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U.S. Department of Health and Human Services

Tobacco Products

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Process

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?

Submit your report electronically via the Electronic Secure Gateway or in paper format to CTP's address.

 

What happens after FDA receives the report?

To learn more about our review process, visit the Review and Evaluation of Substantial Equivalence Reports page.

 

Draft Guidance

FDA published Draft Guidance for Industry about substantial equivalence which is available for public comment.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.

 

For more information

 

 

Additional Resources

 

 

 

 

 

 


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.