This is what I've been talking about for a year now

[markarich159]

Apples and Oranges. You are really going to equate the making of e-juice with the manufacture of complex medicines? Really?

Mixing an IV bag or a simple opthalmic solution is far from manufacturing a "complex medicine", but still has to be done in an appropriately aseptic environment due to the final product's intended route of administration. You also have to be sure what you're mixing is chemically/physically stable; so even the production of what would appear to be "simple" product(s) does require some modicum of skill/knowledge. My main point about DIY was simply to state that there are variables in your home that cannot be controlled and this should be considered. For example, accidental transfer of a particularly virulent strain of pseudomonas aeruginosa from your desktop/sink/etc... into your eliquid solution could be very problematic. Cleanliness in ALL DIY eliquid activities should be paramount.

As for the other "quit smoking fad herbal treatments" mentioned. The 1994 Dietary Supplement Health & Education Act(which I am not entirely happy with), allowed products like this to be marketed without formal approval as long as they bear the disclamer *This statement has not been evaluated by the FDA. This product is not intended to treat or cure any disease* in regard to any health claim made. I explain the reasoning behind the passage of this act in my PG/VG sticky in the DIY liquid section. This is something that the ecig/eliquid manufacturers could have done as well(i.e adding the DSHEA disclaimer to their packaging/labeling) and would have probably sufficed to keep the FDA off their back. Why they did not go this route is another mystery.

 

[Pav]

The 1994 Dietary Supplement Health & Education Act(which I am not entirely happy with), allowed products like this to be marketed without formal approval as long as they bear the disclamer *This statement has not been evaluated by the FDA. This product is not intended to treat or cure any disease* in regard to any health claim made.

I too wonder why this has not been done considering some of the things I've seen out there for sale that use this disclaimer.

 

[markarich159]

I too wonder why this has not been done considering some of the things I've seen out there for sale that use this disclaimer.

Not that the DSHEA disclaimer route would have been a completely acceptable option(in my opinion it allows many unsafe products to skate to market & has caused problems in itself which has led to passage of another 2006 congressional act requiring mandatory reporting of OTC and dietary supplement adverse reactions). But, technically, it could have kept the FDA off the industry's back; at least allowing time for industry growth and safety testing to be performed.

 

[rothenbj]

Me too - I did the magnet / pressure point on the ear thing that was supposed to decrease nic cravings. All it did was give me a pressure ulceration on my ear and a really nasty disposition towards everyone and every -thing!

I get the same symptoms every time the FDA comes out with another press release on this subject.

 

[markarich159]

rothenbj, the vendors I would be most concerned about are the ones making it out of their house using flavorings that aren't even regulated as a food product for ingestion. New ones are popping up daily and their fans keep them in business without knowing the facts. It's obvious that these vendors are in it for the immediate money and not for the long haul. I refuse to support this mentality when the entire e-cig industry is at stake.

I meant to respond to this post earlier. I completely agree GoodDog, it seems like there is, at least, one or two new "homemade" eliquid vendors popping up every month. Some of these vendors are in blatant violation of not only Federal, but State and Local laws. For example, in California it is illegal to produce any product intended for human consumption(through any route) for sale to the general public out of one's private home(the issues with this practice I've already addressed). I've also gotten PM's and emails from vapers concerned with homebrewers using inferior and in some cases totally inappropriate ingredients(specifically, flavorings/essences intended for external use only in eliquid intended for pulmonary inhalation). It's quite obvious that vendors employing such methods have no regard for anything but taking expedient monetary advantage of a completely unregulated marketplace. Then to turn around and use the guise of "looking out for people's health" is the height of hypocrisy. This is why it is essential to be an EDUCATED vaping consumer and know what you're buying. Not just purchasing any "new thing" out there and delivering rave reviews, thereby giving free advertising, to a business entity whose manufacturing standards/practices you know nothing about.

 

[DaDuke]

Originally Posted by markarich159
I have done nothing in my tenure on ECF...

I hate to come off as pretentious, but...

