Tobacco Documents Online

Tobacco Use in America Conference • January 27-28, 1989 for research on tobacco use in minority groups and women; increasing the budget for the Office of Minority Health for anti-smoking programs for rninorities; encouraging women and minority groups not to purchase magazines which adver- tise tobacco products; deveboping alternative sources of sup- port for youth and minority programs that now depend upon support from the tobacco industry. A number of other initiativos can complete a comprehen- sive anti-tobacco campaign. They include: increasing the budget for the Office on Smi ~king and Health; requiring feder- ally funded educational instititions to provide a smoke-free environment for children; ap;)ropriating additional federal funding for anti-smoking activities; including graphic pictures on cigarette package warnin(l labels; eliminating any pre- emption clauses in federal le;lislation that might prevent states from taking more strir gent action against the tobacco industry; tying anti-tobacco :ftorts with drug prevention ef- forts; and encouraging additional efforts by physicians to help prevent patients from siarting to smoke and to help them stop. Recommendations For children: 1. Federal policy should est, blish, or provide incentives for states to adopt, age 21 a°; the minimum age for purchase of tobacco products. Provisions for strong enforcement should be made, including meaningful penalties for viola- tions. 2. The federal government should ban the sale of tobacco products through vending machines. 3. The federal government should ban the distribution of free samples of tobacco i roducts through the mail, on public property and other places open to the public. 4. The federal government should require federally funded educational institutions to provide a smoke-free environ- ment for children. For women and minorities: 5. The federal government should increase federal funding for research on how to d:-crease tobacco use by minority groups and women. 6. Congress should fund a strong program of anti-smoking public service announcen ents, as well as a paid counter- advertisement campaign :;pecifically directed to women and minorities. 7. Federal grants should be provided to minority health pro- fessional and other organ zations to support programs to prevent tobacco use and :o help smokers stop. 6 For all Americans: 8. Congress should eliminate the tax deduction for tobacco advertising and promotional expenditures. 9. Congress should increase the budget of the Office on Smoking and Health. In addition, the budget of the Of- fice of Minority Health should be increased for anti- smoking programs targeting minorities. 10. Congress should provide additional federal funding for anti-smoking activities provided within existing federal public health programs serving women, children and minorities. Tobacco Use in Awrtica Conference TIMN 295319

T)bacco Use in America Conference • January 27-28, 1989 Nicotine Addiction Introduction The Surgeon General's 988 report, "Nicotine Addiction," concludes that cigarettes <<nd other forms of tobacco are ad- dicting, that nicotine is th_ addicting drug in tobacco and that the addictive process for nicotine is similar to that for drugs such as heroin and i;ocaine. People who are in troubl:_~ in our society are especially likely to use tobacco. They may be attracted to tobacco because it literally makes them feel good about themselves-euphoric, relaxed, less anxious. Scientists now know that nicotine regularly causes addiction in the users of tobacco products. And like other addicting drigs, nicotine more and more is victimizing vulnerable groups, especially the poor, women, children and minorities. Addiction to nicotine is tie most common serious drug problem in the United Stai:;s today. It is a complex disease with social, behavioral, physiologic and pharmacologic aspects. Like other addictions, it can be prevented and treated. However, at this time, adequate services are not available for the large numier of people who may benefit from such therapy. Therefore, treatment services need to be expanded in number and it scope to provide help for highly addicted persons as well a:, those who suffer from psychi- atric conditions or other dr.ig problems which are compli- cated by nicotine addiction Products such as cigareites and smokeless tobacco are nicotine delivery systems, and many other devices for ad- ministering nicotine are technically feasible. Nicotine itself can have harmful effects not only because it helps to main- tain smoking and tobacco iise. Therefore, our objective is to prevent and treat all forms of nicotine dependence. Understanding Nic•>tine and Addiction Classification Nicotine is the active dru) in tobacco. The 1988 Surgeon General's report reviews th; extensive literature on nicotine Prepared by: John Slade, MD St. Peter's Medical Center University of Medicine & Dentistry of New Jersey and concludes that nicotine regularly causes a true drug ad- diction in a high proportion of regular tobacco users. Many professional societies, including the American Medical Association, the American Psychological Association and the American Medical Society on Alcoholism and Other Drug Dependencies, agree that nicotine causes addiction, also known as dependence. The American Psychiatric Association has classified tobacco dependence with other addictive diseases since 1980, and in 1987, changed the technical name of the condition from tobacco dependence to nicotine dependence. In the 1950s, the World