Developing Legislation For Tobacco Control
Developing Legislation For Tobacco Control
Developing Legislation For Tobacco Control
Developing
Legislation
for Tobacco
Control
Template and Guidelines
Pan American
Health
Organization
Regional Office of the
World Health Organization
ACKNOWLEDGEMENTS ............................................................................................................. 2
FOREWORD ................................................................................................................................. 3
INTRODUCTION .......................................................................................................................... 4
Development .................................................................................................................... 8
Implementation ................................................................................................................ 13
Enforcement ..................................................................................................................... 13
ACKNOWLEDGEMENTS
This document was prepared by Heather Selin and Monica Bolis of the Pan
American Health Organization (PAHO). We would like to acknowledge those
who reviewed and provided comments on the document: David Sweanor, Harley
Stanton and, in particular, Rose Nathan, who generously allowed us to borrow
language from a legislative template she has prepared for individual country
consultations. We would also like to thank those who provided help with gath-
ering evidence and providing citations, who we will not name as we are almost
certain to leave someone out. Most importantly, we would like to acknowledge
the work of policy makers, government officials, legislative drafters, and advo-
cates who have made possible the passage of the various laws, regulations and
policies referred to in this document. Their achievements demonstrate that effec-
tive regulation of the tobacco industry is possible, and provide indispensable
precedents to make the path ahead for others a little less daunting.
May 2002
FOREWORD
FOREWORD
In October 2000, PAHO Member States joined with other WHO Member States to
begin negotiations on the Framework Convention on Tobacco Control (FCTC), a
WHO-sponsored international treaty on tobacco control. If a strong FCTC is ratified
by WHO Member States at the World Health Assembly in May 2003, as planned, the
efforts by governments around the world to reduce the scourge of tobacco will have
received a strong boost.
However, even independent of the FCTC process, the evidence accumulated over
the past several decades makes a compelling case for the need for governments
to regulate tobacco products. Tobacco products kill one-half of all long-term
users, including more than one million people annually in the Americas. Half of
those users will die before the age of 70. The vast majority of those addicted to
tobacco became addicted as children or adolescents. And—as court cases, parlia-
mentary and congressional investigations, and internal documents of the compa- The costs of tobacco
nies themselves show—the tobacco industry has engaged in a widespread, active
campaign of consumer deception for over 50 years to ensure the longevity of its use in lives—as well
business at the expense of the longevity of its customers. It is difficult to imagine
a more compelling case for consumer and health protection. as in financial
The most effective measures to reduce tobacco use are regulatory in nature. resources that could
Ample evidence shows that policy measures—such as higher tobacco taxes, the
elimination of tobacco promotion, strong health information on tobacco packages, be redirected to a host
and the mandatory implementation of smoke free environments in public places
and workplaces—reduce youth smoking initiation and help smokers quit of other pressing, less
smoking.
While some countries may initially see these policies as being unachievable, it is preventable health
important to consider the costs of inaction. A report released in April 2002 by the US
Centers for Disease Control and Prevention shows that every pack of cigarettes sold problems—are ones
in the US costs that country an estimated $7.18 in medical care costs and lost produc-
tivity, not to mention the 440,000 annual deaths caused by tobacco. The costs of that no country can
tobacco use in lives—as well as in financial resources that could be redirected to a host
of other pressing, less preventable health problems—are ones that no country can afford. This should
afford. This should provide the strength and political will needed for governments
to act. provide the strength
Regardless of the pace and outcome of the FCTC negotiations, PAHO urges and political will
governments to move their domestic legislative tobacco control agendas forward.
We trust that the evidence compiled here will support them in doing so. needed for
governments to act.
George A.O. Alleyne
Director
INTRODUCTION
INTRODUCTION
PAHO/WHO has chosen the approach of a “template” for tobacco control legis-
lation, that is, a proposal for legislative language that will best advance public
health goals, given the evidence of the measures we know to be most effective in
reducing tobacco use.1 As a public health institution that relies on scientific
evidence as the basis for technical cooperation, PAHO/WHO’s first responsibility
is to present the most effective options justified by the evidence, while recog-
nizing that Member States will determine how they wish to respond to the
Research shows that evidence.
the implementation Member States will want to evaluate the applicability of provisions contained in
the template in the context of their legal, social and political environments, and
of a combination obviously will wish to consider particular modifications in light of these. They
also will have to consider their policy priorities in determining which, if not all,
of measures has a aspects of the template they wish to consider at any given time.
greater impact The examples provided draw heavily on existing laws in the common law tradi-
tion of very few countries. This is not meant to be exclusionary or to imply a pref-
than that of each erence for a common law approach. Rather, we tried to gather the best examples
of legislative experience that we could find, with a preference for examples from
of the measures the Americas where they exist. Unfortunately, the most progress in regulating
tobacco has occurred in a handful of countries, most of them within the common
implemented law tradition. As tobacco control continues to progress, we hope to see good
examples from other legal traditions.
in isolation. Although we present a single template law covering a broad range of policy
goals, as many countries have implemented, countries can obviously address
separate policy goals with separate legislative instruments. An advantage of a
step-by-step approach is that governments can move forward in one area while
political support is built for progress in others. However, a multitude of laws and
regulations passed here and there can result in a piecemeal approach to legisla-
tion without a comprehensive vision. A single piece of legislation, with various
measures taking effect within a short time frame, has the advantage of these
measures complementing and enhancing one another. Research shows that the
implementation of a combination of measures has a greater impact than that of
each of the measures implemented in isolation.
We note here that WHO, with the cooperation and input of countries from all
WHO regions, is in the process of developing a more comprehensive “tool kit” to
assist the development of tobacco control legislation. The tool kit will consider
1
Reducing tobacco use refers in this document to preventing initiation, encouraging cessation, and
reducing the amount consumed by those who continue to use tobacco products.
issues more broadly than we present here, and will address in more detail the
process of policy development leading up to legislation, the drafting of legislation
itself, and subsequent implementation and enforcement issues. The current publi-
cation is not intended to replace the forthcoming tool kit, but rather to comple-
ment it.
Finally, we appeal to all who use this template to contact us if you encounter
problems or have suggestions for improvement. No template can be perfect, as
those who have watched tobacco companies manoeuver around “watertight”
provisions know well. We will do our best to accommodate all constructive
comments.
PAHO
Washington, D.C.
May 2002
This publication consists of two major parts. The basic component is the presen-
tation of template legislative language. The second component is an annotation of
the provisions of the template that explains the evidentiary and legislative back-
ground for each provision and, where the provision is drawn from actual legisla-
tion passed by one or more countries, the source of the provision.
It is hoped that these annotations will assist Member States in evaluating the
applicability of various provisions to their policy goals. In addition, we provide
references to the actual laws from which provisions in the template are drawn, to
examples of more detailed regulations, and sources for the evidence described.
Many of the provisions in the template are drawn or adapted from actual laws at
the national or sub-national level. The source of these provisions is cited.
The range of tobacco control issues that can be addressed by legislation is very
broad. In addition to restricting tobacco manufacture, packaging, promotion,
distribution and use, legislation can be used to:
• implement taxation and other fiscal policies that deter tobacco use;
These issues are not addressed here, however their absence from the template
should not be seen as diminishing their importance. Indeed, using fiscal policy to
raise the price of tobacco products is the single most effective measure known to
reduce tobacco use. Additionally, when tax revenue is used to support compre-
hensive evidence-based tobacco control programs, dramatic declines in tobacco
use have occurred. If Member States are interested in these or other avenues to
reduce tobacco use not covered by the template, PAHO/WHO is able to provide
specific technical cooperation upon request. In addition, the following references
are offered as examples.
Section 104350-104495, Health and Safety Code, State of California (USA) (also
known as “Proposition 99”)
http://www.leginfo.ca.gov/cgibin/waisgate?WAISdocID=
47204815307+1+0+0&WAISaction=retrieve
Litigation-Enabling Legislation
Tobacco Damages and Health Care Costs Recovery Act, Province of British Columbia
(Canada)
http://www.legis.gov.bc.ca/2000/3rd_read/gov15-3.htm
Medicaid Third-Party Liability Act, State of Florida (USA)
http://stic.neu.edu/Fl/2florida.htm
General Laws of Massachusetts, Part I, Title XVII, Chapter 118E: Division of Medical
Assistance, State of Massachusetts (USA)
http://www.state.ma.us/legis/laws/mgl/118E-22.htm
The flexible regulatory structure of the template speaks to the need to view the
development of tobacco legislation as an evolving process. For those countries
that are unable to implement all of the proposals simultaneously, a flexible
legislative structure allows for incremental, progressive regulation. However,
even those jurisdictions that implement the “best practices” in all areas of regula-
tion may find that in one, or two, or five years, there are even “better practices”
that could be implemented. Governments will want to update legislation for a
number of reasons, including:
Good legislative • a need to close unintended loopholes;
language is necessary • evaluation of the impact of legislation indicating the need for improvements;
implementation of a Responding to these factors requires at least a basic monitoring system that
enables evaluation of all major elements of the legislation. This monitoring
law. should include a research and surveillance system to track tobacco use (including
initiation and quitting), exposure to second-hand tobacco smoke, and public
knowledge and attitudes. It should also include monitoring of enforcement to
ensure that the law is being implemented consistent with the intentions of legis-
lators. This monitoring will help countries to continually evaluate their legislation
with a view to expanding or strengthening it on a regular basis as needed.