That was by far the worst case of culling two statements completely out of context I've seen in a while. At least quote the entire sentences in the future.

heh, just found it humorous in a contradictory way

I never thought the FDA should regulate eliquid as a drug.

Wasn't specifically referring to you but anyone that thinks eliquid needs to be produced in a manner consistant with drug production. Drug manufacturers don't do that out of the kindness of their hearts so unless eliquid is classified and regulated as a drug it is unlikely it will be produced in that manner in the US. Market forces may encourage some to do so and it will be reflected in their costs and you may be able to choose to pay more for their brand or pay less for Krusty Karlas Kitchen Koncoction. I prefer the choice although i wouldn't choose Karlas

In fact if you go back a few posts, I referenced my very early "a pharmacists View" thread; in which I hoped that a new class of non-therapeutic, recreational tobacco substitute would have/could have been created

Yes, i agree that would be nice but the odds are very slim we could get the FDA or congress to create a new category.

I would support regs requiring all nic/pg/vg fluid to be manufactured and packaged in usp class facilities to virtually eliminate the risk of too high of nic levels in the juice, then sold in bulk to the small eliquid suppliers. The end supplier would then use these products along with their flavoring recipes to produce their final product.

Combine that relatively simple manufacturing change with food service level regs and inspections on the retailers mixing facilites and i would be more than satisfied with the level of quality without having to pay pharma prices. This shouldn't increase price much since the seperate ingredients are produced in this manner anyway with the only additional step in the supply chain being the pre mixing with vg/pg before it gets to the retailer.

In any case, said, new class of substitute would still need realistic manufacturing regulations/QC standards owing to the route of admistration of eliquid; and there would still need to be, at the very least, some level of safety/toxicity analysis done. I for the life of me cannot believe, since ecigs have been marketed in China since 2004; that some Chinese ecig manufacturer does not have some data somewhere that they could pull together.

Are you saying that the USP grade nicotine is not tested as to the level of nicotine they actually contain or the claims that a supplier is using usp grade nicotine produced in the US is a fabrication?

by DaDuke: When was the last time your cheeseburger was produced within a cleanroom? Do you feel reasonably safe consuming that burger?

I'm not inhaling that burger directly into my lungs, which do not have the inherent bacterial/fungal/parasitic protection that my gastrointestinal tract does.

True enough but how many forms of dangerous bacteria can survive within a mix of nicotine and PG? Out of those how many are common enough to have a substantial chance of causing serious harm? Has there been even one case yet? I'm not personally concerned with 1 in a million worst case scenarios. Now, how many can survive within a burger that can easily bypass your gastrointestinal tracts natural defenses?

I feel reasonably safe with my burger... and my juice. But then again, i live my life taking reasonable risks every day. As an example i don't like the helmet law. Before it existed i would wear a helmet when driving on the freeway or crowded city streets but if i was cruising a country setting i would remove it. I no longer have that choice because of those that want to coddle me craddle to grave. My life, my risk, my choice. Disclaimer: that is not directed at you personally.

 

[markarich159]

Yes, i agree that would be nice but the odds are very slim we could get the FDA or congress to create a new category

Probably not now, but three years ago when initially introduced; or possibly prior to the SE NJOY suit; Certainly before mall kiosks were making outright health claims; If ecigs/eliquids were properly marketed from the jump with cooperation from manufaturers/suppliers and the appropriate govn't agencies - It could have been.

Are you saying that the USP grade nicotine is not tested as to the level of nicotine they actually contain or the claims that a supplier is using usp grade nicotine produced in the US is a fabrication?

No, I'm saying the Chinese have had 6 years and KNEW they would ultimately be marketing to the WEST(US, UK, Europe, Canada). You would think someone at Ruyan China, Joyetech, DK/Boge, etc... would have said "Hey, they require safety/toxicity analysis data over there - don't you think we should put someone on that NOW BEFORE we introduce these products to the west so we'll have some data to show them??? Hey even better idea, let's set up a US subsidiary and get the process started BEFORE we actually introduce the product to market, maybe hire a US attorney/attornies and see what we need to do to get the ball rolling. Nah, we'll just stealth market these through mall kiosk distributors and online distributors selling out of their garages. Hate the FDA all you want, but that was NOT a good marketing strategy.

