The following are the declarations to the Food and Drug Administration of three former tobacco industry employees that seemingly contradict the publicly held position of the industry on the purposes and nature of their own research into the effects of their products and the process of "restoring" nicotine to cigarette tobacco. The FDA is soliciting comment on these declarations.

Food and Drug Administration

[Docket No. 95N-0253J]

Analysis Regarding The Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products; Reopening of the Comment Period as to Specific Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period as to specific documents.

SUMMARY: The Food and Drug Administration (FDA) is reopening to (insert date 30 days after date of publication in the Federal Register), as to specific documents, the comment period on its analysis regarding FDA's jurisdiction over these products, which was published in the Federal Register of August 11, 1995 (60 FR 41453). FDA is reopening the comment period for 30 days for the sole purpose of inviting public comments on the information being added to the administrative record. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period, as to specific documents, for its proposed rule entitled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents.

DATES: Written comments must be received or postmarked on or before (insert date 30 days after date of publication in the Federal Register). Comments postmarked after such date will not be considered.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF;-23). Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 1995 (60 FR 41453), FDA published a notice containing an analysis of FDA's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products. The analysis supported a finding at that time that nicotine in cigarettes and smokeless tobacco products is a drug and that these products are drug delivery devices within the meaning of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-395).

In the Federal Register of October 16, 1995 (60 FR 53620), FDA extended to January 2, 1996, the comment period on the notice that set forth the jurisdictional analysis.

FDA is adding three statements from former industry scientists and employees to the administrative record. These statements, describe among other things, the industry's understanding of nicotine and industry practice with respect to the control of nicotine levels in cigarette manufacture.

FDA might rely on these statements in support of any final decision it may make on its jurisdiction. The agency is therefore providing the public an opportunity to comment on them.

FDA believes that 30 days to comment is ample in this case, as the agency is specifically limiting its reopening of the comment period to comments on the statements being added. Comments are invited, and will be considered, only to the extent they are focused on the information being newly added to the record and only to the extent the comments regarding such information raise new issues not already raised by the person submitting the comment.

The documents being added to the record are as follows:

1. Uydess, Ian L., Declaration of Ian L. Uydess, Ph.D., February 29, 1996.

2. Farone, William A., Ph.D., "The Manipulation and Control of Nicotine and Tar in the Design and Manufacture of Cigarettes: A Scientific Perspective," March 8, 1996.

3. Rivers, Jerome K., Declaration of Jerome K. Rivers, March 7, 1996.

As part of its ongoing investigation, the agency has compiled information that includes notes and transcripts of interviews with former industry scientists and employees. These notes and transcripts have been referenced in this proceeding (Federal Register of December 27, 1995 (60 FR 6698 1)), but have not been included in the public docket because, among other reasons, they would likely disclose the identity of sources that furnished information to FDA on a confidential basis (60 FR 66981), they were obtained under assurances of confidentiality, and in some cases they contain trade secret or other confidential information. Among these documents are notes and transcripts reflecting conversations with Dr. Uydess, Dr. Farone, and Mr. Rivers, whose statements are identified above. Since the agency may rely on these statements, the agency is making them available for public comment now. The agency will not rely on any notes or transcripts made by the agency reflecting conversations with any former industry scientists and employees.

Interested persons may, on or before (insert date 30 days after date of publication in the Federal Register), submit to the Dockets Management Branch (address above) written comments regarding the documents listed above. Four copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

Dated: March 18, 1996

William B. Schultz

______________________________________________________

DECLARATION OF IAN L. UYDESS. Ph.D.

29 February 1996

Preface: The following accounts are offered with the understanding that they are 'to the best of my recollection' and relate to matters that occurred during the period of December, 1977 through September,1989 (some dates are approximate).

Ian L. Uydess, Ph.D., declares as follows:

1. Employment Summary: Since June, 1993 I have been employed by the Analytical Laboratory Division of Pharmaco International, Inc. (previously Pharmaco LSR, Inc.) as Manager of Training & Safety. My office is located at 2244 Dabney Road in Richmond, VA, where my duties include the development and delivery our division's various technical, orientation, supervisory and safety training programs. I also developed and co- administrate our lab's new Performance Assessment Program and support our new business development group on an as-needed basis. Prior to my employment at Pharmaco. I worked as a resource development consultant to a number of small businesses in the Richmond area. However, a majority of my professional career over the past 15+ years was spent in the employment of Philip Morris USA, Inc., at their R&D facility at Commerce Road in Richmond, VA. This occurred over two separate periods, the first being December. 1977 through September,1981, and the second between (approx.) April, 1982 and September, 1989.

2. First Period of Employment at Philip Morris (1977 - 1981): From December, 1977 to August.1981, I was employed as a Research Scientist by Philip Morris USA in their Richmond-based, Research & Development (R&D) department under Dr. William Farone (Division Director). I was promoted to Associate Senior Scientist near the end of that period (spring of 1981?) as a result of my research in tobacco microstructure which attempted to correlate certain aspects of tobacco leaf structure to some of its chemical, physical and mechanical properties prior to, and after a number of the processing steps in the manufacture of a cigarette. This included scientific investigations of: (1) native ('green') tobacco leaf, (2) flue and air-cured leaf, (3) 'expanded' leaf, and occasionally (4) reconstituted leaf ('RL'; discussed in greater detail in Section 5 page 4). To accomplish this, I frequently collaborated with the staff of other departments within Philip Morris (such as Product Development, Manufacturing, Engineering, Park 500, the Leaf Department and the Analytical Research Division) in order to support my studies on the impact of various processing conditions on the structure and chemistry of tobacco.

However, while I found my early employment at Philip Morris to be generally rewarding, I decided to leave that company in September, 1981 (of my own volition) to accept what seemed like a challenging management opportunity at Carl Zeiss-USA, Inc., in New York (as Product Manager for their Electron Optics Department in the US). Prior to resigning, I discussed the prospect of my leaving with some of the people with whom I had developed a close relationship over the years (so as to get their input and recommendations regarding this offer). They included: Dr. Frank Gullotta, Mr. Cliff Lilly, Dr. William Farone and Dr. Thomas Osdene. Each expressed regret that I was thinking of leaving, but wished me well and added that they were confident that I would be welcomed back to Philip Morris should my situation in NY not meet my expectations. In a very thoughtful gesture, Dr. Osdene took me out to an extended lunch at his private club (the Commonwealth Club) during my last week at PM.

While working at Carl Zeiss, I continued to maintain contact with many of my Philip Morris coworkers and supervisors as a result of the friendships that had developed during my employment with that company. This included frequent visits with Dr. & Mrs. Frank Gullotta, as well as occasional social gatherings with some of my previous management.

3. Second Period of Employment at Philip Morris (1982 - 1989): I decided to return to Philip Morris in the spring of 1982 as a result of a number of contributing factors that included: (1) my family's mixed feelings about relocating to New York, as well as (2) my own (growing) disappointment with some of the aspects of my new job with Carl Zeiss. My decision to return to Philip Morris early in the spring of 1982 was made with the mutual agreement and support of Dr. Jerry Whidby (Department Manager), Dr. William Farone (Division Director) and Mr. Cliff Lilly (Principal Scientist). I returned to Philip Morris at the same technical level at which I left (Associate Senior Scientist) and remained there until September,1989, at which point I resigned as a result of: (1) my great disappointment (disillusionment) with the course (direction) of that company, and (2) my growing professional and moral concerns regarding a variety of smoking and health issues which had troubled me deeply for a great many years.

4. Educational Background: I received my Bachelor of Science (BS) degree with a major in Pre-Med./Biology from Fairleigh Dickinson University, Madison, NJ in June, 1968. Subsequent to that (summer of 1971 ?), I received a Masters of Science (MS) Degree at the Roswell Park Division of the State University of New York at Buffalo, followed in 1975 by a Ph.D. in Biology (major: Cell Biology/Microbiology) from the Graduate School at the University of Rochester, Rochester, NY. I actually began my post-doctoral work on a project sponsored by the National Aeronautics & Space Administration while I was preparing my thesis. Once this was completed, I transferred from the Graduate School at the University of Rochester to the University Medical Center (Strong Memorial Hospital) as a Postdoctoral Fellow in Medicine to work in the area of immunology and infectious disease (fall, 1975 - December,1977) . I subsequently left Rochester in December, 1977 to accept a position at Philip Morris

5. I first began working at Philip Morris after being recruited by Dr. William Farone, Director of Basic Research. I was originally hired by Philip Morris to work in the field of plant structural analysis and biochemistry, with the hope that the information generated would contribute to the development of new and/or improved products and processes. In pursuit of this, I worked in the Microstructure Analysis Lab where I investigated the relationship between: (1) the structure and organization of native ('field') tobacco leaves, and (2) some of the mechanical properties of processed leaves (such as after 'curing' and 'expansion'). In addition to this, I was later asked to support one of the company's early attempts to investigate the usefulness of bioengineering as a route to new and/or improved products and processes under the umbrella of the company's 'lowered biological activity' program.

