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U.S. Department of Health and Human Services

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Cumulative number of Provisional Substantial Equivalance (SE) reports 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.

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was both commercially marketed after February 15, 2007 but before March 22, 2011 and a Substantial Equivalence Report was submitted by March 22, 2011, then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product. (Section 905(j))

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 March 31, 2020. CTP began tracking this measure FY15 Q4.

Fiscal Year - 2020

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TimeTargetNumber
Oct 2019N/A3,605
Nov 2019N/A3,605
Dec 2019N/A3,605
Jan 2020N/A3,645
Feb 2020N/A3,645
Mar 2020N/A3,645
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 3,645

Cumulative number of Provisional SE 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FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.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 - 2020
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TimeTargetNumber
Oct 2019N/A3,074
Nov 2019N/A3,089
Dec 2019N/A3,095
Jan 2020N/A3,095
Feb 2020N/A3,119
Mar 2020N/A3,119
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 3,119

Total number of SE Provisional reports 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.

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was both commercially marketed after February 15, 2007 but before March 22, 2011 and a Substantial Equivalence Report was submitted by March 22, 2011, then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product. (Section 905(j))

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

Fiscal Year - 2020

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TimeTargetNumber
Oct 2019N/A0
Nov 2019N/A0
Dec 2019N/A0
Jan 2020N/A0
Feb 2020N/A0
Mar 2020N/A0
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 0

Total number of SE Provisional 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 - 2020
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TimeTargetNumber
Oct 2019N/A35
Nov 2019N/A15
Dec 2019N/A6
Jan 2020N/A0
Feb 2020N/A24
Mar 2020N/A0
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 80

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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