Uncovered FDA Memos Reveal Murky Strategy to Reject PMTAs

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While PMTAs for small to medium-sized businesses are being rejected by the thousands, new documents reveal that PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without reviewing their submitted documents. 

Despite shifting the PMTA deadline back and forth numerous times, leaving the smaller vape companies unprepared, over 500 businesses (most of which are small) managed to meet the deadline.

In total, over 6.5 million Premarket Tobacco Applications were submitted, one for each product from every brand and any slight variation of it.

The CTP used “a database query to identify the top twelve manufacturers with the largest number of pending PMTAs not in Phase III for non-tobacco flavored e-liquid products,” and put them through the “Fatal Flaw” review.

Read full article here.

Diane Caruana – VapingPost – 2021-12-09.

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