Why shouldn't the FDA interfere?

[DisMan]

Hi DisMan,
Although I don't have a box of Cornflakes handy I'm pretty confident in stating that more than corn is listed under its ingredients. There are probably such items as perservatives, artificial agents, colouring, ect... Which have required government testing.
There have been no long term studies that I am aware of that show the long term health affects of inhaling Proplyne Glycol, e-liquids primary ingredient. Until professional studies are conducted we are all in the dark.

Mark

The effects of Propylene Glycol have been evaluated back in the 1950's and it is listed as GRAS (Generally Recognized as Safe) by the FDA.

That's the whole reason it was selected for use in e-liquid.

Yes, the manufacturers did *not* drop the ball.

We are not in the dark, as you say. *You* may be in the dark, but I am well aware that PG is GRAS by the FDA.

It's used in fog machines at night clubs...which generate far more vapor than an e-cig at high levels of inhalation.

 

[markab]

Hi Kate,
I commend you on your stand on animal testing. It's a contentious issue and I'm glad that it's not used as frivolously as it once was used by such groups like the cosmetic industry. Unfortunatly, it's my understanding, that certain medical analisys cannot be determined without it. Prehaps e-cigs could be properly tested and evaluated without it. Ultimately I think it needs to be before being released to the public.

Mark

Well I suppose I think somebody has to test it and I'd rather do that than some poor lab animal that hasn't got any decent quality of life. This is my choice and I take responsibility for my vices. I'd like to be as educated about it as possible and make informed decisions but I don't want someone else to do this stage of the testing for me, I'm enjoying it too much.

I hate the way we use other animals and cause suffering for our own vices and vanity, it's not right. Medical treatments might have a different argument but I don't see that a non essential habit has the same justifications.

 

[Kate]

I hear what you're saying Mark and do agree that if something new is being released there should be a reasonable amount of caution and testing. I don't want to go back to smoking while we wait for someone to take the initiative to test and evaluate all the risks of vaping. If I'm not told lies I can make up my own mind about doing it or not.

You could be saying what the FDA will say however and we might not be allowed to carry on.

 

[DisMan]

Every chemical has been tested....the manufacturers did not drop the ball...the only ball the MFG's dropped was labeling of product.

 

[markab]

Hi DisMan,

Please provide the link to your source? The only studies I've read so far do not include long term exposure. Perhaps I missed this one. Thanks.

Mark

The effects of Propylene Glycol have been evaluated back in the 1950's and it is listed as GRAS (Generally Recognized as Safe) by the FDA.

That's the whole reason it was selected for use in E-Liquid.

Yes, the manufacturers did *not* drop the ball.

We are not in the dark, as you say. *You* may be in the dark, but I am well aware that PG is GRAS by the FDA.

 

[Kate]

Only nicotine and propylene glycol have testing results for inhaling as far as I know.

The flavourings could be a big worry, not everything suitable to eat is safe for lungs - http://www.e-cigarette-forum.com/fo...oking/2666-inhaling-flavouring-chemicals.html
Some flavourings cause lung disease when inhaled.

Glycerine isn't tested nor is the new ingredient PEG400 as far as I know.

 

[DisMan]

Hi DisMan,

Please provide the link to your source? The only studies I've read so far do not include long term exposure. Perhaps I missed this one. Thanks.

Mark

I will provide my link to long term exposure studies of PG when you provide your link to a study of long term exposure to corn flakes.

Seriously, that's a reach.

Now, if you would like to have such studies, talk to people who work night clubs for a living and their use of fog machines. Link fog machine usage to cancer in night club DJ's. Now you have an argument. Until then, this is a moot point that is irrelevant.

Don't get me wrong...there are people with allergies out there. But long term exposure studies on every product to be marketed? Come on now...

Fog machines have been used in theatrics for enough time to show a trend for threat.

I'm sure TB can show the link to the study that showed PG has some potential virucidal effects and no ill effects on a group of like 300 children.

 

[markab]

Hi Kate,
I agree. I'm currently in a transition phase between tradional cigs and e-smoking and I would hate to loose the use of my e-cig. Having said that I recognize the importance of the FDA, Health Canada, ect... in ensuring that products released to the general public are indeed safe. In all fairness traditional cigarettes should have been band many moons ago. Hopefully if politics don't get in the way e-cigs will have an opportunity of proving itself as a safe alternative.

Mark

I hear what you're saying Mark and do agree that if something new is being released there should be a reasonable amount of caution and testing. I don't want to go back to smoking while we wait for someone to take the initiative to test and evaluate all the risks of vaping. If I'm not told lies I can make up my own mind about doing it or not.

You could be saying what the FDA will say however and we might not be allowed to carry on.

