FDA is streamlining its voluntary, standalone grandfathered tobacco product status determination program. Tobacco product manufacturers, importers, and distributors should be aware that the updates will take effect on Jan. 15, 2020.
Based on years of experience reviewing thousands of voluntary, standalone grandfathered submissions, FDA observed many grandfathered requests do not include sufficient information for FDA to make a determination as to whether the product is grandfathered. FDA’s new streamlined program for reviewing requests will help the agency to better use its resources and allow for more productive and timely responses to industry.
For submission requests received on or after Jan. 15, 2020, FDA will issue:
- Unable to Accept (UTA) letters to industry if a standalone grandfathered status determination request is not submitted individually. FDA will not accept or review submission requests if they contain multiple products for which a firm is seeking grandfathered status determinations. Each product must be submitted in an individual submission request either electronically via CTP Portal using FDA’s eSubmitter or mailed to CTP’s Document Control Center (DCC).
- Unable to Review (UTR) letters to industry and close-out the submissions if a standalone grandfathered status determination request does not include sufficient information for FDA to find that the tobacco product is grandfathered and continued agency review of the submission would be an inefficient use of agency resources. The UTR letter will describe the basis for issuing the UTR letter and inform the firm that they may resubmit their grandfathered submission, at any time.
In addition, starting Jan. 15, 2020, FDA will no longer issue multiple Request for Information (RFI) letters. Only one RFI letter will be sent, if needed. Firms will have 30 calendar days to respond to the letter.
A grandfathered tobacco product is a tobacco product commercially marketed (other than exclusively in test markets) in the United States as of Feb. 15, 2007. Grandfathered products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), but are not considered new tobacco products and do not require premarket authorization to be legally marketed. Submissions of standalone grandfathered status determination requests are not required under the FD&C Act. However, firms may voluntarily submit requests for grandfathered status determinations.
Certain deemed products, such as cigars and pipe tobacco, may likely qualify as grandfathered products. FDA encourages manufacturers of these potential grandfathered products to learn more and submit a request for grandfathered status determination, where applicable. Non-grandfathered deemed products must apply for premarket authorization in order to be marketed.
Substantial Equivalence Marketing Orders: Information provided within these orders may also contain information on predicate products that are also grandfathered
For specific questions about your existing Grandfathered submissions, please contact CTP-Grandfather@fda.hhs.gov. Be sure to reference the assigned STN in the inquiry.