ECA vs FDA

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mm485

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I have been pondering the issues ever since I decided to order my first e-cig kit (just recently) and ran into some insane red tape via Paypal...

I went to 3 suppliers with my orders. Paypal rejected every order - not because the funds weren't there, and they wouldn't say why. I am sending the supplier closest to me a check.

I have been guilty of the "rant", but it is for one reason. E-cigs are still not illegal, yet under investigation. Until that time, I would like to think I have the freedom to "destroy my own body" or however the FDA would like to view it. I'm destroying it now with good ol' fashioned tobacco and no one seems to care (except to tax the living crap out of it). I never once thought for a second that this was my road to a nicotine-free life, or that it would be without risk. Anyone who does is just as bad as those that blindly believe the media hype to the contrary. I completely agree that the e-cig manufacturers have put themselves (and consequently us) in this situation, but the hypocrisy definitely bothers me.

It is a shame that the e-cig companies had to act so irresponsibly, or we probably would all be here exchanging delightful insights and wonderful experiences - not rants. A curious question for TB though - have you ever read a rant and thought it at least insightful? Some rants, albeit emotionally charged, have been worth the read. Some are capable of ranting "intelligently".
 

grimmer255

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Well ECA I haven't heard to much (or nothing at all) about you guys working with the manufactures that are over seas to get the e-cigarettes tested and to also follow the FDA requirements of getting the approval. That will be the only way to get these popular and get them to stay on the market. We are losing and I haven't seen any positive actions being done by you about getting these ecigs tested.....Keep working with the press but also spend a lot of time working with manufacturers. oh well......if we lose this case it will be several years before we see something like the ecigs getting an aproval.....oh well.......
 

TropicalBob

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A curious question for TB though - have you ever read a rant and thought it at least insightful? Some rants, albeit emotionally charged, have been worth the read. Some are capable of ranting "intelligently".

I normally don't answer an item like this, because it doesn't usually contribute to the flow of a thread. But, yes, I have read insightful rants. My gripe is usually stated as being against "ignorant rants." Remember that ignorance and stupidity are different things. Ignorance is lack of knowledge, or knowledge needed to form an intelligent opinion. Flawed knowledge, or lack of, leads to flawed conclusions and opinions.

I've read stupid posts, and pity the poster, but the rants I detest are based on ignorance. If a poster would educate himself or herself on an issue's facts, then the opinion expressed would carry more validity.

I enjoy an educated rant. Siegel does them. Rodu does them. They are excellent and further the e-smoking cause. As for striking out blindly and ignorantly at authority, well .. we won't win a fight with the FDA. We can win by following established rules.

Rants to the contrary can be dismissed as someone's personal problem.
 

Dorian_Gray

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I normally don't answer an item like this, because it doesn't usually contribute to the flow of a thread. But, yes, I have read insightful rants. My gripe is usually stated as being against "ignorant rants." Remember that ignorance and stupidity are different things. Ignorance is lack of knowledge, or knowledge needed to form an intelligent opinion. Flawed knowledge, or lack of, leads to flawed conclusions and opinions.

I've read stupid posts, and pity the poster, but the rants I detest are based on ignorance. If a poster would educate himself or herself on an issue's facts, then the opinion expressed would carry more validity.

I enjoy an educated rant. Siegel does them. Rodu does them. They are excellent and further the e-smoking cause. As for striking out blindly and ignorantly at authority, well .. we won't win a fight with the FDA. We can win by following established rules.

Rants to the contrary can be dismissed as someone's personal problem.


Unfortunately the cry of the average person these days (bearing in mind that the vocal minority rules these days) is "Don't confuse me with the facts - my mind is made up."

Einstein's take on the situation:
"Few people are capable of expressing with equanimity opinions which differ from the prejudices of their social environment. Most people are even incapable of forming such opinions."
 

mm485

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I normally don't answer an item like this, because it doesn't usually contribute to the flow of a thread. But, yes, I have read insightful rants. My gripe is usually stated as being against "ignorant rants." Remember that ignorance and stupidity are different things. Ignorance is lack of knowledge, or knowledge needed to form an intelligent opinion. Flawed knowledge, or lack of, leads to flawed conclusions and opinions.

