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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.

The final rule: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports describes the required content, format and review of Substantial Equivalence Reports. For FDA to complete a substantive review, an SE Report must include the information described in the final rule.

Provisional SE Tobacco Products

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

An SE Report must meet the content requirements specified within the SE Final Rule, (per 21 CFR 1107.18(a)). The following is not meant to be an exhaustive list of all requirements for an SE Report, but rather highlights information for the new product and predicate product commonly omitted by applicants.

An SE Report should include:

  • General information, such as:
    • Manufacturer
    • Product name, including brand and sub-brand
    • Product category, subcategory, and associated product properties 
  • Summary including descriptions of similarities and differences between the new tobacco product and the predicate tobacco product with respect to their characteristics (materials, ingredients, design, composition, heating source, or other features)
  • New tobacco product description
  • Predicate tobacco product description 
    • Eligible predicate tobacco products have either been: 
      • Commercially marketed (other than for test marketing) in the United States as of February 15, 2007; or
      • Previously determined to be substantially equivalent by FDA
    • A predicate tobacco product must also be:
      • An individual product and not a composite of multiple products
      • Not subject of a rescission action by FDA
      • Not removed from the market at the initiative of FDA 
      • Not misbranded or adulterated as determined by judicial order 
  • Comparison information
    • Comparison of product design 
    • Comparison of heating sources 
    • Comparison of product composition
      • Materials
      • Ingredients other than tobacco
      • Tobacco ingredients
      • Container closure system
    • Comparison of tobacco processing
    • Shelf life and stability information
  • Comparative testing information, which must include the test protocols, quantitative acceptance criteria, and test results (including means and variances and complete data sets)
  • Statement of compliance with applicable tobacco product standards
  • Health information summary or statement that such information will be made available upon request
  • Environmental assessment prepared in accordance with 21 CFR 25.40 or a valid claim of categorical exclusion
  • Certification statement

SE Reports must also meet applicable required items per the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions.

SE format requirements must be met to facilitate review. The application must:

  • Use appropriate FDA submission forms
  • Include a comprehensive index (listing of files and associated metadata)
  • Include a table of contents
  • Be well-organized, legible, and written in English 
  • Be submitted in an electronic format that FDA can process, read, review, and archive, unless FDA has granted a waiver 
    • Applicants who cannot meet the requirement to submit their SE Report in an electronic format that FDA can process, read, review, and archive must request and receive a waiver from FDA to submit in another format. 
    • Waivers will be granted if use of electronic means is not reasonable for the applicant.

How to Submit an SE Report

Amendments should 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.

Deficiency responses (including requests) should follow the submission instructions outlined in the 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

    SE Decisions

    SE Resources 

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