FDA Mission ~ FAIL!!!!

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Tom09

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As it is also found in trace amounts in food stuffs, and allowed by the FDA. Wasn't the amount found actually below the max amount allowed? Correct me if I'm wrong here.

I'd say it wasn’t. “Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%” (quote from the report). Relevant criterium is compliance with the present acceptance limit of 0.1% DEG (e.g, Yvilla’s USP link). It does not take the related question about actual intake into account, though.
 

yvilla

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My Question is
How could the FDA approve a product which contains an ingredient that is found in Anti-Freeze ? Especially when they are saying they don't know the long term effects of that Ingredient.

Dee, I get where you are coming from, but it is important to note that the FDA was NOT referring to PG (propylene glycol) as a problem in eliquid, as you can see in the press release I quoted above. They were talking about a tiny amount of DEG (diethylene glycol) when they condemed that one SE cartridge as having a "toxic chemical" found in antifreeze.

There has been a LOT of confusion here about that - probably because we do know that a special non-toxic antifreeze IS made with propylene glycol, whereas the normal toxic kind is made with ethylene glycol (and I guess the FDA thinks some kinds have DEG too, although that's not commonly seen).

But, the FDA's scare tactics have always been about the DEG (and TSNAs and nicotine), and not the PG. Other uninformed or deliberately ignorant opponents of the ecig have complained about the PG in eliquid, but not the FDA.

And that's to be expected, because your medication is only one out of literally dozens that contain PG in various concentrations, ranging from 1 or 2% all the way up to 99%.

You can see them for yourself - just go to the FDA inactive ingredients database (link to follow), put "propylene glycol" in the search box you see at the top right of the page, and you will be taken to a huge list of medications, of all forms (injected, ingested, inhaled, intravenous and topical), containing propylene glycol.

Inactive Ingredients in FDA Approved Drugs
 

deewal

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Dee, I get where you are coming from, but it is important to note that the FDA was NOT referring to PG (propylene glycol) as a problem in eliquid, as you can see in the press release I quoted above. They were talking about a tiny amount of DEG (diethylene glycol) when they condemed that one SE cartridge as having a "toxic chemical" found in antifreeze.

There has been a LOT of confusion here about that - probably because we do know that a special non-toxic antifreeze IS made with propylene glycol, whereas the normal toxic kind is made with ethylene glycol (and I guess the FDA thinks some kinds have DEG too, although that's not commonly seen).

But, the FDA's scare tactics have always been about the DEG (and TSNAs and nicotine), and not the PG. Other uninformed or deliberately ignorant opponents of the ecig have complained about the PG in eliquid, but not the FDA.
Inactive Ingredients in FDA Approved Drugs
Yes yvilla, i understand that but the Headlines on the Web and TV were
"Antifreeze found in E-Cigarettes". The Antifreeze word was jumped on immediately by our Opponents and still has not been dismissed. PG is not only in E-Cigs and Antifreeze. It's loads of food ,toothpaste etc as you know. I just thought that as the FDA are playing dirty to try and discredit us it might be an idea to fight fire with fire and try to discredit them.
This professor of Psychology( chemistry is not his field) wanted to prove a Psychologic Theory and when it's failed he's gone back to the good old Long Term Affects of PG. He say's it in one of the Videos. Well as far as i'm concerned the FDA have had at least a Decade of Data on PG.
I would just like to see a Video pointing out that Americans have been using Antifreeze eating,drinking Brushing their teeth and using deoderant and painkillers for years.
 

Kurt

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I'd say it wasn’t. “Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%” (quote from the report). Relevant criterium is compliance with the present acceptance limit of 0.1% DEG (e.g, Yvilla’s USP link). It does not take the related question about actual intake into account, though.

Thanks for clarifying this, Tom09. To be honest, it was the whole uncertainty of what is actually in the juices, which few vendors disclosed, that led me to going 100% DIY.
 

ChipCurtis

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Keep in mind that the tiny amount of DEG that was found in one of the 18 SE carts probably got the DEG contaminant from the processed tobacco that they extracted the nicotine base from. So I don't even see this as a matter of sloppy or careless manufacturing. The DEG is there simply because legal processed tobacco already contains it, and in much greater amounts than in any e-liquid.
 

Drummel

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First off, I'm not great at making educated arguments. I shoot for simple logic. So if I sound stupid, my apologies. :D


FDA said:
*the products may contain ingredients that are known to be toxic to humans


This quote is in direct reference to E-Cigarettes..


