FDA acts against electronic cigarette distributors

[LowThudd]

The FDA realizes at this point that they may very well lose their case or are seeking "willingness" of companies to be governed by the FDA before the outcome of the case so they may present it as evidence that similar companies agree it is a drug. Those 5 companies should be easily protected from the FDA involvement until the outcome of the case.

By no means should any company state that e-cigs help people quit smoking. There have been no formal university studies proving or disproving that fact. Companies should be given the chance to re-word their advertising. Which then goes the other direction, can they state that "E-cigs do not help people quit smoking"?

Correct. The FDA is attempting to undermine e-cigs by using a new slurry of companies to set precident as a drug delivery device. This is an obvious strong arm tactic. They didn't win in court, so they are setting up the "Little Guy" companies through fear tactics to comply w/ making them a drug delivery device/drug "substance.

 

[Vocalek]

I know your gonna hate me for saying it, and I know its the government so I know their trying to use this as a back door to get control of ecigs.
but IMHO

THEY HAVE A LEGITIMATE ARGUMENT. MOSTLY

Said it bf ill say it again, we got to work with them, not against them, because these are safer alternatives to smoking, and the truth will prevail in this situation.

People putting unapproved drugs in vapor, people making crappy juice, and even crappy ecigs (usually overpriced too, i might add, by at least 200%) needs to be stopped, IDK about you but I want a quality, safe product when I order my ecig.

Thank god we live in a country that allows us enough freedom to use these products, and makes an effort, (Yes, an effort with a biased agenda) but none the less a effort to safely allow these products. Look at how many countries out there simply told their citizens NO! NO ECIGS FOR YOU.

ONE MORE TIME,

We have to work with them

(....ty and ridiculous as it may be)

I agree with you that it would be good to get rid of unapproved drugs being added and products that might be tainted. All of that can be accomplished if the FDA regulates those products that do not make any health claims as tobacco products under the Tobacco Act.

But if by "Work with them" you mean companies should start the New Drug Approval process for regulation under the FDCA, then you don't understand what we are up against. Mark my words: Any company that starts that process will be ordered to take all their products off the market until they receive approval as a new drug. That process costs millions of dollars (did you see the words "clinical trials" in the FDA's advice letter to the ECA?). It also takes years and years. The manufacturer wasn't allowed to freely sell Nicorette gum during the time that it was undergoing the NDA approval process.

The development of Nicorette started at the end of the 1960s. Nicorette gum was first approved for sale in Switzerland in 1978. It became available in the U.S. as a prescription medication in 1984. (The FDA does not accept clinical trials that were conducted in other countries.) It took to 1996 before it became available OTC. At first, it was only available in the 2 mg. strength in a very yucky flavor. It took several more years for the FDA to approve the 4 mg. strength, and even more years to be made available in flavors other than "Gag Me".

If the FDA prevails in the SE V. FDA case, then all the products--whether they choose to make health claims or not--will be ordered removed from the market. MARK MY WORDS.

Are you willing to go without access to any e-cigarettes for the next, say 8 to 10 years* because you are concerned about the companies that sell crappy equipment and crappy juice? I'm not. I'm willing to do my homework and make sure that I buy from reputable vendors. Caveat Emptor. Deliver me from the nanny state.


*That's assuming that the FDA isn't just pulling our leg about ever really allowing an e-cigarette to be approved as a drug delivery combination product. I would not put it past them to collect the fees, allow the company to spend years and years and millions of $ jumping through the hoops: completing all the animal testing, human clinical trials, etc., etc., and then just say, "Nahh...we don't think so. Sorry." They have done it before.

 

[frisco]

Did the homeopathic industry have to go through this? I know that the FDA regulates them but are they in the drug classification?

 

[LowThudd]

Did the homeopathic industry have to go through this? I know that the FDA regulates them but are they in the drug classification?

Nope, dietary supplement. But since we are not eating our e-juice, I don't think we will fall into that catagory. Unless some genious lawyer could argue that vaping is "Consuming" and is therefore part of the dietary intake. Not sure if that will work.

 

[MrsAngelD]

I suggest we write these companies as concerned consumers and ask that they remove any references from their website which cite e-ciggs as being used to help with quitting smoking as well as asking them any other questionable drug references. They can't ignore all the letters they receive if we each write them, as well we could include a warning to them of the dangers of following the FDA recommendations of it e-ciggs being called a drug delivery device.

 

[BigJimW]

Been preaching for years that the FDA wants us to go back to the money maker smoking real ciggies. .......s.

 

[Vocalek]

Given the fact that they just received letters from a U.S. government agency, I don't think consumers need to scold these companies into removing health claims. If they are smart they are talking to their attorneys even as I write this.

Better way to approach this is to offer to help. You might offer to review their web site, point out any text that the FDA might mis-interpret as a health claim, and suggest alternative wording.

 

[GrimmGreen]

Been preaching for years that the FDA wants us to go back to the money maker smoking real ciggies. .......s.

someone on my new FDA video called me BigGrimmW .. not sure if that is a compliment or not , gonna need to get myself a hat

 

[voltaire]

I agree with you that it would be good to get rid of unapproved drugs being added and products that might be tainted. All of that can be accomplished if the FDA regulates those products that do not make any health claims as tobacco products under the Tobacco Act.

