The Food and Drug Administration (FDA) recently released new regulatory science policy memos related to the premarket tobacco product application (PMTA) review process. These memos outline the internal roles, responsibilities, and processes within the FDA’s Center for Tobacco Products (CTP). Developed between 2020 and 2022, the memos address various topics, including the FDA’s approach to acceptance and filing review, prioritization of applications for nontobacco nicotine products, and clarification of responsibilities among different divisions within the FDA.
The five memos that were released include guidelines for marketing plan review and evaluation, clarification of responsibilities regarding harmful constituents, and divisional responsibilities for PMTA review. The FDA had initially aimed to complete the review of applications by the end of the previous year but due to legal challenges and manufacturer amendments, the deadline has been extended to June 30.
The release of these memos follows recommendations from the Reagan-Udall Foundation. These policy updates provide insights into how the FDA is handling tobacco product reviews in-house. However, it is important to note that these memos reflect the center’s internal thinking at a specific point in time and are subject to change based on regulatory framework or policy updates.
