When the FDA put out its list of vape products for which a PMTA was filed before the September 9th deadline, it was difficult to miss the fact that over 65% of the vape juices on the list were all made by one company: JD Nova Group.
JD Nova had received an initial acceptance letter from FDA but, on August 9th, the FDA issued a "Refuse to File" letter to the company which will result in 4.5 million e-juice products being yanked from the market. While that sounds significant, the fact that each nicotine level, PG/VG base ratio, and bottle size counts as a separate "product," the actual number of vape juice flavors being pulled is far less than 4.5 million. JD Nova also has additional PMTA's still pending FDA review.
The FDA press release about the rejection noted that the ruling was based on the lack of "an adequate Environmental Assessment." An Environmental Assessment (EA) was one of many required sections of the PMTA that all vape companies had to submit to the FDA by September 9th. Preparing the EA portion of the PMTA was extremely arduous as it involved calculating total carbon emissions based on sales data, bottle packaging choices, cardboard usage and more to come to a total carbon emissions number. For pretty much all small businesses, the final number fell far below the threshold, meaning that total emissions were negligible, however, all companies had to put in the time to prepare these assessments anyway.
Given the extremely large number of products that JD Nova Group submitted to the FDA, it's not surprising that the company was not able to adequately complete EA's for each product as required.
It also seems likely that the FDA may not have considered the JD Nova application to be a serious attempt at compliance and the shortcomings in the Environmental Assessment section may have provided a convenient excuse to kick the company out of the running.
It would certainly seem doubtful that JD Nova, a relatively small company, was prepared to pony up the hundreds of thousands of dollars per product a serious PMTA application requires to get the product all the way through the FDA approval process. Because they submitted so many applications, it's possible the FDA viewed JD Nova as clogging up the PMTA process for the FDA and for other companies that were taking a more serious approach.
Many companies submitted PMTA's knowing they would never make it through the entire process but, by submitting something--anything--they hoped to at least buy themselves a few more months in business. The FDA was swamped by so many PMTA's that a vape company could have, conceivably, written "F--- you, FDA" on a piece of paper and, as long it was submitted by the September 9th deadline, they could continue with business as usual until the FDA got around to reviewing the application.
Whatever the motivation of either JD Vapes when the company submitted the PMTA's or the FDA when they rejected them, with the stroke of a pen, the FDA just reduced its own PMTA review burden by around two-thirds.
JD Nova Group sells e-juices under several brand names including De-Ja Juice and Ideal Elixirs. All JD Nova vape juice subject to the FDA's refuse to file letter are now illegal to sell in the United States, effective immediately.