Health Organization classified tobacco use as an habituation. This classification was con- sistent with the belief at the time that drug addictions were manifestations of personality disorders and that in order to be considered addictive, a drug had to produce physical and psychological dependence. Under this paradigm, nicotine, cocaine, marijuana, and LSD were not thought to cause ad- diction, only habituation. This view is reflected in the 1964 Surgeon General's report. Today, addictive' diseases are no longer regarded as per- sonality disorders. And, although recent research has clearly shown that nicotine produces a true physiologic dependence, this characteristic is no longer essential for classifying a drug as addictive. Instead, scientists define addiction in terms of certain behavioral interactions of an individual with a drug. The primary criteria for a drug addiction used in the 1988 Surgeon General's report are: -There is a highly controlled or compulsive pattern of drug use, -Psychoactive or mood-altering effects are involved in the pattern of drug taking, and -The drug functions as a reinforcer to strengthen be- havior and lead to further drug ingestion. Additional criteria used in the report are tolerance, physical dependence, continued use despite harmful effects, pleasant 7 Tobacco Use in America Conference TIMN 295320

Tobacco Use in America Conference • January 27-28, 1989 (euphoric) effects, stereotypic patterns of drug use, relapse following drug abstinence an(I recurrent drug cravings. All of these criteria apply tc nicotine. People use tobacco for the nicotine: nicotine-free products do not succeed in the market)lace. A major policy issue for the federal government is wh;;ther and how the Food and Drug Administration. (FDA) or some other agency should regulate products which deliv;r nicotine. While the FDA has not asserted jurisdiction over traditional tobacco products (ex- cept in extraordinary circums:ances), the 1988 report recom- mended that the federal gove,nment review new, alternative nicotine delivery systems for toxicity and addictive potential before they are marketed. It i:, time to develop a system of regulatory oversight for tradit'onal tobacco products. Health Complications The 1989 Surgeon General's report estimates that in 1985, one in six deaths in this coun try was caused by cigarettes. These 390,000 deaths were distributed among the following terminal illnesses: Diagnostic Category Deaths (thousands) Coronary Heart Disease 115 Chronic Obstructive Pulmoi ary Disease 57 Cerebrovascular Disease 27.5 Other Vascular and Pulmon ary Diseases 45 Lung Cancer 106 Other Cancers 31.6 Infant and Neonatal Deaths 2.5 Lung Cancer in Nonsmoker:, 3.8 Deaths from Fires caused by Cigarettes 1.7 TOTAL 390.1 In addition to these diagnoctic categories, there is substan- tial evidence that among non-,mokers, tobacco smoke polllu- tion also causes deaths from coronary heart disease and cancers at sites other than th;; lung. In Environment Interna- tional, J.A. Wells estimates the additional number of deaths among nonsmokers from tobacco smoke pollution at 43,000. Determinants of nicotine addiction and recovery Nicotine addiction occurs m the result of complex interac- tions of the drug nicotine witi a specific individual living in a specific social and cultural coitext. For the most part, it is a pediatric disease: if an individual has not started to smoke by age 20, it is very unlikely he t_ir she will ever become ad- dicted to nicotine. On the ord;;r of three-fourths of children growing up in this country experiment with tobacco; about 70 percent of use has begun )y age 15, half by age 13. Be- tween one third and one half •)f those who experiment be- come chronic users; and most of these people are addicted to nicotine. Table 35 (page 11) from th:; 1989 Surgeon General's report summarizes the pharmacologic, cognitive, personal 8 and social factors involved in the onset of this disease, in its chronic stage, and in recovery from the addiction. Typically, nicotine addiction develops over a period of several years from late childhood to early to mid-adolescence. There is evidence that most teenagers who smoke want to quit, and most make at least one serious attempt to do so in these early years of the disease. For adults, too, thoughts about quitting and attempts to stop smoking are common, although repeated failure makes many relatively reluctant to try yet again. Still, more than two-thirds of adults and adolescents who smoke would like to quit. At the same time, people who smoke are highly condi- tioned to continue. This happens in part because the smoker perceives the pharmacologic effects of nicotine as positive. Thus, the person addicted to nicotine has lost control over his or her use of the drug, and truly free will is not operative. Thus, recovering from addiction involves a number of pro- cesses, including deconditioning, or unlearning all the associations with nicotine. Social and cultural influences are important in starting and continuing smoking as well as in recovering from addiction. Some of these influences are the smoking behavior of people around the individual (the smoking status of peers and rela- tives have been specifically studied), availability of tobacco products, advertising and promotion of tobacco, public health messages about tobacco, counter-marketing and policies about where smoking is permitted, if at all, in public places, schools and workplaces. If we understand these influences, we can begin to control the nicotine