Roll Call: FDA to review huge applications from vaping companies
09/10/2020 | Andrew Siddons
Char Owen, a Texas vape shop owner with a background in programming and engineering, said she developed a software application that would allow other owners like her to automate some of the paperwork to make it more feasible to file applications for hundreds of flavors.
Owen is still pessimistic about her chances. She pointed to one of the previous PMTA authorizations, for a tobacco-heating device called iQOS, as proof that the FDA would want to see human studies that would cost millions of dollars to conduct.
“That’s what they want to see. We’re small businesses; we can’t provide that.” Using anecdotal evidence from customers “really is our only hope,” she said.