The FDA Issues PMTAs for Several NJOY…


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The FDA has been reckless in issuing MDOs without presenting relevant evidence to back up its decisions.

The FDA has just granted NJOY LLC marketing permits to for its Ace closed vape device and three accompanying tobacco-flavoured pods. This authorization allows these products to be legally marketed across the US, yet it does not mean that these products are safe or “FDA approved.”

The agency also issued marketing denial orders (MDOs) to NJOY for multiple other Ace products. These products must be removed or the FDA may take enforcement action, and two menthol-flavoured Ace vape pods remain under FDA review.

Similarly, the FDA recently issued MDOs for the myblu vaping device and several of its tobacco-flavoured pods. The agency said that allowing the sale of the products would not be “appropriate for the protection of the public health”  because Fontem failed to present “sufficient evidence regarding design features, manufacturing, and stability.” Reason highlighted that this “illustrates how nebulous that standard is and how arbitrarily the FDA applies it.”

Issuing MDO’s recklessly

Previous articles have reported that the FDA has been reckless in issuing MDOs without presenting relevant evidence to back up its decisions. 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 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 FDA Has Granted PMTAs to Several Tobacco Flavoured Vape Products 


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