Donate to Dr Farsalinos' new study

[Jman8]

How do you know your steak isn't full of deadly poison or e-coli?

Short answer, you don't, nothing is 'certain'.

But we aren't talking about "full of deadly poison."

Instead, I liken this to finding out that of 150 steaks sampled from different vendors, 70% of them contain about 3 to 5 rat hairs, or at least that percentage when it comes to steak that has lots of marble on it, and thought to be lower if it has no marble. And then segment of steak consumer population insisting this needs to be corrected or eating steak could be considered ... really bad. Not even sure how to put that last part, as I imagine the people that do care about this diacetyl issue are still vaping products that they, in reality, don't 100% know if it is diacetyl free, so not sure how awful it is for these people to vape such products, even knowingly. Up to each individual I guess. Though steak analogy I just came up with is not all that great IMO, as rat hair isn't a naturally occurring by product in manufacturing of steaks. But was attempting to capture something that is teeny tiny addition while also being not wanted in final product for consumption.

 

[Kent C]

But we aren't talking about "full of deadly poison."

Instead, I liken this to finding out that of 150 steaks sampled from different vendors, 70% of them contain about 3 to 5 rat hairs, or at least that percentage when it comes to steak that has lots of marble on it, and thought to be lower if it has no marble. And then segment of steak consumer population insisting this needs to be corrected or eating steak could be considered ... really bad. Not even sure how to put that last part, as I imagine the people that do care about this diacetyl issue are still vaping products that they, in reality, don't 100% know if it is diacetyl free, so not sure how awful it is for these people to vape such products, even knowingly. Up to each individual I guess. Though steak analogy I just came up with is not all that great IMO, as rat hair isn't a naturally occurring by product in manufacturing of steaks. But was attempting to capture something that is teeny tiny addition while also being not wanted in final product for consumption.

How Much Rodent Filth Does the FDA Allow? | Mental Floss

Because of the way foods are mass harvested, factory processed and packaged in the States, the FDA has to allow food companies to include a certain number of “defects” in the final products. The term “defects,” we learned, is code for the inclusion of “foreign matter” in canned and packaged foods, including insects, insect parts, rodent hairs, larvae, rodent poop, mammal poop, bone material, mold, rust, and cigarette butts. These “defects” are not dangerous in the quantities they’re allowed, the FDA says, but still: what was that about ignorance and bliss?

 

[Jman8]

The term “defects,” we learned, is code for the inclusion of “foreign matter” in canned and packaged foods, including insects, insect parts, rodent hairs, larvae, rodent poop, mammal poop, bone material, mold, rust, and cigarette butts. These “defects” are not dangerous in the quantities they’re allowed, the FDA says

...or nothing that a little diacetyl can't take care of.

 

[rurwin]

But there does seem to be an officially allowed amount of diacetyl in eliquid. That would be the "NIOSH-defined safety limits" of 60μg per day that Dr F references. (20μg/ml assuming 3ml daily consumption.)

So the analogy would be that your steak contains over twice, sometimes ten times and occasionally a hundred times the allowed amount of "insects, insect parts, rodent hairs, larvae, rodent poop, mammal poop, bone material, mold, rust, and cigarette butts." Would you find that acceptable risk?

 

[Oliver]

Here's the issue. Diacetyl appears to be in a huge variety of flavors, even ones not obviously "creamy". It seems to me that diacetyl's function is something like MSG - it's a "flavor enhancer", and the issue is all the more insidious because of it.

Furthermore, diacetyl tastes good and vapers love it (although probably, in the main, don't know that it's a troubling compound or, even, that it exists).

I don't like it being described as a "contaminant", because it's not a contaminant in any real sense. It's an ingredient - it's there for a reason, either because it was added to the flavoring, or because it was extracted and exists as a natural component in the flavor extracts and those extracts were added. Ignorance is not a reason to describe diketones as "contaminants"

Either way, it's being added on purpose (with or without knowledge) to eliquid by manufacturers, and accordingly those manufacturers need to be held responsible.

Here's the meta issue for me: as others have said, it's likely to be far less dangerous than smoking, so we can still speak of reduced harm. And the fact is, it contributes to the pleasure of the product. the Clive Bates equation says the following:

Harm reduction (population level) = Reduced harm (in the product) * the number of people using the product (preferably full substitution).

