FDA Could the FDA really regulate E-Liquid??

[LaraC]

My post in another thread (the sticky to donate to the flavors study fund.)

Vapers Place - Show Schedule and Replays

click: VP Live - Smoke Free Radio Episode 3 and move over to the 1:21:30 mark.

At 1:21:30 Dimitri begins discussing his interview with Dr. Farsalino regarding the doctor's recent flavor study.

The voices:

James says:
"One of the things we need to keep in mind here is we're talking about something that's inhalable..."

Dimitri says:
"Let me start off by saying how this study got started. For those of you who don't know, Dr. Farsalino was doing a study on NETs. For people who don't know what NETs are... "

My note: It's very important to listen to the background Dimitri gives about Dr. Farsalino's older NETs study. This leads up to the discussion with Dr. Farsalino on his preliminary report of his most recent study - chemical analysis of a large sampling of today's flavored e-liquids.

Dimitri's interview with Dr. Farsalino begins at 1:23:36.

The two undesirable ingredients found in quite a few of the flavor samples are:
diacetyl and acetyl propionyl

An interesting excerpt beginning at 1:26:35

Dr. Farsalino: Now, I'm not accusing the vendors. I think there was a big mistake in the strategy. And this mistake started from 2010. The mistake was that when the issue of diacetyl came up, basically business, every vendor just asked his flavoring supplier whether the liquid, the flavorings, had diacetyl or not. And they just accepted an oral response or a phone response that, 'No, our flavorings are diacetyl free.' They didn't ever ask for proof that they are diacetyl free, which means the result [inaudible] (sounded like "is questioned.")

Dimitri: No chemical studies or... [inaudible]

Dr. Farsalino: No chemicals analysis to make sure that the liquid is diacetyl free. And I think that was the problem. It's not that the vendors knew that the liquids were containing diacetyl and they just tried to hide it. It's basically that the vendors didn't even know it."

Dimitri: And obviously the vendors didn't do the testing themselves as well...

Dr. Farsalino: Exactly.

Dimitri: ... on the flavors. They basically went on the word of the flavoring company. They didn't test it. The vendors themselves didn't test it. They began mixing, thinking they had a safe ingredient.

Dr. Farsalino: Although in my opinion I think that it's the job of the flavoring supplier to do the test. The problem is that the e-cigarette vendors are the ones who are marketing the products. So, at the end it's their responsibility towards the consumers.

 

[Jman8]

Dr. Farsalino: Although in my opinion I think that it's the job of the flavoring supplier to do the test. The problem is that the e-cigarette vendors are the ones who are marketing the products. So, at the end it's their responsibility towards the consumers.

I think this opinion will end up being pervasive, that vendors/manufacturers ought to take on all costs to ensure quality. Which in reality means consumers will take on that cost, or business won't be around for the long term.

But if it is really a responsibility towards the consumers, then realistically consumers ought to have vast majority of say in how quality and regulations work. So, if intermediary, such as FDA, wants to be in that process, then they ought to bear costs (which comes from taxpayers), and so not all costs ought to come from vendors. Otherwise, FDA isn't really necessary. Likewise, if entirely left up to consumers, then while there are likely to be some consumers that demand quality ingredients and methods / environment for mixing, there will also be ones that realize that comes with never ending inflated costs, and would instead be okay with little to no quality controls. Which, IMO, cannot be emphasized enough. And is why black market is now fully in play with way FDA is spinning the justification for regulations. If regulations are going to be costly (either to taxpayers or consumers), then it must be fully acknowledged that some consumers would rather participate in market that doesn't constantly seek to justify a refinement in quality and methods. Maybe I'm okay with vaping trace amounts of diacetyl. Ever consider that science?

IMO, just looking at how responsibility works with DIY, helps simplify what is really going on here.

 

[Gato del Jugo]

Besides, diacetyl (and thousands of much more dangerous chemicals) are also present in tobacco.

Determination of toxic carbonyl compounds in cigarette smoke - Fujioka - 2006 - Environmental Toxicology - Wiley Online Library

Thanks for posting that link, which has been floated around ECF before.. Saves me the trouble of finding it myself, too


All 15 major brands of traditional cigarettes tested in that study found that their smoke contained fair amounts of diacetyl.. In other words, diacetyl is nothing new to our lungs.. Why aren't all these cig smokers walking around with "popcorn lung"? And arguably one could have gotten a lot more diacetyl from smoking than from vaping, depending on all sorts of variables...


Not trying to brush off the diacetyl thing, but vaping is believed to be harm-reduction -- not harm-elimination..

How much reduction has always been the question.. But isn't any overall reduction better than no reduction?


Obviously anti-e-cig groups will jump all over this, and probably try to be used against us in the fight with the FDA...

 

[Kent C]

Besides, diacetyl (and thousands of much more dangerous chemicals) are also present in tobacco.

