Tommy-Chi Jul 1, 2016
FDA DEEMING RULES AND WHAT THEY MEAN TO YOU

--Vape goods being sold before 2007 can remain available indefinitely at this point in time
--After August 8, 2016 no new products or changes to existing products are allowed
--Manufacturers of ALL e-liquids or vaping related products will have up to two years to submit FDA PMTA applications for products that have come to market after April 15, 2007 (KNOWN AS THE PREDICATE DATE) so that they may be reviewed for fitness within the market in accordance with FDA intents and purposes for tobacco products.
--The FDA PMTA review process is estimated to take a year and cost as much as $1 million per product
--There will be very few PMTA applications submit with most (if not all) coming from Big Tobacco
--There is no way of knowing if the FDA will approve any PMTA applications, as in the past few new tobacco products have been allowed to be marketed as tobacco products after the initial set of FDA regulations became law
--For products not passing the PMTA process, they must be withdrawn from the market
--It is expected that scarcity or the lack of vaping products will occur across all segments of the market


THE RESPONSE

--Remove tobacco classification because vaping products are primarily 100% tobacco free
--Change the predicate date from April 15, 2007 to the current date in (2016/2017/...) for the Pre-Market Tobacco Applications process (PMTA).
--Requesting a Substantial Equivalence (SE) Report instead of PMTA, so that all products that are essentially similar in operation to that which has already been accepted to also be accepted and allowed to be sold
--Overturn the ban on FREE SAMPLES so that vendors can send samples out to vapers


THE WHY

ECF: @Mazinny, "By 2010, eighteen states, the District of Columbia, and three U.S. territories securitized some or all of their revenue entitlements from the MSA (TOBACCO: Master Settlement Agreement) payment schedule into bonds. The issued bonds totaled $40 billion and are backed by expected future MSA payments." (These bonds would eventually be worthless to the states if vaping continued to grow as it has b/c it is demolishing the market for cigarettes and has so far not been aggressivly regulated or taxed.)


EVERYTHING IN DETAIL
MSA: http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-msa-overview-2015.pdf