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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.

Full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation.

Full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation.

An identifying reference to any tobacco product standard, if applicable.