Fda news release

[LaceyUnderall]

also, anyone else notice that one of their methods was redacted?

as in, they tested something one way, didn't like the result and then didn't use it in the final analysis?

 

[SharonLM]

I've just seen this and will go back and read it more thoroughly. Geez.

 

[TheIllustratedMan]

no, as in they blocked out what the method was... the quote is:

Extraction with [redacted] as described in NDA 20-714, Phamacia & Upjohn method “Nicotine, Content Uniformity, Identification and Determination of Nicotine Related Substances in Nicotine Inhaler 10 mg” method NM-046-6 dated 1999-07-16

on page 6

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

I'm no scientist, but I can't see how this is a scientifically sound study. There's no hypothesis, there's no reason given for testing for Diethylene Glycol, they tested one each of the cartridges, there's no summary, and their control was only involved in one test out of many.

Am I missing something here?

 

[pbusardo]

A chat with Ms. Sonia Kwok of Dekang:

Phil Busardo:
Ms. Kwok? (2009-07-23 09:38:38)
Sonia Kwok: hi (2009-07-23 09:48:09)
Phil Busardo:
Hello Ms. Kwok. Thank you for talking to me. (2009-07-23 09:48:29)
Phil Busardo:
I'm interested in your company's smoke juice, however, I'm very concerned by the recent FDA report. Can you please speak to it? (2009-07-23 09:49:00)
Sonia Kwok: We are applying the FDA report (2009-07-23 09:50:11)
Sonia Kwok: but still have not got it yet (2009-07-23 09:50:50)
Sonia Kwok: but we have another report such as SGS (2009-07-23 09:51:30)
Phil Busardo:
No, I'm not talking about FDA approval; I'm speaking about the report that was just released: FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. (2009-07-23 09:52:06)

Phil Busardo:
Specifically, DPA's analysis of the electronic cigarette cartridges from the two leading brands revealed the following:

* Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an ingredient used in antifreeze, is toxic to humans.
* Certain tobacco-specific nitrosamines which are human carcinogens were detected in half of the samples tested.
* Tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.
(2009-07-23 09:52:47)
Phil Busardo:
Ms. Kwok, can you please tell me if your juice is pure, what the ingredients are and if it has this bad stuff in it? (2009-07-23 09:57:57)
Sonia Kwok: wait for a monment (2009-07-23 09:58:47)
Phil Busardo:
Sure. (2009-07-23 09:58:58)
Sonia Kwok: we are aware of this report and we are preparing an announcement to clarify on this issue
(2009-07-23 10:00:10)
Sonia Kwok: Yunnan Changning Dekang Biotechnology here declares that our e-liquid does not contain Diethylene Glycol. e-liquid tested positive for this chemical by the US FDA is not produced by Dekang.
(2009-07-23 10:00:29)
Sonia Kwok: this is what we are saying at the beginning of our announcement
(2009-07-23 10:01:10)
Sonia Kwok: Our e-liquid has been thoroughly tested by SGS, Korean FDA and German TUV LFGB.
(2009-07-23 10:01:12)

I will be getting some additional information from Dekang as well as a copy of the report that I will be posting here.

Also from Johnson Creek:

Response to the FDA – Why Johnson Creek is Different

Since inception, Johnson Creek Original Smoke Juice has always stood for high standards of quality, safety and innovation. Many of you have likely seen today’s press release from the FDA about the contents of certain manufacturers’ e-liquid and concerns about the use of electronic cigarettes. While we applaud the FDA for continuing to look after the safety of the general public, we wanted to take a moment to remind everyone that not all e-liquid is created equal. That’s why we coined the term Smoke Juice. But what’s in a name?

In our name is quality. We use the finest ingredients of food and pharmaceutical grade to ensure the purest liquid possible.

In our name is consistency. From top to bottom, our staff is dedicated to making the same great Smoke Juice time and time again.

In our name is responsibility. The FDA wants to talk about warning labels, ingredients and child safety? All important considerations…that we instituted long ago. This news feed is a big part of our new site and our company. We want to be able to communicate with our customers easily and effectively so you can be assured we’re here to stay.

In our name is confidence. The same ingredients you see in the foods at your local grocery store are used right in the midwest – right in Johnson Creek, Wisconsin – so our products have exactly what it needs for a great taste.

