Tuesday, January 29, 2013

The FDA and Why Vaping Won't Die


The FDA and Why Vaping Won't Die

Since 2008, the FDA has been aggressively pursuing regulation that would either ban e-cigarettes outright, or severely limit the number of choices available to consumers.  While they do, at least theoretically, have the best of intentions- keeping the public healthy and safe- they are currently both bogged down by bureaucratic and procedural conventions, as well as being lobbied by both Big Tobacco and Big Pharma (and their paid constituents in congress), both of which are wholeheartedly against the e-cigarette industry.

With that being said, I would like to point out that I was once deeply involved in an industry that has, until recently, been a nascent greyish-black-market.  There are lessons to be learned from the methods used in the past to side-step the rules and regulations, no matter how any one person may view or think of these other nascent markets.  These past experiences give me high hopes for the future of our beloved hobby and industry.  I will attempt to allay some fears that many vapers may have about the future of the vaping scene, and show that even in a worst-case scenario, we will always have the option to be vapers- no matter what happens.

The FDA, a Rock, and a Hard Place

It is quite easy to blame all of the regulatory issues with our industry squarely on the regulatory body that oversees the products- the FDA.  Since 2008, the FDA has been fighting a losing battle to regulate e-cigarettes as drug-delivery devices, effectively banning their recreational use without a prescription and millions of dollars in R&D and testing.  Many people view this event as an obvious attempt by the pharmaceutical industry to limit ex-smokers to buying their own smoking cessation products.  In 2010, the Federal courts ruled against the FDA, and claimed that instead, the e-cigarette should be regulated under the Tobacco Control Act, so long as no claims of therapeutic/medicinal value or smoking cessation were made.  

In the two years following, there have been numerous hearings conducted to determine how e-cigarettes (and other "modified risk products") should be regulated.  The most important questions they asked:

 "Should there be a separate category for modified risk products, or should they be lumped together with traditional tobacco products?"

"How should the FDA implement regulations- such as quality control, taxation, branding limitations, etc.- and what other industries may be a model for such regulations?"

Unfortunately, even though there was a public hearing and comment period after the following notice was issued, the plans haven't substantially changed.  Again, the intense pressure from big business' lobbying groups has forced the agencies' hand.  Here is an excerpt:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act.   The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

And while this makes it appear that there will be legal, regulated cigarettes allowed for sale after the regulations take effect, no one knows for certain how difficult the "general controls" will be to comply with.  Any business owner reading through some of the procedural statutes on regulated tobacco products would immediately know that the industry is in for quite an uphill struggle, if they intend on keeping their existing business model unchanged.

The Wild West is About To Get Wilder

...and this is where my former experiences come into play.  Keep in mind, that this is intended to be a general guide to the community, and NOTHING I say below is set in stone.  It is, above all, my best assessment of the future, based on educated guesswork and parallels to other Grey industries. 

We'll start off with the items that will be, effectively, banned:

Fully-assembled electronic cigarettes, containing nicotine:  Any kits that are on the market today that contain cartridges, cartomizers, or bottles that have nicotine in them will no longer be legally available, unless they are properly registered with the FDA. 

Cartridges, Cartomizers that contain nicotine:  See Above.  The only exception may be if the FDA chooses to adopt the model used by other countries, which allows for very low amounts of nicotine to be sold in said products.

Eliquid (containing nicotine): The FDA has not specified how they will regulate eliquid, but there is a good chance that they will require manufacturers to meet the same standards as other tobacco products.  This will require a large financial investment on the part of the manufacturers in order to comply with the legal and research requirements of the FD&C Act "New Tobacco Products" registration.  We may or may not see nicotine-containing eliquid if this is the case- and what we will see, if the regulations are applied, is a severe drop in the number of choices available to consumers, as small businesses and operations will be forced to close shop or change their formats (I'm getting to that).  Again, the FDA may pull a rabbit out of their hat, but it is unlikely.

And now, let's see how the industry might be able to survive:

Defining what constitutes a certain product is what will make or break our industry.  In other markets, regulations have been avoided by circumventing the strict definitions that cover a certain product.  In this case, the art-glass "tobacco pipe" industry is a great example of how a product has been aggressively pursued by the government, only to reappear time and time again under a different name and intended use.  The gun industry is another example- whereas one can buy certain parts and pieces of some outlawed guns-legally- but not an illegal gun that's assembled and fully functional.  Let's see some novel examples of how this might play out:

Batteries and Battery Tube Mods:  The FDA will never, ever be able to regulate batteries on their own.  Even those that contain a 510 connection and are obviously used to vape with should be safe.  Why is that?  Because if they do not have any tobacco products in them or sold with them-and if they are not sold as e-cigarettes- they will not fall under the TCA.  It may be an uphill struggle, and we might see them re-branded as "flashlights", "battery tubes", etc...but we will almost certainly continue to have easy access to them.

Empty Cartridges, Atomizers, RBA's:  I am not so certain on this as I am with the batteries, but as long as said devices do not contain any nicotine AND are not specifically marketed as e-cigarettes, I would put my money on all of these things being readily available.  Again, names will change, there may be warnings such as "not for human consumption", etc.- But these types of products, sold individually, will most likely remain available.