Good legislative language is necessary but is not sufficient to ensure the satisfac-
tory implementation of a law. The process of developing successful legislation
consists of three basic phases: development, implementation, and enforcement.
Development
The development of the content of the law will be guided by various factors, the
most important of which is the broader goals of a country’s tobacco use reduction
strategy. What does the country (or other jurisdiction) wish to achieve, and what
role does legislation/regulation play in achieving these goals? (For example, a
target might be set to reduce tobacco use by a specific percentage within a specific
time period.) This context will inform the initial development of a legislative
proposal.
Public Consultations
The process of public consultation is invaluable in building support for and aware-
ness of a new law and in assisting implementation. Consultation may take the form
of written proposals to which the public can respond, or it can include oral hearings
in which the public or interested parties can express their views. Both of these types
of consultation allow support as well as opposition to be expressed in a transparent
manner.
funds “front groups” with more credibility than themselves to make their argu-
ments. These arguments should not necessarily be dismissed out of hand, but expe-
rience shows that many, if not most, industry arguments rest on false assumptions
or misrepresent experiences in other countries. The duplicity commonly found in
many of these arguments is described in great detail internal tobacco industry
documents.2 Industry opposition to proposals generally falls into the following
broad themes:
2
For example, see: Glantz et al, The Cigarette Papers, University of California Press, June 1996
http://www.library.ucsf.edu/tobacco/cigpapers/, UK House of Commons Health Committee,
Second Report, June 2000
http://www.publications.parliament.uk/pa/cm199900/cmselect/cmhealth/27/2702.htm,
Hammond R & Rowell A. Trust Us: We’re the Tobacco Industry. Campaign for Tobacco-Free Kids
(USA), Action on Smoking and Health (UK), May 2001.
http://www.ash.org.uk/html/conduct/html/trustus.html
3
World Bank. Curbing the Epidemic: Governments and the Economics of Tobacco Control. Washington:
World Bank, 1999. http://www1.worldbank.org/tobacco/reports.htm
Probably the most compelling economic arguments have come from arts and
sports events who receive sponsorships from tobacco companies and who claim Probably the most
that their events will close if tobacco money disappears. Although, as with bill-
board companies, other sponsors have generally stepped in to replace tobacco compelling economic
sponsorships, the emotive arguments of arts groups are difficult to rebut success-
fully. To resolve this political obstacle to eliminating tobacco promotion including arguments have come
sponsorships, some jurisdictions, including the states of Western Australia and
Victoria in Australia have, through legislation, created replacement funds to help from arts and sports
compensate for any losses of tobacco sponsorships.6,7 The Province of Quebec in
Canada has also made funding available to events formerly sponsored by tobacco events who receive
companies that have given up tobacco sponsorship.8
4
Non-Smokers’ Rights Association. Chicken Little brochure. Ottawa: NSRA, 1996.
5
Ibid.
6
State of Western Australia (Australia). Tobacco Control Act 1990, Part 3-Western Australian Health
Promotion Foundation.
http://www.slp.wa.gov.au/statutes/swans.nsf/Current+Legislation+Version2?SearchView
7
State of Victoria (Australia), Tobacco Act 1987.
http://www.dms.dpc.vic.gov.au/l2d/T/ACT01228/2_1.html
8
Grandes manifestations: fini la dépendance au tabac! Tourisme Québec news item.
http://www.tourisme.gouv.qc.ca/mto/publications/tqvi/v4n2/echos/echos.html#manifesta-
tions
9
Mahood G. Canadian tobacco package warning system. Tobacco Control 1995; 4: 10-14.
Communications Strategy
One of the most direct ways in which countries can build support for and assist
the implementation of new legislation is through public education. Many coun-
tries have used communications campaigns to build support for legislation, to
inform stakeholders about the changes to the law, and to independently educate
the public about tobacco as a complementary strategy to change behavior. A
communications strategy is critical to ensure that the government’s aims are
understood, and that communications by opponents of the law do not over-
A communications whelm the debate.
strategy is critical Communications campaigns can be expensive if paid media are used. However,
cost alone should not deter use of paid media as this may save costs during the
to ensure that the implementation and enforcement phases. In any case, communications can also
occur though less costly channels. Public health personnel, the education sector,
government’s aims are nongovernmental organizations and municipalities can be mobilized to dissemi-
nate messages that support the law.11 In addition, news conferences and opinion
understood, and that pieces in the print media provide an avenue for free media coverage. Providing
complete and timely information to the media is central to any communications
communications by strategy. A proactive strategy helps ensures that the debate takes place on govern-
ment terms rather than on terms that provide an advantage to opponents.
opponents of the law The U.S. Centers for Disease Control and Prevention maintains a library of print,
television, and radio ads that have aired in the US (primarily in English although
do not overwhelm the some materials are available in multiple languages). These materials are distributed
without cost on request for viewing purposes, although permission must be
debate. obtained to use them. Details on how to order are found at:
http://www.cdc.gov/tobacco/mcrc/ index.htm
The use of positive language and an emphasis on the positive aspects of the
proposals is very important in a communications strategy. For example, if the
legislation proposes to eliminate smoking in indoor public places such as restau-
rants, the focus could be on the advantages of smoke-free dining, such as the
improved taste, smell and freshness of food, the support for the majority of the
population for smoke-free dining, and the decreased maintenance costs to propri-
etors of smoke-free establishments.
10
Graphic Arts Technical Foundation. An Investigation of Health Warning Labels for Tobacco Packaging:
A GATF Report to Health Canada. Undated.
http://www.hc-sc.gc.ca/hppb/tobacco/bureau/current_research/investigation.html
11
For example, see the Smoke-Free Ottawa web site developed by a nongovernmental coalition in
support of smoke-free public and work places:
http://www.smokefreeottawa.com/english/default.asp
Implementation
Implementation of legislation primarily involves decisions about when and how
the law is implemented. For a provision such as the elimination of tobacco
promotion, implementation may simply be a question of setting a date in the
legislation for the elimination of promotion. However, the implementation of
smoke-free environments will require not only the designation of smoke-free
establishments, but also the posting of required signs. Implementation will be
aided if the government actually provides the signs required by the law to
proprietors of establishments. While this increases costs, it aids enforcement by
eliminating arguments by proprietors that they did not know what was required
or that they were not provided with sufficient guidance. It will require advance
preparations to ensure that all establishments receive the needed number of
signs in advance of coming into force of the law and are given ample time to All stakeholders—
post them.
such as tobacco
All stakeholders—such as tobacco manufacturers and retailers and proprietors of
workplaces and public places— need to be informed of the law and of their obli- manufacturers and
gations under it. Individualized letters, meetings, or public fora can be used for
this purpose. Explanatory materials and guidelines can be developed and retailers and
disseminated. This education is critical to create a sense of fair process and to
encourage compliance. As mentioned above, it will also eliminate the argument proprietors of
that stakeholders were not properly apprised of their obligations.
workplaces and public
Enforcement places— need to be
Legislation should primarily be self-enforcing, particularly if the development informed of the law
and implementation phases have been successfully carried out. However, it is
important for the government to demonstrate its commitment to enforcing the and of their
law. Often, first violations by individuals or businesses receive only a warning in
order to allow time for implementation, and to avoid the appearance of being obligations under it.
draconian. However, after the first few months of coming into force of the law, the
government will have to prosecute offences if it wishes to encourage compliance.
This does not necessarily require a massive enforcement operation, however it
should involve random checks sufficient in number to encourage deterrence, as
well as investigations and appropriate action in response to complaints. In addi-
tion, prosecutions should be high-profile and communicated to the media to
ensure that the public knows that the law is being enforced.
• reviewing tobacco advertising and promotion (for conformity with the law if
any promotion is allowed, and for the existence of any promotional efforts if
promotion is banned);
• checking for the presence and display of health messages on tobacco packages
at point of sale; and
Countries should also enlist the assistance of the public in enforcing the law.
Particularly with regard to sales of tobacco to minors or the enforcement of
smoke-free environments, citizens who support the law can be valuable to
enforcement efforts. Many jurisdictions, particularly at the municipal level, have
Countries should also established a toll-free number that the public can call to report violations of the
law. This greatly reduces the burden of enforcement on inspectors and also
enlist the assistance empowers the public to take responsibility for enforcement of the law, in this case
by asserting their right to breathe indoor air free of tobacco smoke.
of the public in
Meaningful and varied penalties tailored to the offence are critical to providing a
enforcing the law. deterrent effect while not appearing draconian. A variety of enforcement mecha-
nisms can increase the efficiency of enforcement. An alternative to judicial
Particularly with enforcement (court system) is administrative enforcement (provision for hearings
of cases within the Ministry of Health or other designated agency).
regard to sales of Administrative enforcement may enable the resolution of more cases, more
quickly, provided this mechanism is allowed in the legal system of a country and
tobacco to minors or the Ministry of Health has the capacity and political will to conduct such hearings
and enforce appropriate penalties. Finally, a mechanism to recover the costs of
the enforcement enforcement from convicted violators can create a system that is largely self-
financing, and provides a further deterrent to breaking the law.
of smoke-free
environments, citizens
who support the law
can be valuable to
enforcement efforts.
