Fda Very Bad News

[Christopher]

Here is another story that made it to the front page of Google's Health section

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/22103

[Merlin]

This is complete BS the FDA as well as our government is a joke, as a by product of becoming "civilized" and coming as far as we have the last 100 years we have all become cattle and don't fight for anything. The government taxes us at will, makes bad decisions, covers things up and are as corrupt as any organized crime. It really disgusts me as this is a much healthier way to quit smoking, they won't ban cigarettes which are toxic? But want to put e-liquid through the ringer? Don't be surprised if we see a revolt by the American people in our lifetimes.

[owutaqt]

I wish the language was simpler so we could understand exactly what we are fighting.

I don't know if its the ecig part or the liquid part or what.

[LoriHNC]

Here is another story that made it to the front page of Google's Health section

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/22103

Okay, that article doesn't sound too good. It sounds like all ecig suppliers will be getting a letter to conform to FDA guidelines or not sell them.

[Uma]

Okay, that article doesn't sound too good. It sounds like all ecig suppliers will be getting a letter to conform to FDA guidelines or not sell them.

that's an awful article. Very easily misconstrued.

"The FDA has sent letters to five manufacturers of electronic cigarettes warning that they are in violation of federal law by claiming their products help smokers quit. In order to make such claims, the e-cigarettes would need to be approved by the FDA as drug-delivery devices, the agency said. None are."

That's like saying they're not worth beans and all just a big lie and if they really worked then they would be approved like they do all the weight loss pills.

"No e-cigarette company has submitted an application to the FDA for evaluation or approval, the agency said, although the devices meet the definition of a drug-device product under the Food, Drug, and Cosmetic Act (FDCA)."

No ecig company has 800 million dollars to have the tests done so they can submit it. The lawyers got all the money from the only ecig company that stood a chance at affording the testing. (surprise surprise).

and then they have the nerve to bring up the antifreeze crappioly ....

edited to include: But hey! There's a "CHOOSE A RATING" thingie for this article at the end of the article

Edited September 9, 2010 by Uma

[BEERCITYVAPRZ]

WTFWTFWTFWTFWTFWTFWTF!!!!!!!!!!!!!!!!!!!!!!!!!!!!!@#$@ the FDA!!!!!!!!!!!!!!!!!!!!!!GGGGGGGRRRRRRRRRRRRRRR!!!!!!!!!!!!!

[Tim]

While it would seem that this is about nicotine on the one hand -- that e-juice without it should not be subject to regulation -- on the other it seems much more likely the FDA will say that all juice is subject to regulation as it potentially contains all manner of substances. This could put us all out of the liquids business. Additionally they are claiming the devices themselves are drug-delivery devices irrespective, presumably, of what they are delivering. If e-cigs are ruled as such, as drug-delivery devices, then only the deep pockets will be able to play. The reason PM et al has been silent about marketing a device, one should think, is because they have been playing the legislative game behind the scenes while developing their own devices and liquids. This is surely a war. A war in which none of us stands a chance of survival alone and but a marginal chance together. Certainly we must to the best of our efforts hang together lest, as Benjamin Franklin once opined, we will surely hang separately. What we need as suppliers is a code of conduct. Both from an ethical standpoint as well as a protocol for dealing with government agencies. This necessitates legal counsel of course. And there are a number of e-cig organizations out there, one, some or all of which may prove an effective vanguard. The thing for all of us is to be on the same page. Thoughts?

[Compenstine]

“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the letter to the association read.

I think we all saw some regulation coming down the pipe.I think the statement above shows they (the FDA) are not trying to outlaw them permanently. Yes it is not news that is all good but, I think it shows that E-Cigs have a future. It shows the FDA is trying to set standards for safety. I for one have been making my own fluids now from products that I can get in my home town. I think the statement above is a call for those that want to supply the E cig market with high quality products to do so in time legally with FDA approval. I can assure you that even Nicotine patches and gum needed to be cleared through FDA regulations.