addiction epidemic by adopting policies that encourage young people not to start smoking and support and encourage smokers of all ages to quit. Most former smokers have quit smoking without formal treatment assistance. However, in many cases stopping smoking was associated with important personal or social changes in a person's life. (These are outlined in the section on nicotine and other addicting drugs.) But for many people addicted to nicotine treatment is not only helpful, it is essential for them to become abstinent. And treatment works. An extensive collection of scientific literature is devoted to the treatment of nicotine addiction and documents a number of valid intensities and approaches to treatment from single brief encounters with a therapist and self-instruction courses to inpatient treatment programs and Smokers' Anonymous groups. Adjunctive drug therapy, such as with nicotine resin complex (Nicorette) along with behavior modification treatment is also proved to be useful for selected patients. Other drugs such as clonidine and some anti-depressants, and other forms of nicotine have also shown promise as adjunctive therapies in preliminary studies. There are many settings in which treatment may be under- taken. Unfortunately, an important limiting factor is the lack 7bbacco Use in America Confererace TIMN 295321

Tobacco Use in America Conference • January 27-28, 1989 of health insurance reimbu,sement for stop-smoking ser- vices. The reimbursement ssue is complicated by the fact that there are no formal standards for what constitutes ac- ceptable therapy of this disease or for therapist training, and many proprietary clinics oi er unproved remedies. Comparisons with other addicting drugs Data in the 1988 Surgem General's report indicates that the use of nicotine shares inany characteristics with the use of cocaine, opiates and alcohol. People who use any of these drugs in a sufficient dose can detect the presence of the drug by their subjective feeling state. The drugs produce ef- fects regarded as pleasural_le, and they all have been shown to be positive reinforcers in both animal and human studies. Place conditioning-the association of a specific environment with drug use, drug effects and/or drug withdrawal-is com- mon to all four. Tolerance .ind withdrawal phenomena are regularly observed (physical dependence). Finally, each drug has been used in medicine as a therapeutic agent. It is well known that man y people have recovered from nicotine addiction without formal treatment. Tobacco in- dustry spokespersons are particularly intrigued by this phe- nomenon, as though it suggests that nicotine does not cause addiction. However, so-call:;d spontaneous remission is not unique to nicotine; it is also seen with other addictive di- seases, including those related to alcohol and heroin. The 1988 report reviews many factors which are important moti- vators for spontaneous remission in all three conditions. These include health proble:ns, social sanctions, significant others, financial problems, :>ignificant accidents, manage- ment of cravings, positive r;inforcement for quitting, internal psychic changes and chang;s in lifestyle. In fact, the resolu- tion of an addiction is seldom (if ever) a random event, stim- ulated merely by the freely oxercised choice of the individual involved. Nicotine addiction, alcoholism and psychiatric illness There is a significant overlap between alcoholism and nicotine addiction. While less than 30 percent of the adult population smokes, around 30 percent of those presenting for treatment of alcoholism are also addicted to nicotine. Similar patterns are well kntlwn for other drug dependencies among both adults and adol;scents. Patients in psychiatric hospitals and clinics also have high rates of nicotine addic- tion. Traditionally, there has been a profound reluctance on the part of clinicians to interfere with nicotine addiction in these settings: quitting has often been discouraged by those in authority. However, this approach lacks empirical support, and many experts question ihe special status nicotine addic- tion enjoys in these settings The growing popularity of smoke-free hospitals, the inc;reasing recognition that nicotine addiction shares much in common with other addictive dis- orders, and, especially, the :;normous risk of morbid compli- cations from smoking are bringing these issues into focus for both the mental health and the addiction treatment communi- ties. Federal policy initiatives might help foster changes which will lead to nicotine addiction being treated as a primary problem in these patient groups. Product liability Tobacco product liability suits have been brought in recent years by individuals who have developed major complica- tions from smoking such as lung cancer. Litigation has a number of benefits for the overall effort to control the nicotine addiction epidemic. Liability suits typically claim that the plaintiff was addicted to tobacco, usually becoming addicted before the age of consent and before the legal age of sale. Although the plaintiff accepts some responsibility for smoking, the claim is that this responsibility should be shared with the tobacco company because of nicotine addiction, the inherently dangerous char- acteristics of the product and the company's behavior. The grounds available for pursuing these suits have been limited in many jurisdictions by court opinions that the Federal Cigarette Labeling Law pre-empts tort actions against ciga- rette companies. While this issue may yet