FDA has denied a marketing order for Fontem’s myblu menthol e-cigarette. This is FDA’s second denial of a marketing order for a menthol e-cigarette, following its denial of RJR’s Vuse Solo menthol and other menthol e-cigarettes.
With this decision, FDA continues to move away from its previous permissive policy toward menthol e-cigarettes, which appears to have been based on the unjustified assumption that menthol e-cigarettes are necessary to help menthol smokers quit.
In a related development, the Ninth Circuit Court of Appeals published its decision upholding FDA’s decision to deny marketing orders for Lotus and Naked Nicotine e-cigarettes, joining the Second, Third, Fourth, Seventh, and D.C. Circuit Courts of Appeals in upholding FDA’s decisions to deny marketing orders for several other e-cigarettes. These decisions specifically uphold the FDA’s requirement that applicant companies provide affirmative evidence that their flavored e-cigarettes increase adult quitting enough to offset the harm flavors do by attracting kids. While FDA does not make marketing denial orders public, that is almost certainly an element of the current decision on myblu menthol.
FDA has yet to accept the reality 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. That means that there is no benefit to adults against which risks to youth have to be balanced.
But, FDA’s actions to keep menthol e-cigs off the market is a good thing.
Stanton Glantz blog 