Post on 16-Jul-2015
Regulation of tobacco ingredients for largest possible
reduction of health risks
Lars M. RamströmInstitute for tobacco studies
Stockholm, Sweden
Workshop on tobacco ingredients, 30 and 31 October 2003, National Institute for Public Health and the Environment
Bilthoven, The Netherlands
Regulation of:
- amounts of various constituents in cigarette smoke
- information on packages regarding smoke constituents
- smokefree tobacco products
To be meaningful from health point of view, regulation of smoke constituents should
relate, not to machine yield, but to smokers’ intake, taking into
account the interaction between the smoker and the product.
Jarvis MJ, Boreham R, Primatesta P, Feyerabend C, Bryant A. Nicotine yield from machine-smoked cigarettes and nicotine intakes in smokers: evidence from a representative population survey.
J Natl Cancer Inst. 2001 Jan 17;93(2):134-8.
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1
Nicotine yield (mg) - LGC 42
0
100
200
300
400
500
600
700
800
900
Sa
liv
a c
oti
nin
e (
ng
/ml)
Saliva cotinine by brand nicotine yield in 2031 smokerof 0+ cigarettes per day: HSE 1998
Cotinine=173.5+138.7 (nicotine yield); r=.19, r²=.034
Nic
oti
ne
in
take
pe
r d
ay (
mg
) 63
56
49
42
35
28
21
14
7
0
From: Jarvis et el 2001
SMOKING HUMAN MACHINE SMOKER
PHYSICAL Fixed by Varying, accordingPARAMETERS protocol to smokers’(puff volume (=same for all adaptation toetc) cigarettes) cigarette
characteristics
NICOTINE Varying, Fixed,DELIVERY depending on (= the amount
cigarette needed by the characteristics smoker),
independent ofcigarettecharacteristics
InI2001, the U.S. National Cancer Institute (NCI) published Monograph 13
Monograph 13 concluded: “Measurements of tar and nicotine yields using the FTC method do not offer smokers meaningful information on the amount of tar and nicotine they will receive from a cigarette.”
and therefore asked for: “Measurement of constituent yields in a manner that more closely resembles the way smokers actually consume cigarettes.”
But, there is no such thing as ”the (one and only) way smokers actually consume cigarettes” because:
• Different smokers use different ways to smoke the same cigarette
• Each individual smoker uses different ways to smoke different cigarettes
What is it that determines an individual smoker’s intake ?
• Nicotine: His personal need for nicotine (governing the way he smokes in order to get the amount he needs).
• Any other substance: The (brand-specific) amount of the substance in question that accompanies his personal amount of nicotine (as expressed by the ratio between the yield of that substance and the yield of nicotine).
A smoker’s intake of substance A =
machine yield of A (his nicotine intake) × machine yield of nicotine
Amount of nicotine RATIO substance A / nicotine
determined by determined by the smoker cigarette properties
Tar/Nicotine ratios (mg/mg):Under "standard" (ISO) conditions (upper line)resp. under "intense" conditions (bottom line)
du MaurierKing Size
du MaurierLight KingSize
du MaurierRegular
Player'sRegular
Player'sLightRegular
Player'sExtra LightRegular
Player'sLight KingSize
MatineeExtra MildKing Size
RothmansKing Size
Export ARegular
Export ALightRegular
11 10 12 11 11 10 10 10 11 11 11
11 11 12 11 11 11 11 12 12 11 12
There is very little variation between ratios achievedunder different smoking conditions.Consequently, ratios can be expected to be equallyvalid for different smokers.
Example of brand comparisonBrand (1999 market)
Emission to ISO smoke machine
Average intake by smokers
Status by Current EU rule
Spar Light (Germany) - Nicotine - Tar
(T/N ratio
0.3 mg 6 mg 20)
≈1.2 mg** ≈ 24 mg
Permitted
Right Filter (Sweden) - Nicotine - Tar
(T/N ratio
1.2 mg 10 mg ≈ 8)
≈ 1.3 mg** ≈ 10.4 mg
Forbidden
**According to Jarvis et al 2001
Example of rule in an ”intake-related” regulation of cigarette smoke constituents.
