Electronic Cigarettes: FDA Miscalculates Real Danger to Smokers

[KermieD]

That is incorrect. Again, it is to be assumed that this was part of a bad batch, as, historically, issues of mass poisoning due to DEG (remember the big toothpaste scare of a few years back? That was 6% concentration and people died just brushing their teeth and spitting it out) have traditionally been a result of DEG contamination being in what should have been pure glycerine. The same is true of any DEG found in analogs. It is not an ingredient. It is an aberration, not a normal occurrence. Glycerin is commonly used as a humectant in cigarettes, and any DEG would be the same situation as what I'm sure the FDA found in that one cartridge.

1% concentration of DEG in anything being inhaled is very serious stuff. If that were the norm for e-cigs, I would go back to analogs in a heartbeat. A 1% concentration in cigarettes would kill a pack a day smoker in a month. Period.

 

[kristin]

They must have been swallowing massive amounts of toothpaste. DEG is listed as low acute toxicity. Probable lethal dose to humans is 0.5-5 g/kg.

There is no way to tell how many grams/milligrams that 1% found by the FDA actually is, because they don't tell us the size of the cartridges tested.

There are numerous references to diethylene glycol and triethylene glycol being used as tobacco humectants - not by accident.

I'm sure if there was any DEG in electronic cigarettes that was in more than trace amounts, some of the millions of people regularly using them over the past 5 years would have either become seriously ill or died.

Either way, I made sure to include the actual amount of DEG found in the FDA report - I didn't just call it "trace." I didn't hide or misrepresent anything.

 

[KermieD]

Ok, you continue to miss the point in your defensiveness. I can SEE that you said 1%. They told you that up front in the study. However, you DID call it "traces" which is exactly the reason the FDA is going to kick our backsides in this lawsuit. Calling it "trace" while acknowledging the 1% is not hiding, as you correctly stated, but it IS casting spin on the finding (and very misleading spin at that), which is definitely misrepresenting. As much as we talk about them sweeping stuff under the rug, that's a perfect example served up to them about us doing the same.

I have given you the facts about DEG and the dangers of it, and it's NOT hard to look up and verify, and your assertions to the contrary do not change any of that. Yes, they did say how big the cartridge was that they found it in, because the specificially identified it as a SE 555 cartridge. And 1% is 1% regardless of volume because vapers will vape different amounts, so talking about how many mg it was is pointless. It was 1% of the volume. If you vape 30ml a week, that's .3 ml a week. If you vape 5ml a week, that's .05 ml a week of DEG. Size of the cart is pointless either way.

Your assertion that DEG is used in cigarettes as a humectant is ludicrous. They use the same thing juice makers do -- PG. On top of that, your assertion here that DEG is more prevalent than 1% in cigarettes is downright ignorant. The average king sized cigarette has 1.077g of tobacco. The average king sized cigarette has 3mg of humectant. Even if the tobacco company got an absolutely craptastic batch of PG that was, let's say a whole 10% DEG, you're talking about 0.3mg of DEG. Simple math (we'll round the tobacco down to 1g to make it easy and to give you the benefit of the doubt) lands you to the obvious math that the DEG in the worst case scenario cigarette is 0.03%.

This is exactly why the FDA is going to win the case. All we're doing is saying that it's too narrow a study, misrepresenting the dangers of what they actually DID find and not doing any science on our own. If you want to see how it's done and how it's done properly, take a look at the lawsuit the National Association of Rocetry and the Tripoli Rocketry Association took down the BATFE in court, even post 9/11. And, with a much smaller user base than exist in the e-cigarette business.

You will not win this case either in court or in the court of public opinion by misrepresenting facts and countering corrections with defensiveness and further misrepresentation. I am not trying to bring this out as a personal attack but as a heads up that well written stories that try to dismiss actual experimental findings by using terms like "trace" to describe toxic levels. Until someone gets their act together and contracts an independent lab to do some studies that show any data that specifically refutes the FDA's findings and not just some smoke and mirrors arguments, this is over already.

