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U.S. Department of Health and Human Services

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Cumulative number of Substantial Equivalence (SE) reports received (1)

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)). Substantial Equivalence (SE) Reports submitted to FDA after March 22, 2011 are defined as Regular Substantial Equivalence (SE) reports.

Information is current as of December 31, 2013

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A594
Nov 2012N/A599
Dec 2012N/A760
Jan 2013N/A781
Feb 2013N/A811
Mar 2013N/A821
Apr 2013N/A825
May 2013N/A835
Jun 2013N/A849
Jul 2013N/A849
Aug 2013N/A851
Sep 2013N/A852

FY 2013 Cumulative Total: 852

Footnotes

  • (1) The number of applications reported as received (in a given month) may be revised due to subsequent unbundling of applications submitted with multiple products and if applications are re-categorized. The numbers reported for June 2013 have been updated as of June 25, 2013

Total number of information request letters sent to regular 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 - 2013

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TimeTargetNumber
Oct 2012N/A3
Nov 2012N/A20
Dec 2012N/A123
Jan 2013N/A22
Feb 2013N/A18
Mar 2013N/A29
Apr 2013N/A145
May 2013N/A17
Jun 2013N/A39
Jul 2013N/A26
Aug 2013N/A0
Sep 2013N/A5

FY 2013 Total: 447

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

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

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A57
Dec 2012N/A0
Jan 2013N/A54
Feb 2013N/A55
Mar 2013N/A40
Apr 2013N/A78
May 2013N/A16
Jun 2013N/A53
Jul 2013N/A48
Aug 2013N/A55
Sep 2013N/A52

FY 2013 Total: 508

Cumulative number of SE orders issued

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

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A2
Jul 2013N/A2
Aug 2013N/A2
Sep 2013N/A6
Oct 2013N/A9
Nov 2013N/A17
Dec 2013N/ATBD
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2013 Total: 6

Total number of SE orders issued during the month

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A2
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A4

FY 2013 Cumulative Total: 6

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

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

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A4
Jul 2013N/A4
Aug 2013N/A8
Sep 2013N/A8

FY 2013 Cumulative Total: 8

Total number of NSE orders issued during the month

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A4
Jul 2013N/A0
Aug 2013N/A4
Sep 2013N/A0

FY 2013 Total: 8

Cumulative Number of SE Reports withdrawn

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

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A19
Nov 2012N/A19
Dec 2012N/A19
Jan 2013N/A19
Feb 2013N/A23
Mar 2013N/A23
Apr 2013N/A30
May 2013N/A30
Jun 2013N/A37
Jul 2013N/A37
Aug 2013N/A37
Sep 2013N/A47

FY 2013 Cumulative Total: 47

Number of SE reports withdrawn during the month

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A4
Mar 2013N/A0
Apr 2013N/A7
May 2013N/A0
Jun 2013N/A7
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A10

FY 2013 Total: 28

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.