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 In this section:

                Market and Distribute a Tobacco Product

Market and Distribute a Tobacco Product

                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications Home
          Tobacco Products
          Products, Guidance & Regulations
          Market and Distribute a Tobacco Product
          Pre-Existing Tobacco ProductsMarket and Distribute a Tobacco Product Pre-Existing Tobacco Products
  
  	
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Overview of Pre-Existing Tobacco Products
	Search Pre-Existing Tobacco Product Determinations
	Preparing a Voluntary Pre-Existing Tobacco Product Status Determination Request
	Voluntary Pre-Existing Tobacco Product Status Determination Program
	Pre-Existing Tobacco Product ResourcesOverview of 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 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:**

A description of the product, including the name it was commercially marketed under as of February 15, 2007, and characteristics that uniquely identify it.
	A statement that the product was commercially marketed, in the United States as of February 15, 2007.
	If the pre-existing product is intended to be a predicate product in the Substantial Equivalence (SE) pathway or a legally marketed product that has been modified in the Exemption from Substantial Equivalence (EX REQ) pathway, a statement that the product was not exclusively in a test market should also be included.
	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**:

Submission content or evidence in English.
	Labeled as a “Pre-Existing Tobacco Product Submission.”
	Applicant name (may be the manufacturer, distributor, or importer of the tobacco product) and contact information.
	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.
	Unique identifying characteristics of the product, such as package type, quantity, length, diameter, tobacco cut size, portion mass, and flavor.
	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.
	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:**

Pre-existing tobacco product submission is missing the following pieces of information:
	Commercial marketing evidence
		Unique product identifiers
	Pre-existing tobacco product submission or evidence contained in the submission is not translated into English.
	FDA determines that the specific product identified in the pre-existing tobacco product submission is not a tobacco product.
	Pre-existing tobacco product submission lacks firm/manufacturer name and contact information.How to submit a request for a pre-existing tobacco product status determination

Online:Request an Industry Account Manager (IAM) account to establish a CTP Portal account, if your company does not already have an IAM.
	Prepare your submission electronically using FDA's eSubmitter software.
	Submit online via the CTP Portal.**Note:** *The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP.*By Mail: If you are unable to submit online, mail submissions to CTP's Document Control Center.For specific questions about an existing pre-existing tobacco product submission, please contact CTP-PreExisting@fda.hhs.gov. Be sure to reference the assigned STN in the inquiry.

Voluntary Pre-Existing Tobacco Product Status Determination Program

pre-existing tobacco product reporting pathway
**Request received:**

	Output:
		**Acknowledgement letter** with Submission Tracking Number (STN) and the official date of receipt
			**Unable to Accept (UTA) Letters** will be issued for 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).
			Note: Unable to Accept letters are not final agency action and do not preclude a firm from providing a revised pre-existing tobacco product submission.
	**Review**: FDA reviews the submission to determine if it meets the definition of a pre-existing tobacco product. During this process, FDA cannot provide a specific date by which the review will be completed. 
	Output:
		**Unable to Review (UTR) letter**may be issued for several reasons:
			Pre-existing tobacco product submission is missing the following pieces of information:
				Commercial marketing evidence
					Unique product identifiers
				Pre-existing tobacco product submission or evidence contained in the submission is not translated into English.
				FDA determines that the specific product identified in the pre-existing tobacco product submission is not a tobacco product.
				Pre-existing tobacco product submission lacks firm/manufacturer name and contact information.**Note:** Unable to Review letters are not final agency action and do not preclude a firm from providing a revised pre-existing tobacco product submission; however, that submission will be assigned a separate STN number and undergo a new review.
			**Request for Information (RFI) letter** to obtain additional information or evidence necessary to complete the review. Firms will have 30 calendar days to respond to the RFI letter. Only one RFI letter will be sent.  No extensions to this timeline are typically granted.
	**Determination:** 
	Output
		**Pre-Existing Tobacco Product Status Determination letter:** Based on the information submitted, FDA determines that the tobacco product is pre-existing tobacco product. The tobacco product is added to the FDA’s Standalone Pre-Existing Tobacco Product Determination Database including the name of the tobacco product as commercially marketed in the United States on February 15, 2007, category of product, and the name of the company/request submitter.
			**Unable to Determine Pre-Existing Tobacco Product letter:** Based on the information submitted, FDA cannot determine that the tobacco product is a pre-existing tobacco product.  
			Note: Unable to Determine Pre-Existing Tobacco Product letters are not final agency action and do not preclude a firm from providing a revised pre-existing tobacco product submission; however, that submission will be assigned a separate STN number and undergo a new review.For specific questions about your existing pre-existing tobacco product submissions, please contact CTP-PreExisting@fda.hhs.gov. Be sure to reference the assigned STN in the inquiry.

If your tobacco product is unable to be determined as a pre-existing tobacco product, you may resubmit your pre-existing tobacco product submission request for that product at a later date.


Pre-Existing Tobacco Product Resources

CTP Updates “Grandfathered Tobacco Product” Term to “Pre-Existing Tobacco Product”
	Guidance: Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
	Memo: Unique Identification of Tobacco Products
	Substantial Equivalence Marketing Orders: Information provided within these orders may also contain information on predicate products that are also pre-existing tobacco products
	Q&A: Tobacco Product Review and Evaluation and Pathways to Market
	For specific questions about your existing pre-existing tobacco product submissions, please contact CTP-PreExisting@fda.hhs.gov. Be sure to reference the assigned STN in the inquiry.Additional Resources

Small Business Assistance for Tobacco Product Industry
	Contact CTP
	CTP Ombudsman

                                                                                  Content current as of:
      06/15/2023
              
              
Regulated Product(s)
		 TobaccoMarket and Distribute a Tobacco Product

          
                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications
 
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