Tobacco Documents Online

46 FooD AND DRUC LAw JouRNAL SuPrLEMENT VoL. 53 • the brain.'" The use of different nicotine-delivery devices produces different patterns of blood nicotine increase. The more rapidly the nicotine level rises in the blood, the more reinforcing and dependence-producing it is. For example, absorption of nicotine into pulmonary circulation results in the delivery of nicotine to the arterial system and from there to the brain in less than ten seconds. Inhaled nicotine reaches the brain at effective levels in less than half the time required for orally absorbed nicotine, and more rapidly by far than nicotine administered through the skin. Moreover, the peak arterial drug concentration immediately after smoking a cigarette is typically more than three times higher than the simultaneous venous level?' Inhalation provides higher, more rapid, and briefer surges of nicotine to the brain compared to oral or nasal administration, permitting more fine-tuned adjustment of dosing to internal and external stimuli. Accordingly, inhalation is regarded as being more capable of initiat- ing and sustaining addiction than other routes of administration. Similar findings have been obtained with respect to smoked cocaine.'6 A. Cigarettes In 1997, an estimated 475 billion cigarettes were sold in the United States," comprising about ninety-five percent of all tobacco product consumption. A cigarette is composed of a roll - consisting of several types of tobacco leaf (primarily flue- cured and burley, but also some oriental tobacco and Maryland leaf), tobacco deriva- tives (such as shredded papers known as "reconstituted tobacco"), and tobacco stems - that is wrapped in a paper and usually is attached to a filter. Nicotine content in the finished product is a function of the different blend components selected for a given product (table I)." TABLE l29 Average Nicotine Content of Major Cigarette Brands Sold in Massachusetts in 1997 Brand Average Nicotine Range Number of (Manufacturer) Content (mg) (mg per stick) SubBrands GPC (Brown & Williamson) 10.0 8.3 - 12.8 19 Doral (R.J. Reynolds) 10.6 9.1 - 14.1 16 Winston (R J Re nolds) 11.8 9.9 - 13.5 11 . . y Winston Select (R.J. Reynolds) 12.1 11.1 - 13.3 6 Marlboro (Philip Morris) 13.4 11.4 - 15.5 20 Newport (Lorillard) 13.6 11.4 - 15.4 13 24 Jack E. Henningfield & Robert M. Keenan, Nicotine Delivery Kinetics and Abuse Liability, 61 J. 0__ CONSULTINC & CLINICAL PSYCHOLOCY 743 (1993). 00 's Jack E. Henningfield, June M. Stapleton, Neal L. Benowitz, Roger F. Grayson & Edythe D. London, j Higher Levels of Nicotine in Arterial than in Yenous Blood After Cigarette Smoking, 33 Daoo & ALCOeoL ~ DFasrvnFracE23 (1993). V 40 r' Suzene M. Evans, Edward J. Cane & Jack E. Henningfield, Arterial and ttenoru Cocaine Plasma (~ ~ CO

• 74 FOOD AND DRUG LAW JOURNAL SUPPLEMENT VOL. 53 unfold in an orderly manner, mistakes harmful to public health are very likely. Fi- nally, tobacco product manufacturers continue to adhere to positions that contradict the very rationale for regulation. Industry's approach makes it very difficult to engage them in even normal conversation about what might be done to reduce illness and death from these products. - --- At the same time, many opportunities seem to exist to make tobacco products less poisonous and to improve public health in how they are made, labeled, marketed, and distributed. The system for regulating these products should be developed in parallel with a re-examination of how nicotine delivery devices from pharmaceutical compa- nies are regulated.1e' Coregulation may offer the best opportunity for offering those who use nicotine an optimal range of nicotine delivery devices, thus, reducing mor- bidity and mortality caused by tobacco products by both reducing thepoisonousness of these products and offering a range of markedly less dangerous products to those who cannot or will not stop using nicotine.'xa Illness and death from tobacco is such a large problem that people of good will simply must come together and work to solve this complex problem. To be successful, it will be essential that FDA has the appropriate tools, structure, and resources to permit the agency to do its job. Once these are assured, the agency can work with the industry and with the medical and public health communities to seek answers to the appropriate scientific questions. 0 N O _ "'SeeHenningfietd&Slade,supmnote179. ~ uaWarneretal.,supranote67. 0) V W W O.

