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Premarket Tobacco Product Applications An Explanation


Unless you're a policy wonk, the above phrase, and its incongruent abbreviation, PMTA, probably mean little to you. At least so far as you're aware of – but it's actually a matter of grave importance to vapers.


Remember the flood of new vape products, new e-liquid flavors in particular, that effectively swamped the market last summer? We were so busy stocking our shelves we hardly had the chance to effectively review them all! Have you noticed that new flow of products to the shelf has slowed down considerably since then?


That's PMTA for you. A part of the FDA's new "deeming regulations" that declare all vapor products, regardless of whether they contain nicotine or are even consumable, to be "tobacco products," the FDA requires any new product introduced after August 8 to go through an approval process that vape experts warn could cost a million dollars or more (the FDA says this is overblown – applications should only cost around "several hundred thousand dollars").


This fee applies to each individual product. Got a new strawberry flavor? You're going to have to pony up between several hundred thousand and a million dollars to introduce it. Want to offer that flavor in 0, 3, and 6 mg/ml nicotine strengths? Triple the cost – by varying the amount of nicotine you add, you're creating an entirely new recipe.


Does this sound onerous to you? It does to most suppliers, too – unless you've got the deep pockets of Big Tobacco on your side. A million dollars is a drop in the bucket for Altria or RJ Reynolds to bring a new cigalike product to market, but for artisanal craft mixers, it's likely more than they'll ever make through the lifetime of a juice offering.


That's not to say that products offered before the August 8 deadline are safe – they simply have two years to file the applications or stop selling their products. As it currently sits, the only new liquids we'll be seeing are ones manufacturers have quietly debuted on a "test market" prior to the deadline and are holding off on the major rollout (we've heard Five Pawns and a couple others took this tactic when they saw the new regulations coming).


Still, August 8, 2018 looms as the potential doomsday for vapers in the United States. A little less than two years from now, any product introduced to the market later than early 2007 (when even cigalikes were primitive as compared to today and only a few undeniably wretched tobacco-flavored liquids existed) will be banned, unless it's gone through the PMTA process.


So, what can we do? At the moment the greatest hope for the future of vaping lies in getting Congress to change the "predicate date," or the point in time that the FDA's regulations take effect, to coincide with when they were actually released, rather than when Congress first gave the FDA the authority to regulate vaping products. Such a proposal is currently tucked into an omnibus spending bill under consideration, though a similar provision last year got bumped in a round of political horse-trading.


Now is the time to contact your congressional representatives and let them know what vaping means to you. Advocacy organizations like CASAA can point you in the right direction and suggest points to make when you write or call. If, like us, vaping has been the difference that allowed you to finally abandon actual tobacco products, take some time to protect your rights and those of future quitters everywhere.