American E-Liquid Manufacturers' Standards Association launches

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TheBoogieman

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>> I don't see where that is going to influence how the FDA sees you one way or the other.<<

Sorry you don't.
Being FDA registered and although nic juice isn't regulated (maybe just planning ahead) being an FDA registered tobacco manufacturer.
Regulated by the tobacco industry standards and going above those standards. I don't think puts you at the bottom of the pack.

TheBoogieman
 

TheBoogieman

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>>I don't have any idea how the FDA works. What does "FDA registered" mean?
I thought the FDA approves products. I didn't know they approved manufacturers.
And does "registered" imply any sort of approval?
There is a Tobacco Industry Standard?
And it's regulated how?<<

This should be able to help you with your questions:
Google

TheBoogieman
 
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Quick1

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Thank you for the pointer.

RESULTS: The tobacco industry has been involved in the development of ventilation standards for over 20 years. It has successfully influenced the standard and continues to attempt to change the standard from a smoke-free framework into an "accommodation" framework. The industry acts directly and through consultants and allies. The major health groups have been largely absent and the health interests have been poorly represented in standard development.
CONCLUSION: The tobacco industry determined that allowing smoking in ventilation standards for indoor air quality was a high priority and dedicated significant human and financial resources to ensure that its interests were represented.
OBJECTIVE To describe the extent of the tobacco industry involvement in establishing international standards for tobacco and tobacco products and the industry influence on the International Organization for Standardization (ISO).
RESULTS It is clear that the tobacco industry, through the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA), play a major role in determining the scientific evidence and suggesting the standards that are eventually adopted as international standards for tobacco and tobacco products in several areas, including the measurement of cigarette tar and nicotine yield.
CONCLUSIONS ISO's tobacco and tobacco products standards are not adequate to guide tobacco products regulatory policies, and no health claims can be made based on ISO's tobacco products standards. There is an urgent need for tobacco control advocates and groups worldwide to be more involved with the work of the ISO, both directly and through their national standardisation organisations.
The Family Smoking Prevention and Tobacco Control Act (also known as the FSPTC Act) was signed into law by President Barack Obama on June 22, 2009.
The act itself, which spans eighty-four pages in its final edition, gives the FDA comprehensive control on tobacco products for sale in the United States.
The Center for Tobacco Control (CTC) is the Branch of the FDA created in response to and for the implementation of the Family Smoking Prevention and Tobacco Control Act.
The Center for Tobacco control is the newest branch of the FDA, and officially was opened on August 19, 2009.

I can't seem to put my finger on what regulated by the "Tobacco Industry Standard" is? and how that might favorably impress the FDA?

Got another pointer?
 
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metropolitan

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any industry that shows some aspect of self regulation tends to get off easier when legislators regulate them.
regulation is going to come, no matter what. the best thing to do is to come up with regulations we can stand and use that as a proposal to the FDA. if there are good industry standards you can get a seat at the table when the FDA considers how to regulate nicotine liquids. this is how lobbying works and it works very well for many industries.
if we just sit around and whine and complaint and somehow expect that to lead to no regulation, all that is going to happen is the FDA will make regulations without industry input.
anyone who thinks that e-liquid is somehow going to escape regulation is living in a fantasy world. the way to deal with such things is to show that you have some responsibility and ability to self regulate.

registering with the FDA is a basic part of the deal. the tobacco industry does it and you might be surprised to find out all food that has to cross state lines do it too. you might also be surprised to find out all food makers that do interstate commerce have to buy insurance in case any of their products sicken or kill someone. insurance would be another good place to start in terms of self regulation.
 
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zoiDman

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From this web page...

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188), Letter from Center Director

Section 305 (Registration of Food Facilities) - requires the owner, operator, or agent in charge of a domestic or foreign facility to register with the FDA no later than December 12, 2003. Facilities are defined as any factory, warehouse, or establishment, including importers. The Secretary, through FDA, is required to issue final regulations addressing the registration requirements no later than December 12, 2003; however, food facilities must register with FDA by this date even if FDA has not issued final regulations. The Bioterrorism Act exempts farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer; and fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k)) from the requirement to register. Also, foreign facilities subject to the registration requirement are limited to those that manufacture, process, pack, or hold food, only if food from such facility is exported to the United States without further processing or packaging outside the United States.
 

