FDA Deeming E Cig Regulations
The federal Food and Drug Administration's long-anticipated "deeming regulations," in which the agency will assert its authority to regulate vaping products as tobacco, are upon us. As of August 8, products introduced to market after February 15, 2007 (note: that's pretty much everything you'd recognize as a vaping device or liquid) will have two years to either obtain FDA approval or be taken off the market.
How does that process work? The FDA recently published a giant cache of information on the subject. Let's try to boil it down.
Under the new regulations, all vape gear and e-liquid makers are now classified as "tobacco product manufacturers." This includes makers of mods and tanks that are not designed to burn or vaporize actual tobacco, as well as makers of zero-nicotine and tobacco-free nicotine liquids.
In order for products released to market after the FDA's 2007 date to remain available for sale, manufacturers will have file reports on each product (one flavor of liquid offered in four nicotine strengths counts as four products) at a cost estimated between $5000 and $24,200. They'll then have to submit a "premarket tobacco application," with costs estimated at between $117,000 to $466,000 by the FDA. Though the agency says these figures are much lower than the "millions of dollars" claimed by vaping advocates, at a cost of up to $490,200 per product for a single flavor offering nicotine strengths of 0, 3, 6, and 12 mg could potentially approach the $2 million mark.
Further, no new products are legally allowed to be introduced to market without express FDA consent. This means that, aside from introducing already-existing products that hadn't made it to the site yet, the release of new devices and flavors is coming to a screeching halt.
Obviously, this is bad news for many of the smaller, independent mixologists that deliver some of our favorite flavors, and it'll also put a serious damper on the constant bombardment of new flavors that have spoiled us with an abundance of riches over the last few years. At worst, fears have been expressed that the future of vaping may be handed over to Big Tobacco, whose pockets are among the only ones deep enough to absorb the costs of keeping their products on the market.
There is some hope – the FDA says that over time, the establishment of "tobacco product master files" may allow new products to piggyback onto existing approvals rather than relying on clinical trials of their own for each new product or device, thus lowering application costs and allowing applications to be bundled. At this point, though, it's unclear how or if this would work.
Concerned that these new regulations may harm your vaping experience or your attempt to quit smoking? We are too. Please, if you haven't done it already, join a vaping advocacy group and contact your senator and congressmember to let them know how you feel about the laws, particularly urging them to pass legislation changing the effective date of the deeming regulations to grandfather products released before the new laws were announced, thereby saving tens of thousands of vaping products from potential extinction.