The Food and Drug Administration’s (FDA) final Deeming Rule requires manufacturers of deemed tobacco products to submit their products to the agency for approval before those products can be introduced into the market. On September 25, 2019, the FDA published a proposed rule titled Premarket Tobacco Product Applications and Recordkeeping Requirements. Linked here is the Office of Advocacy’s (Advocacy) public comment letter on that proposed rule. The premarket tobacco product application (PMTA) rule has yet to be finalized. For most electronic nicotine delivery systems (ENDS) products, the only approval pathway available is the PMTA.
The timeline for PMTA compliance has been adjusted several times. As an outcome of the American Academy of Pediatrics litigation against the FDA, the United States District Court for the District of Maryland set the PMTA compliance date for May 12, 2020. On March 30, 2020, the Government requested under Fed. R. Civ. P. 60(b) that the court extend that deadline because of the “exceptional and unforeseen” circumstances of the current pandemic. On April 22, 2020, the court granted the Government’s request, setting September 9, 2020, as the new PMTA compliance date.
On August 24, 2020, several small ENDS manufacturers, retailers, and trade associations submitted a citizen petition under 21 C.F.R. § 10.30 and the Family Smoking Prevention and Tobacco Control Act. Advocacy is concerned that many small businesses in the vaping industry will be forced to close without a further extension of the PMTA deadline and that many of the issues the FDA cited as reasons for an extension in March 2020 are still present today. The letter below constitutes Advocacy’s public comments in support of the citizen petition.