FDA Proposes New Deadline for E-Cigarette Applications
The Food and Drug Administration (FDA) told a court that it will move up the date for premarket tobacco applications (PMTA) for Vape Starter Kit to next year, instead of the 2022 date it had previously set.
The agency's new deadline is in response to a May 15 ruling by U.S. Judge Paul W. Grimm of the U.S. District Court for the District of Maryland. Grimm ruled that the FDA sidestepped its authority when it pushed back deadlines set by its deeming rule.
The agency released the long-awaited deeming rule in May 2016, and the regulations — with spelled out deadlines — included in it went into effect in August of that year. However, one year later the agency said it was delaying the provision requiring manufacturers to submit applications for products on the market as of Aug. 8, 2016, for agency review.
Under the revised timelines, applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as electronic nicotine delivery systems or e-cigarettes would be submitted by Aug. 8, 2022, as Convenience Store News previously reported.
In a court filing on June 12, the agency proposed a 10-month deadline for e-cigarette and vapor companies to submit the applications after a final ruling, if the court decides not to remand the case back to the agency for further action, according to Reuters.Under its authority to regulate tobacco products, the agency must approve a PMTA to commercialize any tobacco product not on the market as of Feb. 15, 2007.
However, the groups that first brought the legal challenge against the FDA that led to the court ruling are asking for a much stricter deadline — 120 days.
According to Bonnie Herzog, managing director of tobacco, beverage and convenience store research at Wells Fargo Securities LLC, if the proposed shorter timeline for PMTA becomes a reality, Altria Group Inc. and Juul Labs Inc. would be well positioned relative to smaller manufacturers.
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