FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

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Rossum

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You cannot prove a negative. Catch-22.
Right, but if a company submits a 100,000+ page application, they might actually have a chance. Of course there's a substantial COST in preparing such an application.

FWIW, burying regulators in mounds of paperwork is a time-tested method of getting "approved". Way back in the mid 1980s, my wife worked at a very large manufacturing company that was seeking approval to merge with another. The regulators who needed to approve this merger asked for certain records and documentation. They got it -- literally several tractor-trailer loads full of (Xeroxed) files. Approval was granted.
 

Rossum

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If its not GRAS rated ingredients its not e-juice.
GRAS for ingestion, skoony. There are a few substances found in some flavorings that are Generally Recognized as UNSAFE for inhalation. Yes, yes, it's debatable whether they will ever cause anyone a problem when used in vapes, but the reality is there are those of us who wish to avoid those substances.

Does that mean we want the FDA to come in and demand (at the point of a gun) that all e-liquids and vape gear be submitted for their approval? Oh heck no!
 

Jingles

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Generally, if you're adding anything mysterious to the ejuice , you are also increasing your costs. So why would vendors want to add something to the juice? If they water it down, it won't vape as well and their customers stop buying. If their was something cheaper than PG or VG, that was also vapeable, I could see them substituting ingredients, but I don't believe there is anything cheaper out there that could be vaped.
 

AndriaD

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Aside from from the battery problems caused mostly by abusing battery's and causing venting our equipment is quite safe. We do know whats in our juices. If its not on the label make an inquiry.

There haven't been any reported cases of harm from the hardware nor the juice as of yet aside from
obvious abuse.

Protection? There is no master e-cigarette agreement.

Again, what is the mythical anything that's being put in the juice?
If its not GRAS rated ingredients its not e-juice.
:2c:
Regards
Mike

Exactly. And hey.. the FDA lets food mfrs add sulfites to anything they want, despite knowing that sulfites could be fatal to asthmatics. That's some real protection. /sarcasm

:facepalm:

Andria
 

zoiDman

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Little mom and pop juices, might be. They have 2 years to come up with the money to get approved. I think if they are using the pharmaceutical grade nicotine and already FDA approved flavors and pg/vg, that shouldnt be hard to get approval.

...

Many believe that the FDA will give a 24 Month grace period for applicants to file a PMTA for Hardware. And this might also be True for the Sale of e-Liquids that contain Nicotine.

But some do Not Believe that this means that there Can't be Restrictions place Immediately on the Sale of e-Liquids that contain Nicotine once the FDA has Regulatory Authority to do so.
 

AndriaD

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GRAS for ingestion, skoony. There are a few substances found in some flavorings that are Generally Recognized as UNSAFE for inhalation. Yes, yes, it's debatable whether they will ever cause anyone a problem when used in vapes, but the reality is there are those of us who wish to avoid those substances.

Does that mean we want the FDA to come in and demand (at the point of a gun) that all e-liquids and vape gear be submitted for their approval? Oh heck no!

Exactly this too. For those of us who absolutely require that those things not be in our juice... we make our own. Not hard at all.

Andria
 
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skoony

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GRAS for ingestion, skoony. There are a few substances found in some flavorings that are Generally Recognized as UNSAFE for inhalation. Yes, yes, it's debatable whether they will ever cause anyone a problem when used in vapes, but the reality is there are those of us who wish to avoid those substances.
Your quite right. My point is saying they are putting anything in it is wrong. We all pretty well
know what e-juice is made of. If not one can find out specifically with a little googling.
When one says we don't know whats in it as opposed if there is a specific ingredient in it
is misleading and implies negative connotations as to the make up of anything in the juice.
There are glycols and glycerin's. Then there's propylene glycol and vegetable glycerin.
:2c:
Regards
Mike
 

AndriaD

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Your quite right. My point is saying they are putting anything in it is wrong. We all pretty well
know what e-juice is made of. If not one can find out specifically with a little googling.
When one says we don't know whats in it as opposed if there is a specific ingredient in it
is misleading and implies negative connotations as to the make up of anything in the juice.
There are glycols and glycerin's. Then there's propylene glycol and vegetable glycerin.
:2c:
Regards
Mike

And there is product liability for anything made in the US, no matter what it is. If it harms someone because of negligence of the maker, they will get sued and maybe even shut down. Makers know this, so they DON'T put "just anything" in it.

Andria
 

MacTechVpr

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Rossum

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But that's just way too much common sense ros. I mean, the thought of it, that we actually have access to that much information. Actually make choices based upon it. How unreasonable to expect so much from so little.
It's perfectly reasonable to expect that from adults. Sadly, the government wants to treat us all like little children who are not yet capable of making rational decisions.
 

Kent C

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It's not the gov't's job to protect you from yourself and whenever they do, the unintended consequences are of greater harm to your health and your pocketbook, than anything that the free market could do. Except in rare occasions - ie criminals that should be prosecuted to the full extent of the law - businesses don't want to harm their customers, who are their only chance of making profit from their goods. Most of the raw materials used in ecigs already have some 'regulation'. VG and PG have been around for ages and have tests done on factory workers for the inhalation of these substances. Studies that go back to at least 1947 that have shown no harm to workers. The metal industry has gov't and their own standards. So do batteries.