DC2

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any industry that shows some aspect of self regulation tends to get off easier when legislators regulate them.
regulation is going to come, no matter what. the best thing to do is to come up with regulations we can stand and use that as a proposal to the FDA. if there are good industry standards you can get a seat at the table when the FDA considers how to regulate nicotine liquids. this is how lobbying works and it works very well for many industries.
if we just sit around and whine and complaint and somehow expect that to lead to no regulation, all that is going to happen is the FDA will make regulations without industry input.
anyone who thinks that e-liquid is somehow going to escape regulation is living in a fantasy world. the way to deal with such things is to show that you have some responsibility and ability to self regulate.

registering with the FDA is a basic part of the deal. the tobacco industry does it and you might be surprised to find out all food that has to cross state lines do it too. you might also be surprised to find out all food makers that do interstate commerce have to buy insurance in case any of their products sicken or kill someone. insurance would be another good place to start in terms of self regulation.
I doubt anyone here reading this would disagree with a word of that.
It's the same song we've all been singing for years now.
 

EddardinWinter

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FDA Registration Johnson Creek Smoke Juice


Johnson Creek Enterprises, LLC is fully registered with the U.S. Food & Drug Administration pursuant to Section 305 of the United States Public Health and Bioterrorism Act of 2002, P.L.

What does this mean? It does not mean we are "FDA Approved." Johnson Creek Enterprises, LLC facilities and operations are FDA Registered. The law now requires that all companies who produce products for human consumption, must register their facility and operations with the FDA. Further, all information pertaining to a company's address and nature of business must be current with FDA at all times.

Being FDA Registered assures our accounts, customers and the public that Johnson Creek Enterprises, LLC is a fully disclosed company with the federal government. Being FDA Registered does not imply that Johnson Creek Enterprises is a pharmaceutical company or that our products have been approved or certified by FDA. Being FDA Registered does mean that we place public safety and well being as our top priority.

We have our own lab with a corresponding Quality Control department. We are the industry leader in our use of current Good Manufacturing Processes (cGMPs) and though we are regulated by the Tobacco industry standards, we have pushed past those standards and we use the food grade standards as our guide.

Registration and Listing

TheBoogieman

You keep saying "we". Are you with Johnson Creek Enterprises, LLC?
 

metropolitan

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I doubt anyone here reading this would disagree with a word of that.
It's the same song we've all been singing for years now.

maybe in this thread, but not in these boards.

glad to hear you agree though. we need some sanity in dealing with the FDA, not the paranoid conspiracy theories and wishful thinking that seem to dominate the discussion in ECF.
 

DC2

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glad to hear you agree though. we need some sanity in dealing with the FDA, not the paranoid conspiracy theories and wishful thinking that seem to dominate the discussion in ECF.
Can you clarify exactly which concepts you consider to be conspiracy theories, and which thoughts you consider to be wishful thinking?
I am pretty sure I won't agree with you on the first answer, but you have a better chance with the second one.
:)
 

metropolitan

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Can you clarify exactly which concepts you consider to be conspiracy theories, and which thoughts you consider to be wishful thinking?
I am pretty sure I won't agree with you on the first answer, but you have a better chance with the second one.
:)

wishful thinking = anyone who insists on no regulations on e-liquids. this is a constant thing people bring up. i don't understand how they think that's a possibility.
the belief that vaping is 100% safe.

paranoia / conspiracy theories = the belief that FDA is planning regulation because they are evil people and/or enjoy trampling people's rights.
the belief that the FDA considering regulation must mean that they are planning on banning it completely, despite a history of the FDA being open to nicotine delivery alternatives.
the belief that anyone who supports even the most modest of regulations in these boards must be some plant from the FDA.
 
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DC2

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wishful thinking = anyone who insists on no regulations on e-liquids. this is a constant thing people bring up. i don't understand how they think that's a possibility.
the belief that vaping is 100% safe.

paranoia / conspiracy theories = the belief that FDA is planning regulation because they are evil people and/or enjoy trampling people's rights.
the belief that the FDA considering regulation must mean that they are planning on banning it completely, despite a history of the FDA being open to nicotine delivery alternatives.
the belief that anyone who supports even the most modest of regulations in these boards must be some plant from the FDA.
I can agree with most of that, but have a couple more questions for you...

Would you accept that the FDA regulations could be influenced to some extent by money rather than science and public health?
Do you have any examples of the FDA being open to alternative nicotine delivery systems that are NOT from Big Pharma?
 

metropolitan

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I can agree with most of that, but have a couple more questions for you...

