Regulatory challenges regarding Regulatory challenges regarding the ISO/FTC standards on tobacco the ISO/FTC standards on tobacco products testing products testing

WSC high-level workshop onInternational Standards for Medical Technologies

Dr. Vera Luiza da Costa e SilvaDirectorWHO Tobacco Free Initiative26 February 2004

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The smoker’s body

Tobacco is the only legal Tobacco is the only legal Tobacco is the only legal Tobacco is the only legal product that kills half its product that kills half its product that kills half its product that kills half its consumers when used as consumers when used as consumers when used as consumers when used as recommended by tobacco recommended by tobacco recommended by tobacco recommended by tobacco manufacturers.manufacturers.manufacturers.manufacturers.

Evidence and extent of the problem

• Preventing uptake

• Protecting the public from exposure to second-hand tobacco smoke

• Promote tobacco use cessation

• Tobacco product regulationTobacco product regulationTobacco product regulationTobacco product regulation

The key four strategiesThe key four strategiesfor tobacco controlfor tobacco control

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Tobacco Product Regulation:Tobacco Product Regulation:First StepsFirst Steps

US Federal Trade CommissionUS Federal Trade Commissionmidmid--1960s standardized testing methods for tar 1960s standardized testing methods for tar and nicotine of cigarette smokeand nicotine of cigarette smoke1966 mandated the disclosure of ratings in 1966 mandated the disclosure of ratings in cigarette advertising cigarette advertising 1981 standardized testing for CO of cigarette 1981 standardized testing for CO of cigarette smokesmoke

International Organization for StandardisationInternational Organization for StandardisationSimilar testing methods adopted in EURO and Similar testing methods adopted in EURO and many other countriesmany other countries

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Limitations of ISO/FTC method Limitations of ISO/FTC method and protocolsand protocols

Smokers smoke with a variety of puff profilesSmokers smoke with a variety of puff profilesModern cigarette designs and compensatory smoking Modern cigarette designs and compensatory smoking of lowof low--yield cigarettes expose ISO/FTC limitsyield cigarettes expose ISO/FTC limitsConcern exists on the misuse of test results by tobacco Concern exists on the misuse of test results by tobacco companiescompanies““lower yieldslower yields”” is misinterpreted by consumers as is misinterpreted by consumers as ““safersafer””ISO/FTC protocols were never designed to accommodate the variations in human smoking habits

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Low tar cigarettes do not reduce the health Low tar cigarettes do not reduce the health related risks for smokersrelated risks for smokers

"Epidemiological and scientific "Epidemiological and scientific evidenceevidence…………..does not indicate a benefit ..does not indicate a benefit to public health from changes in to public health from changes in cigarette design and manufacturing over cigarette design and manufacturing over the last 50 years"the last 50 years"

NCI Monograph 2001NCI Monograph 2001

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Tobacco Product Regulation:Tobacco Product Regulation:WHOWHO’’s First Stepss First Steps

• WHO Conference on the regulation of tobacco products: Helsinki, 1999

• International Conference on Advancing Knowledge on Regulating Tobacco Products: Norway, 2000

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The International Conference on Advancing Knowledge

on Regulating Tobacco Products

Countries were urged to:

• introduce tobacco control policies recommended by WHO• evaluate and implement effective ways to unify framework for nicotine delivery products• support global tobacco research needs• establish under WHO an international expert group on tobacco and nicotine delivery devices

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The birth of the The birth of the SACTobSACToband of the WHOand of the WHO’’s Study Groups Study Group

• in the summer of 2000, the Director-General, established the WHO Scientific Advisory Committee on Tobacco Product Regulation (SACTob).

• in November 2003, the Director-General formalised SACTobfrom scientific advisory committee to Study Group on Tobacco Product Regulation

• six meetings were held in the last four years

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SACTOB/Study Group RecommendationsSACTOB/Study Group Recommendations

1. Conclusions and Recommendations on Health Claims Derived from ISO/FTC Method to Measuring Cigarette Yield2. SACTOB Statement on Nicotine and Its Regulation in Tobacco and Non-Tobacco Products3. Statement of Principles Guiding the Evaluation of New, or Modified Tobacco Products4. Recommendation on Tobacco Product Ingredients and Emissions5. Recommendation on Smokeless Tobacco Products6. Tobacco Product Research and Testing Capacity: Guiding Principles and Proposed Protocols to Initiate Product Testing)

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Study Group conclusions and recommendations Study Group conclusions and recommendations on ISO/FTC on ISO/FTC Health Claims Derived from ISO/FTC

Method to Measuring Cigarette Yield

• tar, nicotine, and CO numerical ratings based on ISO/FTC methods are misleading and should not be displayed on packaging, brand names, advertising and other promotions • all misleading health and exposure claims should be banned -- these terms include “light”, “ultra-light”, “mild”, etc.

