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U.S. Department of Health and Human Services

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Cumulative number of Premarket Tobacco Product Applications (PMTA) received since Program Inception

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

To market a new tobacco product, Premarket Tobacco Application must be submitted under Section 910 of the Food, Drug, and Cosmetic Act. Before marketing a product in the United States, written notification must be received from FDA permitting the marketing of the new tobacco product. (Section 910 (b)).

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Information is current as of June 30, 2019. CTP began tracking this measure in FY15 Q4.

Fiscal Year - 2019

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TimeTargetNumber
Oct 2018N/A397
Nov 2018N/A397
Dec 2018N/A399
Jan 2019N/A399
Feb 2019N/A401
Mar 2019N/A401
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 401

Cumulative number of PMTA Closed since Program Inception

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2019
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TimeTargetNumber
Oct 2018N/A383
Nov 2018N/A383
Dec 2018N/A383
Jan 2019N/A383
Feb 2019N/A383
Mar 2019N/A383
Apr 2019N/A387
May 2019N/A387
Jun 2019N/A389
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

Cumulative YTD Total since Program Inception: 389

Cumulative number of Premarket Tobacco Product Applications (PMTA) received in the month

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

To market a new tobacco product, Premarket Tobacco Application must be submitted under Section 910 of the Food, Drug, and Cosmetic Act. Before marketing a product in the United States, written notification must be received from FDA permitting the marketing of the new tobacco product. (Section 910 (b)).

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Fiscal Year - 2019

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TimeTargetNumber
Oct 2018N/A0
Nov 2018N/A0
Dec 2018N/A2
Jan 2019N/A0
Feb 2019N/A2
Mar 2019N/A0
Apr 2019N/A0
May 2019N/A0
Jun 2019N/A0
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 4

Total number of PMTA Closed in the month

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2019
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TimeTargetNumber
Oct 2018N/A0
Nov 2018N/A0
Dec 2018N/A0
Jan 2019N/A0
Feb 2019N/A0
Mar 2019N/A0
Apr 2019N/A4
May 2019N/A0
Jun 2019N/A2
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 6

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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