True enough but how many forms of dangerous bacteria can survive within a mix of nicotine and PG? Out of those how many are common enough to have a substantial chance of causing serious harm? Has there been even one case yet?

We'll never know at this rate, there's been next to no data or studies(again back to the safety/toxity analysis data requirement). It's standard industry practice for inhalation solutions to be made in the manner I have described ad nauseum in previous posts(aseptic technique/ HEPA laminar flow hood for compounding - Sterile cleanroom for large scale manufacture).

My life, my risk, my choice. Disclaimer: that is not directed at you personally.

Agreed, but that assumes the risks have been clearly established or there is enough information available to make an honest assessment. In this instance, with respect to US eliquid manufacturers, this is, unfortunately; not the case.

P.S. This post is also not directed at you personally, just responding as honestly as I can to very valid arguments. Also, this post has not been evaluated by the FDA. This post is not intended to treat or cure any disease.

 

[markarich159]

Probably the industry should be trying to firmly establish the fact this is a consumer product not a drug.

May have worked a few years ago, I doubt it now.

But in any case I'd be interested to know how the cost of drug licensing compares in the US and UK. An estimate for the minimum cost in the UK is about $150k, as the pharmaceutical license is £28k (GBP) and the cheapest clinical trial would be about $75k, plus documentation/legal costs. What would the minimum cost be in the US?

The average time can be anywhere from 8- 12 years depending on the drug. Average cost anywhere from $500million to $2 billion. Wiki has 2 good, fairly comprehensive articles on this.
Drug development - Wikipedia, the free encyclopedia
&
Clinical trial - Wikipedia, the free encyclopedia

Considering these facts, your first opinion about the consumer product route looks great in hindsight.

P.S. I agree with pretty much everything else you've posted in this thread. Good insight from a fairly unique perspective.

 

[Dawolf]

To bring a new drug into the market would take some time and alot of money and research. This is way not even close to being the case here. Nicotine is a known drug that is currently ingested in Tobacco, Oral, Inhaled (Nicotrol) and dermally. Specifically what the FDA would need in a case such as this is standards of quality for both consumables and the devices. More than likely, since Nicotine has been around and being ingested through various ways, alot of the clinical trials have already been performed and as such may be leveraged in this case. For example The Gum and patches use nicotine in a chemical form. There were tests performed that had to prove claims that These methods were a safe form of consumption, and that they were effective to help in smoking cessation. When these showed up to market, the FDA wanted to make sure that said dosage levels were consistent, the process for extracting and processing nicotine were consistent and stable etc. Almost simultaneously, the Patch, Gum, lozenge and inhaler all came out.
The testing that would need to happen obviously would cost alot more than 75k, but nowhere near what it costs to bring a new drug to the market. Inhaling a processed chemical through a PV is new and as such someone needs to know that this does not pose any immediate health risk either by inconsistent product or inconsistent delivery device. This is not so much so they can regulate dosage etc. But more so they can establish a baseline for the public to know what is considered safe.
Its kind of like the cheeseburger thing. We all know that there is a risk associated with eating a cheesburger too rare. So some restaurants post warnings about it, or simply will not serve burgers that are cooked less than medium. These baselines were established when they found certain bacteria and instead of pulling meat off the shelves, they validated that if meat were to be cooked over a certain temperature, that it kills the bacteria.

Back to PVs, noone seems to know what the "safe" vaping dosages are. For example, am I at risk if I vape constantly with a 48 mg mix? Will I experience any symptoms and is this recommended? Or do you recommend that if I need to vape 48mg that I should do no more than 2 ml/day. Is PG safe to vape all day? or is VG a safer alternative? The results of this need to be made public and "intended safe" guidelines need to be published. Just the same as the FDA mandates that all food have ingredients and nutritional info printed on a label. If I am a Diabetic and always drink Diet Coke, they better make the same thing consitently and have a solid process in place that insures that they label things correctly and don't mistakenly put Diet coke label on a regular coke. My mother is very allergic to sunflower seeds and oil, its an automatic trip to the hospital and in some cases life threatening. We have to read all ingredients and we rely on them that they are safe. Did these people have to go through a long clinical trial? No, they just have to have processes in place that insure that they put out a consistent product and that has to be validated. From the Raw materials, to the labeling, these are consumed products and the consumer needs to be informed and protected.