What’s not in our name? The same things that aren’t in our products! There’s no diethylene glycol, there’s no tobacco, no known carcinogens. There’s no marketing to minors or false advertising – just no nonsense facts so adults can make their own decisions.

In just one year, our company has quickly become a leader in this young industry. We’ll keep raising the bar, we’ll keep making the best product on the market, we’ll keep communicating changes and we’ll keep listening to your feedback.

All you have to do…
is keep vaping.

Thanks for your time,
Mike Galesky
President
Johnson Creek Enterprises, Inc

 

[spaceburrito]

no, as in they blocked out what the method was... the quote is:



on page 6

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

I'm no scientist, but I can't see how this is a scientifically sound study. There's no hypothesis, there's no reason given for testing for Diethylene Glycol, they tested one each of the cartridges, there's no summary, and their control was only involved in one test out of many.

Am I missing something here?

If you are then we're both crazy, every scientific method based test i've ever encountered required a control to be present (and FULLY tested) in all tests.

 

[kinabaloo]

I'm no scientist, but I can't see how this is a scientifically sound study. There's no hypothesis, there's no reason given for testing for Diethylene Glycol, they tested one each of the cartridges, there's no summary, and their control was only involved in one test out of many.

Am I missing something here?

I agree with you.

By not using the control properly, it's possible to screech "X found" without a comeback of "found in Y too" being possible.

Sadly, many scientists (vapers or others with an interest) will not dare speak on these issues in case they are traced and demoted etc. That's why seem invisibly un represented in the forums.

 

[tannerk]

T
The devil is in the detail. By 'find'/'detect', we are talking one part per million, at most.

Your hypothesis is correct. It is also important to note that DEG was found only in liqud sampling (less than 1%) and not in vapor sampling.

The toxicity data on MSDS and FDA own admission is given for a standard state (at 25 °C, 100 kPa). From FDA's report, liquid was heated to 60 °C.

Since we are not drinking the liquid, The data on DEG toxicity and it's state (breakdown/reactions if any) we all should be looking for is at 60 °C.

 

[Krakkan]

Now that it's 2am and i'm on a tyrade tonight , I will proceed to sum up how I view my experience with the communication between the ecig community, the public, and the FDA:

Vaper: Hey, check this out! I cut my smoking in half the first day I tried this!

FDA: But can you prove it's safe?

Vaper: Well they've been around for a few years, and no ones become seriously ill or died.

FDA: Ok, now prove they're safe.

Vaper: Well I've had mine for a week now, and smoked maybe 3 analogs. That's 140 analogs I didn't smoke! And I didn't kill anyone in the process! yay me!

FDA: Yea but they aren't proven safe.

Vaper: Well I feel better, at least better then I did when I was on chantix... I mean, I got really depressed, even suicidal...

FDA: This isn't about chantix, we're banning ecigs. Stay on topic.

Vaper: Well there are thousands of people using this, I would go as far as saying tens of thousands, and only mild side effects have been reported. They seem to be the only thing NOT making me overweight, or depressed, or stressed, or ill, or anything else.

FDA: Well until you prove them safe we're telling the public their children are in danger and should run away from you if they see you. Thanks for your concern.

Public: huh?

The end.

(bedtime for me )

This makes me smile good one

 

[dochogan]

A proposed solution:

<kid friendly packaging>

Thoughts?

DEFINITELY funny as hell! My paranoia jumps to the front, though, and wonders if you might want to pull that image. It's obvious that dirty tactics and lies are going to be the weapons used against us; I have NO doubt that if this is seen, the next hearing will have a 3foot by 3foot blowup of that, and the claim that PV druggie hippy wierdo commie freaks are planning to market this in this way. Ya know?

the man came into the hell the last president left behind...he is working on trying to create jobs....make health care more affordable...and trying to end this war that is going on. Remember he didnt make this mess...

And you still haven't said what he's
done. The only think that I can think of that he's actually
done is sign an executive order outlawing smoking and sending us into the mess we are discussing in this thread.

What he's doing, or trying to do, is a whole different thing, and questionable as to how ill-conceived some of those things are, as well.

He signed the anti-smoking act last month. That's the fact, and currently the only fact germane to this discussion.