TEMPLATE — PART 1
TOBACCO PRODUCTS CONTROL ACT
(A TEMPLATE)
PART 1
Principles and Purpose
Most laws contain a general statement of the purpose and/or principles of the
law. Although the wording may be general, the purpose of a law provides the
framework within which the law will be implemented and interpreted. In the
context of a legal challenge to a law or its regulations, this framework can play a
critical role. Therefore, words should be carefully chosen and should clearly and
accurately reflect the scope of issues that the government intends to regulate.
Legislative Text
WHEREAS the use of tobacco products constitutes one of the major public health
problems in the world, causing more than one third of all deaths from cancer and
heart disease and responsible for numerous other debilitating and fatal diseases;
WHEREAS most smokers start smoking at a very young age, are not aware of the
extent and nature of the harm caused by tobacco products, and because of the
addictive properties of nicotine are often unable to quit even when they are
highly motivated to do so;
Be enacted by … as follows:-
1. The purpose of this law is to reduce tobacco use and its consequent harm by:
c) ensuring that the population is adequately informed about the risks of tobacco
use and exposure to secondhand tobacco smoke and about the benefits of quit-
ting smoking;
d) ensuring that tobacco products are modified to reduce harm to the extent tech-
nologically and practically possible; and
PART 2
Preliminaries, including Definitions
Definitions are very important in the interpretation of any legal instrument.
Definitions generally should be limited to those terms that have potential for
ambiguous interpretation, or for which the generally accepted dictionary defini-
tion does not adequately reflect the meaning of the term for the purpose of the
law. Clear and unambiguous definitions will greatly assist the efficient imple-
mentation of the law and reduce the likelihood of unanticipated loopholes.
Legislative Text
(Note: The proposed detailed definition of “brand element” derives from the need
for a broad and clear definition of how indirect promotion of tobacco products and
brand names might occur. Experience from numerous jurisdictions demonstrates
the reasonable ease with which tobacco companies have been able to circumvent
definitions that, on the face of it, appeared to be broad and “water-tight.” For
example, many tobacco advertisements in the US and elsewhere use partially
obscured brand names or logos. However, these partial representations are still
recognizable as belonging to the particular tobacco brand. Many commentators
have suggested that tobacco companies are using these partial representations in
anticipation of future restrictions on promotion of brand names. The definition
above would guard against this particular loophole as well as many others.)
12
Adapted from Government of Canada, Tobacco Act. Chapter T-11.5 (1997, c. 13)
http://www.cctc.ca/CCTCLAWweb.nsf/MainFrameSet?OpenFrameSet and from the United
States Food and Drug Administration’s Draft Rule on Regulating Tobacco Products, 1996.
distribute means to sell, offer to sell, expose for sale, give, supply exchange,
convey, consign, deliver, furnish, or transfer possession for commercial
purposes, or offer to do so, whether for a fee or other consideration or as a
sample, gift, prize, or otherwise without charge;
(Note: If individual packages are required to carry health messages while other
packaging, such as cartons containing multiple packages, is not, retailers and
manufacturers will increasingly display containers without the message require-
ments. This would diminish the impact of health messages.)
13
Adapted from Government of Canada, Tobacco Act, op cit.
14
Government of Canada, Tobacco Act, op cit.
15
Adapted from Government of Canada, Tobacco Act, op cit.
16
Adapted from New Zealand Smoke-free Environments Act 1990 108
http://www.govt.nz/nzgovt/leg.php3 and from United States Food and Drug Administration
Draft Rule, op cit.
17
Adapted from Government of Canada, Tobacco Act, op cit.
(Note: A broad definition of tobacco products is advisable for several reasons. First,
it ensures that all tobacco products are treated equally under the law, reducing the
potential for a shift by consumers to products that are less regulated, and that are
therefore more appealing and accessible than cigarettes, and preventing a shift by
manufacturers to the promotion of products with less stringent regulations.
Second, a broad definition eliminates the need to amend the law every time a new
form of tobacco product comes on the market. Finally, the inclusion of products
used in combination with tobacco products eliminates a loophole that has been
exploited in the past, which is the promotion of these related products (for example
cigarette papers) without regard to promotional restrictions or health messages.)
toxicity refers to the quality, relative degree or specific degree of being toxic or
poisonous;
(Note: The age of 18 is used here as a marker; obviously countries will wish to set
an age consistent with other national laws and taking into account national norms.)
PART 3
Just as manufacturers Product Regulation
This part of the act addresses regulation of the tobacco product itself, including
design tobacco the ability to require disclosure of ingredients to consumers and to set standards
for the composition and design of tobacco products.
products to sell them,
legislative
Rationale
requirements can
Tobacco products, and particularly cigarettes, are highly engineered and sophis-
force manufacturers to ticated products.18 Their ingredients and design features can be and are manipu-
lated by manufacturers in ways that affect their safety, appeal, and addictiveness.
make tobacco products For example, the pH level of smoke affects how easily nicotine is absorbed in the
mouth or lungs.19 Tobacco company researchers have also discussed the need for
in a way that reduces “low irritation” cigarettes in response to the “impediments to starting smoking
tracing to a physical intolerance at early experiences.”20 Of course, since most new
their appeal to smokers are children and adolescents, this really refers to the problem of kids
getting sick from smoking their first cigarettes.
children, decreases Just as manufacturers design tobacco products to sell them, legislative require-
ments can force manufacturers to make tobacco products in a way that reduces
their addictive their appeal to children, decreases their addictive qualities, and decreases poten-
tial harm to users. In addition, consumers have a right to know the ingredients in
qualities, and
decreases potential
18
World Health Organization. Monograph: Advancing Knowledge on Regulating Tobacco Products, 2001.
harm to users. http://tobacco.who.int/page.cfm?sid=67
19
United States Food and Drug Administration Draft Rule, op cit.
20
Project Viking, Volume III: Product Issues. The Creative Research Group Limited for Imperial
Tobacco Limited, April 1987.
tobacco products and in tobacco smoke. This information can help them make
more informed decisions about starting or quitting smoking.
Legislative Text
6. No person shall sell, offer for sale, distribute, advertise or promote any brand
of tobacco products that was not sold, distributed, advertised or promoted in
the country at least one year before the effective date of this Act.23
(Note: The introduction of new varieties of tobacco products into the market has
been associated with increased uptake among specific population groups, such as
women and children. This clause prevents the proliferation of new brands and vari-
eties of tobacco products during discussion of and after passage of the legislation.)
ii) prescribing substances that may not be added to tobacco products; and
iii) prescribing product design standards to reduce the harmful effects of
tobacco products and to reduce their appeal to youth.
21
Adapted from Government of Canada, Tobacco Act, op cit.
22
Adapted from Government of Canada, Tobacco Act, op cit.
23
Adapted from United States Food and Drug Administration Draft Rule, op cit.
24
Adapted from Government of Canada, Tobacco Act, op cit.
PART 4
Packaging and Labeling
This part of the act addresses the labelling and packaging of tobacco products,
including information that may be required on the package (such as health and
ingredient information), as well as information that is prohibited on the package
(such as misleading descriptors and brand names).
Rationale
The tobacco package provides a potent vehicle for tobacco promotion, and has
increased in importance within the “marketing mix” as other forms of promotion
are restricted.25 Aside from the obvious visibility of packages to smokers every
time they light a cigarette, in most countries, tobacco retailers are paid by tobacco
PART 4
Youth are known to use packages and brands as symbols of the image that they would
display becomes a like to project to the outside world, whether that image is one of femininity, adventure,
or sex appeal.32 Health information on packages detracts from the glamour and appeal
valuable vehicle for of the colorful brand images with factual, graphic information about the not-so-glam-
ourous consequences of tobacco use.
health promotion
25
Tobacco International March 1, 1991: 14.
messages. 26
Feighery EC et al. Cigarette advertising and promotional strategies in retail outlets: results of a
statewide survey in California. Tobacco Control 2001;10:184-188.
27
Mahood G. Warnings that tell the truth: breaking new ground in Canada. Tobacco Control
1999;8:356-362.
28
Environics Research Group Limited. The Health Effects of Tobacco and Health Warning Messages on
Cigarette Packages, February 2001. http://www.hc-sc.gc.ca/hppb/tobacco/bureau/current_
research/index.html
29
Environics Research Group Limited. Evaluation of New Warnings on Cigarette Packages, January
2002. http://www.ontario.cancer.ca/Siteboth/English/cigarette_package_warnings.asp
30
Australia, Brazil and Canada have printed toll-free numbers on tobacco packages for smokers to
call for advice on quitting.
31
Canada requires more detailed messages on the inside slides of packages.
32
House of Commons. Towards Zero Consumption: Generic Packaging of Tobacco Products. Report of
the Standing Committee on Health. Ottawa, June 1994.
