• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

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 December 31, 2020. CTP began tracking this measure in FY15 Q4.

Fiscal Year - 2021

Skip graphic and jump to text data

TimeTargetNumber
Oct 2020N/A167,741
Nov 2020N/A167,741
Dec 2020N/A167,741
Jan 2021N/ATBD
Feb 2021N/ATBD
Mar 2021N/ATBD
Apr 2021N/ATBD
May 2021N/ATBD
Jun 2021N/ATBD
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 167,741

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FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.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 - 2021
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2020N/A1,380
Nov 2020N/A4,420
Dec 2020N/A4,479
Jan 2021N/ATBD
Feb 2021N/ATBD
Mar 2021N/ATBD
Apr 2021N/ATBD
May 2021N/ATBD
Jun 2021N/ATBD
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 4,479

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 - 2021

Skip graphic and jump to text data

TimeTargetNumber
Oct 2020N/ATBD
Nov 2020N/ATBD
Dec 2020N/ATBD
Jan 2021N/ATBD
Feb 2021N/ATBD
Mar 2021N/ATBD
Apr 2021N/ATBD
May 2021N/ATBD
Jun 2021N/ATBD
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: TBD

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 - 2021
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2020N/A613
Nov 2020N/A3,040
Dec 2020N/A59
Jan 2021N/ATBD
Feb 2021N/ATBD
Mar 2021N/ATBD
Apr 2021N/ATBD
May 2021N/ATBD
Jun 2021N/ATBD
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 3,712

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.

-
-