IN MY VIEW: In Reality, FDA Deeming Regulations are Thinly Veiled Prohibition
From: TobaccoAnalysis
Yesterday, based on my analysis of the FDA draft guidance that will accompany the electronic cigarette deeming regulations, I explained that the requirements for a pre-market tobacco product application (PMTA) are so cumbersome and expensive that only a few of the largest e-cigarette manufacturers would be able to keep their products on the market.
Today, I add a few clarifications and expansions on my commentary, which I didn’t have time to discuss yesterday because I wanted to present a general overview of the regulations and their likely impact.