Note that the definition of tobacco packaging provided in the definitions section
would ensure that cartons or other containers displayed for sale would carry
health warnings. Therefore, whatever container tobacco products are sold in,
health messages would be visible to the consumer when tobacco products are
displayed.
Also note that warnings will need to be described in great detail through regula-
tion in order to ensure that they appear the way the government intends.
For examples of the packaging regulations from Brazil and Canada and for
visuals of the health messages please refer to:
Legislative Text
(Note: This clause would cover misleading terms such as “light,” “low-tar” and
“mild,” however for greater clarity governments may wish to issue regulations
specifying terms that are prohibited.)
10. Any requirements arising from the above-mentioned clauses, do not relieve a
manufacturer or retailer of other obligations or liabilities arising from other
applicable legal norms to warn consumers of the risks of using tobacco prod-
ucts.38
36
Adapted from Government of Canada, Tobacco Act, op cit.
37
Ibid.
38
Ibid.
PART 5
Advertising and Promotion
This part of the act proposes a prohibition on all promotion of tobacco products
through direct and indirect means, including advertising, sponsorships, give-
aways, discounts, displays at point of sale, and promotion of tobacco brand
PART 5
names through non-tobacco items or through venues.
Rationale
The extent of promotion of tobacco products influences the level of tobacco use Partial restrictions
both in the general population and in particular target groups.40 In addition,
promotion has been associated specifically with smoking initiation among are difficult to define
youth.41, 42 A study of more than 100 countries showed that countries with compre-
hensive restrictions or bans on tobacco promotion have lower levels of tobacco and enforce, and have
use than countries with weak or no restrictions on tobacco promotion. The same
study found that in order for restrictions to have an impact, they need to be total often resulted in
or near-total, and that weak restrictions have little or no impact on tobacco use.43
unforeseen loopholes.
The experience of many countries graphically illustrates why this is so. Partial
restrictions are difficult to define and enforce, and have often resulted in unfore-
seen loopholes.44 When tobacco promotion is restricted in one medium, such as
billboards, companies simply increase the level of promotion in another. For
example, in the United States, in 1998 the tobacco companies agreed under a legal
settlement to eliminate outdoor advertising and advertising targeted at youth.45
39
Ibid.
40
An excellent review of the evidence is found in Hammond R. Tobacco Advertising and Promotion:
The Need for a Coordinated Global Response. Paper prepared for the WHO International Conference
on Global Tobacco Control Law: Towards a WHO Framework Convention on Tobacco Control. 7-
9 January 2000, New Delhi. http://tobacco.who.int/repository/tld94/ROSS2000X.doc
41
Pierce JP, Gilpin EA and Choi WS. Sharing the blame: smoking experimentation and future
smoking-attributable mortality due to Joe Camel and Marlboro advertising and promotions.
Tobacco Control 1999;8:37-44.
42
Pierce JP et al. Tobacco industry promotion of cigarettes and adolescent smoking. JAMA February
18, 1998;279(7),511-15.
43
Curbing the Epidemic. Op cit.
44
Cunningham R. R.J.R.-MacDonald Inc. v. Canada (A.G.): Reflections from the Perspective of
Health. McGill Law Journal 1995 40, 229-267. http://journal.law.mcgill.ca/arts/401cunni.pdf
45
Master Settlement Agreement with the Tobacco Industry. National Association of Attorneys General.
http://www.naag.org/tobac/cigmsa.rtf
However, three years later the companies were spending even more money on
promotion than they did before the settlement, with an increase in advertising in
youth publications and a shift in advertising from outdoor to other media.46, 47
Even when all direct advertising has been prohibited, companies have success-
fully used other promotional tactics, such as sponsorships, distribution of
tobacco-branded non-tobacco items such as t-shirts and hats, the tobacco-brand
naming of bars, restaurants and other establishments, and massive displays of
cigarettes at retail outlets, to promote their products.
Constitutional Considerations
Despite the difficulties involved with partial advertising restrictions,
some countries believe that a total prohibition on tobacco promotion
would violate their constitutions. It is likely that tobacco companies
will threaten to or actually mount a constitutional challenge to any
promotional restrictions that they perceive may reduce sales. This
does not mean that the challenges are always valid or that they will
succeed. However, countries will need to evaluate their constitutions
carefully to determine whether or not they may be limited in imple-
menting a ban on promotion. To be certain that they protect the public
health as much as possible, they may wish to should test the limits of
the constitution by implementing a total ban and defending it in
court.
46
King C & Siegel M. The Master Settlement Agreement with the Tobacco Industry and Cigarette
Advertising in Magazines. The New England Journal of Medicine, August 16, 2001, 345, 504-511.
http://content.nejm.org/cgi/content/abstract/345/7/504
47
Wakefield M et al. Changes at the Point-of-Sale for Tobacco Following the 1999 Tobacco Billboard
Ban. Research Paper Series, No. 4. ImpacTeen. July 2000.
http://www.tobaccofreekids.org/reports/stores/
48
Curbing the Epidemic, op cit.
Legislative Text
12. No person shall promote or cause to promote by any other person, a tobacco
product or a tobacco product-related brand element through direct or indirect
means, including through sponsorship of an organization, service, physical
establishment or vehicle of any kind, or event.49
12. No person shall promote or cause to promote by any other person, a tobacco
product or a tobacco product-related brand element, except as prescribed by
this Act or its regulations.
13. Notwithstanding any regulation made under this Act, no person shall
promote or cause to promote tobacco products or brand elements:
e) utilizing any athletic, musical, artistic or any other social or cultural event, or
any entry or team in any event, in the brand name (alone or in conjunction
49
Adapted from United States Food and Drug Administration Draft Rule and from New Zealand
Smoke-free Environments Act, op cit.
50
Ibid.
51
Province of British Columbia (Canada) Tobacco Sales Act [RSBC1996] Chapter 451
http://www.cctc.ca/ncth/docs/legislation/ncthproj/docs/bc/451e.html
52
Adapted from United States Food and Drug Administration Draft Rule, op cit.
15. No person shall offer or provide any consideration, direct or indirect, for the
purchase of a tobacco product, including a gift to a purchaser or a third party,
bonus, premium, cash rebate or right to participate in a game, lottery or contest,
or distribute a tobacco product without monetary consideration, or in consider-
ation of the purchase of a product or service or the performance of a service.56
(Note: Subclauses a), b) and c) below are not necessary in the case of a total prohi-
bition.)
53
Adapted from United States Food and Drug Administration Draft Rule, op cit.
54
Adapted from United States Food and Drug Administration Draft Rule, op cit.
55
Adapted from New Zealand Smoke-free Environments Act, op cit.
56
Adapted from Government of Canada, Tobacco Act, op cit.
PART 6
Distribution
This section addresses the minimum age of persons who can legally buy or sell
tobacco products, the size of packages in which tobacco products can be distrib-
uted, the places where tobacco products can be sold, and the way in which prod-
ucts can be displayed at retail.
Rationale
Sales to young persons. This part covers a wide range of topics. The first, elimina-
tion of tobacco sales to and by young people, is a common provision of tobacco
control laws. However, the evidence supporting the effectiveness of this measure
in reducing tobacco use by youth is limited. It has been determined that, in order
PART 6
for this measure to even minimally impact tobacco use, compliance with the law
needs to be nearly 100%.57 This speaks to a need for an effective enforcement
strategy to support this provision. The provisions here are designed to maximize
ease of enforcement by setting clear standards of defense and specifying the types
of identification necessary to establish proof of age.
Limitations on package or unit size. The second type of measure proposed in this
section is regulation of the quantity in which tobacco products can be sold. The
main problem prompting this measure is the sale of single cigarettes and small
packages (defined here as fewer than 20 cigarettes), which makes tobacco more
affordable for youth. However, sales of cigarettes in larger quantities may also
promote tobacco use. Many smokers smoke a pack a day. As standard pack sizes
increase beyond 20 cigarettes, smokers may smoke more cigarettes per day in
relation to pack size. In Australia, where tax advantages have led manufacturers
to produce packs of as many as 50 cigarettes, researchers found that adults
favouring packs of 40 or 50 cigarettes smoked almost twice as many cigarettes
each day as smokers favouring packs of 20.58 Among children aged 12-17, the
correlation between pack size preference and number of cigarettes smoked per
day was even more marked.59
However, in countries where sales of single cigarettes are the norm, minimum
packs of ten may be seen as an improvement. Therefore, the template proposes
flexibility with regard to setting minimum and maximum quantities/sizes for
sale of tobacco products.
57
DiFranza J. Active enforcement of minors’ access laws: a moral and ethical imperative. Tobacco
Control 1995; 4:5.
58
Hill D White V and Scollo M. Smoking behaviours of Australian adults in 1995. Medical Journal of
Australia 1992; 168.
59
Hill D White V and Segan C. Prevalence of cigarette smoking among Australian secondary
school students in 1993. Australian Journal of Public Health 1995;195:445 –449.
