobacco industry has marketed these products with the clear intention that by using low-tar and low-nicotine products a smoker can "mitigate" or "prevent" diseases associated with the smoking habit A series of advertisements run by, Vantage brand cigarettes;such as the one below in Time on January 8, 1973, biatantlyindicated this intended'purpose: "For years, a lotof people have been telling the smoking public not to smoke cigarettes, espeeialri cigarettes with high 'tar''and nicotine...Since the cigarette critics ane concerned about high 'tar' and nicotine, we would like to offer a constructive proposal. Perhaps, instead of telling us not to smoke cigarettes;,they can telli us what to smoke. Forinstance; perhaps they ougjtt to recom- mend that the Americatr public smoke Vantage cigarettes...Vantage gives the smoker flavor like a fuMavor cigarette. Butit's the onlyciganette that gives him so mudt flavor with so little 'tar' and nicotine:..": Tfie message contained in that Vantage advertiseJnent is one that is repeated'over and over again in today's marketing of low yield' cigarettes. In one recent edition,of Life magazine, three (3) such advertisetnents appeared. The Coalition's petition has remained pendinI FDAsince 1988. Since that petitionwa.s filed, over one and a halfimillioni Americans have died from ciganette smoking

Wt,rkshops ~",.N~.~~ ... . Also in 1988, the Coalitionion Smoking tDR'Nlealth and the Ameri'- can Medir.allAssociation filed separate petitions seeking to classify a newly developed R. J. Remolds', cigarette-like device named Premier as a drug under the FDC Act The arguments asking FDA to asserrjurisdietion were based on ia premise similar to the low, tar and low-nicotine petii that R. J. Remolds called its new, product "deatter,"'one which "reduces the controversial com- pounds7and sold it as "safer," that is, designed to mitigate and prevent disease and to affect functions or structures of the body. Because R J. Reynolds withdrew the product from the market, place, no action from the FDA was forthcroming; Petitions on other similar products were filed in 11991 and 11991 Defining wfien FDA can-or cannot-assert jurisdiction over, cigarette or cigarette-like products was further clarified in Febru- arv 1,9&'. A manufacturer wanted to market a non-tobacco "ciga- rette-like device consisting of a plug impregnated with nicotine: solution inserted with a small tube--cornesponding in appear- ance to a conventional cigarette." FDA had no difficulty inclassify- ing the product as a"drug.' After reviewing promotional ~ material as well as registration material filediwith the Securities and Ex- change Commission (SEC), the FD'A'reached!the following conclu• sion: "It is our position that, Favor is a nicotine delivery system intended to satisfi a nicotine dependence and to affecnthe structure or one or more functions ofithe body." Masterpiece Tobacs is another case of 'FDA asserting jurisdiction over ai nicotine delivery system, in this instance one which con- tained tobacco. The product was being soldiin the form oflai chewing'gum. T1tte manufacturer argued that because the product contained shreds of tobacco„it was outside the FDA's jurisdiction. The FDA disagreed and ruled that the productiwas a"food'..' under the FDC Act because that definition included "chewing gum " Because tobacco is not an approved substance for use as an additive in foods, the FDA ruled that the product was aditlterated and could not be marketed for health and safety reasons. Finally, in 1'989 the FDA issued a regulAtoryletterto C.A. Blbckers, Inc. indicating that a cigarette additive, "N=Bloetin, "was a "drug" subject to regulation bythe FDA. "N-Bloctin," according to the FDA regulatory letter "is analcohol-containing cigarette additive, the intended uses of'iwhieh include, throughiactionat the tissue cells, to inhibit the accumulation in the lungs of nitro- samines present iniconventionai cigarette smoke and thereby to prevent lung cancer."'The regulatory letter goes on to state that "[;c] jgarettes marketed as containing the 'N-Bloctin' additive such as the '(;!ptima' and 'Spectra' brands, are also 'drugs' under Section 201(g)(11) (IB) and (C) of the Food, Drug and Cosmetic Act. When one or more of'these uses for cigarettes containing, 'N+Blocun' is recommended or suggested!in the labeling they would be 'new drugs"as defined in Section 201 (p) of the FDC Act and subject to Section 5o5(a) and 802 of the FDC Act:" At the state level, efforts are already underway to seek classifica- t;on of low tar and low nicotine product~ as drugs under; state laws Petitions have been Piled!in a number of states citing state drug laws which mirror alhnosrword for word the federal drug statutes. State attotne}rs general hape afSo been asked to use tfkir authorities to crack down on the adverti5ittg„promotion; and sale of these products u'drugs''thereby