97° Annual Meeting and All‐Industry ConferenceEvidence‐Based Science and RegulationEvidence‐Based Science and Regulation 

of the Tobacco Industry May 20‐22, 2012Williamsburg, VA

“The EU on Testing Ingredients

I i R M i MD FACS

“The EU on Testing, Ingredients and Constituents”

Ignazio R. Marino, MD, FACSProfessor of Surgery, Jefferson Medical College

Chair, Investigative Committee on National Health System, Senate of Italy

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WHAT DOES WHAT IN THE EU

• 2001 Tobacco Products Directive (2001/37/EC): consolidates and updates existing• 2001 Tobacco Products Directive (2001/37/EC): consolidates and updates existinglegislation on manufacturing and sale of tobacco products. It contains provisions to setlimits for tar, nicotine and CO, to place warnings on packs and to prohibit misleadingdescriptors. For other issues such as prevention and cessation, responsibility forproviding appropriate rules and structures lies with the individual Member States.

• 2003 Council Recommendation on Smoking Prevention on sales to minors and health d ieducation.

• 2003 WHO Framework Convention on Tobacco Control (WHO FCTC), the firstinternational treaty today comprises 172 partiesinternational treaty, today comprises 172 parties.

• 2009 Council Recommendation on Smoke‐Free Environments.

• 2010 Public consultation promoted by the Directorate‐General for Health &Consumer Protection (DG SANCO) to analyze options to revise the 2001 Directive.

• 2012 the EC agreed on a revision of the 2001 Directive, adopting 14 new warnings toappear on tobacco packs 2

SMOKE‐FREE LEGISLATION IN EUROPE

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SMOKERS, HEALTH & COSTS

EUROPE• 650,000 EU citizens die prematurely every year because of tobacco

consumption, including non smokers

• 13 million Europeans suffer from diseases related to tobacco smoking

ITALY *• In 2010, 20% of the total female adult population and 24% of the total male

adult population smoked, totaling 11 million smokers

b % f ld k• About 20% of 15‐year‐olds smoke

• Tobacco smoke responsible for 70,000 deaths yearly (about 15% of total deaths) 

• Tobacco‐related direct health costs in 2005: ‐ 4,2 billion euro (5,5 billion USD)‐ 81% for hospitalization related to cardiovascular diseases cancer COPD81% for hospitalization related to cardiovascular diseases, cancer, COPD 

4* Total population: over 60,7 millions (as of September 2011)

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ITALIAN LEGISLATION ON TOBACCO

1934: the Royal Decree 2316 prevents smoke in young citizens and prohibits selling tobacco to people under 16 years of age, as well as smoking in public places for said citizens.

1975: law 584/1975 banned smoking in hospitals, schools, theaters on public transportationtheaters, on public transportation.It had very limited application among smokers. 

1983: advertising is regulated by law 52/1983. All kinds of direct and indirect advertisements are banned. Since 1991, television advertisements are also bannedadvertisements  are also banned.

2003: the turning point is law 3/2003 that extended the ban to all public places and was actually enforced. 

A COMPREHENSIVE PROPOSAL

AS8/2008‐ bipartisan proposal in 2008f k i h S‐ fast‐track in the Senate 

Main contents:f‐ establish national Fund for school education and awareness 

campaigns‐ sale ban extended to 18 year‐olds‐ cessation therapies available free of charge through the NHS‐ oblige tests and info disclosure on 37 constituents* every 5 years‐ measure substances also for other tobacco products‐ informative leaflet in every pack of cigarettes and other products‐ give the Italian NIH responsibility to set strict scientific requirements 

for new Modified Risk Tobacco Products (MRTPs) approval

* Refer to the Hoffman list

Madame Amédée (Woman with Cigarette), Amedeo Modigliani, 1918

INGREDIENTS

Manufacturers’ claim: ingredients help control moisture levels,maintain product quality or act as binders or fillers.

Public Health authorities’ claim: most ingredients make tobaccomore palatable and smoking more attractive and addictive,especially to young consumersespecially to young consumers.

Attractiveness and its impact on addictiveness are crucial issuespfor discussion among all the stakeholders involved.

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CONSTITUENTS

More than 5,000 smoke constituents (or emissions) have been identified.

A i t l 70 h b id tifi d b bli h lth th iti lik l fApproximately 70 have been identified by public health authorities as likely causes of smoking‐related diseases (lung cancer, heart disease, emphysema). 

Some countries, including all of the EU countries, have established ceilings for tar, nicotine, and/or carbon monoxide yields. 

With the exception of a handful of countries (e.g.: the Netherlands), very few countries regulate tar, nicotine, and carbon monoxide yields in other tobacco products such roll‐your‐own tobacco. 