Anything that reduces pleasure will reduce the second part of the equation or, as Clive says: "What's the point in a perfectly safe but bland product which no-one wants to use?"

So, my overall view is that there's a relative range of risk within the vaping category itself (although impossible to quantify). This includes formaldehyde generation at higher temps. Vapers starting out may require the most pleasurable vapes to distance themselves from smoking, but choose to move to safer device/liquids for long-term use.

This relates to my Proximity Principal, which I've been pimping out to anyone that will listen. I've had positive feedback on it so far - quite simply, the closer a vaper is to their former smoking behaviour, the more they think about safety in relative terms. The longer a vaper uses the products, the more they think about safety (proviso: they have to have doubts about the absolute safety of vaping).

In terms of the overall commercial pressure on manufacturers, in a rapidly expanding market there is huge pressure to cater to the needs of new vapers - those of us who have been vaping for 3/4 years are (by my estimations) less than 20% of the overall market.

 

[Oliver]

By the way, there was an interesting exchange of views between Drs Polosa and Farsalinos and the Global Forum on Nicotine in Warsaw a couple of weeks back.

Dr. F had been talking about the overall problem with the samples he'd tested, and Polosa made the point that the vast majority contained less Diacetyl than cigarette smoke, and that bronchiolitis obliterans is not a disease associated with smoking.

Farsalinos countered that smokers do develop COPD and that COPD is a complex disorder of uncertain aetiology and that diactyl may well be a contributing factor.

I'd further note that diacetyl in the form delivered by ecigs is much more similar to that which the popcorn workers were exposed to, in that it is not oxidised. I don't know how relevant that point is, but it's worth keeping in mind.

 

[Racehorse]

Can you think of a current eLiquid around, including no nic stuff, that is highly safe for everyone to vape it? And I'm feeling confident that we currently understand that no type of eLiquid is harmless, or at best we don't know.

You need to stop moving for a moment, Jman, and listen to what has been said to you.

As has been pointed out to you, numerous times, we are talking about AVOIDABLE risk here.

You do understand what that means, right? I ask because you keep coming back with the same dance or new dances, when everybody has already understood the difference between avoidable risk and "at best we don't know."

Where it concerns AP, DA, etc. we do know. It doesn't have to be in eliquid, and it is considered an inhalation risk.

I'm done talking to you about this part. You don't seem to want to make very simple distinctions. Either you are not willing to slow down long enough to absorb that, or you just like to argue on and on. I'm not the only person who has mentioned to you that its an avoidable risk.

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None of this is insurmountable rocket science. Flavoring manufacturers traditionally supplied product for food / injestion. They have access to lab and testing facilities.

Any flavoring manufacturer who wants to sell to the vaping industry needs to separate out a line of products. Some already have moved in that direction.

Eliquid vendors need to educate themselves on "not safe for vaping" flavorings, and everybody just needs to get on the same page.

 

[squee]

Just gonna throw this into the mix

Diacetyl and 2,3-pentanedione exposures ...... [Crit Rev Toxicol. 2014] - PubMed - NCBI

Diacetyl and 2,3-pentanedione exposures associated with cigarette smoking: implications for risk assessment of food and flavoring workers.

Abstract

Diacetyl and 2,3-pentanedione inhalation have been suggested as causes of severe respiratory disease, including bronchiolitis obliterans, in food/flavoring manufacturing workers. Both compounds are present in many food items, tobacco, and other consumer products, but estimates of exposures associated with the use of these goods are scant. A study was conducted to characterize exposures to diacetyl and 2,3-pentanedione associated with cigarette smoking. The yields (μg/cigarette) of diacetyl and 2,3-pentanedione in mainstream (MS) cigarette smoke were evaluated for six tobacco products under three smoking regimens (ISO, Massachusetts Department of Public Health, and Health Canada Intense) using a standard smoking machine. Mean diacetyl concentrations in MS smoke ranged from 250 to 361 ppm for all tobacco products and smoking regimens, and mean cumulative exposures associated with 1 pack-year ranged from 1.1 to 1.9 ppm-years. Mean 2,3-pentanedione concentrations in MS smoke ranged from 32.2 to 50.1 ppm, and mean cumulative exposures associated with 1 pack-year ranged from 0.14 to 0.26 ppm-years. We found that diacetyl and 2,3-pentanedione exposures from cigarette smoking far exceed occupational exposures for most food/flavoring workers who smoke. This suggests that previous claims of a significant exposure-response relationship between diacetyl inhalation and respiratory disease in food/flavoring workers were confounded, because none of the investigations considered or quantified the non-occupational diacetyl exposure from cigarette smoke, yet all of the cohorts evaluated had considerable smoking histories. Further, because smoking has not been shown to be a risk factor for bronchiolitis obliterans, our findings are inconsistent with claims that diacetyl and/or 2,3-pentanedione exposure are risk factors for this disease.

