What is a grandfathered product?
A grandfathered tobacco product is a product commercially marketed in the United States as of February 15, 2007. Grandfathered products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and do not require prior authorization to be legally marketed.
Grandfathered products may serve as a predicate tobacco product in a Substantial Equivalence Report.
What if I modified my grandfathered product?
Then your grandfathered product would be considered a new tobacco product according to Section 910(a)(1)(B).
What is a predicate tobacco product?
A predicate tobacco product is what a new tobacco product is compared to in a Substantial Equivalence Report. A predicate tobacco product is either:
- A grandfathered product, or
- A product previously found to be substantially equivalent and in compliance with the FD&C Act
How can I determine if a particular tobacco product is grandfathered?
Submitting a request to validate the grandfathered status of your tobacco product is not required, however, should you wish to do so, below are the steps:
- The request should be prominently identified with the applicant’s name and labeled as a “Grandfathered Submission”.
- Each tobacco product should be submitted in a separate Grandfathered Submission.
- Submit Grandfathered Submissions electronically via the CTP Portal using FDA’s eSubmitter tool. If you are unable to submit online, you may mail submissions to: CTP's Document Control Center.
Search Grandfathered Determinations
FDA's standalone grandfathered submissions database contains grandfathered determination information from voluntarily-submitted requests for a grandfathered status review of a tobacco product.
Please note that this database does not list all grandfathered tobacco products. Substantial Equivalence Marketing Orders also contain information on predicate products.
The standalone grandfathered submission database will be updated periodically and contains original submission information that is typically released in response to a FOIA request.
For more information
FDA published Final Guidance for Industry about grandfathered tobacco products.
- Guidance Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007