Location of sale. The third issue dealt with in this part is the locations where the
sale of tobacco products is allowed. The rationale for this is twofold. First, certain
types of institutions are seen as having the responsibility to promote a healthy
environment, and from this perspective the sale of tobacco products in these insti-
tutions undermines their mandates and responsibilities. Second, from a very
practical perspective, reducing the types of institutions that sell tobacco facilitates
enforcement of various tobacco control measures. Some jurisdictions, for example
the Province of Ontario in Canada, have successfully regulated place of sale.60 An
emerging concern is the sale of tobacco products through mail and the Internet,
as it is impossible to establish the age of the purchaser through these channels.
is the sale of tobacco Displays. Two issues related to the display of tobacco products are addressed here.
First, self-service displays, including the use of vending machines to sell tobacco
products through mail products, are prohibited in the template. These modes of sale may become a
preferred method of obtaining cigarettes when restrictions against tobacco sales to
and the Internet, as it minors are enforced. Youth worried about being asked for I.D. can obtain tobacco by
stealing it from self-service displays.61 Internally, tobacco companies acknowledge
is impossible to that stealing (“pilferage”) from self-service displays is a problem, but they try to
convince retailers to keep self-service displays by arguing that product placement
establish the age of fees more than compensate for losses from theft. They also acknowledge that a move
from self-serve to non self-serve displays results in sales declines.62
the purchaser through The visible public display of products for sale is also prohibited in the template,
although retailers may post signs indicating that tobacco products are sold there,
these channels. the brands available, and their prices. The display of tobacco products at point of
sale is an important paid vehicle of promotion for tobacco manufacturers.63
Tobacco product displays become even more important and conspicuous when
other promotional vehicles are eliminated, and provide a tempting display to
encourage youth and smokers who are trying to quit to purchase tobacco prod-
ucts. The States of Victoria and Tasmania in Australia have restrictions on the
display of tobacco products,64, 65 and the Province of Saskatchewan in Canada has
60
Province of Ontario (Canada), Tobacco Control Act, 1994, Statutes of Ontario, 1994, Chapter 10.
http://www.cctc.ca/ncth/docs/legislation/ncthproj/docs/on/tc94-10e.html
61
DiFranza J and Coleman M. Sources of tobacco for youths in communities with strong enforce-
ment of youth access laws. Tobacco Control 2001;10:323-28.
62
RJReynolds. Pilferage Presentation. 1985. http://www.rjrtdocs.com/rjrtdocs/summarydisplay.
wmt?z=1&tab=search&SEARCH=3&stab=summary
63
Campaign for Tobacco-Free Kids. Tobacco Marketing that Reaches Kids: Point-of-Purchase Advertising
and Promotion. Fact Sheet. 28 June 2001.
http://www.tobaccofreekids.org/research/factsheets/pdf/0075.pdf
64
State of Victoria (Australia) Tobacco Act 1987, op cit.
65
State of Tasmania (Australia) Public Health Act 1997 (No. 86 of 1997).
recently banned the display of tobacco products for sale in places where young
persons are allowed to enter.66
Signage. Finally, the law allows for the government to require the posting of signs
at retail. Signs are an important component of law enforcement and retailer
education, but they can also be used to educate the public. The most effective
signs are those that not only clarify the law, but also inform the public about
addiction and other health effects. For example, a sign that simply says, “It is
against the law to sell tobacco to youth” may actually send a subtle message that
tobacco use is an adult behavior, making it even more tempting for youth to try
to purchase cigarettes. However, a strong visual combined with an educational
message, such as “Tobacco products addict and kill. We want to prevent the next
generation from making the mistakes we did. We don’t sell to minors,” sends a
stronger and probably more effective message. For an example of innovative
signage, refer to the requirements in the Province of New Brunswick in Canada,
available at: http://www.cctc.ca/CCTCLAWweb.nsf/MainFrameSet?Open
FrameSet
Tobacco manufacturers have run numerous retail campaigns ostensibly aimed Tobacco product
against preventing the sale of tobacco to minors. However, these campaigns do
not promote the enforcement of laws, and have been evaluated to be ineffective.67 displays become even
In addition, signs from these campaigns distract from more effective signs that a
government jurisdiction would like to put in place. The template includes a more important and
clause banning the posting of signs regarding age of legal sale other than those
approved by the government. conspicuous when
other promotional
Legislative Text
vehicles are
17. No person shall sell or offer to sell tobacco to a person who is less than [insert
age] years old.68 eliminated, and
18. It shall not be a defense to the above-mentioned clause that the person provide a tempting
appeared to be [insert age] years old or older.
19. It shall be a defense to clause 17, that the purchaser presented a prescribed
display to encourage
form of identification showing his or her age and that there was no apparent
reason to doubt the authenticity of the document or that it was issued to the
youth and smokers
person producing it.69
who are trying to quit
20. Nothing in this section prevents a person from giving tobacco or a tobacco-
related product to a young person if the gift is made solely for use in tradi- to purchase tobacco
tional Aboriginal spiritual or cultural practices or ceremonies.
products.
(Note: Tobacco use is an integral component of the spiritual practices of peoples
native to North America and may be a component of other traditions. This use of
66
Province of Saskatchewan (Canada), The Tobacco Control Act, Bill No. 56 of 2001
http://www.qp.gov.sk.ca/publications/index.cfm?fuseaction=details&c=117363&id=2
67
DiFranza JR Savageau JA and Aisquith BF. Youth access to tobacco: The effects of age, gender,
vending machine locks and "It’s the Law" programs. American Journal of Public Health
1996;86:221-4.
68
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
69
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
tobacco is not typically in the form of manufactured cigarettes, and the practice
does not condone the regular use of tobacco as smoked in manufactured form.)
21. No person shall sell or offer to sell tobacco products except in a package
containing the quantities or number of units prescribed by regulation.70
22. No person shall sell or offer to sell tobacco products in a place other than
those prescribed by regulation.71
23. Notwithstanding any regulation made under this Act, no person shall sell or
offer to sell tobacco products in the following places:
24. No person shall sell or offer to sell a tobacco product unless it is hidden from
view of the general public at point of sale.72
25. Notwithstanding Section 24, retailers may post signs indicating that tobacco
products are available for sale, the specific products or brands available for
sale, and their respective prices, provided that brand elements are not visibly
displayed.
26. No person shall sell or offer to sell a tobacco product by means of a display
that permits a person to handle the tobacco product before paying for it.73
27. No person shall sell or offer to sell tobacco products through a vending
machine.74
28. No person shall sell or offer to sell tobacco products through the mails or
through the Internet.
29. No person shall sell or offer to sell tobacco at retail unless signs bearing
health warnings and other information are posted at the place in accordance
with the regulations.75
70
Adapted from Government of Canada, Tobacco Act, op cit.
71
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
72
Adapted from Province of Saskatchewan (Canada), The Tobacco Control Act, op cit.
73
Adapted from Government of Canada, Tobacco Act, op cit.
74
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
75
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
PART 7
PART 7
Use
This section regulates the places where tobacco products can be smoked. The scientific
community is united
Rationale
in its conclusion that
The scientific community is united in its conclusion that exposure of nonsmokers
to tobacco smoke causes serious harm and even death from a variety of causes.77 exposure of
It is also known that there is no known “threshold” or safe level of exposure to
tobacco smoke, and that the mere separation of smokers and nonsmokers within nonsmokers to tobacco
the same airspace does not protect nonsmokers from harm regardless of the venti-
lation system used.78, 79 Therefore, strictly from a standpoint of health protection of smoke causes serious
nonsmokers, there is a strong case for implementing smoke free environments in
every sector possible. harm and even death
However, there is an additional benefit of smoke free environments: they are one from a variety of
of the most effective ways to reduce smoking. Smoke free environments
encourage prevention of smoking initiation by striking at the heart of the social causes.
acceptability of tobacco, and they promote smoking cessation more effectively
76
Adapted from Province of Saskatchewan (Canada), The Tobacco Control Act, op cit.
77
See, for example, National Cancer Institute. Health Effects of Exposure to Environmental Tobacco
Smoke: The Report of the California Environmental Protection Agency. Smoking and Tobacco
Control Monograph No. 10. Bethesda, MD: US Department of Health and Human Services,
National Institutes of Health, National Cancer Institute, NIH Pub. No. 99-4645, 1999
http://cissecure.nci.nih.gov/ncipubs/details.asp?pid=200; World Health Organization.
International Consultation on Environmental Tobacco Smoke (ETS) and Child Health:
Consultation Report, Geneva, 11-14 January 1999. (and related background papers)
http://tobacco.who.int/page.cfm?sid=50
78
Repace JL and Lowrey AH. Issues and answers concerning passive smoking in the workplace:
rebutting tobacco industry arguments. Tobacco Control 1992;1:208-219.
79
Americans for Nonsmokers’ Rights. Smoking and Ventilation Standards. (fact sheet), October 15,
1998. http://www.no-smoke.org/vent.html
Smoke free environments also offer economic advantages: They lower the costs of
health and fire insurance and of maintenance costs, create more productive workforces
by offering a safer, healthier working environment, and in many cases may increase
business (for example, in the hospitality sector).82
Many jurisdictions, usually as a compromise to ensure passage of legislation, Examples of nonsmoking signs
have allowed some locations (most often bars or restaurants) to have enclosed, from the Pan American Health
separately ventilated smoking areas. We have rejected this option in the template Organization, the Province of
for several reasons. First, this option creates enforcement difficulties because Ontario in Canada, and Costa
adherence to technical standards needs to be monitored. Second, these smoking Rica.
areas increase harm to smokers, and also put at risk workers who may be
required to enter them. They may also not adequately protect nonsmokers
because of drifting smoke as entrances are opened. Finally, in many countries
separate ventilation systems are economically unfeasible and therefore impractical.
