TY - JOUR
T1 - Consortium on methods evaluating Tobacco
T2 - Research tools to inform US food and drug administration regulation of snus
AU - Berman, Micah L.
AU - Bickel, Warren K.
AU - Harris, Andrew C.
AU - Lesage, Mark G.
AU - O'Connor, Richard J.
AU - Stepanov, Irina
AU - Shields, Peter G.
AU - Hatsukami, Dorothy K.
N1 - Publisher Copyright:
© The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.
PY - 2018/9/25
Y1 - 2018/9/25
N2 - Introduction The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. Methods In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Results Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Conclusions Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. Implications This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.
AB - Introduction The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. Methods In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Results Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Conclusions Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. Implications This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.
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U2 - 10.1093/ntr/ntx228
DO - 10.1093/ntr/ntx228
M3 - Review article
C2 - 29059363
AN - SCOPUS:85054093178
SN - 1462-2203
VL - 20
SP - 1292
EP - 1300
JO - Nicotine and Tobacco Research
JF - Nicotine and Tobacco Research
IS - 11
ER -