The clinical effects of DEG poisoning can be divided into three stages: The first phase consists of gastrointestinal symptoms with evidence of inebriation and developing metabolic acidosis. If poisoning is pronounced, patients can progress to a second phase with more severe metabolic acidosis and evidence of emerging renal injury, which, in the absence of appropriate supportive care, can lead to death. If patients are stabilized, they may then enter the final phase with various delayed neuropathies and other neurological effects, sometimes fatal. Toxicity of DEG. Doses of DEG necessary to cause human morbidity and mortality are not well established. They are based predominantly on reports following some epidemics of mass poisonings, which may underestimate toxicity. The mean estimated fatal dose in an adult has been defined as ∼1 mL/kg of pure DEG.

Diethylene glycol poisoning - Clinical Toxicology

Now, perhaps my assertion that 1% would kill you in a month was a bit of an exaggeration, but as I see people talk about their vaping habits, you're still talking about less than a year to kill some vapers here if they smoke purely off a bad batch , and note that the abstract states that that amount is based on factors that UNDERSTATE the toxicity.

 

[KermieD]

The fact here is that what should be said is "yes, this is concerning and it is a quality control issue, but we have formed industry organizations that are in the process of taking steps to institute quality control standards that will be as effective if not more so than governmental oversight will accomplish", not "oh, 1% is just a trace amount" when it's very clearly a serious potential hazard.

 

[kristin]

You're absolutely right. I did get defensive about being called irresponsible. I felt I still was being responsible by giving the actual amount - letting people decide for themselves.

Seriously, I have found many references to diethylene glycol and triethylene glycol use as "a humectant in tobacco." I wouldn't just make it up, I promise. I know that propelyne glycol is primarily used.

I don't know if I understand that 1% is the same amount regardless of the amount? If you consume 2oz of liquid, 1% would be .2 ounces of DEG you'd be consuming. If you use 10oz of at 1% you'd be consuming 1.0 ounce of DEG. So the amount DOES make a difference in what you're actual intake is - that's how I was looking at it. Those kids consumed 5 oz tubes of toothpaste at 6%.

I don't know how much liquid is in a Smoking Everywhere 555 cartridge? The FDA listed the Nicotrol amount as 10ml, but not how many ml was in the e-cig cart.

I saw one tobacco report that the weight of a cigarette is as much as 5% humectants. Who knows how much of that is DEG? I think we can agree, though, that there are a lot of other things in the tobacco that is much, much worse - arsenic, ammonia, etc!

I completely agree that it's a quality control issue that should be definitely be addressed - I even endorse setting manufacturing standards later in the article. So, I guess I felt the "irresponsible" remark was a bit harsh, considering.

 

[kristin]

From that link:

"The mean estimated fatal dose in an adult has been defined as ∼1 mL/kg of pure DEG."

A cart is what, .25ml at most of liquid? (It takes me over a month to use up 30ml of liquid, using about 3-4 carts per day.) That means the 1% DEG found would be about .0025ml of DEG per cart? So, you'd have to vape about 400 carts to get 1ml of DEG?

I'm not so good at math, lol! I may be figuring this wrong...

 

[ZorbaTheGreek]

The mean estimated fatal dose in an adult has been defined as ∼1 mL/kg of pure DEG.

So, at 1%, I'd need to smoke about 1,000ml of juice before the DG can be removed from my system before I'd reach toxic levels. Right? And the toxicity for nicotine is actually higher, at 3.4mg/kg, so I should stop buying juice with nicotine in it too? 1% is high, too high, but the consumption rate is low, high end of what, a few ml a day? Maybe 10? So at a very high consumption rate, 10ml a day (taking in potentially 0.1ml DEG a day), you'd have ~1000 days, give or take, before you reach toxic levels. I'm not sure how much/how quickly it leaves your system, or even sure it does. But I'm just curious if your alarm is entirely deserved. Not trying to flame, and correct me if I'm wrong anywhere here. Just saying what I've found in my own research is that even 1%, it would be very hard to reach toxic levels.

 

[kristin]

Yes, I'd be curious to know how fast the body eliminates the DEG or if it can actually build up over time.

 

[KermieD]

I think you would be hard pressed to find an article about DEG being used as a humectant outside of an anti-tobacco activist site or someone using their data from such a site, and even then, you'll find that they will seldom go any farther than saying that DEG is a component of the humectant.

When I say it doesn't matter how big the cart is, I'm just saying that 1% is 1%. If you go through 30ml a month, you get 0.3 ml a month of DEG in that scenario. If you go through 60 in a month, you get 0.6ml a month.

Again, you will probably come to the conclusion that you'll never vape enough DEG to kill you, but that would still ignore the potential for extensive permanent damage at lower levels and the fact that you're inhaling rather than ingesting and digesting.