 

[grimmer255]

And you still haven't said what he's
done. The only think that I can think of that he's actually
done is sign an executive order outlawing smoking and sending us into the mess we are discussing in this thread.

What he's doing, or trying to do, is a whole different thing, and questionable as to how ill-conceived some of those things are, as well.

He signed the anti-smoking act last month. That's the fact, and currently the only fact germane to this discussion.

also Im sure you are aware of his nicotine addiction. He sign that bill b/c the FDA needs to regulate how it is marketed....And I also believe that cigarettes need to go. Tobacco kills 400,000 people a year in the US alone. 3.2 million world wide. Knowing those numbers I would have signed that damn paper years ago. see your thinking in terms of about you...well what about people who never smoked but was in directed contact with second hand smoke and got cancer b/c someone like you and me smoked around them.

 

[pbusardo]

In case you weren't aware, Smoke Assassin, as heard on Satellite Radio uses Smoking Everywhere product.

 

[TheIllustratedMan]

This thread is getting unruly.

 

[Trypwyr]

If only we could stick to FDA discussion, and not what our president is doing/not doing...

Tryp

[EDIT]: BTW TheIllustratedMan, awesome contributions to this thread by you. Thanks!

 

[dochogan]

also Im sure you are aware of his nicotine addiction. He sign that bill b/c the FDA needs to regulate how it is marketed....And I also believe that cigarettes need to go. Tobacco kills 400,000 people a year in the US alone. 3.2 million world wide. Knowing those numbers I would have signed that damn paper years ago. see your thinking in terms of about you...well what about people who never smoked but was in directed contact with second hand smoke and got cancer b/c someone like you and me smoked around them.

He signed something that had far, far further reaching consequences, as we're finding out right now. That is something I don't condone in any politician.

He signed something that legislates my safety at the expense of my freedom, which I don't condone from any politician.

He MADE MY DECISIONS FOR ME, and TOOK AWAY my opportunity to make decisions for myself, based on HIS (so I am informed, so I assume) inability to deal with his own addictions. His addiction is NOT my problem. And do you *really* think that a smoking ban is going to affect the PUSA in *any* significant way? Is the Secret Service going to tell him to put out his illegal tobacco product, regardless of the law?

We're getting way off topic here. The point his that I've only seen one actual significant policy come from the new pres, and IMO it was a bad bad thing, in the context of this threads topic of discussion.

 

[tannerk]

AP video on e-cigs (more BS propaganda)

http://www.youtube.com/watch?v=b5i_7rAGQpQ

 

[quovadis]

Phil i deal with the Chinese all day long regarding products and certification.
Plastics-ROHS-bedding flammability-and many others.
It's not possible to approach the Chinese and ask them if their liquids are safe.
Compared to what?
There are no standards to date, no laws, no certificates of conformity to abide by.
What needs to be done here is that Dekang have to re-create a perfectly non toxic e-juice then obtain the FDA'S approval so as to export to the USA.
This is feasible but will take years.
In the meantime, or during this lengthy process, they will restrict all imports until there is "proof beyond a reasonable doubt" that e-liquids are safe.

 

[grimmer255]

This thread is getting unruly.

Sorry about that but he asked and i told....i agree we need to get back to business....so what do you think would be the best option....we have the facts laid out.....
1. quality controle
2.ID verification
3.using the FDA report against them

i know i missing something here.

 

[kinabaloo]

Your hypothesis is correct. It is also important to note that DEG was found only in liqud sampling (less than 1%) and not in vapor sampling.

Does the report say that or show that, or is this your supposition? Would be strange if true.

 

[DaBrat]

Reading the PDF document. It looks as if the FDA is trying to prove that these are not smoking cessation devices. I don't remember smoking everywhere EVER stating that these were smoking cessation devices. Even though some delivered more nic than labeled.. As a rule most were consistant with labeling... Inquiring minds wanna know what Big Brother will do now.

 

[maryjo]

The "kid thing" makes me wonder which children will actually have the
patience to recharge batteries constantly and top off every few minutes
even if lured in by the fruity flavors. (*)

From what I read, ADD is rampant among the chillin of today.

Maybe they can make a Ritalin Flavor!


(*) Actually, I have found the fruit flavors to among the most disgusting
and/or disappointing in the line of eLiquids.

Dave - I've just been reading and trying to be quiet, but you almost made me choke on my curly Q.