Russ WareThe FDA has announced that four new menthol-flavored vape products have been granted marketing authorization, as of Friday, June 21, 2024. This 17% increase in FDA-authorized vape products, which takes the total to 27, could be seen as a minor win for vapers. Yet it is still a tiny fraction of the 27 million deemed products submitted for approval since 2016, 26 million of which have already been denied authorization.
All four of these newly authorized products belong to the NJOY e-cigarette brand, a subsidiary of Altria, one of the largest tobacco companies in the world. This latest batch of Marketing Granted Orders (MGOs) takes the total number of authorized NJOY vape products to ten, more than a third of the total legally available in the United States.
Of note, however, is the fact that these are the first ever non-tobacco flavored products to meet the rigorous FDA standards for safety and risk reduction that are required for an MGO to be given. So rigorous, in fact, that despite NJOY already having similar products on sale, it still took four years for these authorizations to be granted.
The four newly authorized products are:
- NJOY ACE Pod Menthol 2.4%
- NJOY ACE Pod Menthol 5%
- NJOY DAILY Menthol 4.5%
- NJOY DAILY EXTRA Menthol 6%
The two ACE products are pre-filled 2ml closed pods for the previously authorized NJOY ACE Device, and the two Daily products are single-use disposables containing 1ml of e-liquid. As the percentages on display show, all have relatively high nicotine content, ranging from 24mg/ml to 60mg/ml. That’s about as strong as you can get when it comes to e-liquid.
Obtaining Marketing Granted Orders for Vape Products
Even the summaries of these latest decisions to allow the marketing of the NJOY products are long, complex, and likely to be baffling to the average person reading them. But, in essence, they state that the evidence submitted by the applicant (NJOY) shows that these menthol-flavored products would be of benefit to adults who want to completely switch from smoking cigarettes. And that those benefits are sufficient to outweigh the risks of the product, including youth appeal.
According to the 2023 National Youth Tobacco Survey (NYTS), menthol-flavored vapes came fourth (20.1%) in a list of the most popular among young users, behind fruit (63.4%), candy/desserts/sweet (35.0%), and mint (27.8%). Tobacco-flavored vapes accounted for just 6.4% of underage use.
Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products, said:
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome. This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
It would be reasonable to wonder how many times he would be able to say that about cigarettes or cigars if they had not been grandfathered out of the requirement to prove they are currently safe for public health.
The FDA announcement of these latest product authorizations is keen to point out that they are not “FDA-approved” and that the agency will closely monitor their popularity. It may, at any time, suspend or withdraw authorization if it is determined that they are no longer appropriate for the protection of public health. That includes whether there is a significant increase in the use of the products by young people and former smokers or a decrease in the number of current smokers who completely switch to the products.
That is a reasonable stance for the FDA to take, yet it also highlights the disparity between the controls deemed sufficient to control other harmful activities popular with young people (including smoking and drinking alcohol) and those being applied to control vaping. If the rate of youth smoking increased, would marketing authorization be removed for packs of Marlboro or Newport?
Robert Barnes
Versed Vaper Team
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