But if by "Work with them" you mean companies should start the New Drug Approval process for regulation under the FDCA, then you don't understand what we are up against. Mark my words: Any company that starts that process will be ordered to take all their products off the market until they receive approval as a new drug. That process costs millions of dollars (did you see the words "clinical trials" in the FDA's advice letter to the ECA?). It also takes years and years. The manufacturer wasn't allowed to freely sell Nicorette gum during the time that it was undergoing the NDA approval process.

The development of Nicorette started at the end of the 1960s. Nicorette gum was first approved for sale in Switzerland in 1978. It became available in the U.S. as a prescription medication in 1984. (The FDA does not accept clinical trials that were conducted in other countries.) It took to 1996 before it became available OTC. At first, it was only available in the 2 mg. strength in a very yucky flavor. It took several more years for the FDA to approve the 4 mg. strength, and even more years to be made available in flavors other than "Gag Me".

If the FDA prevails in the SE V. FDA case, then all the products--whether they choose to make health claims or not--will be ordered removed from the market. MARK MY WORDS.

Are you willing to go without access to any e-cigarettes for the next, say 8 to 10 years* because you are concerned about the companies that sell crappy equipment and crappy juice? I'm not. I'm willing to do my homework and make sure that I buy from reputable vendors. Caveat Emptor. Deliver me from the nanny state.


*That's assuming that the FDA isn't just pulling our leg about ever really allowing an e-cigarette to be approved as a drug delivery combination product. I would not put it past them to collect the fees, allow the company to spend years and years and millions of $ jumping through the hoops: completing all the animal testing, human clinical trials, etc., etc., and then just say, "Nahh...we don't think so. Sorry." They have done it before.

Yup, and further complicating any attempt to seek approval as a drug device is the fact that no one company has effective patent protections. So which company would be willing to risk so much money, and so much time off the market, to MAYBE be able to legally sell their products POSSIBLY over-the-counter, in a HOPEFULLY palatable and effective form? When at the end of all that time and money spent, they will still have to compete with companies selling as Tobacco-alternatives and on the black/gray-market. NOBODY, that's who.

If the FDA persists, all they will accomplish is driving it further underground, and every individual ecig component and ingredient will be sold separately under the guise of other legitimate uses. This will, of course, do NOTHING for protecting consumers of ecigs, or to help smokers quit smoking much more dangerous cigarettes. Way to go FDA!

 

[smilin0117]

I think the best thing for every company to do is to remove all heath claims. It feels like we are at a very vulnurable time in our fight. I for one do not want to loose my PV, my juice or my nic.

 

[bassnut]

What is the FDA's beef with Johnson Creek? I'm not getting that.
I just went to their website and saw nothing in the way of health claims.
I also visited everybody's favorite, Cignot (not on FDA's list yet) and it looks clean as a whistle.
It's a really good model in fact. No nonsense whatsoever.

 

[D103]

Elaine and many others are correct: message to all e-cig companies..."clean up your marketing/advertising including your websites, remove ANY mention of e-cigs 'helping consumers to quit and/or reduce' smoking traditional cigarettes. This should include any testimonials (even the positive ones) where consumers claim they have "quit and/or reduced" smoking. Remain very strict with promoting this technology as an alternative to smoking....period.
This is obviously a shoddy and bullying ploy by the FDA - again another example of the FDA circumventing the law since this case is still before the Federal Apellate Court. I agree with those that have posted that this may be an indication that the FDA senses it will lose the court case; but the FDA's playbook is deep and they quite clearly have only begun to fight.
I would expect to see them pull out all the stops and I firmly believe there is no limit to the lengths they will go to get their way.

 

[thephoenix]

This is very foolish of the companies who received the letters (minus Johnson Creek who seems really above the fold to me). The others were simply not paying attention to the legal climate in the US and to stick by health claims is simply foolish.

We actually put up a lawyer approved FAQ just to ensure we weren't crossing lines. More suppliers should do this.

The FDA is merely posturing up for their court case, but I'm not entirely sure it's the wisest move since they're still in litigation & this gives the air they're higher than the courts - unless they know the judges are all ready with them...lots of backroom deals go on that we're not privy to so who knows, really.

The light here is the FDA seems to understand they won't win and are all ready posturing up for regulation. Which is good, so long as independent eCig sellers don't have to pay for clinical trials - that's where I believe the Chinese (or any) juice manufacturers are responsible.

One of the tactical mistakes I see is going after Ruyan which could end up being in our favor as Ruyan is the company responsible for funding the New Zeland study. They are a Chinese company and could very well have the funds to meet FDA approval & ensure their juice produced in China is complaint - keeping it cost effective. If we move to only US based juice - there goes the cost savings (no offense to my US-based juice makin' brothers! It's just simple economics)...

If any juice manufactures in China are paying attention this should be a real kick in the pants to immediately start playing ball with the FDA and getting their manufacturing practices in line with what can be sold to US customers. That is actually the silver lining. I have all ready contacted my manufacturer to see what they intend to do & will only work with manufacturers who will walk that walk...

