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

[kristin]

No, you misread - I said I checked FROM July 2009 through the most recent reports. And I downloaded the full reports - there is no indication that they were only partial.

I don't "lambast" anyone. Just because I don't agree with you doesn't mean that I'm being unfair or attacking you. But I have just as much right to counter the points you make as you have to make them. I do, however, feel the need to negate alarmist and over-reactionary comments. I think most vapers - former smokers - get the irony of being so overly concerned about e-liquid when they were already killing themselves by smoking. It's apparent that the industry isn't rampant with foul, poisonous liquids, as after 5 years on the market, no one has reported serious illness related to e-cigarette use - and you can bet that if anyone had reported this to the FDA, they would have already made it VERY public to support their position. so, it obviously hasn't happened.

How is asking users of e-cigarettes what the frequency of their symptoms are biased? Either they had the symptoms or they didn't. It's certainly less biased than the survey done by that children's hospital.

It's the law that the FDA must regulate products based on their intended use. They are the one's breaking the law by calling e-cigarettes a drug treament, when they obviously don't treat nicotine addiction and the vast majority of companies never claimed to be nicotine cessation treatments.

It is CASAA's mission to "encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation" but we don't believe that what the FDA is trying to do is "reasonable" as their regulations will directly oppose the first part of our mission, which is to "ensure the availability of effective, affordable and reduced harm alternatives." FDA actions will remove e-cigarettes from the market. CASAA supports regulation of quality control, labeling, safe handling & manufacturing practices, etc., but we feel that can be done without treating these products as drug delivery devices. Katherine's theory sounds good on the surface, but the fact of the matter is that bleach isn't a consumable and the FDA oversees consumables - anything that is intended to go into the body - and since nicotine is intended to go into the body, the FDA has juristiction. The FDA classifies nicotine into two catagories - drug or tobacco. The chances of getting ecigarettes regulated by the same body that regulates bleach are nil.

CASAA is not an industry organization and has no control over the industry, other than making the suggestions to them as we already have. Other groups have attempted to force regulation/standards on vendors and received extreme backlash from both the vendors and the consumers. We support the same kind of regulation that would cover any other recreational consumable product - clean manufacturing facilities, informative/accurate labeling, steps taken to reduce contaminates, truthful advertising and no sales to minors, amojng other things. These can be achieved by regulation as a tobacco product.

Being in the pharmaceutical industry, you seem to have an insurmountable bias as to how these should be regulated. I simply don't agree with your opinion.

That article was from today, not July 2009(so MedWatch from a year ago would be dated - FDA also does not list online ALL of the reported Adverse Events especially for products that are unapproved or have no viable NDC#). And a CASAA survey is, how can I put this, a bit biased to say the least; completely non-randomized to say the worst. And yes it DOES matter what the FDA wants to compare ecigs to #1. because that's the law and ecigs get no special exemption #2. I , and others, want to know if ecigs are indeed safe, short and long term. Diacetly is used in ALOT more then just popcorn and butter flavor-it's 2-3 butanedione-and can be used in many formulations to add a buttery richness or consistency to a formulation, so who are the disreputable merchants using it? do you know?. And your still touting that ecigs can and are to be safely used for maintenance or cessation of Nicotine addiction(that's a medical/health claim regardless if smoking cessation is mentioned)- just as methadone is used for the maintenance of opiate addiction.

I think Katherine from ECITA may be able to offer you some better solutions to working through the current FDA and ecig industry issues, rather then lambasting any vaping consumer who may have a contrary opinion(and this hasn't been the 1st time) to how the industry has developed so far in the US; as well as a concern to the safety/QC issues grossly apparent in the industry(i.e. unqualified, untrained persons producing unregulated liquid intended for direct pulmonary inhalation in their home with no regard for any typical industry quality control standards). I would think to CASAA, being a consumer advocacy group, whose mission statement includes " to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation"; this would be a complete affront to the industry and something deserving of top PRIORITY in order to keep vaping consumers safe.

 

[ACM]

I have not read all of the posts in this thread, so please forgive me if some of what I say here is redundant.

