Robert BarnesThe FDA has authorized yet another NJOY product, this time in the form of a disposable e-cigarette — the NJOY Daily. NJOY’s authorized offerings are their Rich Tobacco and Extra Rich Tobacco flavors, each having a 4.5% and 6% nicotine strength, respectively.
The announcement came as part of a statement released on June 6, 2022. This marks the fifth marketing decision from the FDA since the premarket tobacco application (PMTA) process began.
Like prior FDA authorizations, only tobacco-flavored products have been met with approval, whilst the other offerings faced marketing denial orders (MDOs). Alongside numerous others, the menthol-flavored ‘Daily’ products are still under FDA review.
For those unaware, these FDA authorizations are not to be confused with FDA approval. They simply represent permission for manufacturers like NJOY to market the authorized product. All products met with MDOs must be removed from all forms of marketing upon the marketing issue being ordered.
“NJOY could have continued to sell its flavored Daily disposable products post-Trump flavor restrictions, but chose not to avoid any negative publicity,” Greg Conley, the president of the American Vaping Association tweeted. “Their reward, not surprisingly, is all but the tobacco (any maybe menthol) varieties being banned.”
With the authorization of the NJOY and the other products on the list, the FDA has stated that their benefit in terms of harm reduction outweighs the potential risk associated with them.
On the other hand, MDOs are incredibly intertwined with underage vaping, meaning flavored products face much stricter reviews as they have been openly criticized for enticing the youth populations to take up vaping and eventually smoking.
At the time of writing, the only other manufacturers to have been granted marketing authorizations are Vuse and Logic, which begs the question…
Why Is NJOY Getting Authorized?
NJOY is an independent vape and e-cigarette manufacturer based in the United States. Its mission statement has been to assist in the eventual goal of smoking cessation since 2007.
NJOY is also one of the only manufacturers to have received authorizations from the FDA. Not only that, but they have received authorization for multiple products, these being the disposable Daily and the Ace pod device.
This authorization is notable in two main aspects. Firstly, NJOY remains the only small independent manufacturer to have received FDA authorization. Secondly, the Daily is the only disposable device on the premarket marketing granted order list.
While the fact that a manufacturer that is independent of big tobacco has managed to receive multiple authorizations, it remains unknown why NJOY continues to be given authorizations amidst countless others facing MDOs.
The list of other products to have received marketing authorization remains small. These products include the aforementioned NJOY Ace, Vuse Solo, and Vuse Vibe, as well as several Logic brands. Logic’s Vapeleaf, Pro, and Power products were all authorized on March 24.
What Does This Mean for Disposables?
The significance of a disposable product receiving authorization should not be overlooked. The FDA has clear goals to reduce underage vaping, yet disposable vapes and e-cigarettes are by far the most popular amongst youth populations — and the FDA knows it.
This could prove to be an interesting case study as to how significant a role marketing plays in underage users starting to vape.
On the one hand, the marketing of a disposable will no doubt be accessible to minors. On the other hand, only tobacco-flavored products will be seen by these populations.
This is something the FDA has addressed based on data reviewed from the 2021 National Youth Tobacco Survey (NYTS). “Although the NYTS showed the relative popularity of disposable ENDS among youth, it also indicated that the most commonly used flavor types among youth who currently used any type of e-cigarettes were flavors such as fruit, candy or mint, and not tobacco flavors,” said the FDA in their statement.
All of that is good and well, but the theory is one thing, while the application is another. Only time will determine the effectiveness of barring the marketing of flavored products, yet allowing the attractive disposable products to be seen – albeit in their tobacco-flavored variations.
The next set of marketing decisions issued for a disposable vape product could give insight into how the FDA plans to treat other disposable offerings from larger companies, particularly under the new guidance of Brian King.
PMTA Outcomes on the Rise
This year has marked a significant year for vaping regulation, as the FDA has only now begun making decisions regarding the marketing of vapes and e-cigarettes after a review period of nearly two years.
The premarket tobacco application submission deadline was set as September 9, 2020. The FDA remained all but silent until their first authorization (the Vuse Solo) in late 2021.
It appears that marketing decisions are increasing steadily, most likely as a result of the order that was issued by US District Court Judge Paul Grimm in April. 2022.
In accordance with this court order, the FDA has stated that an expected minimum of 120 product marketing orders will be issued by the end of June. This comes after being granted a two-week extension past the original deadline of April 29.
When considering the millions of products still under review, it is fair to say that the FDA will not complete the PMTA process in the near future.
The increase in authorizations, particularly that of NJOY, could leave some optimism for future authorizations of more popular brands. However, the FDA being led by Brian King, along with the ever-increasing regulation around vaping means things are likely to continue to worsen in the US and all those who adopt their guidance.
In Summary
The NJOY Daily becomes the first disposable vape to have FDA authorization, in NJOY’s second set of PMTA successful outcomes. Along with all of the other products to have marketing authorization, only the tobacco-flavored Daily products were not met with marketing denial orders. The authorization of a disposable e-cigarette could allow for insight into upcoming marketing orders as they continue to be frequently released.
Russ Ware
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