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Key Findings from 2017 Data Analysis Nearly 40 percent of all patients used nicotine 10 percent of patients 31 patients started using nicotine while in treatment Only 3 percent of all patients quit smoking while in treatment 84 percent of patients who were nicotine users at admission refused tobacco intervention offered by their Skyland Trail psychiatrist during treatment Nicotine Cessation Implementation The clinical team concluded that more targeted intervention must take place at Skyland Trail to address the use of nicotine by our patient population and have assembled a Nicotine Cessation Task Force

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)

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