Product Design
Request for Approval for Use of High Nicotine Reconstituted Tobacco Containing Organics and Nicotine Salts of Those Acids in Tobacco Products for Project GT and GT-X
Abstract
Indicates a request is submitted for approving use of reconstituted tobacco sheet containing high levels of nicotine. Describes G7-1 and G7-2 base web sheets as having malic or levulinic acids and nicotine salts of those acids added, lists the formulations used and experimental design. Says experimental cigarettes where lower or insignificant when gas phase components were analyzed, puff counts increased with ventilation and FTC "tar" increased for all experimental cigarettes. States nicotine yields increased with levulinic or malic acid additions, while nicotine salts of these acids significantly increased nicotine yields. Ames tests revealed no statistical difference with strain TA98 but notes strain TA100 showed higher activity in the control when compared to the experimental cigarettes. Asks for review of these data, proposes sensory testing of these prototypes and indicates smoke nicotine yields of these experimental cigarettes will not be greater [1.5 mg/cigarette nicotine] than commercial products.
User-Contributed Notes
Fields
- Author
- Perfetti, Thomas Albert, Ph.D. (RJR Flavorist)
- Recipient
- Suber, R.L.
- Hypothesis
- Design changes over timeChanges in cigarette design over the past half century.
- Mainstream constituent yields
Modification of selected mainstream smoke constituents in response to health concerns.- Nicotine transport, transfer, and uptake
Design changes which alter nicotine delivery or effect how the product causes and maintains dependence, including transfer of nicotine from tobacco to smoke, and uptake into the body.- Smoke constituent testing
Development of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.- Use of additives
Modification of tobacco products through use of additives and measuring effects on dependence, behavior, and toxicity.- Use of tobacco processing/ blends
Modification of tobacco products through changes in tobacco processing and use of blends, and measuring effects on dependence, behavior, and toxicity. - Mainstream constituent yields
- Keyword
- Delivery modification
- Metabolite
- Nicotine delivery (Smoke nicotine or nicotine yield)
- Puff count
- Reaction products
- CO/Tar ratio (Tar/CO ratio)
- Tumorigenic
- Tar/Nicotine ratio (Nicotine/Tar Ratio or T/N ratio)
- Metabolite
- Additive
- Levulinic acid
- Malic acid
- Smoke Constituent
- Nicotine salts
- Benzo(a)pyrene
- Design Component
- G7-1
- Pressure drop (PD, Resistance to draw (RTD), Flow rate or Draft)
- G7-2
- Pressure drop (PD, Resistance to draw (RTD), Flow rate or Draft)
- Operation/Project
- Project GT
- Project GT-X
- Named Organization
- HRRC
- Federal Trade Commission (Enforcement agency for laws against deceptive advertising)
Enforces laws against false and deceptive advertising, including ads for tobacco products. Ensures proper display of health warnings in ads and on tobacco products;collects and reports to Congress information concerning cigarette and smokeless tobacco advertising, sales expenditures, and the tar, nicotine, and carbon monoxide content of cigarettes. - Federal Trade Commission (Enforcement agency for laws against deceptive advertising)
- Subject
- acids (additives)
- Levulinic Acid (Additives)
reduces the harshness of cigarettes- nicotine technology
- Reconstituted Tobacco (Design)
- Smoke Nicotine (Measures)
- Transfer to Smoke (Measures)
- Test/Smoke Constituents (Testing)
- Levulinic Acid (Additives)
Document Images
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RJR INTER-OFFICE MEMORANDUM
SUBJECT: Request for Approval for DATE: August 31, 1989
Use of High Nicotine Reconstituted
Tobacco Containing Organics and
Nicotine Salts of Those Acids in
Tobacco Products for Project GT and GT-X
TO: Dr. R. L. Suber FROM: T. A. Perfetti
A request for approval is being submitted for the use of a high nicotine containing
reconstituted tobacco sheet in tobacco blends for Project GT and GT-X. The
reconstituted tobacco base sheets are either G7-1 or G7-2 base web products. To
these base web sheets, the normal extract (G7-1 or G7-2 extract) is applied to
prepare the final products G7-1 or G7-2. The extracts normally contain -20-30%
solids and the amount added to the base web is such that the final G7-1 and G7-2
is nearly double the weight of the base sheets. The special reconstituted tobacco
sheets that approval is being requested for contain organic acids (malic acid or
levulinic acid) and nicotine salts of those organic acids (nicotine malate and nicotine
levulinate). The nicotine salts were prepared as described in Beitrage zur
Tabakforshung 12, No. 2, 43-54 (1983) by T. Perfetti. Nicotine levulinate is a 3:1 salt
(acid:base) and nicotine malate is a 2:1 salt.
