FDA acts against electronic cigarette distributors

[rothenbj]

In part, some of this is warranted. Companies should know better than to make unsubstantiated health claims. They should know better than to add actual drugs (either approved or not) in another form and sell them. Not sure what Johnson's Creek's issue was, but like Kristin said, they actually worked with the FDA and got smacked for it. I'm actually more interested in what JC's problem is/was than the others. The others sound like they got what was coming to them.

What I don't understand however, is there is a lot of this kind of thing that goes around. You see it on late night TV and magazines; companies advertising weight-loss products and health pills, but with the disclaimer "These claims not evaluated by the FDA". And they get away with it....so what is the difference?

Perhaps JC's problems occurred because they've shown up in the news lately. That might not have set well with the drug lords.

 

[trying]

Of the 5 companies only Ruyan America appears to be talking to reporters as they are the only company quoted in the several news articles I read.
I also read all 5 Warning letter to the companies and I think I see why Ruyan America is the only one talking. All the nicotine content E-cigarettes, cigars and pipes FDA sites
in it's letter are products Ruyan America no longer sells. The company FDA is complaining about is the parent company Ruyan China and the FDA has no power over them.
The other 4 companies all sell nicotine content products and the FDA claims authority over nicotine no matter what federal judges or the general public think, so I think their battle will be much more difficult to win.
I think the FDA is over stepping its boundries but I do not see anyone with enough power to stop them who is willing to do so.

 

[Bahnzo]

Perhaps JC's problems occurred because they've shown up in the news lately. That might not have set well with the drug lords.

I'm not sure I'm willing to put on the tin foil hat just yet. Like I said, I'm curious to find out what JC's issue was...some sort of sanitary issue or what?

 

[KDK]

YES!!!! What Spivey said!

 

[KDK]

What still irkes me is their totalitarian method. These products shouldn't be banned until proven safe; that's not how or government is 'supposed' to work. We should be left to our own devices unless they are found to cause harm.

Sorry, that is what i was trying to agree with! just recently learned how to do this whole quote thing. But, YA!

 

[Bahnzo]

What still irkes me is their totalitarian method. These products shouldn't be banned until proven safe; that's not how or government is 'supposed' to work. We should be left to our own devices unless they are found to cause harm.

Ummm, no. How would you feel about this if it doesn't apply to e-cigs? What if every pharma company out there could just flood the market with drugs that didn't go thru any testing? It just can't work that way. E-cigs are different, but your post only tells that you don't understand how it *is* supposed to work.

 

[Enigma32]

JC did nothing. FDA is saying ok fine, you're not drugs, then watch how ......ed we can be about the rules. If a customer even states they stopped touching cigs in your reviews BAM Drug.

But it would basically come down to yet another lawsuit, they're bing rediculous.

 

[instamix]

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"?

Spot on

I think the FDA is slumming around looking for ammo...............................

 

[Bahnzo]

JC did nothing. FDA is saying ok fine, you're not drugs, then watch how ......ed we can be about the rules. If a customer even states they stopped touching cigs in your reviews BAM Drug.

But it would basically come down to yet another lawsuit, they're bing rediculous.

I don't think that's the case tho:

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.

It has nothing to do with any claims (even customer made) about quitting smoking, but something to do with their manufacturing, etc. There needs to be more clarification on this as I see this as a warning to all juice manufacturers that they might be on the verge of the FDA coming in and shutting them down.

 

[Enigma32]

I don't think that's the case tho:


It has nothing to do with any claims (even customer made) about quitting smoking, but something to do with their manufacturing, etc. There needs to be more clarification on this as I see this as a warning to all juice manufacturers that they might be on the verge of the FDA coming in and shutting them down.

Keep diggin...

Looking through the letter to Johnson Creek they are claiming JC markets it as a drug because of comments by users mentioning no longer touching cigarettes. I take 2 things from that: 1. They forbid any mention of not smoking cigarettes 2. User generated comments on your website become YOUR comments. Would a standard "Comments/reviews are user submitted and do not reflect the views of blah blah inc." disclaimer take care of that?

The whole thing is pretty pathetic. All I see here is that this is all FAR from over. We can win the battle and electronic cigarettes alone do not a drug make, but mentioning anything about not smoking or reducing smoking or even mentioning getting nicotine from it then makes it a drug? They opened a new attack that probably won't fall in the judges ruling and this is the start of a lawsuit all over again.

 

[voltaire]

In Johnson Creek's case at least, it's not JUST the user comments.

From the FDA's letter to JC, which quoted excepts on their website (other than those from users):

"News from Johnson Creek ...

"Effect of an E-Cigarette on Cravings and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-Over Trial" - The University of Auckland Faculty of Medical and Health Sciences ... Aim ... To measure the effects of the Ruyan e-cigarette (EC) on craving relief and withdrawal and explore its acceptability and pharmacokinetic properties in comparison to placebo EC (i.e. with cartridges containing no nicotine), Nicorette nicotine inhalator and factory made cigarettes ... Conclusion ... The EC shows promise as a device that might aid cessation."

Promotional materials [brochures]

"Welcome to E-Smoking! A beginner's guide to E-Smoking ...

E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ...

Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ...

Nicotine ... Nicotine is an alkaloid found in certain plants, predominantly tobacco ... When absorbed in small amounts, whether from cigarettes, cigars or e-cigarettes, nicotine can cause stimulation, a feeling of relaxation, calmness, and alertness. The effects of nicotine can last from minutes to hours, Although addictive, nicotine is widely considered far less dangerous than the ingredients in regular cigarettes."

 

[Enigma32]

Do any single one of the companies mentioned state "this product is not intended to treat, diagnose, prevent or cure any disease" ?

Nope.