• 1998 TOBACCO PRODUCT REGULATION: CONTEXT & ISSUES 61 Because of the experience with light cigarettes, there also is a concern that even if products such as Eclipse and Accord pose substantially less hazard than cigarettes, they might compete and interfere with public health goals. This interference could happen by keeping some consumers in the nicotine market longer than they otherwise would be, by bringing new consumers into the market for nicotine delivery devices who otherwise would not become addicted to nicotine, and by initiating dependence in new generations more effectively than existing products. Many of the regulatory issues raised by these products are highlighted in table II, which compares major features of Eclipse with those of the Nicotrol inhaler. TABLE II • Comparison of Two Nicotine Inhalers FEATURE ECLIPSE NICOTROL INHALER (Tobacco Company) (Pharmaceutical Company) heat source volatizes nico- ambient air passing oug eration 0p tine and glycerol, and nicotine reservoir volatizes nic tin Dose mimics cigarette (lung de- similartolowNicorettedose livery of nicotine) (buccal delivery of nicotine) Projected Abuse Liability high low high carbon monoxide, ac- Contaminants rolein, "soot," and other none allowed contaminants. Claims/Indications reduced delivery (unprove smoking cessation (FDA- to FDA) approved studies) Intent cause and sustain depen- treat dependence dence Cost over $3.00/20 pack ($0.15 $55.00/42 pack ($1.30 each) each) was mo ified to be more any modification requires Modification Oversight palatable ( more toxic) FDA approval Premarketing Approval none submitted to FDA conventtona new g ap- plication submissioa and Data FDA a roval Availability over-the-counter prescription only As table II illustrates, the product that provides low doses of a pure form of nico- tine has a much greater regulatory burden and more restrictive marketing oversight that the more toxic product produced by the tobacco company. Because these products would compete with abstinence as well as with some ciga- rette brands, thoughtful consideration also should be given to what effects mainte- nance use of one of these products for a substantial period of time might have on consumers. O W i W ~ V W IV W

0 1998 TOBACCO PRODUCT IZ6GULATiON: CONTEXT & ISSUES 45 tion to use for "medicinal purposes." The definition was expanded in 1938 to include "articles intended to affect the structure or any function of the body."'s In 1995, after an extensive investigation, the agency determined that it had juris- diction over cigarettes and smokeless tobacco products because both overwhelmingly met criteria as drugs and as devicesl' In 1996, the agency issued its final rule, which included regulations to reduce the availability of cigarettes and smokeless tobacco products to persons under eighteen years and to reduce the volume of advertising for these products that reached children and adolescents.'s Classifying these products as both drugs and devices (combination products), the agency issued the regulations under its device aufliority. While loose cigarette tobacco was included under the FDA's final rule,'y other tobacco products, such as cigars, pipe tobacco, and nasal snuff, were not included. As yet, FDA has not issued specific public health regulations for any tobacco product regarding the product itself, its ingredients, or how it is made. This article will explore the pertinent background of tobacco products and examine options and opportunities that may exist to regulate such products in ways that reduce the amount of illness and death that they cause. II. TOBACCO PRODUCT TYPES • • Although tobacco products both are widely used and are complex devices, they have escaped meaningful regulation in part because of Ute lacunae in knowledge about them outside of the industry. While there is general information about such factots as what tobacco products contain, what they deliver to consumers, what their effects are, and how the way they are used alters their performance, there is little or no specific information about these factors in particular brands. This situation exists largely be- cause the acquisition and use of this information by regulators has been precluded by congressional action (for example, ingredient disclosure),20 and reporting of the deliv- ery of certain constituents left to the oversight of FTC, which has with little experi- ence in matters such as drug bioavailability, toxicology, and the performance of drug delivery testing." I - Modern commercial tobacco products are highly engineered devices that deliver carefully calibrated doses of nicotine.'2 The patterns of use characteristic of these products are largely those typical of drug addiction." The reinforcing qualities of nicotine and other psychoactive drugs are not only functions of dose, but also critically involve the rate at which the dose is presented to 3661 Fed. Reg. at 45,222 n.1160 (quotingU.S. Departmentof Agriculture Regulatory Announcements, No. 13 (1914)). ° Analysis Regarding Food and Drug Administration's Jurisdiction Over Nicotine Containing Cigarettes and Smokeless Tobacco, 60 Fed. Reg. 41,453 (Aug. 11, 1995). See also 61 Fed. Reg. at 44,619. 