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Study Group conclusions and recommendations Study Group conclusions and recommendations on on Tobacco Product Research and Testing

Capacity: Guiding Principles and Proposed Protocols to Initiate Product Testing

( forthcoming)

• Tobacco Product Research and Testing Capacity• Recommended tobacco product testing protocols and guidance• Recommended action by regulators• Guidelines for testing• Laboratories requirements and framework• Considerations about additional products

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Example of initiatives of measures that Example of initiatives of measures that reflect human intake reflect human intake

Parameter ISO/FTC More Intense Protocol

puff volume 35 ml 55 mlpuff duration 2 seconds 2 secondspuff interval 60 seconds 30 secondsventilation holes unblocked blocked: all (to avoid compensation) butt length filter overwrap filter plus 3 mm

plus 3 mm

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Developments in productDevelopments in productregulation approach regulation approach

Globally:Globally:WHO Framework Convention on Tobacco Control (FCTC)WHO Framework Convention on Tobacco Control (FCTC)

Experiences in Member States/REIO:Experiences in Member States/REIO:USAUSACanadaCanadaBrazilBrazilEuropean UnionEuropean Union

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Example of a regulatory framework: Example of a regulatory framework: the global treatythe global treaty

WHO Framework Convention on Tobacco Control (FCTC)WHO Framework Convention on Tobacco Control (FCTC)

Provisions on the FCTC addressing specifically the product regulation area:

Art. 9: Regulation of the contents of tobacco productsArt. 10: Regulation of tobacco product disclosuresArt. 11: Packaging and labelling of tobacco products

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Example of a regulatory framework: Example of a regulatory framework: USA (starting in mid 1960’s)

Federal Laws:• requiring that each person who manufactures, packages, or imports cigarettes provide the Secretary of Health and Human Services annually with a list of ingredients added to tobacco in the manufacture of cigarettes and smokeless products. • requiring that each person who manufactures, packages, or imports smokeless tobacco is required to submit annually to the Department of Health and Human Services a specification of the quantity of nicotine contained in each smokeless tobacco product.

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Example of a regulatory framework: Example of a regulatory framework: Canada (starting in 1997)

• tobacco products must be manufactured in conformity with productstandards • manufacturers of a tobacco product must provide information about the product and its emissions• manufacturers or retailers may not sell a tobacco product unless the package containing it displays information about the product and its emissions, and about the health hazards and health effects arising from the use of the product or from its emissions • inspectors may enter any place in which they believe a tobacco product is manufactured, tested, stored, packaged, labelled or sold.

Health CanadaHealth Canada

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Example of a regulatory framework: Example of a regulatory framework: Brazil Brazil (starting in 1999)

• ANVISA is mandated to regulate tobacco products• Mechanism for funding the agency -- the tobacco industry is required to pay ANVISA an annual registration fee of $35,000 for every brand• ANVISA is mandated to establish and maintain a tobacco testing laboratory in Brazil

the National Agency of Sanitary Surveillance (ANVISA)the National Agency of Sanitary Surveillance (ANVISA)

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Example of a regulatory framework: Example of a regulatory framework: the European Union the European Union (starting in 2001)

Article 9Article 9Article 9Article 9Regulation of contents of tobacco productsRegulation of contents of tobacco productsRegulation of contents of tobacco productsRegulation of contents of tobacco productsIn 2001, the European Parliament issued a directive for

Member States concerning, manufacture, presentation, and sale of tobacco products. The provisions limits the maximum yield of tar, nicotine, and carbon monoxide in cigarette.

Article 10Article 10Article 10Article 10Regulation of tobacco product disclosuresRegulation of tobacco product disclosuresRegulation of tobacco product disclosuresRegulation of tobacco product disclosuresRequires the tobacco industry to submit to Member States a

list of ingredients used in tobacco product manufacture.

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How the tobacco industry has How the tobacco industry has influenced ISO standardsinfluenced ISO standards

“… all ventilated cigarettes produce higher deliveries during human smoking than during machine smoking…” 1986, a tobacco company employee

“There are two international organizations controlled by the industry: CORESTA and ISO… CORESTA is 100% controlled by the industry… ISO Technical Committee 126 is made of approximately 80% Industry… The best way to work with these two organizations is to do all the technical work within CORESTA and then have it endorsed by ISO…”

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1976 True ad –direct link with health benefits

1977 – low tar associated with good “true” cigarette taste

1991 – more subtle association between lights and lifestyle

Application of ISO/FTC standards Application of ISO/FTC standards in tobacco marketing strategiesin tobacco marketing strategies

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Mid to late 1990’s – brand recognition, same image for “lights”

Application of ISO/FTC standards in Application of ISO/FTC standards in tobacco marketing strategiestobacco marketing strategies

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Application of ISO/FTC standards in Application of ISO/FTC standards in tobacco marketing strategiestobacco marketing strategies

B& H Silver, Germany

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Application of ISO/FTC standards in Application of ISO/FTC standards in tobacco marketing strategiestobacco marketing strategies

Brazil

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Poland

Lebanon

Application of ISO/FTC Application of ISO/FTC standards in tobacco standards in tobacco marketing strategiesmarketing strategies

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The link between the regulators The link between the regulators and the standards developers: how the and the standards developers: how the

tobacco industry is manipulating the processtobacco industry is manipulating the process

“You already know about the EEC mandate to reduce all deliveries to 15 mg. As we knew this was going to happen as early as 1988, we began to develop a strategy to react… The 3 year effort resulted in a new method (now known as the ‘new ISO’) which reduces the smoke delivery results by about 1 mg at the 16 mg level. The Marlboro sold in the EEC was initially delivering about 15.5 mg prior to any analytical new technology change. When the new system was implemented, the deliveries were around 14.5 mg, but remember, no product change ever took place…”

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Globalization has been accompanied by global Globalization has been accompanied by global badsbads and and has increased health risks.has increased health risks.

Health risks include: hazardous practices such as drug Health risks include: hazardous practices such as drug abuse, increased marketing of tobacco, spread of abuse, increased marketing of tobacco, spread of communicable diseases through food and travel across communicable diseases through food and travel across borders.borders.

The regulatory standards to address globalization should The regulatory standards to address globalization should not solely be driven by market interests.not solely be driven by market interests.

Regulation of global Regulation of global ““badsbads””

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