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Substantial Equivalence

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Substantial Equivalence Overview

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 (also known as a 905(j) Report) submitted by the manufacturer 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).

A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may qualify to apply for an exemption from demonstrating substantial equivalence (known as an Exemption Request).

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.

Learn more about the FDA’s process for reviewing substantial equivalence reports.

Recommended steps to prepare an SE Report

  1. Determine a predicate product.
  2. If the predicate product you’ve selected is eligible for grandfather status, it may be helpful to Submit a standalone grandfather submission
  3. SE Reports typically include the following information:
    • Cover letter
    • Summary
    • 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
    • Final summary or closing statement
    • Prepare an environmental assessment (EA) per National Environmental Policy Act (NEPA) requirements.

Submit an SE Report

Submit Online:

  1. Request, in writing, an Industry Account Manager (IAM) account for CTP Portal, if your company does not already have an IAM.
  2. Prepare your submission electronically using the 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.

Submit by Mail:

If you are unable to submit online, mail submissions to CTP's Document Control Center.

Help with SE Reports

Response to SE Report

  • Deficiency Letter: FDA may ask for specific additional information that is needed or will be helpful in making a substantial equivalent decision. Applicants have 180 days to respond to this type of letter.
  • SE order: If FDA determines that a new tobacco product is substantially equivalent and is in compliance with all other legal requirements, a written SE order will be issued to legally market the product in the United States.  See issued SE Marketing Orders to date.
  • Not substantially equivalent (NSE): If FDA determines that the new tobacco product does not have either the same characteristics as the identified predicate tobacco product or that the new product raises different questions of public health, FDA will issue an order stating that the product is not substantially equivalent (NSE).  An NSE tobacco product may not be legally marketed unless it receives a marketing order via one of the premarket application pathways.

Learn more about the FDA's review process for SE Reports.

Additional Resources