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

[o4_srt]

I think this is more of a political issue than a safety one.

On one hand, people expect the government to step in and "save us from ourselves."

On the other, the (decreasingly existent) lassaiz-faire economics that our country was built on dictates that it's the consumers who need to be making smart, economic decisions about where they buy from, and that, in turn, will regulate the industry.

What is going on is just increasing government intervention in a (fundamentally) non-government issue, which will only hurt consumers (financially), and the economy in the long run, by reducing competition.

If you really want to know what's in your juice, make it yourself. If that's not an option, stop vaping, and go back to smoking, at least THOSE are safe

Anyone ever read the newspaper/health inspections that are done on restaurants in your area? Most are HARDLY clean. In addition, 95% of most home kitchens would fail government safety inspections. Just because someone makes liquid in their basement does NOT mean it is unsafe. There is more to every story than meets the eye; those "clean" factories could be adding cyanide to your liquid, those "shiny" tables could be covered in salmonella bacteria.

I feel like we are being a tad hypocritical here, we smoked for years, killing ourselves in the process, yet we are judging manufacturers who have nothing but the best intent (as most vendors do, again, economically motivated, as stated by Adam Smith in The Wealth of Nations, paraphrased: "The reason for this is that self-interest drives actors to beneficial behavior.) for their "possible" unclean facilities.

Regulation hurts trade. Trade hurts growth. Lack of growth hurts the economy, poor economy hurts consumers. If everyone is so suddenly concerned about their health, then, the best thing would be to stop vaping. Inhaling anything, no matter how "generally regarded as safe" it is, is still not the safest option. It is merely safer than continuing to smoke. vaping never was, nor is intended to be completely safe. It is just for those who prefer to continue consuming nicotine in a more safe manner.

 

[GoodDog]

So does that mean we should stop asking questions? No!

 

[o4_srt]

So does that mean we should stop asking questions? No!

not sure who that was a response to, but certainly not. Like I said, it is our job as consumers to make the best choices we can, not only economically, but with regards to safety. An agency saying something is safe or unsafe doesn't make it so. *cough*Chantix*cough*

Don't cheat, do your homework.

 

[lonercom]

Thanks Kate. So wouldn't the same apply to someone developing and selling flavorings for human consumption in their home? It seems e-liquid would also fall into this category but maybe vaping is different than consuming or are vendors just ignoring these regulations???

There are many small bakeries that don't have millions to invest in complying with FDA Regulations so it must not be that difficult.

Businesses that prepare or serve products for human consumption do not register with or sit through FDA inspections. The are sublect to State and Local Health Department regulation. Companies that manufacture consumable products for sale or distribution are subject to regulation by numerous Federal agencies. FDA, Department of Agriculture, ATF, ad nauseum. When Johnson Creek registered with the FDA, they agreed to meet the FDA standards in all areas. The fact that they are a small business is irrelovant. That's what the term standards means; Standard minimum requirements.

JC is not going to respond to this letter publicly. They are going to consult with an attorney, develop a plan and timeline to address those discrepancies and submit it to the FDA.

I believe that JC registered and submitted to the authority in good faith. I believe that they have complied to the best of their ability and want to do what's necessary to get in compliance.
Ohter than sharing my opinions open,y, the only other thing that I can do to show my support is to place an order with them which I did for the first time last night.

 

[GoodDog]

not sure who that was a response to, but certainly not. Like I said, it is our job as consumers to make the best choices we can, not only economically, but with regards to safety. An agency saying something is safe or unsafe doesn't make it so. *cough*Chantix*cough*

Don't cheat, do your homework.

As I stated in a previous post I strictly DIY and HAVE done my homework! My question related to flavoring vendors and what regulations they are required to follow. There is no need to be rude when people are trying to find answers. Not everyone is disagreeing - some are gathering information to be more informed!