In the end, countries may find as much support for totally smoke free environments
as for separately-ventilated areas. In some jurisdictions, small businesses have
supported the smoke free option, because separate ventilation systems are expen-
sive and are advantageous to larger, wealthier businesses.
Legislative Text
32. No person shall smoke tobacco or hold lighted tobacco in enclosed, indoor
areas of any private or public work place, or any public place.86
33. For the purpose of this Act, private or public work places and public places
include inter alia the following:
b) factories;
86
Adapted from Province of Ontario (Canada), Tobacco Control Act, op cit.
c) health institutions;
i) cinemas;
j) concert halls;
k) sports stadia;
PART 8
34. All private and public workplaces and public places shall post signs, in
accordance with regulations, that clearly indicate that the establishment is
smoke free.
35. The Minister/Government may make regulations:
PART 8
Measures to Combat Smuggling
This section covers provisions designed to reduce distribution and sales of contra-
band tobacco products.
Rationale
87
Joossens L and Raw M. Smuggling and cross border shopping of tobacco in Europe. British
Medical Journal 1995;310:1393-7.
ability of cheap tobacco products, and strains the law enforcement resources of all
levels of government.
In recent years, primarily through the release of internal tobacco industry docu-
ments, a compelling story has emerged of the apparent involvement of multina-
tional tobacco companies in facilitating smuggling through distribution networks
deliberately established to supply the contraband market.89 This story is suffi-
ciently compelling that several countries, including Colombia, Ecuador and
Canada in the Americas, have launched lawsuits against tobacco companies to
recover lost tax revenue and enforcement costs, although most have been
dismissed at lower court levels on technicalities. There is a
The provisions in the template focus on two strategies: misperception that
• Eliminating the immediate tax advantage of exporting tobacco products by
requiring exporters of tobacco products to post bonds until they prove that smuggling is a result
the tobacco products have reached their purported legal destination. If prop-
erly implemented, this would provide a positive incentive for manufacturers of high taxes on
to ensure legal distribution of their products because they would assume a
financial risk for products that end up as contraband. tobacco products.
• Implementing ways of tracking and tracing the chain of custody of tobacco However a much
products so that the point at which the distribution becomes illegal can be
more easily identified and those responsible for selling to unauthorized better indicator of
distributors prosecuted. The specific means of tracing are left open to regu-
latory authority to allow flexibility to update requirements based on techno- the level of smuggling
logical advances.
is the level of
Legislative Text corruption in a
36. Bond required for exported tobacco products. country as measured
a) No tobacco product shall be exported from [specify country name] without by the so-called
the posting by the manufacturer or exporter of a bond for each shipment
with the [specify Ministry or agency] in an amount [describe how the bond “transparency index.”
amount will be determined] and containing the following information and
documents, as applicable:
88
Curbing the Epidemic, op cit.
89
Beelman M Ronderos MT and Schelzig EJ. Major tobacco multinational implicated in cigarette
smuggling, tax evasion, documents show. The Public I: An Investigative Report of the Center for
Public Integrity. March 23, 2000.
II. the name, license number, address, telephone, and telefax numbers
of the exporter, including the country of export;
III. the name, license number, address, telephone, and telefax numbers
of the importer/purchaser, and any person who receives the ship-
ment on the importer/purchaser’s behalf;
IV. the name, address, telephone, and telefax numbers of the intended
carrier(s) of the shipment and the means of transport;
V. the names of the cities and countries through which the shipment
will be transported;
VII. the name, license number, address, telephone, and telefax numbers
of any distributors and other intermediaries handling the ship-
ment;
VIII. the date of the shipment, the period of time over which the ship-
ment is to be in transit, the date of expected arrival in the country
of final destination, and the itinerary correlated with dates of entry
and exit for each point of entry and exit;
IX. physical description of the products (e.g., cigarettes, cigars, bidis,
smokeless tobacco, etc.) shipped, including lot, batch or serial
numbers of all products contained in the shipment;
iii. he or she has complied with all labeling and other legal
requirements; and
b) The bond made pursuant to subsection (a) shall be forfeited unless the
manufacturer or exporter, as applicable, provides [specify Ministry or
agency] with the following information within [specify number] days of
[specify triggering event (e.g., the date the goods are shipped)]:
I. evidence of the chain of custody and proof that all goods reached
their final destination without any product being sold or distrib-
uted without the full payment of all applicable duties, including
but not limited to:
37. The Minister may make regulations under this Part to establish requirements
that enable the tracking and tracing of tobacco products through the distri-
bution chain from manufacture to the point where all relevant duties and
taxes have been paid, for the purpose of assisting competent law enforce-
ment authorities in detecting and investigating illicit manufacture and distri-
bution of tobacco products and identifying those responsible for illegal
activity. These requirements may include but are not limited to the use of:
PART 9
Enforcement, Inspection, Offences and Punishments
Rationale
The enforcement provisions of any law play a large part in determining the
success of implementation of the law. If the provisions of the law are unenforced,
or if they are understood to be unenforceable, they become nothing more than
words on paper. Effective enforcement consists of four basic components:
• penalties for violation of provisions of the law that are sufficiently serious to
If the provisions deter violations;
of the law are • an enforcement process that allows for effective prosecution of violations,
including adequate powers of inspection and reasonable burden of evidence;
unenforced, or if and
to be unenforceable, The first three of these are influenced primarily by the content of the law. Other
enforcement and implementation issues are discussed in the introduction.
they become nothing
The template language provided generally proposes a two-tiered penalty system
more than words with a higher level of penalties for manufacturers and large institutions than for
individuals and smaller institutions. This is because different levels of penalties
on paper. are deterrent for individuals versus manufacturers, and because violations by
manufacturers or other larger institutions have a greater impact on the effective-
ness of the law than those by individuals.
Obviously, the template cannot suggest particular levels of fines appropriate for
each country. However, countries should ensure that the penalties are sufficiently
high to produce a deterrent effect, and should be at least as great as the benefit
gained from the illegal activity. For example, if a retailer can make more money
from selling tobacco to minors than he or she has to pay in penalties within the
same time period, there is very little deterrent effect.
Legislative Text
38. For the purpose of this Act the Ministry/Government may appoint any
person or designate any class of persons to perform the duties of inspector or
analyst. The responsibilities of an inspector shall be specified in the act of
appointment.90
90
Adapted from Province of Quebec (Canada), Tobacco Act, Bill 444 (1998, chapter 33)
40. Authorized inspectors and analysts shall have the following powers, which
no person shall deny, obstruct, or hinder:
f) to stop, search, and detain any aircraft, ship, vehicle or other means of
transport or storage in which the authorized officer reasonably believes
tobacco products are contained or conveyed and examine, open, take
samples of and have tested any tobacco products or product components
found therein; and
91
Ibid.
41. An inspector or analyst entering a place to inspect it under this chapter must,
on request, provide the operator of the place with proof of identity and
produce a certificate or appointment signed by the Minister, or by a person
designated in accordance with the regulations.92
42. An inspector may not enter a dwelling-place except with the consent of the
occupant or under the authority of a warrant issued in accordance with
section … of the Criminal Code.93
43. No person shall hinder in any way the performance of the duties of an
inspector or analyst, mislead them by concealment or false statements, or
refuse to provide them with any information or document to which they are
entitled under this Act, or destroy any such information or document.94
44. During an inspection under this Act, an inspector may seize any tobacco
product or other thing by means of which or in relation to which the inspector
believes on reasonable grounds that this Act has been contravened.95
45. Any person found guilty of violating any provision under Part 3 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences; and
b) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
46. Any person found guilty of violating any provision under Part 4 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences; and
b) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
47. Any person found guilty of violating any provision under Part 5 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences; and
92
Ibid.
93
Adapted from Government of Canada, Tobacco Act, op cit.
94
Province of Quebec (Canada), Tobacco Act, op cit.
95
Adapted from Government of Canada, Tobacco Act, op cit.
b) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
48. Any person found guilty of violating any provision under Part 6 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences;
b) in the case of the proprietor of a retail establishment, not less than $xxx
and not more than xxx for the first offence, and of not less than xxx and
not more than xxx for subsequent offences; and
c) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
49. Any proprietor, owner, and/or manager of any premise listed under Part 7
of this Act found guilty of failing to enforce the smoke-free policy applicable
to the facility under his or her responsibility, including the posting of
prescribed signs and ensuring that any designated smoking areas meet the
requirements of the Act and its regulations, shall be liable for a fine of not less
than xxx and not more than xxx for the first offence, and of not less than xxx
and not more than xxx for subsequent offences.
50. Any person found guilty of smoking in a place where smoking is prohibited
under Part 7 of this Act shall be liable for a fine of not less than xxx and not
more than xxx for the first offence, and of not less than xxx and not more than
xxx for subsequent offences.