I appreciate your answer to my question. I have also noticed that some responses to FDA videos and the like have been immature and stubborn in nature. Although I agree with many who believe that their rights are being challenged, it is not exclusively the FDA - after the research I have done, I believe that the FDA (in this case) is doing their job, and just wants the manufacturers to do theirs as well. It is not unreasonable to ask a company to back up their claims, no matter what the product. However, I am also not inclined to believe that everything the FDA is doing is "innocent" in nature either (blocking shipments coming into the US, etc.)

I think that in order to win this battle, people have to realize that e-cig companies are not without blame and go from there. To continually defend them blindly will do us all in.
 

robbiehatfield

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Bryn: I'm comfortable with my decision to use an e-cig. I own many and use them daily. I bought and received my first in January 2008. But I'm not comfortable advocating their use by others who have not researched the products and understand the unknowns that exist. We are not doing something without risk. We just don't understand the severity or extent of the risks we are taking. That's fine by me.

I was an early poster at Right to Vape (a misnomer name if ever one existed). But I bowed out by saying that if I do something wrong and die, then it's my bad. If I tell others to do something and they die, then it's my crime for as long as I live.

I will preach e-smoking from the rooftops -- when the facts come in and the products are approved. Until then, we have a theory that e-smoking is safer and healthier than tobacco smoking. We have a theory that it can save lives by getting many smokers off tobacco cigarettes for good.

Now let's prove those theories. But until that's done, I have trouble advocating theory as fact to others.

I hope that makes sense to you. I mean it from my heart, and fear life without e-cigs will be terribly difficult for me.

This is basically how I feel too, but don't you think that the recently released FDA study displayed just a little bit of bias against the ecig? It seemed to me like they went out of their way to show the worst thing they found by 1 manufacturer with 1 out of 18 cartridges. I personally wish all the posturing would stop and that they'd instead simply investigate whether or not vaping CAN be done in a way that's much safer than ecigs from a conceptual perspective. To have the whole ball of wax tossed away because a single manufacturer was irresponsible would be akin to banning all cars because Firestone had a run of faulty tires due to mismanagement.

Robbie
 

grimmer255

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i think my question and concern was valid. I am worried that I may end up smoking again if or when a ban takes place. People are not just ranting.....there very upset because they finally were free from tobacco and simply do not wish to return to analogs. most of these people smoked analogs for 20-50 years and finally free from tobacco and b/c of the FDA B/S everyone about e-cigs makes them feel hopeless. Its like hanging on to the side of mountain for dear life with out a safety rope.
 

TropicalBob

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Drop the "because of the FDA" and I'd mostly agree with you. The FDA has a job to do. It is doing it as defined under U.S. law. That agency is not to blame for our present problems. Direct your wrath to manufacturers who certainly should have known legal requirements to sell a drug product in the U.S., yet ignored those requirements and marketed their products anyhow.

And it's not about "claims." Other endless posts have made that clear. It's about regulations, and meeting or failing to meet them.
 

grimmer255

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Don't get me wrong Im glad the FDA is in place. But when they get on national TV and say these are as bad as cigarettes knowing what is in them just makes me a little worried. They ran the tests and they know that there is no tar and smoke. And anything that is bad that was found is at the same level as in NRT products. So they know that ecigs are in acceptable level.

Yes the manufactures screwed up by not running the test before going into production. But when they first start out they did not have the money to take on such a research. Who has millions just laying around. Now they do so what is the hold up?

I dont blame the FDA for wanting test results. But I do not approve of there method of scaring the public into believing that these are as bad as analogs. New Zeland's tests proves ecigs are 1400 times safer than analogs. The FDA's test proves ecigs are 1400 times safer than cigarettes and they are as safe as NRT products.

The main issue is QC and having millions of dollars done in research which will take years and mean while 800,000-1.2 million people will die from smoking while the tests are being done. ( just in the US alone)
 
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Vaporista

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Yes the manufactures screwed up by not running the test before going into production. But when they first start out they did not have the money to take on such a research. Who has millions just laying around. Now they do so what is the hold up?