 

[markarich159]

A quick word on DIY juice making. I was emailed a few weeks ago by a vaper who had questions about another health issue and he/she asked me my opinion about the safety/sense of DIY eliquid preparation(this was right after the RATH incident and it threw him/her off of buying US made liquid) the question was: Is there a reason I can't make my own liquid as long as I'm careful to only use USP ingredients and keep small quantities on hand? this is what I told him/her:

Good question;
No, there is no reason AS LONG as you use USP ingredients(for the main components-Nicotine, PG, VG) and the flavorings(as well as the other minor ingredients) are AT LEAST guaranteed food grade from the FCC-food chemical codex(I would prefer everything being pharmaceutical grade, but that’s just me), and you know, from experience, you have no problems with tolerating any of them. The Dekang/Boge Chinese stuff(already being certified by SGS, TUV etc…) has already been certified to this standard. I would also TRY to make the DIY in the most cleanly environment humanly possible(when compounding items of this nature – IV solutions, Opthalmics, Inhalation solutions, etc…-, pharmacists use a technique called aseptic technique which guarantees maintenance of sterility- of course this technique necessitates the use of a several thousand dollar HEPA certified , laminar flow air hood; which is not usually available to the general vaping consumer). In industry, a sterile or cleanroom environment with an airlocked entrance would be standard. Hope that helps.

Mark

I have since re-thought this. If you want to make your own DIY liquids at home, no one can stop you, it's a free country and, as long as you don't SELL what you've concocted; more power to ya. But think of this, if you had pancreatic cancer or glaucoma would you feel confident mixing an IV chemo bag or a sterile opthalmic solution to drop into your eyes with the level of your current knowledge of admixture preparation, extemporaneous compounding, chemical stability/instability; and/or the facilties available at your home to undertake such a task. Just something to think about.


As for the JC response: What else were they supposed to say???? The proof is going to be in their actions from this point, not in their politically expedient and totally predictable press release.

To Bassnut about the pretentious thing. I really, really, really have tried to be patient with my postings and my PM and email responses over the course of the last year(you can do a search of my postings if you disagree). If I have come off as anything otherwise I apologize. This is something I feel extremely strongly about and closely attached. I would not want to see vaping go away as it HAS helped me tremendously and I know it has helped others as well. I also know the consequences that can occur (physically, financially, legally) when strict adherence to quality control standards is not followed in an industry such as this. Also, I see your a bass Guitar Nut, I saw RUSH for the 1st time 2 weeks ago in my city on their Time machine tour and Geddy Lee is unbelievable.

To the person who brought up government regulation and laissez faire economics(I just used that term in a few posts about 2 weeks ago). There are a myriad of industries/modalities in which govermental regulation is a PITA and unnecessary, this is NOT one of them. Do a google search on the food/drug/health industry prior to the Pure food and drug Act of 1906 or before the F D & C act of 1938 and you'll see a host of examples of "what was" and "what could be" prior to proper regulation in this industry. Hell, there have been examples of de-regulation problems in this industry even as recently as the past 15 years since Congress passed the Dietary suplement health and education act of 1994(which drastically lowered regulation standards in the helath food/dietary supplement industry). This is one industry where I don't mind someone watching the industry players over their shoulders.

 

[rolygate]

There many issues here of course, but two that stand out are:

1. Government agencies in several countries are attempting to re-classify a consumer product as a drug, and therefore subject to pharmaceutical licensing and control. This is entirely driven by financial motives and has nothing to do with public health - which of course would be best served by fast-tracking ecigarettes to a wider public uptake, and assisting the suppliers with quality control issues instead of trying to shut them down.

Since the only possible result of these agencies' actions will be to cause loss of life, it is not necessary to question or dissect the details of their actions as they are entirely motivated by financial gain in one way or another; simply to find ways of legally countering them.

2. Ecigarette hardware and liquid refill suppliers have had a long time to do something about self-regulation and cooperation. The formation of trade bodies in order to thwart the obvious and predictable attack from well-funded commercial rivals and their agents is an obvious requirement. They have done little or nothing in this regard.

The result is that the situation is becoming serious. It was always going to go this way and it is remarkable how short-sighted the industry has been. Instead of strong trade associations with firm self-regulation and sets of standards for marketing, packaging, and materials testing, and a joint fighting fund to counter the assaults that were obviously going to come - there is nothing whatsoever. In fact there is only one place to lay the blame for the current situation. It is easy to excuse this cottage industry mentality when talking of small businesses with one or two staff, but there are many now with ten, twenty, even thirty staff or more, each turning over millions a year.

The attitude that the golden times would last for ever, and that no one would challenge the industry in any way, is just unbelievable.

 

[Bahnzo]

I have since re-thought this. If you want to make your own DIY liquids at home, no one can stop you, it's a free country and, as long as you don't SELL what you've concocted; more power to ya. But think of this, if you had pancreatic cancer or glaucoma would you feel confident mixing an IV chemo bag or a sterile opthalmic solution to drop into your eyes with the level of your current knowledge of admixture preparation, extemporaneous compounding, chemical stability/instability; and/or the facilties available at your home to undertake such a task. Just something to think about.

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

1. Government agencies in several countries are attempting to re-classify a consumer product as a drug, and therefore subject to pharmaceutical licensing and control. This is entirely driven by financial motives and has nothing to do with public health - which of course would be best served by fast-tracking ecigarettes to a wider public uptake, and assisting the suppliers with quality control issues instead of trying to shut them down.

That's a good way to think about it. Of course there are financial motives behind this, the FDA itself is run by industry insiders. But it would be best served if they thought of it like you said...they should be assisting the suppliers and not trying to hamper them.

2. Ecigarette hardware and liquid refill suppliers have had a long time to do something about self-regulation and cooperation. The formation of trade bodies in order to thwart the obvious and predictable attack from well-funded commercial rivals and their agents is an obvious requirement. They have done little or nothing in this regard.

And this is why they aren't trying to assist. The industry is rag-tag and unorganized. They have no collective voice to oppose those who would try to shut them down. The industry themselves is to blame for this. Tobacco and Pharma have lobbying groups to give them a voice with legislators...what does e-cig have? It's time for the suppliers to band together and form an organization to represent them. For years they have operated in a vacuum, but now they need to realize they need to take some of those profits and put them towards an effort to keep themselves in business.

I see all these posts talking about writing the FDA, calling local media, signing petitions, etc. And that's fine I suppose. But we need to put a lot of the emphasis of this on the suppliers. They are the ones making a profit from this business, they are the ones who ultimately need to step forward with a collective, organized effort to combat the FDA and other agencies.

 

[Optimal]

So JC need to set up a QMS to address the requirements of the standard. This is fairly straightforward in itself, though costly (welcome to the world of the medium-sized business JC!) However the part of the letter addressing qualty aspects is after the main point of the letter:

Products that are labeled, represented, or promoted as smoking deterrents, such as the Johnson Creek Smoke Juice products marketed by your firm, are regarded as "new drugs" under section 201(P) of the Act (21 U.S.C. § 321(P)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use.

Complying with the requirements of CGMP seems a little moot, if the FDA insist that JC are supplying a new drug. Setting up a QMS is doable, even by a small company, gaining approval for a new drug is way beyond the resources of companies of this size.

 

[Vocalek]

So JC need to set up a QMS to address the requirements of the standard. This is fairly straightforward in itself, though costly (welcome to the world of the medium-sized business JC!) However the part of the letter addressing qualty aspects is after the main point of the letter:

Products that are labeled, represented, or promoted as smoking deterrents, such as the Johnson Creek Smoke Juice products marketed by your firm, are regarded as "new drugs" under section 201(P) of the Act (21 U.S.C. § 321(P)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use.

Complying with the requirements of CGMP seems a little moot, if the FDA insist that JC are supplying a new drug. Setting up a QMS is doable, even by a small company, gaining approval for a new drug is way beyond the resources of companies of this size.

Good point! The FDA is sending mixed messages.

 

[rolygate]

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

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?

In the UK the agency in charge states that a small-scale trial with 20 people is acceptable if the results can be combined with data from other related, published trials. The trial needs to show, in the main, that the product is 'acceptably safe'. In fact of course no trial of six month's duration can show anything to be either safe or effective, but for practical reasons that is what is required.

 

[wv2win]

I am all for and, I believe most vapers want, SENSIBLE oversite of e-liquid that provides a level of safe human consumption manufacturing principles but allows for significant freedom of choice that doesn't eliminate the small vender/supplier.

The only logical conclusion to markarich159's proposition is that the only companies that would be able to produce e-liquid would be a few large pharmeceutical companies. When that happens, the only thing that will be available to vape legally will be e-liquid that tastes like early nicorette gum in a maximum strength of 6 mg. The history of NRT's proves that point conclusively and would push us all to a black market existence.

 

[lonercom]

The issue (IMHO) still appears to be the claims made or implied by these 5 sites about the medicinal value of the e-cig. When a manufacturer, distributor, or dealer says that these can help a smoker not smoke, they are making a medicinal claim. When they publish someone else's comments to that effect, they are implyig a that medicinal claim. When they make reference to a study or editorial that makes a medicinal claim they are implying the same thing. In all of these areas the FDA believes that thet have to get involved to ensure that those medicinal claims are backed up.

