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Statement of John Slade, M.u. Department of Medicine St,. Peter's Medical Center New Brunswick, New Jersey before the Subcommittee on Health and the Environment Houee Energy and Commerce Committee FDA Jurisdiction Over Tobacco Products . March 25, 1994 Washington, 1).C. TI]V.IN 0046847

Harch 25, -994 ?age 2 Mr. Chaia rran, mecr:blrp of the Subcommittee, my name is John Slade. I am a:-, internist gperializing in addiction medicine. 2 8m & me:nber of the Department of MPdicine at the Robert Wood Joh"eon Medical. 8chool of the UniverAity of Medicine and Deaal.ietry ©f N=:w Jcraey and am the chairman nf the Committee on Nicctiija Depe:z-lence of thc American Society of Aric3i r.tior_ Medicine. My -,profesaional work largely involvea thp nllnical and public health -x.bpects of addictiono, eapecially addiction to nicotine. Cigarettee cause mct~a i1.lneds and death in the t3nited States than anything else (U9DHHS, 1989). The nicotine in cigarzttee makes cigarettes addicti.ve. Cigaretc.m manufacturers know their customers want nicotine, and their productu are deeigned to deliver nicotine. The evidence presented here will show that ciQarette rnan+_,facturere intend to affect the Zunction of Lhcir custotr,era' bo~.dLes. This, in turn, provides a basis for regulatiorn of cigarettes as drugs under the rlood, Drug and Cosmetic Act. Moreover, they intend to sustairn addiction to nir.otine in ctiatomers dependent on the drug. 0 What cau-see cigarette smoking? The cause ot emok:ng is not advertising, it is not low price, it is not widespread availability_ zf ._the-product, .t it is. not amoks.ngu_by_family.. members, and it ia not peer pressure. These things (among the others described as riak factors in the 1994 Surgeon General's Report (vSDxxs, 1994)) 4:acilitate the development of smoking, but they arc not thsm-_.elvee r.augal. The fundamental cauae of cigarette ~'IMN 0046548

March 25, 1994 Page 3 snoking is nic•:)tir.e, and ad.dicticn to nicotine largely sustains the practice (~JSDHHS, 1988). W<thout nicotine, adolescent tobacco use wouid all but vanish. Nicotine Addiction The 1994 Surgeon General's Report tells us that it is not the first cign-rette that produces addiction. It is the second, the third, azr-1 those that follow. Most adolescents who have ever smoked as few ae half a carton of cigarettes have a very difficult t.i:n-, stoppi ng. What do 1' mean by the t-Prm "addiction" ? The standard clinical dsfia6ition for a drug addici-i nn - also called a drug depcndence -4,s lops of contro]l over use of the suhAt-ance plus its coxLtinueid uae despite problems. This definition is embodied in the approa.h takcn to the addictions in the current editien of the Dia=o-a-ti•: and Qtati tical Manua (DSM) of the American Psychiatric A-ssociation, publishod in 1987 (American Psyahiatric Asuvc:iaLion, t987) . The D8M is the standard autlaority for diagnosing adiic:Lions in this country. Nicotine fits thin deiinition very well. Nicotine also fully satisfies the rese3rCh-ori~nted C~iteiia, emp~.uye~1 by the Public Health yervicc the 1988 surgsoa•-Ger.erai's •Report,--T-i•-•x 1±-h-Cna€,~~r-Ms ._f Smokina: Nicotiri Addiction, (USDHI3S, 1987) . " I Spoke=;men for cigarette makers have taken issue with whether or nCt nicotine is addicting. While questioning the interpretatirn of some of the data on which this conclusion is based, they L,ave mostly questioned the deiil-iition of addiction. TIMN 0046849

