FDA Issues First Marketing Order Denials

September 01, 2021

The FDA issued a press release on August 26th to notify the world that it had issued marketing order denials for 55,000 vape products. This represents the first time that official marketing order denials have been handed down since the September 9th, 2021 PMTA deadline and it doesn't bode well for many small vape businesses.

The rejected vape juices were made by three companies: JD Nova Group LLC, Great American Vapes, and Vapor Salon. Readers of this blog may remember the name JD Nova Group from our recent post about FDA's refusal to file nearly 4.5 million PMTA vape product applications from the same company just a few short weeks ago.

That previous refusal to file was based on the lack of an Environmental Assessment with the applications, however, the new marketing order denials have introduced a new factor. These denials were issued because they "lacked sufficient evidence that [the vape flavors] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products."

In other words, the manufacturers didn't offer enough evidence that, although they were making flavors with names like Apple Crumble, Dr. Cola and Cinnamon Toast Cereal that could appeal to kids, the products were helping adults get away from smoking leading to a net public health benefit.

Such evidence is costly to come by. Kai's Virgin Vapor has hired expert consultants in order to create and execute a detailed study of customer use of our products in order to try to address FDA requirements. That study is currently underway--at a cost of hundreds of thousands of dollars. 

But many other companies lack the resources to address FDA behavior and use concerns and, from what we have heard, most if not all PMTA's submitted by smaller companies did not include any such information leaving them vulnerable to what is likely to come next. 

The FDA is under pressure from anti-vaping organizations such as Tobacco Free Kids as well as members of Congress to give the boot to all flavored vape products. Some see the new FDA marketing order denials as heralding a sudden, swift purge of all flavored e-juices from the market in the coming weeks.

We don't think it's going to go that far but we do predict a wave of marketing order denials before the September 9th deadline as FDA rushes to boot from the PMTA process any company that did not address behavior and use studies in their applications in order to clear the backlog and demonstrate forward progress.

While Kai's Virgin Vapor supports the need for increased regulation of the vape industry, our hearts go out to our vaping brothers and sisters who are losing their favorite vape flavors, their jobs, or, worse, their livelihoods and the businesses they spent years building.

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