Regulation of tobacco ingredients for largest possible

reduction of health risks

Lars M. RamströmInstitute for tobacco studies

Stockholm, Sweden

ICAA Venice 2004

Regulation of

amounts of various constituents in cigarette smoke

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

Sal

iva

coti

nin

e (n

g/m

l)Saliva cotinine by brand nicotine yield in 2031 smoker

of 0+ cigarettes per day: HSE 1998

Cotinine=173.5+138.7 (nicotine yield); r=.19, r²=.034

Nic

oti

ne

in

tak

e p

er

da

y (

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 (that governs the way

he smokes in order to get the amount he needs). This intake is NOT essentially brand-related.

Any other substance, for example ”Tar”: The amount of ”Tar” that in the smoke of the brand accompanies the

smoker’s personal intake of nicotine.

This intake IS brand-related, since it is influenced by the smoke composition (expressed by the proportion between the amount of ”Tar” and the amount of Nicotine, the Tar/Nicotine (T/N) ratio, for the brand).

Is the T/N ratio (or an other such ratio) a fixed brand characteristic?

The smoke composition does vary to some extent depending on the way the cigarette is smoked. However, the variation among all smokers except some very few, is small enough to be unimportant for brand comparison purposes.

Consequently, an acceptable T/N ratio could be derived from the machine yield measures.

EXAMPLE

A smoker’s intake of tar =

machine yield of tar= his nicotine intake × machine yield of nicotine

Amount of nicotine Tar/Nicotine ratio

determined by determined by the smoker brand properties

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)

Summary 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 certain substances and the yield of nicotine.

Regulation of

information on packages regarding smoke constituents

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

Summary Regulation of information on packages

• Machine yield figures as displayed by current EU (and other) regulations are not only meaningless but misleading.

• Smokers should be informed that their intake of…

- nicotine can be varied in a wide range by themselves depending on the way they smoke, but not very much by the choice of cigarette brand.

- other substances is influenced by cigarette properties (brand-specific amount of various substances per unit of nicotine) so that choice of brand may help reduce intake of other substances.

Regulation of

smokefree tobacco products

Mean nitrosamine content of moist snuff products from various sources based on dry weight

Country Brand (yr sampled)

NNKg/g

NNNg/g

Total TSNAg/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

U K E D I T I O N T h u r s d a y , 1 J u n e , 2 0 0 0

M i n o r i t i e s w a r n e d o v e r o r a l c a n c e r

P e o p l e f r o m e t h n i c m i n o r i t i e s s h o u l d h a v e r e g u l a r c h e c k s b e c a u s e m a n y a r e a t g r e a t e r r i s k o f o r a l c a n c e r , s a y d e n t i s t s .

T h i s i s b e c a u s e o f t h e p o p u l a r i t y o f c h e w i n g t o b a c c o a n d b e t e l q u i d s , a m i x t u r e o f t o b a c c o , l e a v e s a n d s p i c e s , a m o n g t h e s o u t h A s i a n c o m m u n i t y .

U K E D I T I O N M o n d a y , 3 M a r c h , 2 0 0 3

O r a l c a n c e r f e a r f o r A s i a n s A s m a n y a s 6 0 0 m i l l i o n p e o p l e a r o u n d t h e w o r l d c o u l d p r o t e c t t h e m s e l v e s f r o m c a n c e r i f t h e y s t o p p e d c h e w i n g t o b a c c o . H o w e v e r , m a n y a r e n o t a w a r e o f t h e r i s k s a s s o c i a t e d w i t h t h e h a b i t , w h i c h i s p o p u l a r i n s o u t h A s i a a n d a m o n g e t h n i c g r o u p s i n t h e W e s t .

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 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.