.March 25, 1994 Page 4 Nicotine, a centrai nervous system stimulant, produces effects in the zrain that are reinforcing. The consumer becomes addicted as he Dr she seeks the sensatior.is nicotine provides again and again, and the individual gradually requires an increasing dose to obtain the desired effects. Suddenly stopping nir_otine use often produces a characteristic withdrawal syndrome charar..t-Arized Iry such central nervous system effects as irritab'_lity, cifficulty concentrating, headache, trouble sleeping, chan,=*s in appoltite, and feelings of anxiety or depression. Tl:ese symptoms can perxist for weeks unless nicot'-ne is ingeated on:e again, either in the f.orm rlf a cigarette or some ~ other tobacco -oroduct or in the torm of a nic.atine rPpl ar.r?ment product auch a-i nicotine gum or a nicotine patch. The Public HeaLtr. Service uses a different definition of dddic:tion from that preferred by tho cigarette makers. The data strongly support the conclusion that nicotine regularly cauees addic:L,ian in a very high proportion of uscr®. The government's policies towards tobacco products should be based on its best underatandiaig •,~L the process, ae reflected in its undcratandiz~g of addictive processes and the entire range of relevant data. Spokesmen for cigarette makers frequently draw attentior_ to the large number of people whc have stopped amoking as evidence that nicotine is not addictive, While a large number of people have managed to stop smoking, the coricluwion is false. It ignores the fact that more than two-thirds of those who continue to arnoke wa.n_L to quit but feel Lhey cannot. IL i9~zorGs the fact that a third cf smokers-txy to atop each year. zt ignores the fact that the overwhelmizYg -ma-3-ors.ty- -of , quit_ .a,t.te4nYL..d ._t!XL~i in failure. it ignores the fact that spontaneous recovery is a well-known fe=,ture of 3_U addictions. (Ir. faca;, ulinicians and public health officials have long used general advice to stop using drugs Vi take advantage of this well-known phel.ouYeYlon. ) it ignores the f;_,ct that people who have addictions to more than one drug, such as heroin, cocaine, alcohol and nicotine, often rmydzd their addiction to nicotine as the most difficult addiction to stop. Millioiis ot people smoke and are also addicted to alcotivl. TIMN 0046850

March 25, 1994 Page 5 Nicotine Abeoy pta.on and Basic Cigarette Design Nicotine from tobacco products is absorbed in the mouth in the case of moist snuff, chewing tobacco, and cigar smoke, while nicotine is absorbed f.rom the lungs in the case of cigarettes (Gori , 198&; TLSDHHS, 1988) . The reason for t.his is a maj cr differerr.e in the degree of acidity or alkalinity, or pH, o= the nicotine fn,.m, - in thee~e various products. Nicotine at an alkaline pH i-_, reada 1 y absorbed in the mouth while '_t is not absorbed ther--: at all if the pN is acidic. Cigarette smoke is acidic while ~aioot other tobacco products p.r.etxArt_ nicotine in alkaline form to the oral membranes. A1kalin.e nicotinP i R harsh and irritatin-r to the throat (Faitelowitz, 1930: VSDmHS, 1988), so it is hard and unpleaaant to inhale cigar smoke. The acidic smoke from a.:igarette is readily inhaled, hokrever. . in f actc , unleso ci34rei:te smoke is inhaled, nicotine is not absorbcd (3ori, 1986). With inh-Llation, ac:idic nicotine is absorbed and transported to the brain lar more rapidly sud alL higher corlcentration than alkaline nico:ine absc+rbed in the mouth (Heauxingfield et al, 1990). The differenee: is like the difference between ca-nc;k cocaine, whichh is smoked by inhalation, and-powdered_cocaiiie, - which is sniffed 1nto the. ..noses. .',1he .fD.rmerx.ia. more..potent mg Lor mg and gives a more intense experience. it is also moz-e addictive. The cigxrette is the most efficient r.icotine delivery device on the market today (USDHHS, l9es). its complex balance of TIMN 0046851 -