From the letters that I have read regarding what the FDA is looking for and what they need to be compliant, it seems to me that they are just looking for the industry to get up to the standards of quality. Yes this will cost money, and yes 95% of the companies that are selling juice will be forced out of business, and then the big boys will get into the game. Phillip Morris NicJuice, Johnson and Johnson, and maybe Bic will start making PVs? It is inevitable because there is a market and an appetite.

 

[lonercom]

Thanks for respondng to my post Rolygate, markarich159 and all.

I'm wondering if one of the 5 involved will go back to the FDA with modified advertising and perhaps consider the DSHEA disclaimer as an alternative (Kinda why I posted it here). It would be interesting to see how they respond to it. I agree with markarich159 that lots of dangerous products find their way to market this way and believe that existing reporting systems are an effective way to track problems. If one distributor goes the consumer product route successfully then the rest will have a clear path to follow. For those foolish enough to go their own way, they will gain a fast understanding of Darwin's theory. I'm not in the business and frankly have no desire to start one. I am interested in seeing this industry survive and thrive just to protect my supply. I want more competition as this will drive prices down. I dream of the day that I can buy filled KR808 cartos @.50 USD. At that price point they become disposable after 1 use to me.

Mom and Pop Juice companies will come and go and standards for cleanliness, etc will winnow out the folks that really shouldn't have been in the business to begin with.

Small businesses can survive and thrive in the consumer goods market with an effective business plan and good customer service. I'm afraid that buying a few hundred or even thousand dollars worth of product and throwing up a website is just a good way to waste money. The goal of most entrepreneurs is to start a successful business, develop it over a few years and sell it to a big company for some serious $$$.

I can't wait to see how this chapter plays out.

 

[DaDuke]

I wonder what the cost would be and if it's even possible to contract a current USA usp plant to mix and package your recipes for you? Even if they didn't produce all the base ingredients at that site (especially the flavorings for example) they could receive the drums of USP grade ingredients from each respective manufacturer and then mix, package and shrink wrap them in their own USP facility. That final product would then be shipped to the retailer for end user marketing with all the quality controls and assurances done by an already established and certified US usp grade company.

What do you think about this idea?

 

[rolygate]

It is ECF's position that e-cigarettes and e-liquids are a consumer product of the same class as caffeine products or alcohol products. Neither of these are licensed drugs as there is no need for them to be.

For some time now we (ECF) have been stating that classification as a consumer product and/or a tobacco product, or in some countries as a harm reduction product, is the way to go. Note that a while back when we first published the opinion that ecigs should be classed as a tobacco product there was a lot of resistance to this statement. Now the best-informed commentators agree.

The situation varies in each country of course; and we are basically discussing legal semantics and nothing more - a way to survive in the regulatory framework that exists in each country. Ecigs are an alternative method of smoking, nothing more, nothing less, and if government agencies, or suppliers, want to state otherwise then things start to get complicated.

Suppliers who market their products with even a hint that that they might be used to 'quit smoking' (or one of its alternate forms of phrasing) are putting their head on the chopping block. We have always known this. It is a direct challenge to pharmaceutical licensing agencies to license them, ie shut them down.

Personally I am a smoker and don't want to stop smoking, ecigarettes just seem a far better option to me. If the end result at some time in the future is that I stop all forms of smoking for some reason then that's fine, as presumably it will be something I want to do. Right now I'm a smoker and want to smoke, don't want to quit, and want to be able to choose my brand or even type of smoking, as I'm an ordinary consumer and that is an everyday consumer choice.

