With a Month to Go, FDA Closes Out 4.5 Million PMTAs

In one fell swoop the FDA has eliminated two-thirds of the PMTAs clogging its authorization pipeline. The agency announced today it has issued a Refuse to File (RTF) letter for 4.5 million applications submitted by one e-liquid manufacturer.

The company, Texas-based JD Nova Group (parent company of Vapolocity), submitted more than 4.5 million of the total 6.5 million Premarket Tobacco Applications (PMTAs) received by the FDA. The RTF letter cited the lack of Environmental Assessments submitted for most of the company’s products.

The FDA noted that not all of JD Nova’s applications were rejected. The company submitted some products with the required Environmental Assessment, and those PMTAs are “still moving through the review process.” The 4.5 million JD Nova PMTAs don’t represent 4.5 million completely different products. A separate application must be filed for each variation of a product, including flavor, nicotine strength, PG/VG ratio, and bottle size.

JD Nova can refile the RTF applications—with the required paperwork—at any time. However, those products cannot continue to be sold, and they cannot be sold in the future until the company receives final marketing authorization (an approved PMTA). They must be removed from the market immediately, or risk enforcement actions.

When the FDA issued the original version of its “temporarily legal” product list in May, JD Nova/Vapolocity was the talk of the vaping world. Other PMTA hopefuls debated whether it was beneficial or detrimental to the vape industry for one company to essentially spam the federal agency with applications that couldn’t possibly be serious entrants in the regulatory sweepstakes. Many thought it amounted to little more than trolling the FDA.

Manufacturers were required to submit PMTAs for existing products by Sept. 9, 2020. Those that did were allowed a one-year enforcement grace period, during which those products could remain on the market until Sept. 9, 2021, while the FDA Center for Tobacco Products assessed their applications.

No vaping product has been authorized yet by the FDA. It’s not certain what will happen on Sept. 9, 2021, the final day products that were submitted on time may legally be sold under the FDA’s enforcement discretion. The agency has made clear that it is unable to grant a blanket exemption from enforcement for all products. However, the FDA does have the leeway to issue case-by-case exemptions.

The agency has said that mass-market manufacturers like Juul Labs, NJOY and the tobacco companies would have priority in the PMTA process (because their products are used by more people). That leaves independent manufacturers—especially very small e-liquid makers—questioning whether they’ll have a chance at approval, or if they'll be able to survive an extended wait for an answer.

Some industry insiders believe companies that are advanced in the scientific review process and communicating with the FDA will be given more time to remain on the market. But nobody knows for sure—and Sept. 9 is just a month away.