There are a couple of videos, accessible thought the Johnson Creek website, of news reporters touring their facility. Their workers wear protective clothing and maintain what they claim (or imply) is a clean, if not sterile, workplace. They use high grade, quality ingredients. The problem the FDA has with them is not that they lack "quality control" but that their promotional literature puts them in the category of pharmaceutical manufacturing, and the FDA guidelines for that kind of company are clear and stringent. If they did not position themselves in that way through their marketing, then the FDA would not have had a legitimate beef with them.

I don't believe there is anything wrong with JC's product or methods of manufacture. I think it's their marketing approach that needs revision.

 

[Pav]

One more point on the marketing. From what I gather it seems the FDA has a problem with user comments on vendor forums. While it's true that the vendor is not making the claims themselves, they do have control over what is posted on their own website, so they might want to consider either shutting down the comments on their websites, or tightly controlling what is said there. Less ammo for the FDA that way.

 

[markarich159]

I have not read all of the posts in this thread, so please forgive me if some of what I say here is redundant.

There are a couple of videos, accessible thought the Johnson Creek website, of news reporters touring their facility. Their workers wear protective clothing and maintain what they claim (or imply) is a clean, if not sterile, workplace. They use high grade, quality ingredients. The problem the FDA has with them is not that they lack "quality control" but that their promotional literature puts them in the category of pharmaceutical manufacturing, and the FDA guidelines for that kind of company are clear and stringent. If they did not position themselves in that way through their marketing, then the FDA would not have had a legitimate beef with them.

I don't believe there is anything wrong with JC's product or methods of manufacture. I think it's their marketing approach that needs revision.

Ok, one more before I go, I had to comment when I saw this. As a pharmacist I read the FDA non-complete list of violations, JC is horrendous, they don't even have ONE PERSON tasked with any QC responsibilties, no standard operating protocol, no paperwork, no testing of anything coming in or going out, etc.... To an untrained eye(please, no offense is intended toward you with the untrained remark ACM) a pre set-up "news interview" with people walking around a non-sterile or non-aseptic production environment with protective garbing,masks on and gloves is at best, still pitiful, at worst simply deceptive window dressing for a news crew. Standard industry protocol for a product such as this(liquid intended for direct pulmonary inhalation) requires , on a small compounding scale a fully garbed pharmacist or technician(just like a doctor in an operating room) utilizing strict aseptic technique with sterile USP grade starting ingredients in a HEPA certified laminar flow air hood; on a large manufacturing scale, an airlocked sterile cleanroom facility with properly garbed technicians/operators is standard.

Good Night all

 

[KDK]

OK! I have to respond to this. I understand the ideal as the repiratory system is considered sterile. It is not in fact. We aren't talking about medications here, e-liquid is not an RX, nor do we want it to be. Do we want it clean - of course. If you are talking sterile, thats talking a lot of money. It really does not need to be. The air we breathe 24/7 is far from sterile. It really should not be a problem for most people if the liquid is made in a clean manner rather than sterile.

 

[Hudsonkm]

Johnson Creek Lab Tour
YouTube - Johnson Creek Enterprises on CBS 58


Edit : Whoops just saw that this is the link referred to a few posts up. And I do understand your point Markarich, seeing as you have related experience in the field.

 

[markmcs]

I have not read all of the posts in this thread, so please forgive me if some of what I say here is redundant.

There are a couple of videos, accessible thought the Johnson Creek website, of news reporters touring their facility. Their workers wear protective clothing and maintain what they claim (or imply) is a clean, if not sterile, workplace. They use high grade, quality ingredients. The problem the FDA has with them is not that they lack "quality control" but that their promotional literature puts them in the category of pharmaceutical manufacturing, and the FDA guidelines for that kind of company are clear and stringent. If they did not position themselves in that way through their marketing, then the FDA would not have had a legitimate beef with them.

I don't believe there is anything wrong with JC's product or methods of manufacture. I think it's their marketing approach that needs revision.

