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In order to reach such a decision and to authorize marketing, FDA considers (per section 910(c)(4)), among other things: Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product What Is the Final PMTA Rule

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