Would you accept that the FDA regulations could be influenced to some extent by money rather than science and public health?
Do you have any examples of the FDA being open to alternative nicotine delivery systems that are NOT from Big Pharma?

example of FDA being open to alternative nicotine delivery systems not from big pharma includes the de-regularization of things like the patch, gum, lozenges. big pharma had the monopoly on it until the FDA made it over the counter. now there's a good number of small companies that produce these items. big pharma lost the monopoly because the FDA opened up the market in the mid 90's. despite what some people might think, little pharma is not big pharma.

i totally accept the idea that the FDA can be influenced by lobbying (i.e. money). this is why i support some sane lobbying from the e-cig/e-liquid industry as opposed to scare mongering which just wastes a lot of energy fighting straw men instead of coming up with sensible plans.

look, we're on the same side, though we might differ on some of the details. i want the e-liquid industry to influence the FDA and use its energy in a well planned manner that will have the most possibility of influence.
 

DC2

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example of FDA being open to alternative nicotine delivery systems not from big pharma includes the de-regularization of things like the patch, gum, lozenges. big pharma had the monopoly on it until the FDA made it over the counter. now there's a good number of small companies that produce these items. big pharma lost the monopoly because the FDA opened up the market in the mid 90's. despite what some people might think, little pharma is not big pharma.
Well, if the FDA proposes regulations that won't screw us over, I'm sure we'll all be happy.
:)

look, we're on the same side, though we might differ on some of the details. i want the e-liquid industry to influence the FDA and use its energy in a well planned manner that will have the most possibility of influence.
I can't imagine finding anyone that wouldn't agree with that, but "the industry" has a long history of not doing that.
There have even been a couple of past attempts... that didn't really go anywhere.

Perhaps this particular attempt will be different.
:)
 

EddardinWinter

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I must say, I do not see where the FDA has shown any interest in giving vaping the same benefit of the doubt it has given patches, gum, lozenges, etc.

So you have stated clearly why the FDA is not doing this in your opinion:

paranoia / conspiracy theories = the belief that FDA is planning regulation because they are evil people and/or enjoy trampling people's rights.
the belief that the FDA considering regulation must mean that they are planning on banning it completely, despite a history of the FDA being open to nicotine delivery alternatives.
the belief that anyone who supports even the most modest of regulations in these boards must be some plant from the FDA.

So why do they do the things they do, like for example....

Example 1

Here is a sample of what the FDA is saying to “protect” you.
As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing:

• whether e-cigarettes are safe for their intended use,
• how much nicotine or other potentially harmful chemicals are being inhaled during use, or
• if there are any benefits associated with using these products.
Additionally, it is not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.
FDA SOURCE
Electronic Cigarettes (e-Cigarettes)

Now, the bullet points are all reasonably sound, I think they are fine. But then we come to the meat of the FDA’s thinly veiled attack on vaping. “It is not know if e-cigarettes may lead young people to try other tobacco products.” The FDA is unbelievably irresponsible in this speculation. What evidence is there to support this premise? Has anyone ever heard of children trying vaping to begin smoking? I do not know anyone who has began smoking after vaping. I know dozens who began vaping after smoking.

How about this statement:
It is not known if the FDA has intentionally hidden evidence of its own agents putting toxins in the milk supply of several Midwestern states, which are known to cause sickness and deaths of innocent children. If it did happen, this action could kill hundreds or thousands of our helpless boys and girls. To date, they have presented no evidence to the contrary, nor have they denied these events transpired.

I have not accused them of any misdeeds, I have not stated any falsehoods. I have only insinuated wrongdoing by creating a presumption of guilt. But does that make the statement fair? You tell me.

Example 2
Q: What concerns does FDA have regarding electronic cigarettes?

A: FDA has not evaluated any e-cigarettes for safety or effectiveness. (1)When FDA conducted limited laboratory studies of certain samples, FDA found significant quality issues that indicate that quality control processes used to manufacture these products are substandard or non-existent. FDA found that cartridges labeled as containing no nicotine contained nicotine and that three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff. (2)Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products. Visit FDA’s Electronic Cigarettes webpage for additional information.
FDA SOURCE
E-Cigarettes: Questions and Answers

I have pointed out two excerpts from this short Q&A by underlining them and numbering them. Let’s examine them, shall we?