OK! I have to respond to this. I understand the ideal as the repiratory system is considered sterile. It is not in fact. We aren't talking about medications here, e-liquid is not an RX, nor do we want it to be. Do we want it clean - of course. If you are talking sterile, thats talking a lot of money. It really does not need to be. The air we breathe 24/7 is far from sterile. It really should not be a problem for most people if the liquid is made in a clean manner rather than sterile.

I've got to agree with both ACM and KDK that a sterile production environment would be prohibitively expensive and is unnecessary to make a safe e-liquid. Of course, quality control guidelines need to be developed and enforced for this "hybrid" industry; but as long as a company uses quality ingredients in a clean environment, and employees follow 'universal precautions' like proper protective clothing and proper equipment sanitization techniques, the FDA should not interfere with the production and sale of e-liquid. I don't feel that an operating room, or "clean room" environment is necessary, and as KDK stated, the very air we breathe is far from sterile. No offense to you, markarich...but I feel this is just the slippery slope that big tobacco and big pharma would love to get on to ensure that if any e-liquid is sold, it will be they who sell it. I very much like the personal touch that these small, mom and pop outfits provide, and I am willing to accept their 'homemade' approach to keep it.

 

[freakindahouse]

I think we need to keep in mind why we are vaping, and what that has replaced: smoking. Just picture the two side by side and it becomes obvious.

That's not to say there shouldn't be standards, and good manufacturing practices - of course, there should - but let's keep it in perspective! I smoked 30 a day for 27 years and was a totally unfit blimp. Switched to vaping last year and will be taking my black-belt in maarlisk next year. Go figure! LOL

(NB: I didn't quit, I switched!)

Just my humble....

 

[freakindahouse]

Kristin, I understand your problem. The US has such a vastly different legislative/regulatory system to ours that it is nigh on impossible to draw analogies. I shouldn't have tried, really, but I simply do not accept that there is a legitimate argument for dragging ecigs kicking and screaming into either tobacco or drug regulation. It's just wrong, and if the US doesn't have a regulatory framework that CAN fit, then it needs to rethink its approach.

Once I get our situation sorted out, I hope to be able to look more closely at what's possible over with you guys. In the meantime, keep up the good work!

Katherine

 

[BCB]

Kristin, continue to fight bravely against stupidity as you have been doing. Keep the faith. It always amazes me when people insist on a surgical environment for the production of e-juice, then go downtown (opening doors all the way with BARE HANDS), ride a bus, use money, touch stair rails, etc. without a second thought. The air we breathe is chock full of toxins, germs, mold and dust. Logic dictates that if we've eliminated cigarette smoke we're doing a great service to our bodies. It's harm reduction, pure and simple. I appreciate your continued advocacy and logic in this arena.

 

[kristin]

I simply do not accept that there is a legitimate argument for dragging ecigs kicking and screaming into either tobacco or drug regulation. It's just wrong, and if the US doesn't have a regulatory framework that CAN fit, then it needs to rethink its approach.

I was right there with you for a long time, Katherine. But in order to allow ecigarettes to be considered anything other than a tobacco product or a pharmaceutical product, we'd basically have to change the entire regulatory system and create a new agency, because we definitely don't want the EPA to control these (they regulate chlorine bleach) because they even more zealous than the FDA and the CPSC does not currently have authority over any products that are used in or on the human body. That would pretty much take an act of congress to add products to the CPSC or create a new regulatory body, which would take a huge - we're talking billions - amount of money for lobbying that the vaping industry and the vaping community doesn't have. And in the meantime, even if we did try to do that, there is nothing to stop the FDA from doing as it intends (as it obviously is ignoring a federal court opinion even now) and making it a drug delivery system. That would equal immediate removal from the market, forcing vapers into the black market or back to cigarettes.

