Tobacco Documents Online

March 25, 1994 Page 11 Becai.:se oE the large amount of tobacco leaves used in the manufactLCe U cayarettes and the extreme var:ability in nicotine content of the =eaves, it is not practically possible Cor respondent [P. Lorilla,nci Colupany] , or ai:y of the other manufacturers of leading brands of cigarettes, to maintain a constancy of nicotine in the finiehed 4igaLeLte. (Federal Trade Commission, 195C, page 6) This is na longer the case. Innovations in materials processing and cigarette design since the 1950a have made it possible for cigarette manufacturers zo make products that are uniform despite the variability inherent in their chief raw material. The Appendix summarizes some patents _hat illustrate major ways ciqarette manufacturers can use modern technology to assure a uniform product, a product that performs as intended, as a nicotine delivery device. The patents demonstrate a concern with providiny predictable, controlled doses of nicotine to the r..nnmummr, engineering that makes it easier for the consumer to titrate his nrhAr nicotine Level. This overarching concern is especially c1-ar in patent rn. 1,584,930 from Philip Morris. Reconstituted toba.cao (paper sheets made fror Pt:Pma, finas and trash) ha= an inherently lower nicotine level than does tobacco loaf. fiimilarly, etems themselves, which are often finely cut an.l rollcd ao that they can be incorporated into c:igarette ble=tda, have a far lower nicotine- aonAnt than the leafy pdrt Uf t1~ bvba~ce-ledf -(laat-inal.. ~hcr~c._de£icianaiee, as well ae LtiG v4riabili.ty inherent in different batchec, can be compenwa4ed Mr with the wide variety of techniques illustrated TIMN 0046857

Mesrch 25, 1994 Page 12 in the Appendi: ;.' Nicotine i,s lost during processing, and it can be (and is; readded at muli:iple steps. Unlike the cigare-.te of 1950, the f ir.al result i~ s a product that is urifarr.t and consistent. The custotr,e= is th-.reby assured o= ea predictable subjective efrect f rom a ga.ven b~.-and atyle. The added nicotine can be recycled within the factory or it can be purchas=:d from outside suppliers. The Bureau of Alcohol, Tobacco and Fi-rearms ®icenses Special Denatured.Alcohol Num:.er 4 (SDA 4) exclusLvely for use in the manufacture of tobacco products. SDA 4 is 1 gallon of nicotine in 100 gallons of ethanol. Toba--.co extracts, designed for specific applications and with varyilq nicotine content, are available from 32 different suppLiers in 10 different countriea (Table 1). Nineteen extract suppliers are either based in the U. S. or have subsidiaries here. The existence of so many suppliers sugqests that° there is a relatively substantial market for these materials. ' LTR. Ta.duntria.Q, ,.a, subaidiary .of .,KimberLy., 0'1_ark, makae reconstituted sheet with nicotine content that varies from 0.7 to 3.5 pereent.~; eiiberat®isa, 1985) An advert isement f_cr T,TR 'e sheet tobacco emphasizes this property. Another advertisement attempts to p-Arsuade cigarette manuFacturers to use AhPArt instead of cut, rolled i stems. It offers to process stems from a factory into sheet an,I so reduce the overhead required to npprarp R stem processing fa,;ility. Copies of both ads are included with the statament. TIMN 0046858

