Broughton Nicotine Services has published a summary of the U.S. Food and Drug Administration’s rule for the premarket review of new tobacco products.
Released on Jan. 19, the FDA’s final rule makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for the agency to determine whether a marketing granted order should be issued for a new tobacco product.
The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Amongst other topics, the rule addresses:
- The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
- Whether the product presents the same or different risks compared to other tobacco products. The FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
- Electronic submission of the PMTA.
- Post-market reporting requirements for applicants that receive marketing granted orders.
- Retention of records requirements for PMTAs
- Procedures by which the FDA reviews a PMTA
Broughton Nicotine Services summarized the 516-page recommendations and requirements report into a digestible guide, which is available for download here.