My guess is they're just waiting to see which way the wind blows. They know what exactly they're making but to shove some of their millions on a gamble against big tobacco and big Pharma probably isn't in their best interests right now. It wouldn't be over the top to predict that once and if the legal stance is clearer in the US and looking favourable to them, that the manufacturers will get into bed with big Pharma and big tobacco.
 

TropicalBob

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Grimmer, as I recall it was not the FDA that made those statements. Some irresponsible statements were made by "experts" at the FDA conference, but that's different. "Experts" can be found to say ANYTHING. Literally. Just ask a good criminal lawyer. He'll have you an expert on the witness stand in no time.

After the conference, newspapers who in the past two years fired all their veteran journalists and now employ former bloggers for minimum wage embellished the truth. Scary stuff makes better stories. Young "reporters" know that, so they just jack the facts around until we get headlines proclaiming e-cigs to be more dangerous than tobacco cigarettes. Now, that is ludicrous.

But the FDA didn't say that. Sensation-seeking reporters wrote that.

It is a mess. That's for sure. We try to counter with truth, but FDA press conferences with experts will trump any effort we can mount. The public got the word, so much so that almost all of us have had friends or relatives caution us on the "dangers" of e-smoking.

The ECA has done some decent PR in the past few weeks. They need to keep it up, and keep hoping our friendly doctors chime in with their valuable expertise, far more expert than what the FDA trotted out.

Still, my guess is that if the ECA called a Washington, D.C., press conference to clarify misinformation, no one important would show up.
 

grimmer255

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Will the ECA start recruiting doctors that know the ecigs are better than analogs? And if so can they get them to help the public understand how strong the nicotine addiction is? Also allow the doctors to educate the public on how many FDA approved NRT products rarely work in the long run. I believe NRT products have a 15 percent chance to quit smoking for the long term.

There needs to be some research teams on this. My thoughts to help with this are to allow this forum to bring up a thread which asks for any volunteers that have doctors that have been monitoring there health. And they need to show proof of improvement in health switching to ecigs as an alternative to analogs . Also the doctors need to show that there have been no indication of extreme harm done to a person using these as an alternative to analogs.

This might help with getting these ecigs the approval faster but then again Im not really familiar with how they go about getting there testing done.

Also why doesn't the ECA go above the journalist and go straight to the source who approve articles for the press. There has to be someone who is in charge that have been wanting to go up against the FDA, AG...ect. Not to bad mouth the FDA and AG but to get them to have a more positive opinion of ecigs. So the FDA will allow a faster approval time. There is no way around it the ecigs have to be tested and researched.
 

FUMA king

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Aug 23, 2009
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Hello all and allow me to say this is a very interesting post.

Ok ….. Here is my soap box speech…. Please forgive me,

As a board member of an E-Cig company here, I have to say TropicalBob makes a very valid point; we welcome the FDA and/or the ECA as our industry needs regulating to guarantee product quality and that all the companies have to follow documented QC programs that are complaint in nature. I know most companies out there just lean on their suppliers to give them such data. How good is that data?

We are witnessing the birth of an industry that needs to be classified with Tobacco products. Not as a drug or combination drug device.

Again, I also have to agree that there are E-Cig companies out there causing problems with claims and the FDA is also has made their mistakes too, but for reasons. Also, I feel too that Big Pharma and Big Tobacco have a stake in this but what is that stake? I get the feeling the FDA is caught between a rock and hard place on the whole issue and maybe some of their actions may not have been the right way to handle things, but it is what it is. We all need to just put this behind us (FDA and E-Cig companies) and move on in harmony and cooperation together.

As a company, we personally need to make sure that we receive testing from our sub-suppliers and do our own testing internally as well. As a company we also perform random outside testing with FDA approved testing facilities. While this has been a very large expense for us and we have had to incur these costs, we are being a corporately responsible company. With our multiple manufacturing facilities throughout the US and overseas, we are already following protocol proactively before it is required to guarantee our investors that ethically we will be able to meet reasonable guidelines set forth by the FDA for Electronic cigarettes as a tobacco product.

