US brand JD Nova Group is the company that submitted the most applications, at 4.68m submissions. ECigIntelligence revealed that the company’s president Jack Blaisdell’s LinkedIn profile, lists four subsidiaries for the company, including Vapolocity, a vape shop located in El Paso, Texas.
The second company that topped the list is the Texas-based Matrix Minds, with a total of 336,272 submissions. Owner Char Owen said that she has helped approximately 180 small companies file PMTAs by creating standard files that just had to be filled by the different companies. “For small manufacturers that had no information technology staff, this was an impossible task,” said Owen who has a background as a computer engineer.
With 120,399 submissions, Oklahoma’s Perfect Vape, holds the third position, while the forth and fifth down the list are Big Time Vapes and Imperial Vapors, with 96,950 and 65,382 submissions respectively.
The US vape industry’s PMTA concerns
Meanwhile the industry is growing concerned about the number of rejected applications. The first batch of rejections came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications from the same company, JD Nova, on grounds that they did not include an adequate Environmental Assessment.
At the end of the same month, the agency issued marketing denial orders, or MDOs, for applications related to flavoured vaping products (55,000 from one company and 800 from another), saying that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
A recent blog on Competitive Enterprise Institute’s website highlighted that the amount of applications received by the agency was way over the 25 applications a year the FDA initially expected. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.
Double standards?
However, it added, these rejections came as a shock to say the least, as over the last six years, the FDA has approved new tobacco products from three companies, for which it was happy to accept more general evidence about the product category’s appeal to adults and youth, as well as their general risks to public health. These approvals included eight varieties of Swedish Match North America’s snus, the heated tobacco product, IQOS, made by Philip Morris, and combustible cigarettes with reduced nicotine made by 22nd Century Group.
