Product Design
Report on Plasma Cotinine Levels in Smokers of Ultra - Low and Low Yield Cigarettes
Abstract
States ultra-low or low yield male smokers have significantly higher plasma cotinine levels when they smoke Barclay cigarettes than when they smoke Now cigarettes. Finds subjects that smoke 1 mg FTC 'tar' cigarettes have cotinine levels similar to Vantage, while subjects that smoke a 7 to 12 mg FTC 'tar' cigarette have cotinine levels higher than Vantage. Says these data indicate Barclay yields are equivalent to Vantage and rejects the hypothesis that Barclay smokers receive the same delivery as smokers of Ultra-Low brands.
Fields
- Hypothesis
- FTC machine testing and ratingsDesign changes to achieve altered FTC smoke machine tar and nicotine ratings, with or without measured changes in human intake.
- Inhalation ProfileAre cigarettes designed to cater to individual inhalation profiles?
- Low-yield cigarettesModification of low yield products to assure that adequate levels of nicotine delivery are maintained, and effects of yield changes on toxicity and dependence.
- Mainstream constituent yieldsModification of selected mainstream smoke constituents in response to health concerns.
- Nicotine transport, transfer, and uptakeDesign 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 testingDevelopment of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.
- Smoking psychology and behavior
- Keyword
- Brand differences
- Cotinine
- Human testing
- Low delivery (Reduced delivery)
- Metabolite
- Nicotine delivery (Smoke nicotine or nicotine yield)
- Smoker behavior (Human smoking behavior)Puff parameters, daily intake, etc.
- Strength attributes
- Tar/Nicotine ratio (Nicotine/Tar Ratio or T/N ratio)
- Total particulate matter (TPM or Tar)
- Smoke Constituent
- Nicotine
- Total particulate matter
- Named Organization
- A.D. Little, Inc. (Performed biological research & testing for Liggett & Myers)Performed biological research and testing for Liggett on XA (Palladium) cigarette
- Bernett Research
- Brown & Williamson Tobacco Corp.Brown & Williamson Tobacco Corp.
- 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.
- Franklin Institute
- Medical and Technical Research Association
- Paul, Weiss, Rifkind, Wharton and Garrison
- *R.J. Reynolds Tobacco Company (Cigarette manufacturer (Camel, Winston, Doral brands))Cigarette manufacturer (Camel, Winston, Doral brands)
- Dennis and Company, Inc.
- Hewlett Packard
- Brand
- Barclay
- Cambridge (PM)
- CAMEL LIGHTS
- Carlton (ATC)
- Kent Golden Lights
- L&M Flavor Lights
- Lark II
- LARK LIGHTS
- LUCKY TEN
- Marlboro (PM)
- MARLBORO LIGHTS
- Maverick
- Merit (PM)
- Now (RJR)
- Old Gold Lights
- Pall Mall Extra Light
- PARLIAMENT LIGHTS
- RALEIGH LIGHTS
- Vantage (RJR)
- VICEROY RICH LIGHTS
- WINSTON LIGHTS
- Subject
- Low Yield Cigarettes (Products)
- Metabolites (Measures)
- nicotine technology
- Puff Count (Measures)
- Sensory Effects—Impact (Effects)
- Sensory Effects—Taste (Effects)
- Smoke Delivery/Transport (Measures)
- Test/Smoke Constituents (Testing)
- Ventilation (Design)
Document Images
Report
on
Plasma Cotinine Levels
in Smokers of UItra-Low and Low Yield Cigarettes
Prepared for
R. J. Reynolds Tobacco Company
Winston-Salem, North Carolina 27102
Prepared by Arthur D. Little, Inc.
Acorn Park
Cambridge, Massachusetts 02140
A
T.
TABLE OF CONTENTS
1. Conclusions
II. Introduction
III. Objective and Scope
IV. Experimental Design
V.
VI.
RI
Cigarettes
Scheduling
Blood Samples
Monitoring of Smoking
Method for the Analysis Of Cotinine
X.I. Results
Methods,
(a) Selection of Subjects
(b) The Questionnaire
Protocol
Statistical Analysis of Plasma Cotinine
Cigarette consumption
Subject Plamsa Cotinine Levels vs. FTC Nicotine
Determinations in the Laboratory
Discussion of FTC Nicotine vs. Plasma Cotinine
1
T.r i. CONCLUSIONS
These results are in agreement with those found by the
Franklin Institute and reported to FTC October 22, 1981.
nicotine 0.16 mg) (175 ng/mL and 166 ng/mL, respectively).
clay 85 cigarettes (FTC 'tar' 0.7 mg; nicotine 0.09 mg)
than when they smoked Now cigarettes (FTC 'tar' 1..2 mg;
Males who usually smoke either Ultra-Low (1 mg 'tar' FTC)
or Low Yield (7 to 12 mg 'tar' FTC) cigarettes were found
to have significantly higher plasma cotinine levels
(279 ng/mL and.345 ng/mL, respectively) after smoking Bar-
sub j ects who normally smoke 1 mg FTC 'tar' cigarettes,s`r*-40
For
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plasma cotinine levels (279 ng/mL) after smoking Barclay
(FTC 'tar' 0.7 mg; nicotine 0.09 mg) cigarettes were equi
cotinine as a measure of smoke and tar intake, the results
indicate that the Barclay cigarette is equivalent to the
valent to the cotinine levels ('273 ng/mL) after smoking
Vantage (FTC 'tar' 5.4 mg; nicotine 0.51 mg) cigarettes.