 

[Sun Vaporer]

Prolonged PG contact is essentially non-irritating to the skin. Undiluted PG is minimally irritating to the eye, and can produce slight transient conjunctivitis (the eye recovers after the exposure is removed). Exposure to mists may cause eye irritation, as well as upper respiratory tract irritation.18

Inhalation of the PG vapors appears to present no significant hazard in ordinary applications. However, limited human experience indicates that inhalation of PG mists may be irritating to some individuals. Therefore inhalation exposure to mists of these materials should be avoided. In general, Dow does not support or recommend the use of PG in applications where inhalation exposure or human eye contact with the spray mists of these materials is likely, such as fogs for theatrical productions or antifreeze solutions for emergency eye wash stations.19-- Sun

See 19 A Guide to Glycols (File Not Found), page 36.

 

[Kate]

Just to try to get this thread back to the point a little.

Forgetting the pros and cons and rights and wrongs, what are the possibilities of eliquid becoming a controlled substance?

If it does come under FDA definitions of controlled substance what restrictions would that mean?

Anyone know?

 

[DisMan]

Only nicotine and propylene glycol have testing results for inhaling as far as I know.

The flavourings could be a big worry, not everything suitable to eat is safe for lungs - http://www.e-cigarette-forum.com/fo...oking/2666-inhaling-flavouring-chemicals.html
Some flavourings cause lung disease when inhaled.

Glycerine isn't tested nor is the new ingredient PEG400 as far as I know.

Glycerine is glycol.....the words are interchangeable. <-- Edit: I have to retract this statement. Glycerine is interchangeable with Glycerol, not Glycol. Sorry for that. As for Glycerine, there are some studies...although I don't understand the results. http://www.informapharmascience.com/doi/abs/10.3109/08958379209145307?journalCode=iht

You're right, excessive exposure to flavorings *may* pose a risk. We'll never know with that. I'm with TB on that one...I have to have faith that the chemists/mixers are smart enough to do the research there. If there is worry there, get unflavored mixes of PG, Water, and Nicotine. If you're really worried, get PG and Water mixes. And, if you're extra worried, inhale some water!

In the end, calling for regulation and demanding long term studies to take place on every potential mixture of chemicals is just downright irresponsible to the corporate world. I dislike many corporations...but I gotta side with the "free market" concept that demanding long term studies would be extremely damaging.

When you think about it, you'll find that 1/1000 studies would yield a potential harm...wasting millions of dollars. Then you'll find that 30/999 that passed found bad results later on (think Ephedrine). You can't save the world and you can't prevent problems.

Now, I do agree that the product should be labeled with every ingredient. My food is labeled. My pills are labeled. My gasoline is labeled. E-Liquid should not be any different. And I do shame the suppliers for not labeling. BUT, keep in mind that every supplier has listed the ingredients on their websites, much like a fast-food restaurant lists the ingredients to their food on their websites.

So, we're not in the dark here. We're all very much aware of what we're putting in our bodies. We can't plead "stupid" in 10 years when/if a problem does arise. And we all cannot sue the suppliers...they let you know what was in the liquid before you bought it.

Of course, you do have a leg to stand on with "but which fragrance?"

Don't take this as a negative post....there's a lot of honesty here.

 

[markab]

Disman,
I'm not going to play this silly game. If you have a link share it with us. The point I made was not with "corn flakes" it was with some of the ingredients in it like preservatives.

Mark

I will provide my link to long term exposure studies of PG when you provide your link to a study of long term exposure to corn flakes.

 

[DisMan]

Disman,
I'm not going to play this silly game. If you have a link share it with us. The point I made was not with "corn flakes" it was with some of the ingredients in it like preservatives.

Mark

Then don't play this "game". The bottom line is that you're asking for more than you demand of other products. The product was tested. I don't have to prove it to you, and vice versa. Do your own research as I have (and many others) done prior to purchasing an e-cig.

Don't get me wrong...I agree with the labeling of the product. Corn flakes are labeled, as is gasoline. It's interesting that Tobacco related products are not though.....but we didn't demand that for the 20 years we all smoked.

 

[Kate]

... we're not in the dark here. We're all very much aware of what we're putting in our bodies. We can't plead "stupid" in 10 years when/if a problem does arise. And we all cannot sue the suppliers...they let you know what was in the liquid before you bought it. ...

I'm in the dark ... I don't know if what I vape will give me lung disease in ten years, it's never been done before - untested. What we're putting into our bodies is a novel cocktail that has never been inhaled before.

If a supplier says that something is safe, safer or healthier then they make claims about a product that I can legally have a case with. They have a responsibility to sell me goods fit for purpose, if they harm me then they are not fit for purpose.

Even if I'm given a list of ingredients (and I wish I was) I'm not necessarily going to have access to information to research whether any of the ingredients are harmful. If the ingredients are untested for the purpose they are being sold to me and there are health implications then that could be negligence on the part of my supplier.

Anyone dealing with products that have a health impact has a responsibility to do no harm. Toxicology tests and reports, risk assessments and clinical trials are essential before millions of people are put at risk. Only Ruyan's formula even comes near to having decent assessment.

