FDA Premarket Tobacco Product Applications and Recordkeeping Requirements Comment Period Reopened
On November 26, 2019, the Food and Drug Administration (FDA) published the proposed rule Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period. The FDA has reopened the comment period for the premarket tobacco product application (PMTA) proposed rule for 20 days. The agency will accept comment letters until December 16, 2019.
On September 25, 2019, the FDA published the proposed rule Premarket Tobacco Product Applications and Recordkeeping Requirements. The proposed rule establishes the requirements for the content and form of PMTAs for new tobacco products and requires manufacturers to maintain records establishing that their products are legally marketed. Additionally, the proposed rule establishes the general procedures FDA will follow to review PMTAs.
In the past, FDA has estimated that PMTA costs would be between $28,566 and $2,595,224 per electronic nicotine delivery system (ENDS) delivery unit, with an average cost of $466,563, and between $12,112 and $398,324 per e-liquid used in such devices, with an average cost of $131,643. As a result of a court order, the deadline for complying with the PMTA process is May 11, 2020, six months from now, for all new tobacco products. Over 90 percent of tobacco manufacturers and tobacco retailers are small businesses.