Tobacco Documents Online

T I STATEMENT OF TAYLOR M. QUINN SUBMITTED TO THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT HOUSE ENERGY AND COMMERCE COMMITTEE MARCH 25, 1994 Mr. Chairman, members of the Subcommittee, thank you for the opportunity to submit this statement addressing the issue of nicotine in the processing and manufacturing of cigarettes - an issue which has recently been the subject of considerable attention. I retired from the U.S. Food and Drug Administration in 1985 after 34 years of service. My FDA experience includes 10 years as an investigator conducting comprehensive field investigations of food, drug and cosmetic manufacturing facilities. These inspections included the review of ingredients and additives as well as material balance evaluations. I held the position of Director, Division of Regulatory Guidance, Bureau of Foods, from January, 1970 through September, 1976, and served as Associate Director for Compliance, Bureau of Foods from September, 1976 until my retirement on February 1, 1985. Since 1985, I have been President of Taylor Quinn Consulting Inc., conducting inspections and audits of manufacturing facilities in the food industry for quality control procedures, good manufacturing practices, contamination problems and material balance evaluations. Philip Morris U.S.A. recently engaged me to conduct an independent investigation concerning nicotine in their tobacco processing and manufacturing practices, and I am appearing today at their request.

7 Page 2 In the course of conducting my independent investigation I inspected Philip Morris facilities in the Richmond, Virginia area including the two plants where reconstituted tobacco sheets are prepared, the Flavor Center responsible for the ingredients added to cigarettes and the Cigarette Manufacturing Center. I wish to emphasize that I had complete autonomy in conducting the investigation and directed that I be given access to comprehensive information and data regarding Philip Morris tobacco processing and manufacturing. My investigation focused on several key questions: (1) nicotine in tobacco processing; (2) what processing aids and ingredients were being added during the various stages of tobacco processing and manufacturing; (3) determining which processing aids or ingredients contained nicotine and, if so, how much; (4) the nicotine content in various finished products; and (5) how much of the nicotine in the finished product came from the raw tobacco and how much nicotine, if any was added.

Page 3 During the course of my investigation I randomly requested data with respect to brands and time periods, and all of the information requested was provided. For example, while I reviewed all of the ingredients used in the manufacture of Philip Morris cigarettes I randomly chose three brands - Marlboro, Merit Regular and Merit Menthol - and was provided with a list of flavors and processing aids for each brand. I also requested this information for randomly selected time periods and was provided with this information for all three brands currently as well as six months and one year ago. Similarly, data regarding nicotine content for all three brands for all three time periods was produced at my instruction. I was permitted to ask any question of any Philip Morris employee I chose, and all inquiries were readily answered. Also, all records that I requested were readily provided. The conclusions of my investigation can be summarized as follows: 1. There is nothing I observed in the processing of tobacco or the manufacture of cigarettes at Philip Morris that would materialiy increase the nicotine in their products above what naturally occurs in the tobacco. 2. The denatured alcohol used as a processing aid by Philip Morris contains nicotine in the form of nicotine sulfate (SDA- 4) as approved by the Bureau of Alcohol, Tobacco and Firearms and 27 C.F.R. § 21.38. Denatured alcohol contains

Page 4 nicotine in amounts so small that it would be undetectable in the tobacco in the finished cigarette considering the much larger amount of nicotine from the tobacco. This is confirmed by my calculations demonstrating that the nicotine contribution from SDA-4 denatured alcohol is 0.0006 to 0.0008 milligrams of nicotine per Marlboro Regular cigarette, 0.0011 to 0.0015 milligrams of nicotine per Merit Regular cigarette and 0.0012 to 0.0023 milligrams of nicotine per Merit Menthol cigarette. The level of total nicotine in these cigarettes ranges from approximately 16 milligrams to approximately 13 milligrams. So the amount contributed by the SDA-4 could not be measured against this naturally occurring background. 3. The commercial tobacco flavoring commonly referred to as "tobacco extract" was used by Philip Morris in 1993 in its Merit Menthol cigarette. This extract contains naturally occurring nicotine in small amounts. No other flavor used by Philip Morris contains nicotine and this flavor was used only in Merit Menthol. The nicotine contribution from tobacco extract to the finished cigarette in which it was used is so small that it does not measurably change the level of nicotine in the cigarette. For example, the maximum possible contribution of nicotine from tobacco extract in Merit Menthol is about 0.0029 milligrams of nicotine per cigarette by my calculations. When this is combined with the nicotine contributed by SDA-4, it would result in a

Page 5 maximum of approximately 0.0052 milligrams of nicotine per cigarette. Again, considering the total nicotine in the cigarettes, the nicotine contributed by these two sources could not be measured against the naturally occurring nicotine. 4. My extensive investigation into the Philip Morris processes of preparing reconstituted tobacco resulted in the conclusion that no measurable nicotine is being added. As an experienced investigator, I was satisfied with the cooperation and candor of all Philip Morris personnel during my inspection of their facilities. I observed no evidence that would support any allegation that Philip Morris adds any measurable level of nicotine to cigarettes over and above the amount of nicotine naturally found in tobacco. Thank you.