March 25, :994 ?age 6 various tobacco-derived components and additives includinc sugars, as well as its paper, filter, and tipping paper are precisely desiqned to work.as a unit ta produce controlled dcses of an acidic, Aicotine-lader_ smoke for inhalation into the lungs. The cigarette Ls engineered to deliver carefully controlled doses of nicotine to the smoker's brain. The 9'TC Method Test and Sales Weighted Nicotine Deliveries In the mid-1960s, the Federal Trade Commission began to test cigarettes offared for sale in the United States with rnachine- based measurem.nts. The test parameters, codified :,n 1969, were derived from some first used in the 1930s by workers at the American Tobac:o Company (Slade, 1993). In the standard test, a 35 m1 puff is taken over 2 seconds once a minute until the cigarette is reduced to a certain specified butt length. The results are ekpressed (in milligrams) as the amounts of nicotine, particulate matter minus nicotine and water ("tar"), and (recently) carbon monoxide that appear in the mainstream smoke generated by the series of 35 ml puffs.l The test has been done consigtently on all cigarette brands ;.n wi cip Ai atri huti nn since 1968, initially by the FTC and recently througis. the- Tobacc.o Inst:tt.u.te.. Th.#.4+sm_ rfa.au.l r,R.,. c-omhinPC3 with brand apscific sales data f.or, ear-h year, havo pPrmi t-i-Pd t-np 2 The teat results are not enforceable standards. That is, there is no r, . qui rpmAnt- r.har r.i garai-tAa brands ar.tually prnvide the tar, nicotine and carbon monoxide deliveries measured in the samples of th= products tested. TIMN 0046852

March 25, 1994 Page 7 calcujation of sales weighted average nicotine deliveries, as depicted in Figure 1.3 Figure : shows a decline in sales weighted nicotine delivery from around 1.4 mg per cigarette to about 0.94 mg in the period 1968-1991.. However, nearly all the decline occurzed between 1972 and 1980. Since 1980, there has been no changr. Cigarett-. manufacturers rely on comparisons based on smcking machine tests to help sell their products. Enclosed with this statement is =, recent (1993) advertising insert from the American Tobacco CompaILV for its Carlton brand. The leaflet makes explicit comp.Lrisons of various versions of '-arlr.on with brands made by compe'~;itors. The FTC D4.tho-L T.®t is a Frgud. Despite ;.!he r..;garette companies' reliance on FTC method test results for c.garette brand prnmot:i nna, the FTC method test doeo not provide c-)nsumors3 with a re].iable index of the amount nf sraoko they in-;est from a particular cigarette. Unlike all other test results :a.ma.liar to consumers that are included in the ' The r=,port of sales weighted nicotine delivery prior to a,968 relied u:Pon by Mr. Johnston in hio 2/a8/9. letter to Dr. Kessler is un-available to me. The source referenced in the 1989 Surgeon Ganer al' s Report (LTSDF~I3 ,~~~ ~, pagc..8 8}.. .•~ca~s . a private communication from Helmut Wakeham of Philip Morris to another investigai:cr in 1976. Neither the 1988 Report nor the chart it references in:lude the actual numerica]l values being plotted, vnless the az?3lytic methods used are ahowrn to be comparable to those employed for the period 1968-1991, and unless the actual values aru available fcr replotting and ar.alya_a, the numbers taken off these charts prior to 1968 ehould not be used in comparisons with tLlYe later time period. TIMN 0046853

