New PMTA deadline

New PMTA deadline

July 17, 2019

The District Court of Maryland on July 12 issued an order that will set the U.S. Food and Drug Administration Center for Tobacco Products’ (CTP) Premarket Tobacco Application (PMTA) deadline for vapor products to May 12, 2020—10 months from now.

The new deadline is more than two years ahead of the current August 8, 2022 PTMA deadline that was reset in 2017 when former FDA Commissioner Scott Gottlieb took over his position.

As part of the order Judge Grimm noted that products can remain on the market for a year while the FDA-CTP reviews their applications and that the CTP has the ability to exempt new products from filing on a case-by-case basis.

The FDA last month proposed the shorter timeline after the court ruled in a lawsuit filed by anti-tobacco groups that the agency had exceeded its authority in allowing e-cigarettes to remain on the market until 2022 before companies applied for regulatory approval.

Morgan Stanley tobacco analyst Pamela Kaufman does not expect the CTP to contest the judge’s decision.

Category: Breaking News

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