On August 9, the Food and Drug Administration (FDA) ordered that approximately 4.5 million vaping products from a single company, JD Nova LLC, could not be sold in the United States.
As a result, JD Nova cannot introduce these vaping products—many of which were not actually on the market—nor can it continue to sell the ones that were already available to customers.
The sudden decision caused fevered speculation among manufacturers and consumers, who worried that the federal agency was starting to crack down on e-cigarettes. But it turns out that technicalities—reflecting the enormously high hurdles of a legal application process, particularly for smaller companies with fewer resources—were to blame.
The FDA issued JD Nova a refuse to file (RTF) letter, stating in a press release that it did “not meet the filing requirements for a new tobacco product seeking a market order.” This was despite the fact that the company had filed premarket tobacco product applications (PMTAs) for each of those 4.5 million products—with each minor variant and component requiring a separate application—before a September 2020 deadline.
Alex Norcia – Filter – 2021-08-24.
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