Robert BarnesThe Center for Tobacco Products (CTP) under the Food & Drug Administration has rejected several Vuse offerings in its latest batch of marketing orders under the premarket tobacco application (PMTA) process.
Menthol refills for both the Vuse Vibe and Vuse Ciro were the subject of the FDA’s focus in a news release posted on January 24, 2023.
“Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the statement read.
This is not the first round of marketing orders issued from the agency to R.J. Reynolds’ Vuse. Both of these products in their tobacco-flavored variants were already authorized in May, 2022.
At this point, the agency has not yet authorized a single menthol-flavored e-cigarette product.
The Problematic PMTA Process
The PMTA process has been a long and arduous process for all parties involved. The FDA has issued so many marketing denial orders (MDOs), while only authorizing a small handful, that the entire situation is looking like a lost cause.
This is mostly due to the fundamental flaws that the whole process and its methodology have been based on.
As mentioned, the tobacco-flavored versions of both of these vapes were authorized mid-2022.
This is one of the main critiques of the PMTA process as a whole. The FDA has had plenty of time to review a specific product, but then withholds their marketing orders for non-tobacco-flavored products for what seems like an unprecedented duration.
To make matters worse, there are few repercussions to stop the agency from continuing this problematic behavior.
Where Do Menthol-Flavored Vapes Fit Into It All?
Every round of MDOs is always met with the same response by the vaping community, but denials for menthol-flavored products hit just a little harder.
The reasoning behind this decision, as cited by the FDA, demonstrates that the FDA sees these as the same class of product as a flavored vape.
This does not really fit into their philosophy that flavored-vapes are always fun and exciting flavors used to lure in the underage population, it also means that there is little hope at this point for any kind of compromise.
It is not a huge assumption to believe that with only a select number of tobacco-flavored vapes being allowed, smokers will keep smoking and dedicated vapers will seek out less legal methods to acquire their favorite products.
In Summary
The Food & Drug Administration has issued yet another round of marketing denial orders for multiple menthol-flavored vape products. All menthol-flavored Vuse Ciro and Vuse Vibe products, including refill pods, will now not be allowed to be sold in the US.
Similar to other previous denial orders for flavored products, the agency cited that these products present too much risk to the youth population, with not enough benefit to adult smokers.
With even menthol-flavored products being denied, the future is looking bleak for American vapers.
Russ Ware
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