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:
- It was commercially marketed after February 15, 2007 but before March 22, 2011; and
- A Substantial Equivalence Report was submitted by March 22, 2011,
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.
What is a substantially equivalent tobacco product?
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, but does not raise different questions of public health. If the new product raises different questions of public health, the product is not substantially equivalent.
What is a predicate tobacco product?
- A predicate tobacco product is one that was commercially marketed (other than in a test market) as of February 15, 2007, or
- A product previously found to be substantially equivalent by the FDA and in compliance with the requirements of the FD&C Act.
How does substantial equivalence work?
For FDA to determine that a new tobacco product is substantially equivalent to a predicate product, you 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.
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 February 15, 2007, and March 22, 2011; and
- Did you submit a Substantial Equivalence Report to FDA by March 22, 2011?
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 If FDA makes this determination, your product must be withdrawn from the market.
No: If you answered “no” to either question, then your new tobacco product may not be marketed without an order from FDA based on either a Substantial Equivalence Report or a Premarket Tobacco Application. There is one other option: You may request an exemption from demonstrating substantial equivalence under 21 CFR 1107.1 and Section 905(j)(3).
FDA has published Draft Guidance for Industry about substantial equivalence and the public may provide comments on the document. When this guidance is finalized, it will represent FDA’s current thinking on this topic.
- Frequently Asked Questions – Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
For More Information
- Guidance for Industry – Demonstrating Substantial Equivalence for Tobacco Products (Section 905(j))
- Most recent webinar - “Common Issues Identified During FDA’s Scientific Evaluation of SE Reports”
- Other archived webinars – Substantial Equivalence - FDA presentations
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 February 15, 2007.
This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C 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 relevant sections are linked to throughout the web content.