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Submission of Approval of Urea to Independent Scientific Committee on Amoking and Health, United Kingdom

Date: 14 Sep 1984
Length: 2 pages
2000571190-1191
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Abstract

Philip Morris also adds urea to its cigarettes.

This memo indicates that in 1984 Philip Morris (PM) prepared a submission to the Independent Committee on Smoking and Health seeking approval of urea as a "flavor additive." The memo, which was received by Donald P. O'Brien, Vice President of International Services for PM's Tobacco Technology Group, contains a handwritten question, "What is it's role as a flavor component?"

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Philip Morris U.S.A Inter-Office Correpsondence Richmond, Virginia

PERSONAL & CONFIDENTIAL

To: Distribution From: T.S. Osdene Subject: Submission of Approval of URea to Independent Scientific Committee on Smokign and Health, United Kingdom September 14, 1984

We are in the process of making a submission to the Independent Scientific Committee on Smoking and Health (ISC, formerly the Hunter Committee) for approval of urea as a flavor additive...

Urea is considered to be of very low toxicity in humans and animals. Urea is produced endogenously as the end product of protein metabolism and is excereted in the urine...

Chemical analyses of smoke were carried out using cigarettes treated with 2% urea versus untreated controls...There were not discernible differences in the gas phase smoke components of urea-treated cigarettes as compared with the controls...

...We intend to request ISC approval for a maximum use level of 1.0% urea in the fanly blend which is approximately five times that of the current level in several current PM products.

Company
Philip Morris Cos., Inc.
Author
Osdene, Thomas Stefan, Ph.D. (Director of Science and Technology, Philip Morris [1986])
Ph.D. in Organic Chemistry. Ten years of research when he started with PM in 1965. Worked in Chemical Research Division of PM 1965-66; Chemical and Biological Research Division 1966-69; Director of Research 1969-1984, also assumed independent position as Director of Research and Extramural Studies during these years; became Director of Science and Technology in 1984, reporting directly to Philip Morris USA Executive VP Mark Serrano. Involved with Center for Indoor Air Research (CIAR) 1988. Attended PM's Operation Downunder Conference in June, 1987. Retired 1993.
Recipient
Charles, James L., Ph.D. (PM, R&D VP, Pharmacologist, Industry Expert)
Vice President of Research and a scientist for Philip Morris, Inc. Vice President of Research for Philip Morris, Inc. in 1986 and then again from 1992 to 1993.
Cullman, H.
Hausermann, M.
Heretick, R.
Houghton, K.
Meyer, L.
Newman, F
Obrien, P.
Remington, J.
Resnik, F.
Serrano, M.
Region
United Kingdom
United States
Litigation
Stmn/Produced
Operation/Project
Urea additive
Type
Memorandum
Subject
Additives

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Page 1: mnh35e00
PHILIP MORRIS U. S. A. r Or~, ~ 1MfER-OFFICE CORRESPONDENCE RICHNGMD, VIRGINIA a~ v Date: September 14 ,X _.?84 We are in the process of making a submission to the Independent Scientific Committee on Smoking and Health (ISC, formerly the Hunter Committee) for approval of urea as a flavor additive. Based on my initial discussions with Dr. Robert Walier, Scientific Secretary, ISC, we have conducted limited smoke chemistry analyses on urea- containing cigarettes, A brief summary of the toxicology, smoke chemistry, and regulatory status of urea is provided for your consid- eration. Urea is considered to be of very low toxicity in humans and animals. .Urea is produced endogenously as the end product of protein metabolism ,,,,and is excreted in the urine. Urea has been used therapeutically as a ; diuretic at gram per kilogram dosage levels in humans. The oral LD50 of urea in rabbits is 5 g/kg. An extensive Japanese study found no :: significant acute, subacute, or chronic toxic effects in rats. Urea was evaluated under the National Cancer Institute Carcinogenesis Bioassay.program and the results failed to show any biologically significant effects in rats or mice. Chemical analyses of smoke were carried out using cigarettes treated with 2% urea versus untreated controlsa The blend composition was ~``similar to the University of Kentucky Reference 1R4F cigarette. There were no discernible differences in the gas phase smoke components of .urea-treated cigarettes as compared with the controls, using either NP (nitrogen-phosphorus) or flame ionization detectors, .The FDA (US) recently affirmed urea as a GRAS food additive for use as a fermentation aid in the production of alcoholic beverages, in yeast-raised bakery products, and as a formulation aid in gelatin (CFR 21, 184,1923). We intend to request ISC approval for a maximum use level of 1.0% urea in the final blend which is approximately five times that of the current level in several current PM products. Your comments and suggestions for this submission should be returned to me by October 15. ,
Page 2: mnh35e00
•Distribution: f°•• J. Charles :-H. Cullman ' -- M. Hausermann ~ ' -.R. Heretick ~_ K. Houghton~~ L. Meyer 'F. Newman P. OTBrien J. Remington.j=---.. F. Resnik F H. Serrano°l~

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