March 25, 1994 Page 13 Alternative Nicotine Delivery Devices Table 2 lists many of the novel devices shat have been patented which imitate the function of cigarettes. Figure 2 is an i11u$tration taken from one of the patents for these devices assigned to PLilip Morris. The provision of heat, from electricity,'ns in the device illustrated in F'igure 2, or from =hustion, a.i in Premier, (needed to volatilize pharmaco].ogi rA11y effective doses of nicotine) is a common feature_ The individual patents and the body of work taken as a whole domonrat cata a core cor_r_exnn wi th delivering material to aoneumers tha: is at least relatively free of most if not a11 toxins other rha.n nicotine. Some patents mention nicotine, some "tobacco flav=,H and some only "flavor." The pair from B.A.T. and Sror+rn & Williamson are noteworthy since the- Sritiah version explicitly discusses nicotine, while thc very cimilar invention pdt,eiil.ed by its U. S. subsidiary at the same time makos no mention of nic:ol,ins or of tobacco. 2t only discusses "flavor. « The 2mperial Wup patent explicitly mentions the inhalation of nicotine as a goal auuyht by consumers of cigarettes. tndustry RWArch on Nicotine The CoL=_lcii •t:or•••Tobacco .k+tesearch, MOrris f and R. J. Reynolds hav e each funded auksstantial programs of rawedruh on the pharmacology ot nicotir.e. :n addition to a program K extramural research, R. J. Reynolds has supported an intramural "icotine laboratory since at least the early 1980s. Funded research Wa TIMN 0046859

March 25, 1994 Page 14 encompassed th.: entire spectrum of subjects relevant to nicotine pharmacology. Studies have ranged from basic work on nicotine receptors and iiicotine analogues to human psychopharmacology studi.es. The =:xistence of these research programs means that the cigarette :ndu-;try is knowledgeable about all aspects of the pharmacology o-: r.icotine. While the~;e is a very large body of published research on the pharmac®logy of nicotine, there is remarkably little on the contribution nLcotine makes to the taste and flavor of tobacco products. In .2act, apart from a few patents in which experimental cLgarettes were assessed for flavor, taste, harshness and :he like, I cannot recall a single published study since the 1930-3 in which this aspect was a central focus of the research.° - Cigiretto am;k. SnhaistiQn is Intended by the Manu,factttrers. Cigaretteo are designed to f.ar..i 1 i f°ai-P inhalation, and nicotine from =igarettea can only be absorbed blr ' inhalati on . This is doli.berat• and intentional on the part of the manuf acturers . 8 The e~La~tasc© . of• Ncxt., . tha..deniao.tiniz.fad..c3.gar®t.t© . from Philip Morris, suggests that substantial quantities of nicotine are not necessary for the achievement of characteristic tobacco taste and flavor. Philip Morris ofdered this product in three & di_ferent packaginga: aa Next, aa M®rit da-Nic and as Benson Hedges de-Nic. it is inconceivable that a company as careful about its prc~lucta aa Philip Morris would have done this unless it knew from Lareful premarket testing that these products provided the ta©te aeneatione of convontional cigarettes. TIMN 0046860

March 25, 1994 Page 15 • Both the R.J. Reynolds Tobacco Company and the American Toba,.co Company referred to inhalation as part of the smokLng process in their advertising in the 1930s (Tye, 1986). The text of a Lucky Strike ad from 1932 tAmerican Tobacco Co., 1932; read in part, Do you inhale? What's there to be afraid of? 7 out of 10 inhale knowingly ® the other 3 do so unknowingly. ... Do you inhale? Of course you inhale: Every smoker breathes in some part ot the smoke re or she drs.wa out of a cigarette.' • Until such claims were banned by the FTC in 1955, cigarette advertising often featured claims of reduced thrcat irritation. Table 3 provides an example of this phe_r-om&non from each of the six major cigarette marn_faaturers circa 1952. Throat irritation is only an iagi.Q if the r.nnsumer inhales. If a puff of smoke is tak--.n in and then Axpwlled from the mouth without inh-Ll.ation, there is no ; mpAct on the throat. The=,e£ore, claims of reduced irr; tAt_ion are the equ.valent of claims for ea®s of inhe.Iat; nn _ e If nhalation were a misuse of the product, the ab+l,idant evidencc of harm from inhalation should have led tha.-aoutipan.i*a- to .tak.e, firat ste~+s ..to, .wa._rn its cus:cmera against inhalation and to change ciga.r.Pt-te dcaign to discourage the practice. Nothing of the anrt I A cop•r of another ad from this series is included with this sLatemenG. I TIMN 0046861 -