Determination of toxic carbonyl compounds in cigarette smoke - Fujioka - 2006 - Environmental Toxicology - Wiley Online Library

Maybe we can use it to show 'Substantial Equivalence'

 

[Kent C]

If we were dealing with objective media, the Dr. F. thing wouldn't be a big deal. To me, the news isn't a big deal cause product is still relatively harmless. But as you noted, ANTZ/mainstream media is going to treat diacetyl (that appear in eCigs ONLY) as akin to the plague and run that story for all its worth.

Plus, the comments by Dr. F. that he is/was disappointed. That looks like bias, even while astute/objective observers would easily be able to note that he wasn't actually biased when it came to the science. Can't say that for ANTZ scientists, even with regards to traditional cigarettes.

I honestly expected news such as this back in 2012, that would be discovered by an objective scientist which shows some legitimate level of harm in eCigs, and then some degree of panic, even among vapers. All trying to downplay the relative harmlessness of the product. Get enough people to believe the negative hype and it is similar to what smokes have had to contend with in last 20 to 50 years.

Re: bold - that was my point. Look at what they've done with the trace formaldehyde in one carto in 2009. Or the DEG found in only one other. I could site other 'one time' examples some of which were user error.

 

[Katya]

A few thoughts:

1) Diacetyl is included in the FDA GRAS list. It was the vapers (like Kurt) who first raised the alarm that it may not be so benign when inhaled. The industry is trying to self-regulate.

2) Per Dr. Farsalinos, diacetyl (and other diketones) can easily be eliminated from e-liquids. It's added to eliquids. It's a non-issue.

3) The only potentially dangerous chemical that cannot be easily avoided is formaldehyde, because it forms in the process of heating the eliquids.

Formaldehyde release in ecigarette vapor The New York Times story explained in detail

We currently do not know whether the elevation in formaldehyde levels happens just at the time of dry puff phenomenon, or it happens earlier (before being detected by the vaper). Clearomizer-type atomizers (also called tank systems) seem to be the future in e-cigarette use, giving consumers the ability to know when they need to resupply the atomizer with liquid.

 

[zoiDman]

A few thoughts:

1) Diacetyl is included in the FDA GRAS list. It was the vapers (like Kurt) who first raised the alarm that it may not be so benign when inhaled. The industry is trying to self-regulate.

2) Per Dr. Farsalinos, diacetyl (and other diketones) can easily be eliminated from e-liquids. It's added to eliquids. It's a non-issue.

3) The only potentially dangerous chemical that cannot be easily avoided is formaldehyde, because it forms in the process of heating the eliquids.

Formaldehyde release in ecigarette vapor The New York Times story explained in detail

I like this portion...

The main criticism to this study is that in my opinion it is highly unlikely that a top-coil atomizer like the one used in this study would be used at 4.8 volts. At a resistance of 2.2 Ohms that would represent 10.4 watts of energy delivery to the atomizer. I tried 10 watts with an EVIC battery in a Vivi Nova top-coil atomizer (for a clinical study i perfomed few months ago), and many vapers were unable to use it due to the dry puff phenomenon. ...

 

[Roger_Lafayette]

Honestly, I don't see it a very bad news. I don't want harmful chemicals in my juice. I stopped vaping buttery/custard and cinnamon flavors a long time ago. I know that responsible vendors and flavoring manufacturers have been trying to remedy this problem for quite a while. Kurt wrote about dangers of diacetyl (acetyl propionyl, acetoin) and cinnamaldehyde at length and often (long before Dr. Farsalinos appeared on the scene).

We all know that the flavorings/colorings/additives/sweeteners are and will be a problem.

My main issue is with nicotine itself, frankly.

Just curious about why you bailed on the cinnamaldehyde flavors? I saw your post and decided to do some digging, because I do a lot of TFA red hot, and am about to order 4oz of the cinnamon spice which goes well w/ clove.

From everything I can find, the cinnamaldehyde issues are different - certain people have short-term reactions/sensitivities. But the kind of insidious long-term (and catastrophic) pathologies associated with diacetyl and the related items (acetyl propylene and acetoin) are not associated with cinnamon flavorings.

As far as I can tell, the rule with cinnamon seems to be - if you don't experience any problems after vaping it for a while, just keep on enjoying it. Kinda like eating peanut butter.

Comments?

 

[Katya]

It was a personal decision. The very first cinnamon-flavored e-liquid I tried in my early vaping days didn't agree with me (it was all the rage then it had a the word "cinnacide" in its name). Then Kurt confirmed that cinnamaldehyde in a known lung irritant:

http://www.e-cigarette-forum.com/fo...u-vape-cinnamon-flavors-read.html#post3906345

So I decided to stay away form cinnamon. Even though I like cinnamon and I use it in cooking. Clove is another flavor I can't vape. Just make sure your flavorings are water-soluble (oil-based flavorings are still a no-no, AFAIK).