avoiding the issue of federal pr eemption. While the federal Gganette Izbelittg and Advertising Aetipreempts states from regulatingthe advertising and Iabeling of cigarettes, states retain their full authority to regulate any and all products which are deemed'to be drugs. If Congress had!intended to limit their authorities in this area they would have done so. The neer! for FLfA to use exfstdng,autborities is urgent. While the 1990 Surgeon General's re.port, Tbe FJealt h' Beneftts of Smoking Ceasation, touts the beallti benefits of quitting, the tobacco indtt.stry continues to promote low-tar andilow-nicotine brands of cigarettes at an ever increasirtg,rate. The cl.ear, implica- tions of this calculated stmtegq'ts that, instead of quitting, smok- ers will continue to smoke, believing tharthe products they switch toare somehow safer and!will mitigate their risks of disease. More and more so-called "safer" products are appearing on the mar- ket A consortittm iof over 60'national health otgitnizati.ons be- lieves the FDA has the authority to puta slop to this deception, and to prohibit unsubstantiated health claims. III0(l The need!to amend the Foodj Drug and Cosmetic Act to regulate the tnanufaeture, distribution, sale, advertisittg, and promotion of tobacco products Because tobacco products are dangerous and addietive: it is onlv rational that, atialminimum, tobaccarproducts be reguLtted in a marmer similkr, to how other dangerous but legal consumer products are regulated. Past attempts to bring tobacco under the jurisdiction of one ormore ofithe federal health and safety agutt- ci.es have falled in recentl}ears, however, new efforts to regulate tobacco have enjoyed incteasing support inside and!outside of Congress:. The Congress and dte public are beconting increasingly aware that, unlike other eonsumer prodttas, and because ofithe clout of the tobacco industry, no federal regulatory agency has exerted or been able to exert any health or safety jurisdiction over tobacco products except in the narrow exceptions outlined above: The tobacco industry would rather this fact be ignore(L otte of tEte tobacco industrn?s public relations ploys has been to try to con, vince legislators and the public t}iat they are already burdensomely over-regulated and that there is no need to apply standards similar to those that are applied1to foods, drugs andd cosmetics to tobaeco:lhe reality of the matter is that tobacco products are so dangerous ttiat subjectirtg them to present FDA lawsgqverning other products would!likely result in their total ban. Thus the industry has had to ensure that no health and Isafetv regulations are applied to their products. The discovery dbcu- ments released in the Cipollone case indicate that thev_ have done this with exceptional skill. Somewhere between the extremes of the presetttabsence of significant health and safety regulation and a complete ban of the prodltct is aimiddle ground thatwill both allow the product to remain on the market and at ahe same titne subject it to necc-,sarn• T,>fi;:cco l's,, .l;":1mc7icirn C.-ais, `5 . 20,114-04196962

t1 atrksltclits regulations governing its tmnutacntre, distribution, sale, labeling, advertising and promotioa Achieving this wifl require amending the Federal Food; Drug and Cosmetic Act to,specificany and unequivocally give the FDA authorityover tobacco products. Under such an approach„the tobacco indusuywould be required to adhere to requirements with which manufacturers of other products have had to eomply. For example, does it tnake settse for the FDA to live full regulatory control ot+er nicotine patcties and gum which are designed to help people quititheir addictive smoking habits and not be able to have comparable regulatony, ccontrol over the products causing addiction and'death?'Cleariy, the double standard'must end. The health of the public should'be put above the political clout of the tobacco indttstry: Tobacco products shottldrthus be subjected to.regulation~governing:; • toxicologic testing and disclosure oflchemical additives in tobacco products, • disclosureand warnings related to constituents in both main- stream and'sidestream smoke (there are some 4;000 distinct chemicals in tobacco smofce), • requirements for additional labeling such as warning ofaddic- tion, stroke, use of tobacco products with birth control pills;,and other eontraindications (imclhding information about the health effects of environmental tobacco smoke), and practical advice and assistance to consumers on stopping,'tobacco product use, • distribution and sale of tobacco prodltcts (for example, prohib- iting free sampling, prphibiting sales through vending machines and enforcing restrictions on sales to ~minors), . • prohibiting advertising and promotional practices commensu- rate with the risks inwolved from use of the product; (comparable with other legal drugproducts, Le. prescription