This is a pivotal thread. I used to work in getting medical diagnostic products into the market. We had the FDA on our minds at all times and the wording and categorization in our proposals could mean the difference between getting a product on the market in months versus years.
Lacey is absolutely on the right path here by looking at the Nico Water precedent. However, eliquid will likely have to be designated a tobacco product (I am fairly certain) due to its strength as is Nico Water's high concentration product. Now- there are two very distinct issues here: 1) the vaporizer 2) the nicotine-containing liquid.
The vaporizer we all use does indeed have precedence with the vaporizers that are sold in head shops for much more dubious purposes. This whole discussion on the semantics of "smoking" or "vaping" is really irrelevant. Knowing in a common sense way what something is "really" used for can be quite different than it's legal defintion as a product. Headshops sell their vaporizers as "Herbal Vaporizers." Period. No more elaboration than that is offered. The design principle for e-cigs is exactly the same as for the Herbal Vaporizers that headshops have sold for years. Therefore, this one is easy- our devices are just small personal herbal vaporizers.
Now Ruyan has in my opinion gone and shot themselves in the foot by pursuing the NRT route. It's enormously expensive and time-consuming to get approval for that. However, I can understand why they did it: they know the money is in the cartridges, not the vaporizer. Plus there is the issue of the patent. They knew that there is no real design difference between their vaporizer and all the ones that have been on the market for years- except in terms of using it as an NRT device. Old device, new application, and that I believe is the basis for the patent claim.
The hype we all have going here for the e-cig as the safe & sexy 21st century cigarette needs to give way somewhat to a lower profile image in light of what is happening with the FDA right now. Instead it needs to be marketed as a personal vaporizer that could
theoretically be used to imbibe a tobacco preparation if the owner so chose to do so. Sellers should make no claims whatsoever about what it is intended to vaporize other than herbal preparations in general. This is where the FDA and WHO have gotten jumpy. They have a big hardon when people start making claims about health benefits of their products- especially when they meander into areas like NRT where the FDA forced Big Pharm to cough up millions to play. They simply will not stand for some innovative upstarts to enter the business without forking up the big bucks as well. So, for those that sell vaporizers, refraining from mentioning TOBACCO, CIGARETTES, STOP SMOKING, HEALTH or anything else vaguely resembling NRT claims will go a long way toward ensuring you can keep selling them.
The eliquid is even more of a slippery slope. But Lacey and Lithium and others sure seem to be on the right path with the precedent of Nico Water and other tobacco products that barely resemble tobacco as we have known it. Nicotine Water screwed themselves the first time around by claiming it was a dietary supplement instead of a tobacco product. The FDA used the opening and banned it on grounds that it's intended use was as a smoking cessation product. (search FDA site for ruling)
This is where the FDA gets very tricky. In Nico Water's situation it wasn't so much the stigma that surrounds nicotine and tobacco as it was the claims they made for Nico Water's intended use. The FDA has officially designated nicotine addiction to be a disease. Therefore, any product claiming to help or mitigate that addiction is automatically designated as a medical drug or device and thrown in with all the new drugs and medical devices requiring exhaustive clinical trials. Nico Water finally got it right 6 years later by officially marketing it as a tobacco product. That puts it in the same category as cigarettes and snuff and out of reach of the FDA. Despite the actual legal category of Nico Water, they still use the health/quitsmoking angle. Look at how the wording on their site
implies that it is an NRT without actually saying it:
(search for Nicotine Water)- noobs can't post URLS I discovered just now. sorry lol!
So the model for keeping e-cigs, vaping, personal herbal vaporizing or whatever you want to call it out of reach of the FDA already has some very nice precedents. Head shops provide the working model for marketing vaporizers. Their devices have been promoted in a general way allowing the consumer to define how they use them. They do not come packaged with any kind of formulation and the manuals are written only to cover basic maintenance and general function of the device as opposed to any specific utilization. Our portable vaporizers would be well-served by such a marketing philosophy. That approach would go far to prevent the FDA from seizing them in customs as NRT devices if they weren't so clearly defined as such in the user manual and by the controversial chemical compounds packaged with them. Moreover it would also also help prevent any patent infringement concerns for NRT devices.
Eliquid should be introduced as a "tobacco product" under the same legal definition as Nico Water making it immune from FDA control according to rulings laid down in 2000. The fact that Nico Water is made in such a way so that it contains no tobaccoo tars appears to be very similar to the processing of tobacco for eliquid so that shoes in nicely. It's just a matter of properly referencing the precedents that already exist as a model toward sanctioned approval of eliquid. In this way, while there would certainly be government oversight and taxes on the eliquid as a tobacco product, it would be vastly better than having the FDA jump all over it and ban it outright. Quality control of eliquid would be a very nice bonus as well. Child-proof packaging would be of paramount importance and I personally believe this is an issue that eliquid suppliers should implement NOW.
The only real issue I can foresee is with the PG (propylene glycol). The FDA has approved medical device inhalers that use PG as a vehicle for drugs and I can very well see how they would alight upon that precedent to make claims that the PG in the formulation constitutes a medical drug delivery device. In fact I would bet on it that they would. The solution there is a rather easy one too I think- make the commercial eliquid without it and let users buy their own PG or VG to add to it if they wish.
On the marketing end, websites that sell vaporizers and eliquid would have to eliminate "how to" type info that is specific to nicotine eliquid. The same tacit discretion as seen in headshops would apply. Also, with this great forum as an "unaffiliated" resource, it shouldn't be a problem for people to figure it all out. I think it can be done.