Smoking wasn't initially thought to be harmful ... now how many people are addicted and experiencing health problems. I don't think that should be allowed to happen again. If smoking had been tested before being allowed general public exposure a lot less harm would have been caused.

 

[Sun Vaporer]

Just to try to get this thread back to the point a little.

Forgetting the pros and cons and rights and wrongs, what are the possibilities of eliquid becoming a controlled substance?

If it does come under FDA definitions of controlled substance what restrictions would that mean?

Anyone know?

Wheather it be OTC (doubtful) that would mandate restictions and regulations on dosing, labeling and other minor issues --but only after application--Controlled (likely) that would be a full blown presription and again after application and proper studies and clinical trials--it is a very time consuming and costly venture that is budgeted in the R&D of drug companies budgets--I do not see any company other then Ruyan doing anything along these lines and no indication that they will.---Sun

 

[DisMan]

Jesus christ...some people just keep asking for reports instead of finding their own....

Subchronic nose-only inhalation study of propylene...[Food Chem Toxicol. 1989] - PubMed Result

Mice received PG for 6/hours per day 5 days/week, for 90 days.

The effects were stuff like nasal hemmorraging but that is mentioned as due to be dehydrated.

That's just one of the many reports I found using the Google results for "Propylene Glycol inhalation study"

There, I did *some* of your research for you...there's 10,600 hits for that search. Probably the first 20 would be worth reading.

In the end, I concur that labeling of the product is as far as it should go. Further requirements is stemmed from paranoia and an unfair practice of demanding more requirements from a supplier than are required from equivalent suppliers. Not once have you demanded that your cigarettes be labeled.

And, in the end, you buy the product. You're very aware of the potential harm they may cause.

 

[Kate]

Wheather it be OTC (doubtful) that would mandate restictions and regulations on dosing, labeling and other minor issues --but only after application--Controlled (likely) that would be a full blown presription and again after application and proper studies and clinical trials--it is a very time consuming and costly venture that is budgeted in the R&D of drug companies budgets--I do not see any company other then Ruyan doing anything along these lines and no indication that they will.---Sun

Thanks Sun.

The FDA have already called this a drug, if they decide enforcement is in order then it looks like it's going to be a while before it's easily available.

If they enforce the law then eliquid can't be used. If they don't enforce then we only have voluntary compliance with good practice standards from manufacturers and traders.

 

[markab]

I'm in the dark ... I don't know if what I vape will give me lung disease in ten years, it's never been done before - untested. What we're putting into our bodies is a noval cocktail that has never been inhaled before.

BINGO! Gold star for you Kate! We don't know what these concoctions will do to us in the long term. Hopefully though, through a proper scientific evaluation we can. In my eyes if a company can fund to have a product researched, engineered, produced, and marketed ,they can pay to ensure that its safe for the consumers they want to sell it too.

Mark

 

[Sun Vaporer]

Thanks Sun.

The FDA have already called this a drug, if they decide enforcement is in order then it looks like it's going to be a while before it's easily available.

If they enforce the law then eliquid can't be used. If they don't enforce then we only have voluntary compliance with good practice standards from manufacturers and traders.

Kate -- I honestly think the FDA is having some internal trouble with how to execute their mandates--something is not right in how they are preceeding with the issue. They normally do not make harsh statements that a product is illegal without acting on it--There is some other factor holding them up that we are unaware of---Sun

 

[Bellinghamster]

In my eyes if a company can fund to have a product researched, engineered, produced, and marketed ,they can pay to ensure that its safe for the consumers they want to sell it too.

I agree things should probably be tried by their makers... To make sure they feel our pain if it isn't safe. To ask for a 10-year clinical trial to determine long-term effects is completely unrealistic. We live, we learn... all of us, with every product we use. Did you know that the weight-loss drug Alli causes a genetic mutation that doesn't show any symptoms for 15 years, then suddenly you develop a lust for human blood? No? That's because no one has taken it for 15 years... and it's FDA-approved. [No basis in fact for the blood-lust bit, please don't sue!]

Jesus christ...some people just keep asking for reports instead of finding their own....

Subchronic nose-only inhalation study of propylene...[Food Chem Toxicol. 1989] - PubMed Result

Stop acting like a recalcitrant 15-year-old. You cite the study, be prepared to back it up with a link. Don't hide behind cornflakes. We should be sharing information for the benefit of all, not slinging mud to prove how "smart" we are. This is our health at stake, and people are right to question assertions. While we are in 100% agreement about labeling, if you think no one should be VALIDATING those labels and inspecting products for purity, then you are a trusting soul indeed.

They have a responsibility to sell me goods fit for purpose, if they harm me then they are not fit for purpose.

Agreed... Even though I would like to believe that manufacturers and distributers act in good faith, we need some labs, people, and money to get answers. The government has all 3.