FDA Adds Menthol Vuse to Growing List of Marketing Denial Orders

The Food & Drug Administration recently released their latest batch of marketing denial orders (MDOs). This time these were for the menthol-flavored products under the Vuse Solo brand. The FDA had previously issued MDO’s for menthol refills for both the Vuse Vibe and Vuse Ciro.

The FDA released a statement about this decision on March 17, 2023.

As with almost every MDO, the FDA cited the potential risk that the flavored aspect of the product in question poses to the underage population outweighs the known benefit to adult smokers looking to quit smoking through vaping.

While the decision is unsurprising, it remains painfully frustrating for vaping advocates to watch the FDA slowly strip away some of the most enjoyable and appealing aspects of vaping. 

FDA’s Anti-Flavor Crusade

It should come as no surprise that these menthol products have been given MDOs. For those paying attention to the ongoing premarket tobacco application (PMTA) process, there has not been any non-tobacco-flavored products be given marketing authorization. 

Every time that a product is denied, the FDA statement cites underage vaping as the reason. Often, the statement will read something like this: 

“Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows 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,” the FDA statement claims. “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.”

Of course, the statement leaves out the important fact that the appeal is not exclusive to the youth population. Cutting back on this appeal directly impacts the number of adult smokers that will look toward vaping as a means to save their health and ditch traditional cigarettes. 

The Few Authorizations Granted

The list of products to be given marketing authorization by the FDA is incredibly short and it does not seem to be increasing very quickly. 

Interestingly, the tobacco-flavored versions of the Vuse Solo actually managed to get authorization.

While other flavored offerings under the Solo brand were met with MDOs fairly early on, the agency’s decision regarding the menthol-flavored products was held back for a very long time. 

This may have led some to believe that it may in fact be authorized. However, these hopes are now gone. 

The fact that a product that already has seen some success in overcoming the PMTA process has now been denied for their menthol-flavored versions likely means that there is no hope for any other flavored products to make the cut. 

Summary

The Food & Drug Administration recently released a press statement denying marketing orders for the menthol-flavored Vuse Solo products. 

The Solo is one of the few to have originally gained authorization for its tobacco-flavored products, but evidently the merits that allowed it to succeed back then were not sufficient in persuading the FDA to allow its only-slightly more appealing menthol-flavored products to be authorized.