FDA Regulations

Totally Wicked FDA Vaping Regulations Timeline

FDA Regulations  

Totally Wicked e-liquid (TW) is a global company. Founded in 2008 and the first brick and mortar vape shop in America, it has operations in the USA, UK, and Germany; has more than 200 authorized resellers and employs over 250 people. TW has a well-earned reputation for plowing its own path, standing up for the rights of vapers, and for being a genuinely independent vaping company.

Totally Wicked was one of the first vaping companies to introduce childproofing in 2009, and long before others companies were even formed, began to use pharmaceutical grade nicotine and ingredients for all of its e-liquids. Taking pride in its wide range of products has been at the backbone of our business model.

So why now take the step to inform our USA customers that it looks almost certain that TW will be closing its doors in 2018? Why not keep quiet? Many will see this is a rash move that could scare off both customers and staff and force an even earlier closure.

We definitely do not see it this way.  

Informing our customers is the right thing to do. Our mission has always been to do what we feel is right, and letting our customers know the devastation that the FDA is raining upon the vaping industry is without doubt the right thing to do. We will, of course, continue to monitor the situation, (and praying for a miracle or shot of common sense to prevail), but the writing is clearly on the wall and all of us need to face up to this. We are not going to be offering platitudes nor misleading our customers in the hope of making extra money at their expense.

The FDA have for us, created an impasse - a situation where no progress is possible. They have created this due to their unwillingness to truly engage with the industry and vapers, and from their unwillingness to learn from eminent scientists all over the world, nor even from their European cousins. The FDA have had ample opportunity to truly investigate electronic cigarettes, but instead they have chosen to use the same old tried and tested strategy of couching their terminology in untruthful and manipulative ways to shut the vaping industry down. 

For them to say otherwise simply adds to their list of untruths. 

The FDA are demanding electronic cigarettes follow the tobacco product pre-market authorization route - a route deliberately created to prevent tobacco companies from being able to bring new products to market. The cost per SKU - and that means per e-liquid flavor and strength for example -  is estimated to be between $300,000 and $1 million each. The same route is required for hardware, and products that in any other setting are not considered a tobacco product (such as a battery) become tobacco products as soon as they are placed in the shell of an electronic cigarette. The thinking behind this is quite mind boggling.

TW has, as part of its business model, a vast choice of devices and liquids. To even put through one liquid range - assuming each strength of one flavor costs $ 300,000 each - would rapidly put TW out of business.

The FDA are deliberately moving the Industry towards a future where only closed systems produced by either the tobacco or pharmaceutical industries will be legally available. Why they are doing this is possibly down to lobbying, as the argument that vaping is as harmful as tobacco does not stack up. There is no logical reason apart from a financial one to close down an industry that is assisting people to move away from tobacco smoking. By the end of 2018, there will be no USA vape shops, no USA-based vaping companies, and to bring into the country a non-FDA licensed e-cigarette will be breaking the law. 

Unless one of the large tobacco or pharmaceutical companies can produce an e-cigarette that has been granted an FDA PMTA, effectively there will be no products or e-liquid on sale in the USA, or perhaps just an antiquated device with flavor free e-liquid.  

So why is TW doing this now? 

Why are we putting our head above the fray and saying we will, in less than 2 years, if the rules don't change - be shutting down? Why not wait with the herd and do a fire sale at the end?

The answers are simple. TW does not need to do a fire sale; we can ship all our products back to the EU (where we are one of the largest e-cigarette companies) and sell everything there. 

This is not about the money.

What TW wants to do is give back. And we can do this by informing as many people as possible as to what is going on, what the FDA are doing, how they are doing it, and pull back the veil to the way the US public are being played by the big corporations. TW is going to cut our prices, hold flash sales, and do this in a manner that means our customers can plan ahead. They will be able to budget long term and get in the products and e liquids they will need, so that when the FDA does force closure, TW's customers will be prepared and will not be forced to turn to the black market, to break the law and put their lives at risk from products smuggled into the US, simply to stay away from smoking.  Most importantly, they will not be forced to return to smoking.

The FDA are taking away a product that is allowing people to transition away from a habit that kills half of its users. We feel that is grossly unfair and so will do all what we can to alleviate this ‘taking away from’ as long as we can. We do not have the financial resources to take on USA court cases (we do not have the same presence in the USA as we do in the UK), but we want people to become aware of exactly what those charged with looking out for “your” interest are really doing - and from our perspective the FDA is looking out for the large corporations, not the man in the street. If it were, the e-cigarette regulations would look entirely different.

How do we know this?

Look at the EU as case in point. 

In the European Union, the Members of Parliaments listened to the concerns of their constituents. They met with vapers; they met with scientists. Conferences were organized, tobacco control took part, Public Health took part, and the result is that vaping will continue to flourish in Europe. As time goes by, more and more research is showing that vaping can assist in smokers moving away from tobacco, vaping is less harmful and is not enticing non-smokers of any age to take up smoking. To deny this is yet another untruth. In Europe, the democratic systems and health systems are different, and the way the vaping industry is being treated clearly shows the difference of publicly funded health care where it is of benefit to the nations that their populations remain healthy, versus a private business model of health, where the profit is, in fact, in disease and poor health.

Are the Europeans stupid to allow vaping to continue? The FDA would have you believe that they are, that our European cousins are queueing up a time bomb of poor health; this is not true.  And yes, TW does have the authority to state this, as TW’s HQ is in the UK where the government’s health bodies are now actively encouraging smokers to take up vaping, as they see the benefit for the individual and the public as a whole. 

We want our USA customers to benefit from our products for as long as we are able to sell them in the USA, but we are not going to pretend that the garden is rosy. It is far from it, but while we have the time and the resources, we will look after our customers to the best of our ability, because it is our loyal and dedicated customers who have helped TW be the company it is.    

As we continue to honor our promises and fight the good fight, we encourage all of you to join us – engage with us via Social Media and on Forums, share our blogs and educational posts with family, friends, and legislators, and let your voice be heard.  We will support you in your fight until our last day, and shall an unexpected victory for us all be the result, TW will surely stand tall and carry on providing the very best products and customer service at the lowest possible prices; this is who we are and what we believe is right.

Watch Fraser Cropper Anouncing TW Changes 

Watch Fraser Cropper Addressing a Pressing Question