This early biotechnology effort, the Naturally-Occurring Denitrification Program ("NOD"), attempted to employ selected bacteria to remove nitrate from SEL. 'SEL' (Strong Extract Liquor), is the hot water extract of tobacco that is used to make one of Philip Morris' reconstituted leaf ('RL') products at that company's Park 500 facility in Hopewell, VA. These reconstituted leaf materials (also known as 'sheet' and 'recon') become one of the blend constituents in many (if not all) cigarettes. A great variety of materials are present in SEL which, depending upon the tobaccos used in this process, can frequently contain a substantial amount of nitrate. The problem with nitrate is that it can be degraded (converted) to nitrite, an acknowledged, biologically-active material that once in cigarettes, could pose a potential health hazard to smokers. Over the years (mid 1970s on), Philip Morris scientists attempted to remove this nitrate by a variety of other technologies, but were not satisfied with the results. My initial function during the early stages of this denitrification (lowered biological activity) program, was as an internal consultant in microbiology.

It was shortly after this that I decided to leave Philip Morris to accept the position that had been offered to me at Carl Zeiss-USA in New York (Sept.,1981). However, as mentioned earlier, I returned to Philip Morris in the spring of 1982 to resume my research with that company.

A short time after returning to Philip Morris (early/mid-19837), I was asked to take charge of the microbial denitrification program ("NOD") which had continued during my absence under the leadership of a variety of individuals, including: Dr. Vedpal Malik, Dr. Peter Kussel and Mr. Joseph Banyasz. Drs. Malik and Kussel had both been hired by Philip Morris expressly for this program. Mr. Banyasz, on the other hand, had already been employed by Philip Morris for a number of years and was an associate of Mr. Lilly who, as Principal Scientist, helped to coordinate/manage this and other high priority/new technology projects of the Company. The request that I take over leadership of this project was communicated to me by my manager, Dr. Jerry Whidby, with the input/support of the Division Director, Dr. William Farone and Mr. Cliff Lilly (Principal Scientist). The technical goal of this project (to denitrify the SEL from Park 500 by microbial means) was successfully demonstrated soon thereafter (1983-1984), although this technology was never used by Philip Morris in the production of any of its products, allegedly for 'subjective' ('flavor') reasons.

Virtually all of my duties from that time forth focused on work related to product improvement issues.

6. My knowledge of the research conducted by Philip Morris during the period Dec., 1977 through Sept., 1989 is the result of a number of factors including: (1) my own, direct participation in a variety of research and development projects conducted by Philip Morris during this period. (2) my personal observations of activities in other parts of the company over the 10+ years that I was employed by that company, (3) my attendance at meetings and/or discussions held between the scientists, engineers and management at Philip Morris, and (4) my close association and friendship with a number of scientists and senior management personnel over the many years that I was there.

Dr. Victor DeNoble and I were peers who discussed his work on a number of occasions. This was facilitated by the fact that we worked in adjacent labs on the 3rd floor of the R&D building, as well as by our growing friendship during this period.

At one point, we even discussed the possibility our collaborating on a project that I had suggested to Dr. Thomas Osdene, the Director of Dr. Noble's division. Dr. Osdene was enthusiastic about a research proposal that I had written which recommended that we conduct 'in vitro' studies using the white cells (lymphocytes and macrophage/monocytes) from the blood of some of Dr. DeNoble's experimental animals. The studies that were proposed were designed to evaluate the effect of various smoke constituents such as Nicotine, CO2, 'tars', etc., on the functionality (immunocompetence) of these cells in culture. This proposal was an outgrowth of my work at the University of Rochester Medical Center, and was based upon my belief that it might provide Philip Morris with some positive data regarding smoking and health (since these cells sometimes become more 'competent' as a result of long-term, low dose exposure to foreign materials/irritants dissolved in the blood). Dr. Osdene, apparently excited by this prospect, went so far as to advocate that I transfer into his division so as to facilitate these and other (related) studies which he believed were better suited to his area of experience and responsibility. He also suggested that these studies could be conducted in Germany at INBIFO (a Philip Morris supported research facility) if they proved to be 'too sensitive' to conduct in Richmond. This option was apparently brought up in light of the company's awareness and growing concern over the increased scrutiny of the tobacco industry by the government (FDA) and public regarding smoking and health issues. I was told that my participation in these plans was incorporated into Dr. Osdene's proposal to expand the animal behavior facilities of Dr. DeNoble. It was my understanding that this proposal was being prepared for submission to the VP of R&D in Richmond (Dr. Seligman), as well as to the appropriate management personnel in NY. However, apparently unhappy with this arrangement, Dr. Farone petitioned Dr. Seligman to keep me within his division. This disappointed me and was one of the reasons that I decided to leave Philip Morris in September 1981.

Dr. Frank Gullotta and I were not only colleagues at Philip Morris but also, close personal friends (and, at least as of the time of this writing, we still are). Dr. Gullotta and I discussed our respective work on a regular (almost daily) basis throughout my employment with Philip Morris (usually over coffee at informal, early morning meetings in his office). During these discussions, Dr. Gullotta informed me of the general results/observations of his research and was especially excited to tell me about any new additions or modifications that were made to his instrumentation (a computer-based 'olfactometer'/EEG).

During this time I also developed a close, professional relationship with Dr. Thomas Osdene, the director of the Applied Research Division. Dr. Osdene occasionally shared information with me which (I assume) he thought would give me a broader understanding of the inner workings of the company. In pursuit of this, he sometimes exposed me to information that I probably would not have known about from my own position within Philip Morris. Some of this information regarded research that was being conducted within Philip Morris, while on other occasions it was related to work that was being contracted out to 'external partners' in the US and Europe (like INBIFO).

Dr. William Farone was the director who first brought me into Philip Morris. I reported directly to Dr. Farone during my early employment with that company and later, to a number of different departmental managers under him. Over the next few years, Dr. Farone and I developed a relationship (friendship, mutual respect) that extended outside of our work at Philip Morris. In his attempt to support my development, Dr. Farone shared with me various aspects of his experiences and understanding of the company.

Mr. A. Clifford ('Cliff') Lilly (now Dr. Lilly) was a Principal Scientist & 'Fellow' at Philip Morris whose charge it was to help manage/guide projects of special import to the company (particularly with regard to large, corporate initiatives involving new processes or technologies). Mr. Lilly was at least informally associated with most, if not all, of the projects that I participated in over a majority of my years at Philip Morris (particularly between 1982 and 1989). Initially, this was a result of my involvement with the Naturally- Occurring Denitrification Program ('NOD') which he helped to oversee. Like Dr. Farone, Mr. Lilly frequently mentored me in a variety of topics related to the various efforts and/or undertakings of Philip Morris and shared with me much of his knowledge and experience with the company.

7. To the best of my knowledge, Nicotine has always been an important consideration to Philip Morris in the design, development and manufacturing of cigarettes. Nicotine levels were routinely targeted and adjusted by Philip Morris in its various products at least in part, through blend changes and blend design. It is important to note, however, that there are two nicotine levels that can be targeted (and manipulated) in a cigarette: The first is the amount of nicotine that is resident in the various leaf components that are used in the blend (tobacco cultivars, stalk positions, amount of RL, etc.). The second is the 'deliverable' nicotine that is found in the smoke (which, while related to the chemistry of the tobaccos used, is modified by the mechanical/burn characteristics of the cigarette). Both of these sources must be (and were) considered by Philip Morris' development scientists when formulating a new or modified product.

Whenever nicotine, or any other major component (such as sugars, tars. etc.) had to be adjusted by Philip Morris in a new or existing product, it was frequently a matter of knowing which tobaccos to use in the blend to make the necessary (targeted) adjustments. This would include the selection of various tobacco parameters such as: (a) the mixture of cultivars used, (b) crop years and growth regions of each and (c) relative stalk position and ripeness ('grade') of the tobaccos that were selected. The amount and type of reconstituted leaf ('RL', 'BL', etc.) could also be used to contribute to the character (flavor, 'impact', etc.) of the final product. Adjustments such as these were sometimes made as minor corrections to maintain the overall quality of an existing product like Marlboro (which had to be manufactured year after year without significant 'change'), while on other occasions, they were employed in the design of a new product so as to meet the targeted 'subjectives' (flavor and 'impact') of the new blend.

8. I have always believed that one of Philip Morris' key, corporate advantages is its detailed knowledge of tobacco chemistry. Over the years, Philip Morris scientists compiled a tremendous amount of information about the chemical composition, moisture levels and mechanical properties of a wide variety of tobaccos from various regions around the world. This included trips made by a variety of the company's research and/or management personnel (or agents) to tobacco growing regions throughout the world.

In support of this, Philip Morris maintained an extensive database containing information about the various chemical, mechanical and agronomic properties of the tobaccos that it used in its products. Philip Morris scientists even investigated the changes that took place in hogs heads while the company's tobaccos where being held in inventory in their warehouses. These investigations included an analysis of how the environmental conditions of the warehouses (temperature, relative humidity, microbial loading, presence or absence of preservatives, etc.) affected this tobacco 'aging' process. A special curing chamber was even built within R&D so that Philip Morris scientists (such as Dr. Daniel Teng) could conduct experiments in which different aspects of the flue curing process could be evaluated under carefully controlled and monitored conditions.

