Standalone Grandfathered Determinations

This web page will allow users to perform a search by entering criteria in order to view determinations for Grandfathered Submissions. Users can search by entering any or all of the following fields:

  • “Tobacco Product Name” is the name of the tobacco product submitted as part of the Standalone Grandfathered Submission.
  • “Company” displays the company name as it was originally identified in the Standalone Grandfathered Submission.
  • “STN” defines the Submission Tracking Number (STN) of the Grandfathered Submission.
  • “Tobacco Product Category” defines the type of grandfathered tobacco product.
    • Cigarettes
      • For example: Combusted or Filtered Cigarettes;
    • Roll-Your-Own Tobacco Products
      • For example: Rolling Papers, Filtered or Non-filtered Cigarette Tubes, Filters;
    • Smokeless Tobacco Products
      • For example: Moist Snuff, Loose Snuff, Portioned Snuff, Dissolvable, Loose Chewing Tobacco;
    • ENDS (Electronic Nicotine Delivery System)
      • For example: E-liquid, open or closed E-Cigarettes, ENDS components;
    • Cigars
      • For example: Sheet-Wrapped Cigar, Leaf-Wrapped Cigar, Cigar Tobacco Filler, Cigar Components;
    • Pipe Tobacco Products
      • For example: Pipes, Pipe Tobacco Filler, Pipe Components;
    • Waterpipe Tobacco Products
      • For example: Waterpipes, Waterpipe Heat Sources, Waterpipe Components.

  • “Determination” is the grandfathered status determination for a Grandfathered Submission.
  • “Date of Submission” is the date when a Grandfathered Submission was sent to the FDA.
  • “FDA Receipt Date” is the date when a Grandfathered Submission was received by the FDA.
  • “Determination Date” is the date when the grandfathered status determination was made by the FDA.
  • “Grandfathered Tobacco Product” is a tobacco product that was commercially marketed in the United States on February 15, 2007. This term does not include tobacco products exclusively marketed in a test market as of that date. FDA interprets the phrase “as of February 15, 2007,” as meaning that the tobacco product was commercially marketed in the United States “on February 15, 2007.”

Search for a “Company” using the search option

  • User may enter any of the following combinations:
    • If the user enters “Acme and Company” in the Company search box and clicks the search button, it generates search results for terms displaying both Acme and Company.
      Example: Acme Snuff Company LLC
    • If the user enters “America not Company” in the Company search box and clicks the search button, it generates search results for terms displaying only America and not Company.
      Example: Acme America Inc.

Search for a Tobacco Product Name using the search option

  • User may enter any of the following combinations:
    • If the user enters “Acme and Box” in the Tobacco Product Name search box and clicks the search button, it generates search results for terms displaying both Acme and Box.
      Example: Acme Non Filter Kings Box
    • If the user enters “Acme or Box” in the Tobacco Product Name search box and clicks the search button, it generates search results for terms displaying either Acme or Box.
      Example: Acme 100's Soft Pack, Acme Box
    • If the user enters “Acme not Box” in the Tobacco Product Name search box and clicks the search button, it generates search results for terms displaying only Acme and not Box.
      Example: Acme 100's Soft Pack

Validation Rules

  • User needs to enter at least one or more search criteria in order to perform a search.
  • Date of Submission: Enter a date range in the “From” and “To” fields in the format of mm/dd/yyyy. The “From” date must be earlier than the “To” date. The “To” date cannot be a future date.
  • FDA Receipt Date: Enter a date range in the “From” and “To” fields in the format of mm/dd/yyyy. The “From” date must be earlier than the “To” date. The “To” date cannot be a future date.
  • Determination Date: Enter a date range in the “From” and “To” fields in the format of mm/dd/yyyy. The “From” date must be earlier than the “To” date. The “To” date cannot be a future date.

Sorting

Users can click on the column header of the search results table to change the sort order. The default sort order will be ascending by “Company”.
Example: Click on the “Company” column header. It displays the results sorted by “Company” in ascending order. Click again on the “Company” column header and it will display the results in descending order.

Export All Data to Excel

“Export All Data to Excel” link downloads the CSV data file containing all the data available in the dataset. The user will need an App that supports CSV file downloads, i.e. Excel, Notes, CSV Lite, etc.

Export Results to Excel

“Export Results to Excel” link downloads the CSV data file containing the records from the most recent search. The user will need an App that supports CSV file downloads, i.e. Excel, Notes, CSV Lite, etc.

Page Last Updated: 02/17/2017
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