Two of the earliest devices accepted by the FDA (Food and Drug Administration) via the PMTA gateway (Pre-Market Tobacco Application) have been denied refills with menthol flavors. Rejected. Each Vuse Vibe and the Vuse Ciro Vuse Ciro device has been dismissed refills. The FDA has accepted both devices’ tobacco-flavored pods.
The FDA has been putting off an announcement on flavorings containing menthol for a long time, probably due to plans to introduce an all-menthol ban on the entire tobacco industry. This is the first time the FDA has made an official decision on a product with flavor to justify its rejection. While many other flavored products were ruled out of market approval, these vape products were not dismissed because of their taste. They were denied because the applications did not provide sufficient evidence to show that the advantages to adults who smoke outweighed the dangers they could pose to younger vapers.
A formal prohibition on menthol-based products is not yet in place but only suggested. Menthol is an ingredient that was once permitted in cigarettes despite many flavors being prohibited. Because of the background of menthol, its appeal to Black tobacco smokers, and the absence of information on what direction the FDA will take about the menthol vapes, the denial of menthol-flavored pods is significant news. Furthermore, the FDA has used language that clearly stated they saw e-liquids as tobacco-flavored, flavored, or flavorful vapes. Flavored and menthol flavors.
The following statement is clear: the FDA will likely reject menthol flavors shortly.
“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.”
In general, the present FDA administration tends to be a pro-vape. In light of the decision to deny Vuses’s menthol vape refills and the comments made in the press release that accompanied it, It is doubtful that vapes with menthol flavors will receive approvals. The only likely path for legal vapes is one of the litigations between vape firms and the FDA.
