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U.S. Department of Health and Human Services

About FDA

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 Equivlance 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 Tobacco Products - Product Requirements, Marketing and Labeling.

Information is current as of May 30, 2014

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A52
Dec 2011N/A9
Jan 2012N/A27
Feb 2012N/A28
Mar 2012N/A6
Apr 2012N/A139
May 2012N/A10
Jun 2012N/A55
Jul 2012N/A35
Aug 2012N/A38
Sep 2012N/A0

FY 2012 Total: 407

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.

Number of Regular Substantial Equivalence Submissions (SE) received in the month

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.

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A48
Dec 2011N/A9
Jan 2012N/A27
Feb 2012N/A28
Mar 2012N/A6
Apr 2012N/A139
May 2012N/A1
Jun 2012N/A52
Jul 2012N/A35
Aug 2012N/A38
Sep 2012N/A0

FY 2012 Total: 391

Number of Provisional SE Reports received in the month

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))

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A0
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A0

FY 2012 Total: 0

Number of SE Exemption Submissions received in the month

A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if certain conditions are met. (Section 905 (j)(3)).

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A9
Jun 2012N/A3
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A0

FY 2012 Total: 12

Number of New Products Submissions (PMTA) filed in the month

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)).

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A0
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A0

FY 2012 Total: 0

Number of Modified Risk Products (MR) submissions received in the month

A modified risk tobacco product (MRTP) is a tobacco product that is sold or distributed for use to reduce harm and the risk of tobacco-related disease associated with commercially marketed tobacco products. You can legally market a modified risk tobacco product only after FDA issues an order permitting its marketing (Section 911(g)).

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A4
Dec 2011N/A0
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A0
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A0

FY 2012 Total: 4

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.