FDA to regulate e-cig as tobacco

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Demarko

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This essentially "protects" Big Pharma. Under the Dietary Supplement Health and Education Act (DSHEA) vitamin C is a dietary supplement, and as such, it can only make structure/function claims (i.e. Vitamin C boosts the immune system). DSHEA came about after intense lobbying against the FDA's attempts to control supplements, herbs, etc. and restricts its authority over them PROVIDED manufacturers make no claims about their products treating, preventing or curing diseases, etc.

Making such claims about any product makes it a drug - and since Big Pharma is the drug cartel, only Big Pharma can make those claims. This is why I'm not allowed to tell you that lavender helps insomnia, muscle pain, and acne, or that it helps heal burns, bites and abrasions - even though we all know it does all this.

This is also why we don't claim e-cigs help smokers avoid tobacco cigarettes. To do so would be claiming that they treat a disease, which means they're drug, which means they belong to the FDA and BP.

So basically it's okay to say, "Vitamin C boosts the immune system." not "Vitamin C prevents scurvy"
 

Demarko

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I like the sound of that. :2cool: I brought that up in another discussion and got shot down, that no, it's a new product.



I would hope the concept, application and functional design would be the determining factors, but who knows :confused:

You ever buy a new phone, and then find out a month later, that it's obsolete? 6 months later, and it's obsolete twice?

Well, ecigs apply technology to something that's been around since the first multi-celled organism consumed a single-celled one. Consumption. Evolution is a wonderful thing.
 

StormFinch

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Question: What exactly would constitute a "functional equivalent" to products marketed before February 2007? I mean, NJOY's current products aren't even the same as the NJOY products from 2007.

I would hope the concept, application and functional design would be the determining factors, but who knows :confused:

I've been doing some digging on this, and though I can't find a specific definition by the FDA I did find some examples. The FDA considers generic drugs to be functionally equivalent to name brand drugs. In my eyes at least, that means that although they aren't made by the same company, or even look the same, they work the same. Although e-cigarettes may have changed somewhat in outer design (bigger batteries=bigger housings with a different shape) they still all work exactly the same; battery heats atomizer or cartomizer, atomizer/cartomizer produces vapor. E-juice is basically always been nic in a base plus flavor, but I believe they were either PG or VG. I'm not 100% sure but I think the PG/VG mixes started coming along about the time I joined ECF.
 

jlarsen

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The list of permitted chemicals are related to flavoring and to preserving the tobacco. The List of Additives in Cigarettes - Additives in Cigarettes

Tobacco companies are not permitted to add toxic or cancer-causing chemicals.

So is ammonia considered a flavoring or a preservative? I was under the impression that the reason it was added was to increase the nicotine absorption and therefore the addictiveness of cigarettes? Ammonia is classified as toxic, though it is not extremely toxic, especially in small amounts.

I have a hard time believing that all 599 additives on that list contribute only to the flavor and/or preservation of the tobacco. I also have a hard time believing that smoking tobacco with those 599 chemicals is not more dangerous than smoking tobacco without them.

Of course the greatest health risk is the small particulate matter from the smoke, with or without the additives, but adding all those chemicals certainly increases the harmfulness, even if only slightly.
 

Demarko

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So is ammonia considered a flavoring or a preservative? I was under the impression that the reason it was added was to increase the nicotine absorption and therefore the addictiveness of cigarettes? Ammonia is classified as toxic, though it is not extremely toxic, especially in small amounts.

I have a hard time believing that all 599 additives on that list contribute only to the flavor and/or preservation of the tobacco. I also have a hard time believing that smoking tobacco with those 599 chemicals is not more dangerous than smoking tobacco without them.

Of course the greatest health risk is the small particulate matter from the smoke, with or without the additives, but adding all those chemicals certainly increases the harmfulness, even if only slightly.

The problem, really, is putting all those 599 chemicals together and getting unintended results from the combusted result. I think, personally, that whatever they put in to keep cigarettes from burning hurts more than anything. I never felt any problems from smoking until they added THOSE.
 