If juice manufacturers do not pony up - the FDA has just run a lot of the independent players out of business if each have to submit to clinical trial. Game over. Unless they're just going to sell hard goods and no juice.

 

[bassnut]

OK I found it in the FDA's press release.

The FDA cited Johnson Creek Enterprises, which markets Smoke Juice, a liquid solution used to refill depleted cartridges in e-cigarettes, for several significant deficiencies in its manufacturing processes, including failure to establish quality control and testing procedures required under the FDCA

 

[Teach]

I just wanna say that I've been (happily) vaping for almost two years now and my "pee pee" works just fine. That is all.

Boogar.... where's it say we're 'sposed to check that!? Crap.... be right back........

 

[Less is more]

This is troublesome indeed. Smacks of big tobacco's hand in the mix. While I want control over what I'm inhaling, which is why I dropped analogs 15 months ago, I also want the freedom to pursue my nicotine in whatever manner I choose safely. Are they attacking tobacco companies additives with the same verve?

Back when I started, I don't recall seeing ANY claims about it being a way to kick the habit. On the contrary, suppliers seemed to go out of their way to make it clear that this was NOT a smoking cessation product. Have things changed that much?

I was shocked to see JohnsonCreek in the mix, but agree it's the FDA's way of strong-arming the little guys.

 

[crashinbrn]

Given the fact that they just received letters from a U.S. government agency, I don't think consumers need to scold these companies into removing health claims. If they are smart they are talking to their attorneys even as I write this.

Better way to approach this is to offer to help. You might offer to review their web site, point out any text that the FDA might mis-interpret as a health claim, and suggest alternative wording.

when i first bought my first e-cig at a mall they were advertising in a big banner it would help you quit smoking. in the back of my mind i knew that they could not legally say that unless it was approved by the FDA for that purpose. the 'company' i bought from was based in France(or that is what the box said 'made in France') so i thought that is how that were getting away with being able to say it.

i don't think that anymore. now the FDA is coming down on those companies. for that fact i am not so worried about these letters. i am still concerned about the pending court case with NJOY tho, i believe that decision will affect us more directly.

 

[richs10]

I know your gonna hate me for saying it, and I know its the government so I know their trying to use this as a back door to get control of ecigs.
but IMHO

THEY HAVE A LEGITIMATE ARGUMENT. MOSTLY

Said it bf ill say it again, we got to work with them, not against them, because these are safer alternatives to smoking, and the truth will prevail in this situation.

People putting unapproved drugs in vapor, people making crappy juice, and even crappy ecigs (usually overpriced too, i might add, by at least 200%) needs to be stopped, IDK about you but I want a quality, safe product when I order my ecig.

Thank god we live in a country that allows us enough freedom to use these products, and makes an effort, (Yes, an effort with a biased agenda) but none the less a effort to safely allow these products. Look at how many countries out there simply told their citizens NO! NO ECIGS FOR YOU.

ONE MORE TIME,

We have to work with them

(....ty and ridiculous as it may be)

I also generally agree with what you say. I've been vaping for a few months and it has been a godsend as far as regaining my breath, feeling better, smelling better and everything else, but I am also very careful about who I buy my juice from. I am VERY VERY fearful of a lot of the juice sellers out there (whether ECF vendors or not). There is very little verifiable information about what is in most juices, where it came from, who made it, etc. Only a handful of sellers give us any reassurance as to these questions on their sites, and even then, some of them are very carefully worded. For example, one seller says "All of our Juices are made here in the USA", but that doesn't tell us if they are, in fact, made from US made ingredients or just mixed here. IMHO, that's kind of shady. And that's what worries me sometimes.

The fact that the birthplace of most of our equipment and e-juice is China doesn't help either. We have all seen the horrible quality control issues that have been coming out of China in the last few years.....from dog food that kills Rover to lead paint on McDonald's toys. If these merchants want to survive the on-coming war with the FDA, Big Pharma and Big Tobacco, they better start thinking Smart.

Some possible suggestions for our suppliers:

- Get organized among themselves.
- Set up some basic guidelines that all members agree to comply with.
- Provide basic labeling on your bottles stating who made it and where
- Accurately label the content and sources of your ingredients in your Juice
- Start determining appropriate expiration dates and include that information on each bottle
- Hire some independent companies to periodically verify that what you say on the bottle is true.

We expect this basic information on almost everything else we consume. So, why not e-juice?

I'm sure a lot of suppliers are making a lot of money right now, but if they don't take some basic steps to protect themselves from the coming attack (and it's coming....for sure!) they are going to kill their golden goose......and screw up my ability to get good e-juice and equipment!

Just my 2 cents.
Rich

 

[BigJimW]

someone on my new FDA video called me BigGrimmW .. not sure if that is a compliment or not , gonna need to get myself a hat

HAHA! Get a hat from Tasty Vapor

I posted a video response to you Grimm on your video.

YouTube - BigJimW10 Says .... The FDA

 

[Skwerl]

@Rich: and help them find a damn good attorney. I wonder if we could get Andrew Napolitano to represent us.