Other, Non-Nicotine Supplies:  This covers all of the other essential components of e-cigarettes, such as drip tips, wick and wire for rebuildables, tanks, drip shields, etc.  All of these things will, with near-certainty, remain available so long as they are not included in kits that contain nicotine.

E-liquid that contains no nicotine/drugs, and DIY liquid supplies:  These will almost certainly not fall under the FDA's future ruling on e-cigarettes, because they will not contain any tobacco or derivatives.  In the future, you may need to buy all of your liquid nicotine free- and it may be branded as another type of product entirely, depending on how harshly the FDA and other government agencies crack down on the industry.  But suffice it to say that there will never be a shortage of access to 0-nic liquid and most DIY supplies.  

Even fully assembled PV Kits should be safe from regulation, so long as they are not marketed as e-cigarettes nor contain nicotine.

The notable exception here is the nicotine concentrate itself;  Depending on how the FDA chooses to construct their ruling, it may be harder to buy concentrated, purified nic base.  It may be impossible to buy it from the same source as your other liquid and DIY supplies.  However, the outright banning of the sale of nicotine base would be nearly impossible, unless the FDA decides to take extraordinary measures in defining the new regulations.

The Green Market and How Playing Hardball Worked

To see an example of what the prohibition or severe regulation of a particular substance can do to an industry, one would have to look no further than to the century-old struggle over marijuana.  Despite the plant itself remaining federally illegal, it remains one of the largest and most lucrative industries in the country.  However, I'm not going to focus on the plant itself in this article;  Like the e-cigarette industry may soon need to do, the marijuana industry has had to cope with the fact that people need access to the end-user devices- pipes, vaporizers, and flavored blunt/cigarette papers.  All in all, the industry has been very successful in circumventing harsh regulatory actions, and obviously, all of the aforementioned items are still widely commercially available.  Usually all it takes is enough of a change in labeling a devices "intended use" to cast doubt as to its actual use.  In plain terms, that means calling a bong a "vase", or stating that a vaporizers' intended use is with "legal blends".  It really is that simple, and a quick google search will show how successful the industry has been.

So in conclusion, I don't think we have too much to worry about.  Yes, it may be harder to find ready-made eliquid, or nicotine-containing cartridges or cartos (who uses pre-filled stuff anymore, though?)- but the industry stands an excellent chance of survival.  Let's all relax, take a vape and remember that hopefully, a year or two from now, most of this BS will be behind us, and we'll still be vaping on strong.




5 comments:

  1. Very well written! I also work in the industry and fear little. I made the same inference on batteries. As for the nic, this can be circumvented. Nicotine in of itself is not a sole derivative of tobacco and CAN be found in other plants. Yes it may raise the cost of said eLiquid, but it can still be made available. VAPE ON! Eric - QV

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  2. Thank you for a well-written piece. It was a pleasure to read. :)

    I agree that, if the FDA chooses to regulate the life out of e-cigarettes, knowledgable vapers will be able to get their supplies (though it will be a lot less convenient, likely more expensive, and certainly more risky). But in my view, that's not the problem.

    There are tens of millions of smokers in the U.S. who have yet try vaping. If we don't continue to fight to keep vaping as accessible, affordable, and attractive as possible, many smokers who might have tried vaping will, instead, continue to smoke. What's more, the smokers most in need of a low-risk alternative are those who have smoked for several decades, putting them in a demographic that is less likely to purchase "underground" products.

    And why should should they--or any adult--have to go to that kind of trouble to get an e-cigarette when they can walk into any corner store or gas station and purchase traditional cigarettes or into any pharmacy and purchase nicotine patches and gum?

    It's beyond time for the message of tobacco harm reduction to be heard loud and clear, and I think e-cigarettes are the product that can make that happen. In fact, they're already making it happen, as more smokers switch and all but the most corrupt in tobacco control are forced to admit at least some of the truth.

    As vapers, we're all indebted to those who came before us, and there's an amazing spirit among vapers to pay it forward. In that spirit, it seems to me that now is the worst possible time to relax….

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  3. That is also one of my fears is that they will end up making them so costly that many people will just go back to smoking.

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  4. There is always controversy about the advantages or disadvantages of electronic cigarettes. Critics say that these negatively effects on human’s body as they contain nicotine. They also continue saying that these have substances that may cause of several deadly diseases. But on other hand manufacturer of e cigarettes claim that they are safe to use as now manufacturer provides a way for smokers to use Smoke Relief Electronic Cigarettes with their own mixture of E-liquid. Now, smokers can also decide how much nicotine content they want to put into the mixture or they also can remove the nicotine content from the cigarettes if they don’t want to take it.

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  5. Seems like the big boys of vaping are trying to kill the smaller ones!

    The only reason FIN, LOGIC, NJOY, Altria, Reynolds and Lorillard have endorsed FDA regulation of e-cigs is to eliminate several hundred smaller e-cig competitors.

    Love how in our country the govt is allowed to kill 200-300m in small business revenue! But small business contributes to the majority of jobs and taxes paid!!!!

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