 

[Mr.Mann]

Just gonna throw this into the mix

Diacetyl and 2,3-pentanedione exposures ...... [Crit Rev Toxicol. 2014] - PubMed - NCBI

This has already been addressed. See SmokeyJoe's post #226 and Dr.F's post #152.

 

[Jman8]

You need to stop moving for a moment, Jman, and listen to what has been said to you.

As has been pointed out to you, numerous times, we are talking about AVOIDABLE risk here.

You do understand what that means, right? I ask because you keep coming back with the same dance or new dances, when everybody has already understood the difference between avoidable risk and "at best we don't know."

I'd actually like to have you explain it. I do understand it, but am likely filtering it in different way than you are and believe my understanding is found in previous (or recent) posts by me on this thread.

I will just note that for me, common sense measure for avoidable risk is to stop the activity that contains the risk, if that risk is considered significant (to particular people).

And would like to note that overcoming one avoidable risk, could manifest another risk via new additive designed to accomplish what first component was serving. Or, as SmokeyJoe was conveying, could lead to bland products or even ones that are no longer as appealing to certain segment of vapers.

Where it concerns AP, DA, etc. we do know. It doesn't have to be in eliquid, and it is considered an inhalation risk.

I'm done talking to you about this part. You don't seem to want to make very simple distinctions. Either you are not willing to slow down long enough to absorb that, or you just like to argue on and on. I'm not the only person who has mentioned to you that its an avoidable risk.

And what I find you and all others thus far not speaking to is how costly the avoidable risk will actually be, and what benefit will actually result? Will eliminating this risk while maintaining same benefit that the ingredient performs, mean another avoidable risk is present but currently 'unknown' as to any linked adverse health effects? IMO, the reasonable answer to that is "yes, likely" but common sense answer is, "we just don't know, right now."

None of this is insurmountable rocket science. Flavoring manufacturers traditionally supplied product for food / injestion. They have access to lab and testing facilities.

Any flavoring manufacturer who wants to sell to the vaping industry needs to separate out a line of products. Some already have moved in that direction.

Eliquid vendors need to educate themselves on "not safe for vaping" flavorings, and everybody just needs to get on the same page.

I would agree that none of this is insurmountable rocket science.

But again, my point is if consumer wants to be in the know, consumer will gain access to lab testing, or will not actually be in the know, and base purchasing decision on credibility (or faith).

The "not safe for vaping" claim seems incredibly loaded. I'd love if you clarified what you mean there.

------------

I will admit that I may be spinning in a direction in this thread that others are not. I think that direction is highly relevant to the issue of "vaping safety" and economics within the market.

I strongly believe that so far in this thread, the 'correction of this problem' is being greatly minimized and offering nothing but, "it can be done, so let's all do it." I think it becomes a very tricky political issue for the consumer/end user and one that I think could come up again in similar form with any other ingredient in eLiquid.

If, let's say vaping diacetyl is different than what is received via smoking, while end user may perceive it as exact same (both cases of inhaling the ingredient), but is instead 'vastly different' - then I would wonder how the same is not true for nicotine? Vaping nicotine and smoking nicotine may be thought of as the same, but may have vastly different effects on users.

Hence, all the comparisons to smoking could arguably go out the window and be treated as vastly different. I currently think of them as nearly the same. I currently reason that vaping diacetyl is trivial for persons (ex-smokers) that perhaps went through years, if not decades, of inhaling this ingredient at levels far greater than what is received through vaping.

 

[rurwin]

I've been chatting to Tom Pruen of ECITA, and he pointed me at an interesting document.

http://ec.europa.eu/social/BlobServlet?docId=6511&langId=en

It seems that the EU Occupational Exposure Limit is four times the NIOSH limit. There is still some confusion about how Dr. F converted 5 ppb in room air into a 60μg daily limit, unless there's a NIOSH limit I'm not seeing.

