August 24, 2022
On Aug. 19, FDA’s Center for Tobacco Products (CTP) updated the term “grandfathered tobacco product” to “pre-existing tobacco product” on all the Center’s systems. As described in the Premarket Tobacco Application (PMTA) and Substantial Equivalence (SE) final rules published in 2021, the updated terminology more clearly and appropriately describes these products. Additionally, the term “grandfathered” – when used to describe someone or something exempt from a new law or regulation – has its roots in 19th century racist voting laws. Therefore, this terminology has been updated in accordance with CTP’s commitment to diversity, equity, inclusion, and accessibility.
A pre-existing tobacco product has the same definition as a grandfathered product. Specifically, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007. FDA interprets “as of” to mean “on” that date. As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of your tobacco product is voluntary and not required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The terminology has been updated in the eSubmitter and CTP Electronic Submission applications. The system updates are limited to terminology changes and users will not encounter major changes. In both systems, “grandfathered” will no longer be a selectable option in menus and will be replaced with the “pre-existing tobacco product” terminology. Similarly, the acknowledgement letter CTP sends after receiving a voluntary determination request will now use this updated terminology.
CTP also plans to update guidances that previously included the term “grandfathered.” The Center will announce the availability of revised final guidances for industry, collectively entitled, “Pre-Existing Tobacco Product Guidance Documents” via the Federal Register in the future.
If you have a pending grandfathered determination request, no additional action based on the terminology update is required.
- Pending or completed submissions do not need to be resubmitted or amended due to the terminology update, and processing of these requests will not be impacted by the terminology update. All submissions will continue to follow the standard review process as outlined on the pre-existing tobacco products webpage. Determinations made under the previous terminology do not need a new status determination request and will be automatically considered a pre-existing tobacco product if they were previously determined to be a grandfathered tobacco product.
- Applicants with a pending or previously authorized Substantial Equivalence Report that references a grandfathered product are not required to take any additional action based on this terminology change.
- Submission Tracking Numbers (STNs) will not change and will retain either the grandfathered (GF) or pre-existing (PX) STN number as originally assigned under the acknowledgement letter sent to submitters to confirm receipt of the submission. Submitters should refer to this number for all correspondence with the FDA regarding the submission.
This important update will not adversely impact CTP’s continued progress on programmatic work to protect the public from the harms associated with tobacco use, including review of premarket applications and enforcement of illegally marketed tobacco products. We will continue to use the best available evidence to make marketing authorization decisions while enforcing regulations that reduce the public health burden of tobacco products at the population level. At the same time, we must also continue our commitment to diversity, equity, inclusion, and accessibility by updating this outdated term. If you have a question about pre-existing tobacco products, please send an email to CTP-PreExisting@fda.hhs.gov.