In passing the Family Smoking Prevention and Tobacco Control ACT (“FSPTCA”), Congress established specific pathways to market for new or modified tobacco products and a process for seeking FDA authorization to make modified risk claims. These pathways, including the Substantial Equivalence (“SE”) pathway and the Premarket Tobacco Application (“PMTA”) pathway, each have different standards. For example, under the PMTA pathway, FDA must find that a new tobacco product is “appropriate for the protection of public health.” The Modified Risk Tobacco Product (“MRTP”) process is intended to permit truthful and accurate communication of relative risk information about a tobacco product to adult tobacco consumers.
Successful implementation of the SE and PMTA pathways and the MRTP process requires predictable “rules of the road” in order for the pathways to comply with the FSPTCA’s requirements and advance the goal of reducing the harm caused by tobacco.
Where We Stand:
We have encouraged FDA to establish foundational pathway rules through notice-and-comment rulemaking processes. To date, FDA has published proposed SE and PMTA rules. This is an important step as tobacco product manufacturers need clear, efficient, and achievable requirements that are science- and evidence-based and which create a consistent and predictable regulatory environment.