patricia richter ph.d., dabt centers for disease control and prevention office on smoking and health...
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Patricia Richter Ph.D., DABTCenters for Disease Control and PreventionOffice on Smoking and Health
Tobacco Product Constituents SubcommitteeJune 8-9, 2010Gaithersburg, Maryland
Example Lists of Harmful/Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
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Relevant terms
Entities requiring or considering constituent reporting
Examples of lists of harmful and potentially harmful constituents
– Origin
– Rationale
– Potential associations with smoking-related disease
Clarifying questions
Objectives
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Relevant Terms
Cigarette smoke
– Produced by the incomplete combustion of a tobacco cigarette
– An aerosol composed of liquid droplets in a gas
– More than 5,300 identified constituents
Mainstream smoke
– Generated during active puffing and drawn into the smoker’s mouth
– Portion exhaled by a smoker and becomes a component of secondhand smoke
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Relevant Terms, cont.
Sidestream smoke
– Generated between puffs
– Surrogate for secondhand smoke
Hoffmann Analytes
– 44 Chemicals/chemical mixtures
– Summary of toxic and carcinogenic chemicals in mainstream smoke
– Originally attributed to Dietrich Hoffmann/ American Health Foundation
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World Health Organization, Framework Convention on Tobacco Control (FCTC)
Brazil
Canada
Australia
New Zealand
Example of Entities Requiring or Considering Mandated Tobacco or Tobacco Smoke Constituent Reporting
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Constituent Reporting
World Health Organization, FCTC: Article 9 “…guidelines for testing and measuring the
contents and emissions of tobacco products, and for the regulation of these contents and emissions…”
Assessment of toxicants considered animal and human toxicity data (esp. cardiovascular and pulmonary toxicity and carcinogenicity), toxicity indices, variation in toxicants across brands, the potential for the toxicant to be lowered, particulate and gas phase constituents, and from different chemical classes in cigarette smoke
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Constituent Reporting
World Health Organization, FCTC: Article 9
– 18 Mainstream smoke constituents
– 7 “Most hazardous” mainstream smoke constituents
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Constituent Reporting
Brazil
National Health Monitoring Agency
RDC Resolution No. 90, December 27, 2007
– Registration of smoking products derived from tobacco
• Mandatory for all brands of smoking products derived from tobacco
• Analytical and reporting format specified
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Constituent Reporting
Brazil
― 27 Tobacco constituents
― 45 Mainstream smoke constituents
― 44 Sidestream smoke constituents
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Constituent Reporting
Canada Health Canada
The 2000 Tobacco Reporting Regulations
– Requirements for the reporting of toxic constituents and toxic emissions
• Mandatory for cigarettes, cigarette tobacco, leaf tobacco, tobacco sticks, kreteks, bidis
• Analytical and reporting format specified
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Constituent Reporting
Canada
– 26 Tobacco constituents
– 39 Mainstream smoke constituents
– 38 Sidestream smoke constituents
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Constituent Reporting
Australia In 2001 three tobacco manufacturers voluntarily
provided cigarette smoke chemistry data for selected Australian cigarette brands to the Australian Department of Health and Ageing
– 37 Mainstream smoke constituents
Provide evidence of variation in levels of constituents across brands within countries (FCTC/WHO)
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Constituent Reporting
New Zealand
New Zealand Ministry of Health
1997 Amendment to the 1990 Smoke-free Environments Act, Sections 33 and 34
– Clarified regulatory powers to limit harmful constituents in tobacco products
2000 Environmental Health Effects Programme, Environmental Science & Research report to the New Zealand Ministry of Health
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Constituent Reporting
New Zealand
“Risk-based priority-setting scheme” for cigarette harm reduction
– 95 Chemicals in cigarette smoke
– Risk assessment
• Mainstream and sidestream smoke data
• Cancer and non-cancer (cardiovascular, respiratory, reproductive/developmental, neurotoxicity, etc.) health effects potency data
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Constituent Reporting
New Zealand
– 16 Mainstream smoke constituents
– 14 Sidestream smoke constituents
– Ammonia and 4-(methylnitrosamino)- 1-(3-pyridyl)-1-butanone (NNK)
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Summary of Constituent Lists
59 Chemicals/ chemical mixtures
48 Mainstream smoke
46 Sidestream smoke
27 Tobacco products
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Association with Smoking-related Disease— Cancer
32 Constituents
– International Agency for Research on Cancer, National Toxicology Program, Environmental Protection Agency, peer reviewed literature
– 26 Known, probable, possible human carcinogen, tumor promoter
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Association with Smoking-related Disease— Cancer, cont.
Known human carcinogens
– 2-Aminonaphthalene
– 4-Aminobiphenyl
– Inorganic arsenic
– Benzene
– Benzo[a]pyrene
– 1,3-Butadiene
– Cadmium/cadmium compounds
– Chlorinated dioxin
(TCDD)
– Chromium
– Nickel compounds
– 4-(Methylnitrosamino)- 1-(3-pyridyl)-1-butanone (NNK)
– N-Nitrosonornicotine (NNN)
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Association with Smoking-related Disease — Non-neoplastic Respiratory Effects 24 Constituents
Peer reviewed literature
Eye and respiratory tract irritants (e.g., acrolein)
Ciliatoxicants (e.g., cresols)
Chronic obstructive pulmonary disease (e.g., volatile aldehydes, hydrogen cyanide)
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Association with Smoking-related Disease — Cardiovascular Effects
17 Constituents
Peer reviewed literature
Atherosclerosis, peripheral artery disease (e.g., benzo[a]pyrene, cadmium)
Elevated blood pressure (e.g., lead, aldehydes)
Reduced oxygen carrying capacity (e.g., carbon monoxide, nitrogen dioxide)
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Association with Smoking-related Disease — Addiction
6 constituents
Peer reviewed literature
Nicotine
Reinforcing effects (acetaldehyde)
Pharmacological activity (anabasine, anatabine, myosmine, nornicotine)
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Association with Smoking-related Disease — To Be Determined
8 constituents
– Glycerol– Menthol– Nitrate– Propylene glycol
– Sodium propionate– Sorbic Acid– Triacetin– Triethylene glycol
Peer reviewed literature, reference materials
Hazardous combustion products – e.g., carbon monoxide, aldehydes
Precursor of smoke carcinogens – tobacco-specific nitrosamines (nitrate)
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