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It is not possible to incorporate all possible manufacturing process variations into a single controlled study, therefore the findings of the current controlled snus processing and aging study must be regarded as indicative of events that can occur with snus rather than a precise reflection of events occurring with all snus products

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FDA will ensure that its review of cigarette plans will be completed no later than 6 months after receipt of an adequate plan from persons who work in good faith with FDA to complete its review (e.g., persons should work diligently with FDA and be responsive by submitting any requested information in a timely manner)