In a separate but related effort. Philip Morris routinely investigated the chemical, physical, material and mechanical characteristics of its competitor's products so at to keep itself informed (on a continuing basis) of any 'changes' that might occur in these products as a result of: (1) the use of new or modified processes and/or technologies, (2) the use of new or modified materials (papers, filters, etc.), and (3) any changes in the blend composition of those products which Philip Morris might interpret as a competitive advantage in the marketplace. This effort was the responsibility of the 'CI' (Cigarette Investigations) Lab at Philip Morris.

9. When Philip Morris designed a new or modified blend, they used their stored tobacco inventories much like a scientist would use a chemical stockroom to select the ingredients needed to synthesize a new material. Whenever a new cigarette was being designed at Philip Morris, product development scientists would work in collaboration with the appropriate leaf department, manufacturing and R&D personnel to map out the targeted flavor and delivery (tar/nicotine) parameters of the new product. Key individuals in the flavor group (such as Howard Spielberg) were also consulted since new or modified flavor systems ('aftercuts', 'casings', etc.) would typically have to be developed to help deliver both the taste desired by the smoker, as well as the mechanical (moisture) characteristics required by manufacturing. This latter consideration was important, since it allowed Philip Morris to control (within limits), the physical/mechanical properties of its tobaccos (and tobacco shreds) which helped assure that its blends would 'survive' the manufacturing process without too many problems (such as: inconsistent or poor cutting/shredding, over-drying, and excessive breakage during expansion or in the 'makers'; etc.).

10. To the best of my knowledge, Philip Morris routinely applied this knowledge of selective tobacco blending to achieve desired nicotine (as well as other, constituent) levels in the products that it designed and marketed. On some occasions, Philip Morris researchers submitted more than one version of the same experimental product to a test panel or test market. This was done to study the market's potential reaction to variations in the level of a targeted cigarette component such as tars, sugars, flavor ingredients and nicotine. In the case of nicotine, specific levels of nicotine would be targeted in the test products (test 'articles') in a range that extended from 'ultra-low' (or even zero) nicotine deliveries, to deliveries equal to, or slightly above that found in some of their own (or a competitor's) 'full-flavor' or 'full-bodied' products. This was done to examine how the smoker would react to various nicotine levels as a predictor of how well these products might do in the market with specific regard to: "not enough nicotine", "an acceptable level of nicotine", or"too much nicotine" (etc.). The concentrations of nicotine (and/or tar) that were used would span a range from ultra-low or zero levels (at which point the product was sometimes rejected as being nothing more than a 'hot air delivery device'), to test articles that had a somewhat higher level of nicotine (which had a better chance of being 'liked' by the smoker). A number of experiments were conducted in this area prior to, and during my employment at Philip Morris.

11. Philip Morris scientists (development personnel and management) understood the relationship between nicotine level and product acceptability as a result of their long history of research and experience in this area. As a result, it would come as no surprise to anyone having experience in the product development area, that a cigarette having satisfactory ('high enough') nicotine levels but marginal flavor, stood a better chance of being 'accepted' in the market place than a somewhat better tasting product with zero or ultra- low levels of nicotine ('not enough'). This belief, that a cause-and- effect relationship existed between cigarette acceptance and nicotine delivery level, was reflected in many of the comments made at a number of internal meetings at which zero and 'ultra-low' delivery products were being discussed. Some scientists (like Dr. Gullotta) even predicted that products made with 'no' or 'too low' a level of nicotine would (probably) fail in test markets 'no matter what they tasted like!' (e.g., that even smokers who were first attracted to the 'taste' of a new zero or ultra-low delivery product, would probably abandon it after they 'sensed' that there was insufficient reinforcement for them to continue to smoke it).

12. 'Impact' was the term generally used by Philip Morris researchers to describe the (physiologic) effect that nicotine had upon a person when they smoked a conventional, nicotine containing cigarette. It was my understanding that smokers have told Philip Morris (via test panels, etc.) that there is "no impact" in a cigarette that lacks nicotine. The term 'impact' is used by the tobacco industry to generally describe two separate effects. The first is the feeling that the smoker experiences at in the back of the throat immediately upon inhaling a nicotine-containing cigarette. The second is a somewhat more complicated (and delayed) physiological effect which apparently results from the interaction of nicotine with receptor sites in the brain.

'Flavor' (how the smoke 'tastes') and 'impact' (how the smoker 'feels') are two of the most important parameters of cigarette acceptance by the smoker (in addition to smell, firmness, ease of draw, burn characteristics, etc.). However, while both parameters are important to the ultimate acceptability of a product, 'impact' (nicotine delivery) was known to be the more powerful determinant in many of these cases (in the long term, smokers would be more likely to stay with a marginally-tasting product with adequate 'impact', while they would tend to abandon one of relatively good flavor having no or insufficient 'impact'). Philip Morris knew that the 'best' products were obviously those that could deliver the proper amount of both of these factors, 'flavor' and 'impact' (all other factors such as 'firmness' and 'draw', etc., being held constant).

13. I remember one meeting at Philip Morris at which the initial results from the test market of a low delivery (ultra-low nicotine) product were being discussed. The initial sales of the product in the test market were reported to be fairly good, but shortly thereafter, sales suddenly fell off. Apparently, while the test market smokers thought that it tasted' O.K., they ultimately switched back to their original brand because the new product was 'missing something' (phrases like 'not satisfied' and 'lacks impact' were also used to describe the smoker's response to this new product). It was suggested that the product development group might have to adjust the blend so as to raise the nicotine level in order to increase its 'staying power' (acceptability and sales) in the market place. Tar, as well as tar-to- nicotine ratios were also discussed. A rather ;energetic' discussion followed in which the original blend parameters of the test product (low tar/low nicotine) were discussed in light of the rather disappointing, results that were obtained.

14. 1 once saw a graph during an informal discussion at Philip Morris that generally correlated nicotine level to product acceptability. The graph depicted this relationship between nicotine level and product acceptability over a fairly wide range of nicotine levels from 0 mgs. to those commonly found a variety of products on the market at that time (including some Philip Morris products as well as some competitor's brands as reference points in the low- to high- nicotine delivery range). Two lines had been hand-drawn, horizontally, across the graph as 'high' and 'low' limits to indicate, at least in a general manner, the range of nicotine levels over which adequate product acceptability (market share) was believed to occur. The discussion at that time centered around the prospect that there was, in fact, some minimally-acceptable level of nicotine below which product acceptability would be severely in question. Other comments had to do with whether or not the company should even venture below this level given the problems that were known to occur. It was my understanding at the time! that these concerns were based upon the results from test panels and/or test markets in which very low delivery nicotine products had previously been evaluated. Some participants at this meeting forwarded the idea that the flavor group could overcome these 'problems', while others held fast to their belief that the data 'spoke for themselves'.

15. Tobacco companies like Philip Morris learned a long time ago, that it was hard to get people to stay with a good tasting product if the nicotine level was too low. It is fairly safe to say, that while taste is a very important component of a smokers experience ('satisfaction') with a cigarette, that good taste alone does not sustain a market Philip Morris clearly understood this relationship between nicotine level and product acceptability (e.g., that they could develop a market for a medium to high nicotine product that had marginal taste, but that they would have trouble sustaining the sales of a good- tasting product that was too low in nicotine).

The information gained by Philip Morris from the chemical analysis of tobaccos of different varieties, ripeness, (etc.), was used in the blend design of new products to ensure that the desired amount of 'high' or 'low' nicotine tobaccos were present in order to deliver the amount of nicotine (or other tobacco constituents) that had been targeted for that product. It was my impression that Philip Morris researchers and product developers knew, that if the nicotine level in a cigarette fell too far below this lower limit, that they would have great difficulty establishing a viable, long-term market for that product. This knowledge about the optimum range for nicotine in a cigarette was developed as a result of a great many years of investigation at Philip Morris and could (generally) be reproduced by graphing the nicotine levels of different brands of cigarettes (from 'high' to 'ultra-low') against the market share that they each held.

16. Tobacco leaf chemistry (in particular, alkaloid/nicotine chemistry) was exhaustively studied by Philip Morris. Philip Morris wanted to know everything there was to know about nicotine, particularly with regard to: (1) How nicotine levels varied in the tobacco plant with regard to cultivar, stalk position, seasonal variations and 'ripeness', (2) What happened to nicotine after curing' and during processing, (3) What chemical 'forms' was it in, and (4) How much of it wound up in the smoke when burned under different conditions (such as in the presence or lack of oxygen, at different temperatures, in the presence of varying amounts of other tobacco constituents, etc.). A substantial amount (and variation) of equipment was purchased by Philip Morris to study these topics, including: liquid and gas chromatographs (HPLCs & GCs), mass spectrometers, infra-red (FT-IR) spectrometers, nuclear magnetic resonance instruments (NMRs), etc. In addition, Philip Morris researchers were frequently sent out to acquire new skills (at classes, universities or workshops) to support their investigations of these and other topics. On several occasions, Philip Morris scientists helped advance the state-of-the-art of some of these technologies by discovering/developing new or improved ways of using their equipment to study tobacco. Few people outside of Philip Morris truly understood the extent and depth of Philip Morris' knowledge and expertise in chemistry, biology and engineering (manufacturing). Philip Morris routinely used its knowledge of tobacco chemistry in the design and manufacturing of its products.