CASAA's hope is to have them temporarily classified as tobacco products, to keep them on the market with the minimal regulation they require (not pharmaceutical-level regulation), while we work on pressuring the FDA to work on the mandated reduced harm programs and standards already ordered by Congress, which also need revamping, because even those standards are impossible to meet. (The industry didn't have this option when it hit our shores in 2005, because the Tobacco Act, which gave the FDA jurisdiction over tobacco products and officially introduced the concept/policy of reduced harm products hadn't been passed until 2009.) We would also keep working on getting the word out about the reduced harm concept and increasing the number of vapers and gaining public support. But this all takes time. Time we don't have right now as the FDA is hell-bent on classifying these as drug delivery devices and removing them from the shelves. A lot of hope is pinned on the Njoy vs. FDA case right now, because if Njoy wins and is considered a tobacco product and it's customer testimonials aren't allowed to be considered "intended use," it will set precedence and give a solid footing for the other companies.

It's very important that companies be allowed to post these testimonials and for the public to understand the concept that smoking cessation is still possible while continuing nicotine use and that it has a huge, positive impact on public health. They need to know that "switching" is a good thing and very nearly the same as quitting all tobacco and nicotine use, even though it doesn't treat nicotine addiction. People need to know the truth to protect and improve their health and a consumer saying on an ecig site that the product helped them quit smoking is invaluable to motivate people to switch. (Companies should just be required to distinguish between smoking cessation and nicotine cessation.)

It'd be great if the U.S. would rethink its approach to e-cigarettes, but there is no reason for it to do so. Smokers are vilified and only make up 20% of the population (and vapers make up an even smaller percentage) so have no significant voice, yet they supply billions in pharmaceutical profits and government tax revenues. They have every reason NOT to rethink it's approach - what they are doing is working. People think e-cigarettes are just as bad a smoking; that kids are being hooked on nicotine by them; that smokers are inhaling anti-freeze; that even reputable companies are filthy and dangerous simply because they didn't meet excessive FDA pharmaceutical standards, etc., so they could very well convince the public to remove them from the market - under the guise of testing, quality control and efficacy as a smoking cessation device (by which they mean nicotine cessation devices, which ecigarettes most certainly couldn't prove, as they continue nicotine addiction, they don't treat it.)

By the way, people need to realize that just because Johnson Creek didn't meet the criteria and follow the required steps for pharmaceutical products, it doesn't mean that they didn't have ANY quality standards or control. Restuarants, grocery stores, packaging plants and other food manufacturers and distributors don't have to meet pharmacuetical standards of quality control, yet we all eat food from them. One has to wonder if Johnson Creek would have passed inspection had they been held to food & beverage standards, instead of pharmaceutical standards. My guess is yes - and then some. And they never made any claims of treating or abating a disease or illness, even with the customer testimonials. Smoking is not a medically recognized disease and helping people quit smoking is not a treatment for a disease unless you are treating actual nicotine addiction. Since e-cigarettes sustain nicotine use, they obviously aren't treating nicotine addiction. So as long as a company doesn't claim its product can get you off nicotine, they are well within the law. That is something we need to force the FDA to acknowledge - smoking cessation and nicotine cessation are two different things. But for now, smart companies will remove even claims of smoking cessation, because the FDA seems to have taken it upon itself to reclassify smoking as a disease.

Think of it this way - drunk driving is not a disease, it is a behavior associated with the disease of alcohol addiction. Smoking is not a disease, it is a behavior associated with the disease of nicotine addiction. An interceptor breath test device, which stops alcoholic drunk drivers from driving their car, is not a medical device treating alcoholism, it's a tool to avoid drunk driving. An ecigarette is a tool to avoid smoking, it is not a treatment for nicotine addiction.

It blows my mind that the vaping community clearly saw the manipulation of the public with the "anti-freeze and carcinogens" press release, but so many can't see the same manipulation with this "violating regulations" press release. They are trying to divide and conquer the community and as evidenced by this thread and many other posts where people are turning against even reputable and consciencious companies like Johnson Creek, it's working.

CASAA does NOT support companies who make nicotine cessation claims, add other pharmaceutical products to their liquids, have unsanitary manufacturing facilities or cut lab-made liquids with inferior products risking contamination and supports regulation in those areas.

 

[kristin]

Thanks, BCB, we really appreciate continued support from the community!