Must appear with any statement that could possible be construed as a health claim. Even "I smoked 1 less cigarette today"

Same with the user comments. If it appears on your site, then it is part of your marketing material. A user submitting a comment stating "ecigs saved my life, cured me from aids, and made my junk grow big" they are legally holding you to those claims.

again: "Comments and reviews are submitted by blahblah.com website visitors and do not reflect the opinions or claims of blahblah.com, blahblah inc. or its employees or affiliates."

All in all, its still a good sign, they're resorting to nitpicking how we market and not the product. It reaks of desperation. Its tough, but you have to think semantics not logic.

 

[spivey]

Ummm, no. How would you feel about this if it doesn't apply to e-cigs? What if every pharma company out there could just flood the market with drugs that didn't go thru any testing? It just can't work that way. E-cigs are different, but your post only tells that you don't understand how it *is* supposed to work.

Our ecigs aren't supposed to cure cancer, aids, the common cold, help you lose weight or sleep better at night. In a sense they are self medicating, but so is vitamin c.

Let's not apply it to just ecigs then: scenario - forest fire.
Company - "Hey, we got this stuff that will put out that fire."
Gov - "Nope. We need to test to see how it will affect the local wildlife first."
Company - "Well your wildllfe is on fire right now."
Gov - "Nope. They might get cancer in 20 years"

I work in the medical field and do see a need for what the FDA does; but not when it comes to labeling ecigs as a drug delivery device.

 

[ec!gg]

I thought about this, and it probably was not a good idea to sell e-juice that claims the benefits of helping erectile dysfunction and weight loss... But when you think about it, there are plenty of herbal remedies and supplements that support these same claims. The FDA seems is targeting e-juices\ecigs when there are a variety of supplements and herbal remedies sold at any local vitamin store. Are any of these supplements being tested and proven to the FDA? I highly doubt it.

 

[potholerepairman]

The US goverment is trying to outsource every job, for what reason I have no clue.Think ordering juice from overseas can not be much harder than grandma ordering a script.Do not want the juice men and woman of the usa to go under for any reason and hope if they go underground they profit like Pablo Escobar and live to spend the fruits of their labor.When silly laws are passed it gives the goverment less authority in the publics eye and gets people to question the motives which may be a saving grace.

 

[thorn]

Candles, aromatherapy, incense, Glade, Fabreeze, Vicks humidifier and vaporizer, Vicks vapor rub, don't they all affect how you feel and have "benefits"? Maybe we can get the illegals to smuggle it in from Mexico. They smuggle in everything else, including themselves.

 

[DaveP]

Except for the hardware manufacturers, the Ecig business is primarily a cottage industry run from various locations, many of those being home based businesses. The brick and mortar storefront is generally the exception since there isn't a large enough clientele to warrant the added cost of maintaining a walk-in environment.

I, for one, would like to see voluntary compliance by juice suppliers. Having a periodic lab test of random samples might cost the end user a few more bucks a year, but would ensure that the product is relatively safe from an ingredients standpoint. I suspect that the PG and VG components are already tested as consumer products due to their wholesale and retail sale by larger companies who provide products for other uses.

Intended use is what the FDA is concerned about. The products are used in a manner not prescribed by previous testing of the components. I'm not a proponent of restrictive FDA involvement, but I suspect that few suppliers have had the product tested as used and rely on their manufacturing suppliers to provide MSDS on individual components.

I would like to see an industry wide test that was supported by the entire industry where samples of hardware and juice were collectively tested for harmful additives and components. This would speak to the formation of an industry co-op that shared the expense of testing on a regular basis by an independent lab recognized by the FDA as competent and used by all members of the association. If it raises my cost by 5% to 10% it's worth it to know that the products I use are safe.

 

[Vocalek]

In Johnson Creek's case at least, it's not JUST the user comments.

From the FDA's letter to JC, which quoted excepts on their website (other than those from users):

That first quote is not written by JC. It is a news item describing research conducted by Health New Zealand, presented as a Poster at the Society for Reseearch on Nicotine and Tobacco meeting. It is ridiculous to count this as a claim by the company.

 

[Vocalek]

Except for the hardware manufacturers, the Ecig business is primarily a cottage industry run from various locations, many of those being home based businesses. The brick and mortar storefront is generally the exception since there isn't a large enough clientele to warrant the added cost of maintaining a walk-in environment.

I, for one, would like to see voluntary compliance by juice suppliers. Having a periodic lab test of random samples might cost the end user a few more bucks a year, but would ensure that the product is relatively safe from an ingredients standpoint. I suspect that the PG and VG components are already tested as consumer products due to their wholesale and retail sale by larger companies who provide products for other uses.

Intended use is what the FDA is concerned about. The products are used in a manner not prescribed by previous testing of the components. I'm not a proponent of restrictive FDA involvement, but I suspect that few suppliers have had the product tested as used and rely on their manufacturing suppliers to provide MSDS on individual components.

I would like to see an industry wide test that was supported by the entire industry where samples of hardware and juice were collectively tested for harmful additives and components. This would speak to the formation of an industry co-op that shared the expense of testing on a regular basis by an independent lab recognized by the FDA as competent and used by all members of the association. If it raises my cost by 5% to 10% it's worth it to know that the products I use are safe.

We (the Vapers Coalition) have been trying to pull that one off by over a year. Whenver we get more than 3 vendors together on the same discussion, war breaks out. You need to realize that the majority of these companies have one or two employees and run on a shoe-string profit. They don't have the big bucks that an NJOY has to spend on lawyers and scientists. Even Johnson Creek (with about a dozen employees) will have a difficult time jumping through all the hoops that FDA has laid out, which correspond to the hoops that a Johnson & Johnson, Pfizer, or Upjohn have to jump through to manufacture pharmaceutical products.

 

[CHUCKLEHEAD]

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

I agree 100% And so does this guy