March 25, 1994 Page a labe=ing for other ingested items such as foods or dxugs, F^C method test results do not accurately reflect the bioavaa.labilicy of the meaaured components. The test is, therefore, a fraud. Ne:.l Benowitz and his colleagues at the University of California at =an Francisco have shown that nicotine yields as measured with +-he FTC method do not significantly correlate with blood levels oc cotinine, the major metabolite of nicotine (Benowitz et aT, 1983). This work has been confirmed by Gio Gori of the Frankl1=s Institute Policy Analysis Center and his colleagues (1906) as well as by David Coultas and his colleagues at the Universiyo of New Mexico School of Medicine (Coulcas et al, 1993). Thare is, however, a marked correlation between the number of ciga.vettes smoked and cotinine levels. In two de;,ailed studies, smokers ingested substantially more nicotine from .ndividual cigarettes and from an alternate nicotine deliv=:ry device than predicted by the FTC test. The first study, by Dr. Benowitz's group (Benowitz et al., 1991), found that smacers who inhaled absorbed an average of 2.49 mg of nic:otine from .i cigarette, when only 1.1 mg was predicted by the machine test. This is a 127% increase over the machine-based result. The eaconc3 atudy, by the biobehavioral research group at the R. J. Rayx±aldse Tcabacr_o. Company .1R. J.. Rey.nal.ds, .1,988a) , found that smokers who i.nhAl.ed absorbed an average of 1.0 mg of niaotino from a cigarette retec3 at 0.66 mg (51% inc_ease), ar.d the same subj ects absorbed an avarage of 0.7 mg of nicotine from TIMN 0046854

March 25, 1394 Page 9 a prototype of Premier that was rated at 0.34 mg ;106% increase) .4 People doa't smoke like the machi.ne, As detailed in the ., .988 Surgeon Ga-neral' s Report (T7SDHHS, 1958 ), they generally take larger puffs t nan 35 ml and do so in a shorter amount of time than 2 seconds. Robinson, Pr-tchard and Davis of R. J. 3eynolds also found that smokers take :arger puffs (mean 51 ml) (Robinson et al, 1992).§ Shorter, larger puffs, like those most smokers actually take, move air at a higher velocity through the cigarette. This may permit prcximal parts of the cigarette to reach higher temperatures rharn those reached under FTC test conditions. This effect would ~-ie expected to release more volatile components such as nicotine iLLto the smoke. This, in turn, predicts that, puff by puff, the -imoke ingested by smokers who draw in air through t-he cigarette at higher velocities than that used by the machine will hevoa hig=ier concentrations of nicotine than those taken by ® 4 1n all., three of 22 subjects in these two studies had atrikingly loaer nicotine lavels than the other 19. Tn interpreting their data, both teams of investigators assumed that a low nicotine .l.ua1.. maasit .that.. thee aubj.ert inhalPr.3,., very 1; r.ttP smoke. The RJR team did not even include the two non-inhaling Oubjects in its study in their final analyses. 'rh^ RTR t_aam was only interested in the data from the ten subjects who inhaled. 5 Their paper, "Psychopharmaco].ogical effects of smoking a cigarcttc wi*h typical "tar" and carbon monoxide yields hut-t minimal nico*ine,° is included as an attachment to this gtatomcnt. TIMN 0046855

March 25, 1994 Page 10 the machine wikh the ider.tical cigarette, g In actual use, the cigarettes most people smoke provide them with similar amounts of nicotine over the course of a day regardless of Ae FTC test-rated yield. This is a function of both the numbey of cigaret_es smoked and the way those cigarettes are smoked. The FTC test does not provide consumers with reliable infonvation about what they can expect to ingest when smoking cigare;:tes of a particular brand. The Coatrol of Nicotine in Cigarettes In 1952, Oha Food and Drug Administration found thar cigarette tobacco from the five leading brands contained an average of froa 1.58 to 1.82 percent nicotine on a dry weight basis (Wright, 1952). These values may be compared to the 1.5 to 2.5k nicotine 'tRr. Johnston reported for finished cigarettes in 1994 in his re•.ent letter to Dr. Kessler. If anything, cigarettes on the market forty years ago appear to have contained Iggg nicotine than many do now. This suggests that the losses of nir.cr_ina durinj manufacture from raw leaf bo finished product may have been moro prcnouncad than than now. Howevar., thA whrld nf cigarette manuEacture was vastly different four decades ago. In 1950,-Zha-Fade.ral .x'.rad.a-••fiommias3.an fouazd, s Groate- heating of the proximal part of the tobacco rod and of the filter by increased velocity of the draw would be expected to release even more nicotine from these potentially nicotine-enriched regions. The jeck.nology for a:nAching these regions with nicotine irs discussed in the next section. TIMN 0046856