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Focus On eCig Pre-Market Approval As FDA Bears Down

By Tyler McCanus

Thursday July 2, 2015
the fda pre market approval process could crush ecig brands

Ecig news comes fast and furious these days, with everything from new research to new products and even new legislation. Sometimes it feels like it is just hard to keep up with all that is going on. Not only the enormous amount of news that surrounds electronic cigarettes and the growing industry, but the wide variation in the types of stories that was see every day. But as we get into the throes of summer, we are also getting closer to the FDA finally speaking its peace. FDA ecig regulations are bearing down now more than ever, but what we think is the key to it all and the words you are likely to hear plenty is eCig pre-market approval.

Ecig pre-market approval is the lynchpin in the plans the FDA has for regulating the industry. It’s what Big Tobacco and their brands, namely Blu Cigs, MarkTen and Vuse, are holding their breath to hear about. But really, everyone is waiting to hear what kind of decision will come down with regard to pre-market approval. This is because it has the power to simply change everything, making that predicate product scoop of ours invariably relevant and incredibly important.

At this point you may be asking yourself what is this pre-market approval bit that we insist is going to be featured in so much ecig news from here on out. What makes it so important that the overall success of Blu Cigs and their current retail store competition MarkTen and Vuse hinge on the way the chips fall? First you need to know what this concept of pre-market approval is all about and then we can take you through the significance of it and how it may be structured within the coming FDA ecig regulations.

The “E-Cig Pre-Market Approval” Concept


The FDA Pre-Market Approval Process Favors Big Tobacco Companies

The idea is pretty simple really. Even though no ecigarette is currently “approved” by the FDA, in the same way that no traditional tobacco cigarette is, there is a push to contain the growth of electronic cigarettes.

Ecig pre-market approve is one way to do that in a sense, because it would force all current ecig brands, Blu Cigs, MarkTen, Vuse, and smaller companies, to go through an approval process. Of course all of the Big Tobacco ecig companies will have no issue meeting the financial burden. It is the independent ecig companies that will suffer.

This was perfectly surmised in a recent Associated Press report. “Companies would have to submit the applications within two years of the final rule, and then the FDA would ensure that the product is “appropriate for the protection of the public health.” If not, the agency could take it off the market.”

This type of move would essentially stop the industry in its tracks, slowing growth to a crawl and perhaps sending the evolution of electronic cigarettes backwards. It is, perhaps more than any other provision in the proposed FDA ecig regulations, a huge sticking point. Other aspects of the FDA’s proposal are much easier to agree upon. Banning the sale of ecigs to minors? Definitely, this is something we can all agree on. Creating certain safety standards that manufacturers would have to comply with? No doubt, we have all been looking forward to something like that, something which is reasonable and helpful. But a pre-market approval process could stifle an industry that is already helping millions.

The impact of the final ecig pre-market approval decision is why you are likely to see the words pre-market approval in a slew of ecig news articles over the next few months or longer. The pushback is understandable given the billions of dollars at stake for ecigarette companies. But it is equally important to vapers and current smokers who are thinking of making the switch. Imagine walking into your local vape shop or skimming our reviews section and seeing almost no brands that are still in business. On top of that, imagine that the brands left are so limited in scope and performance, that you feel like we are back in 2009 when the industry was just starting to really develop.

The Irony of Helping Big Tobacco Dominate

premarket-approval-ironically-helps-big-tobaccoSomehow those advocating for strict ecig pre-market approval miss the following irony. It goes like this. Those who want to create this convoluted process want to do so because they say they are worried about safety, especially for an industry so closely linked to tobacco. They don’t want ecig brands to “roam free” like Big Tobacco did back in the day. Yet the only companies that would be able to afford the financial marathon of a difficult pre-market approval process would be in fact those owned by Big Tobacco!

It would be Blu Cigs, MarkTen, and Vuse that would instantly have a leg up. Not because of superior performance, but because of sheer dollars.

The other side effect would be that someone with big money would just acquire technology that is grandfathered in. This is where the predicate product dilemma came from and it is why we think that could be a huge story that changes the industry entirely. Either we would see a big slowdown in the growth of electronic cigarettes, especially those which are high performance, or we would be relegated to ony a few choices that have been simply bought by Big Tobacco. They also would have no motivation to improve their product, because if customers don’t like it they would simply turn back to their primary business: traditional tobacco cigarettes.

Scary thought, right? Thankfully there are some in congress that understand the full scope of this conundrum and are pushing forth legislation that can solve it. Recently Alabama Congressman Robert Anderholt introduced a bill to the House of Representatives that would eliminate the ecig pre-market approval aspect of the pending FDA ecig regulations. Not everyone sees the urgent need in rolling back this aspect of the FDA’s pending rules. The top Democrat on the Appropriations Committee, Rep. Nita Lowey of New York, sees it the exact opposite way. She insists that the proposed legislation is “nothing short of a giveaway to the tobacco industry.” There’s that irony again! For some reason, public officials are unable to understand that the war on ecigs only benefits Big Tobacco.

It seems that no matter how much reason we can talk or write, there is always a skewed viewpoint from the other side. More than that, those viewpoints generally have money behind them. We all know Big Tobacco is lobbying to crack down on open systems so that they can corner the market with cigalikes only , so we can only imagine they would be in favor of pre-market approval as well. It is right up their ally in being a great way to eliminate the competition without having to fight them. The affect on consumers would be great, because along with the competition they could be eliminating the huge potential of the electronic cigarette too. That, unfortunately, won’t seem to bother them one bit.

So as we find more ecig news focused on this issue, we know that this fight is an important one and one that could make or break the future of vaping. Everyone who is dedicated to the amazing impact these devices make on their own lives and millions of others should be ready for the battle. Stay on top of it and be prepared to speak up when needed because our voices do count!



Read More About Ecig Pre-Market Approval And How The

Predicate Product Could Be The Game Changer



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