Pre-Existing Tobacco Products

In August 2022, FDA updated the term "grandfathered tobacco product" to "pre-existing tobacco product." A pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. The FDA interprets “as of” to mean “on” that date. Pre-existing tobacco products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed.

FDA’s Center for Tobacco Products (CTP) webinar, "What Is a Pre-Existing Tobacco Product (PTP),” explains what a pre-existing tobacco product is in reference to preparing a voluntary pre-existing tobacco product status determination request. The webinar includes information on:

FDA’s Center for Tobacco Products webinar, “Pre-Existing Tobacco Products: Update to Term,” explains how the terminology update of “Grandfathered” to ‘‘Pre-Existing” tobacco product impacts pre-existing tobacco product determination requests and FDA’s Submission Tracking Number (or STN) system, key things for applicants to remember, and additional future updates.

A pre-existing tobacco product that has been modified in any way is considered a new tobacco product according to Section 910(a)(1)(B) and must apply for an FDA marketing order via one of the three pathways for new tobacco products.

Search Pre-Existing Tobacco Product Determinations

FDA's standalone pre-existing tobacco product submissions database contains pre-existing tobacco product determination information from voluntarily-submitted requests for a pre-existing status determination of a tobacco product.

This database does not list all pre-existing tobacco products. It is updated periodically and contains original submission information that is typically released in response to a FOIA request.

Preparing a Voluntary Pre-Existing Tobacco Product Status Determination Request

Submitting a request to determine the pre-existing status of your tobacco product is voluntary and not required under the FD&C Act. A pre-existing tobacco product is not considered a new tobacco product and does not need premarket authorization to be legally marketed.

There are three main components of a request to determine a tobacco product’s pre-existing status:

  1. A description of the product, including the name it was commercially marketed under as of February 15, 2007, and characteristics that uniquely identify it.
  2. A statement that the product was commercially marketed, in the United States as of February 15, 2007.
  3. Dated evidence that shows the product was commercially marketed in the United States as of February 15, 2007.

Commercially marketed means selling or offering for sale a tobacco product in the United States to consumers or to any person for the eventual purchase by consumers in the United States.

When preparing a request to determine a tobacco product’s pre-existing status, be sure to complete a separate pre-existing submission for each tobacco product.

Unable to Accept (UTA) Letters: FDA will issue UTA letters to industry if a pre-existing status determination request is not submitted individually. FDA will not accept or review submission requests if they contain multiple products for which a firm is seeking pre-existing tobacco product status determinations. Each product must be submitted in an individual submission request either electronically via CTP Portal using FDA’s eSubmitter or mailed to CTP’s Document Control Center (DCC).

Every submission should include the following:

  1. Submission content or evidence in English.
  2. Labeled as a “Pre-Existing Tobacco Product Submission.”
  3. Applicant name (may be the manufacturer, distributor, or importer of the tobacco product) and contact information.
  4. Full exact name, including brand and sub-brand, of the tobacco product as it was commercially marketed in the United States on February 15, 2007. Keep naming consistent throughout the submission.
  5. Unique identifying characteristics of the product, such as package type, quantity, length, diameter, tobacco cut size, portion mass, and flavor.
  6. If the pre-existing product is intended to be used in the SE or EX REQ pathway also demonstrate the product was not exclusively marketed in test markets. This confirmation may be submitted in the form of a statement from a responsible official who has knowledge of the test marketing status of the tobacco product in the United States as of February 15, 2007, and has authority to make such a statement.
  7. Evidence that the product was commercially marketed in the United States as of February 15, 2007. All evidence of commercial marketing should be dated and include the product’s full name. Examples of documentation of commercial marketing include advertisements, catalog pages, promotional material, trade publications, bills, invoices, purchase orders, inventory lists, receipts, and manufacturing documents.

Unable to Review (UTR) Letters: FDA will issue UTR letters to industry if a pre-existing tobacco product status determination request does not include sufficient information for FDA to find that the tobacco product is pre-existing, and continued agency review of the submission would be an inefficient use of agency resources. Under these circumstances, FDA will issue a UTR letter to the firm and close-out the submission request and Submission Tracking Number (STN). The UTR letter will describe the basis for issuing the UTR letter and inform the firm that they may resubmit their pre-existing tobacco product submission, at any time. Firms will receive UTR letters if the pre-existing tobacco product submission contains any one of the following problems: