During the PMTA Review, the Food and Drug Administration (FDA) issued a “Refuse to File” letter to JD Nova Group, the parent company of brand Vapolocity, on August 9th. This was due to the lack of required Environmental Assessment (EA) reports in the 4.5 million applications submitted by the company. The agency immediately ruled that the relevant products must be taken off the market.
The first premarket tobacco product application (PMTA) approved by the FDA went back to 2015, when several snus products of eight Swedish companies were authorized to be sold in the U.S. In recent years, the FDA has extended its stringent control over nicotine products to the vaping industry.
That stems from growing concerns over nicotine’s negative impacts on children’ developing brains, and its risk of increasing children’s vulnerability to such addictive substance. As claimed by the FDA, its moves are critical to protecting “youth from the potential lifetime of nicotine addiction.”
Last year, the FDA ordered that all vaping manufacturers submit PTMAs for their products before September 9, 2020. Otherwise, they have to remove all the products from the market. The FDA reviews the applications in four steps:
First, the FDA conducts a check on whether the submitted applications come complete with required materials;
Second, the agency files applications that include in required materials;
Third, the FDA initiates substantive reviews of the filed applications;
At last, it releases the list of authorized applications.
The FDA’s review process was originally scheduled to close down on September 9, 2021, spanning exactly one year. However, there could be a change of plan. According to a post by the FDA in May 2021, the agency received over 6 million applications.
With such a tight deadline, an FDA staff believed “the likelihood of FDA reviewing all of the applications received by Sept 9, 2021, is extremely low.” The agency is considering about using its discretion to extend the review period.
Some vaping manufacturers and suppliers are sitting on pins and needles. Apart from JD Nova’s 4.5 million applications, there’re another 2 million from countless vape firms queuing up for reviews. The FDA previously ruled that if an application was not filed by September 9 this year, it would be regarded as illegal to market or sell the product concerned.
So far the agency’s “filing” letters have been sent to only some of the manufacturers, whose applications altogether cover about 138,000 vape products. That means these applications are about to enter the next “substantive review” phase. However, not a single vaping product has received the FDA’s final authorization.
There’s less than one month to go before September 9. But for vape firms who have heard nothing from the FDA, it’s a hard period to weather.