18 21 C.F.R. pt.801 et seq.; Regulations Restricting llle Sale andDistribution ofCigarettes and Smokeless Tobacco to Protect Children and Adolescents; Final Rule, 61 Fed. Reg. 44,396 (Aug. 28,1996). "61 Fed. Reg. at 44,422, 44,616. --- - 20 See, e.g., id. at 44,463-64. " See, e.g., Nnr1oNA1. CANCErt INsT., supra note 9, at 1-11. '2 Slade, eunra note 14, at 2-23. u U.S. DEP TOF HEALTH & HUMAN SE2vs., TF@ HBALTH CONSPQUENCES oFSMOxING. NICOTINn AnnttTGN: A REPORT OF THE SuxcEON GENeaAt. (1988) (DHHS Pub. No. (CDC) 88-8406); Gary A. Giovino, Jack S. Henningfield, Scott L. Tomar, Luis G. Escobedo & John Slade, Epidemiology ofTo6acco Use and Depen- dence, 17 ErmeMml.oauc Rev. 48 (1995); 61 Fed. Reg. at 44,619.

0 0 1998 TOBACCO PRODUCT REGULATION: CONTEXT & ISSUES 59 otomy.In recent years, lte had used one and half to two packs each day of Merit Ultra Light 100 Box (FTC tar: 6 milligrams, nicotine: 0.6 milligrams). After surgery, he was abstinent for only three weeks. Once smoking had resumed, he tried to stop again without success despite trying a variety of nicotine-replacement products. In October 1996, he first obtained Eclipse through a business associate who visited Chattanooga, Tennessee regularly. After trying both the Full Fla- vor (FTC tar: 3 milligrams, nicotine: 0.2 milligrams) and the Mild (FTC tar: 2 milligrams, nicotine: 0.1 milligrams) versions of the product, he settled on the Mild because it had a less harsh taste. At presentation, he had used about one pack of Eclipse Mild daily for five months. The patient liked a number of features of the product. What he espe- cially liked was that, while producing the satisfaction of a cigarette, there was no tell-tale odor; other people could not tell that he still was smoking. The product helped him conceal his smoking from his relatives and from most of his friends (those who did not themselves smoke), reducing his feel- ings of guilt at not being able to stop. He also was fascinated by the fact that Eclipse produced virtually no ashes and by other features unique to the prod- uct. He liked the fact that it had such low tar and nicotine numbers. At the same time, he found that lie was unable to stop using it; he felt addicted. An adverse reaction to the product led him to want to quit. Eclipse gave him bronchitis and made him short of breath. While using Eclipse Mild, he rapidly developed a cough productive of a mostly whitish, mucoid sputum. The consumption of each stick provoked a cough and the production of some phlegm. At a dosage of twenty Eclipse Milds daily, sputum production was so copious that he regularly awoke from sleep during the night to clear the phlegm. He also developed noticeable wheezing and shortness of breath on exertion (such as brisk walking for one block). While on cigarettes for the previous twenty-eight years, he had noticed some milder dyspnea, and spu- - tum production, while present, had been far more scanty. On the day he presented, he reported having consumed about twenty sticks of Eclipse Mild in the previous twenty-four hours. The plasma cotinine was 117 micrograms per liter,17 implying an intake of 14 milligrams of nico- tine the previous twenty-four hours, or about 0.7 milligrams per stick of Eclipse."s Behavioral counseling combined with bupropion did not lead to a reduc- tion in consumption. In the first week of nicotine replacement with both a nicotine patch and nicotine gum, however, Eclipse usage diminished to about nine sticks per day. The bronchitic symptoms promptly improved but did not disappear. At this dose of Eclipse, however, he was able to sleep through the night. The dyspnea resolved. After the patient became discouraged with his lack of progress and dis- , "'The method used to analyze cotinine is the same as that described in William 1. Sandlwrn, William J. Tremaine, Kenneth P.Offord, George M. Lawson, Bret T. Petersen, Kenneth P. Batts, IvanaT. Croghan, Lowell C. Dale, Darrell R. Schroeder & Richard D. Hurt, Transdernwl Nicotine for Mi(dly to Moderately Active Ulcerative Colitis: ARmtdomized, Donble-Blind, Placebo-ControlledTrral, 126 AnnAts Itareawu. Mm. 364 (V (1997). "'Nea1L.Benowitz,TheHmnanPfiarmacologyofNicotine,9Res.AovnrvcesAt.coxo, &DavcPaoss. 00 .. j ~ 1 (1986). W O) V W N ~