be resolved by the judiciary, a clarification of the law by Congress-as has been done for smokeless tobacco-would facilitate the pursuit of these actions. Need for Action Nicotine addiction is the cause of the greatest epidemic of disease in this century. Its complications resulted in 390,000 deaths in 1985 alone. The disease is both preventable and treatable, and the federal government has many opportuni- ties to control this deadly disease. Summary of Workgroup Discussion Nicotine causes an addictive disease in a high proportion of users. The disease typically beings in childhood or adoles- cence and continues through a large proportion of adult life. Personal, social and cultural factors act in conjunction with nicotine to produce the disease. Recovery is possible at any age or stage of the condition, and although a minority need specific clinical treatment, most can learn to not smoke with only general support from society. Because treatment ser- vices are not now available for the 40-million plus smokers who may want them, a major challenge facing public health is how to provide no-smoking support and how to minimize influences which encourage and sustain the addiction. There are many opportunities for prevention and treatment of nicotine addiction. The 1988 Surgeon General's report has brought the fact of nicotine addiction into clear focus for policy makers for the first time. It is now time to explore the policy implications of nicotine dependence being an addictive disease. Tobacco Use in America Conference 9 TIlVI~i 295322

Tobacco Use in America Conference • January 27-28, 1989 Recommendations 1. Nicotine leads to more deaths than any other addictive drug in our country. Adi itionally, it is implicated in the development of other drug dependencies, it contributes to the severity of other : ddictions and it is often a com- plicating factor in treatin 3 these conditions. Therefore, legislation should ensure that all programs for the pre- vention and treatment oi alcohol and other drug depen- dencies should address nicotine as well. 2. Preventing nicotine addit:tion is critical because the ad- diction which develops can be so strong. Prevention programs need to begin at the preschool age and should include educatior about the dangers of drug ad- dictions in general and :,fhat these conditions are. Op- portunities to begin the :;ducation exist in programs which target young children and pregnant women, such as the Special Supplemental Food Program for Women, Infants and Children (WI1j), AID to Families with Depen- dent Children and Head :3tart. 3. Because nicotine is such a highly addictive drug, aggres- sive efforts to counter-market tobacco products are needed to help shift the momenium which initiates and sus- tains this disease. 4. Tobacco use and nicotine addiction are not a matter of free choice. Therefore, warning labels on tobacco prod- ucts should not be cons :rued as protecting tobacco manufacturers from procluct liability. Legislation which establishes labeling requirements for tobacco products should specify this. 5. Tobacco product manuf.[cturers' stated intent for their products is to provide tobacco taste, pleasure and satisfaction. Pleasure and satisfaction are actually ac- complished by producinii changes in the structure and function of the body, intluding increasing nicotine receptors, modulating m:urochemicals and activating nicotinic receptors. Therefore, new legislation should affirm FDA's authority tc regulate existing tobacco products. 6. New nicotine delivery sy3tems should be evaluated by the FDA for toxicity and addictive potential. 7. Because the addiction to tobacco is the greatest public health problem facing orir nation, a portion of revenues from increased excise taxes on tobacco products should be devoted to co antermarketing, public health promotion and research efforts to prevent and treat tobacco use. The use of tax money for anti-tobacco efforts should be clearly stated on package labels. In addition, increases in ex,,ise taxes on tobacco products are themselves an important part of a comprehensive program to control tobarco use: such taxes are known to reduce use, especiall;, among the young. The same phenomenon is observed when the "cost" of heroin or cocaine is manipulated experimentally. 8. Current levels of funding to reduce tobacco use are in- adequate considering the magnitude of the problem. Therefore, funding should be substantially increased. 9. Studies of the public's level of awareness of the enor- mity of nicotine addiction and its consequences should be conducted serially at the Federal level. 10. Treatment for nicotine addiction should be widely available and reimbursed by insurance carriers, in- cluding Medicare and Medicaid. Standards and guidelines for managing nicotine addiction ought to be developed as have been done for other diseases in- cluding alcoholism and other drug addictions. 11. The training of health professionals such as physi- cians, nurses, psychologists and counselors should specifically include instruction and clinical experience with managing nicotine addiction. 12. Tobacco-free environments enhance efforts of those who have stopped using tobacco to remain abstinent, encourage currerit users to consider quitting and help discourage the young from beginning to experiment with nicotine. Further, tobacco-free schools, work- places, healthcare institutions and other facilities also help prevent health problems caused by tobacco smoke pollution. 13. The behavioral and physiological processes of addic- tion begin with the first dose of nicotine, and the easy availability of tobacco products encourages use and promotes relapse to nicotine addiction. Therefore, ac- cess to nicotine delivery systems should be limited to those age 21 or over, free sampling of tobacco prod- ucts should be banned and the locations where to- bacco is sold should be sharply limited. 10 7bbacco Use in America Conference TIMN 295323 ~