T/N ratio <10 (and, optionally
Machine yield of tar <12 mg
Machine yield of nicotine <1.4 mg)
Example of brand comparisonBrand (1999 market)
Emission to ISO smoke machine
Average intake by smokers
Status Current EU rule
by: Rule related to intake *
Spar Light (Germany) - Nicotine - Tar
(T/N ratio
0.3 mg 6 mg 20)
≈1.2 mg** ≈ 24 mg
Permitted
Forbidden
Right Filter (Sweden) - Nicotine - Tar
(T/N ratio
1.2 mg 10 mg ≈ 8)
≈ 1.3 mg** ≈ 10.4 mg
Forbidden
Permitted
* T/N ratio <10 (and, optionally: **According to Machine yield of tar <12 mg Jarvis et al, 2001 Machine yield of nicotine <1.4 mg)
Regulation of:
- amounts of various constituents in cigarette smoke
- information on packages regarding smoke constituents
- smokefree tobacco products
Health-related purpose of consumer info on cigarette packages:
To help the smoker minimize his intake of harmful smoke constituents.
Therefore, info should be related to potential INTAKE.
Consequently, machine yield figures are meaningless.
Machine yield figures on packages are even MISLEADING, since their appearence gives the false impression that:
- nicotine intake were determined by cigarette properties and differing widely between different brands but independent of how you smoke.
- low figures for a substance, e.g. tar, would
indicate low intake of that substance i.e. ”This is a mild cigarette”.
Instead, smokers should be aware...
- that they are themselves influencing their intake by the way they smoke
- that the self-determined intake of nicotine is about the same from all cigarettes
- that the intake of other substances
is influenced also by cigarette properties (yield ratio to nicotine)
Possible model for a meaningful and truthful info box on packages:
Nicotine delivery from one of these cigarettes - to a smoking machine (ISO standard): 0.6 mg - to a smoker: 0.1 – 2.0 mg depending on how it is smoked
Every milligram of nicotine is accompanied by: Tar: 8 mg Carbon monoxide: 9 mg
Regulation of:
- amounts of various constituents in cigarette smoke
- information on packages regarding smoke constituents
- smokefree tobacco products
Mean nitrosamine content of moist snuff products from various sources based on dry weight
Country Brand (yr sampled)
NNKµg/g
NNNµg/g
Total TSNAµg/g
Sweden Ettan snus (2000) 0.5 1.1 2.8
Sudan (Toombak) 3 samples (1993)
188- -362
241- -369
United States Skoal (2000) Copenhagen (2000)
4.33.4
20.814.3
64.041.1
BangladeshIndia
PakistanSudan
UKSweden
0,0
2,5
5,0
7,5
10,0
Source: GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, .IARC CancerBase No. 5. Lyon, IARCPress, 2001
Cancer of oral cavity, males all agesAge standardized (World) mortality rates per 100,000
UK EDITION Thursday, 1 June, 2000
Minorities warned over oral cancer
People from ethnic minorities should have regular checks because many are at greater risk of oral cancer, say dentists.
This is because of the popularity of chewing tobacco and betel quids, a mixture of tobacco, leaves and spices, among the south Asian community.
UK EDITION Monday, 3 March, 2003
Oral cancer fear for Asians As many as 600 million people around the world could protect themselves from cancer if they stopped chewing tobacco. However, many are not aware of the risks associated with the habit, which is popular in south Asia and among ethnic groups in the West.
Gothiatek standard Voluntary market based toxicity standard used for snus products by Swedish Match Tobacco Company. ___________________________________________________________________________
Toxin Limit _ Nitrate 3.5mg/kg Tobacco Specific Nitrosamines (TSNA)
5 mg/kg
N-Nitrosodimethylamine (NDMA) 5 µg/kg Benz(a)pyrene (BaP) 10 µg/kg Cadmium 0.5 mg/kg Lead 1.0 mg/kg Arsenic 0.25 mg/kg Nickel 2.25 mg/kg Chromium 1.5 mg/kg µg = microgram or 10-6g. mg/kg ~ parts per million (ppm). µg/kg is equivalent to parts per billion (ppb). Limits based on 50% water content – double the limits for dry weight equivalents.
Summary (1)Regulation of amounts of smoke constituents
• A smokers’ intake of nicotine is about the same from all cigarettes and can therefore not be effectively influenced by limits for machine yield of nicotine.
• A smokers’ intake of other smoke constituents can be reduced by setting limits for the ratio between yield of a certain substances and the yield of nicotine.
Summary (2)Regulation of information on packages
• Machine yield figures are not only meaningless but even misleading.
• Smokers should be informed that their
- intake of nicotine can be varied in a wide range depending on the way they smoke, but not very much by the choice of cigarette brand
- intake of other substances is influenced by cigarette properties (brand-specific amount of various substances per unit of nicotine)
Summary (3)Regulation of smokefree products
• Regulations must recognize the very large differences in toxicity between different smokefree products and aim at eliminating from the market those who carry serious health risks rahter than those who do not.
• There are examples of standards that can serve as models for designing meaningful regulations.