Why the FDA Denied 4.5 Million Product Applications From One Vape Company – Filter

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.
It was the first major move by the FDA ahead of the agency’s own September 9, 2021 deadline to determine, through its PMTA process, the legality of vaping products remaining on the market. Should an application be successful, that vaping product would be designated “appropriate for the protection of public health,” in what would be an incredibly significant development for harm reduction.
The PMTA process is intended to increase oversight of vaping products and should, in effect, quell well-publicized scares over teen use and unsubstantiated health concerns. It essentially requires manufacturers to accomplish three steps: acceptance, filing and finally, a scientific review—which is the time-consuming and expensive portion. It can cost potentially millions of dollars per product, and many companies are still sending sections of their scientific reviews piecemeal to the FDA, even if that is not necessarily by-the-book procedure.
In JD Nova’s case, the FDA explained that the company’s products lacked an appropriate Environmental Assessment (EA)—an onerous and complicated section that covers a product’s environmental impact from the point of manufacture to disposal. The agency added that, under its own regulations, “implementing the National Environmental Policy Act (NEPA), an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues.” (Emphasis my own.) 
What occurred could largely be defined as a misstep in the expensive, laborious and not-completely transparent PMTA process.
“At the outset, we explained to the FDA what was going on, and that there would be delays, and that we’d be sending them more data,” Amanda Wheeler, the president of the American Vapor Manufacturers Association, told Filter. “Up until this point, the FDA has worked with us on that.”
Still, the JD Nova development was met with confusion among industry players and active observers of the United States’ ongoing e-cigarette saga. It appeared the FDA had—at a stroke—ripped around 75 percent of the total 6 million or so pending vaping products off the marketplace.
But that is not, really, what happened. For one thing, there were nowhere near 4.5 million JD Nova products on the market.
Instead, what occurred could largely be defined as a bureaucratic misunderstanding, a misstep in the expensive, laborious and not-completely transparent PMTA process. In the eyes of the FDA, denying a large portion of the applications for what amounts to a technicality was also perhaps an easy way to show progress being made.
Wheeler explained the specifics to Filter.
For context, a few years ago, she had begun corresponding with the FDA, in the hopes of helping smaller businesses through the PMTA process. The agency, Wheeler said, wasn’t offering the guidance that she and others needed.
Meanwhile, Char Owen, who owns a small vapor company in Texas, created an informal Facebook group where manufacturers could post and share information. With a background in IT, she also developed a program that allowed applications to be duplicated for all of their products.
Wheeler became heavily involved, and after the PMTA submission deadline in September 2020, she and Owen realized that they should formalize their efforts. So the two women founded the American Vapor Manufacturers Association, which now has 83 members. Wheeler estimates that 230 companies used the resources from that Facebook group to initially file their PMTAs—representing “a very high percentage” of the total number of PMTAs ultimately filed, she said.
JD Nova, a mid-size vape manufacturer based in Texas, was one of them.
Wheeler said that JD Nova had submitted a PMTA for every single potential product that had been previously registered with the FDA, following the agency “deeming” e-cigarettes to officially be under its regulatory umbrella. In other words, when JD Nova initially registered products with the FDA in 2016, many of them were simply hypothetical—including, for example, various nicotine levels and bottle sizes that would never be sold. Wheeler compared it to someone trying to achieve extra credit on homework assignment.
But the strategy backfired. In the end, JD Nova seems to have included an EA for each flavor that it makes—but not for each variation of that flavor. Put another way: If you’re a manufacturer, and you have an e-liquid that comes in five flavors, three nicotine levels, and two bottle sizes, you had to submit an EA for each minor variation of that product—a total of 30 in that made-up example—even though they’re virtually identical. The 400 or so PMTAs for which JD Nova submitted specific EAs remain in process. (Through Wheeler, JD Nova declined to comment.)
At this point, nobody really expects a consistent outcome to the PMTA process. Amid panicked headlines about vaping, it had been rushed from the start—especially considering most companies had initially been aiming for an anticipated submission deadline in 2021 or even 2022. But after anti-nicotine groups sued the FDA—claiming the agency had essentially exceeded its authority by allowing e-cigarettes to remain on the market largely unregulated for that long—a US district court judge in July 2019 imposed a new, 10-month deadline. (The judge later extended the date to September 2020, following complications and delays related to COVID-19.)
“The court order gave FDA one year from the submission deadline to review these applications,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises clients on nicotine regulations. “But it has taken FDA years to review individual applications [for nicotine products other than vapes] that have been approved so far, like the ones for IQOS and Swedish snus. The idea that the FDA was going to be able to complete the actual scientific review of what we thought were going to be thousands, but ended up being millions, of vaping products within that time frame has always been fairly low.”
Whatever rulings the agency ends up making will have major consequences for the industry—and, therefore, for millions of Americans who vape, most of whom used vapes to quit smoking. Producers, tobacco harm reduction  proponents, and consumer advocates fear that the process could decimate mom-and-pop vape shops and smaller manufacturers in favor of the large companies that had the money and resources to file robust applications.
Recently, the FDA has signaled that it’ll likely judge the major companies first, followed by the smaller ones down the line. The agency will almost certainly not have enough time to make decisions on all of the applications before the legally imposed deadline.
“If products are not authorized by September 9, 2021, and do not come off the market at that time, they risk FDA enforcement.”
“The FDA is working to review as many of the applications by September 9, 2021 as possible,” an FDA spokesperson told Filter. “In general, the court gave the FDA until September 9, 2021 to complete review of the applications. However, given the unprecedented number of applications, the size, complexity and diversity of the submissions and the finite nature of our review resources, among other factors, the likelihood of FDA reviewing all the applications by September 9, 2021 will be challenging. We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by FDA.”
“With that being said, as with all unauthorized products generally, if products are not authorized by September 9, 2021, and do not come off the market at that time, they risk FDA enforcement,” the spokesperson continued. “Additionally, if a negative action is taken by the FDA on the application prior to September 9, 2021, the product must be removed from the market or risk FDA.”
 
 
Photograph by Vaping360 via Flickr/Creative Commons 2.0
The Influence Foundation, which operates Filter, has previously received unrestricted grants from Philip Morris International, the manufacturer of IQOS.

Alex is a staff writer at Filter. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times Magazine, The Columbia Journalism Review, The Nation and The Daily Beast, among other outlets. He is also a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received both restricted and general support grants from the Foundation for a Smoke-Free World. Alex is currently based in Phoenix, Arizona.
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