hbacco Use in America Conference • January 27-28, 1989 Determinants of smoking within each domain by stage Stage Domain Pharmacologic processes and conditioning Onset/development Regular use Cessation Initial psychopharmacologic effects encourage transition from experimental to regular use Cognition and decision- Poor awareness of long- and making short-term health conse- quences and addictive nature of smoking Positive characteristics are attributed to smokers and smoking Personal characteristics arid Inclination toward problem social context behaviors Extraversion Peer and family norms and values support smoking Youth-oriented advertising Numerous conditioned asso- ciations among smoking, environmental events, and pharmacologic effects of nicotine Health consequences are minimized or depersonalized Positive characteristics are attributed to smokers and smoking Stress/negative affect are reduced by nicotine Social acceptability and peer and family norms support continued smoking Cigarette marketing en- courages and legitimizes smoking Withdrawal symptoms and conditioned and reinforcing effects of nicotine en- courage relapse Increased awareness of smoking-related symptoms or illness Perceived benefits of cessation Belief in one's ability to stop Social norms and support for stopping and maintained abstinence Skills for coping with stimuli associated with smoking Economic, educational, and personal resources to minimize stress and main- tain cessation 7bbacco Use in Awerica Conference 11 TIMN 295324

'Ibbacco Use in America Conference • January 27-28, 1989 Federal Regulation of Tobacco Products Introduction In spite of the fact that tobacco products are responsible for more than 300,000 d:aths each year-more deaths than from alcohol or drug abus:;, accidents and suicides combined- tobacco products are the least regulated of all. The reasons for the lack of regulation :are historical, economical, and political-not logical. Tobacco regulations arp, a haphazard patchwork of incom- plete and diminishing control. To date, only the Congress has had any clear authori :y to regulate these products for health and safety purposcs. Attempts by the states in the late 19th century to regulate tobacco and cigarettes have all but disappeared as laws to ban cigarette sales have gradually been repealed. No federal laws have been enacted to take their place. Regulating Comp-ments of Tobacco Products Nicotine The recent Surgeon General's Report, "Nicotine Addic- tion," notes that cigarett:s and other tobacco products that contain nicotine are powerfully addictive. The National In- stitute of Drug Abuse call:, cigarettes the most widespread form of drug abuse in the United States. Yet despite these conclusions, tobacco products and the nicotine in them are out of the control of any ;ederal regulatory agency. The Food and Drug Administration (FDA) regulates nicotine when it is sold as a drug, such as in Nicorette brand gum. This is a prescription druii manufactured by Lakeside Phar- maceuticals and is a drug therapy to help people quit the nicotine habit. To sell thiF product, Lakeside must adhere to all the regulatory standards required for new drugs, including the manufacturing, labelhig, distribution, sale, and advertis- ing requirements established under the Food, Drug and Cosmetic Act (FDCA). Prepared by: Scott D. Ballin Vice President, Public Affairs American Heart Association Additives Today's tobacco products are not the tobacco products of the past. They contain hundreds, if not thousands, of chem- ical additives used as flavors and fillers. No federal agency has any authority to require that these additives be disclosed or even removed if found to be harmful. Many of the addi- tives used in tobacco products are suspected of being car- cinogens or cocarcinogens. The FDA requires that food prod- ucts list and ensure the safety of additives. In fact, the Delaney clause of the FDCA requires FDA to remove any ad- ditive from the market found to induce cancer. It seems ironic that for cigarettes, which cause an estimated 80,000 lung cancer deaths each year, the FDA is powerless to im- pose the same authority. The 1984 Surgeon General's report sums up the problem of additives as follows: A characterization of the chemical composition and adverse biologic potential of these additives is urgently required, but is currently impossible. . .. With this lack of basic information and the usually prolonged latent period before manifestation of adverse effect of smok- ing, it is likely that a long time period will elapse before we know the hazards of the new cigarettes. Testing and labeling of tobacco products for tar, nicotine, carbon monoxide and other constituents Until 1988, the Federal Trade Commission (FTC) tested cigarettes for amounts of tar, nicotine, and carbon monox- ide. But now the FTC laboratory is closed, and all testing is the responsibility of the tobacco industry. While the FTC tested the cigarettes, the tobacco industry used the results for its own economic advantage in selling cigarettes. Cigarette manufacturers embarked on the so- called "tar wars," with each company trying to outdo the other by producing the lowest tar, but best-tasting cigarette ibbacco Use in America Conference 13 TIMN 295325