An important thing to consider here before we try to sweep an 1% concentration of DEG under the rug as a trace amount is that, gram for gram, DEG has a higher mean fatal toxicity level than arsenic. If you told me that something that contained a full percentage point of arsenic in it was okay or better for you than, say, a cigarette, you'd lose any and all credibility in my eyes.

Again, perhaps "irresponsible" is too strong a word and I apologize for opening with that term, but it's incorrect to try to sweep a 1% concentration of DEG under the carpet by calling it a "trace" amount, implying that it's irrelevant.

 

[KermieD]

So, at 1%, I'd need to smoke about 1,000ml of juice before the DG can be removed from my system before I'd reach toxic levels. Right? And the toxicity for nicotine is actually higher, at 3.4mg/kg, so I should stop buying juice with nicotine in it too? 1% is high, too high, but the consumption rate is low, high end of what, a few ml a day? Maybe 10? So at a very high consumption rate, 10ml a day (taking in potentially 0.1ml DEG a day), you'd have ~1000 days, give or take, before you reach toxic levels. I'm not sure how much/how quickly it leaves your system, or even sure it does. But I'm just curious if your alarm is entirely deserved. Not trying to flame, and correct me if I'm wrong anywhere here. Just saying what I've found in my own research is that even 1%, it would be very hard to reach toxic levels.

3.4mg/kg would be a lower toxicity than 1mg/kg.

 

[KermieD]

Yes, I'd be curious to know how fast the body eliminates the DEG or if it can actually build up over time.

Looking at news stories in the past, again going back to the contaminated toothpaste, cosmetics and other news stories over the last decade or so, I would have to surmise that it does build up over time. It would have to be secreted/excreted at some point in time as it's almost impossible to purify any glycol to where it doesn't have DEG in it in truly tiny amounts, but with many of the mass poisoning stories out there, it appears that it can build up to some degree.

 

[ZorbaTheGreek]

3.4mg/kg would be a lower toxicity than 1mg/kg.

I used your 1mg/kg for my examples of how long it would take to reach toxic levels from vaping. But MSDS have it's toxicity much higher than 1mg/kg.

Probable lethal dose to humans is 0.5-5 g/kg.

Approximate. Lethal Dose, Human, adult 2 Ounces

(56grams, assuming a weight of 100kg, 1.7g/kg)
I'd post the URLs for these but apparently haven't hit 15 posts still. Just google Diethylene glycol msds. I'm not sure why your information is so different from two similar MSDS. But at any rate, from your own information on another question...

Metabolism occurs principally in the liver and both the parent and the metabolite, 2-hydroxyethoxyacetic acid (HEAA), are renally eliminated rapidly.

So once it is metabolized, it and it's products leave the system rapidly is how I'd read this. Making poisoning from vaping pretty near an impossibility, even at high estimates of contamination, consumption, and toxicity.

 

[ZorbaTheGreek]

An important thing to consider here before we try to sweep an 1% concentration of DEG under the rug as a trace amount is that, gram for gram, DEG has a higher mean fatal toxicity level than arsenic. If you told me that something that contained a full percentage point of arsenic in it was okay or better for you than, say, a cigarette, you'd lose any and all credibility in my eyes.

You do have to look at consumption though. Flu vaccines have mercury in them. Do you not get vaccines? People smoke 20+ cigarettes a day easy. If that 1% contaminated arsenic item lowered my consumption of toxins daily, it would be an improvement still. With ecigs you are vaporizing maybe 2-3 mg a day of chemicals. While each cig is about 1g.

 

[KermieD]

Zorba, you're extrapolating things that aren't part of this conversation and you're not paying attention to the statements that are being made.

Let me try to put this into perspective. You would have to smoke thousands of cigarettes in a day to get the level of DEG that you would get out of smoking the one cartridge they tested. Improvement? No. Not in a million years. Again, it has to be assumed they got one off of a batch where there were some QA issues with the PG production, but you couldn't be more wrong by saying that vaping that cartridge was better for you than 50 cartons of cigarettes.

 

[ZorbaTheGreek]

And you would have to smoke an infinite number of ecigs to get the Acetone, Ammonia, Arsenic, Benzene, Lead, Turpentine, and ~400 other toxins and carcinogens in cigarette smoke. It has more DEG, yes. But relatively, the DEG is in still low enough amounts to be relatively safe it seems. And vastly safer than the alternative. Where you are treated to a small dose of DEG, and huge doses of hundreds of carcinogens and toxins.