Take any reference to smoking away and it takes the FDA's drug/device authority away. This action appears to be consistent on the FDA's part.

Cheerios says this will clower cholesterol, FDA says prove it or stop saying it General Mills stops saying it and the FDA goes away.

Thousands of products show up every year making medicinal claims. Once the FDA gets wind of them, they tend to disappear. Many entrepreneurs know that they can get rich making unsubstantiated health claims and then just kill that business and move on when regulators get involved.

We, as consumers want these products to stick around awhile and take the FDA actions personally. If the folks that are involved in the sale and distribution of e-cigs want to make more than a quick buck from this, they need to pay attention, organize, and quit making these claims.

There is not one dealer associated with ECF that needs to say anything about smoking in their literature or websites. We are most likely the largest source of their income and we are already well aware of the benefits of vaping.

I have been carrying business cards from favorite vendors and writing ecf's address on them, I think it's time to do the opposite and hand out ECF cards and write the names of trusted vendors on them.

 

[rothenbj]

So JC need to set up a QMS to address the requirements of the standard. This is fairly straightforward in itself, though costly (welcome to the world of the medium-sized business JC!) However the part of the letter addressing qualty aspects is after the main point of the letter:

Products that are labeled, represented, or promoted as smoking deterrents, such as the Johnson Creek Smoke Juice products marketed by your firm, are regarded as "new drugs" under section 201(P) of the Act (21 U.S.C. § 321(P)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use.

Complying with the requirements of CGMP seems a little moot, if the FDA insist that JC are supplying a new drug. Setting up a QMS is doable, even by a small company, gaining approval for a new drug is way beyond the resources of companies of this size.

Sounds like time for a white knight. Johnson Creek becomes acquired by Johnson and Johnson who has the expertise, quality controls and has the impact to get the FDA to fast track a pharma grade liquid through the system. Something like this could be moved very quickly by NDA standards. They just have to insure that nic level remains low enough that they have moderate success (based on what the FDA needs to see to give an okay) and insure that after treatment, the patient returns to BT as soon as possible.

Of course, with harm reduction not yet defined, a pharma buyer may work through a newly defined process and make E liquid available in higher levels of nicotine with some pharma grade flavors (remember, the Pharma industry isn't accused of marketing to children with their flavors).

The only problem with this scenario is that it would only be sold in pre-filled carts sealed dispensers (imagine the nic inhaler on steroids). Once exhausted, you just dispose of it and use the next. Price of course would remain close to current cigarette rates, perthaps at a premium. However that could be justified in marketing it as "A safer alternative to smoking!"

 

[rolygate]

Lonercom - The issue (IMHO) still appears to be the claims made or implied by these 5 sites about the medicinal value of the e-cig. When a manufacturer, distributor, or dealer says that these can help a smoker not smoke, they are making a medicinal claim.

You're right of course.

Ecigarettes are an alternative method of smoking, and if someone wants to claim they are useful for other things like quitting tobacco then they need to prove it. Since none of the vendors have bothered to fund any proper research, that can't be done.

Because of this issue we *try* to enforce a no-medical-claims rule, but you wouldn't believe how hard this is. When we contact suppliers about removing claims of this type, we are often met with incomprehension, and sometimes with screams of rage or a barrage of abuse. It's as if they just can't see that making medical claims puts you under the pharmaceutical licensing authority.

One supplier we couldn't accept because of these types of claims on their website wrote a long letter to us criticising us for the position we take, and claimed they would fight the government through the courts and win the right to make any and all claims they felt like. Some of these people live in a fantasy world and there is no way to fix that.

To describe some of these vendors as blind or stupid or both is the understatement of the year. They just can't seem to figure it out. It's as if they think they have an automatic right to put anything they like in their marketing materials. Unfortunately they might take all of us down with them.

Trying to explain to them that you cannot avoid the universal law that medical claims make you a drug seller and therefore licensable, and that you can only state as fact what is proven in medical research trials, is like talking to a brick wall. It's as if they have a collective death wish.

 

[Vocalek]

The issue (IMHO) still appears to be the claims made or implied by these 5 sites about the medicinal value of the e-cig. When a manufacturer, distributor, or dealer says that these can help a smoker not smoke, they are making a medicinal claim. When they publish someone else's comments to that effect, they are implyig a that medicinal claim. When they make reference to a study or editorial that makes a medicinal claim they are implying the same thing.