Tobacco Use in America Conference • January 27-28, 1989 on the market. These marketing strategies (and the use of "federally" determined tar am_ nicotine levels) lull con- sumers of cigarettes into believing that low-tar and low- nicotine cigarettes are safer. But, in addition to the tar and nicotine, tobacco smoke contains an estimated 4,000 constituents. None of these constituents are disclosed to u e public, nor does the Public Health Service have any authority to ensure the safety or reduction of these constituents. The 1983 Surgeon General's report notes: A cigarette considered less harmful for cancer etiology might not reduce the risk of -oronary disease. It appears a formidable task to develop a product that satisfies the smoker and does not increase disease risk exposure to carbon monoxide, cyanide, nitrous oxide or still unknown agents. Interesting enough, as far ba,,k as 1959, Philip Morris was well aware of the problems of potential FDA regulation of its products. An internal Philip Morris document released in a tobacco litigation suit (Plaintiff's exhibit 323) notes "if the food and drug laws were ever ~ pplied to cigarettes certain constituents like arsenic and otier insecticides and certain minor smoke constituents migi t have to be controlled." Again, in 1963, in another iniernal memo (Plaintiff's exhibit 605) the Philip Morris research director notes, "We believe that the next medical attack on cigarettes will be based on the cocarcinogen idea. With hundreds of compounds in smoke this hypothesis will be hard to oontest." In more than 20 years of anti-smoking activity, ihis is an area that is unre- solved and unregulated. Regulating Cigarette _,'-~aies and Promotion Sale of Cigarettes to Minors Although many states have I: ws that restrict the sale of cigarettes to minors (varying from no restrictions to age 21) these statutes are rarely enforc;d. Cigarettes and other to- bacco products are readily obtained from vendors, as free samples, or uncontrolled vendirig machines. There are no federal restrictions on the sale and distribution of cigarettes sold in interstate commerce. B1 cause the use of tobacco products is a national problem, and because almost all cig- arettes and tobacco are market:;d in interstate commerce, federal action to limit the acces3ibility of cigarettes to minors may be warranted. Advertising The advertising and marketinq of cigarettes clearly requires federal regulation. Without appropriate federal r~ gulatory control, the tobacco industry will continue to adverti:,e and promote their prod- ucts with one goal-profits at i1he expense of health. 14 Regulating of Tobacco Products Under the Food, Drug and Costmetic Act Expanded Definition of "Drug" In 1906, Congress enacted the first federal food and drug law. The primary purpose of the Act was to ensure safety of products sold as foods and drugs. The Act defined "drug" very narrowly to include only those articles which were listed in the U.S. Homeopathic Pharmacopeia. Tobacco or ciga- rettes were not listed at that time. Since 1906 the authority of the FDA has been expanded to include cosmetics and medical devices as well as food and drugs. 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 only covers the composition of the products, but also their labeling, sale, distribution, advertising and promotion. In the 1930s Congress, concerned with an increasing number of ineffective, unsafe and dangerous products and devices appearing on the market, expanded the definition of "drug" under the Act. The Senate Committee Report accom- panying the 1935 Act noted: The definition of "drug" has been expanded to include, first substances and preparations recognized in the Homeo- pathic Pharmacopeia of the United States; second devices intended for use in the cure, mitigation, treatment or prevention of disease; third substances, preparations and devices intended for diagnostic purposes, and fourth such articles other than food and cosmetics intended to affect the structure or function of the body. Such expan- sion of the definition of the term "drug" is essential if the consumer is to be protected against a multiplicity of devices and such preparations as "slenderizers," many of which are worthless at best and some of which are distinctly dangerous to health. Court Tests The expanded definition of "drugs" was applied against cigarettes in three court cases in the 1950s. In two of the cases relevant to FDA jurisdiction, the courts found that con- ventional cigarettes could be "drugs." The question of whether or not the FDA could assert jurisdiction hinged on whether or not the products were being sold as articles in- tended to either mitigate or prevent disease or intended to affect the function or structure of the body. As the court in U.S. v. 46 Cartons Fairfax Cigarettes noted: If claimant's labeling was such that it created in the mind of the public the idea that these cigarettes could be used for the mitigation or prevention of the various named diseases, claimant cannot now be heard to say that it is selling only cigarettes and not drugs... The ultimate impression upon the mind of the reader arises from the sum total of not only what is said, but also all that is 7bbacco Use in America Conference TIMN 295326