I do find it interesting that the cost of introducing new medical products is so high in the US, but find it hard to believe that would apply to the simplest types of materials, or to those with an ingredient or ingredients with a long history of consumer and medicinal use (such as PG and nicotine). Nevertheless I think we can agree that, universally, the cost of medical licensing is beyond all but the largest vendors, and that this route would entail 99% of suppliers closing up shop. It is after all why opponents are pressing for that route for ecigs, as it will in effect remove them from the market.

Incidentally as an ordinary consumer I am not happy at all that products that I inhale large quantities of can be sold without any form of testing or checks. As it stands right now, anyone can sell any materials made in any way, for use as e-liquid. That is basically wrong, from my personal perspective as the end user. Therefore for me personally the key is to find a way to regulate these products that means they are safe for people to use, without going the whole nine yards and licensing them as medicines - which would in effect kill them off. And of course it's that old, broken record song that ECF has been singing for so long: vendors, get your act together and form trade associations that can test and approve members' products. If only they'd done that a while back...

This regulation/legal/government pressure situation will never end, by the way. It's going to be a permanent battle for the next 30 years and beyond, whatever happens. For example if government agency X in country Z lose a court case that stops them regulating ecigs in one particular way, they will come back later and try to regulate them in another way dependent on the classification that ecigs were subsequently given in the previous round. It will never end, so it would be best not to think, "Once this is over we'll be OK", or "Such-and-such a decision will mean the pressure is off" - because it won't ever be. Now we've stuck our head above the parapet the shooting will never stop.

It's all about the money, and nothing else, so in Round 1 - where we are at the moment - commercial rivals and their paid lackeys try to kill us off. If we win Round 1, then in Round 2 it becomes about the precise ingredients. In Round 3 it's about the tax. And in Round 4...

See you down the road

 

[justincase]

I tend to agree with whoever said a lot of these products are purchased from various vendors/suppliers, and then mixed to our favorite juices.
As far as food regulation safety, well, it's not really that big of a deal. I have a mobile food license for the state of Ohio. It's not that hard to comply. Think of the food vendors at a festival or fair. They all have to have this license. And the health department comes around to ever one of them and does an inspection before they can open. If they are found not to be in compliance, they simply are not allowed to operate. The Health inspector MAY come back the next day and inspect them again, but they don't have to.
A friend of mine that lives in PA makes homemande candy and fudge, out of her home, but she is not allowed to use HER kitchen, she had to build another kitchen in her basement. Totally seperate from her personal use and has to meet all the same requirements as a restuarant kitchen.
In both instances, each "business" has to have at a minimum of a 3 sink system (wash, rinse and sanitize) and a seperate hand washing station.
I am pretty sure that when it comes to a bakery or whatever, they would have the same standards pretty much across the board. And would you really want to eat something from someone else's kitchen if you don't even know them??? How gross is that?
Kinda OT, but I am going to try and bring it all back around.
Now if they can make regulations that are pretty easy and standard for people that make food to be comsumed by the public at large, they couold probably jusrt as easy put some standard regulations in place for folks that want to make e-juice.
My friend doesn't make sugar for her fudge, she buys it. But it has to be properly stored. Nic juice could be regulated the same way. You can buy it, store it properly, and use it in a matter that is necassary for concocting that "perfect juice recipe".

Just my 2 cents!

 

[rolygate]

This is a fair comment - you feel that these products should be regulated in the same way other consumer products are.

The problem is that ecig and liquids need to conform to existing product regulation procedures. There is absolutely no question that some sort of new framework can be introduced for them - this is not going to happen in either the US or the UK. In the UK the government has formally stated there will be no 'green paper' solution for new types of products, ie a blank sheet to draw up new procedures or regulations (this is in regard to all/every new product type, not specifically ecigs). That message has been reinforced by the pharma licensing authority there, specifically with regard to ecigs.

In the US this stage has not been reached yet due to the vast scale of any issue compared to the UK - perhaps twenty times the scale, with all the added complexity that brings with it, such as the State/Federal issues. At present the argument is based on the pharma licensing issue, and once that is resolved one way or the other, other options will be no doubt be discussed. However a new product-type arrangement is even less likely than in the UK, due to the scale. New procedural arrangements would cost a lot of money and that just isn't going to be there.