r • 1998 TOBACCO PRODUCT REGULATION: CONTEXT & 1SSUES 55 Cigars can cause of nicotine addiction and other diseases, including cancers of the mouth, throat, and lung, as well as heart disease.o' There is no evidence that the health risks of premium brand cigars are lower than for the less expensive, machine- made types. Nicotine absorption from cigars is facilitated by the smoke generally being more alkaline than cigarette smoke, presenting a larger proportion of nicotine to the con- sumer in a freebase form. One result is that nicotine from cigar smoke is absorbed readily in the mouth; inhalation is unnecessary for nicotine to reach the brain. Many cigar users, however, actually do inhale the smoke, especially those who have had experience with smoking cigarettes. No information is provided to consumers about the content of nicotine in cigars or their delivery of nicotine or other materials. The marketplace offers consumers cigars that contain anywhere from ten to more than 300 milligrams of nicotine with- out providing any guidances' This is a surprising omission when compared, for ex- ample, to the careful dosing information that is available to consumers of medicinal forms of nicotine. FDA has not asserted jurisdiction over cigars. At the time the rule was issued, the agency had insufficient data that indicated that cigars were a growing problem for young people, and it did not have information regarding the intent of manufacturers to control the delivery of nicotine to their customers .~ Nonetheless, it is now clear that cigars are highly effective nicotine delivery systems, that they cause disease, that they are widely used by the young, and that they are alternatives to other tobacco products ys One effect of the FDA rule when fully implemented is that cigarettes and smoke- less tobacco will be moved behind the counter.vb Already, clerks are required to check the identification cards of prospective purchasers who appear younger than twenty- seven years of age. Because these requirements do not apply to cigars, cigars will become relatively more available to adolescents than cigarettes and smokeless to- bacco. (Inexpensive cigars sold in pharmacies and convenience stores are often dis- played in self-service racks that cannot even be seen by clerks at the checkout counter.) Because of these issues, cigars should be regulated by FDA as tobacco products. The precise requirements for cigars should be tailored to this category.v' D. Novel Tobacco Products Tobacco companies and others have developed a wide array of novel devices and variations on conventional nicotine delivery devices over the years y" In the past de- cade, R.J. Reynolds has brought two of these products to test market (Premier and " NATtoNAa CANCeR INST., supra note 88; A. Petersen, A Study Warns of Cigars' Role in Some Hean Disease, WALL SLJ., Mar. 20,1998, at B I; AAfERICAN PSYCHIATRIcASs'N, DSM-IV: DIAGNOSTTc AND STATISTICAL MANUAL oF McrvTAL Dlsotmeas 242-47 (1994). zf NATIONAL CnNcEx INSn, supra note 88; Jack E. Henningfield, M. Hariharan & Lynn T. Kozlowski, Nicotine Coruent and the Risks af Cigars, 276 JAMA 1857 (1996). --~ - . - - 9° 61 Fed. Reg. at 44,422, 44,424. ~ Y's NATIONAL CANCERINST., sunrti note 88. N '" 61 Fed. Reg. at 44,616 (codified at 21 C.F.R. § 897.14(e)). p41 Similarconsideraflons apply to pipe tobacco and to nasat snuff. 00 'a [n 1992, BAT briefly considered entering the nicotine patch market but decided against it. See Suein L. (A) - Hwang&AlixM.Freedman,[7.A.T.CousideredPatchesbutStucktoMakingCigarettes,WALLST.J.,Oct.9, ~.,: ` 1995, at B3. ,4 i . -4

0 0 60 FOOD AND DRUG LAW JOURNAL SUPPLEMENT VOL. 53 continued therapy, he stopped using Eclipse and returned to smoking ciga- rettes in order to avoid the bronchitic symptoms. For this patient, Eclipse would have been an acceptable alternative to abstinence but for the bronchitis it produced. The product sustained his addiction to nicotine. A key advantage of Eclipse was that by using the product, the patient was able to conceal from family and friends the fact that he had been unable to stop smoking. The appar- ent nicotine delivery he achieved was seven times greater than the nominal yield of the product, but this result is similar to that which R.S. Reynolds scientists have de- scribetl."y This probably is because the operating temperature of Eclipse is highly dependent on the way that it is used.120 The patient's distressing respiratory symptoms are unexplained, but may be re- lated to the fact that the aerosol produced from Eclipse has a relatively large amount of acrolein,1z' probably from the breakdown of the glycerin used in the device. Ac- rolein is a lung toxin."' The occurrence of an adverse effect seemingly related to the use of a product that might be predicted to reduce adverse effects is a reminder that studies of such devices such need to be large enough to conduct two-tailed tests of significance. 