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INTEROFFICE MEMORANDUM Biological Chemistry Laboratory TO: W. S. Caldwell J. M. Greene DATE: April 13, 1993 W. J. Casey , J. H. Reynolds W. M. Dufour J. H. Robinson A. Gonzales-Parra D. J. Wilson FROM: G. D. Byrd SUBJECT: Follow-Up of 1 mg "Tar" Meeting This is a compilation of ideas gleaned from the blue slips collected at the end of the meeting. I wish to thank you all for excellent input. The Issue • If we are to make satisfying ULTs, how.much nicotine is needed? Which smoker group needs how much? • To access the product use and how it is being used (i.e., metabolized). • How much nicotine do smokers want? Is compensation real? • To determine amount of nicotine a smoker (1mg) can achieve from cigarette @ x amount of "tar" and nicotine (FTC). • To explain to our anti's that lower "tar" cigarettes do lower risk and people do intake less "tar" and nicotine. • To determine nicotine deliveries needed for smoker satisfaction. • Assumption: nicotine is reason why people smoke cigarettes. Take Home Ideas • Low "tar"/nicotine cigarette smokers tend to push cigarette to get maximum amount of "tar"/nicotine. • Does banding change smoking behavior? It seems to. • 1 mg smokers are used to less nicotine. 0 Can't get much more out of 1 mg products.

• A smoker has to be very efficient to get nicotine satisfaction out of a 1 mg "tar" cigarette. • What did very low nicotine uptake NOW smokers give as the reason for smoking? How do they rate their smoking satisfaction? • We have an opportunity to sell the merits of 1 mg cigarettes to smokers with our data. • XB2 nearly achieved objective of providing as much nicotine as an HUL smoker wanted but with much less "tar". • Does banding change the way a smoker "smokes"? • How can we use this information to "help us" (legal)? • How would a Premier-type product fare in this type of study? Next Steps • Complete analysis of nicotine response study. • Do it again with 5 mg product. • Determine reality of supposed increase in nicotine uptake in 1 mg study when smokers switched to banded NOW. • Look at full flavor versus Premier cigarette smokers and possible crossover study. • Compare banded versus unbanded for more smokers (regular brand banded and unbanded). • 1 mg switched to HUL and FFL. • Develop a profile of regular FF, FFLT, ULT, and 1 mg smokers; show nicotine uptake and "tar" uptake; compare to XDU for exposure to our opponents for PR to use. • Perform similar studies with XDU and FF (high nicotine) cigarettes. • Do Premier but with larger sample size, approximately 50 inhalers. • A study varying smoke pH only. • Obtain human mimic smoking yield to get better estimate of "nicotine in".

• Interview on why smoking, or smoking history. • NOW smokers with 5 mg XB-type cigarette. • Smokers profile - high yield of nicotine groups profile versus low yield nicotine. • Full flavor smokers. Improvements • Larger number of smokers per group. • Do double crossovers, e.g., regular brand -> control -> regular brand. • Answer the question, if using banded cigarette causes a change in smoking behavior. • Get some measure of smoking behavior (puff profile, number of puffs per cigarette, etc.) for each subject. • Concentrate on dose - when did they smoke the cigarettes may help explain some of the variability in the data. • Concentrate on output per cigarette smoked on the graphs; may be revealing and may lead to different decisions. • Can we combine this collection of data with sensory or acceptance data to enhance our learning to answer a few "why's"? • Change a few of the slides and graphs to help us with which study, which cigarette, etc., since it is hard to listen and retain and look at charts. • More than two weeks. • Switch smoke nicotine level during the study to see if output of nicotine changes or number of cigarettes smoked. • Ask taste and satisfaction questions during test. • Have them smoke once in the lab to get profile and human mimic smoking.