According to tobaccoreporter, the U.S. Food and Drug Administration (FDA) has completed most of its review of Pre-market Tobacco Product Applications (PMTAs) for major e-cigarette products on the market.
In its latest progress report, the FDA said it has taken action on 185 of the 186 marketing applications for e-cigarette products covered by the 2022 court order, which applies to products with a significant market share that were filed before September 9, 2020. The manufacturers of these orders have received a Market Denial Order (MDO) or FDA authorization.
According to other sources, the application still under review may belong to Juul. The FDA issued a market denial order to Juul in 2022, but soon agreed to further review the application. In June of this year, the FDA lifted the denial order and once again conducted a full scientific review of Juul’s products.
The FDA said in its report that the agency has issued more than 18 million denial-of-acceptance decisions, more than 67,000 denial-of-document decisions, and about 46,000 market denial-of-acceptance orders, most of which were for bottled vapes made by small – and medium-sized manufacturers.