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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

Dictionary: 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))

Information is current as of March 18, 2015

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A3,517
Nov 2014N/A3,517
Dec 2014N/A3,517
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

Cumulative Total since March 2011: 3,517

Total number of SE Provisional reports received in the month

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A0
Nov 2014N/A0
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 0

Number of information request letters sent to SE Provisional report submitters 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.

Alternately, a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. The Substantial Equivalence provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were commercially available on February 15, 2007.

Additional information about premarket review requirements for tobacco products can be found on the CTP website

Monthly total of information request letters sent. Each submission is reviewed for completeness. Letters will be sent to manufacturers advising them of missing information in their submissions.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A0
Nov 2014N/A0
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 0

Total number of SE Provisional scientific reviews initiated (assigned technical lead) in the month

Dictionary: Monthly total of number of SE Provisional submissions assigned to a scientific lead (proxy for initiating scientific review).

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A27
Nov 2014N/A25
Dec 2014N/A123
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 175

Cumulative number of SE Provisional orders issued

Dictionary: Cumulative total of number of SE Provisional product submissions reviewed and determined to be substantially equivalent to a predicate product.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A0
Nov 2014N/A0
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

Cumulative Total since March 2011: 0

Total number of SE orders issued during the month

Monthly total of number of Provisional product submissions reviewed and determined to be substantially equivalent to a predicate product.

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A0
Nov 2014N/A0
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 0

Cumulative number of Non-Substational Equivalence (NSE) Provisional orders issued

Dictionary: Cumulative total of number of Provisional products reviewed and issued a not substantially equivalent order which will result in the products being removed from the market.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A10
Nov 2014N/A10
Dec 2014N/A10
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

Cumulative Total since March 2011: 10

Total number of NSE Provisional orders issued during the month

Monthly total of number of Provisional products reviewed and issued a not substantially equivalent order which will result in the products being removed from the market.

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A0
Nov 2014N/A0
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 0

Cumulative Number of SE Provisional Reports withdrawn

Dictionary: Cumulative total number of SE Provisional reports withdrawn by tobacco product manufacturers.

Fiscal Year - 2015

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TimeTargetNumber
Oct 2014N/A185
Nov 2014N/A190
Dec 2014N/A190
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

Cumulative Total since March 2011: 190

Number of SE Provisional reports withdrawn during the month

Monthly total number of SE Provisional reports withdrawn by tobacco product manufacturers.

Fiscal Year - 2015
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TimeTargetNumber
Oct 2014N/A4
Nov 2014N/A5
Dec 2014N/A0
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 9

Glossary

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.