FACTSHEET #4

FCA Framework Convention Alliance

for Tobacco Control

T O B A C C O P R O D U C T R E G U L AT I O N

n a sense, the tobacco industry may be thought of as being Cigarette manufacturers have adjusted

I
■

the pH of cigarette smoke — notably

a specialized, highly ritualized and stylized segment of the through use of additives such as
ammonia — in order to maximize
pharmaceutical industry. Tobacco products, uniquely, contain
nicotine ‘hit’. Higher pH values mean
and deliver nicotine, a potent drug with a variety of physiological a larger proportion of the nicotine in
the smoke is more rapidly absorbed.3
effects. — R.J. Reynolds Tobacco Company, confidential 1972
■ A variety of flavourings are used to mask
memorandum1 the harshness of tobacco smoke and,
in some cases, to act as bronchodilators
which allow greater absorption of
smoke into the lungs, in part to
Tar, nicotine, and CO numerical ratings based upon current reduce coughing and increase smoke
absorption.4
ISO/FTC methods and presented on cigarette packages and in
■ Manufacturers adjust cigarette paper
advertising as single numerical values are misleading and porosity and add various chemicals
to paper to ensure that cigarettes do
should not be displayed. — WHO Scientific Advisory Committee
not extinguish themselves when left
on Tobacco Product Regulation, 20022 unsmoked for several minutes. This
means more cigarettes are sold because
The tobacco industry often refers to considered ‘too dangerous’ to be regu- they burn faster — and thus more
itself as a ‘tightly regulated industry’. In lated as pharmaceuticals. As a result, fires are caused by dropped or forgotten
fact, in most of the world, the industry’s product contents, emissions and design cigarettes.5
leading product, the cigarette, is largely are either loosely regulated under recent
■ Manufacturers have added small holes
exempt from safety standards, testing tobacco-specific legislation (as in Brazil,
around the filter (‘filter ventilation’) and
and regulation even though many of South Africa, Thailand, the European
made various other design changes to
the dangerous chemicals found in Union, etc.), or not regulated at all.
create cigarettes that provide the illu-
cigarettes and cigarette smoke (e.g.,
In this regulatory void, tobacco companies sion of a lighter smoke which makes
lead) are banned or strictly regulated
have had many decades to perfect the smokers believe the cigarettes are less
in other products. Though nicotine is
design of their products, not to reduce harmful. Filter ventilation actually
now widely recognized as a drug, and
the harm they cause, but solely with a reduces the tar and nicotine numbers
nicotine-based pharmaceutical products
view to increasing sales by making them measured by machines, under the tra-
are regulated under normal drugs legis-
as addictive and as attractive as possible. ditional test methods currently used
lation, tobacco products are generally
In particular: (the ISO method), but does not

appear to have any measurable effect on tar and nicotine
intake by human smokers. Smokers simply end up inhaling
a larger quantity of more diluted smoke, with about the
same dose of nicotine and toxic substances.6
What Regulators Should Do
Because of litigation in the United States, the public health
community and regulators now know far more about prod-
uct engineering and chemistry than they did a decade ago.
In particular, they understand that cigarettes are highly
engineered products, not merely shredded tobacco leaf in a
tube of paper. They also know far more about the interaction
between smokers and cigarettes, and how smokers uncon-
sciously adjust their smoking behaviour to achieve specific
doses of nicotine.
Most importantly, however, pulic health authorities also
understand clearly just how large an information gap there is
between manufacturers and regulators. The immediate regula-
tory priority, as indicated in Article 10 of the FCTC, is to
take measures to force the industry to provide more infor-
mation. Article 10 requires that tobacco manufacturers and
importers “disclose to governmental authorities information
about the contents and emissions of tobacco products” and
calls on Parties to publicly disclose “information about the
toxic constituents of the tobacco products and the emissions
that they may produce.” In particular what is needed is:
■ Full disclosure of product contents, including information
about the intended purpose of additives and their known
and suspected effects.
■ Information about product emissions (i.e. what happens
when the product is burnt).
■ More generally, information about manufacturers’ product
research. For example, Canadian regulations require manu-
facturers to report annually, for every brand they produce, all
research activity relating to toxicity, health effects, ingredients,
taste and flavour, modifications, marketing, and the way it
is used by consumers.7
Of course, it is not much use requiring manufacturers to
provide information if the data obtained must be kept in a
locked drawer afterwards. To the extent possible, regulators
should aim to make data as widely available as possible to
researchers and to the general public. For example, smokers
should have the right to know that they are inhaling
FACTSHEET #4
formaldehyde, cyanide, carbon monoxide, etc. — particularly
if information is provided on the effects of such chemicals on
the human body.
What Regulators Should Not Do
■ Regulators should not rely on ISO numbers on tar, nicotine
and carbon monoxide emissions as an indicator of level of
hazard from a particular brand of cigarettes. In particular,
manufacturers should not be allowed, directly or indirectly,
to use lower tar/nicotine numbers as a sales argument
because this is a way of evading the FCTC ban on use of
terms such as ‘low tar’, ‘light’, ‘mild’ and other misleading
descriptors (Article 11.1.). Recent Brazilian regulations
specifically ban manufacturers from using tar numbers in
association with brand names, or in any other promotional way.
■ Regulators should not require manufacturers to print ISO
tar and nicotine numbers on packs or on advertising. In
fact, these numbers should not be displayed at all.
■ Rather than set limits on tar or nicotine levels, regulators
should instead provide in their laws the legal authority to
broadly regulate constituents, emissions, and additives (and
product design) through implementing regulations. That
way, as scientific knowledge advances, regulators can exercise
that authority with respect to tar, nicotine, and a whole
host of other constituents, emissions, and additives.
Regulators should also require manufacturers to disclose much
more specific information about the product including the
design features of the cigarette, levels of toxins in the smoke,
smoking topography among a sample of smokers and actual
bodily exposure to toxins through biomarker measurements.
■ Manufacturers are preparing a new generation of so-called
harm-reduced cigarettes and cigarette-like products. Given
the tremendous scientific challenge of determining in
advance whether such products actually do reduce harm,
regulators should be cautious about allowing such claims
in the absence of scientific evidence.
The need for international co-operation
Article 9 of the FCTC calls upon the Conference of the Parties,
in consultation with “competent international bodies” to
“propose guidelines for testing and measuring the contents
and emissions of tobacco products, and for the regulation
of these contents and emissions.” Even wealthy Northern
countries with substantial tobacco control staff have found it
 FACTSHEET #4