Kristin, continue to fight bravely against stupidity as you have been doing. Keep the faith. It always amazes me when people insist on a surgical environment for the production of e-juice, then go downtown (opening doors all the way with BARE HANDS), ride a bus, use money, touch stair rails, etc. without a second thought. The air we breathe is chock full of toxins, germs, mold and dust. Logic dictates that if we've eliminated cigarette smoke we're doing a great service to our bodies. It's harm reduction, pure and simple. I appreciate your continued advocacy and logic in this arena.

 

[alnjessie]

I'd like to point out two things:

• "Regulations for Finished Pharmaceuticals" may differ significantly from regulation of products manufactured for human consumption (other than pharmaceuticals.)
• You are assuming that the FDA is telling the truth, the whole truih, and nothing but the truth in their letter.

Just because JC does not have a qualtiy control department does not mean that no quality control is performed. Johnson Creek is not Johnson & Johnson. In most small businesses everyone wears more than one hat.

Some of this is just pure BS: "Your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness." Mark, do you really believe that you are consuming an oral liquid drug? Furthermore, propylene glycol has antibacterial properties. So (I just discovered) does nicotine: http://jmm.sgmjournals.org/cgi/reprint/49/7/675.pdf

And do you really want them to start adding preservatives into your liquid? What is supposed to be preserved? Nicotine? PG? Health New Zealand tested for growth of bacteria in empty cartridges (and found no growth). They knew there would be no bacteria in the liquid. http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf


I would love to hear Johnson Creek's side of the story.

You are right on with this Vocalek
If they added preservatives in it.....that would be more dangerous than anything combined in it now.....Preservatives are considered soft kill to us humans as the fact they may help preserve something but the chemicals they use to do it are toxic to us....the fact that Nicotene and the liquid is just like honey is and does not grow bacteria makes this uncalled for.

 

[alnjessie]

What will probably end up happening, and what needs to happen is that either an American Facility or Facilities, possibly one of the many closed down pharmaceutical plants will start to manufacture e-liquids for everyone in a regulated form, and the small businesses will begin to re-sell, white label, rebrand these. This will ensure that there is a product out there to consumers that was manufactured according to cGMP and is generally safe.

I'm afraid that the e-liquid here is just part of the equation. The hardware has to be suspect too. Look at the atomizers, Cartomizers and even the batteries in some cases. There are primers in some atomizers that are just nasty. What about the materials in some Attys/Cartos? Ever take a puff of a burnt or dried up Carto?...this cannot be safe either. The hardware makers need to be put up to a standard as well. What if the materials used in some of these had some kind of toxic output when you heated them up.

I'm saying here that there is as much of a conspiracy theory here with the makers of the hardware and e-liquids as there is with the FDA. All the propaganda I hear on here and on supplier web sites insinuates that vaping is free from toxins and is a cleaner, greener, healthier way to smoke. I have done my homework and I know the risks, but despite that I choose to vape. Don't forget that only a small percentage of vapers bother to go on a board or look up any other information on vaping other than what they were told by a supplier's web site, or at the mall, and we all know what that message is. I believe that it is absolutely right for the FDA to attempt to hold suppliers and manufacturers to a higher standard.

Suppliers, refrain from advertising that vaping can help quit smoking until there is an independent test done that can prove that. We all know that it does help, certainly did for me, let the customers speak, believe me they will if it works for them. Secondly STOP advertising that e-cigs are free of toxins or are a healthier alternative because none of us can state that as fact. We can make a good hypothesis judging by the fact that we are not inhaling anything burnt etc.

Manufacturers, step up to the plate and make hardware that will satisfy the requirements set forth, and insure that your consumers are safe using your product.

I am sick of hearing that we are only inhaling "Water Vapor" and that it is harmless. Who knows this? Yes PG is used in Pharmaceutical inhalation delivery devices and in foods, but until now no one has tried inhaling PG, VG, flavorings, sweeteners, and nicotine on a daily basis for a prolonged period of time. I'm sure PG is fine for use in some nebulizers, inhalation therapies but not all day everyday? How fast do your lungs metabolize PG? VG? Lorann Mint Chocalate chip flavoring? I would like to know. But for now I view vaping as the lesser of 2 evils and I choose to take the "risk".