3. CurrentStatus Accord and Eclipse presently would seem to be niche products. These types of products, however, have the potential to substantially replace conventional tobacco cigarettes. Should such a transition be encouraged by regulation? Will it be possible to ensure that the public health consequence of such a transition does not recapitulate that of the transition from regular cigarettes to light cigarettes? In that case, cessation and prevention efforts were seriously undermined by the reassuring aura of safety that surrounded the then-new cigarette types. The danger of certain diseases (such as squa- mous cell carcinoma of the lung) merely were replaced by other diseases (such as adenocarcinoma of the lung), while the risk of other diseases (such as heart disease) was unchanged. There are a number of questions that need to be answered before it will be clear what, if any, role these products might play in reducing the toll of illness and death caused by tobacco products in this country. Both products deliver carcinogens to con- sumers, and Eclipse delivers more carbon monoxide than any cigarette on the mar- ket.123 Toxicology testing by the companies has focused only on tests associated with screening for cancer risk, and it is uncertain whether the most appropriate controls have been used in these studies. The companies have not reported on the long-term safety issues associated with the use of nicotine for lengthy but indefinite periods of time. "J. Robinson, Human Smoking Behavior Studies, presentation at EcHpseand theHarm Reduction Strat- egyforSmokingsymposiumatDukeUniversity,Durham,NC(Aug.23,1996). - -- -- '"Slade, supra note I06. '2' Borgerding et al., supr¢ note49. "' Haffmann & HoHmann, supra note 36. --- -M There is a marked increase in expired carbon dioxide levels among subjects when using Eclipse com- pared to when they use their usual brands of cigarette. Karl Fagerstr8m, A Comparison of Regular Cigarettes with aNicotine ReplacementInhaler and Eclipse on Smoking Behavior, Attitudes and Exposurein Smokers Not Willing to Quit, presentation at the Founh Annual Meefing oftheSociety for Research on Nicotine and Tobacco, N • New Orleans, LA (Mar. 27-29,1998). O 00 .i W V W >V N

0 i 1998 TOBACCO PRODUCT RF.cur.nTtota: CoNTaxT & IssuEs 65 Now may be the time when this strategy actually can be implemented. Based on past experience, however, it can succeed only if FDA has the means and the resources to set and revise standards, to monitor results, and to hold industry accountable. A. Overall Standards for Tobacco Products Product specifications (performance standards) for the various categories of to- bacco product will be the measures that every product in a given category must meet. Tobacco products cannot meet the "safe and effective" standard applied to drugs;'" such products are inherently toxic. Rather, the overall standard should be no more poisonous (or dangerous) than necessary, as is consistent with the recommendations of several major public health reports.145 Within this overall parameter, the specific requirements mandated should be set by FDA to likely result in a more than trivial reduction in toxic potential. It would be unwise for there to be a specific requirement that performance standards be proven to result in a significant reduction in illness and death before they are implemented. This approach only would insure endless delay in making a number of relatively small adjustments that (taken as a whole or imple- mented across a broad, exposed population) could lead to important public health benefits. Performance standards should become more demanding over time, as knowl- edge about product design advanced and as far less hazardous (and even safe) alterna- tive products replaced conventional products in the marketplace.14fi Potential health claim (PHC) products, in contrast, aspire to make claims as part of their labeling and advertising. Thus, prior to initial marketing of one of these prod- ucts, data should be required that would at least support the conclusion that the prod- uct has a substantial chance of substantially reducing the risk of illness and death compared to the tobacco products against which it would compete. It also would be appropriate to require that manufacturers eventually demonstrate such products are safe and effective, because health claims will be made and because at least some who will use the product would otherwise be abstinent and others who use these products may not previously been tobacco users. This review could be accomplished by grant- ing initial conditional marketing approval and reviewing approval within a certain time frame, after additional studies were completed and experience was gained in the