[DarthVapor]

ok, time to get pissed.....

the FDA approves drugs for treatment of arthritis, erectile disfunction, high cholesterol etc..etc...ALL of those drugs that the FDA approved have side affects that have been documented, yet there are no reports of any of these kinds of side effects fro E-cigs, yet they want to target this industry?

Somewhere there is a check from Phillip Morris or RJ Reynolds written to the FDA....just gotta find out whose desk it's on.

Wrong. The government doesn't like big tobacco, and the feeling is mutual. However, the government does get big money in the form of taxes from traditional tobacco products that they DON'T get from e-cigs, and that IS the issue. Until the government gets it's sticky fingers into the e-cig business both through regulation, and taxation, the e-cig business is in jeopardy.

[girldragon]

I think we all saw some regulation coming down the pipe.I think the statement above shows they (the FDA) are not trying to outlaw them permanently. Yes it is not news that is all good but, I think it shows that E-Cigs have a future. It shows the FDA is trying to set standards for safety. I for one have been making my own fluids now from products that I can get in my home town. I think the statement above is a call for those that want to supply the E cig market with high quality products to do so in time legally with FDA approval. I can assure you that even Nicotine patches and gum needed to be cleared through FDA regulations.

Do you get nicotine liquid in your home town? If so where-I am not giving up getting my fix lol! it's going to skyrocket in price after regulation and I want to stock up!

[Compenstine]

Do you get nicotine liquid in your home town? If so where-I am not giving up getting my fix lol! it's going to skyrocket in price after regulation and I want to stock up!

Yes it will go up in price that is true, and yes, I can make Nic liquid with bulk tobaccos.

[LoriHNC]

Yes it will go up in price that is true, and yes, I can make Nic liquid with bulk tobaccos.

Wow, I'd be interested in knowing how that is done. Very cool.

[FTJoe]

I think we all saw some regulation coming down the pipe.I think the statement above shows they (the FDA) are not trying to outlaw them permanently. Yes it is not news that is all good but, I think it shows that E-Cigs have a future. It shows the FDA is trying to set standards for safety. I for one have been making my own fluids now from products that I can get in my home town. I think the statement above is a call for those that want to supply the E cig market with high quality products to do so in time legally with FDA approval. I can assure you that even Nicotine patches and gum needed to be cleared through FDA regulations.

I believe they are going to kill this with a two prong approach. Fluids fall under the food jurisdiction, they said to have found two suppliers that are tainting the juice. That's the Food part of the agency. Fine. But now if you want to add a substance called nicotine, that falls under the D part of FDA. They will claim, rightfully so, that absorption rates are unknown, the other chemicals being brought in with the nicotine are unknown, side effects are unknown, etc. And they will be right, this is actually their job. It sucks and I'm 0 nic so I can actually make out. But how long do you think the hardware will be around if the juice goes away? I have to go clean out one tainter of juice, Johnson Creek before they get shut down. Maybe its all lies, but I saw vids off their site of clean rooms etc. that made me proud of them. You know half the stuf you get is bathtub gin (not VT of course, I'm talking the mixers out there).

BTW - schizo had plans to buy something to extract nicotine, maybe he will chime in. If not I will PM him.

[Christopher]

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

[LoriHNC]

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

So you think we could possibly still get nic liquid and parts from out of the country if theres a US ban? Isn't customs stopping it from coming in?

[Compenstine]

Wow, I'd be interested in knowing how that is done. Very cool.

It is not really hard to do and stumbled on it quite by accident. That is all I want to say because, I have been working on selling it, the lawyers I have been working with are not cheap. Now it looks like I will have to jump through more hoops.

[Compenstine]

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

With all due respect, I would take what I make any day over the stuff from China. What is the lead content of the water in China or Mercury to name a few heavy metals.

