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FDA Approves NJOY Vape Products

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Author: Andres RomanDecember 14, 2022

In an incredibly positive turn of events, the Food and Drug Administration (FDA) approved several NJOY vape products for distribution. The news hit the front pages on April 26th and caused a flood of positive feelings among key industry players and consumers, even more so if it’s taken into account that NJOY is the third-largest vape manufacturer in the U.S. being sold in convenience stores.

With the PMTA approval of NJOY products, other major vape companies are starting to feel like it’s in fact possible to be approved by the FDA for distribution regardless of the latest decision concerning synthetic nicotine flavor bans. Of course, it’s logical that NJOY also has access to greater economic and legal resources than other smaller companies.

However:

NJOY is the first independent vape company with no links to Big Tobacco that is granted FDA authorization. So, while decisions regarding PMTAs submitted in 2021 (like the NJOY PMTA) were expected the previous year, the final decision (although late) is still a positive one for the industry.

NJOY FDA approval is specifically granted to the Ace device and three tobacco-flavored pods that fit it. While other big companies’ PMTA submissions remain under review, it is suspected that the FDA is evaluating these in the order they came in.

Unfortunately, not everything is positive.

While bigger companies do see a light at the end of the tunnel, multiple smaller companies with fewer resources have received Marketing Denial Orders (MDOs), something that we’ve been first-hand witnesses of here at VapeRanger.

On top of that, tobacco-flavored NJOY products were approved but the brand’s menthol-flavored pods remain ‘under review’. What will happen with these pods is uncertain, but many suspect that the FDA is waiting to publish a rule that bans menthol-flavored vape pods to communicate their decision on these. While this type of delay was expected for other fruit flavors, menthol-flavored pods have never encountered the same issue.

In a nutshell:

The FDA remains reluctant to allow sales of flavored vape products, a decision that shocks many as most adults will not switch from cigarettes to tobacco-flavored vape products and prefer other flavors when it comes to vaping. This is exactly the reason why companies are required to submit PMTAs: to prove that a product will help protect public health by helping adults switch from smoking to vaping.

So, if flavored vape products are more appealing to long-time smokers, then why are we banning them while we could be looking for other ways of preventing youths from purchasing them?

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