The Campaign for Tobacco-Free Kids says it intends to take the FDA to court if it does not “immediately clarify” the timeline and reason for these delays.
The US vape industry is growing concerned about the number of rejected PMTA 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 these rejections came as a shock to say the least. The reason being, that 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.
The FDA is pressured to banish Juul
Naturally, this mass denial of PMTAs has been welcomed by certain anti-vaping politicians and groups, some of whom have been pressuring the FDA to flat out reject any applications by Juul. To this effect, such entities such as the American Lung Association (ALA) and the Campaign for Tobacco-Free Kids said they are “deeply disappointed” that the FDA was still studying a percentage of the applications, including Juul’s. ECigIntelligence revealed that the Campaign for Tobacco-Free Kids has gone as far as saying that it intends to take the agency to court if it did not “immediately clarify” the timeline and reason for these delays.