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  1. Market and Distribute a Tobacco Product

Substantial Equivalence

On Jan. 19, 2021, the Premarket Tobacco Product Applications final rule and Substantial Equivalence final rule were displayed in the Federal Register, but did not publish. On Jan. 20, 2021 a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules have been withdrawn. The FDA will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.

On this page:

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 in the United States (other than in a test market) as of Feb. 15, 2007, or is a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act (FD&C Act).

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

If the predicate product you’ve selected is eligible for grandfather status, it may be helpful to submit a standalone grandfather submission. If a grandfathered status determination has been made by FDA regarding your predicate product, please reference the GF STN number 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 GF STN assigned to your review.

  •  An SE Report should include: 
    • Predicate product information, including GF STN if applicable
    • 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
  • We recommend the following structure:
    • Cover letter and Administrative Information
    • Table of contents 
    • Summaries
    • Product Description and Manufacturing (as applicable)
    • Nonclinical (if applicable)
    • Clinical -- Product Impact on Individual Health (if applicable)
    • Clinical -- Product Impact on Population Health (if applicable)
    • Environmental Impact 
  • How to Submit an SE Report
  • Amendments 
    Amendments can be submitted using the above instructions. Any amendment should include a cover letter that includes 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

SE Review Process Flow Chart
  • Acceptance 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. 
    • 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 via teleconference for clarifying information on 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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