Despite all the evidence indicating the relative safety and effectiveness of e-cigarettes as smoking cessation tools.
Yet while this evidence is as strong as that for the other new tobacco products recently approved for sale by the Food and Drug Administration (FDA), PMTAs for the former are being rejected by the thousands.
Sadly, following the FDA’s September 9 deadline to decide which vaping products are fit to be kept on the market, and which ones must go, it is becoming clear that the agency is biased against the products.
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 FDA was expecting less applications
A blog on Competitive Enterprise Institute’s website highlighted that this was way over the 25 applications a year the FDA initially expected. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.
Diane Caruana – VapingPost – 2021-10-07.