I'm not recommending anyone to extract pure nicotine from tobacco. All e-liquid recipes are a home brew at some point when they start. I would not sell it or give out the process without having it tested by a lab and have it consistent. This is why I'm paying lawyers and working on having the testing done and it is not cheap.

Edited September 10, 2010 by Compenstine

[Brian]

So you think we could possibly still get nic liquid and parts from out of the country if theres a US ban? Isn't customs stopping it from coming in?

I think China will continue to ship anything we want to buy, but yes, some will get seized. But how much time is going to be spent looking for packages sent to individuals? My guess is with the volume of shipments coming in, they won't get many, but I could totally be wrong.

Not the news I wanted to hear today.

[ecigg]

While this is a concern, I hope that we will be okay. I can't believe that some of these companies put that crap in their e-juice. I am about to write an email to ecig.com and say what the heck were u thinking!!

[ThaHodgehound]

I think China will continue to ship anything we want to buy, but yes, some will get seized. But how much time is going to be spent looking for packages sent to individuals? My guess is with the volume of shipments coming in, they won't get many, but I could totally be wrong.

Not the news I wanted to hear today.

I agree with Brian on this......hit and miss AT BEST with individual, small orders.

[ecigg]

I agree with Brian on this......hit and miss AT BEST with individual, small orders.

The people at some of these companies are from China themselves. IE e-cig.com. Yes their "office" is in Las Vegas, but they are technically based out of China. It's companies like them they are ruining this for the rest of the good suppliers.

[FTJoe]

I completely agree. In a perfect world, I would want regulation. In this world I have no idea how we get it without giving something up. But they will force many into doing "odd" things in order to do what they KNOW is healthier for them, vape.

FYI - got my JC order in, I noticed this on their site, as I suspected, because they are an American company making juice, they kind of put themselves out there...stupid stupid stupid, they did the right thing, they registered with the FDA.

https://www.johnsoncreeksmokejuice.com/category/fda

I'm looking for the clean room video. Look what I found while searching, the complaint against JC, its about the drug part of it all, nicotine, replacement, they even submitted reviews as evidence. Christopher, heads up on this, the forums could be as well.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm

"As presently labeled and promoted, these Johnson Creek Smoke Juice products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Johnson Creek Smoke Juice products are unapproved new drugs marketed in the United States in violation of section 505 of the Act (21 U.S.C. § 355) and are misbranded under section 502 of the Act (21 U.S.C. § 352).

Both the "drug" and "device" definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. §§ 321(g) and (h)) encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the Johnson Creek Smoke Juice products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including your Internet website at www.johnsoncreeksmokejuice.com. that reflect these intended uses for the products you market include, but are not limited to, the following:"

Edited September 10, 2010 by FTJoe

[BEERCITYVAPRZ]

I just want to make it clear to everyone that I'm all for regulation and improved safety of electronic cigarettes (of course) My worry is about a ban or handing over the technology to the same people that have been killing us for years.

Judging by the articles here it sounds like the FDA may be changing their stance on things, but the lawsuit isn't over and my products are still getting seized at the boarder. So while they may appear to only be going after suppliers making false health claims and adding ED drugs into their liquid that isn't the case. We don't make any health claims in our store, in fact we where one of the FIRST American suppliers to add warning labels, yet monthly our products are taken by the FDA. Last time I checked my hardware didn't contain any E Liquid.

I totally agree with this Chris. the hardware shouldn't be siezed at all especially batteries.

[FTJoe]

Me too. If you read the FDA complaint against Johnson Creek I just posted (I'll be happy when my juice ships) they are complaining about drugs in the juice (nic). They are complaining about drugs which means drug delivery is not far behind. Am I over-reacting? I hope so. But I have 180 ml of my JC juice on the way!!!!

[mcquinn]

It looks from the letter they sent Johnson Creek that if you just list your products and leave out all the other stuff you would not be in violation.As the complaint was they were making claims based on customer testimonials.The other stuff could be in a forum seperate from the store site.