FDA Seeks Comments on Premarket Tobacco Product Applications Proposed Rule
On September 25, 2019, the Food and Drug Administration (FDA) published the proposed rule “Premarket Tobacco Product Applications and Recordkeeping Requirements.” The proposed rule establishes the requirements for the content and form of premarket tobacco product applications (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. Written comments on the proposed rule are due by November 25, 2019.
In the Deeming Rule, the FDA 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. Through guidance issued in 2017, the FDA set 2021 as the compliance date for PMTAs for combustible tobacco products, such as cigars, and 2022 as the compliance date for noncombustible tobacco products, such ENDS. On May 15, 2019, the United States District Court for the District of Maryland released a Memorandum Opinion that vacated the FDA’s August 2017 guidance; the Court then ordered a new deadline for the PMTA process of May 11, 2020, eight months from now, for all new tobacco products. Over 90% of tobacco manufacturers and tobacco retailers are small businesses.