The final rule will require manufacturers of Pre-Existing Tobacco Products and manufacturers of products that are exempt from the requirements of demonstrating substantial equivalence to maintain records to demonstrate that they can legally market their products. For products that receive a Premarket Tobacco Product Application (PMTA) marketing granted order, the final rule will require certain postmarket reporting, including periodic reporting and adverse experience reporting. The final rule will also implement and set forth requirements for the content and format of PMTAs and the general procedures we intend to follow in reviewing and communicating with applicants.
The final rule will make the review of PMTAs more efficient. As a result, the final rule will create cost savings for FDA related to the review of some PMTAs. The final rule will also create cost savings for FDA and for PMTA applicants by reducing the number of PMTAs submitted.
This is the first regulation to address the costs of PMTA requirements for new, originally regulated tobacco products. While we already included the costs to submit and review PMTAs for deemed tobacco products in the final regulatory impact analysis for the Deeming Rule, no regulatory impact analysis includes the costs to submit and review PMTAs for originally regulated tobacco products. Therefore, we include the costs to prepare and review PMTAs for these tobacco products in this analysis.
The final rule will increase the cost for applicants to prepare a PMTA. As a result, the final rule will generate incremental costs related to the preparation of PMTAs for ENDS products. Firms will incur costs to maintain and submit postmarket reports and we will incur costs to review these reports. Finally, firms will incur costs to read and understand the rule and costs to maintain records for some Pre-Existing Tobacco Products.
Regulatory Impact Analysis
PMTA Final Regulatory Impact Analysis (PDF 865KB)
Federal Register: 86 FR 55300, October 5, 2021