Biomarkers of tobacco exposure: Summary of an FDA-sponsored public workshop

Cindy M. Chang, Selvin H. Edwards, Aarthi Arab, Arseima Y. Del Valle-Pinero, Ling Yang, Dorothy K. Hatsukami

Research output: Contribution to journalReview articlepeer-review

93 Scopus citations


Since 2009, the FDA Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified-risk tobacco products and identifying and evaluating potential product standards. On August 3-4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: (i) approaches to evaluating and selecting biomarkers; (ii) biomarkers of exposure and relationship to disease risk; (iii) currently used biomarkers of exposure and biomarkers in development; and (iv) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems. This article synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation.

Original languageEnglish (US)
Pages (from-to)291-302
Number of pages12
JournalCancer Epidemiology Biomarkers and Prevention
Issue number3
StatePublished - Mar 1 2017

Bibliographical note

Publisher Copyright:
© 2016 American Association for Cancer Research.


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