The U.S. Food and Drug Administration Centerfor Tobacco Products (CTP) recently published a list of research priorities deemed most relevant to its responsibility for the regulation of tobacco products. The first priority listed is "understandng the diversity of tobacco products." While extensive data are available on the chemical composition and human exposure to tobacco toxicants for conventional cigarettes, much less is known about new and emerging tobacco products such as snus, electronic cigarettes, and hookah, that users may perceive as less harmful than conventional cigarettes. Our funded PSO, DA012393, provides analytical chemistry support to numerous investigators carrying out behavioral and toxicological studies of tobacco, including some relevant to the mission of CTP. Our PSO also develops new biomarkers of exposure, and improved analytical chemistry methods for assessment of exposure to tobacco toxins. In this Revision Application, we are proposing to develop new biomarkers of exposure: (1) the tobacco alkaloid nicotelline as a biomarker for tobacco smoke particulate matter (TPM, "tar"), and (2) pseudooxynicotine, the chemical precursor to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(S-pyridyl)-1-butanone (NNK). In developing these biomarkers, we will analyze urine samples from subjects using new and emerging products: hookah, snus, and electronic cigarettes. We will also analyze urine samples from users of conventional tobacco products: cigarettes, cigars, and oral snuff. We will also analyze new and conventional tobacco products for toxic substances and their precursors. Our application addresses four FDA research priorities (2-5) listed in the FOA for the present program. If funded, we expect that the new biomarkers that we develop will aid the FDA in evaluation of new and emerging tobacco products, enhance the ability of our PSO to support studies relevant to the FDA CTP's mission, as well as advance the field of tobacco exposure assessment. We expect that our analytical chemistry methods will identify substances in tobacco that predict human toxicity, and thus represent possible targets for regulation or development of reduced harm products.

Public Health Relevance

Tobacco companies are putting considerable effort into developing new products that might reduce human exposure to tobacco toxins. Evaluation of claims of reduced exposure will be an important part of the FDA's regulatory process. We expect that our research will aid the FDA in the evaluation of the risks of new and emerging tobacco products and in their regulation.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Center Core Grants (P30)
Project #
3P30DA012393-14S1
Application #
8642414
Study Section
Special Emphasis Panel (ZRG1-RPHB-K (40))
Program Officer
Chiang, Nora
Project Start
1999-09-01
Project End
2015-06-30
Budget Start
2014-02-01
Budget End
2014-06-30
Support Year
14
Fiscal Year
2014
Total Cost
$453,245
Indirect Cost
$157,998
Name
University of California San Francisco
Department
Psychiatry
Type
Organized Research Units
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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