marketplace. As product specifications became more rigorous, the regulatory standards bar also could become higher for products that make health claims because this category would exist only in relationship to its members being substantially less poisonous (or dangerous) than products that met the minimum criteria of the performance stan- dards. B. Preliminary Work To enable thoughtful regulation, FDA will need to further develop its science base about tobacco products. Knowledge to be acquired as the agency undertakes this process includes: how products are made and why they are made a certain way; what ingredients are used and why; what altemative methods manufacturers have consid- '94 See 21 U.S.C. § 355(b)( I). lV 14' See supra note 143. . 0 1HiCUUNCQ.UN$c1ENTIFlCAFFAIRS,ANffWCANMm.ASs'N,REDUCINGIL.NF.SSANDDFATNCAUSFDBYCIGA- 00 3 • rzeiau sv Rmucmc Ttn:na Nlconrvn Con^Irslr (7998) (CSA Rep. 9-A-98); Warner et al„ supru note 67. (,J ~ V W IV _ V -

• 1998 TOBACCO PRODUCT IZF,GULATfON: CONTEXT & ISSUES 73 dangerous than necessary, and to examining possible health claims for novel prod- ucts. A common standard for the regulation of conventional tobacco products and treatment products probably will be neither practical nor socially acceptable.181 It may be possible and preferable, however, to seek common standards between putative re- duced-risk tobacco products and treatment products. In evaluating a PHC product, FDA should seek to establish that there is sufficient evidence to indicate that the product has a sufficient likelihood of providing a sub- srantial public health benefit and that such claims (with appropriate qualifiers) are warranted. In addition to short-term chemical and toxicologic data, an application provided by a manufacturer for a PHC product should include a plan to address the issues related to continued, maintenance use of the product by consumers compared to both the continued use of medicinal forms of nicotine and abstinence, as well as a plan to provide long-term evidence of the supposed health benefit.te2 Each product with an approved claim should be regulated in comparison to a particular performance standard for conventional products and to the specific tobacco products that it will most likely compete at the time of approval. The performance standard should change over time. Moreover, there also should be long-term studies of products that have approved claims after initial market approval that will shed light on whether the products actually can meet their promise of being substantially less dangerous than directly competing tobacco products and not substantially more dan- gerous for the public health than either competing pharmaceutical products and absti- nence. These considerations suggest that approvals for claims made for tobacco prod- ucts should be subject to review and rc-approval at regular intervals (five to ten years, for example). Tobacco product manufacturers probably will raise an array of objections to this proposed approach. Such an approach, however, with its step-by-step plan, provides an orderly way to develop a regulatory system for tobacco products. The chief advan- tage of this approach is that there will be a much reduced risk of making another mistake such as light cigarettes and a much improved chance that what is done actu- ally will benefit the public health. Another advantage is that this approach is more likely to enlist the active and timely cooperation of industry in the development of adequate testing methods and useful performance standards than one that puts re- duced-risk products on a fast track, short-circuiting and corrupting the process at the outset. In this plan, manufacturers have an incentive to cooperate with the testing and performance standard development process that they otherwise lack, because the test- ing standards first would need to be in place before health claims are considered for products such as Eclipse or Accord and performance standards form one of the bench- marks by which reduced-risk products can be recognized. VII. 0BSTACLES AND OPPORTUNITIES • A seemingly daunting array of problems exist for tobacco product regulation. Specifically, there are three particular major difficulties. First, available knowledge about tobacco product design and opportunities for product improvement are limited outside of the industry itself. Second, unless the process of regulation is allowed to "' See Henningfield & Slade, aupru note'179. '"'T7tese postmarketing studies should be the responsibilityof the sponsor. Dependence on other sources for this work, including the government, will lead to gaps in the conduetof the necessary studies and to unneces- sary delays. Only the sponsor has both the resources and the incentive to do the work. .