I always considered this lack of public knowledge about the true capabilities of Philip Morris to be one of that company's greatest corporate advantages.

17. In the 1980's, Philip Morris conducted field experiments on the growth of tobacco with elevated nicotine levels for possible use in their products. Philip Morris examined a technique called 'ratooning' which involved cutting down of the tobacco plant early in the harvest cycle before the plant had fully matured. As the cut plant resumed its growth, the roots deposited elevated levels of nicotine in the leaves of the plant. The 'ratooned' plant was allowed to grow for a while and was then harvested. This technique produced tobacco leaves that had higher nicotine levels than the leaves of non-ratooned plants. I do not know if any of the nicotine-rich leaves that were produced through ratooning ever got into production, but it is my understanding that a number of these studies were conducted by Philip Morris in the US and possibly, overseas as well (under the guidance of Dr. Daniel Teng).

18. Philip Morris conducted experiments in which nicotine was produced in tissue culture. During the mid to late 1970's. Philip Morris scientists set up a laboratory to investigate the production of nicotine and other substances (such as mint) in tobacco cell and tissue cultures. An outside investigator, Dr. Don Dougall was brought in as a consultant to help support these investigations. Dr. Dougall, an acknowledged expert in this field, made frequent trips to Richmond to consult on this topic with Mr. Lou Weissbecker, Project Leader of this group (Project 1730). Dr. Dougall was also contracted to conduct similar (parallel) investigations in his own laboratory at the University of Kentucky. A variety of cultural techniques (including variations in growth conditions, nutrients, plant hormones, etc.) were evaluated in each laboratory in an attempt to maximize the production of the targeted materials. Samples of these cultures were periodically analyzed to determine the level of nicotine (or other targeted substance) that had been obtained. The overall goal of these studies was to: (1) optimize the production of the targeted materials (such as nicotine) in culture, (2) isolate the cells/tissues that demonstrated elevated levels of production, and then (3) regenerate plants ('plantlets') from these tissues to see if the desired characteristic would be expressed (maintained) in the regenerated plant. While Philip Morris explored the potential (future) use of this and related technologies, they did not at that time employ it in the manufacture of any of their products. A similar group of programs was later contracted out to Dr. Peter Carlson of Crop Genetics International in a joint venture with Philip Morris to explore the application of plant tissue culture and cloning techniques to the selection/regeneration of tobacco plants with 'most desirable' characteristics (characteristics selected/targeted by Philip Morris).

19. Understanding the chemistry of tobacco alkaloids was very important to Philip Morris and was investigated by their scientists in a variety of manners. Some of these scientists, like Dr. Jeff Seeman, were skilled synthetic chemists who helped prepare a variety of nicotine analogues for investigation by other researchers at Philip Morris. This was done to examine how slight variations in nicotine structure might impact its chemical, biological and behavioral properties. The analogues that were prepared were provided to scientists like Victor DeNoble for evaluation. Dr. DeNoble and his coworkers examined these materials in a well known, animal behavior system to see if they could identify a nicotine relative that had the same habituating effect as nicotine without nicotine's reported negative effect upon the cardiovascular system.

20. Doctor DeNoble's research on nicotine analogues was premised upon the reported, habituating effect of nicotine. While Dr. DeNoble and I frequently used this term when discussing the results and observations of his experiments, there was a growing concern/sensitivity among Philip Morris management regarding the propriety of use of this and related terms (such as 'addictive') even when used within the company. As time went on, memos, notebooks, external communications and internal reports were increasingly scrutinized (revised/censored) by Philip Morris management to make sure that no 'sensitive' terms were being incorporated into any of the company's written documentation.

21. The tobacco companies' response to allegations that nicotine was 'addictive' was to reply that nicotine was not addictive, because nicotine did not cause the physiological responses necessary to meet the classic definition of addiction. While this may be the position taken by the management of Philip Morris, a number of scientists like myself believed differently. We believed that nicotine was the critical component of tobacco that compelled (motivated) people to smoke. Our views on this topic were shared by a wide variety of individuals within Philip Morris, although many people were very guarded about who they would speak freely around. I always found it difficult to understand Philip Morris' rigid position on this topic, particularly in light of their obvious support of the rather unique research that they were conducting in animal and human behavior. One explanation commonly given by Philip Morris was, that this research was 'defensive' in nature and being done solely to inform the company about the methods being used by antagonists/enemies of the tobacco industry (in an effort to protect Philip Morris against potentially adverse information developed by researchers external to the company). However. if this was true and the only reason for this work, why were some of these programs so long-term and extensive in nature? In fact, instead of being short-term efforts conducted to gather preliminary information on the kinds of results that may be obtained by these technologies, these projects were expanded and supported with additional resources as if they were indeed, formal, long-term research initiatives of the company.

22. The public position of Philip Morris that nicotine was not addictive was possibly contradicted by the electrophysiology research that was conducted by Dr. Frank Gullotta. One of Philip Morris' greatest frustrations was it's inability to fully understand and use the subjective information it received about a smoker's reaction to a cigarette (regarding its 'feel', 'flavor', 'impact', etc.). This is because a smoker's response to a new or existing cigarette product has been based, historically, upon information obtained from personal interviews and written questionnaires, both of which suffer from the very same problem: the imprecise nature of the words that we use to express our thoughts and experiences. This made it difficult for Philip Morris researchers to really understand all of the reasons why a smoker 'liked' or 'didn't like' the brands that they tried, as well as how it (Philip Morris) could use this information to formulate new products.

Because of this, Philip Morris researchers wanted to find a way to become less dependent upon these necessary, but imprecise subjective results. To do this, they wanted to come up with a method to generate 'objective' (physical) data that they could: (1) understand more easily, and (2) use more reliably to help formulate new products (hopefully, through some kind of scientific measurement). This is where Dr. Gullotta's electrophysiology work came in.

Dr. Gullotta is a Philip Morris scientist (Ph.D. in Experimental Psychology) who worked closely with a variety of Philip Morris engineers, flavor chemists and development personnel to design and build a specialized aerosol delivery system, the 'olfactometer'. This instrument was used in conjunction with an electroencephalograph (EEG) to conduct experiments on human subjects using a variety of test materials such as nicotine. Dr. Gullotta also worked closely with Dr. Gehrt Kobol, a German researcher and recognized expert in this field, who was hired by Philip Morris as an external partner and consultant. Drs. Gullotta and Kobol communicated regularly (via phone and mail) and visited one another on a number of occasions. Substantial, technical upgrades were made to Dr. Gullotta's equipment (olfactometer, computer and EEG) on a number of occasions to increase its capabilities for use in these studies.

Cigarette smoke, or a specially formulated aerosol containing nicotine or some other cigarette component (such as a flavorant, carbon dioxide, or a mixture of materials), was administered to a subject (usually a volunteer from the PM staff) under highly controlled, experimental conditions. The smoke or aerosol was introduced into the mouth or nose of the subject in precise amounts using the sophisticated metering system (of reservoirs, valves, etc.) of the olfactometer. The olfactometer, in turn, was integrated with a state-of- the-art EEG and a computer. The relationship between a variety of chemical substances and the brain's electrochemical response to those materials (as measured by EEG) had already been 'mapped' and reported in the literature for a number of substances including nicotine. These data, methods and observations were used as the basis for the studies that were conducted at Philip Morris.

Dr. Gullotta's initial investigations were conducted to verify the effectiveness and utility of this approach. However, they soon graduated to sophisticated experiments designed to evaluate (and hopefully, establish) a correlation between the structure/chemistry of the chemical agent to which the subject was exposed, and: (1) the effect that this chemical had on the subject's ability to perform a task during (and just after) their exposure to the agent, and (2) changes in the electrical activity (EEG pattern) that occurred in the brain while this was being done. The 'task' usually involved the subject's response to an auditory or visual stimulus (such as changing patterns on a TV monitor). The subject's own interpretation of their experiences was also evaluated in some of these studies in an attempt to correlate the subjective data to the EEG patterns that were observed.

The responses monitored by Dr. Gullotta were known (from the scientific literature) to be due to the physiological changes that occurred as a result of a chemical's interaction with certain receptors in the brain. It is my understanding, that some of the responses observed by Dr. Gullotta after administration of various levels of nicotine, appeared to mimic those that had been reported in the literature for addictive substances like cocaine. A substantial amount of information regarding the brain's reaction to a wide variety of substances was generated by these studies, many of the observations going well beyond what was generally known in the literature (once again, attesting to Philip Morris' ability to first learn a new technology, and then to use it to go far beyond what was known to the 'public'). Over the years, a large number of studies were conducted in this area on both single chemicals (like menthol and nicotine), while others were conducted to study the additive or synergistic effect when some of these chemicals were administered in the presence of other smoke constituent like CO2.

Dr. Gullotta's pioneering work in this area appeared to demonstrated that a cause-and- effect relationship could be measured in the central nervous system between exposure to nicotine and changes in the electrochemical activity of the human brain. However, Dr. Gullotta's electrophysiology program was ultimately shut down in Richmond and moved to a lab in Germany (at INBIFO), ~~presumably because of the sensitive nature of the results that had been obtained. Dr. Gullotta told me that he was caught off-guard by the sudden nature of this decision. I found his action by Philip Morris extremely interesting in light of the preceding deletion of Dr. DeNoble's animal behavior project. The nicotine synthesis work of Dr. Seeman was also discontinued during this same (general) period of time.