51. Any person found guilty of violating any provision under Part 8 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences;
b) in the case of a proprietor of a retail establishment, not less than $xxx and
not more than xxx for the first offence, and of not less than xxx and not
more than xxx for subsequent offences;
c) in the case of a wholesale distributor, not less than $xxx and not more
than xxx for the first offence, and of not less than xxx and not more than
xxx for subsequent offences;
d) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
52. In addition to any fines imposed, any person found guilty of violating any
provision under Part 8 of this Act shall be liable for a penalty equivalent to
the proceeds from the distribution of illegal tobacco products as well as taxes
and duties owed on those products.
53. Nothing in this Act shall preclude the criminal enforcement of its provisions
in a Court of competent jurisdiction.
(Note: This clause, as well as clause 52 above, are included to, among other
things, provide a higher deterrent to smuggling, which can bring enormous
profits to smugglers that may exceed “normal” penalties under the law. In addi-
tion, in acknowledgement of the criminal nature of illegal distribution of tobacco,
wider prosecutory powers are granted that would allow penalties other than
solely financial ones.)
54. Where a person is found guilty of an offence under any part of this Act other
than Part 8, the judge may impose an additional fine in addition to any other
penalty, following an application by the prosecuting party appended to the
statement of offence, equal to the amount of monetary benefit gained by the
person as a result of the offence, even if the maximum fine is imposed under
another provision.
PART 10
55. A person who commits or continues an offence under this Act on more than
one day is liable to be convicted for a separate offence for each day on which
the offence is committed or continued.
56. Any person found to have violated any requirement under this Act or imple-
menting regulations may be ordered to pay the reasonable costs associated
with any inspection, investigation, and enforcement action brought about by
the noncompliance.
PART 10
Final Clauses
Legislative Text
58. This Act shall come into force no later than one year [or specify other time
period] following its passage into law.
ANNEX 1
Consolidated Template Without Notes
Tobacco Products Control Act
(A Template)
PART 1
Principles and Purpose
WHEREAS the use of tobacco products constitutes one of the major public health
problems in the world, causing more than one third of all deaths from cancer and
heart disease and responsible for numerous other debilitating and fatal diseases;
WHEREAS smoke from tobacco products is a serious health threat to nonsmokers
exposed to the smoke, causing serious diseases in adults, and particularly in children;
WHEREAS most smokers start smoking at a very young age, are not aware of the
extent and nature of the harm caused by tobacco products, and because of the
addictive properties of nicotine are often unable to quit even when they are
highly motivated to do so;
WHEREAS the marketing of tobacco products though product design, promo-
tion, packaging, pricing and distribution, is known to contribute to the demand
ANNEX 1
for tobacco products,
Be enacted by… as follows:-
An Act to regulate the manufacture, labeling, promotion, distribution, and use of
tobacco products
1. The purpose of this law is to reduce tobacco use and its consequent harm by:
a) protecting children and other nonsmokers from inducements to use
tobacco;
b) protecting nonsmokers from exposure to tobacco smoke;
c) ensuring that the population is adequately informed about the risks of
tobacco use and exposure to secondhand tobacco smoke and about the
benefits of quitting smoking;
d) ensuring that tobacco products are modified to reduce harm to the extent
technologically and practically possible; and
e) promoting a climate where nonsmoking and the absence of tobacco
promotion is the norm.
PART 2
Preliminaries, including Definitions
2. This Act may be cited as The Tobacco Control Act.
3. The definitions in this section apply to this Act:
appeal refers to the ability of a product to provide physical or psychological
pleasure, satisfaction, or other positive quality to the consumer;
brand element includes the brand name, trade-mark, trade-name, distin-
PART 3
Product Regulation
4. No person shall manufacture, sell, or import a tobacco product except in
compliance with this Act and any regulations made under this Act.
5. Every manufacturer and importer of a tobacco product shall provide the
Ministry/Government, in the prescribed manner and within the prescribed time,
information about the product and its emissions as required by the Regulations.
6. No person shall sell, offer for sale, distribute, advertise or promote any brand
of tobacco products that was not sold, distributed, advertised or promoted in
the country at least one year before the effective date of this Act.
7. The Minister/Government may make regulations:
a) establishing standards for the manufacture of tobacco products, including
i) prescribing the amount of substances that may be contained in the
product or its emissions;
ii) prescribing substances that may not be added to tobacco products;
and
iii) prescribing product design standards to reduce the harmful effects
of tobacco products and to reduce their appeal to youth.
b) prescribing test methods, including methods to assess conformity with
the standards;
c) prescribing information that manufacturers must provide to the
Minister/Government and/or the public about tobacco products and their
emission, including sales data and information on product composition,
ingredients, hazardous properties, and brand elements;
d) generally as needed to carry out this part of the Act.
PART 4
Packaging and Labeling
8. No person shall manufacture, sell, or import a tobacco product unless the
package containing it displays, in the prescribed form and manner including
through an enclosed leaflet if prescribed, the information required by the regu-
lations about the product and its emissions, about the health hazards and health
effects arising from the use of the product or from its emissions, other health-
related messages such as inter alia advice on how to quit smoking, and markings
designed to facilitate efforts to identify illegally manufactured or distributed
tobacco products or products on which tax has not been paid.
9. No person shall package tobacco in a manner that allows a consumer or
purchaser of tobacco products to be deceived or misled concerning its char-
acter, properties, toxicity, composition, merit or safety.
10. Any requirements arising from the above-mentioned clauses, do not relieve a
manufacturer or retailer of other obligations or liabilities arising from other
applicable legal norms to warn consumers of the risks of using tobacco products.
11. The Ministry/Government may make regulations:
a) respecting the content and format of information described in section 8
of this Act that must appear on packages and in leaflets;
b) respecting information that may not appear on packages; and
c) generally as needed to carry out this part of the Act.
PART 5
Advertising and Promotion
cultural event, or any entry or team in any event, in the name of a corpo-
ration which manufactures a tobacco product, provided that both the
corporate name and the corporation were registered and in use in this
country prior to (specify a date approximately 1 year prior to antici-
pated passage of the law) and that the corporate name does not include
any brand name (alone or in conjunction with any other word), trade-
mark, trade-name, distinguishing guise, logo, graphic arrangement,
design, slogan, symbol, motto, selling message, recognizable color or
pattern of colors, or any other indicia of product identification identical
or similar to, or identifiable with, those used for any brand of tobacco
product. ] End partial ban clause
14. Nothing in this subsection shall apply to the publication by a manufacturer
of a tobacco product advertisement in a printed publication that is intended
for distribution only to employees of the tobacco trade for trade purposes.
15. No person shall offer or provide any consideration, direct or indirect, for the
purchase of a tobacco product, including a gift to a purchaser or a third party,
bonus, premium, cash rebate or right to participate in a game, lottery or
contest, or distribute a tobacco product without monetary consideration, or
in consideration of the purchase of a product or service or the performance
of a service.
16. The Ministry/Government may make regulations:
(Note: Subclauses a), b) and c) below are not necessary in the case of a total prohibition.)
a) prescribing the form and manner of any health messages to be required on
promotional material or representations by any means;
b) prescribing the format, content and placement of any tobacco promotion;
c) requiring tobacco manufacturers to report the amount of monetary
expenditures on tobacco promotion by brand and by type of media and
prescribing the format and frequency of reporting;
d) prescribing schedules for the implementation of promotional restric-
tions;
e) generally as needed to carry out this part of the Act.
PART 6
Distribution
17. No person shall sell or offer to sell tobacco to a person who is less than [insert
age] years old.
18. It shall not be a defense to the above-mentioned clause that the person
appeared to be [insert age] years old or older.
19. It shall be a defense to clause 17, that the purchaser presented a prescribed
form of identification showing his or her age and that there was no apparent
reason to doubt the authenticity of the document or that it was issued to the
person producing it.
20. Nothing in this section prevents a person from giving tobacco or a tobacco-
related product to a young person if the gift is made solely for use in tradi-
tional Aboriginal spiritual or cultural practices or ceremonies.
21. No person shall sell or offer to sell tobacco products except in a package
containing the quantities or number of units prescribed by regulation.
22. No person shall sell or offer to sell tobacco products in a place other than
those prescribed by regulation.
23. Notwithstanding any regulation made under this Act, no person shall sell or
offer to sell tobacco products in the following places:
a) health institutions, including hospitals, pharmacies, and health clinics;
b) educational institutions, including primary, secondary, and post-
secondary schools;
c) facilities with a significant portion of youth clientele, including amuse-
ment parks, movie theatres and sports stadia; and
d) such other places as may be prescribed by regulation.
24. No person shall sell or offer to sell a tobacco product unless it is hidden from
view of the general public at point of sale.
25. Notwithstanding Section 24, retailers may post signs indicating that tobacco
products are available for sale, the specific products or brands available for
sale, and their respective prices, provided that brand elements are not visibly
displayed.
26. No person shall sell or offer to sell a tobacco product by means of a display
that permits a person to handle the tobacco product before paying for it.
