(1)
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Full reports of all information published or known to, or which should reasonably be known to, the applicant concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products.
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(2)
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Full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation.
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(3)
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Full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation.
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(4)
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An identifying reference to any tobacco product standard, if applicable. If so, either:
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Adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard, or
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Adequate information to justify any deviation from such standard
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Samples of the tobacco product as required
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Specimens of proposed labelling
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Additional applicable required items per the final rule.
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(5)
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FDA recommends the following structure:
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Cover letter and administrative information
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Table of contents
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Summaries
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Product Description and Manufacturing (if applicable)
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Nonclinical information (if applicable)
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Clinical - Product Impact on Individual Health (if applicable)
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Clinical - Product Impact on Population Health (if applicable)
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Environmental Impact
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