Tobacco Documents Online

Produced to Federal Trade Commission pursuant to subpoena ..~ ,,:~.. -oaleoTjune o¢~; .... "~" . ~U'J~T~ ~" -~ .... "- " .... '". ,,, , o~oeqo.T. ate,

RESEARCH PLANNING MEMORANDUM ON THE NATURE OF THE TOBACCO BUSINESS AND THE CRUCIAL ROLE OF NICOTINE THEREIN CX 42-B RH0007590

MEMORANDUM: In a sense, the tobacco industry may be thought of as being a specialized, .... ~ighly ritualized and stylized segment of the pharmaceutical industry. Tobacco :~ ...~ ~,.:~~"products, uniquely, contain and deliver nicotine, a potent drug with a variety ~<.. 6f physiological effects. Related alkaloids, and probably other compounds, :~ ~.~" . ~.~.~.~th desired physiological effects are also present in tobacco and/or its smoke. ~'-:~-*N~cotine is ~ to be a habit-forming alkaloid, hence the confirmed user of i!*:~"~;':~.~::~obacco!~,,,~iii::~:~:~i:: products ,~ pri mari ly seeking the phys i ol ogi cal "sati sfacti on" deri ved~ from nicotine -- and perhaps other active compounds. His choice of product and pattern of usage are primarily determined by his individual nicotine ~;;;il;;i;;!:::. requirements and secondarily by a variety of other considerations ii::ncluding flavor and irritancy of the product, social patterns and needs, physical and manipulative gratifications, convenience, cost, health considera !~: ........ .... ":~'~'~:~;~ 0~ !~.~. ~nd the like. Thus a tobacco product is, in essence, a vehicle for delivery i!ii~i~:i::::ii~:ili~icotine, designed to deliver the nicotine in a generally acceptable and ,....-,~:~,,:~:..~ttract~ve form. Our Industry is then based upon design, manufacture and sale~ i,-.,.,,,..~f attractive dosage forms of nicotine, and our Company's position in our .... i:" ' ii ::i;;~"Industry is determined by our ability to produce dosage forms of nicotine whi ~"~ ........ ~ave more overall value, tangible or intangible, to the consumer than those !%.,.~%1,,,.~ f.:, .=~.',::~ our competi tors. ?~..., .....~i.~...>..,,. ~,~i~:. The habituated user of tobacco products is said to derive "satisfaction" i..' '"~ : from nicotine. Although much studied, the physiological actions of nicotine are still poorly understood and appear to be many and varied. For example, in different situations and at different dose levels, nicotine appears to act as a stimulant, depressant, tranquilizer, psychic energizer, appetite reducer, anti-fatigue agent, or energizer, to name but a few of the varied and often CX 42 - C RH0007591

3 contradictory effects attributed to it. Many of these same effects may be achieved with other physiologically active materials such as caffeine, :~.~.~N~cohol.:.::......::... , tranquilizers , sedatives, euphorics, and the like. Therefore, in i~?..~.~dition to competing with products of the tobacco ~ndustry, our ~roducts ~y, ~n a sense, compete ~th a variety of other ~roducts ~th certain ty~es ~"~'Y drug action. All of these products, tobacco and other, appear to have .~ ~rta~n co~on attributes in that they are used largely to relieve, in one ~.. ~;~;@~y or another, the fatigues and stresses which arise in the course of existen~ in a complex society. : ':~:" . :~.~:~:::~:::~. Happily for the tobacco industry, nicotine .~s '%~'nique in its variety of physiological actions, hence no other active material :..~~"%~r.~:~::-..:~ combination of materials provides equivalent "satisfaction". Whether ~ .... nicotine will, over the long term, ~intain its unique position is subject :~ to some reasonable doubt. With increased sophistication of knowledge in ~e biological and pharmaceutical areas, a superior or at least equivalent ~:::~°duct~. ~..~ or product mixture may emerge. For this reason, it would be a mistake ~£~.~:~:~ assu~ that the tobacco industry, as we now know it, is l~ortal or that no ~}~.~:~:~. ~:"~':'@lrect co~etition from organizations outside of the tobacco industry will ..... ~'~ver occur. It is safe to assume, however, that nicotine will retain its ~s~::~ique position throughout the present ten year planning period, and probably ~::~::;~g~or a much longer span of time. If nicotine is the sine qua non of tobacco products and tobacco products are recognized as being attractive dosage forms of nicotine, then it is logical to design our products -- and where possible, our advertising -- around nicotine delivery rather than "tar" delivery or flavor. To do this we need to CX 42-D

