The United States District Court has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
Overview of PMTAs
- 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.
PMTA Review Process
Presubmission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product. For more information, see Meetings with Industry and Investigators.
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.
Filing Review1: A preliminary scientific review that ensures the application contains all the items under Section 910(b)(1).
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.
Marketing order letter or
No marketing order letter
Postmarket 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.
Preparing a PMTA
- 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.