When do I submit my Substantial Equivalence Report?
At least 90 days before you want to commercially distribute a new tobacco product in the United States, you must submit a Substantial Equivalence Report to FDA.
How do I submit my Substantial Equivalence Report?
What happens after FDA receives the report?
To learn more about our review process, visit the Review and Evaluation of Substantial Equivalence Reports page.
FDA published Draft Guidance for Industry about substantial equivalence which is available for public comment. 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- Frequently Asked Questions – Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions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
- View webinars – Substantial Equivalence - FDA presentations
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.