4 develop new data on such things as the physiological effects of nicotine, the rate of absorption and elimination of nicotine delivered in different %°'~:, ., <:~oses at different frequencies and by different routes, and ways of '~..i~"~"";:enhancing or diminishing nicotine effects and "satisfactions". In the absence ~.. df such data, we may survey the market and conclude that current cigarette ~i~,~:i~roducts delivering about 1.3 rag. of nicotine appear to "satisfy" the typical i~i~oker. This somewhat crudely, establishes a target dosage level for design ~f new products. An accompanying Research Planning Proposal describes that ~. ===================== approach in some detail. However, if we knew more about nicotine absorption, ~..- action, elimination, enhancement and the like, it should, in theory, be )~siii::iiiii!ii::~ssible to more precisely specify, and deliver, the optimum amounts of nicotln~ ,.:-'~x~ ~;:':-:<:'~.i" ::~:~....~..~k;tivity.~:~.:...:..~:. in sophisticated products which would be more satisfying and desirabl~ to the user. This area merits consideration and activity. ~.~!!~ii;! Before proceeding too far in the direction of design of dosage forms for • '~,,.,,-~,-. ..... ~ii. . . :~:~%4~lcot~ne, ~t may be well to consider another aspect of our business; that is, ).. ox~ ~...~i~: $ ~:::>.~.,.:>.% '..:>.!: i~..- ~e factors which induce a pre-smoker or non-smoker to become a habituated ~"i??:>>>~i~oker. Paradoxically, the things which keep a confirmed smoker habituated ~-'"-~Nd "s.tisf~ed", ~.e., n~cot~ne and secondary ~i~.~,~ ,..~atifications, are unknown and/or largely unexplained to the non-smoker. He ....~.~?~. ~:C~i'~:~es..~?- ~ not start smoking to obtain undefined physiological, gratifications or ~:~.~.: reliefs and certainly he does not start to smoke to satisfy a non-existent " craving for nicotine. Rather, he appears to start to smoke for purely psychological reasons -- to emulate a valued image, to conform, to experiment, to defy, to be daring, to have something to do with his hands, and the like. Only after experiencing smoking for some period of time do the physiological "satisfactions" and habituation become apparent and needed. Indeed, the first CX 42-E

smoking experiences are often unpleasant until a tolerance for nicotine has been developed. This leaves us, then, in the position of attempting to :~-~s...~esign and promote the same product to two different types of market with ~4~two different sets of motivations, needs and expectations. The same ~ i}ituation is encountered in some industries, but the problem is usually not ~ .. ~:~ as severe. ~:~.,: If ~hat ~e have sa~d about the habituated s~oker ~s true, then ~roducts esq~ned for him should emphasize n~cot~ne, n~cot~ne delivery efficiency, ~%...~ ........ n coterie satisfaction and the l~ke. ~hat ~e should really make and sell ~#~would be the proper dosage form of nicotine with as many other built-in '~:~"~"attractions and gratifications as possible -- that is, an efficient nicotine > ~£~elivery system with satisfactory flavor, mildness, convenience, cost, etc. ~" ~ ~n the other hand if we are to attract the non-smoker or pre-smoker, there ~ ..... ~s nothing in this type of product that he would currently understand or ~4~::~esire. We have deliberately played d~n the role of nicotine, hence the ~.~.}~:~:£~;~°n'sm°ker.....~.-- .::~ has little or no kn~ledge of what satisfactions it may offer him, ~~rrat~n~l reasons that he should try s~k~n~, ~n the h~e that he ~qll for ...~".~.~elf then ~scover the real "satisfactions" obta~nable. ~nd, of c~urse, ~n not be better, in the long run, to identify in our own minds and in the minds of our customers what we are really selling, i.e., nicotine satisfaction? This would enable us to speak directly of the virtues of our product to the confirmed smoker, and would educate the pre-smoker, perhaps indirectly but effectively, in what we have to offer and what it ~'~',Id be expected to do for him. Cx 42-F

6 But again, the picture is not quite all that clear. ~'~ Critics of tobacco products increasingly allege that smoking is dangerous to the health of ~i~.~he smoker. Part of this alleged danger is claimed to arise from ingestion ~,~:.!~i~ nicotine and part is claimed to arise from smoke components or smoke ~:~ . If, as proposed above, nicotine is the sine qua non of smoking, ~nd ~f we meekly accept the allegations of our critics and move toward ~.~duction or elimination of nicotine from our products, then we shall eventual~/ ~.~i~i~iquidate our business. If we intend to remain in business and our business the manufacture and sale of dosage forms of nicotine, then at some point we .:! .-.:::.r..-must make a stand. We should know more, rather than less, than our critics ,~,~about the physiological effects of nicotine, and we should in all ways ~::,~:~:..~c~ent~fically validate and speak to the beneficial effects and "satisfactions~ ~>~,.~.~.~erived from use of nicotine. Essentially all co~rcial drugs give rise to ~..- So~ undesirable side effects, but we continue to use them with great benefit ~... ~o humanity because of their overriding beneficial effects. Might we not take~ ~ leaf from that book in our approach to nicotine? Unless we do, our ]ong-te~ " "::~"~rospects become unattractive. ~.~i~. Our critics have lumped "tar" and nicotine together in their allegations • ~T~,~I~i~l~bout health hazards, perhaps because "tar" and nicotine are generated together ~:~! varying proportions when tobacco is smoked. An accompanying Research i~i~...j~..~: anning Memorandum suggests an approach to reducing the amount of "tar" in cigarette smoke per unit of nicotine. That is probably the most realistic approach in today's market for conventional cigarette products. However, another more futuristic approach is possible which goes more directly to the fundamentals of the alleged problem. RB_O00'7595 CX 42-G

