Back in May 2016, the FDA announced a “deeming” rule stating that the PMTA guidelines would cover both the traditional market and the vape industry. This means that any vape product manufactured after August 8th, 2016 would need to file a PMTA so that the FDA can make sure the ingredients and everything used are safe. The PMTA would then be approved or declined for the sale of these products. When the deeming rule was implemented, a deadline for August 8th, 2018 was set for vape manufacturers to submit their PMTA’s. The next year (July 2017) the new FDA Commissioner, Scott Gottlieb, announced the deadline would be postponed until August 8th, 2022. The deadline was later set to May 12th, 2020 by District Judge Paul Grimm of the U.S. District Court for the District of Maryland.
In March, NATO sent a letter to the FDA’s Center for Tobacco Products requesting that the PMTAs deadline be extended as there were concerns that the deadline would create an unnecessary burden on companies that sell essential products. “The main reason for the extension is the ongoing COVID-19 crisis,” Tom Briant, executive director for NATO said. “Given the enormous number of products that require [PMTA] submissions, retailers would be very hard-pressed to continue their critical workplace function of providing food, beverages, groceries, medications, and gasoline to the public while simultaneously attempting to comply with FDA tobacco regulations.”
Later that month on March 30th, the FDA filed a request to District Judge Paul Grimm that the PMTAs deadline be extended by 120 days due to disruptions caused by the coronavirus outbreak. The FDA received many inquiries from the tobacco industry expressing concern that they won’t be able to complete their PMTA’s by the May 12th deadline originally set due to interruptions at most stages of preparation, including employees needing to stay home to avoid becoming ill and overseas manufacturing facilities being shut down for the time being.
The vape industry got a win on April 22nd when District Judge Paul Grimm agreed to extend the deadline for the PMTA’s to September 9th, 2020 due to the coronavirus outbreak. This win comes after the House of Representatives Committee sent a letter to the FDA Commissioner, Stephen Hahn, requesting the FDA to immediately “clear the market” of all vaping products. The request was quickly shut down and the extension was granted.
Do you think 120 days is long enough for manufacturers to complete their PMTAs? Leave a comment with your thoughts below.
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