23. I observed an 'inner company' within Philip Morris that appeared to conduct research outside of normal channels. As my own work at Philip Morris expanded over the years (and placed me in greater contact with a broad cross-section of the company's facilities and personnel), I began to notice a pattern of activity within R&D that, for whatever the reasons, attracted my interest. This was facilitated by: (1) my daily interactions with a number of Philip Morris researches both within and external to R&D, as well as (2) my growing interaction/relationship with Dr. Thomas Osdene and some of the other members of his staff (including: Ted Sanders, Bob Pages, Bob McCuen, Jim Charles, among others).

At first, I found it interesting that three, very unique functions at Philip Morris all reported to Dr. Osdene. This included: (1) the toxicology (Microsome/Ames Assay) group of Dr. Charles, (2) the behavioral research lab of Dr. DeNoble, and (3) the electrophysiology lab of Dr. Gullotta. To the best of my knowledge, no similar groups existed at any of Philip Morris' competitors (at least with regard to the latter two). The first group screened a wide variety of tobacco and cigarette constituents for activity as potential 'promotors' of genetic change (damage/modification); the second studied the possible habituating effect of tobacco components (such as nicotine) on the behavior pattern of animals, and the third group measured the effect of a variety of tobacco (smoke) constituents on the electrophysiology of the human brain.

Philip Morris was, in effect, obtaining detailed information about how its products could at least potentially affect three important levels of human health: genetics, behavior and the electrophysiology of the brain. This all became even more interesting when I learned that a fourth group (headed by Dr. Jeffrey Seeman) had synthesized a variety of nicotine analogues and had submitted them to Dr. DeNoble's group for evaluation in their animal behavior studies.

During this period, I also learned (from Dr. Osdene, as well as from some of his coworkers) that he had been making periodic trips to Germany to visit 'external partners' that were supporting some of his (Philip Morris') efforts. Similar trips to other European locations (such as to the UK) may have also been made. Apparently, this travel was in addition to the trips that Dr. Osdene occasionally made to Philip Morris' European headquarters in Switzerland (although they may, on occasion, have been combined with those trips).

One of these partners was INBIFO. I subsequently found out (by asking around), that hardly anyone knew anything about INBIFO let alone the reason for Dr. Osdene's periodic trips to some of these other European locations. It was my understanding that Jim Charles and/or Bob Pages were also involved in some of this travel. I also remember hearing that on occasion, some of the results and/or initial observations from some of Dr. Osdene's programs were being communicated verbally, rather than in writing (apparently at the request of Dr. Osdene and/or Dr. Charles).

All in all, it seemed as if there was an 'inner company' within Philip Morris that conducted at least some of its investigations 'behind the scenes' on a strict 'need-to-know' basis. Interestingly enough, many (if not all) of these activities appeared to be related, in one way or another, to these sensitive topics of 'smoking and health' or to the behavioral impact of nicotine.

I am quite aware that 'inner circles' exist in most companies. However, it seemed to me, that this group of highly placed managers, directors and scientists was planning and coordinating studies that yielded information about Philip Morris' products (or their constituents) that could potentially impact the health and well being of the public (the smoker).

This 'inner company' as I refer to it, first appeared to be coordinated by Dr. Osdene (1970s - early 1980s), and later (mid 1980s - on) by Dr. Charles and encompassed selected individuals both within and external to Philip Morris. I was convinced that some of these groups/individuals (particularly the ones within Philip Morris) may not have even known that they were being used as the 'extended resources' of this 'inner company', while others (the 'inner circle'), were fully aware of this at least, informal alliance and its activities. It was also my understanding that some of this group's activities (and possibly some of the results) were occasionally reported to the VP of R&D in Richmond and possibly, on other occasions, to selected individuals in NY so as to keep them informed (at least in a general manner). However, I was also told (by Dr. Osdene) that some of these people didn't really want to know all the day-to-day details of what was going on, but instead, left it in the hands of Richmond (Dr. Osdene & Co.) to decide what should, or should not be pursued (and by whom).

24. Corporate (New York) management met regularly in Richmond to discuss the status of various research, development and manufacturing initiatives being conducted by PM in the US and Europe. During my early tenure at Philip Morris, I learned that corporate executives from New York traveled to Richmond on a regular, monthly basis so as to keep informed of the status, accomplishments and/or problems of certain 'high priority' projects being conducted within, and external to Philip Morris. This included topics in: (1 ) basic and applied research, (2) product and process development, (3) manufacturing, and (4) reviews of the results from test markets in which the relative success or failure of new products was being evaluated. These meetings (known as the 'Richmond Meetings') were typically closed affairs and were attended only by the company's senior management and technical personnel as well as a few 'invited guests' (an assortment of individuals who, each month, were asked to report on specific projects of interest to NY).

The New York group typically consisted of the CEO, the President of PM USA and representatives (VPs/Directors) from such functions as marketing. They were joined by the senior executive team from Richmond which normally included: the VP and Directors of R&D, the VP of Manufacturing and (possibly) some of the Managers and/or senior technical staff within manufacturing, development and R&D. Principal and Associate Principal Scientists like Dr. William Dunn (Behavior Group), Mr. Howard Spielberg (Flavor Development) and Mr. Cliff Lilly (R&D) also attended on a regular basis, as did representative from the Leaf Department and Richmond's legal staff (local patent attorneys, etc.). On at least some occasions, they would also be joined by one or more members of the corporate legal staff from NY. A portion of these meetings would include short (usually 10- 20 minute) presentations made by selected members of the scientific and/or management staff. These individuals would normally be present only during their own presentations and then leave immediately thereafter. The Richmond Meetings would last between one and two days (depending upon the length of the agenda).

I was asked to give presentations at several 'Richmond Meetings' on topics ranging from tobacco structure and chemistry, to my work on the denitrification ('NOD') process. The animal behavior work of Vic DeNoble and human electrophysiology studies of Frank Gullotta were also discussed in similar presentations. It is from these personal experiences, as well as from my discussions with Bill Farone, Tom Osdene and Cliff Lilly, that I was aware of the nature and content of some of these meetings. It was clear that corporate (NY) management had a formal and long-term interest in understanding, as much as possible, the work that was being conducted by the various research, development and manufacturing groups within the company. This was reflected in the many probing questions that were asked by the corporate attendees at these meetings. In fact, I was surprised (on more than one occasion) by the sophisticated questions raised by individuals like Clifford Goldsmith or one of Culmans (attesting to their focus on what was being presented). These were not just 'Dog and Pony' shows conducted for appearance only. Quite the contrary, a great deal of thought and preparation went into the selection and presentation of these topics which were frequently, quite technical in nature.

The preceding commentary has-been offered solely in an attempt to inform others about the general nature of the activities within the tobacco industry (specifically, Philip Morris) and is not offered, in any manner, as a personal indictment of the individuals mentioned herein.

I declare under penalty of perjury that, to the best of my knowledge,- the foregoing is true and correct. 28 U.S.C. 1746.

Executed on (Day):__Friday__ (Date):__1 March__, 1996

Ian.L. Uydess, Ph.D.

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The Manipulation and Control of Nicotine and Tar in the Design and Manufacture of Cigarettes: A Scientific Perspective

by William A. Farone, Ph. D.

It is well recognized within the cigarette industry that there is one principal reason why people smoke -- to experience the effects of nicotine, a known pharmacologically active constituent in tobacco. The recent discussion concerning the regulatory status of nicotine has led to some confusion over the role of nicotine and tar in the design and construction of cigarettes. As a scientist who devoted seven years to the industry as the Director of Applied Research, in the Research & Development department of Philip Morris U. S. A., part of Philip Morris, Inc., I would like to put forth a scientific, hopefully objective assessment of strides made by fellow scientists within the industry.

Research into the importance of nicotine to (he tobacco industry can be traced to the 1960's when the British American Tobacco Company initiated research to understand some of the activities of nicotine.1 Clearly by the 1970's and early 1980's the tobacco industry established that smokers required a minimal level of nicotine within a cigarette.2

Knowledgeable industry personnel. primarily scientists and blend and development personnel, understood that a level of nicotine had to be present to result in a commercially successful cigarette. As publicly available documents reveal, the tobacco industry began to study how to design and construct cigarettes to ensure acceptable nicotine levels.3

It was common knowledge within the industry that cigarettes without nicotine would not sell. Nicotine free cigarettes in the 1950's and 1980's were failures.4

While the negative health consequences of smoking, particularly emphysema and the increased rate of lung cancer among smokers, are well known, it should also be noted that smoking, like the use of fermented beverages and bean and leaf extracts, is a centuries old phenomenon. The fact that a wide variety of plants contain chemicals with pharmacological activity can either be regarded as positive or negative depending on whether one is looking for a cure for disease or believes that behavior modification is a negative result.