If our business is fundamentally that of supplying nicotine in useful dosage form, why is it really necessary that allegedly harmful "tar" IF ~ccompany that nicotine? There should be some simpler, "cleaner", more ~.. :<'~efficient and direct way to provide the desired nicotine dosage than the ~.. present system involving combustion of tobacco or even chewing of tobacco. ~:.~:..~.....:::~ conventional lO00 mg. tobacco rod containing about 20 mg. of nicotine is :- ....... ~oked to produce only about 1.3 mg of smoke nicotine, accompanied by about ~!!~0 mg. of "tar" and 20 mg. of gas phase matter; and a~ part of the 1.3 mg of smoke nicotine is lost to the smoker via exhaled smoke -- surely an inefficient nicotine delivery system. It should be possible to : ~ ~'~iiii;::iii~btain pure nicotine by synthesis or from high-nicotine tobacco. It should ~ ~hen be possible, using modifications of techniques developed by the .~ ~harmaceutical and other industries, to deliver that nicotine to the user in ~ ~":'"~..... ~..~ ~ efficient, effective, attractive dosage form, acco~anied by no "tar", gas ~ ~.:..~:~:~:~ase, or other allegedly harmful substances. The dosage form could ~ :~'~%~c;~ncorporate various flavorants enhancers and like desirable additives, an~ ~ ~uld be designed to deliver the minimum effective amount of nicotine at the B ~:""~esired release-rate to supply the "satisfaction" desired by the user. Such ~ ~-.~:~ product would maximize the benefits derived from nicotine, minimize ~:~:~.~...~.~legedly..>. undesirable over-dosage side effects from nicotine, and eliminate ~<.?~.~:~. ~%~.~DOSU~ to other materials alleged to be harmful to the user. For the long term, we should be working toward develop~nt of such products -- if we do not, ~evitably so, one else will, and there are strong indications that others are already moving in this direction. CX 42-H RH0007596

In the present real situation, where nothing has been done to counteract the adverse allegations about nicotine and where conventional products :i%~eli vering adequate amounts of nicotine dominate the marketpl ace no .~...~. ' ~.~brupt change in our posture or strate~ would be appropriate or reasonable. ~he approaches advocated above are aimed at stopping and eventually reversing ~...~.a: trend that may in the long term put us out of business, and are intended to ~.~.~..,,~:~:~...~ ..... y a fra~work of philosophy around which research efforts may n~ begin. ~ N~opefully, so~ day we will ~joice rather than despair when a new crop of ~ tobacco sh~s an unusually high content of nicotine, our primary product. ~ L.~~7':%~pefully, with ti~ we will be able to develop sophisticated and improved .... ~ ~ .~::~inimum dosage fo~ for nicotine which will be more satisfying to the user ~:~nd free of alleged health hazards. And hopefully, by that ti~, we will ~":":.,~ve been able to establish and use information showing that use of nicotine ~.,~- f.ills real, de~nstrable human needs, the beneficial effects overriding the ~.-. allegedly hamful side effects. ~:~DI CA TED RESEARCH DEPARTMENT ACTIVITIES AND APPROA~ES: ~ ~ %~:.~ If the above Is a valid line of reasoning, then our long-tem future coB~es ~£ action should be as follow: • .~.~. • ~.- I. Recognize the key role of nicotine in consu~r satisfaction, and design :::::::::::::::::::::::::::: an4 promote our products with this in mind. More precisely define the minimum amount of nicotine required for "satisfaction" in terms of dose levels, dose frequency, dosage form, and the like. This would involve biological and other experiments. 3. Sponsor in-depth studies of the physiological, psychological and other effects of nicotine, aimed at demonstrating the beneficial effects of nicotine and at disproving allegations ~h~, nicotine CX 42-I produces major adverse effects.

9 4. Study, design and evaluate new or improved systems for delivery of nicotine which will provide the minimum satisfying amount of nicotine in attractive form, free of allegedly harmful combustion products. 5. Study means for enhancing nicotine satisfaction via synergists, alteration of pH, or other means, to minimize dose level and maximize desired effects. 6. Monitor developments in materials and products which may compete with nicotine products or which might be combined with nicotine products to provide added advantages or satisfactions. 7. Monitor work by others which might be aimed at improved nicotine delivery systems of the type proposed here. 8. Search for and evaluate other physiologically active components of tobacco or its smoke which may provide desired effects to the smoker. April 14, 1972 CX 42-J RI4000"/59g