Scientific Standards for Studies on Modified Risk Tobacco Products

Institute of Medicine

doi:10.17226/13294

Consensus Study Report

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Scientific Standards for Studies on Modified Risk Tobacco Products

(2012)

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

Contributor(s): Institute of Medicine; Board on Population Health and Public Health Practice; Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

RESOURCES AT A GLANCE

Press Release

Topics

Health and Medicine —Public Health and Prevention

Suggested Citation

Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. https://doi.org/10.17226/13294.

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Publication Info

370 pages | 6 x 9 |

ISBNs:

Paperback: 978-0-309-22398-0
Ebook: 978-0-309-22402-4

DOI: https://doi.org/10.17226/13294

Chapters		skim
Front Matter	i-xx
Summary	1-20
1 Introduction	21-44
2 Governance and Conduct of Studies	45-72
3 Evidence Base and Methods for Studying Health Effects	73-148
4 Methods for Investigating Addictive Potential	149-190
5 Methods for Studying Risk Perception and Risk Communication	191-220
6 Decision Making and Oversight of MRTP Studies: Findings and Recommendations	221-246
Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009	247-256
Appendix B: Chapters 1 and 2 from Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease	257-258
[Appendix B] 1 Introduction	259-274
[Appendix B] 2 Review: Evaluating and Regulating Biomarker Use	275-338
Appendix C: Committee Biographies	339-346
Appendix D: Meeting Agendas	347-350

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Press Release

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