I realize your objection was to the use of the word trace amounts. And I see your point, 1% is too high. The FDA allows 0.2% DEG contamination in products containing PG. QC needs to be there. And I'm all for that obviously. But the biggest contamination point that the FDA has, is very low risk indeed from what I can tell.

Let me try to put this into perspective. You would have to smoke thousands of cigarettes in a day to get the level of DEG that you would get out of smoking the one cartridge they tested.

And I'm still not sure this is even correct. The PG used as a humectant is about 5% by weight of the cig. 1g cig = 50mg humectant. At "safe" levels of DEG contamination (0.2%) that's 0.1mg DEG per cig. So one full 10ml bottle of juice would have about as much DEG as a single cigarette.

*edit* I don't recall where I heard the 5% humectant number, couldn't find it again. looking at the numbers though 50mg seems like way too much for a single cig. I'm not sure what I'm missing, but I'm just throwing it out there that my math seems off. By weight, do you consume 10x in a cig compared to vaping? 20x? 40x? It's pretty high. I think a reasonable estimate for consumption is about 0.5-1ml a day liquid. Most of the chemicals discussed in eliquid have a very close to 1:1 mg/ml density. So you're consuming about 1mg a day. Ok, was late and I was way stupid there 1g/1ml Sounds allot more correct. So Try again.

The 0.1mg per cig is still correct, since it was using weight the entire time. For the liquid 1% of 10ml, 0.1ml is close to 100mg. Much higher than I thought So a full 10ml bottle would have as much DEG as 1000 cigs. That's definitely higher. But buy how much? I can't speak for others, but 10 drops in my m401, lasts me about a day and a half. I'm not that heavy a vaper, I realize that, just the data I'm going to use. 10 drops would be about 0.5ml 5% of the bottle, 5% of 100mg of the DEG. 5mg DEG every 1.5 days. If I smoked a pack a day, at "normal, safe" contamination levels, I would get 3mg every 1.5 days. So worse than cigs, assuming constant 0.2% contamination in cigarettes. But still, not enough to be lethal since DEG leaves your system fairly quickly.

The major hazard from diethylene glycol occurs following the ingestion of relatively large single doses...105 fatalities among 353 people who ingested a solution of sulfanilamide in an aqueous mixture containing 72% diethylene glycol.

But!

Rats and mice exposed to diethylene glycol at 5 mg/m3 for 3-7 months showed structural changes in CNS and endocrine and internal organs along with other pathological effects.

It does have it's dangers if consistently exposed. But even at the 5mg every 1.5 days. It's not very close to the 5mg/m3 administered here. Or even to the lower toxicity numbers found at 1mg/m3.

I hope someone is as interested in this as I am

 

[kristin]

I think you would be hard pressed to find an article about DEG being used as a humectant outside of an anti-tobacco activist site or someone using their data from such a site, and even then, you'll find that they will seldom go any farther than saying that DEG is a component of the humectant.

I agree, it seems that most of the sources of it being in great amounts as a humectant come mostly from e-cig sites - I should have researched it more. DEG most commonly occurs as a by-product of other glycols. However, there are easily found non-ecig & anti-tobacco sites that list it as a tobacco humectant - not just a by product. It was used more commonly in the past and now propylene glycol is mostly used in US processing. I found it being listed as an actual "use" for it, though, on a few non-ecig & anti-cig sites and in a few publications. Just google "diethylene glycol + tobacco humectant"

When I say it doesn't matter how big the cart is, I'm just saying that 1% is 1%. If you go through 30ml a month, you get 0.3 ml a month of DEG in that scenario. If you go through 60 in a month, you get 0.6ml a month.

Again, you will probably come to the conclusion that you'll never vape enough DEG to kill you, but that would still ignore the potential for extensive permanent damage at lower levels and the fact that you're inhaling rather than ingesting and digesting.

This report seems to indicate that ingestion has the highest potential for toxicity: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_139.pdf

That's an overall interesting report.

The same reasoning could be used with a lot of products. Just about everything has something in it that could kill you in greater amounts.

