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.