T)bacco Use in America Conference • January 27-28, 1989 reasonably implied. If cl aimant wishes to reap the re- ward of such claims let it bear the responsibility as Con- gress has seen fit to impose on it. This was the first time Mat cigarettes were found to be subject to the FDA's jurisdiction because they were not sold "merely for smoking plea.-;ure" but had other intended pur- poses. Because those cigprettes could not meet the statutory and regulatory requirements of the FDCA, they were re- moved from the marketplace. The idea of classifying c'garettes as drugs has been reaf- firmed by the FDA in testiinony before Congress and more recently by the courts. In 1,977, for example, in attempting to further clarify FDA's jurisdiction, Action on Smoking and Health (ASH) and others filed a petition with FDA seeking to classify all cigarettes as drugs under Section 201 (g)(C) as articles "intended to affeci the structure or any function of the body of man or other <<nimals." The premise on which the petition was filed was ihat because all cigarettes contain nicotine "they fall easily and squarely within the broad lan- guage of the act." FDA deiied the petition-a decision up- held in court in 1980-and FDA Commissioner Donald Ken- nedy stated the petitioners had failed to establish an intent on the part of the manufacturer to sell a product which "af- fected the structure or function of the body." Specifically, the Commissioner wrote: Statements by the petitirners and citations in the peti- tion that cigarettes are u3ed by smokers to affect the structure or functions of their bodies are not evidence of such intent by the manu:acturers or vendors as required under provisions of the ; DCA. However, in denying the petition, FDA did not say that cigarettes could not be cla:;sified as drugs under Sec. 201. The FDA merely said that in the case of cigarettes in general, petitioners failed to provide sufficient evidence to establish that manufacturers sell cigarettes with an intention of affect- ing the structure or functio,7 of the body. In 1988 the Coalition on 3moking OR Health (American Cancer Society, American i.ung Association, and the Ameri- can Heart Association) filed a petition with FDA seeking to classify all low-tar and low-nicotine cigarettes as "drugs" under the Act. The Coalition's petition is based on a review of the advertising and marketing strategies of these products by the industry as well as evidence released as a result of the 1988 Cipollone v. Liggett Group Inc. liability case. It con- cludes there is a clear indication that the tobacco industry has marketed these products with the clear intention that by using low-tar and low-nicot ne products a smoker can "miti- gate" or "prevent" diseas~is associated with the smoking habit. A series of advertisements run by Vantage brand cig- arettes such as this one in rime on January 8, 1973, blatant- ly indicated this intended purpose: For years, a lot of people have been telling the smoking public not to smoke cigarettes, especially cigarettes with high 'tar' and nicotine. . .. Since the cigarette critics are concerned about high 'tar' and nicotine, we would like to offer a constructive proposal. Perhaps, instead of tell- ing us not to smoke cigarettes, they can tell us what to smoke. For instance, perhaps they ought to recommend that the American public smoke Vantage cigarettes ... Vantage gives the smoker flavor like a full-flavor ciga- rette. But it's the only cigarette that gives him so much flavor with so little 'tar' and nicotine. ... This petition is pending at the FDA. Also in 1988, the American Medical Association and the Coalition on Smoking OR Health filed separate petitions seek- ing to classify the newly developed R. J. Reynold's cigarette- like device Premier as as drug under the FDCA. The arguments asking FDA to assert jurisdiction are based on a premise similar to the low tar and nicotine petition: that R. J. Reynolds is calling its new product "cleaner," one which "reduces the controversial compounds" and selling it as "safer," that is, designed to mitigate and prevent disease and to affect func- tions or structures of the body. Defining when FDA can-or cannot-assert jurisdiction over cigarette-like products was further clarified in February, 1987. A manufacturer wanted to market a non-tobacco "cigarette-like device consisting of a plug impregnated with nicotine solution inserted with a small tube-corresponding in appearance to a conventional cigarette." FDA had no dif- ficulty in classifying the product as a "drug." After review- ing promotional material as well as registration material filed with the Securities and Exchange Commission (SEC), the FDA reached the following conclusion: It is our position that Favor is a nicotine delivering sys- tem intended to satisfy a nicotine dependence and to af- fect the structure or one or more functions of the body. While tobacco products can be deemed drugs under the FDCA where their marketing and sale meet the definitions under the Act, it remains unclear where FDA will draw the line in asserting its jurisdiction. Masterpiece Tobacs is another case of FDA asserting jurisdiction over a product containing tobacco. The product was being sold in the form of a chewing gum. The manufac- turer argued that because the product contained tobacco it was outside the FDA's jurisdiction. The FDA disagreed and ruled that the product was a "food" under the FDCA because that definition included "chewing gum." Because tobacco is a dangerous, unapproved substance for use in foods, the FDA ruled that the product was adulterated and could not be marketed for health and safety reasons. 7bbacco Use in Anzerica ['or;fereuce 15 T~`~ '95311