March 25, 1994 Page 1,0 has h4ppened in f orty years. ® Racher than discourage inha®ation by product design and by consumer warnings, the industry has conducted elaborate animal studies cf tobacco smoke inhalation. For instance, the Council for Tobacco Research, throug'rh its Special Projects operation, funded a $10 millicn moua° study under a contract titled "Smoke inhalation studies in mice." (Henry and Kouri, 1984; Colby, 1992) e Willjam L. Duain, Jr., of the Philip Morris Research Centar, speaking at a C®RSSTA-TCRC sympcs'_um in 1972, repe-.tedly referred to the fact that smokers inhale and cons=;quently absorb nicotine. The thesis of his paper is that absorption of nicotine produces effects that the imoker has sought (Dur}n. 1972). ® Tt,w A. j. Reynolds Tobacco Company treats inhalatiorn as a ma j mr feature of intended cigarette uee. When the comp-.kny sougrt to show the scientific ccmmunity how ciga:ette-like Premier was, it did not publish taste teata. Ir.stead, it published a detailPri6 sttidy of the phaa;•=cokinetics of nicotin®, comparing nicotine absorption from a cigarette with that from prototypes of Prcmier.. W..A,aynolci.a. Tobacco Comg.art3r., 1.9:9.a) • An Imperial Croup Limited patent for a nov1 nicotine delivery system notee, "Among the raasonra why most peorle smoke convcntional cigarettes is that they wish to inhale an aerosol cOnt3ining nicotine." (Imperial TIMN 0046862

March 25, 1994 Page 17 Grottp Limited, 1982) The inhalacion of mainstream cigarette smoke, with its resultant obligatory absorption of nicotine, is an integral, foreseen, and intended part or c:garette smoking. 8ome intendad Ph.rmaeologic Effects During t'Ae segment about cigaretree on the February 28, 1994 broadcast of !)ay Oa.e on ABC, J. Donald deBethizy, Director of Research and oevelopment for R. J. Reynolds, declared that peopr.e smoke because they are "looking for a pleasing sensory experience with mild pha rmacoloqy.'1 What is "mild pha: -acology?" Advertising for Camel brand cigarettes in the 1930s emphasized th: ability of smoking to give the customer a lift and to calm the cuetomer down (Tye, ~986). Similarly, Lucky Strike adverti.sing once included the claim, Smoke a Lucky to feel yn»r IAva1 besti Luckias, fine tobacco picksi you up when you're low...calmFa you down when you're tense. (Walsh, 1952) In a eourt filing, attorneys for Lorillard have noted the benefits of dmoking as follows: ® Lorillaz~d contends that smokers do derive benefits from smoking cigarettos. Theae benefits presumably vary from individ,_.al to individual, are personal, and cannot be put in a univ^---sal or comprehens3ve.l~t•. -Some •-o.£ _•t.he bene: ita that ar=-i commonly reported by various smokers are: enjoymei:t; pleaeure from tasto; Qme11; relaxationr relief of anxiety and stress; reduction of boredom; increased alertne-_is; improvement in concantrationj and enhancement of social '.nteractions. (Reply to interrogatories, Covert v Lo__r'i7.1 a ~~d) SimilarLy, attorneys for R. J. Reynol-da hava dcacribed the TIMN 0046863

March 25, 1994 page 1; benefits of smoking for its customers in the =ollowing way: Among the benefits cf cigarette smoking which have been trequeant+y mentioned by amokera or which have beern noted in the literature are the following: pleasing taste and aroma; satisfac:G ton; stress reduction; relaxation; stimula=ion; aided concentration; increased memory retention; alleviation of boredo«, aiid fatigue; avoidance of loses of vigilance in repetitivn or sustained tasks; and facilitation of social interaction. (Reply tc .iiit.rsrrogatories, 4ilhov v R.-1, RQVnol1) The biobaiiaviora'_ research laboratory at R. J. Reyr.olds has proven that sex,er,a1 of these effects are caused by nicotine acting in the Orain. A paper by Dxs. Robinson, ?ritchard and Davis (1992), copies of which have been provided to the Subcommittee, show that cigarettes which do not deliver nicotine (presumably Ne:ct brand cigarettes from Philip Morris) fail _o change the EEG of smokers irn ways characteristic of the relaxing and the atimulAtinq effects of smoking. Conventional cigarettes do cause these EEG changes. The paper proves that it is the nicotine in c'larette smoke, and the nicotine alone, which causes theeP deaired affects of smoking. Throughout the article, the authors emphasLze that these are important phar:nacolcgic effectg of smoking and r.hat the achievement of these effectg are among the reasons pe-aple Amnka cigarettes. Cigarette companies often aay 1'hay design and market their products in .reapoziee .to.,.cr~asumex.,dema~d~..,au~. t:h.~.. ~xpl,ieit eff.ects mentioned by cigarette companies and di.ar..unnAd in this section are among the effects amokers expect frnm r{garettes. eince cigarette cnan~-?.facturers are market driven r.nmpaniee, they intend that their proaucta provide these effects. TIMN 0046864

