On July 10o the FDA denied the PMTA for myblu Menthol E-Cigarettes.

FDA issued the MDO and released a statement on the reason they issued the denial, “thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”

FDA didn’t forget to pat themselves on the back for approving 23 tobacco flavored e-cigarette products. 

With the FDA poised to ban menthol cigarettes, you would think that leaving a safer alternative for these products would be top priority. Sadly, they seem to keep doubling down on prohibition, which we already know is not an effective solution. The FDA also seems to be pursuing an illegal de-facto ban on flavors including menthol; many studies prove that these “flavors” are most effective when helping adults quit smoking.

While the FDA refuses to acknowledge that flavors help adults quit smoking in products like e-cigarettes, they do acknowledge that flavors help in other adult products. Just three days prior to the myblu MDO they issued an approval for a lemon-lime drink for patients prepping for a colonoscopy. Suflave, the new citrus-flavored liquid colonoscopy prep, is designed to taste more like a sports drink than medicine, according to its developer Sebela Pharmaceuticals. It will be available by prescription starting in early August, Sebela said in a Comunicado de imprensa.

The FDA really needs to rethink this prohibitionist approach to vaping and flavors or the illicit market will take over, leaving responsible retailers out of work and many adults with no other option but to buy unregulated products or return to smoking.