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In order to reach a decision to authorize marketing of a proposed MRTP, FDA must consider under section 911(g)(4): The relative health risks to individuals of the tobacco product that is the subject of the application The increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application The increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application The risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved as medical products to treat nicotine dependence Comments, data, and information submitted by interested persons Preparing an MRTP Application An MRTP application includes (as required by Section 911(d) of the FD&C Act): A description of the proposed tobacco product and any proposed advertising and labeling Conditions for using the tobacco product Formulation of the tobacco product Sample product labels and labeling All documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions Data and information about how consumers actually use the tobacco product An MRTP application must also contain the information specified by 21 CFR 1105.10 for it to be accepted for review (see the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions)

Education is key, Blackmon said

CONTACT E: [email protected] W: Professor Sharon E

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