March 25, 19•94 Page 19 Cther effects many customers expect are relief from withdrawal sy-,,ptcma and help with weight control. The next two sections explore two particular industry terms in more detail,. These terms, "satisfaction" and "physiologic activity," su~~gest relief of nicotine withdrawal and maintenance of nicotine a~_ldiction more than they suggest the relaxation and stimulation ei`fects so emphasized by Robinson, Pritchard and Davis.10 CiQaratte Man+tfacturQre Intend to Provide Tohaaco Satisfaction Tobacco -iatiafaction is a technical term in the tobacco trade that de-lotes a quality separate and apart from taste and flavor. Ite uaage indicates that the term describes certain pha.r.maanlogic effects of nicotine. Table 4 iixta a$ew examples of the term in advertisementse that clearly 3iatinguiah tho r_nncept of "satisfaction'f from that of "tamte." The introduction of Premier in 1987-88 wau acanmpanied by a variety of descriptions of the product in ternns of and similar sounding terma. - -----prom a patent application : - 8rn_king-articlee .of the .iavention.. . ..are cap.ablv of pr<<viding the user with the sensal'-ions and benerits of lo Dr. cleaethi$y'a term, "mild pharmecology," can readily include nico,-ine addiction since the R. J. Reynolds team has tried to mak--, ouch a strong diotinetion between nicotine and other addicti.ng drugs based on the fact that nicotine in usual doses does n~~t cause intoxication (Robinoon and Pritchard, 1992). TjMN

Marcki 25, 1994 Page 20 c-iaax,ette smokina. (emphasis added) (Clearmar et al, 1988) hrom a cc-LUpany prese rclcaac : The •:igarette ie based on t%ew tecr.azalogy that heats racr::r thann burns tobacco to provide smokers with ~~Y~g~:c~ ta te and aat_~~~ctic~. (e;nphad8ia added) (R. u. Reynolds, 1987) F'rom the tlonograph, Chem'_cal and Biolggical S9udiee... c - R.J. Reynolds' Product Development Objectives for deve.oping the NEW CIOARETTE were as follows t '1'o provide the tobacco taste and smoking p1ea_sure of other cigarettes, as demanded by smokers... , (emphasie added) (x.~. xeynolds, 1~88a, page 35) The ~W CIGARETTE is based on a concept that allows a smok-3r to receive the tobacco ta te. sensations and e_nio en of cigarettes without burning tobacco. (empaaeis added) (R.J. Reynolds, 1988a, page 43) From a magazine ad in a test market area: - 3moks that satisfies, yet dissipates almost the moment you exhale. (emphasis added)lI (R.J. Reynolds, 1988b) In none of these five descriptions does "taste" or "sensation" stand alone as a sufficient description of the benefit R. J. Reynolds promises consumers from smoking Premier. Additional promises are made for "benefits of cigarette smoking," "tobacco aatiafaction," "smoking pleasure," and "tobacco enjoyment." Additidn.-.l illuminatiorn of the meaning of the term "satisfaction.. can be found in two patents, copies of which have been submitte~l to the Subcomatittee. li One must have first inhaled the smoke in order to be able to cxhal=i it. TIMN 0046866