Research by the industry has shown that the pharmacological effects of nicotine have been a two edged sword. The industry understood that consumers smoke cigarettes because of the pharmacological properties of nicotine.5 Industry researchers were also aware that the nicotine found within cigarette smoke may have negative peripheral nervous system (cardiovascular) effects.6

However, it should also be pointed out that industry research on nicotine's pharmacological effects has shown some potential benefits. For example, research completed by R. J. Reynolds Tobacco Company maintains that cigarettes provide smokers with psychological benefits, such as increased mental alertness and anxiety reduction.7

In addition, research at Philip Morris analyzed the possible benefit of nicotine related to hyperkinetic children as well as nicotine's beneficial effects on reducing stress experienced by smokers and improving the performance of tasks.8

If we accept the premise -- as the cigarette industry surely does -- that cigarettes are a nicotine delivery system, and that current laws do not forbid the self administration of nicotine via smoking by adults, then it becomes a desirable technical challenge to decrease the "tar" in a cigarette while maintaining the delivery of nicotine. I his has been a key objective of the cigarette industry over the last 20-30 years, as some industry documents now publicly reveal.9

Minimizing the exposure to the potential negative health effects of the undesirable chemical components in tar while maintaining an acceptable and pharmacologically active nicotine level is thus a valid and useful technical challenge that I and many of my former colleagues in the cigarette industry considered a top priority.

Achieving this acceptable and pharmacologically active nicotine level was an enormous challenge. It required cigarette manufacturers to deliberately control the levels of nicotine in their products in order to overcome the naturally-occurring variability of nicotine in tobacco plants. Since tobacco is a natural product and the content of nicotine varies from year to year. by type of tobacco, by varieties within types. and from farm to farm it is also necessary to be able to control nicotine levels and the ratio of nicotine to tar to be able to make a consistent product and to accurately label the product for nicotine and tar as required by law.

Cigarette manufacturers have invested enormous financial resources to achieve the desired level of control over nicotine and tar in their products. The industry employs two principal means of controlling the nicotine levels:

1. By modification and control of the tobacco blend, i.e., the ratio of Burley (air cured), Bright (flue cured), Oriental, stems, expanded tobacco products, and reprocessed tobacco products such as tobacco sheet made from stems and waste leaf.

2. By modification of the construction of the cigarette such as filter type, the type of filter material used, the number and placement of ventilation holes the density composition and porosity of the cigarette paper, the length and diameter of the paper and the types and amounts of flavor additives.

Over the years, these techniques have been described or discussed in the public domain at various meetings and by publications in books, patents. scientific papers. and newspapers.10

The strongly held conviction of most industry scientists and product developers was that nicotine was the primary reason why people smoked. This was sometimes openly expressed.11

In fact, it was commonly understood within the industry that the smoker's acceptance of a cigarette was related to the amount of nicotine it contained. Extensive in some instances ground breaking, research by the tobacco industry was necessary to construct a cigarette that ensured an adequate delivery of nicotine as the cigarette market evolved from the traditional full flavored, unfiltered product of the 1950's to the filtered, low tar cigarette demanded by many smokers for the last 30-40 years. I he objective of industry scientists and product developers, simply stated, was to provide the consumer with the same pharmacological satisfaction derived from nicotine in the natural blends and flavor of the full strength cigarettes of the 1950's as the marketplace shifted to the naturally less flavorful and satisfying low tar and nicotine cigarette demanded by the more health conscious consumer.

A major contributor to this process was Dr. William Dunn, Principal Scientist and manager of the Behavioral Research group of Philip Morris. Dunn believed that nicotine was a beneficial component of cigarette smoke.12

Tar was considered to be the "biologically active," i.e. harmful component of cigarette smoke. Therefore. the development of low tar cigarettes that gave the smokers the nicotine they wanted but exposed them to less tar were considered good research and product development objectives. Industry scientists were proud to be working on the development of these products. Discussions at industry or company sponsored meetings such as the Tobacco Chemists Research Conferences often occurred among blend specialists. market researchers. and research & development scientists on how to attain that level of acceptability while reducing the tar. An attempt by R. J. Reynolds to produce the ultimate low tar cigarette was the PREMIER nicotine delivery device. PREMIER which was test marketed by RJR, delivered virtually no tar at nicotine levels slightly lower than currently marketed fuller flavor low tar cigarettes.13

According to news reports, Philip Morris was also working on their own version of PREMIER, code named TABLE.14

While working at Philip Morris, Dunn and his behavioral science group promoted the need to provide adequate levels of nicotine in the product, and to maintain adequate levels of nicotine in order to keep smokers satisfied. This concept of nicotine delivery being essential to consumer satisfaction was common knowledge within Philip Morris and the rest of the industry.15

When consumer testing indicated that a product was lacking in "impact" or some similar descriptor that could be associated with nicotine experienced market researchers and product developers would compensate by increasing nicotine levels to provide the necessary impact in future versions of that product.

As in any discipline, basic pharmacological research was necessary to properly understand a phenomenon. The industry applied considerable effort and manpower to the study of nicotine in order to understand this relationship between nicotine and the smoker's needs. Many internal industry documents that have recently become publicly available reflect, in part, the novel and extensive research conducted. Philip Morris undertook research into nicotine's effect on brain waves, brain receptors, the cardiovascular system, physiological impact, juvenile hyperkinesis, alleviating anxiety, stress, and aggression, the smoker's motivation to continue smoking, as well as on the smoker's cognitive abilities.16 R. J. Reynolds (RJR) research involved human experimentation including analyzing nicotine blood levels and nicotine urine levels as well as the identification of specific brain receptor locations involving the binding sites for nicotine.17 British American Tobacco Company (BATCO), the parent company of U. S.-based Brown & Williamson Tobacco Co., sponsored pioneering work into the addictive nature of nicotine more than 30 years ago and Philip Morris later conducted state-of the-art animal studies demonstrating that nicotine is a "positive reinforcer," and that this effect is centrally mediated one of the defining characteristics of addictive drugs.18

This basic research provided product developers with the scientific foundation that was necessary to help construct a low tar cigarette that maintained an adequate level of pharmacological activity from nicotine in reduced tar products. Product developers and blend and leaf specialists were responsible for manipulating and controlling the design and production of cigarettes in order to satisfy the consumer's need for nicotine in lower yield products.

Blend changes were an especially important tool used to ensure desired nicotine levels. Tar is a function of tobacco weight. However, an all-burley cigarette will produce a higher nicotine level than an all- bright tobacco cigarette of the same weight. The industry knew that by using a higher percentage of higher nicotine tobacco in their low tar cigarettes they could achieve an increase of their nicotine levels. Therefore a blend change incorporating the greater use of higher nicotine tobacco while reducing the overall tobacco weight, such as through the use of expanded tobacco, could produce a low tar cigarette with the desired pharmacologically active level of nicotine associated with a conventional full flavor cigarette. An example is the Merit Ultra Light which was introduced in 1981 with an elevated nicotine to tar ratio of 0.11.[19] In fact, Philip Morris utilized much of the technology and expertise of leaf and flavor chemistry and behavioral research to mask the harsher taste associated with the presence of higher nicotine burley tobacco in the blend of Merit.20

The cigarette industry also altered the cigarette filter in order to increase nicotine delivery. As the public literature describes, the industry knew that "selective filtration" was possible.21 Filter design and ventilation allowed the design and manufacture of cigarettes that removed a higher percentage of tar than nicotine. Selective filtration was accomplished by altering the technical specifications for a filter, e.g. by selecting different filter tow combinations, varying the denier per filament, and deciding whether or not to use additives in the filter. After the blend was selected, appropriate filters were identified to attain a predetermined nicotine/tar ratio. Manufacturers of cigarette filter materials produced detailed technical presentations promoting filters that provided higher nicotine to tar ratios by selectively filtering out more tar. As noted above. the public literature describes these techniques.22

Another component of cigarettes that is used to control nicotine delivery is reconstituted tobacco. The tobacco industry originally developed reconstituted tobacco as a cost- saving measure. Over the last several decades the industry has used reconstituted tobacco products to assist in controlling the nicotine delivery in cigarettes. Reconstituted tobacco is composed of returned cigarettes, tobacco stems, scraps, and dust. By use of either a wet paper making process or a bandcast process these scraps are made into tobacco sheet or reconstituted tobacco.23

By controlling the ingredients that go into making reconstituted tobacco, the industry controls the chemical and physical properties of the finished sheet, including its nicotine content. For example, reconstituted tobacco used in a low tar cigarette blend can be made differently from the reconstituted tobacco used in a full flavor cigarette. The reconstituted tobacco blend destined for a low tar cigarette can be made with a higher concentration of burley tobacco scraps than the blend of reconstituted tobacco designated for a full flavor brand. Reconstituted tobacco is closely controlled for its chemical properties and burn rate and flavor controlling additives. The alkaloid (mostly nicotine) and sugar content of all the scrap used can be measured and precisely blended into reconstituted tobacco. The levels of nicotine and other key compounds can also be measured to insure control in reconstituted tobacco. Quality control checks involving the use of a gas or liquid chromatography to ascertain the exact nicotine amounts are routinely employed during the process. Final product that fails to meet the design specifications for nicotine can be returned to the start of the process or re-blended.

