Despite shifting the PMTA deadline back and forth numerous times, leaving the smaller vape companies unprepared, over 500 businesses (most of which are small) managed to meet the deadline. In total, over 6.5 million Premarket Tobacco Applications were submitted, one for each product from every brand and any slight variation of it.
The FDA was expecting less applications
A blog on Competitive Enterprise Institute’s website highlighted that this 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.
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), based on the excuse 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.”
The agency added that such evidence, “would likely be in the form of a randomized controlled trial or longitudinal cohort study,” though it leaves room for other types of evidence “if sufficiently robust and reliable.”
Double standards?
However all this 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, PMI’s heated tobacco product, IQOS, and reduced nicotine cigarettes made by 22nd Century Group. “All of this came as a surprise to the vapor industry, which, after years of requests for clearer guidance from the FDA, was never told that the agency was uninterested in more general evidence about the safety of e-cigarette ingredients, products, or their efficacy in reducing risk to adult smokers. One reason they couldn’t have known this is because it isn’t the standard to which the FDA has held other tobacco products that have successfully completed its pre-approval process,” read the blog about the applicants who got rejected.
Tobacco companies remain at an advantage
Meanwhile, a recent release by ECigIntelligence who analysed data from over 6 million submissions received by the FDA, highlighted that this analysis shows that there were many hundreds more applications for the simpler disposable and cigalike devices than for open system hardware. These type of products tend to come from large companies such as tobacco manufacturers, while open systems tend to be produced by smaller specialist businesses.
Of some 200 open system brands available today, only about 30 have filed PMTA applications to the FDA. Even if all these are approved, that disparity implies that about 85% of open system hardware brands will soon be removed from the market. “This may indicate the discouragement non-tobacco companies face when applying for PMTA approval,” said ECigIntelligence managing director, Tim Phillips.
