Audit of the Food and Drug Administration's Premarket Tobacco Product Application Process for Electronic Nicotine Delivery System Products

The Food and Drug Administration (FDA) is responsible for regulating tobacco products. Under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers wanting to market a new tobacco product must first obtain a marketing order. Those seeking a marketing order for a new tobacco product may submit a Premarket Tobacco Product Application (PMTA) to the FDA. FDA has received PMTA submissions from manufacturers of electronic nicotine delivery system (ENDS) products. �Section 910(b)(1) of the FD&C Act contains the requirements for a PMTA submission. �In FDA's assessment of PMTAs, FDA must determine whether the new tobacco product is appropriate for the protection of public health. Our objectives are to determine: (1) FDA's progress on reviewing applications for ENDS products; (2) whether FDA's policies and procedures ensured that marketing orders were granted or denied for ENDS products in accordance with Federal statutes, regulations, and guidance; and (3) what actions FDA has taken to ensure that ENDS products that are not appropriate for the protection of public health are not marketed.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Revised	Food and Drug Administration	Audit of the Food and Drug Administration's Premarket Tobacco Product Application Process for Electronic Nicotine Delivery System Products	Office of Audit Services	W-00-22-59465	2024