27. No person shall sell or offer to sell tobacco products through a vending machine.
28. No person shall sell or offer to sell tobacco products through the mails or
through the Internet.
29. No person shall sell or offer to sell tobacco at retail unless signs bearing
health warnings and other information are posted at the place in accordance
with the regulations.
30. No person shall, at any place or premises in which tobacco or tobacco-related
products are sold at retail, display any sign respecting the legal age to
purchase tobacco or tobacco-related products unless the sign is supplied or
approved by the Ministry of Health.
31. The Ministry of Health/Government may make regulations:
a) prescribing acceptable forms of identification under clause 19;
b) prescribing quantities of tobacco to be sold in a single package;
c) prescribing places where tobacco products may be sold;
d) prescribing required signage at point of sale;
e) generally as needed to carry out this part of the Act.
PART 7
Use
32. No person shall smoke tobacco or hold lighted tobacco in enclosed, indoor
areas of any private or public work place, or any public place.
33. For the purpose of this Act, private or public work places and public places
PART 8
Measures to Combat Smuggling
III. the name, license number, address, telephone, and telefax numbers
of the importer/purchaser, and any person who receives the ship-
ment on the importer/purchaser’s behalf;
IV. the name, address, telephone, and telefax numbers of the intended
carrier(s) of the shipment and the means of transport;
V. the names of the cities and countries through which the shipment
will be transported;
VI. identification of the country of final destination;
VII. the name, license number, address, telephone, and telefax numbers of
any distributors and other intermediaries handling the shipment;
VIII. the date of the shipment, the period of time over which the ship-
ment is to be in transit, the date of expected arrival in the country
of final destination, and the itinerary correlated with dates of entry
and exit for each point of entry and exit;
IX. physical description of the products (e.g., cigarettes, cigars, bidis,
smokeless tobacco, etc.) shipped, including lot, batch or serial
numbers of all products contained in the shipment;
X. number of individual packages, number of sticks in each package
or gram amount, as applicable, number of bulk packages, number
of individual packages contained in each bulk package, and the
weight of each bulk package contained in the shipment;
XI. copies of all purchase orders, invoices, shipping or transport, and
transit documents related to the shipment;
XII. a description of any tax stamps or special marking or design
features on packages contained in the shipment;
XIII. an affidavit of the exporter stating that:
i. he or she has exhausted all reasonable means to investigate the
degree of demand for the products in the country of destina-
tion and determined that there is legitimate demand there for
the number of products ordered and shipped;
ii. there is no substantial basis for believing that any person receiving
or handling the shipment has been or is involved in illegal
commercial activity or that the products will be sold illegally;
iii. he or she has complied with all labeling and other legal
requirements; and
iv. information and documents supplied are true and correct to
the best of his or her knowledge.
b) The bond made pursuant to subsection (a) shall be forfeited unless the
manufacturer or exporter, as applicable, provides [specify Ministry or
agency] with the following information within [specify number] days of
[specify triggering event (e.g., the date the goods are shipped)]:
I. evidence of the chain of custody and proof that all goods reached
their final destination without any product being sold or distrib-
uted without the full payment of all applicable duties, including
but not limited to:
i. copies of all bills of lading or other evidence of receipt by all
importers and intermediaries;
PART 9
Enforcement, Inspection, Offences and Punishments
38. For the purpose of this Act the Ministry/Government may appoint any person
or designate any class of persons to perform the duties of inspector or analyst.
The responsibilities of an inspector shall be specified in the act of appointment.
39. Every person authorized as an inspector or analyst under clause 38 may, at
any reasonable time, to ascertain compliance with this Act and the regulation
under it, enter and inspect any of the following places:
a) referred to in clause 33;
b) where tobacco is manufactured, tested, stored, packaged, labeled or sold;
c) where layouts and requirements stated in clause 25(a) are to be found;
d) where anything used in the manufacture, storage, packing, promotion,
sale or testing of tobacco is to be found;
e) where information relating to the manufacture, storage, packaging,
labeling, promotion, sale or testing of tobacco is to be found.
40. Authorized inspectors and analysts shall have the following powers, which
no person shall deny, obstruct, or hinder:
a) to examine, open, and test any equipment, tools, materials, packages or
anything the authorized officer reasonably believes is used or capable of
being used for the manufacture, packaging, labeling, storage, distribu-
tion, or advertising or promotion [if allowed] of tobacco products;
subsequent offences.
46. Any person found guilty of violating any provision under Part 4 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences; and
b) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
47. Any person found guilty of violating any provision under Part 5 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences; and
b) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
48. Any person found guilty of violating any provision under Part 6 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences;
b) in the case of the proprietor of a retail establishment, not less than $xxx
and not more than xxx for the first offence, and of not less than xxx and
not more than xxx for subsequent offences; and
c) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
49. Any proprietor, owner, and/or manager of any premise listed under Part 7
of this Act found guilty of failing to enforce the smoke-free policy applicable
to the facility under his or her responsibility, including the posting of
prescribed signs and ensuring that any designated smoking areas meet the
requirements of the Act and its regulations, shall be liable for a fine of not less
than xxx and not more than xxx for the first offence, and of not less than xxx
and not more than xxx for subsequent offences.
50. Any person found guilty of smoking in a place where smoking is prohibited
under Part 7 of this Act shall be liable for a fine of not less than xxx and not
more than xxx for the first offence, and of not less than xxx and not more than
xxx for subsequent offences.
51. Any person found guilty of violating any provision under Part 8 of this Act
shall be liable for a fine of
a) in the case of an individual, not less than $xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences;
b) in the case of a proprietor of a retail establishment, not less than $xxx and
not more than xxx for the first offence, and of not less than xxx and not
more than xxx for subsequent offences;
c) in the case of a wholesale distributor, not less than $xxx and not more
than xxx for the first offence, and of not less than xxx and not more than
xxx for subsequent offences;
d) in the case of a manufacturer, not less than xxx and not more than xxx for
the first offence, and of not less than xxx and not more than xxx for
subsequent offences.
52. In addition to any fines imposed, any person found guilty of violating any
provision under Part 8 of this Act shall be liable for a penalty equivalent to
the proceeds from the distribution of illegal tobacco products as well as taxes
and duties owed on those products.
53. Nothing in this Act shall preclude the criminal enforcement of its provisions
in a Court of competent jurisdiction.
54. Where a person is found guilty of an offence under any part of this Act other than
Part 8, the judge may impose an additional fine in addition to any other penalty,
following an application by the prosecuting party appended to the statement of
offence, equal to the amount of monetary benefit gained by the person as a result
of the offence, even if the maximum fine is imposed under another provision.
55. A person who commits or continues an offence under this Act on more than
one day is liable to be convicted for a separate offence for each day on which
the offence is committed or continued.
56. Any person found to have violated any requirement under this Act or imple-
menting regulations may be ordered to pay the reasonable costs associated
with any inspection, investigation, and enforcement action brought about by
the noncompliance.
57. The Ministry of Health/Government shall make regulations:
a) respecting the powers and duties of inspectors and analyst;
b) respecting the taking of samples;
c) respecting the procedure to be followed by the inspector or analyst
during an inspection;
d) respecting the procedure to be followed during an inspection for seizure,
as well as the one to be applied and restoration of any tobacco product;
e) generally as needed to carry out this part of the Act
PART 10
Final Clauses
58. This Act shall come into force no later than one year [or specify other time
period] following its passage into law.
ANNEX 2
Consolidated List of Internet-Available Laws
Australia
Tobacco Act 1987, State of Victoria (Australia), including establishment of the
Victorian Health Promotion Foundation
http://www.dms.dpc.vic.gov.au/l2d/T/ACT01228/2_1.html
Tobacco Control Act 1990, Part 3-Western Australian Health Promotion Foundation,
State of Western Australia (Australia)
http://www.slp.wa.gov.au/statutes/swans.nsf/Current+Legislation+Version2?
SearchView
Brazil
Resolução - RDC nº 104, de 31 de maio de 2001 (labelling regulations)
http://www.anvisa.gov.br/legis/resol/104_01rdc.htm
Canada
ANNEX 2
The site below, maintained by the Canadian Council on Tobacco Control, links
to of all of the Canadian laws cited in this document.
http://www.cctc.ca/CCTCLAWweb.nsf/MainFrameSet?OpenFrameSet
European Union
Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on
the approximation of the laws, regulations and administrative provisions of the Member
States concerning the manufacture, presentation and sale of tobacco products -
Commission statement. Official Journal L 194 , 18/07/2001 P. 0026 - 0035
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnu
mdoc&lg=EN&numdoc=32001L0037&model=guichett
New Zealand
Smoke-free Environments Act 1990 108 http://www.govt.nz/nzgovt/leg.php3
United States
Section 104350-104495, Health and Safety Code, State of California (USA) (also
known as “Proposition 99”) http://www.leginfo.ca.gov/cgi-
bin/waisgate?WAISdocID=47204815307+1+0+0&WAISaction=retrieve
General Laws of Massachusetts, Part I, Title XVII, Chapter 118E: Division of Medical
Assistance, State of Massachusetts (USA)
http://www.state.ma.us/legis/laws/mgl/118E-22.htm
www.paho.org