2024-05-27U.S. Premarket Tobacco Product Applications Introduction
(1) |
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. |
(2) |
Full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation. |
(3) |
Full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation. |
(4) |
An identifying reference to any tobacco product standard, if applicable. If so, either:
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(5) |
FDA recommends the following structure:
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(1) |
Pre submission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product. |
(2) |
Acceptance Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon Section 910 of the FD&C Act and the criteria set forth in § 1105.10. |
(3) |
Filing Review: A preliminary scientific review that ensures the application contains all the items under Section 910(b)(1). |
(4) |
Substantive Review: FDA evaluation of the scientific information and data in an application, as well as recommendations from the Tobacco Product Scientific Advisory Committee (TPSAC), if the application was referred. |
(5) |
Action. |
(6) |
Post market Reporting: Requires applicants to establish and maintain records and make reports that FDA requires as necessary to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order. |