From Judge Leon's opinion document:

To the extent that smoking cessation is a therapeutic claim distinct from the treatment of nicotine addiction and withdrawal, the Court is aware that the two customer testimonials referenced above suggest that electronic cigarettes are intended for smoking cessation, ifnot for treating nicotine dependence (as suggested by FDA). Given Smoking Everywhere's express disclaimer that its electronic cigarettes are not intended as a smoking cessation device, (AR DET 1), and given the overwhelming evidence in the record that its electronic cigarettes are intended merely as a recreational alternative to traditional cigarettes (and not necessarily as a therapeutic replacement for traditional cigarettes), the Court concludes that the two testimonials cited by FDA are not alone sufficient to support a finding that the product appears to be intended to help customers quit smoking.

But even this opinion begs the question as to whether smoking cessation is really a therapeutic claim. "Smoking" is not listed as a disease in any diagnostic code book.

All of these products make smoking cessation claims and to my knowledge, none has received a warning letter from the FDA:
Stop Smoking Program That Will Help You Quit Smoking Easily Without Cravings just $197
Stop Smoking Aid by Smoke Deter 1 month supply $39.95
The GUARANTEED Way to Stop Smoking! Booklets $96
One Step at a Time® quit smoking filters Filters $19.95

 

[rothenbj]

"One Step at a Time® quit smoking filters Filters $19.95 "

I don't believe they are still on the market. I did these or something very much like them a good 30 years ago. I almost forgot about that attempt. I thought I tried more methods than I can even remember and now I'm sure of it.

 

[KDK]

"One Step at a Time® quit smoking filters Filters $19.95 "

I don't believe they are still on the market. I did these or something very much like them a good 30 years ago. I almost forgot about that attempt. I thought I tried more methods than I can even remember and now I'm sure of it.

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!

 

[DaDuke]

I have done nothing in my tenure on ECF...

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

Lol, sorry but i find these two statements in the same post a bit humorous. When exactly were you granted a tenure on the forums?

Anyway, while i appreciate the desire to have a verfiable level of cleanliness in eliquid production how many here actually thought the US juices were produced in clean rooms required for drug production? Isn't the main thrust of most posts against FDA oversight about the belief that eliquid is not a drug and should not be treated as such by the FDA? If you believe the FDA should not regulate the eliquid business in the USA then you must accept the fact that it will not be produced in the same manner as officially recognized drugs.

I would be satisfied with some regulations and inspections along the lines of the food service industry. When was the last time your cheeseburger was produced within a cleanroom? Do you feel reasonably safe consuming that burger? Are you satisfied with the inspection process of the food service industry? How much do you think that cheeseburger would cost if the FDA regulated it as a drug? Are you the type of person that wears a surgical mask when walking down the street or do you live life with an acceptable level of oooh wait for it... contamination?

You can't have it both ways. Either you want the FDA to control eliquid, wait 5-10 years for the clinical trial etc and pay 5 times the amount for the product OR you don't and are willing to accept a level of quality less than that of an official drug and reap the benefits of less expensive juice. I agree 100% that the chinese facilities and quality controls are far above that of US suppliers but i still buy US products when i feel like something different.

 

[markarich159]

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.

by DaDuke: I agree 100% that the chinese facilities and quality controls are far above that of US suppliers but i still buy US products when i feel like something different.

Can't have it Both ways?????

by DadDuke: Isn't the main thrust of most posts against FDA oversight about the belief that eliquid is not a drug and should not be treated as such by the FDA? If you believe the FDA should not regulate the eliquid business in the USA then you must accept the fact that it will not be produced in the same manner as officially recognized drugs.

I never thought the FDA should regulate eliquid as a drug. 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(If you remember last summer Ruyan put out a press release intimating that it was working with FDA on this issue- apparently that report was either false, misleading or the dealings were fruitless). Unfortunately, no industry/manufacturer cooperation with any government entity made this possible(now, apparently the ECA has even disbanded as per Matt Salmon-former President of ECA). 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. Six years of , even minimal, longitudinal data showing safety would be compelling. The fact that no manufacturer appears to have done this shows how badly the industry has dropped the ball. Someone, somewhere in this industry just had to know that this issue would crop up(especially when marketed in the West) eventually.


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.