drugs),. For tobacco products this might «tean a complete el3minationof positive tobacco advertising and promotional!practices, • prohibiting the use of unsubsta<ttiated health or other dtims (i.e. low tar4 low nicotine, etc.), • right of inspection of manufacdirittg plants, subpoena power, seizureof adulterated and misbranded products by the FDA: 1Jegislative recommendations were seriously proposed in 1964 wiuctt would!have accomplished many of the above objectives either by putting tobacco directly under the FDA"s jurisdiction or by, strengthening,the authorities of the Federal Trade Commission. In what is now regarded as standard heaThanded tactics by the tobacco industry, these legisLative proposals were significantly watered downto require only a weak, inconspicuoas; Congres- sionally-written health warning on cigarette packages. While that label has been updated'since 1964, nothing has been accom- plished that would subject the tobacco industry to federal stan- dards thatare applied to every other legal product in our society:. in 1988, and again in 1991„legislationwas intn®duced forthe first time since 1964', that would attemptto correct the gaping regulatory loophole. The legialation introduced originally by former Congressman Bob Whittaker and Senator Jeff Bingaman and later in the 1002nd!Congress by Congressman !Nike Synar wouid establish a new chapter under, the Food, Drug and!Gos- metib AaG For the last thirty years, the tobacco industry has assured the U:S:. Congress that, as a responsible indusuy, it would do everything it could to find the answers as to whether cigarette smoking causes disease. Ih 1954 the Tobacco Indtutryran an advertisement in The New York Times that stated: "We accept anlinterest'in people:s bealtb as a basic responsi- bilfty, paramount to et,ery otber conslderation in our6u.rdr ness: " (Emphasis added) "We believe the products we make are not injurious to health." 'We akuays bave and always mill'cooperrste dosely tuitvti those tubose task it'fs to safeguard tbe public beallh "(!Emphasis added): In 1964 Bopmtan Gtay, Chairman of the Board of'R. J. Reynolds told aMouse Committee;,"lf it is proven that cigarettes are hwm- ful we want to,do something regardless of what somebodv else tells us to do. Ahd1we would do our level besc This is ju.a being human." Thirty years later, after 50;0(D0 studies have proven that cigarette smoking is amajor cause of cancer, cardiovascular disease, emphysema and!stroke, the tobacco industry still denies that'any relationship,between use of their products and disease has been proven and,is still engaged in a "holding strategy"de- sigued to head off any serious or significant attempts at having itss products properly regubwd. Congress was presented wittt te oppottnttity, in 1964 to pass significant legislation that could have restilted in the sawing,:of millions of American lives, but,failed The recent decision bv the US Supreme Court iniCtpoQone; while rea6irming the right of' individuals to sue tobacco contpanies tmdermanycauses of action, also reminded'us of dte glaring loophole that exists, in our federal health and1 safety laws when it comes to tobacco. By at- tempting to reservefor itself the role of solo regulator of tobacco products and'then failing to carryout its responsibilities;,Con- gres,s has done a tremendous disservice to the health of all Amen~ cans. Unless Congress (as wdl as the FDA) has the courage to uttdo wliat1 it did!in 1964 uttder pressuresfran the industry, tobacco products wilL tragically, remain the leading cause of preventable death and disability in the UiS: IV. Opportunities for state regulation of'f tobacco products Under our federal system of'goveinunent; the protection of thc public health,is largely a, responsibility of state and„by extension, local goventment. Although there has been little regulation ot tobacco products at the state level, states have a varietyof powers to protect their citizens. Existing consumer protection laws u:ui be used for this purpose, and the Supreme Court's decision in CipoQone (June 1992) opens up additional opportunities for protecting the public at the state and local leveLs, lnte first part of this century, 24 states severely restricted or banned'the sale of cigarettes. These laws carne about aK part of i

