U.S. Premarket Tobacco Product Applications Introduction
The premarket tobacco application (PMTA) is the process by which tobacco-product manufacturers seek marketing authorization from the Food and Drug Administration (FDA). A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.
- Prepare a PMTA
(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:
- Adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard, or
- Adequate information to justify any deviation from such standard
- Samples of the tobacco product as required
- Specimens of proposed labelling
- Additional applicable required items per the final rule.
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(5)
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FDA recommends the following structure:
- Cover letter and administrative information
- Table of contents
- Summaries
- Product Description and Manufacturing (if applicable)
- Nonclinical information (if applicable)
- Clinical - Product Impact on Individual Health (if applicable)
- Clinical - Product Impact on Population Health (if applicable)
- Environmental Impact
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- PMTA Review Process
(1)
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Pre submission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product.
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(2)
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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.
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(3)
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Filing Review: A preliminary scientific review that ensures the application contains all the items under Section 910(b)(1).
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(4)
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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.
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(5)
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Action.
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(6)
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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.
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- A PMTA Costs
The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. The FDA estimates the PMTA process will cost manufacturers between $117,000 and $466,000 per application.
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