(1) Here is an example of painting with an intentionally broad brush to impugn the entire industry. Why not publish the list of suppliers who were found to have the lack of quality control described? In a very large sample size, a few were found to be as stated in this web page. I love the part about, “three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff”. What? How were the “puffs” measured? Were the methods the same? Who conducted this study? Where are your citations? There are no citations as there is no scientific study. There is only irresponsible un-scientific scare tactics. Is the agenda your health when it comes to e-cigs? It appears to be the expansion of their own power and authority.

(2) Now you can see it again, they express their concern about “marketing these products…may lead kids to try other tobacco products.” This is purposefully misleading innuendo. This is not the act of some rogue agent who is part of a great and noble group. This is not some small minority of the large organization. This is the official position of the FDA from their web site. They appear to be using their position of trust to distort reality and manufacture malicious intent on the part of the e-cig industry. There never was, nor is there now, and never will be in the foreseeable future an effort by manufacturers to market e-cigarettes to kids, and the FDA knows it. They seem to be using the sanctimonious “we protect the children” stance to make their intentions seem pure. What are their intentions? Who knows, but if there is sound reason to warn consumers about e-cigarettes, why resort to these tactics?

So why do they do it?
 

TheBoogieman

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No I do not work for JC. But believe what I said:

When or if the FDA is looking for input from a juice manufacturer, think they will be talking to aemsa or JC?

JC has been in business since 2009. They are registered as a tobacco manufacturer. I happen to think it makes good business sense to do so, even though as of now there is no reason for it, other than planning ahead.
Ejuice is not classified as a tobacco product, but it can be...

Either way it goes, your playing on the FDA,s field, probably helpful you play by some of their rules. Also not going to hurt the connection they had with Blu and now Blu's connection with Lorillard.

Aemsa is still to new, its standards have no history. While length of time in business doesn't prove your doing it the right way. JC has standards that have been in place with a track record, they are FDA registered, and registered as a tobacco manufacturer. In my opinion that's doing it the right way and planning ahead. The FDA is gonna do what it wants to do. But if they are going to be looking for input, I'd put some coinage on JC.

TheBoogieman
 

Quick1

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Well, one reason is, JC is one mfg. AEMSA is more than one mfg.

You seem to be imparting some significance to being registered with the FDA. And that somehow that puts you on a better footing with the FDA.

I don't see where registering with the FDA is anything more than basically sending them your address and product description.

It's required by law (bio terrorism) for certain products or conditions. I see the registration as more of a "if you don't do it, and should have, and you get caught it's bad" but doing so doesn't buy you anything.
I believe I could register with the FDA as a pencil manufacturer. I don't believe that would give me any credence when I registered as an e-juice manufacturer. From what you have pointed to registering with the FDA is simply identifying yourself. Having FDA approved or certified products is a totally different thing isn't it? Getting a SSN doesn't buy me any credence with the IRS other than I've registered myself.

Which brings up the question of what JC registered with the FDA as? You say they are registered as a tobacco manufacturer. JC says they are registered with the FDA but that is not to imply they have any FDA approved or certified products. I would agree with you that if they have a significant track record with the FDA with approved or certified products that might give them a more favorable standing with the FDA. Simply registering, I'm inclined to believe, not so much.
 
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TheBoogieman

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I know of no ecig product approved or certified by the FDA. The other wholesale manufacturer I posted about is an FDA registered tobacco and food manufacturer. That looks good to me and I think with the FDA also. But holds no water with you. That's fine by me.

Excuse me for taking information from somebody else's post:

http://www.e-cigarette-forum.com/fo...eo-lab-independant-testing-6.html#post8850577
Post #57

I find that interesting and passes the smell test to me. Maybe the FDA might find that interesting too. Maybe that doesn't hold water for you either.

The thinking that the FDA would seek input from aemsa with no history over JC with history of its practices, because they number more than one manufacturer. Doesn't hold water for me.

You have your way of thinking. I have mine.

TheBoogieman
 

metropolitan

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everyone here on this thread (and board) is on the same team but it seems like much more time is spent finding minutia where people disagree as opposed to working harder at finding where they agree.
no final proposal will match anyone's perfect wish list but a certain consensus can be reached if people work a little harder on swallowing some pride at times and spend a little less time trying to outsmart each other on minor points.
 
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