FDA Regulations: Welcoming Our New Government Overlords

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Ladies and Gentlemen, the FDA and the end are near.
…Okay, maybe that’s a bit drastic. Let me explain, if you’ve been following the vaporizer industry, you know that talk of regulations and the FDA’s involvement is nothing new. In fact, since the industry’s birth, people of interest have been murmuring about the slowly approaching hand of the FDA and the massive changes to come. While many of these reports are vastly over stated in regards to the damage the FDA could cause, there is a nugget of truth to the wild stories your neighborhood vapor shop associate has been spouting.
This past week the U.S. Food and Drug Administration finalized a ruling extending their authority to all tobacco products. This ruling included e-cigarettes, cigars, hookah tobacco, pipe tobacco and more. The idea behind this ruling is that, with their new found authority, the FDA will be able to regulate the industry protecting public health.
Now before you jump to your windows screaming in fits and tantrums, realize that there is some good that comes out of this. You see, before the FDA had this authority, it was technically legal for stores to sell vaporizers to minors. Now, obviously, this will be out of the question. And that’s an important jump for the industry. You see, while use of traditional cigarettes has indeed declined over the past few decades, use of tobacco products in general, including e-cigarettes, mods etc., have continued to climb over time. In 2015, in fact, over three million middle and high-school students were using e-cigarettes and liquid vaporizers. When was the last time you met an 18-year old middle school-er? The point I’m trying to make here, is that up until recently, the vaporizer industry was the market equivalent of the Wild West.
So let’s start with the easy question: what do these new found FDA overlords mean for us, the consumer? Well, for starters: you will need to be at least 18 to purchase any sort of vaporizer or e-cigarette, and, similarly to traditional cigarettes, all sales to customers under the age of 27 will require photo ID. You also won’t be receiving free samples anymore, the FDA decided we don’t deserve those anymore. And lastly, e-cigarettes and e-liquids can no longer be sold in vending machines outside of licensed adult-only facilities, though I don’t know that many vendors were using machines any way.
Now, as far as manufacturers are concerned, there may actually be a bit of a commotion here. You see, according to the FDA’s new guidelines, manufacturers are going to be required to submit paper work for all their new products as well as their existing products. This is where the main concern lies. How strict are these registrations going to be? Will the average company be able to afford these submissions? Will this cause a number of businesses to go under or remove a lot of products from their shelves? All of these are solid and reasonable questions, but unfortunately we have little in the form of answers. The FDA has stated that businesses with a revenue less than 5 million annually and less than 150 employees will receive help in the form of a Regulatory Health Project Manager to assist with application processes, but we’ll simply have to wait and see what that help truly entails. I myself, am hardly a lawyer, so I’m not much of an authority on the matter. But even so, I can also see how these new requirements may pose a sizable strain on the seemingly endless number of small mom-and-pop manufacturers. And after speaking with a few representatives way more apt to interpret this sizable amount of information, the general consensus is that the new laws heavily favor Big Tobacco companies for a number of reasons.
Big Tobacco has the money to overcome any costly regulations thrown their way. (for those interested I would check out the Tobacco Master Settlement Agreement for an idea on just how much money these guys have.) In addition, costs wouldn’t be nearly as high for larger tobacco companies, as organizations like Blue (Owned by Lorillard), VUSE (Owned by RJ Reynolds), and other subsidiaries of traditional cigarette companies only carry one or two basic e-cigarette devices and liquids/flavors. This is a stark contrast to the variety and power of products by companies like Atmos, Wismec, Kangertech, and other names synonymous with vaping culture. While some of the reports we’ve seen up to know have seemed rather alarmist in nature, there may be more truth to the panic than many previously thought. While Big Tobacco companies aren’t literally knocking down the doors of e-cigarette and liquids vaporizer manufacturers, we are finding ourselves in a situation that feels eerily like a monopoly. And I don’t know about you, but I always hated that board game with a passion.
Before I leave you all, I want to end with a few points. Regulation, as a whole, is a good thing for the vaporizer and e-cigarette industry. It helps protect consumers. Whether it’s by preventing minors from having access to chemicals they don’t fully understand, or by keeping shady companies from selling costumers cheap products made with dangerous materials and shotty workmanship, there is a necessary role filled by regulating the industry. However, there are some problems that occur when you force costly registrations onto a growing industry. You can stifle it, even destroy it, by slowly draining the life out of the smaller innovators that once had their voices heard. And when I say slowly, realize I do mean slowly. For the most part regulations effecting the retail aspect of the industry won’t take effect until 2018, while manufacturer regulations take effect in late 2016. I have high hopes for this industry. I’ve spent a lot of time in it, and while it may seem silly, I feel there is something admirable about the revival of inventors and designers that comes along with any growing industry. Moving forward, we may see some companies rise to the occasion and persevere through the industry changes, or we may see the gradual decline of an industry that was once vibrant and growing. Only time will tell. Until then, I can only hope to see more grass-root support for growing businesses.
If you are interesting in hearing more about the FDA’s regulations and plans for the industry, why not take a stroll to the horses mouth for a more detailed list of industry changes.
This blog post’s image header is a photo taken by Karen Moskowitz of Fox.
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