Scientific Standards for Studies on Modified Risk Tobacco Products

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.

Table of Contents


Front Matter
Summary
1 Introduction
2 Governance and Conduct of Studies
3 Evidence Base and Methods for Studying Health Effects
4 Methods for Investigating Addictive Potential
5 Methods for Studying Risk Perception and Risk Communication
6 Decision Making and Oversight of MRTP Studies: Findings and Recommendations
Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009
Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*
[Appendix B] 1 Introduction
[Appendix B] 2 Review: Evaluating and Regulating Biomarker Use
Appendix C: Committee Biographies
Appendix D: Meeting Agendas