Someday I may be able to drop inhaled nicotine as a habit altogether, maybe I will keep my PV batts charged for an occasional toot (Cuz we all know where the occasional cigarette leads)...but I sure hope that years from now, tests do not start showing that inhaled "Vapor" from e-cigs causes some other diseases or is toxic over time etc.

Something to definately think about

 

[markarich159]

I've said it before and I'll say it again, It's your life, it's your lungs, Vape what you want to vape, believe who you want to believe. The trash the healthcare professional/medical community mentality is ridiculous. To all those who've asked me questions through PM's, email's, etc... in the past; I hope I was able to help you. If you need further assistance feel free to PM me anytime. I will, however, no longer sit here and let CASAA and their "unbiased" opinions and trite propaganda take over this thread(which was intended to show why and how the industry got into the mess it is in and some things it could practically do about it. Also, to Kristin, if you think I am biased, what about your bias, being a CASAA rep as well as an ecig accessory supplier(HMMM....that would be a VESTED biased and conflict of interest in any other industry...not in this industry though...par for the course). Again, anyone who wants to speak with me can contact me through PM. Mods please close this thread.....Also please delete any further threads from CASAA members that may make it here before the thread is closed , they've certainly have had their say and have their OWN personal subforum to aire their views.

 

[kristin]

You keep insisting that I'm trashing the healthcare professional/medical community and that is simply untrue. I have never done so. The FDA, yes, the healthcare professional/medical community, no. If the FDA was truly looking out for our health, I wouldn't have seen ad after ad on tv last night for class action suits against FDA-approved drugs.

Yes, being a CASAA member and a vaper I am biased - biased to keeping these products available not only to the existing vaping community, but to the future community, as well. But I am not blind the the discrimination happening here, nor to the fact that the industry needs regulation. I just disagree with you on HOW it should be regulated.

My status as an accessories supplier has no bearing on my opinion. I sell carrying cases that can be used for e-cig supplies, but if ecigs were banned tomorrow, my cases are also advertised for tampons, cigars, 7-day pill dispensers, make-up, diabetics supplies, etc. I haven't put all my eggs in one basket, so my drive and determination have nothing to do not have any basis on my little side business - it was there before I opened my store (which everyone knows I was a strong advocate and on the CASAA board before I even started selling the cases) and it would be there even if I didn't have my store.

Nice move trying to discredit me. Sometimes I wonder whose side you are on.

 

[Pav]

Mods please close this thread.....Also please delete any further threads from CASAA members that may make it here before the thread is closed , they've certainly have had their say and have their OWN personal subforum to aire their views.

C'mon M. Lighten up a bit. You're definitely entitled to your views which I believe are not without merit. But this is an open forum where we're all members and can speak our opinions. Let's keep it open. I've gotten a lot of info from this thread and hope it stays open.

 

[alnjessie]

I agree ...very informative...but very aggresive nature to this thread that may shut it down and people instead of getting the info. just get to see people hashing it out instead...

 

[freakindahouse]

I was right there with you for a long time, Katherine. But in order to allow ecigarettes to be considered anything other than a tobacco product or a pharmaceutical product, we'd basically have to change the entire regulatory system and create a new agency, because we definitely don't want the EPA to control these (they regulate chlorine bleach) because they even more zealous than the FDA and the CPSC does not currently have authority over any products that are used in or on the human body. That would pretty much take an act of congress to add products to the CPSC or create a new regulatory body, which would take a huge - we're talking billions - amount of money for lobbying that the vaping industry and the vaping community doesn't have. And in the meantime, even if we did try to do that, there is nothing to stop the FDA from doing as it intends (as it obviously is ignoring a federal court opinion even now) and making it a drug delivery system. That would equal immediate removal from the market, forcing vapers into the black market or back to cigarettes.