But just as in the car industry, for example, you could use any industry - guns, hair dryers, food processors, etc. NOTHING stops idiots from harming themselves - neither gov't standards or industry standards. And unfortunately, because of trial lawyers mainly, even IF there is nothing wrong with a product, it ends up being the businesses' fault, mainly because of media, the make up of juries who have been propagandized through gov't schools and movies and TV that depict business men and women as criminals at a rate that is far beyond, multiples of actual stats, of what actually happens in reality. All are murders, racists, sexist, arsons, thieves, embezzlers, polluters, mean, hateful without compassion. And that likely depicts no one you know with whom you do business on a daily, weekly, monthly or yearly basis.

Add that all up and you get someone who thinks that if the gov't gets involved then 'you know it will be safe' :facepalm: And nothing could be further from the truth.
 
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MacTechVpr

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It's not the gov't's job to protect you from yourself and whenever they do, the unintended consequences are of greater harm to your health and your pocketbook, than anything that the free market could do. Except in rare occasions - ie criminals that should be prosecuted to the full extent of the law - businesses don't want to harm their customers, who are their only chance of making profit from their goods. Most of the raw materials used in ecigs already have some 'regulation'. VG and PG have been around for ages and have tests done on factory workers for the inhalation of these substances. Studies that go back to 1947 that have shown no harm to workers. The metal industry has gov't and their own standards. So do batteries.

But just as in the car industry, for example, you could use any industry - guns, hair dryers, food processors, etc. NOTHING stops idiots from harming themselves - neither gov't standards or industry standards. And unfortunately, because of trial lawyers mainly, even IF there is nothing wrong with a product, it ends up being the businesses' fault, mainly because of media, the make up of juries who have been propagandized through gov't schools and movies and TV that depict business men and women as criminals at a rate that is far beyond, multiples of actual stats, of what actually happens in reality. All are murders, racists, sexist, arsons, thieves, embezzlers, polluters, mean, hateful without compassion. And that likely depicts no one you know with whom you do business on a daily, weekly, monthly or yearly basis.

Add that all up and you get someone who thinks that if the gov't gets involved then 'you know it will be safe' :facepalm: And nothing could be further from the truth.

"A powerful preventive against pneumonia, influenza and other respiratory diseases may be promised by a brilliant series of experiments conducted during the last three years at the University of Chicago's Billings Hospital. Dr. Oswald Hope Robertson last week was making final tests with a new germicidal vapor—propylene glycol—to sterilize air. If the results so far obtained are confirmed, one of the age-old searches of man will finally achieve its goal." —Time, Monday, Nov. 16, 1942

Vape on! Sterilize 'em.

:D
 
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Rossum

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"A powerful preventive against pneumonia, influenza and other respiratory diseases may be promised by a brilliant series of experiments conducted during the last three years at the University of Chicago's Billings Hospital. Dr. Oswald Hope Robertson last week was making final tests with a new germicidal vapor—propylene glycol—to sterilize air. If the results so far obtained are confirmed, one of the age-old searches of man will finally achieve its goal." —Time, Monday, Nov. 16, 1942
Another reason for Pharma to hate us. Their sales of cold & flu remedies probably decline almost directly in proportion to the number of people who take up vaping. o_O
 

snork

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It's perfectly reasonable to expect that from adults. Sadly, the government wants to treat us all like little children who are not yet capable of making rational decisions.
There also is the component that so many adults would *like* to be treated as little children, having absolution from their choices and guaranteed a safe, eternal life.
 

MacTechVpr

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My story. I'm a chronic at risk individual. And one of the most perspicaciously skeptical peeps you could know. I undertook my study of vaping both as a challenge to pay back this community and subject myself to the most rigorous examination of the technology, ergonomics and applications of vaping I could conceive. Needless to say I've done a heck of a lot of vaping! LOL My cardio and rheumatologist were not surprised at all to see my respiratory potential, blood pressure and other factors appreciably favored by the exercise after six months. It's a process that continues. Enthusiastically.

Vape on!

:)
 

schatz

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Another reason for Pharma to hate us. Their sales of cold & flu remedies probably decline almost directly in proportion to the number of people who take up vaping. o_O
Funny you should mention that, just realized I havent had acold or flu in 4 years. And you do realize they switched dough conditioners for your bread from iodine, wich your thyroid needs, to bromine wich is not vital to the body. Thank the FDA.
 

Steamix

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Guess it keeps a lot of civil servants in bread 'n butter - making up tons of legalese.
Who are they trying to fool? Could you for once - just once - quit insulting the intelligence of the vaping community ?

All that deeming regs can be easily simmered down to a few lines of plain and simple and easy to understand text :

'BG, BT and BP are profiting hugely from maintaining the status quo. So they want vaping to either go away or get limited to the ratty devices they've invested in already.
They've got enough money and friends in high places to make us see it their way.
So, we try to make it look like we're protecting your health, while in reality we're bending over to protect the turf of some interested parties from innovation and efficiency.'
 
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