Which leaves the current situation as-is for consumable products: pharma licensing or local consumer controls. In the UK the consumer controls are actually very efficient, materials are taken away to be lab tested for safety - and by the way this includes all brick & mortar *and internet* suppliers based in the UK. If that system is stopped by the pharma licensing agency then there will be serious quality and safety issues for the consumer. In the US I don't think the same level of product testing is applied locally, which in effect means the consumer has less protection.

Unless e-liquids are tested in a lab somewhere by somebody then the consumer suffers. It's simply that most would prefer testing to be industry-controlled rather than government-controlled, as that is never the best solution. Some suppliers are very responsible in this area; it is quite likely that others have never had a single batch tested in a lab. As I understand it, suppliers' products are not materials-tested in a lab by trading authorities in the US, as against in the UK. This is part of the problem since there is zero justification for suppliers to tell authorities to keep their nose out of the business. Somebody somewhere has to have oversight.

Several large-scale suppliers have addressed this issue by setting up batch testing skeds for their liquids. One publishes the results online, and you can check your purchase by its label batch number against the published results. Another employs a national-class research laboratory to consult and to test their product, at a cost of around $150,000 a year.

These examples are distinguished by their rarity. If trade bodies were formed, such procedures would be affordable by all. Expensive - but affordable. Remember: the golden years have gone, and gone for ever.

Materials testing and correct packaging should be standard for all, and anyone who says different just shouldn't be in this business. Period.

 

[lonercom]

I did a bit of looking at DeKang and Boge's websites and they do have an impressive collection of inspection and certification reports from a number of countries including the UK. Too bad that list doesn't currently include the US. Hopefully they are working on that.

 

[markarich159]

This is a quote from CJsKee from a similar thread:

I don't know if you get around to other forums or not, but a couple of months ago one of our vaping organizations made some suggestions to vendors along the very points that you make. And let me tell you, there was an uprising like you wouldn't believe! Some consumers and vendors alike threw an absolute s@#! fit. "Nobody was gonna tell them what to do." And mind you, these were only suggestions, and IMO they were very reasonable...labeling, testing, bottling, etc.

I don't know what our vendors' problems are (other than maybe "mine's bigger than your's!), but they absolutely MUST get it in gear. They've waited far too long as it is. Regulation is coming whether they like it or not.

First of all, thank you CJ for the post, I think it highlights the issue perfectly. The vendor's problem and the question of why they waited so long is directly a result of the mindset and attitude cultivated by sellers in a market in which no inherent regulation, of any kind whatsoever, exists. Why should they care about QC, testing, labeling, bottling, etc... if no one in a position of authority is making them, and there's NO pressure from the consumer(rather the opposite-unfettered support and praise regardless of the situation). The vendors, for the most part, took advantage of the unregulated market as well as the consumer's general lack of knowledge of basic industry safety/QC standards.

Even now, after the FDA letters have come to light, the RATH incident, the JC inspection revelations and vapers being somewhat introduced to QC/QA/cGMP issues(and the total lack of their existence in the US eliquid market); I'm still seeing a majority of posters on this and other forums "not getting it" and blindly casting excoriating opinions at the FDA and anyone who dares to question or criticize the vaping industry. This may be last chance we have people. It's time we start demanding that our manufactures/suppliers start implementing some sweeping changes; supporting those suppliers who are seriously in this thing for the long term; and dumping the detritus who are only in this for a quick buck. It may already be too late, but if we as consumers do NOTHING and keep trodding along blindly as if nothing must change; we are most definitely delivering the death blow to something that we value so much.

Even CASAA(which is supposed to be a CONSUMER ADVOCACY group) seems more content to spend the majority of their time addressing the evils of the FDA(and other govn't and medical agencies and organizations) and badgering them with non-constructive email/petition campaigns. Wouldn't their hard work, effort, time and cause have been better served by going after rogue suppliers(i.e. those who had/have no Quality Control standards in place & insist(ed) on continuing to include "health claims" in their advertisements knowing this was inappropriate with respect to current scientific data available); which would have directly & immediately helped/protected the vaping consumer while at the same time giving the FDA less of an obvious target. They seem to more of a SUPPLIER/INDUSTRY advocate then vaping consumer advocates. P.S. this is just my opinion and I apologize , in advance, to any CASAA reps(who I know have worked hard on their own free time) as I'm sure I've offended many of them with my previous statement(although I believe it to have merit)

 

[firhill]

Well, I'm not a supplier, but this US supplier's video tour of their lab is good enough for me.