For subjects who normally smoke 7 to 12 mg FTC 'tar'" cig-
arettes, 'the cotinine levels after smoking Barclay cig-
arettes were actually higher (345 ng/mL) than the levels
after smoking the Vantage cigarettes (282 ng/mL). Using
Vantage (a nominal 5 mg FTC 'tar') cigarette.
Thus, our results rejiect the hypothesis that smokers of
Barclay cigarettes receive the same smoke intake as
smokers of Ultra-Low Yield brands (FTC 1 mg 'tar' and
0.1 or 0.2 mg nicotine), such as Now, and indicate that
the Barclay cigarette delivered amounts equivalent to a
5 mg cigarette (Vantage).
1
Arthur D little, Inc:
To reduce the 'tar' and nicotine delivery to cigarette
each of these brands is measured by the Federal Trade Com-
mission and the values obtained are listed in their reports
,been introduced into the marketplace. Actual delivery of
smokers, various brands of Ultra-Low yield cigarettes have
Since the method of smoking and analysis of
tar' and nicotine for each of the
of cigarettes and their 'tar' and nicotine yield. By comparing
yields among the brands, the individual smoker decides which
brand of cigarette is most appropriate to smoke.
Because of the unique design of the Barclay cigarette
filter,"R. J. Reynolds Tobacco Company and others in the indus-
try have complained to.the FTC that this particular brand de-,
brands is the same, the
report provides the smoker with a list of the various brands
livers more 'tar' and nicotine to the smoker than is implied
from values determined by the standard FTC method for deter-
mination of 'tar' and nicotine.
In response to charges filed with the FTC, the Franklin-
Institute conducted a study on behalf of Brown and Williamson
Tobacco Corporation in which plasma cotinine levels from smokers
of Ultra-Low cigarettes were measured. Smokers were required
to smoke various brands; i.e., Barclay, Cambridge, Carlton and
Now cigarettes, using a cross-over experimental design. Results
were submitted in a Report to Martin London, Esq., dated October
22, 1981.
1000806868
Despite consistency in the mean number of cigarettes smoked
plained the higher plasma cotinine levels as being due to Barclay's
levels were found to be significantly higher (P ` 0.01) after
smoking Barclay cigarettes. The Franklin Institute Report ex-
y each subject among each of the brands, the plasma cotinine
higher nicotine yield; i.e., 0.2 mg instead of the 0.1 mg reported ,
by FTC for Cambridge, Now and Carlton brands. This explanation
requires the authors to assume that cotinine level in the subjects
.that all brands tested appear to deliver similar amounts of smoke
to similar smokers."
eluded that their data "supports the null hypothesis; namely,
relationship is still uncertain. The authors of the Report con-
increased in the same proportion as the apparent increase in
nicotine_delivery of the Barclay cigarette. - At present this
III.- Objective and Scope
smokers of other brands of nominal 1 mg 'tar' yield cigarettes
This study is designed to provide data to establish whether
or not smokers of Barclay cigarettes absorb more smoke than
brands having 7-12 mg 'tar' (FTC). Data from individual smokers
while smoking either Now (nominal 1 mg 'tar' and 0.1 mg.nicotine)
as well as a comparison of smoke absorbed from a nominal 5 mg
FTC 'tar' cigarette (Vantage).
To achieve this objective, plasma cotinine levels were de-
termined in each of two groups of smokers -- those who normally
smoke- brands having 1 mg 'tar' (FTC) and those who normally smoke
or Vantage (nominal 5 mg 'tar' and 0.5 mg nicotine) cigarettes
were used to estimate the relationship between plasma cotinine
10008t}5869
3
,<,.~
and apparent nicotine intake for cigarettes ranging in nicotine
yield over a range of 0.1 to 0.5 mg based on FTC values. Levels __,.,,"
of cotinine from smokers after smoking Barclay cigarettes were
compared with cotinine levels after smoking Now and Vantage c-ig-
The design is one in which smokers of Ultra-Low brand
cigarettes (X group) were recruited, then assigned at random
into two groups. A second group of smokers, made up of low
yield cigarettes (Y group) were also recruited and divided
randomly into two groups. Subjects in Group X consisted of
' - smokers who normally smoke brands labeled according to FTC as
establish the base-line level of this metabolite , each of the
Following an initial measurement of plasma cotinine to
smoke brands labeled, according to FTC, as having.7-12 mg Itar'o4
containing 1 mg'tar'and Group Y consisted of smokers who normally ,
two groups within the X or Y groups was given either Barclay
or Now cigarettes to smoke for the first week. The two groups O
,"smoking only Barclay cigarettes for the first week were then Q
0
instructed to smoke only Now cigarettes for the second week. OD
Similarly, the two groups smoking Now cigarettes for the first 9
week were instructed to smoke only Barclay cigarettes for the
second week. At the end of the second week, all subjects smoked
only a low yield cigarette; i.e., Vantage (85 mm ventilated
cigarette - FTC 5.4 mg'tar' and 0.51 mg nicotine) for the third
week. Cigarette consumption and plasma cotinine levels were
4
monitored twice weekly by having each subject appear at the
laboratory on Monday and Thursday between 3 and 6 p.m, for an
inventory of cigarettes and the drawing of blood samples for
provided by each subject in order to determine urinary pH.
