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Substantial Equivalence

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Overview of SE

A Substantial Equivalence (SE) Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order, under section 905(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equivalence Report demonstrates that the new product does not raise different questions of public health. A predicate tobacco product is one that was commercially marketed (other than for test marketing) in the United States as of Feb. 15, 2007, or is a product previously found to be substantially equivalent by FDA.

Note: *New tobacco products commercially marketed after February 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent.

Preparing an SE Report

  • Determine a predicate product.
    • FDA's standalone grandfathered* submissions database includes information on potential predicate products. The database contains grandfathered determination information from voluntarily-submitted requests for grandfathered status review of a tobacco product.
    • Reviewing decision summaries for previously issued Substantial Equivalence Marketing Orders may also provide helpful information.

      * In the PMTA final rule and SE final rule, FDA has changed the term “grandfathered tobacco product” to “Pre-Existing Tobacco Product” because it more appropriately describes these products. Specifically, FDA considers a “Pre-Existing Tobacco Product” to mean a tobacco product that was commercially marketed in the United States as of February 15, 2007.

If the predicate product you’ve selected is eligible for grandfather status, it may be helpful to submit a voluntary standalone grandfather submission. If a grandfathered status determination has been made by FDA regarding your predicate product, please reference the STN in your SE Report.  If you submitted a standalone grandfathered status determination and FDA has not yet made a determination for that product, we recommend you include all supporting information regarding the grandfathered status of your predicate product in your SE Report and the original STN assigned to your review.

  • An SE Report must include the following information (if applicable), as well as other information, as required in the SE Final Rule: 
    • Predicate product information, including STN if applicable
    • New product information, including unique identification of the tobacco product
    • Listing of design features
    • Listing of ingredients
    • Listing of materials
    • Description of heating source
    • Description of composition
    • Harmful and potentially harmful constituents (HPHCs)
    • Laboratory accreditation
    • Storage conditions of products (both the predicate and new)
    • Health information
    • Additional applicable required items per the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions
  • To facilitate review, your application must comply with the SE format requirements (per 21 CFR 1107.18(b)).  Your application must:
    • Contain a comprehensive index (listing of files and associated metadata), required FDA forms, and a table of contents
    • Be well-organized and legible 
    • Be written in English 
    • Be submitted in an electronic format that FDA can process, read, review, and archive, unless FDA has granted a waiver.
  • How to Submit an SE Report
    1. Request an Industry Account Manager (IAM) account to establish a CTP Portal account, if your company does not already have an IAM.
    2. Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
    3. 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. 

       Applicants who cannot meet the requirement to submit their SE Report online in a format that FDA can process, review, and archive must request and receive a waiver from FDA to submit an SE Report in a format other than electronically. Waivers will be granted if use of electronic means is not reasonable for the applicant. 
  • Amendments can be submitted using the above instructions. Any amendment must include, among other things, the appropriate form and specify the submission tracking number(s) of the amended SE Report in the subject line.  If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.

SE Review Process

Exemption from Substantial Equivalence
    • Acceptance of an SE Report for Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon sections 910 and 905(j) of the FD&C Act and the criteria set forth in §§ 1105.10 and 1107.18. 
      • Output
        • Acceptance letter or
        • Refuse to accept (RTA) letter
    • Notification: FDA evaluation to ensure the predicate tobacco product is eligible.  
      • Output
        • None required.
        • The Office of Compliance and Enforcement (OCE) may reach out to the applicant for clarifying information to support predicate eligibility.
        • *For provisional SE Reports only: A notification letter informing that review of predicate eligibility has started, substantive scientific review will occur within 181 days, and that the applicant may amend their SE Report with any additional information within 180 days.
    • Substantive Review: FDA evaluation of the scientific information and data in an application.
      • Output
        • Deficiency letter: Additional information is needed to make a substantial equivalence decision. Applicants are provided time to respond as noted within this letter.
        • Environmental information request letter: FDA made a scientific decision to support a marketing order; however, the applicant is required to provide information for environmental considerations before a marketing order can be issued. 
        • *For certain product quantity SE Reports: Predicate Advice letter: FDA made a scientific decision to support a marketing order if the predicate is found eligible; however, FDA cannot issue a marketing order because it has not taken action on a different SE Report for a new product that is serving as the predicate product in the current SE Report.
    • Action:
      • Output
        • Substantial equivalence order (SE order) letter or
        • Not substantially equivalent order (NSE order) letter

    Performance and Reporting 

    Resources 

    Additional Resources



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