But I believe you're correct--most people have no problems with cinnamon. Here's Dr. Farsalinos again:

Cinnamon flavours in e-cigarettes: how inappropriate research can misinform the public and the (amateur) professionals

 

[Roger_Lafayette]

Okay, so there are no long-term issues. I won't order any "custard notes" flavors from TFA or anything w/ acetoin. And my impression is that acetoin always exists if there's diacetyl and/or acetyl propionyl? (Thanks for the correct spelling Lara

This ECF thread implies that all fruit flavors are suspect, although I'm still vaping TFA mandarin orange and key lime ... not sure if I should: http://www.e-cigarette-forum.com/fo...s-may-contain-diacetyl-there-really-many.html

I steer clear of all the vanillas, bananas, and nuts. But not clear double chocolate. I also still do creme de methe and absinthe (which aren't listed there).

I would hate to be limited to tobacco and menthol *sigh*

BTW I don't order commercial e-liquids, we're just talking about flavorings.

It was a personal decision. The very first cinnamon-flavored e-liquid I tried in my early vaping days didn't agree with me (it was all the rage then it had a the word "cinnacide" in its name). Then Kurt confirmed that cinnamaldehyde in a known lung irritant:

http://www.e-cigarette-forum.com/fo...u-vape-cinnamon-flavors-read.html#post3906345

So I decided to stay away form cinnamon. Even though I like cinnamon and I use it in cooking. Clove is another flavor I can't vape. Just make sure your flavorings are water-soluble (oil-based flavorings are still a no-no, AFAIK).

But I believe you're correct--most people have no problems with cinnamon. Here's Dr. Farsalinos again:

Cinnamon flavours in e-cigarettes: how inappropriate research can misinform the public and the (amateur) professionals

 

[Katya]

Okay, so there are no long-term issues. I won't order any "custard notes" flavors from TFA or anything w/ acetoin. And my impression is that acetoin always exists if there's diacetyl and/or acetyl propionyl? (Thanks for the correct spelling Lara

This ECF thread implies that all fruit flavors are suspect, although I'm still vaping TFA mandarin orange and key lime ... not sure if I should: http://www.e-cigarette-forum.com/fo...s-may-contain-diacetyl-there-really-many.html

This list is much more extensive than I previously thought. I really believed that diacetyl (& acetyl proprionyl & acetoin) were only present in dairy/buttery/custard flavors...

That would explain why Dr. F found diacetyl in 69% of all eliquids tested... That's a bummer.

However, right now we seem to have a bigger problem:

http://www.e-cigarette-forum.com/fo...nate-e-cig-hearings-insist-they-unbiased.html

 

[Roger_Lafayette]

Well the poster used the word "may." And it refers to commercial e-liquids, not flavorings. I trust TFA to disclose acetoin, although after hearing about the Dr. F. study results, maybe I shouldn't.

This list is much more extensive than I previously thought. I really believed that diacetyl (& acetyl proprionyl & acetoin) were only present in dairy/buttery/custard flavors...

That would explain why Dr. F found diacetyl in 69% of all eliquids tested... That's a bummer.

However, right now we seem to have a bigger problem:

http://www.e-cigarette-forum.com/fo...nate-e-cig-hearings-insist-they-unbiased.html

 

[Stosh]

Before panic sets in, we need to wait to see the study, and the levels of <name your poison> in the e-liquid and in the vapor. Trace amounts of all sorts of bad things are delectable in commonly ingested or inhaled products.

Arsenic is easily recognized as a poison yet allowed in drinking water.....

EPA has set the arsenic standard for drinking water at .010 parts per million (10 parts per billion)

Arsenic in Drinking Water | Arsenic | US EPA

 

[grumpypathdoc]

I think this is the appropriate thread to post this on but anyone with more seniority wants to desiminate it more widely, please do. I've (hopefully) attached a link to a letter to the editor of the NYT by Margaret Hamburg, Commissioner of the Food and Drug Administration that seems to clarify what the FDA may be up to.

http://www.nytimes.com/2014/05/13/opinion/regulating-e-cigarettes-the-view-from-the-fda.html?_r=0

 

[Kent C]

Before panic sets in, we need to wait to see the study, and the levels of <name your poison> in the e-liquid and in the vapor. Trace amounts of all sorts of bad things are delectable in commonly ingested or inhaled products.

Arsenic is easily recognized as a poison yet allowed in drinking water.....


Arsenic in Drinking Water | Arsenic | US EPA

When the ANTZ can make 'nicotine poisoning by skin contact with furniture exposed to ecig vapor', I imagine they'll have a field day with this one. If we're 'waiting' on the study, they're waiting on it 'with bated breath'.

And again, all your very good explanations, all true, won't matter.

 

[zoiDman]

Another Member posted a CDC "Promotion" for a TV Ad which prompted me to make this Thread...

http://www.e-cigarette-forum.com/forum/media-general-news/563140-cdc-tv-ad-2-500-dirty-trick.html

Please Tell the CDC How You Feel about this kind of Deceptive Tactic.