1ti orl:shops the prohibitionist movement. in the wake of the commercial success ofxhe Ameritart blend cigarette following,the 1913 iintro- duction of'Camel, these laws were either tepealed or amended to onlylimit sales to minors by the 1'930s. More recently, two states banned the sale of dove cigarettes in the 1980s following reports of serious acute toxicitv fbom these producis, (Gove cigarettes, or kretek„are a producvof Indonesia which contain a mixture of tobacco and clove.) In the early 1980s, the marketing of moist snuff products by'US Tobacco rtesulted in alepidemic of oral tobacco use among ado- leseentand pre-adolescent boys, an epidemic which continues to this day. Within a few years, several states eitherpassed or consid- ered legislation to regttlate the advertising and labelingof chewing tobacco and moist snuff. Faced with the possibility of diverse regulationat the state level, this segment, of the tobacco industty, began serious negotiations in Washing(on for alfederal law. This was passed ~ in 1986 and resulted in watning labels on chewing tobacco and~moist snuff prodtictsand advertising and a ban on, broadcasradvertising for these products. Consumer Protection lrrws. FuCisting consumer protection laws are amajor potential ltool for tobacco product regulation at the state level. Don Garner, a law professor at the University of filinois School of'Iawin Ckbondale has outlined!this approachimost dearly. State consumer protectionilaws generally describe the following as being inviolation: • Unfair or deceptive trade practice, • omission ofmaterial fact, and! • Creating confusion in the marketplace. The state does not need to prove that consumers relied on unfair, deceptive; incomplete or confusing information, only that such practices occurred: Fraud, since it leads to many if notall of these practices, is, itself, actionable as well. There are manypotentiai bases for cases, including the systematic way the industry has misled the pubGc about hazards caused by its products, the health claims inherent in sa-called low °tar" products, and the bait and switch tactics involved in much of'low tar cigarette advertising., These Laws permit several remedies, including res6tution (di.k- gorging the ill-gotten g.ains) 1 and penalties. States pursuing actions under, these laws might:seek remediess u tiich have symmetry with the losses suffered because of tobacco, products. These might indude: • Funding a public information campaign,' • Payments to Medicaid for the costs of care for tobacco-caused' illness, and! • Undoingthe fraud by paying for quit}smoking,treatment Under many lkws, individuals can pursue private actions as well. lnsuch actions, the person(s) bringing the complaint must make a showing of injury or damage. As with state action, thougha the private party'need not show reliance on the deceptive practice. TfAiccn~!se,.4n.4n:E~rcnn Crisis Penalties are only avaifable for injury or damage caused by decep- tive practices. New Opportunities to Regulate Tobacco ProductS. The Supreme Court"s decision inCipollone severely limits the degree to which federal law preempts state regulation of tobacco products. While the tobacco indusuy had claimed an expansive protection, immu- niattg itself'fbom vitmtally all state action, the Court held that the onlything states could not do was regulate cigarette advertising in a couple of'narnow, specific ways. Section 5 of the Federal Cigarette Labeling and Advertising Act ( 15 . U~.S:Ca S 1334, as amended) includes the fo0owing preemptionn provision: (a) No statement relating to smoking and health, other than the statement required by section 4 of this Act, shall be required lon any cigarette package. (b) No t equirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotionof any cigarettes the packages of which are labeled in conformitywith the provisions of this Acx. Edward 0: Correia, a professor of law atiNortheastern University School of law; has explored the opportunities available to states in the wake of the Cipollone decision in his paper "State [.egislk- tion After Cipollone." He outlined, several areas in which states maynow aet to protect their citizens$om~tobacco products. These ane: • The regulation of express warranties under state contract law. • Requiring tobacco companies to furnish information to the govemment (for instance, informationabout ingredients and information about the toxicity oPtheproducts), and •'Dhe regulation of the flow of information about tobacco prod- ucts and their use through channels of Wormationother than advertising. In additiona,he points out that states may define the remedies available in each ofIthese areas by statute. V. Recottunen+dations. Political maneuverings by the tobacco industry have closed off nearly all regulatory avenues for these most dangerous products. Cigarettes and other tobacco products are both the leasurel;ulaied' and the mosrdangerous consumer produets in the country: ihe only existing ~ potential authority to regulate tobacco products is that of the Foodland Drug Administration (FDA). indeed. FDA has been willing to regulate specifio products when the agency became convinced that the manufacturer had intended a dnig effect. The Coalition on Smoking OR Health has petitioned FDb to regu- late so-catled "lovv tar" cigarettes as drugs because of heaithh claims intheiradsertising and has petitionedIthat certainibr.uidstargeted at womenibe regplittedibecause of their promise of weight control. 202419G9G4