! • • 44 FOOD AND DRUG LAW JOURNAL SUPPLEMENT V OL. 53 lion aspects of tobacco products' and reviews cigarette packaging and marketing to assure that these materials do not involve lotteries and that they do not include words or images that are indecent or immoral.' BATF is the enforcement agency for the Contraband Cigarette Act,e which is intended to discourage large-scale bootlegging across state borders. Pursuant to a voluntary agreement entered into by the major cigarette manufac- turers, the FederallYade Commission (FTC)oversees the inclusion of nicotine and tar yields tested according to the so-called "FTC method" in advertising for those compa- nies' brands.9 This method was adopted in the 1960s, in the unrealized hope that these disclosures would serve the public health by enabling consumers to select ciga- rette brands that would reduce their exposure to toxins. The agency also supervises the rotation of health warnings mandated by Congress for cigarettes and smokeless tobacco products.10 FTC also plays a watchdog role in cigarette advertising (as in its recent case regarding Joe Camel),t' and compiles annual reports on advertising and marketing of cigarettes and smokeless tobacco products!2 The Department of Justice enforces the statutory ban on broadcast advertising for cigarettes." Prior to August 1996, the Food and Drug Administration (FDA) only had taken action against cigarettes on a case-by-case basis; as early as the 1950s, the agency attempted to regulate specific tobacco products as drugs14 or, in one case, as a food" Nonetheless, FDA had asserted its potential jurisdiction over tobacco products, sub- ject to its interpretation of their use, for more than eighty years. As summarized in the jurisdictional analysis of its final tobacco rule, FDA made the following observations: The predecessor to FDA issued the following statement about its jurisdiction over tobacco: "Tobacco and its preparations, when labeled in such a manner as to indicate their use for the cure, mitigation, or prevention of disease, are drugs within the meaning of the act, and, as such, are subject to the provi- sions thereof. ... On the other hand, tobacco and its preparations which are not labeled and are used for smoking or chewing or as snuff and not for medical purposes are not subject to the provisions of the act" .... Thus, to escape regulation under this interpretation of the Agency's authority, a to- bacco product must not be labeled as a drug and must not be used as a drug. At the time this statement was issued, a drug was defined only as an article intended for the cure, mitigation, or prevention of disease, hence the limita- ° 26 U.SC. § 5703 (1994). '!d. § 5723. "Pub. L. No. 95-575, 92 Stat.2463 (1978) (codified at 18 U.S.C. §§ 2341-2346 (1994)). u NATIONAL CANCFA INST., NATIONAL INST.OFHEALTH, THE FTC CmARETTETFST METHOD FOR DPIERRnNINO TaR, NtconNE, ANDCAReON MONOXIDE Yvios oF U.S. CtonRerres: Rerorsr oarnnNCl Exeecr Corvus~(Smak- ing and Tobacco Control Monograph 7) (1996) (NIH Pub. No. 96-4028). '" See Federal Cigarette Labeling andAdvertising Act, Pub. L. No.89-92, 79 Stat.282 (1965) (codified at 15 U.S.C..§ 1331-1341 (1994)). Specifically, supervision of the rotation of warnings falls under 15 U.S.C. § 1333(c). "/n the Matter of R.J. Reynolds Tobacco Co., FTC Dkt, No. 9285 (1997). '" FTC compiles annual reports under 15 U.S.C. § 1337. See, e.g., FFnua.v. TRADE Con7mi N, Rueoxr To CONGRFSS FoR 1996 PURSUAN[ To THe FEUaIwL CtcARErrE LA9ELINC AND ADVEgrtsnm ACT (1998). " 15 U.S.C. § 1335. '" See Nicotine in Cigarettes artd SmokelessTObacco is aDrug andTheseProducts are Nicotine Delivery Devices Under the Federal Food, Drug and Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44,619, 45,219-22 (Aug. 28,1996). - - - - - -- '5 ]ohn Slade, Nicotine Delivery Devices, Lt Nwornue ADDtcnoN: PRmcTrLFS ANO MANACSnmNT 18 (C. Tracy Orleans & John Slade eds.1993).