Tobacco Products

Substantial Equivalence

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However:

If a new tobacco product meets the following criteria:

then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.


Overview

A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product; or has different characteristics than the predicate tobacco product but the information submitted 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 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).

If the new product raises different questions of public health, the product is not substantially equivalent. However, 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 be considered for exemption from demonstrating substantial equivalence.

Which path is right for your new tobacco product?

Use our interactive tool to learn about the three pathways to legally marketing a new tobacco product.


Which path is right for your new tobacco product?

 

How Does Substantial Equivalence Work?

For FDA to determine that a new tobacco product is substantially equivalent to a predicate product, the manufacturer of the new tobacco product must submit a Substantial Equivalence Report.

FDA reviews these reports to determine if the new tobacco product is substantially equivalent and is in compliance with the requirements of the law. If both of these criteria are met, FDA will issue a written order permitting the product to be legally marketed in the United States. You cannot legally market a new tobacco product if you receive an FDA order stating that the product is not substantially equivalent, unless you submit a Premarket Tobacco Application (PMTA) and receive a PMTA marketing order.


Could I Ever Sell My New Tobacco Product Without Receiving an Order from FDA?

To answer this question, determine the following:

  • Was your new tobacco product first commercially marketed between Feb. 15, 2007, and March 22, 2011?
  • Did you submit a Substantial Equivalence Report to FDA by March 22, 2011?

Green check mark YES: If you answered "yes" to both questions, you may market your tobacco product unless FDA issues an order that your product is not substantially equivalent. If FDA makes this determination, your product must be withdrawn from the market.

Red X mark NO: If you answered "no" to either question, then your new tobacco product can not be marketed without an order from FDA based on either a Substantial Equivalence Report or a Premarket Tobacco Application
 

You may also request an exemption from demonstrating substantial equivalence under 21 CFR 1107.1 and Section 905(j)(3).


Guidance & FAQs

FDA has published guidances for Industry about substantial equivalence, which represent FDA's current thinking on this topic:

  • Guidance: Section 905(j) Reports- Demonstrating Substantial Equivalence for Tobacco Products
  • Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.

      FDA is proceeding with its review of substantial equivalence (SE) reports submitted by industry. As part of its SE review process, FDA has taken steps to communicate with manufacturers about the status of their tobacco product submissions. More specifically, FDA has completed jurisdictional reviews for nearly all SE submissions with notifications provided to the submitters about whether or not their product is currently being regulated by the Center for Tobacco Products (CTP). Additionally, FDA has sent "Advice and Information Request" letters to some submitters whose reports were missing administrative and/or scientific information, requesting clarification or the submission of the missing information.

      FDA has also notified some manufacturers that have requested a determination on the eligibility of their product to serve as a predicate, that their product is eligible because the agency has determined that the product was commercially marketed in the United States as of Feb. 15, 2007.

      This web content highlights provisions of the Food, Drug, and Cosmetic Act. It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and links to relevant sections are provided throughout the web content.

Page Last Updated: 05/02/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English