The delivery of tar and nicotine is a complicated scientific problem and recent reports are now shedding more light on how the problem was solved. The use of ammonia chemistry was important to the industry in maintaining adequate nicotine delivery lo satisfy smokers.24 The industry was able to deliver more of the available nicotine in the blend to the smoker by using ammonia compounds. This apparently works by increasing the pH of the tobacco smoke. Commonly, the pH (or level of basicity) is increased by the addition of ammonia compounds either as additives or in the manufacture of reconstituted tobacco. Ammonia is sometimes introduced by casings such as urea that are applied to tobacco and then decompose into ammonia at which point they can increase the pH of the smoke. These casings include ingredients like amino acids, proteins, and other products that decompose or by pyrolysis are changed into pH increasing agents, such as ammonia. In the complex world of tobacco smoke chemistry, by increasing the pH I of the aerosol in the mainstream smoke, more of the aerosol would be in the vapor phase and less in the liquid (or condensed) phase. By increasing the ratio of vapor phase to liquid phase, one increases the total nicotine delivery since the condensed phase is less likely to survive the filter and the trip to the lungs. All of the cigarette components described above were incorporated into complex computer models to help determine nicotine and tar deliveries while cigarettes were in the product development stage. These models allowed blend ingredients, filter and paper components, and numerous other variables to be considered simultaneously. The models enabled nicotine and tar deliveries to be successfully predicted and enabled product developers to identify which components were required to produce specific nicotine and tar deliveries. Models of this type are well suited to the use of computers and are discussed in the published literature.25

The tobacco industry found that in the manipulation of the nicotine/tar ratio, the methods used to increase the nicotine to tar ratio sometimes resulted in a cigarette that was too harsh. With a standard nicotine/tar ratio in a traditional cigarette no flavor smoothing compounds are generally needed to produce a palatable cigarette. The higher tar levels in traditional cigarettes mask the harshness of nicotine and the associated compounds produced in higher nicotine to tar ratios. A low tar cigarette with a higher nicotine/tar ratio than a traditional cigarette could be very harsh due to the lack of sufficient specific tar components to mask the nicotine and related basic compounds. To overcome the harshness due to the increased burley in the blend, the industry used flavor "smoothers."26

While some of the research into the construction and design of the low tar cigarette is now becoming publicly available, much of the novel and groundbreaking scientific research of the tobacco industry has not come to the public's attention. The sequestering of much good science within the industry can be traced to fears within the industry that this research might be used in litigation against the industry. Recent documents and stories have come to light that illustrate the quandry faced by tobacco industry management. The argument is that any company should not create or be exposed to information that may come back to haunt them in civil litigation. The closing down of Dr. Victor DeNoble's nicotine studies at Philip Morris and the screening of British American Tobacco (BATCO) scientific reports by Brown & Williamson attorneys as described by Dr. Jeffery Wigand are two well known examples.27

The point, however, is that much of this research is beneficial to the smoker if we concede the premise that smoking is lawful and enjoyable to many people.

In other countries smoking research is treated in a much more open manner and this has led to a great deal of smoking research being performed outside the U. S. Some countries require testing of flavor additives, including tests on animals. In Japan, where the government controls the tobacco monopoly, the research on lowering carcinogenicity is discussed openly.

Tobacco industry scientists conducted research utilizing electroencephalograms (EEG's) in the 1970's.28 The initial theory behind EEG research was to expand upon published research that nicotine had a beneficial effect on brain wave patterns. The work was demonstrating that positive brain wave patterns could be achieved with persons who smoked a cigarette and were then required to undertake difficult tasks. The workers tested three cigarettes with the same tar level but varying levels of nicotine. Subjects who smoked the cigarettes were monitored by EEG. This research is valuable because as the EEG testing became more sophisticated, the EEG might be used to determine whether cigarettes had adequate levels of nicotine, and whether a particular ingredient was a nicotine enhancer or nicotine substitute.

Research of this type can be carried out in foreign countries, or in an environment where fear of lawsuits do not override the need to improve products. In an "open" environment, with cooperation on the nature of cigarette products between the industry and government regulators, research of this type could be used to "optimize" the cigarette for those who continue to desire to smoke. Rather than restrict the options of what companies could do, agreement between regulators and industry would open up entirely new options for cigarette construction and progress in the industry.

William A. Farone, Ph. D.

MAR 8, 1996

About the Author

Dr. William A. Farone, Ph.D., is the President, Chief Executive Officer, Applied Power Concepts, Inc., a Company which develops chemical technology and biotechnology. Dr. Farone was the Director of Applied Research, Philip Morris, Inc., from 1976 to 1984. He supervised 5 divisions with a total of 150 persons (mostly professionals). He developed and implemented programs leading to new technology for utilization in new products and new processes with strong emphasis on biotechnology, physical chemistry, and physics. From 1975 to 1976, he was the Vice-President, Research and Development of PVO International, Inc. From 1972 to 1975, he was the Director of Scientific Research, Lever Brothers Company. He has a B.S. in Chemistry (1961), M.S. in Chemistry (1962), and Ph.D. in Physical Chemistry (1965) all from Clarkson University in Potsdam, New York.

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Declaration

Jerome Rivers declares as follows:

1. I was employed by Philip Morris for 23 years. My employment at Philip Morris began in 1972 and ended in 1995. During this period, I held numerous positions at Philip Morris, including positions in Research and Development, Production, and Technical Support.

2. From 1991 to 1995, I served as a shift manager at Philip Morris's blended leaf (BL) plant in Richmond, Virginia. The BL plant was used to make a type of reconstituted tobacco called blended leaf or "bandcast."

3. The BL plant operated 24 hours a day. As a shift manager, I had responsibility for and personal knowledge of the operations of the plant during a shift.

4. The ingredients used to make blended leaf are the by- products from the manufacturing of cigarettes, such as tobacco stems, small tobacco particles, and tobacco dust. At the BL plant, these by- products are blended together according to formulas provided to the shift manager by Philip Morris's Technical Support Group.

5. After the by-products are blended together, the by- products are mixed with water and other ingredients, including flavorings, to form a slurry. One of the ingredients regularly added to the slurry at the BL plant was ammonia. Other ingredients included alcohol-based flavors, sugars, urea, and glycerine.

6. The slurry is spread onto a stainless steel belt and passed through a dryer. After the slurry dries, it is taken off the belt and cut up into sheets to form the reconstituted tobacco sheet.

7. The reconstituted tobacco sheet is time-stamped and shipped to Philip Morris cigarette factories, where it is blended into cigarettes.

8. At the BL plant, Philip Morris made about half a dozen different reconstituted tobacco sheets. These sheets would use different blending formulas. For instance, one formula would require the use of more by-products from Burley tobacco, while another formula would require the use of more by-products from Bright tobacco. The formulas might also have differences in the chemical ingredients added to the by-products.

9. During the manufacture of reconstituted tobacco, we frequently monitored the alkaloid content of the by-products, the slurry, and the final reconstituted tobacco sheet. Alkaloid is another name for nicotine. The alkaloid content would be measured using a gas chromatograph located in a laboratory in the BL plant.

10. We would measure the alkaloid content of the by- products approximately once a shift. We would measure the alkaloid content of the slurry approximately once per hour. We would also measure the alkaloid content of the final product approximately once per hour.

11. The alkaloid measurements would be returned to us soon after we had taken a sample. It generally took only 10 to 15 minutes to get the results back.

12. We would record the alkaloid content of the reconstituted tobacco sheet in a computer database. This database recorded the alkaloid content of each time-stamped package of blended leaf.

13. Philip Morris established standards or "specs" for the alkaloid content of the reconstituted tobacco sheet blended leaf product. If our measurements showed that the product was out-of-spec for alkaloids, we would pull the reconstituted tobacco sheet. We would usually then feed the out-of-spec reconstituted tobacco sheet back into BL process in small quantities so that it could be made into a new reconstituted tobacco sheet meeting the alkaloid specs.

14. If the sampling of the by-products indicated that alkaloid content of the by-products did not meet the specs established for the by-products, we would inform the Technical Support Group. The Technical Support Group would fax us a new blending formula. For instance, if the by-product sampling indicated a downward trend in the nicotine content of by- products from Bright tobacco, we might be instructed to add more Burley by-products to the blend. Burley by- products contain more nicotine than Bright by-products.

15. Philip Morris also operated a plant at Park 500, in Richmond, Virginia, for making another type of reconstituted tobacco called reconstituted leaf. I attended meetings at which the operations of Park 500 were discussed. From these meetings, I learned that Philip Morris also operates a gas chromatograph at Park 500. As at the BL plant, Philip Morris uses this equipment at Park 500 to measure the alkaloid content of the reconstituted leaf.

16. I declare under penalty of perjury that, to the best of my knowledge, the foregoing is true and correct. 28 U.S.C. sec. 1746. Executed on March 7, 1996.

Jerome Rivers

______________________________________________________

ENDNOTES for William A. Farone section

1. Haselbach CH., et al., "Final Report on Project HIPPO II," for the British American Tobacco Co Ltd., Battelle Memorial Institute, Geneva, March, 1963.

2. Dunn WL, "Motives and Incentives in Cigarette Smoking," Philip Morris, 1972. Teague, CE, "Research Planning Memorandum on the Nature of the Tobacco Business and the Crucial Role of Nicotine Therein," R.J. Reynolds Tobacco Co., April 14, 1972.