But if we assume the EU limit, and being in the EU I can feel free to do that, and if we assume that NIOSH is at least consistent, then Dr Farsalinos's results are that the liquids average half of the safe maximum. Which is more comfortable than saying they average twice the safe level. On the other hand, some liquids will exceed the limits, and I would be more happy if we used a "unexpected exposure" limit rather than an "occupational exposure" one.

 

[Jman8]

the liquids average half of the safe maximum.

Still not trivial?

I would be more happy if we used a "unexpected exposure" limit rather than an "occupational exposure" one.

Do you mean when "we" consumers are doing our own individual studies to be sure we are vaping within safe limits?

 

[KFarsalinos]

Dr.F, I ask this respectfully, but can you explain to me why the previous test on the cytotoxicity of some tobacco eliquid posted who and what was tested but this one does not?

When the "cinnamon scare" happened, it happened without any vendors being particularly attached to it, so it stands to reason that even providing a (what essentially amounts to) secrecy for vendors to not be outed won't stop any similar, albeit misguided, scare by those who do not want anything to do with these substances.

I personally don't see any vendors being irreparably hurt by this (by being specified), and if anything, all vendors now stand to be hurt by ~70% of sweet flavors being linked to diacetyl (though I bet it's much more targeted than merely "sweet"). But, as I alluded to earlier, for many vapers out there, they have already publicly stated that they couldn't care less about any amounts of diacetyl, no matter what any study says.

So it is my position that those that do care -- people like me who funded this and people who just care -- are the ones that will want to know specifics, but we will be the ones without what we want.

The vendors will get what they want -- to not be named.

Vapers who knowingly vape these flavors will get what they want -- no real incentive for those flavors to be pulled off the shelves.

Studies performed for the purpose of examining the end-effect of exposure (like the cytotoxicity study) are completely different from a study evaluating a component present in the e-liquid. In the cytotoxicity study the sample names were mentioned not in order to target anyone but only for the case someone wants to validate the results and the protocol we followed. By just mentioning e-liquids anonymously, none could do that because with every sample the results are different. Moreover, we associated the results with the method of flavor production rather than with the specific vendor.
For the cinammon study the names were mentioned but that does not matter much because cinnamon is a common flavor, and everyone uses cinnamaldehyde for this flavor. When we will publish a study comparing NETs with food-approved (or tobacco absolute) tobacco flavors we will also mention the names of the samples we tested.

In the diacetyl study, if we mention the names we will be targeting a small group of vendors which were chosen by us while there are thousands more with unknown results. It is of vital importance that every manufacturer addresses this issue through PROPER TESTING. If we mentioned the names, then we would have done what most vendors want. Because we tested 36 out of thousands of vendors currently in the market.

 

[KFarsalinos]

Yep, I misread that. Thanks for pointing it out.

So, then I guess I wonder how to make sure synthetically-produced natural flavors (which seems like any oxymoron to me) are diacetyl-free? I'll admit it sounds easy with just using words.

Also wondering, aren't the natural-extract juices usually the high-end 'gourmet' type?

Synthetically produced natural flavor means that you are making in the laboratory the same chemical that is providing the flavor to the natural product. E.g. vanillin is the natural chemical which gives the characteristic flavor to vanilla. You can make vanillin synthetically. It will be the exact same chemical, but made synthetically.

 

[awsum140]

Thank you for your study, Doctor. I would like to know if the published findings will include at least flavor descriptions, such as vanilla, caramel and various cream and fruit names as well. As a user of many different flavors it would aid in determining the potential, at least, for the presence of diacetyl.

 

[KFarsalinos]

I'll take another crack at what I said in vastly different way in post #201 (where I referenced Zeller).

Farsalino (et al.) is saying this is a problem of the magnitude of 2x the strict NIOSH-defined safety limits but 100 and 10 times lower compared to smoking respectively.

I fail to understand how this is not a trivial concern, or on par with formaldehyde data from before, and anti-freeze data before that. 100 times safer than tobacco truly ought to be good enough. I realize for some it is not. And that population of people (may be the majority) will make it so all the vendors have to change or forever deal with a problem that has taken a molehill and made it into Mt. Everest.