CASAA's hope is to have them temporarily classified as tobacco products, to keep them on the market with the minimal regulation they require (not pharmaceutical-level regulation), while we work on pressuring the FDA to work on the mandated reduced harm programs and standards already ordered by Congress, which also need revamping, because even those standards are impossible to meet. (The industry didn't have this option when it hit our shores in 2005, because the Tobacco Act, which gave the FDA jurisdiction over tobacco products and officially introduced the concept/policy of reduced harm products hadn't been passed until 2009.) We would also keep working on getting the word out about the reduced harm concept and increasing the number of vapers and gaining public support. But this all takes time. Time we don't have right now as the FDA is hell-bent on classifying these as drug delivery devices and removing them from the shelves. A lot of hope is pinned on the Njoy vs. FDA case right now, because if Njoy wins and is considered a tobacco product and it's customer testimonials aren't allowed to be considered "intended use," it will set precedence and give a solid footing for the other companies.

It's very important that companies be allowed to post these testimonials and for the public to understand the concept that smoking cessation is still possible while continuing nicotine use and that it has a huge, positive impact on public health. They need to know that "switching" is a good thing and very nearly the same as quitting all tobacco and nicotine use, even though it doesn't treat nicotine addiction. People need to know the truth to protect and improve their health and a consumer saying on an ecig site that the product helped them quit smoking is invaluable to motivate people to switch. (Companies should just be required to distinguish between smoking cessation and nicotine cessation.)

It'd be great if the U.S. would rethink its approach to e-cigarettes, but there is no reason for it to do so. Smokers are vilified and only make up 20% of the population (and vapers make up an even smaller percentage) so have no significant voice, yet they supply billions in pharmaceutical profits and government tax revenues. They have every reason NOT to rethink it's approach - what they are doing is working. People think e-cigarettes are just as bad a smoking; that kids are being hooked on nicotine by them; that smokers are inhaling anti-freeze; that even reputable companies are filthy and dangerous simply because they didn't meet excessive FDA pharmaceutical standards, etc., so they could very well convince the public to remove them from the market - under the guise of testing, quality control and efficacy as a smoking cessation device (by which they mean nicotine cessation devices, which ecigarettes most certainly couldn't prove, as they continue nicotine addiction, they don't treat it.)

By the way, people need to realize that just because Johnson Creek didn't meet the criteria and follow the required steps for pharmaceutical products, it doesn't mean that they didn't have ANY quality standards or control. Restuarants, grocery stores, packaging plants and other food manufacturers and distributors don't have to meet pharmacuetical standards of quality control, yet we all eat food from them. One has to wonder if Johnson Creek would have passed inspection had they been held to food & beverage standards, instead of pharmaceutical standards. My guess is yes - and then some. And they never made any claims of treating or abating a disease or illness, even with the customer testimonials. Smoking is not a medically recognized disease and helping people quit smoking is not a treatment for a disease unless you are treating actual nicotine addiction. Since e-cigarettes sustain nicotine use, they obviously aren't treating nicotine addiction. So as long as a company doesn't claim its product can get you off nicotine, they are well within the law. That is something we need to force the FDA to acknowledge - smoking cessation and nicotine cessation are two different things. But for now, smart companies will remove even claims of smoking cessation, because the FDA seems to have taken it upon itself to reclassify smoking as a disease.

Think of it this way - drunk driving is not a disease, it is a behavior associated with the disease of alcohol addiction. Smoking is not a disease, it is a behavior associated with the disease of nicotine addiction. An interceptor breath test device, which stops alcoholic drunk drivers from driving their car, is not a medical device treating alcoholism, it's a tool to avoid drunk driving. An ecigarette is a tool to avoid smoking, it is not a treatment for nicotine addiction.

It blows my mind that the vaping community clearly saw the manipulation of the public with the "anti-freeze and carcinogens" press release, but so many can't see the same manipulation with this "violating regulations" press release. They are trying to divide and conquer the community and as evidenced by this thread and many other posts where people are turning against even reputable and consciencious companies like Johnson Creek, it's working.

CASAA does NOT support companies who make nicotine cessation claims, add other pharmaceutical products to their liquids, have unsanitary manufacturing facilities or cut lab-made liquids with inferior products risking contamination and supports regulation in those areas.