My hope is that the FDA does not shut down our industry and force tobacco cigarette consumers back to analog only; it would be a crying shame for the American public, health care and mankind in general. On the other hand the FDA does need to purge all the little POP up companies who are not being ethical or responsible from the system. I am not saying it has to be Big Tobacco or Big Pharma who takes our industry, but what I am saying is there are the bleeding edge and the leading edge in business. The bleeding edge pioneers have been here and for that I thank the good ones and there are the ones who caused problems. In business there are the companies that follow the pioneers that are the long term players that have the capabilities for the long term business survival. These companies have to be highly ethical, responsible, very well planed and proactive. Well, the pioneers have done their job and some will make it through (with many growing pains), most wont, but now it is time for the long term players to get involved with the outcome of this ruling and that is why we are here. A good example - we have not even launched our brand yet as we have been investing great amounts of time, money and effort in our products to ensure what we bring to the market is not just a product, but a product of the highest quality all the way around.

In the end, we have invested substantial money in research & development alone and hope the FDA looks at companies like us and others being just as responsible in favorable light. We also hope they do look hard at the companies who just rushed to market with a brand label to make a quick buck – without regards of the consumer or ethical guidelines.

We have not joined the ECA as we have not seen enough value to date, but over the last week we have been happy with the most recent activities and will continue to monitor. The other side of this too, is the fact that responsible, ethical and professional companies who made the investments that provide the proper processes in place will be the ones who will be able to survive this storm.

There will be a nicotine tax some day and if that is all it takes to gain our path forward then I say let’s do it now.

After this post I am sure there will be a slurry of companies jumping on this band wagon claiming to be ethical and interested in quality control but to date I can count on one hand the companies in business today actually doing this in the e-cig business and can’t even count the number of companies that just brand label the same thing over and over again jumping in for the quick buck band wagon. The companies that have innovative technologies (not just brand labels) and unique products combined with full QC processes will be the ones to buy from. This is what it will take to even think about being in this market in the near future and for the long run, provided the FDA provides a path forward. The industry has not even generated enough profit in the US to fund this for anyone at this point. It is all about long term commitment and dollars invested, price point of entry starting today will be in the millions to do it right.

Electronic Cigarettes are not a smoking cessation device, they are just alternative that eliminates a lot of the hazardous carcinogens, let’s face it - it is still smoking so it cannot be totally healthy for you, "Think about it".

So, it is going to take some large money and large commitments from select companies who will rise to the top while the others wash out, even if the FDA does not fall victim to the politics of big money from big pharma. On the other hand hopefully the ECA stays the course to help encourage the FDA down the best path for the public (i.e. not a medical device for electronic cigarettes or change the rules all together).

We welcome the FDA over sight and self applied industry regulatory compliance through some neutral body, it is the right thing to do as a tobacco born product (i.e. Nicotine based) as we are, it makes good common sense.

It is just business, it has always been this way this is nothing new, just new to some people in this business.

We are here to Help.

WHEW I said a lot and that’s all I have to say about that……….
 

grimmer255

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hey Fuma King
what products will you be offering that are as good as some of the leading companies out there. IM not trying to start a problem, I just want to know what makes you different than other companies. And do you have proof of your testing and research on your product. And can you provide us with that information? Also what exact steps are you taking to assure your product is safe for human consumption.

quote by Fuma King "it is still smoking so it cannot be totally healthy for you, Think about it".

Interesting, vaping is not smoking there is no smoke in ecigs. It's a PG and water base vapor there is no combustion to get your nicotine. There is no tobacco in the e-juice, which means there is no need for temperatures to reach the combustion which then causes smoke. Tobacco Smoke is basically fine particles which contain 4000 chemicals, tar, and lethal gases. That is smoking.

Im not saying vaping is healthy for you but it sure beats smoking.
 
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FUMA king

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Aug 23, 2009
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Gimmer:

Thank your response.

Yes I agree it is not smoking...... but Smoking as a general term....

Definition: The act of Smoking = is the inhalation of the smoke or smoke like vapor.