I can't even say this is science at work. Not if we are ignoring the perspective of what is said above, in bold. At that level, it is how we react and spin the data, and is why we now live in a world where "BT lied to us" is sound bite rhetoric that works for vast majority as if that is undeniable truth. IMO, this sort of study (regardless of who the researchers are) is setting up that sort of situation, likely indefinitely. Cause if they (vendors) were advertising "no diacetyl" and it is still present, then there really will never be a way for any consumer to be 100% certain that what they are vaping at any given moment is diacetyl-free. And keep in mind, this is just our side dealing with the data. So, rest of humanity will be basing all the information we are discussing, filtered through ANTZ perspective, some of which will be 'science based.'

I also think all of what's in eLiquid carries degree of harm with it. And I freely admit that is debatable, as magnitude of harm will be what determines how important that data is to each individual. But I predict that anyone that is a non-ANTZ researcher will continue to find vaping ingredients are as much as 100x safer than smoking those type of ingredients.

Let me clarify something. The issue here is not if diacetyl is present in e-liquids at levels 5 times or 50 times lower than cigarettes. Even 5 times lower would be enough in any other case. However, the issue of diacetyl is about an AVOIDABLE RISK. This is the key point. When we are talking about an avoidable risk, we should not accept any levels to be present. That is my opinion, and this is what i support in the paper.

 

[KFarsalinos]

Dr Farsalinos, I know you've been working with FlavourArt over the years, so I'm wondering if you can please tell me if their claim of their ClearStream line being acetyl, acetoin and diacetyl free can be believed?

thank you

The Clearstream studies had nothing to do with diacetyl and acetyl propionyl.

 

[KFarsalinos]

Not if "science is science."



That is entirely spin. And not one I strongly disagree with, but also not one that I can say is fully accurate. ANTZ stated purpose for charging $330,000 per product (or whatever the figure is) is to address / resolve questions that raise a concern toward public health.



Sounds pretty when you say it. Better positioning of eCigs as a result of this study is going to cost vendors some money. And is fueling the FDA claims that absolutely there is justification in federal research being conducted to ensure safety and address concerns of public health.

I don't have much of an issue with Dr. F.'s research, but with idea that this is an issue that I don't see how it could plausibly be resolved easily. It was already previously "resolved" and as this thread clearly shows, that even vendors may not know. So solution then is vendors must test what was conveyed to them as 'safe product.' Testing costs money. DA and AP aren't only things they'd be testing for, well not if they are playing the CYA game. So, positioning just became a huge added expense for a whole lot of vendors.

Then there is the fact that the consumer will never know for 100% certainty. How would you? Cause they said they did the tests? Welcome to 2011, come see me when you arrive at 2014, and we'll discuss this issue when you are up to speed.

First of all, why is it a problem that vendors should test their products? I have not seen a single industry not testing their products, why should the e-cigarette industry be the first one? Don't you think that some of the billion-dollars of this industry should go to testing?

Secondly, who said that vendors should do the testing? DA and AP are coming from flavors. Thus, the flavor-supplier should provide evidence that the flavors are DA and AP free. Of course, if they don't then it is the duty of the e-cigarette vendor to do the testing because they are providing the end-product to the user and they are responsible for it.

Of course, testing, consultation with experts, research etc cost money. E-cigarette devices and liquids cost money to consumers and provide profits to the vendors. Some of them should be invested on research and testing. It happens everywhere...

 

[KFarsalinos]

A final note. We presented the median values for diacetyl and acetyl propionyl exposure in the poster.
In the paper we additionally mention:
15% of the samples had >10times higher diacetyl levels than NIOSH limits, and a further 10% had >100times higher than the limits levels.

24% of the samples had >10times higher acetyl propionyl levels than NIOSH limits.

 

[Jman8]

Synthetically produced natural flavor means that you are making in the laboratory the same chemical that is providing the flavor to the natural product. E.g. vanillin is the natural chemical which gives the characteristic flavor to vanilla. You can make vanillin synthetically. It will be the exact same chemical, but made synthetically.

Thanks for the response, but wondering still if 'same chemical' would have same naturally occurring byproduct (diacetyl)? I'm thinking answer to that is no, but just leads to more questions (for me). All of which are either taking too much of your time and/or addressing my curiosities that continue to wonder if all this (synthetic) change is actually making vaping more safe.