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Cited by 186Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesGlobal Public Health Policies and Epidemiology

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Abuse Liability Assessment of Tobacco Products Including Potential Reduced Exposure Products

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Carter, Lawrence P., Stitzer, Maxine L., Henningfield, Jack E., O'Connor, Rich J., Cummings, K. Michael, Hatsukami, Dorothy K.·2009·Cancer Epidemiology, Biomarkers & Prevention
DOI 10.1158/1055-9965.epi-09-0948PMC PMC2798587
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Abstract

The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREP). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the pre-market assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based. (Cancer Epidemiol Biomarkers Prev 2009;18(12):3241–62]

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Cited by

Sorted by citations

Metadata

Authors
Carter, L. P., Stitzer, M. L., Henningfield, J. E., O'Connor, R. J., Cummings, K. M., & Hatsukami, D. K.
Affiliations
Roswell Park Comprehensive Cancer Center (US)
Corresponding author
Hatsukami, Dorothy K.
ORCID
Venue
Cancer Epidemiology, Biomarkers & Prevention
Publisher
American Association for Cancer Research (AACR)
Published
2009-12-01
Volume
18
Issue
12
Pages
3241-3262
ISSN
  • 1055-9965 (ISSN-L)
  • 1538-7755
DOI
10.1158/1055-9965.epi-09-0948
PMC
PMC2798587
OpenAlex
W2015080262
Cited by
186
References
11
Citations by year
2026: 9 · 2025: 8 · 2024: 12 · 2023: 9 · 2022: 17 · 2021: 8 · 2020: 53 · 2019: 10 · 2018: 7 · 2017: 9 · 2016: 6 · 2015: 7 · 2014: 5 · 2013: 2 · 2012: 9
FWCI
0.97
Type
journal article
Language
en
Open access
Locations
  • Cancer Epidemiology Biomarkers & Prevention (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (n01pc64402-4-0-0)
  • National Cancer Institute (N01 PC 64402, N01 PC064402)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Global Public Health Policies and Epidemiology
Keywords
modified risk tobacco products, tobacco product regulation, nicotine, addiction risk, FDA tobacco regulation, tobacco harm reduction
MeSH terms
Clinical Trials as Topic, Humans, Tobacco Use Disorder, Smoking Cessation, Behavior, Addictive, Risk Assessment, Tobacco Products

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