Wouldn't let me view their video tour, so I still don't know what their facility looks like.

Oh..they took it down, maybe in light of the recent FDA crap rearing it's ugly head again.

It was a tour of the Puresmoker set-up.

 

[markarich159]

Oh..they took it down, maybe in light of the recent FDA crap rearing it's ugly head again.

It was a tour of the Puresmoker set-up.

The Puresmoker set-up(I saw the video when it first came up) was NOWHERE near cGMP. That is definitely why they took it down. I was a bit encouraged when they said they got a "chemist" to oversee their "new lab"(even though the proper degree for a person setting up a novel product formulation from the ground up, such as this, would be either a Clinical Pharmacist with previous industry experience or a PhD in Pharmaceutics). But then when I saw the video, I knew it was just window dressing. Note to future suppliers/manufacturers- a room with a sink, a few beakers, digital scale, a cheap harborfreight tools moveable non-HEPA fume hood and tract lighting does not qualify as GMP; in fact, it scarcely qualifies as a lab.

 

[lonercom]

@markarich159. I agree with most of your post.

I think that we differ a bit when it comes to CASAA. Their activities regarding legislative intervention has been outstanding and alerting members about local activities is really nothing more then good old fashioned grass roots politicking.

I do think that CASAA suffers a bit from a siege mentality but that is because they and us are pinning alot of our hopes on the outcome of the SE v FDA case. In that case, I agree that they should rule in favor of tobacco status. Remember that the only thing that case has to offer anyone other than NJOY and their customers (I'm not one) is the legal precedent.

This takes us full circle to the conclusion that E-cigs,etal should NOT be regulated as Tobacco OR Drug/Device. The only company that lives or dies by that ruling is NJOY. It's possible that the rest of the industry may still be regulated as an OTC Consumer product if the dealer/manufacturer would just stop suggesting that the product has any medicinal value.

Let NJOY fight their fight. Let the folks that want to make medical claims make them and get shut down. The rest should just drop those statements and focus on organizing and regulating themselves.

I sound like a broken record. Maybe a few folks will get a clue.

 

[markarich159]

This takes us full circle to the conclusion that E-cigs,etal should NOT be regulated as Tobacco OR Drug/Device. The only company that lives or dies by that ruling is NJOY. It's possible that the rest of the industry may still be regulated as an OTC Consumer product if the dealer/manufacturer would just stop suggesting that the product has any medicinal value.

Let NJOY fight their fight. Let the folks that want to make medical claims make them and get shut down. The rest should just drop those statements and focus on organizing and regulating themselves.

Hi Loner;
Thanks for your input to this thread it has been interesting and informative. However, to the point above, and maybe Sun Vaporer(our resident SE NJOY case expert) can chime in; I'm not sure if this is the case. I seem to remember hearing two opposing viewpoints and Sun addressed this , but I can't remember what side the legal fact came down on, with regards to the NJOY case decisions encompassing other ecig vendors. Even if the NJOY decision does not enjoin other ecig/eliquid manufacturer/suppliers, we're back at the point that Rolygate addressed several posts ago- with defining a new consumer entity, which in itself is daunting. And I don't think the FDA , at this juncture and after a long court case, will be willing to say to all the other ecig vendors, "Ok, let's just regulate it as a tobacco product."
So the main question is will the vendors remaining have the wherewithal to do the right thing and take the time and money to do what they should have done 3 years ago and introduce the product to market properly. Or will it even be profitable to do so if they cannot make any overt health claims(remember, that's the reason these became so popular in the 1st place-unfortunately, there was no hard data to back up the claims). Who knows at this point?

Anyway I gotta get going, good night to all.