cotinine analysis. ' A freshly voided sample of urine was also
. __.. . ~.. ~~.
The identity of.brands of cigarettes smoked were not made
known to the subjects or the laboratory personnel who conducted
the plasma cotinine analysis.
5
Methods
(a) Selection of Subjects
Subjects were recruited by Bernett Research, Inc.,
Somerville, Massachusetts, according to criteria contained in
a questionnaire prepared by Dennis and Company, Inc. of Stamford,
Connecticut. Subjects were initially interviewed by telephone in
order to provide twenty suitable male candidates who were smokers
f Ultra-Low cigarettes. Of these twenty subjects, no more
smokers of Low Yield cigarettes (7 to 12 mg FTC 'tar') were also
sought for the study. The following list contains the require-
ments for ascertaining the subjects' eligibility for entry into
the study. .
than seven were to be Barclay smokers. An additional twenty
Requirement and Eligibility.
To qualify for participation in this study, respondents must'
meet the following points of qualification:
Must be a male 21 years of age or older living at home (Q.1)
L. Must not be employed in any of the "boxed" occupations
at Q.2
Must be a male 21 years of age or older who is a smoker (A.3c)
- Other than cigarettes, must not use any other kinds of
tobacco products like cigars, pipe tobacco or chewing
tobacco (A.4)
- Must smoke 20 or more cigarettes per day (Q.5)
- Respondent's usual brand of cigarette is a"FiLtered"
type (Q.6)
- Respondent's regular brand is a non-menthol cigarette (Q.7)
1000806872
6
i
I
- Respondent's regular brand of cigarette must be the
regular, king-sized length (Q.8)
d fill
an
- Must smoke one of the listed brands at Q.9 an
opened Ultra Low'Tar' or Fuller Flavor/Low rTar' quota group.
- Respondent's usual brand of cigarette has been smoked for
at least three months or longer (Q.10)
Must not be restricted from smoking cigarettes during.any.
parts of the day (Q.11)
.
- Has not suffered from a major illness in the past three
months (Q.12)
- Has never been diagnosed by a doctor to have a respiratory
disease like chronic bronchitis, emphysema or asthma (Q.13)
- Has never been diagnosed by a doctor to have any liver
ailments (Q.14)
- Is willing to participate in all seven sessions on the
specified dates between 3 and 6 p.m.
(b) The'Questionnaire and Requirement for Subject Participation
Once the requirements for entrance into the study were ,
formalized, a screening questionnaire was filled out for each
interviewed. The questionnaire is provided in Appendix A-1.
Thirty-four subjects appeared at the initial visit to the
Medical and Technical Research Association laboratory in Boston,
Massachusetts, where the subjects were told to appear, but only
33 agreed to continue in the study.
All subjects were told that in order to be compensated, they
had to complete the study and that they had to agree to adhere to
seven conditions as provided in the Requirements for Subject
Participation. Each subject was then requested to sign the
document, given in Table 1.
7
Table 1
REQUI!REI1ENTS FOR SUBJECT PARTICIPATION
, agree to participate in this study
and agree to adhere to conditions outlined below:
I will smoke in a normal way only those cigarettes that are provided
and unused cigaretteA will be returned to the laboratory each time
I appear at the MTR laboratory.
A form (tally sheet) will be issued at the beginning of the study.
I will record the time when each cigarette is smoked.
. .. .,,;
3. Each time I am requested to appear at the MTR laboratory I will
. receive a new tally form and surrender the completed one. On
Monday visits, if additional cigarettes are needed, they will be
provided to me.
4. A blood sample of 20 ml will be taken from me by trained personnel
on each visit. Depending upon circumstances, I may also be requested
to collect all of the urine voided between the first voidings on
Wednesday morning and Thursday morning. In all cases a freshly
voided sample of urine will be collected when I appear at the MTR
laboratory.
5. All cigarettes will be provided to me without cost. If butts are /
lost an explanation will be given. I will appear at the MTR laboratory
at the times and days designated. Use of any medication or drugs will
be reported by me to the MTR laboratory on each visit.
Only at the completion of the study will I be given previously agreed
upon remuneration for my participation in this research.
7. I will notify MTR laboratory immediately if I cannot appear on assigned
dates or continue in the research for any reason such as illness.
SIGyATURE
8
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