Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.
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.Cancer Epidemiol Biomarkers Prev; 26(3); 291-302. ©2016 AACR.
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland. Cindy.Chang@fda.hhs.gov.
Cindy M
CM
Chang
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland.
Selvin H
SH
Edwards
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland.
Aarthi
A
Arab
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland.
Arseima Y
AY
Del Valle-Pinero
Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland.
Ling
L
Yang
Department of Psychiatry, Tobacco Research Programs, University of Minnesota, Minneapolis, Minnesota.
Dorothy K
DK
Hatsukami
D015415:Biomarkers / Q000097:blood* / Q000652:urine*; D003367:Cotinine / Q000097:blood / Q000652:urine; D066300:Electronic Nicotine Delivery Systems; D006801:Humans; D009538:Nicotine / Q000097:blood / Q000652:urine; D064424:Tobacco Use / Q000097:blood* / Q000652:urine*; D014030:Tobacco, Smokeless / Q000032:analysis*; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers; D009538:Nicotine; D003367:Cotinine