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Total number of product submissions received or filed in the month (1)
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.
Information is current as of November 30, 2012
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 8 |
| Nov 2011 | N/A | 48 |
| Dec 2011 | N/A | 9 |
| Jan 2012 | N/A | 27 |
| Feb 2012 | N/A | 30 |
| Mar 2012 | N/A | 4 |
| Apr 2012 | N/A | 139 |
| May 2012 | N/A | 10 |
| Jun 2012 | N/A | 55 |
| Jul 2012 | N/A | 35 |
| Aug 2012 | N/A | 38 |
| Sep 2012 | N/A | 9 |
FY 2012 Total: 412
Footnotes
- (1) As submissions are reviewed, data may need to be updated to account for duplicates and multiple products on one submission.
Number of Regular Substantial Equivalence Submissions (SE) received in the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 8 |
| Nov 2011 | N/A | 44 |
| Dec 2011 | N/A | 9 |
| Jan 2012 | N/A | 27 |
| Feb 2012 | N/A | 30 |
| Mar 2012 | N/A | 4 |
| Apr 2012 | N/A | 138 |
| May 2012 | N/A | 1 |
| Jun 2012 | N/A | 52 |
| Jul 2012 | N/A | 35 |
| Aug 2012 | N/A | 38 |
| Sep 2012 | N/A | 9 |
FY 2012 Total: 395
Number of Provisional SE Reports received in the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 0 |
| Mar 2012 | N/A | 0 |
| Apr 2012 | N/A | 1 |
| May 2012 | N/A | 0 |
| Jun 2012 | N/A | 0 |
| Jul 2012 | N/A | 0 |
| Aug 2012 | N/A | 0 |
| Sep 2012 | N/A | 0 |
FY 2012 Total: 1
Number of SE Exemption Submissions received in the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 0 |
| Mar 2012 | N/A | 0 |
| Apr 2012 | N/A | 0 |
| May 2012 | N/A | 9 |
| Jun 2012 | N/A | 3 |
| Jul 2012 | N/A | 0 |
| Aug 2012 | N/A | 0 |
| Sep 2012 | N/A | 0 |
FY 2012 Total: 12
Number of New Products Submissions (PMTA) filed in the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 0 |
| Mar 2012 | N/A | 0 |
| Apr 2012 | N/A | 0 |
| May 2012 | N/A | 0 |
| Jun 2012 | N/A | 0 |
| Jul 2012 | N/A | 0 |
| Aug 2012 | N/A | 0 |
| Sep 2012 | N/A | 0 |
FY 2012 Total: 0
Number of Modified Risk Products (MR) filed in the month (1)
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 4 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 0 |
| Mar 2012 | N/A | 0 |
| Apr 2012 | N/A | 0 |
| May 2012 | N/A | 0 |
| Jun 2012 | N/A | 0 |
| Jul 2012 | N/A | 0 |
| Aug 2012 | N/A | 0 |
| Sep 2012 | N/A | 0 |
FY 2012 Total: 4
Footnotes
- (1) Oct 2010 and Nov 2010 counts are amendments to previous submissions.
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.