Correct me if I'm wrong, but aren't Analong Cigarettes "toxic to humans", and if that is the case, why in the hell would they have allowed them in the first place, and secondly if they hadn't allowed them to carry on in the first place, we wouldn't be at our second destination, ECF and vaping. (Don't get me wrong I love all you people and my PV) :rolleyes:

It would seem to me that the FDA is only really good at one thing. Contradiction.

There needs to be serious seperation from our government and studies for approval/banning of anything. Biased studies, the chance for corruption within those studies. Hell anything that involves tax payers money, and Big corporations, such as Tobacco, and pharmaceutical, along with goverment, wether it's the mayor, OR the president should be completely seperated. I don't trust it. I don't have faith in it. And everything I keep reading just reduces that hints of faith(or hope) I had for honesty and proper justice within this system.
 
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Oliver

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Keep in mind that the tiny amount of DEG that was found in one of the 18 SE carts probably got the DEG contaminant from the processed tobacco that they extracted the nicotine base from. So I don't even see this as a matter of sloppy or careless manufacturing. The DEG is there simply because legal processed tobacco already contains it, and in much greater amounts than in any e-liquid.

Chip - do you have any references for that? This seems pretty unlikely to me; 1 % (if that is an accurate measurement) is actually quite a large contamination. Logically it would seem unlikely this much could have resulted from the extraction process. It seems more likely to have occurred in another stage of production, no?
 

yvilla

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Chip - do you have any references for that? This seems pretty unlikely to me; 1 % (if that is an accurate measurement) is actually quite a large contamination. Logically it would seem unlikely this much could have resulted from the extraction process. It seems more likely to have occurred in another stage of production, no?

Since the USP purity standard for PG allows for some levels of DEG and EG, I think it's more likely that any DEG contamination stems from the PG base used in a given eliquid.

That's what Dr. Siegel said as well, in a response to a question I asked him on his blog.
 

deewal

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Since the USP purity standard for PG allows for some levels of DEG and EG, I think it's more likely that any DEG contamination stems from the PG base used in a given eliquid.

That's what Dr. Siegel said as well, in a response to a question I asked him on his blog.

Which is what i was trying to get across in my post's http://www.e-cigarette-forum.com/forum/e-cigarette-news/71519-fda-mission-fail-2.html#post1060059 and http://www.e-cigarette-forum.com/forum/e-cigarette-news/71519-fda-mission-fail.html#post1065660.

Therefore Every FDA Approved product containing PG should be withdrawn from the Market as the same Contamination could be in those product.
Don't forget to clean your teeth 3 times a day. All osteoarthritis sufferers using Voltaren Emulgel could be in deadly danger etc.
As it's not the Nicotine that is contaminated but it's the PG, how can the FDA give this as the reason that E-cigs are not safe ? What about VG based Liquid. Are Vegetables contaminated as well ?
 

Vocalek

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But since tobacco has not been regulated up until now, is there any set limit on the % of DEG that would be permitted in a tobacco cigarette? Does anyone here know the total quantity of DEG, expressed as milliliters, that would be present in a full pack (20) of cigarettes? How does that compare to 0.01 ml? And actually, since the DEG was found in one of the Smoking Everywhere cartridges, that might actually be 0.005 ml or less. Didn't someone say those carts only hold 1/3 to 1/2 of a ml?

The phrase "toxic to humans" is misleading, since it implies that the substances is harmful, without regard to quantity. But "the dose makes the poison." All of us on a daily basis taken in thousands of potentially toxic substances, but in such minute quantities that they do not pose a danger to our health.

So how dangerous to human health was this quantity of DEG? I'm no scientist, so my calculations could be off, but I figured out that a 150-pound e-cigarette user would need to vaporize almost 2 liters of fluid in a single day to reach the dose that would cause illness.

It was irresponsible of FDA to throw out their statement about the DEG without providing a frame of reference regarding the quantity. Why no warning to consumers to restrict their consumption to fewer than 5,000 cartridges per day (or whatever the actual danger level might be) to avoid anti-freeze poisoning?

Reminds me of the arsenic in lipstick scare back in the 50s. The public actually learned what the toxic level would be. Women were warned by the media not to eat more than 20 tubes per day, if memory serves me correctly.
 
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