Agreed this is vaping, not smoking. But for arguments sake and so the general public reading this has an easier time understanding our conversations for their general understanding. In the end, your are absolutely correct, it is not "Tobacco Smoking" but it is the "Act of Smoking" without the "Smoke".

As for our products, we are being very tight lipped for now and will announce once we launch. We own multiple patents and have designed our own products. We are not looking to be totally different just to be the best we can be. There are some very good products on the market today but there are also some very poorly made ones too. Also too, a very big difference with us compared to a lot of other companies is not only our products but our business practices, we will not falter our partners and will guarantee what we will and will not do. Please bear in mind there are a couple of good e-cig companies out there that we respect, however there are companies out there right now that are very unscrupulous and have very poor business practices. It will all work out in the end, you can’t erase the past they will reap what they have sown, it will all come around in the end. We are professionals here and will not smear anyone’s name; I like actions to be the proof. Just watch us work, we are not the cheapest and don’t want to be.

Grimmer please forgive me for being so tight lipped about our Quality Control Processes including testing procedures and policies, yes we have all of this but this is confidential information that we will hold very close and not share outside of regulatory bodies. This does not come easy and costs very large sums of money to get this and why would we “Give it away”? Also too, no one said “Safe for human consumption” as you said that. That is a loaded comment, as I know you already know too. I said “Quality Control” process, we do have a company that will happily build you one for around $500,000 for a product that you may have. That is at least the starting price tag to meet regulatory compliances. It is a very costly thing to do, but worthwhile.

If you are interested send me your email address here and I will pass it on to them to contact you.

All we want to do is help our industry and a part of the solution as an ethically responsible company.
 

katink

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Are you (liaisoned with) Rauchless Innotec, or one of their several other used names?

Does your product produce visible vapor? Will the product be using e-liquid from bottles for refilling by the users, or will they be one-time tamperproof throw-aways that can't be refilled?

Those are very important questions for us vapers (and imo for you as to being sellable; unless you are counting on all who provide these concepts now to be thrown out of the market so you can sell to desperates who are denied any other options?)
 

FUMA king

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Aug 23, 2009
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Allow me to say I do not want to get into all the details at this moment but allow me to say that we feel the consumers will be very happy with all the options we will offer. We are always open to feed back too.

On the other hand, what we are here to talk about is "FDA v ECA" and to that note, all I am saying is that if we do not regulate our self’s and raise the bar to a whole new level then the FDA will do it for us. By not raising the bar to such a high level could mean the end of e-cigs in public and it will all go underground. We will have bath tub gin all over again but with nicotine this time.
 

Kate51

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I think you hit it Harmony, Fuma, the FDA has made it clear, no one has applied for approval. Could that still be true, if not why not? Where does ECA stand on that, are they sponsoring/advising/assisting applicants, which of course would be mostly suppliers from overseas? Can someone help through the hurdles, or is that verboten.
Haven't heard that. Seems to me that at least would be a major hurdle, to get things into the system for approval or banishment. FDA apparently has the testing requirements established now, so where are the suppliers, how does one proceed to checkout! I'm sure a little housecleaning would help the cartridges pass 99% purity.
Or is everyone sitting and waiting for the FDA to act first. Play ball!
 
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grimmer255

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I think you hit it Harmony, Fuma, the FDA has made it clear, no one has applied for approval. Could that still be true, if not why not? Where does ECA stand on that, are they sponsoring/advising/assisting applicants, which of course would be mostly suppliers from overseas? Can someone help through the hurdles, or is that verboten.
Haven't heard that. Seems to me that at least would be a major hurdle, to get things into the system for approval or banishment. FDA apparently has the testing requirements established now, so where are the suppliers, how does one proceed to checkout! I'm sure a little housecleaning would help the cartridges pass 99% purity.
Or is everyone sitting and waiting for the FDA to act first. Play ball!

Your right it does seem to be a major hurdle. And I think all the manufacturers are waiting for the hearing thats coming up. Witch is a fatal move.


Hey Fuma what kind of products will you be offering at least give us a plain idea. Liquid, carts, atomizers.......ect.....or will it be a total new design?
 
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