In 2019, the FDA proposed a rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The objective of this rule is to provide FDA with sufficient information to make a determination on a preliminary PMTA for further, more substantive review or not.
The content requirements instructed an applicant to submit detailed information regarding the physical aspects of its new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product and whether it presents the same or different risks compared to other tobacco products. In addition, the rule requires tobacco product manufacturers to maintain records on the marketing of legal tobacco products. The final rule was implemented on 10/4/2021.