Wow, Kristin! Positively 'War and Peace'! And I thought I was prolific. LOL

Thing is, I agree with pretty much every word you say here, particularly about the importance of suppliers' being able to spread the TRUTH about their products, instead of having to remove any reference to getting away from smoking just to satisfy the clipboard nazis (although, as we all know, this doesn't satisfy them anyway!).

I am also in complete agreement with what you say about the regulatory framework you are stuck with. Now that I am beginning to get more of an idea of the ins and outs of your system, I can see why they went the tobacco route as an 'easy option'. I still maintain that this was a mistake, and believe that even the EPA would have been a better choice, if it had been done properly, but there wasn't time when this all kicked off. You guys have been handling these issues longer than we have!

Clearly, we are just extraordinarily fortunate in Europe to have regulatory frameworks that do allow for correct and appropriate regulation of ecigs. Whether we will be granted the right to remain within these is yet to be confirmed, but the evidence base is building well.

@ markarich: I'm rather surprised that a man as clearly well-educated and intelligent as yourself does not appear willing to engage in healthy debate on these issues without resorting to what amounts to a tirade against Kristin and CASAA! I do hope you will return to this debate, because you have much to contribute, and I am very interested to hear from you on these issues, but I do think it's a shame if that has to involve personal attacks on other forum posters.

Forgive me, but I really don't like it when people - and I am certainly not implying that I mean only you, Mark - start 'spatting' on fora!

 

[Dawolf]

whoa...seriously, all of the backyard brewers gotta be shakin in their boots and making totally ridiculous commentaries here, but the truth is that the FDA is the only governing body that can even help the consumer. Are they perfect? hell no, but will the consumer be more assured of getting a clean and consistent product when they start to enforce cGMP......hell to the yizzow. I work in the Pharma space and I hate the FDA as much as the next guy, but for other reasons. If you guys think that the FDA should just .... out and let us all just keep buying juices and stuff from any tom .... and harry without knowing where their .... is being made and whether the mixmaster has boogers or dog.... on his hands while he is taking orders from his baddass web site that is telling us all they have a clean lab facility they are making this stuff in, then go on about your bad self and vape it.

One fact is, that despite the general consensus that inhaling PG/VG and nicotine (that is extracted by who the hell knows) and flavoring (which contains no less than 100 chemicals in some cases), has never been proven to be safer than cigarettes. Cigarettes were only proven to be deadly after over 100's of years of people smoking. Doctors used to examine people with a cigarette hanging out of their mouth!
Get real and acknowledge the fact that although you want to spread the word and say that Vaping may be a safer alternative to smoking, it may not be. We simply do not have that proof. And I as a Vaper, I would sleep better at night and be more comfortable vaping if the FDA were putting a little pressure on the rinky dink kitchen and basement operations and trying to put forth some standards that insure that I am buying a quality product that really is a safer alternative to smoking tobacco. Sorry but if someone is making product in their kitchen without following a cGMP process, I want to know, so that I will never consume that product.

IMHO, and supplier or vendor that is coming out strong against regulation, is one that you must proceed with caution before consuming that product. If they have a good manufacturing practice, they will be For some regulation, because they want to see quality out in the community.

The FDA regulations in my opinion will not come soon enough to put the dirty backyard rinky dink operations out, so in the meantime I would love to see a body that will come together with some standards of self regulation come together with a kind of "good housekeeping" seal of approval so that I as a consumer can buy with some form of confidence.
Don't get me wrong, I have seen some really unsanitary mixing operations from companies that are selling lots of product and this needs to be rectified. Every day some genius DIYer builds a website and gets tons of Fanboys to do reviews and and go viral with their brand and all they are looking to do is make $ off of the bandwagon. There are plenty of legit vendors out there that are worth the business, but I would not know one from the other aprt from how nice their web site is.

BUYER BEWARE....if you value your health even in the least bit....before you order your next batch of NIC-juice....ask your favorite supplier to send you a picture of the facilities that they make them in. Give your business to the operations that have had the sense to reinvest their profits into building sanitary and stable manufacturing facilities. Reward them for giving back to the consumer and send a message to the greedy rinky dinkers that we want a quality and safe product.