The experimental sheets all contain the same G7-1 base web. To that web was
added a constant load of G7-1 extract in an amount sufficient to increase the weight
of the base sheet by 25%. Two of the experimental G7-1 extracts contained, in
addition to the solids normally present, either a load of malic acid or levulinic acid.
The last two experimental G7-1 extracts contained either nicotine malate or nicotine
levulinate at a load sufficient to prepare a final sheet that contained approximately
10% nicotine. The formulations used to prepare the high nicotine and high organic
acid G7 sheets are as follows:
Experimental
G7 Sheets Wt. of Base
G7-1 Sheet
(g) Nicotine
Added
(g) Acid
Added
(g) G7-1 Extract
at 25% Solids
(g) Final wt.
of Solids in
Sheet (g)
A. Control 600 - - 600 750
G7-1
B. Levulinic Acid (Levulinic)
G7-1 600 - 214.8 600 964.8
C. Nicotine Levu linate (Levulinic)
G7-1 600 100 214.8 600 1064.8
D. Malic Acid (Malic)
G7-1 600 - 165.5 600 915.5
E. Nicotine Malat e (Malic)
G7-1 600 100 165.5 600 1015.5
Tobacco analyses were run on the experimental sheets, above, for % tobacco
nicotine and sugars. The amount of malic acid and levulinic acid that was added
directly via the G7-1 extract and thus the theoretical level of these acids were 18.1
and 22.2% of the weight of the experimental sheets, B, C and D, E, respectively.
Table 1. Tobacco Analyses of Experimental G7 Sheets
Experimental
G7 Sheets Tobacco Nicotine,(%) Total Sugars,
(Theoretical,%) (%) Theoretical
% Levulinic
Acid Theoretical
% Malic
Acid
A 1.44 .26 - -
B 2.44 .28 22.2 -
C 5.66 (9.4) .28 22.2 -
D 3.65 .22 - 18.1
E 8.11 (9.8) .28 - 18.1
Blends of tobaccos were prepared incorporating each experimental sheet at a 25%
(w/w) level. Tobacco and smoke analyses for 85 mm cigarettes prepared employing
a 2.7/48,000 tow and Reference 856 cigarette wrapper are shown in Table 2. Three
levels of filter ventilation were evaluated (0, 50 and 80%). Additionally, all cigarettes
were submitted for Ames tests (see memoranda by C. Fulp to R. Pogrow, August
17, 1989 and to T. Perfetti, August 23, 1989).
Conclusions:
For all gas phase components analyzed (CO, C02, NO, HCN, aldehyde and
ketones) in the experimental cigarette (i.e., cigarettes having 25% levels of the varied
G7 types B-E), across air dilution levels were lower or non-significantly different from
the control products employing the standard G7-1 (Products A at 0, 50 and 80%
dilution). B[a]P levels in the experimental cigarettes across air dilution levels were
not different from the control cigarettes. T/N and CO/T ratios were either
different or reduced for the experimental products across air dilution levels
compared to the controls. Puff counts increased with air dilution as expected for all
products. Pressure drops decreased with increasing levels of air dilution for all
products. FTC "tar" increased slightly for all cigarette types employing the
experimental G7 materials particularly for the products having 0 and 50% dilution.
Nicotine yields increased with the addition of levulinic (-30%) or malic acid (-10%).
Nicotine yield increased substantially for products employing the G7 materials with
either nicotine levulinate or nicotine malate. The yields were directly proportional to
the levels of nicotine in the cigarette with blends containing nicotine malate and
nicotine levulinate. Tobacco analyses (tobacco pH, tobacco acids, tobacco sugar
and tobacco nicotine) were performed and are listed in Table 2. No unusual trends
were present.
Ames tests were performed on all cigarettes. There were no statistical differences
detected between any of the samples at 0% air dilution, nor between any sample at
50% or 80% air dilution with strain TA98. As shown in the attached memo by C.
Fulp, several differences were detected with strain TA100. In these cases, the
control products were all higher in activity compared to the experimental cigarettes.
C. Fulp's conclusions are based on the number revertants per mg of "tar".
Please review these data as soon as possible so that I can bring a request for the
sensory testing of these prototypes to the HRRC. I will not request HRRC to rule on
the use of any experimental cigarettes that have a smoke nicotine yield greater than
that of commercially available products (i.e. 1.5 mg/cigarette nicotine).
Thank you for reviewing this request.
/ e~,
Tom A. Perfetti
TAP/mpm
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