Totally Wicked - a Florida-based e-cigarette and e-liquid company that established the first brick shop in the U.S. - has announced that because of the FDA regulations, they have been forced to go out of business in 2018, once the pre-market tobacco application (PMTA) grace period ends. They will join what will certainly be thousands of other e-cigarette businesses and vape shops which simply cannot afford the capital costs associated with completing PMTA's.
In announcing the closing of its doors in 2018, Totally Wicked explained - in the most succinct and prescient manner I have heard - the absurdity and the irony of the FDA's approach to e-cigarette regulation:
"The FDA may want Americans to continue smoking; we do not."
As Totally Wicked explains:
"As a business we operate in both the EU and the USA, have a
loyal customer base, offer a wide and dynamic range of hardware and
e-liquids and try always to deliver the best possible service in an open
and ethical way. However, this is clearly not enough for the FDA as they actively shut
down this vibrant industry. With the stroke of a pen, the FDA is
demanding fantastically unrealistic pre-market tobacco authorizations
for a product that contains no tobacco, at a cost that is prohibitive to
all but the tobacco giants, and bears no relations to the products’ risk
or indeed, its remarkable potential when compared to the raging tobacco
epidemic. It is designed quite simply to destroy the industry. By the
end of 2018, there will be no independent vaping industry left within
the USA - unless Congress decides to look deeper into this, or indeed
the legal system is willing and able to hold the FDA to account for its
fallacious representation of the risk impact that it has used to justify
this regulatory abomination." ...
"This government and its
federal bodies charged to defend and protect its citizens have failed
the American smokers. While the majority of the rest of the world is
moving towards an enlightened position on the transformational potential
of consumer vaping products, the USA will retrench itself with a ‘year
zero’ firestorm that is already alight in the USA and will consume all
independent vape businesses like ours in Summer 2018."
The Rest of the Story
This is a perfect rendition of exactly what the FDA is doing with its misguided regulatory approach to electronic cigarettes. By treating vaping products exactly the same as deadly cigarettes (in fact, by regulating them more stringently than cigarettes), the FDA is essentially making it clear that it wants smokers to continue smoking rather than switch to a much safer alternative that could potentially save millions of lives. After all, the impact of the regulations - especially the PMTA requirement and the modified risk provisions - will be the decimation of the vaping industry and the creation of a huge impediment to the transformation of the nicotine market from the most toxic to the safest available products.
If the FDA truly wanted smokers to quit, then it would certainly craft regulations that promote smoking cessation, rather than regulations that block or impede smoking cessation by denying smokers the availability of a wide range of much safer alternative products. And it would certainly not create a regulatory infrastructure that gives a huge competitive advantage to real cigarettes over the fake ones.
It is very true: the FDA (and the federal government as a whole) has failed the American smokers. Rather than increasing the available options to quit smoking, the FDA has greatly limited those options. And instead of encouraging smokers to quit, the FDA has permanently stymied smoking cessation efforts.
But there is one ray of hope. As Totally Wicked suggests, the above scenario will occur: "unless Congress decides to look deeper into this." Fortunately, there are a number of federal lawmakers who have decided to look deeper into this. We will work with these members of Congress to try to prevent the FDA from carrying through with its destructive policies by enacting an alternative approach by which vaping products are regulating under a mechanism distinct from that which is used for products which actually contain tobacco.
As Totally Wicked says, it is sheer lunacy to regulate as tobacco products these devices that contain no tobacco.