Following the same logic FDA used to deny marketing authorization of JTI Logic menthol e-cigarettes, FDA has denied authorization for RJR to sell menthol versions of its Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5% e-cigs.
While FDA does not post the Marketing Denial Orders, Center for Tobacco Products Director Brian King said in FDA’s press release announcing the decision, “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
This is the same logic outlines in FDA’s post-Brian King assessment that menthol e-cigs in general do not have public health benefit.
Given that e-cigarettes as consumer products do not help smokers quit cigarettes — with the most recent best evidence showing e-cigarettes reduce quitting of cigarettes, the reality is that there is no benefit to adults against which risks to youth have to be balanced.
Just as FDA updated its assessment of menthol in e-cigarettes, it is time for FDA to issue a formal analysis of e-cigarettes as consumer products and smoking cessation.
In the meantime, FDA needs to move quickly to clear the market of the remaining menthol e-cigarettes.
Stanton Glantz blog 