Last week I had the opportunity to be interviewed by WBEZ’s Kimberly Adams. A very nice person who took her time to understand the issues the industry is facing by untenable governmental oversight. Here is her article: http://www.wbez.org/news/congress-weighing-stronger-fda-regs-e-cigs-112567
I stated that “pre-market review” authority over e-cigs would be useless, since there are already thousands of e-cig and “vaping” products on the market. Not only would the influx of applications swamp the already-stretched FDA, but it might force e-cig companies to take their products off the market while they wait for approval”.
To clarify, the FDA had, in 2008, been given oversight of tobacco products by the passage of The Family Tobacco Control Act. As bureaucrats do when given oversight of anything, they devise a labyrinth of highly inefficient processes assuring no individual governmental employee accountability to a single decision and burdening those being oversought (oversighted??) with highly inefficient regulatory processes for submission and subsequent justification of their innovative products and/or businesses by non-innovative governmental staffers. This is the case with the e-Vapor industry. The FDA whipped up a home brew regulatory process for “new tobacco products” called Substantial Equivalency (SE). SE is the perfect tool for FDAers to utilize assuring that NO new tobacco products will pass their muster regardless of how innovative and safe they are. In essence the FDA built the SE process prior to e-Vapor products being legally classified as tobacco products and when Judge Leon on December 10, 2010 agreed with the industry’s position that our products are a legal tobacco product and not an illegal drug-device, e-Vapor dropped into the FDA’s unwanting laps.
So here we are today. The FDA has to look at our legal tobacco product and decide if we are substantially equivalent or equal to a 2007 legal tobacco cigarette that is known to kill 450,000 Americans annually. No matter how safe we are-we are not SE to a 2007 tobacco cigarette . No matter how many millions of Americans are using e-Vapor products that are scientifically proven to be VASTLY less harmful-we are not SE to a 2007 tobacco cigarette. No matter how many doctors are now recommending our products-we are not SE to a 2007 tobacco cigarette. Our intention was/is developing a product NOT SE to a 2007 tobacco cigarette which now in the mind of the FDA is not a tenable endeavor. Nothing matters to governmental employee types except sticking to their beloved regulatory mazes established to protect them from accountability. Eyes Shielded, Kick the Can down the road regulators if you will.
We all now have to wait to see how the FDA will fit our round peg of product advancement into their square black hole of oversight.