difficult to design effective systems for measuring cigarette

contents and emissions and for analysing the flood of data
they receive as a result. This is one area where technical co-
operation among parties to the FCTC offers not just the
possibility of sharing the financial burden of scientific work,
but also the prospect of avoiding potentially catastrophic
errors and finding innovative regulatory tools.

Resources on the Web:

Recommendations, Reports & Statements from the WHO’s Scientific Advisory Committee on Tobacco Product Regulation
on: 1) ISO/FTC Method of Measuring Cigarette Yields; 2) Effective Regulation of Nicotine in Tobacco and Non-Tobacco
Products; 3) Evaluation of New or Modified Tobacco Products; Tobacco Product Ingredients & Emissions; 5) Smokeless
Tobacco Products can all be found at: www.who.int/tobacco/sactob/recommendations/en/
World Health Organization, “Advancing Knowledge of Regulating Tobacco Products
www.who.int/tobacco/media/en/OsloMonograph.pdf
Model Legislation for Tobacco Control: A Policy Development and Legislative Drafting Manual: www.fctc.org/modelguide/

Endnotes
1. Confidential Research Planning Memorandum on the Nature of the
Tobacco Business and the Crucial Role of Nicotine Therein. (April 14,
1972). <http://tobaccodocuments.org/landman/501877121-7129.html>
2. WHO Scientific Advisory Committee on Tobacco Product Regulation.
Recommendation on Health Claims Derived from ISO/FTC Method to
Measure Cigarette Yield. 2002
3. This is analogous to transforming traditional cocaine to smokable, free-
base cocaine, i.e. ‘crack’. See World Health Organization. “Advancing
knowledge of regulating tobacco products.” Tobacco Control. Vol. 9, No.
2 (June 2000) p. 224–6.
4. For further information, see C. Bates, M. Jarvis and G. Connolly. Tobacco
Additives: Cigarette Engineering and Addiction. (1999).
<http://www.ash.org.uk/html/regulation/html/additives.html>.
5. Health Canada. Regulatory Proposal for Reducing Fire Risks from
Cigarettes: A Consultation Paper. (2002). <http://www.hc-sc.gc.ca/hecs-
sesc/tobacco/pdf/pdf/RIP-ENG.pdf>
6. For more details, see L.T. Kozlowski and R.J. O’Connor. “Cigarette filter
ventilation is a defective design because of misleading taste, bigger puffs,
and blocked vents.” Tobacco Control. Vol. 11 Supplement I (March
2002), p. i40-i50.
7. Canada, Tobacco Reporting Regulations under the federal Tobacco Act.
<http://www.hc-sc.gc.ca/hecs-esc/tobacco/legislation/prop_may_36.html>

Framework Convention Alliance on Tobacco Control www.fctc.org

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Adapted and updated with permission from the 2000 World Conference on Tobacco OR Health fact sheets. June 2005