Tobacco Use in America Conference • January 27-28, 1989 Regulation of Tobaci--o Products Under Other Health and Saf ~ty Laws Attempts to regulate tobaccD and tobacco products under other federal health and safeby statutes have not fared well. Of laws enacted since 1964 to regulate a variety of consumer products, the tobacco industp/ has been successful in having tobacco and tobacco products specifically exempted under:  The Consumer Product Safety Act  The Fair Labeling and Pa;kaging Act  The Federal Hazardous S abstances Act  The Controlled Substanc:.s Act  The Toxic Substances Act The Consumer Product Safety Act governs the safety of a large array of consumer prodi:cts, but tobacco products are excluded. The Toxic Substanc:; Act was enacted to ensure that authority existed to "regulate chemical substances and mixtures which present unreasonable risk of impairing health," but tobacco products are excluded. Despite its harmful ef- fects on health and its addictir g qualities, tobacco is exclud- ed from the Controlled Substances Act. Despite Congress's desire to ensure that consumers are fully and adequately in- formed about the products they use, tobacco products are excluded from the Fair Labeling and Packaging Act. One could reasonably argue that tobacco products would undoubtedly have been strictly regulated or even banned under these Acts if Congress r ad not provided the statutory exemptions. New Regulatory and I.egislative Options Tobacco products are dangerous and addictive. It is only rational that at a minimum tob icco products be regulated in a manner similar to how other dangerous consumer products are regulated. Past attempts tc bring tobacco under the juris- diction of one or more of the fnderal health and safety agen- cies have failed. In recent year3, however, new efforts to regulate tobacco have enjoyed increasing support inside and outside of Congress. To develop strategies for regulating tobacco it is necessary to consider first, the use of existing law, and second, legisla- tive proposals that specify and designate an agency as re- sponsible for regulating tobacc ~ products. Existing Law Over the years, Congress ha:> effectively ruled out using major health and safety statutes to regulate tobacco prod- ucts. The one narrow exception is with the FDA which has the authority to regulate: articles intended for use in ii e diagnosis, cure, mitiga- tion, treatment, or preventiori of disease in man or other animals, and articles (other tian food) intended to affect the structure or any function of the body of man or other animals. 16 Applying these statutory provisions to tobacco products is only feasible when health claims are made, either directly or implied. Even then, if FDA fails to take any independent ac- tion, it is incumbent upon the private sector to initiate action through petitions. While it may have a positive outcome, the petitioning process-as is evident by FDA's failure to act on the RJR Premier cigarette and on low tar and nicotine ciga- rettes-can be long and tedious and may have to be resolved in the courts. But in the absence of clear-cut statutory au- thority to regulate tobacco for health and safety purposes, filing petitions asking FDA to apply its well-established regulatory muscle is one of the few available options. In spite of obstacles, petitioning and demanding that the agency continue to define when it will and when it won't take jurisdiction over tobacco products is important to do. Each time a petition is considered, the public and Congress are reminded that while tobacco products remain the major pre- ventable cause of death and disability, they also are the least regulated products. Legislative Action to Regulate Tobacco Products The Congress and the public are becoming increasingly aware that unlike other consumer products, no federal regu- latory agency has any health and safety jurisdiction over tobacco products except in narrow exceptions outlined above. During the 100th Congress numerous bills were introduced that would for the first time give a specific federal regulatory agency power over tobacco. H.R. 2376 was introduced by Rep. Jim Bates (D., Cal.) to remove the statutory exemptions for tobacco and tobacco products from the Consumer Product Safety Act. The total regulatory ramifications of this approach are not clear, but at the extreme, could result in the product being banned. While logical, this approach may not be feasible at this time. In September 1987, Rep. Bob Whittaker (R., Kan.) intro- duced legislation that would specifically give the FDA juris- diction over all tobacco products. Because incorporating tobacco products under the definition of "food" or "drugs" could result in a total ban, the bill establishes a separate chapter of "Tobacco Products" under the FDCA. Thus, the product remains legal, but regulated. The bill is comprehen- sive in its scope giving FDA specific authority to regulate the manufacture, distribution, sale, labeling, testing of chemical additives such as tar, nicotine and carbon monoxide and pro- motional activities. The debate over whether Premier should be declared a drug under the FDCA has drawn attention to the fact that tobacco products have escaped regulation, because of statu- tory and other legal loopholes. In discussing FDA's failure to act quickly against R. J. Reynold's Premier product, the Chairman of the House Subcommittee on Health and the En- vironment recently stated, "failure to act decisively will only 7bbacco Use in America Conference 'TIMN 295328