Woman with a Cigarette, Pablo Picasso, 1901  11

DIRECTIVE 2001/37/EC

According to articles 3 and 4 of the 2001 Directive, as ofJanuary 1st, 2004, in Europe the following limits apply:

‐ nicotine < 1mg / cigarette‐ carbon monoxide < 10mg / cigarette‐ tar < 10 mg / cigarette

Moreover, the yield shall be measured on the basis of ISOstandards.s a da ds

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2010 FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC)

Article 9    Regulation of the contents of tobacco productsThe Conference of the Parties, …. shall propose guidelines for testing, p p g gand measuring the contents and emissions of tobacco products, and forthe regulation of these contents and emissions. Each Party shall, whereapproved by competent national authorities, adopt and implementeffective legislative measures for such testing and measuring and foreffective legislative … measures for such testing and measuring, and forsuch regulation.

Article 10 Regulation of tobacco product disclosuresArticle 10   Regulation of tobacco product disclosuresEach Party shall, in accordance with its national law, adopt andimplement effective legislative … measures requiring manufacturers andimporters of tobacco products to disclose to governmental authoritiesi f i b h d i i f b dinformation about the contents and emissions of tobacco products.

These remain mere recommendations that Governments should adoptdi t ti l taccording to national systems.

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TESTING METHODS

Cigarette tar, nicotine, and carbon monoxide yields are measured byCigarette tar, nicotine, and carbon monoxide yields are measured bydifferent standardized methods. The most widely used is the ISOmethod. Another is the one developed by Health Canada.

A few countries (Canada, Brazil, Venezuela, and Taiwan) require testingand reporting of other smoke constituents on a “per‐cigarette by brand”basis. These countries require testing of approximately 45 smokeconstituents that have been identified as causes of tobacco‐relateddiseases.

N t h i d ili i k i ld f kNo country has imposed ceilings or maximum smoke yields for smokeconstituents other than tar, nicotine, or carbon monoxide.

Self‐Portrait with Cigarette, Edvard Munch, 1895 15

SCENHR

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)investigated the role of ingredients, evaluating the role of tobacco additives in theaddictiveness and attractiveness of tobacco products.

The methods used to quantify the addictive potency of additives have limitationsb f t h i l h llbecause of technical challenges.

Attractiveness in tobacco products may beincreased by a number of additives but it is alsoinfluenced by external factors such as marketing,influenced by external factors such as marketing,price, etc.

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HARM REDUCTION

Even assuming current rates of decline in consumption, the number of tobacco users is stillexpected to increase to about 1.5 billion by 2025.

There are groups taking an abstinence‐based approach (the “quit‐or‐die” approach) that focusessolely on preventing people from beginning to use tobacco products and encouraging people toquit using tobacco products.

On the other hand, the recognition that people will continue to smoke has led many publichealth authorities to the conclusion thathealth authorities to the conclusion thatdeveloping Modified Risk Tobacco Products(MRTPs) that have a reduced risk of causingdisease, is crucial.

This might be the case of Electronic Nicotine Delivery System(ENDS)(ENDS). 

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ENDS: A REGULATORY GAP

ENDS (and smokeless tobacco products) exist in an international regulatory vacuum. ( p ) g yYet, they are more and more popular.

The WHO Study Group on Tobacco Product Regulation (TobReg) in 2008 concluded that ENDS should be regulated as medical devices. This is the general wish in Europe.

However, for the time being, in several European Union countries, ENDS (with orh ) d d l d d ld h fwithout nicotine) are considered as leisure products and are sold without any safety

control.

C rrentl abo t 50% of EU Member States onsider ENDS as medi al prod ts hileCurrently, about 50% of EU Member States consider ENDS as medical products, while 25% of them has no specific provisions. 

In Italy the Department of Health concluded that to date scientific evidence isIn Italy, the Department of Health concluded that to date, scientific evidence isinsufficient on the efficacy of ENDS as cessation devices, onthe effects on consumers' health, and on addiction creation.Therefore, specific provisions are still lacking.Therefore, specific provisions are still lacking.

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CONCLUSIONS

• Following a harm reduction policy does not precludeGovernments from pursuing the main objectives which are:Governments from pursuing the main objectives, which are:– prevention of initiation– cessation therapies

• Reliable testing systems are needed for regulatory purposes• Define more binding rules for ENDS and assess their role vis a

vis cessation therapyvis cessation therapy• Cooperation among health agencies, manufacturers,

governments, and consumer advocates (let’s abandon thepresumption of uniqueness of tobacco control and let’s enactnational and international policies involving also the industry –same as with food and alcohol control)same as with food and alcohol control)

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