From my understanding, the belief is that the DEG came from nicotine that was extracted from tobacco containing the DEG. How else would it have gotten in there? I'm guessing that China still uses DEG as a tobacco humectant?

I didn't see any references to extensive damage caused at lower levels of DEG exposure in a healthy adult? Can you point to that reference? Don't take offense that I want to see for myself - taking people's word for it got me into this in the first place! LOL

Again, perhaps "irresponsible" is too strong a word and I apologize for opening with that term, but it's incorrect to try to sweep a 1% concentration of DEG under the carpet by calling it a "trace" amount, implying that it's irrelevant.

I appreciate that. I did misunderstand what the term "trace" meant. I thought it was just a small percentage, but I looked it up and it means more like "too small to be measured." I'm glad, in that sense, that I did actually list the amount, rather than just call it a trace amount and leave it at that.

But I wasn't trying to sweep anything under the rug, I assure you. .0025ml of a substance that is toxic at 1.0ml is not as deadly as some would make it out to be and therefore, not as relevant, IMO, as all of the other toxins that ARE in tobacco cigarettes. If we were talking about .1ml of DEG per cartridge, that'd be different. People can decide if .0025ml of DEG is an acceptable risk for them vs. the high concentrations of other toxins and carcinogens in tobacco cigarettes. (Especially since it wasn't found in the majority of the liquid tested - just one cartridge.)

Ethylene glygol - same family & more toxic than DEG - is determined not to build up in the body and is no longer detected after 2 days: http://des.nh.gov/organization/commissioner/pip/factsheets/ard/documents/ard-ehp-12.pdf

To me, personally, .0025% of the 1.0ml it would take to be deadly is the same as a trace amount, because it's not much more than a trace, when you look at how much it would take to kill you and how little of it you consume at a time. But that is my own personal decision and isn't that is what this is all about - choice?

I'm all for reporting the truth.

 

[lotus14]

Yes, I'd be curious to know how fast the body eliminates the DEG or if it can actually build up over time.

I'm not curious in the least. I want liquid that is certified to have NO DEG in it. The FDA only tested a few samples, so we say bleh, they should have tested more samples. It was an aberration. And it was only a "small amount."

Well, they did only test a few samples. How do I know my this bottle of 555 I'm currently vaping - and smugly thinking I know what's good for me and the FDA are a bunch of idiots - doesn't contain 5% DEG? And what else might be in it that wasn't found in the FDA samples? I don't know. No one knows. That's the problem and it a huge one.

Until the manufacturers step up to the plate with independent lab studies done on an ongoing basis the FDA and every vaper should be concerned.

Excuse my while I refill my cart with...um..well damn, it tastes good!

BTW, overall an excellent article kristin, as always. Please keep up the good work on our behalf. Much appreciated.

 

[kristin]

I'm not curious in the least. I want liquid that is certified to have NO DEG in it. The FDA only tested a few samples, so we say bleh, they should have tested more samples. It was an aberration. And it was only a "small amount."

Very good point, Lotus. I would want that as well - why I'm all for regulation of handling and purity of ingredients. I want bottles clearly labeled with ALL ingredients and safe handling & packaging. Just as any other manufacturing plant has to have certain standards, so should e-cig liquid manufacturing. They should be subject to random testing, like everyone else, to show that what they claim is in their liquid is true! No need to have byproducts and unsafe chemicals in the liquid that are easily avoidable!!

I guess most of that argument came from the fact that most of us were using a product that had dozens of bad toxins and carcinogens (tobacco smoke) and the huge uproar over ONE toxin seemed overkill & a scare tactic. To a lot of people, it's a (much) lesser of two evils, if that's even the case.

Personally, if it were impossible to make e-liquid without the .001ml of DEG and DEG doesn't build up in the body and cause harm at that level, I'd still take that over the 50% chance of death with cigarettes.

But we know it's possible to make e-liquid without DEG, so it's unacceptable. It does show that they need to be regulated - but not BANNED, like so many call for because of the DEG.

 

[umop apisdn]

Thanks everyone! Got to get the positive PR!

PR's definition (the one given when hovering on it) completely makes sense now. lqtm... Thank you.

 

[jerrydon10]

Did the FDA not find DEG in just one of 17 cartridges tested? If so, then if I vaped all 17 carts you can divide that 1 % by 17. That's a trace amount.

Also, how many other labs found DEG in the product. Not one.

This DEG thingy is in short: simply Bull****.