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 ContentsFront MatterSummary1 Introduction2 Governance and Conduct of Studies3 Evidence Base and Methods for Studying Health Effects4 Methods for Investigating Addictive Potential5 Methods for Studying Risk Perception and Risk Communication6 Decision Making and Oversight of MRTP Studies: Findings andRecommendationsAppendix A: Section 911 of the Family Smoking Prevention andTobacco Control Act of 2009Appendix B: Chapters 1 and 2 from *Evaluation of BiomarkersandSurrogate Endpoints in Chronic Disease*[Appendix B] 1 Introduction[Appendix B] 2 Review: Evaluating and Regulating Biomarker UseAppendix C: Committee BiographiesAppendix D: Meeting Agendas