The industry's understanding of the need for a minimum level of nicotine is further reflected in patents held by cigarette manufacturers. See U.S. Patent No. 3,584,630. Inskeep GE., "Tobacco Product Having Low Nicotine Content Associated with a Release Agent having Nicotine Weakly Absorbed Thereon," Philip Morris Inc., June 15, 1971, C1: 18-20, 39-43.

U. S. Patent No. 3,109,436, Bavley A., et al., "Tobacco Products," Philip Morris Inc., November 5, 1963, C1: 11 15, 34-39.

3. Eichorn PA and Dunn WL. "Quarterly Report of Projects 1600 and 2302," Philip Morris, December 31, 1970. in 141 Cong. Rec. H18127 et seq.

Philip Monris USA, "Research and Development Five Year Plan, 1974-1978," May 1973, in 141 Cong. Rec. H8130 et seq.

4. Freedman AM., "Past is Ominous for Substitute Smokes," The Wall Street Journal, June 15, 1989.

5. Ryan/Dunn Alternate, "Third Version of Board Presentation," Philip Morris, Fall 1969, in 141 Cong. Rec. H7646 et seq.

Memo from JL Charles to RB Seligman, "Nicotine Receptor Program - University of Rochester." March 18, 1980, in 141 Cong. Rec. H7680 et seq.

Teague, supra n. 2.

6. Charles, supra n. 5.

Hearings on Regulation of Tobacco Products, before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, 103d Cong. 2d Sess., pt. 2 at 33 (April 28, 1994) (testimony of former Philip Morris scientist Victor John DeNoble, Ph.D.).

7. Robinson JH, et al., "The Role of Nicotine in Tobacco Use," Psychopharmacology. 108:397, 1992.

8. Philip Morris Research Center, "Behavioral Research Annual Report." July 18. 1975, in 141 Cong. Rec. H7652 et seq.

Memo from FJ Ryan to WL Dunn, "Proposed Research Project: Smoking and Anxiety," Philip Morris, December 23, 1969, in 141 Cong. Rec. H7648 et seq.

Eichorn PA, et al., "Quarterly Report -- Projects 1600 and 2302," Philip Morris, October 5. 1972, in 141 Cong. Rec. H7649 et seq.

9. Memo from TS Osdene to WL Dunn. "5-Year Plan." Philip Morris, October 29. 1973. in 141 Cong. Rec. H8149 et seq.

Teague, supra n. 2.

Morini HA. "Cigarettes with Health Assurance," BATCO, 1976.

U. S. Patent 4,676,259, Ellis MP., et al., "Nicotine Enhanced Smoking Device," Advanced Tobacco Products Inc., June 30, 1987, C1:21-22, 52-58.

10. The following references cover a wide variety of the published methods for modifying the nicotine to tar ratio:

Spears AW., "Factors Affecting Smoke Delivery of Nicotine and Carbon Monoxide," presented at the "1975 Symposium - Nicotine and Carbon Monoxide," presented by the Tobacco and Health Research Institute and The Kentucky Tobacco Research Board, November 17-18, 1975.

Spears AW and Jones ST, "Chemical and Physical Criteria for Tobacco Leaf of Modern Day Cigarettes," Recent Advances in Tobacco Science, 1981, 7:19-39.

Halter HM., et al., "Effect of Tobacco Reconstitution and Expansion Processes on Smoke Composition," in Recent Advances in Tobacco Science, 32nd Tobacco Chemists' Research Conference, October 30 - November 1, 1978, vol.4, pages 113, 126.

Freedman AM., et al., "Why Don't Low-Tar Cigarettes Have Lower Nicotine?" The Wall Street Journal, July 14, 1995

Freedman AM, "'lmpact Booster' Tobacco Firm Shows How Ammonia Spurs Delivery of Nicotine," The Wall Street Journal, October 18. 1995.

"Filter Material Reduces CO/Tar Ratio Without Pressure Drop," Tobacco Reporter, April 1985; 12(4):30-34.

Kiefer JE., "Ventilated Filters and their Effect on Smoke Composition," Research Laboratories, Tennessee Eastman Company, pages 69-83.

McMurtie A., et al., "Cigarette Paper Effects on Tar/Nicotine and CO/Tar Ratios." Abstract from the 35th Tobacco Chemists' Research Conference, Winston-Salem, NC, Paper No. 17, 1981.

Selke WA, "Making the Cigarette Do Just What You Want It To Do," Journal Tobacco International, September 16, 1983.

Norman V., "The Effect of Tip Dilution on the Filtration Efficiency of Upstream and Downstream Segments of Cigarette Filters," Beitrage zur Tabakforshung International, Vol. 12, No. 4, July 1984.

Browne CL., The Design of Cigarettes, Third edition, Hoechst Celanese Corporation, 1990, page 73.

Browne CL, et al., "The Effect of Filter Ventilation on the Yield and Composition of Mainstream and Sidestream Smoke," Abstract from the 32nd Tobacco Chemists' Research Conference, Montreal, Canada, Paper No. 16, 1978.

Owens WF, "Effect of Cigarette Paper on Smoke Yield and Composition." Abstract from the 32nd Tobacco Chemists' Research Conference. Montreal, Canada, Paper No. 1, 1978.

Lee BM, "Modification of Nicotine to Tar Ratio in Cigarette Smoke," Abstract from the 42nd Tobacco Chemists' Research Conference, Lexington, KY, Paper No.34, 1988.

Philips JA, "Filters for Cigarettes: An Integral Part of the Cigarette," Tobacco Reporter. October 1981.

11. Dunn, supra n. 2.

Charles, supra n. 5.

Teague. supra n. 2.

12. Dunn supra n. 2.

13. "New Cigarette Prototypes that Heat Instead of Burn Tobacco," R.J. Reynolds Tobacco Company, Winston-Salem, NC, 1988, page 3.

14. Freedman AM., "Philip Morris Memo Likens Nicotine to Cocaine," The Wall Street Journal, December 8, 1995, B1.

15. Dunn, supra n.2.

Charles, supra n. 5.

Teague, supra n. 2.

16. 141 cong. Rec. 7646 (reprinting Philip Morris research documents), July 25, 1995.

17. R.J.Reynolds Tobacco company, New Cigarette Prototypes that Heat Instead of Burn Tobacco, supra n 13, at pp. 457-557.

Fluhler et, al. "A Hybrid PBPK/PD Model for Nicotinic Receptor Dynamics in the Rat Brain." Duke University Medical Center and R.J. Reynolds Tobacco Co., Abstract, Society for Neuroscience, 22nd Annual Meeting, Anaheim CA, Vol. 18, Part 1, October 25-30, 1992.

18. Haselbach C., et al., "A Tentative Hypothesis on Nicotine Addiction," Southampton, England, May 30, 1963, pages 1-3.

Hearings on Regulation of Tobacco Products, April 28, 1994, supra n. 6, at 5, 6, 20.

19. Remarks of Rep. Henry A. Waxman, July 31, 1995, 141 Cong. Rec. H 8007.

20. "Second Speaker, Merit Team," Remarks, Philip Morris, January 14, 1976. ~ 21. Browne CL., The Design of Cigarettes, Third Edition, Hoechst Celanese Corporation, 1990. page 72.

22. Supra n. 10.

23. Browne CL., supra n. 21, pages 44-47.

24. Freedman AM. "'lmpact Booster' Tobacco Firm Shows How Ammonia Spurs Delivery of Nicotine," The Wall Street Journal, October 18, 1995, A 1.

25. Schneider M., et al., "Computer Aided Cigarette Design," Abstract from the 36th Tobacco Chemists' Research Conference, Raleigh, NC, Paper No. 34, 1982.

DeBardeleben HZ., "Role of Cigarette Physical Characteristics on Smoke Composition," Abstract from the 32nd Tobacco Chemists' Research Conference, Montreal, Quebec, Paper No. 5, 1978 DeLucia ML., et al., "Principles for the Design of Low Delivery Cigarettes," Abstract from the 34th Tobacco Chemists' Research Conference, Richmond, Virginia, Paper No. 34, 1980.

Ohlemiller, et al., "A Mathematical Model of Cigarette Smoking and Predictions of Cigarette Performance," Abstract from 27th Tobacco Chemists' Research Conference, Winston-Salem, NC, Paper No. 34 1973.

Curran JG, et al., "Perforated Tipping and Porous Plugwrap Effects on Performance of Vented-Filter Cigarettes: Mathematical Models," Abstract from 34th Tobacco Chemists' Research Conference Richmond, VA, Paper No. 34, 1980

26. Leffingwell JC., "Nitrogen Components of Leaf and Their Relationship to Smoking Quality and Aroma," The 30th Tobacco Chemists' Research Conference, Nashville, TN, Paper No. 1, 1976.

27. Freedman AM., "Cigarette Defector Says CEO Lied to Congress About View of Nicotine," The Wall Street Journal, January 26, 1996.

28. Memo from WL Dunn to TS Osdene, "Plans and Objectives -- 1979," Philip Morris, December 6, 1978, in 141 Cong. Rec 7668 et seq.