Our House

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I've been doing some digging on this, and though I can't find a specific definition by the FDA I did find some examples. The FDA considers generic drugs to be functionally equivalent to name brand drugs. In my eyes at least, that means that although they aren't made by the same company, or even look the same, they work the same. Although e-cigarettes may have changed somewhat in outer design (bigger batteries=bigger housings with a different shape) they still all work exactly the same; battery heats atomizer or cartomizer, atomizer/cartomizer produces vapor. E-juice is basically always been nic in a base plus flavor, but I believe they were either PG or VG. I'm not 100% sure but I think the PG/VG mixes started coming along about the time I joined ECF.
So in your opinion, the FDA should consider this NJOY:

ncigf.jpg


...and this NJOY:

npro.jpg


...to be the functional equivalent of this NJOY:

npro2n1.jpg


?
 
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Secti0n31

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So in your opinion, the FDA should consider this NJOY:

ncigf.jpg


...and this NJOY:

npro.jpg


...to be the functional equivalent of this NJOY:

npro2n1.jpg


?

The short answer; yes. Not identical but same functionality and general principle. The FDA is not sure if there are cartridges, attys, or juice cause any unintended byproducts during vaporization. Since atty/cart, and atty/carto are virtually identical (heating coil, filler, juice.

I'd love for the FDA to test the bejeesus out of these products from the major brands like greencig, njoy, blu and volcano, all the way down to generic joye and riva, and every mod and wetbox in between. I'm no scientist, but I do like to know the facts and if legit testing is done on EVERYTHING (which it probably will be, given the huge timeframe it takes for the FDA to get anything done.)
 

Vocalek

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Question: What exactly would constitute a "functional equivalent" to products marketed before February 2007? I mean, NJOY's current products aren't even the same as the NJOY products from 2007.

The juices are essentially unchanged -- a base that creates a mist when vaporized, also containing flavoring and nicotine. It is only the nicotine that meets the definition of tobacco product--"derived from tobacco."

I think it is very important that we encourage the FDA to stay out of regulating the hardware side of the business. The only part of the product they have any business regulating is the liquid that cntains nicotine. Used with a zero-nic liquid, an e-cigarette is nothing more than a novelty.

Technology moves too fast for bureaucracies to keep up. I think there would still be a lot of people smoking if the design had not been improved from the original RN4081 model that NJOY first sold.

We want to encourage further refinements of the hardware, to make the products as effective as possible for as many smokers as possible--not have the technology frozen in the U.S. but able to move forward in other countries.
 
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TennDave

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Vocalek, I agree totally- they should control the e-juice only and only that which contains nicotine. They should stay away from the implements of e-cigs and accessories, etc. As an example in most states the implements for the use of marriagiwana (spelled incorrectly on purpose so it's not censored) is not illegal- only if they find residue in/on them- should be the same w/ what we use.

I posted the JT (Japan Tobacco) version of a so called "e-cig"...it has not battery- doesn't even vape. It's crazy but over-sight group (like our FDA) has convinced the public that nicotine is evil...and you should not become addicted to it. I certainly hope that our FDA doesn't go in that direction....though I know they have to some extent already. Research w/ facts are the only way to help combat this. In looking around youtube I even saw Japanese postings of how to smoke real cigarettes without become "nicotine addicted." A sad state of "consciousness" over there for sure, but one thing for certain- much more transparency with actual tobacco- listing of mg tar and nicotine is required on every pack and 1/3 of the packaging has to be occupied with warnings. One youtube add for vaping e-cigs (0-nicotine...as nicotine in e-cigs is illegal) looked like a 510 (from China) and they had a doctor on there talking about the benefits of both VG and PG in the juice that is vaped as well as the harmlessness of the flavorants- this seems to be general knowledge over there- something I wish the FDA will hurry up and form a positive conclusion about in this country. At least we'll be allowed to use nicotine in the U.S. (and not banned), although it will be controlled (and taxed but not so high as cigarettes, hopefully). :)
 

Our House

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I'd love for the FDA to test the bejeesus out of these products from the major brands like greencig, njoy, blu and volcano, all the way down to generic joye and riva, and every mod and wetbox in between. I'm no scientist, but I do like to know the facts and if legit testing is done on EVERYTHING (which it probably will be, given the huge timeframe it takes for the FDA to get anything done.)
I'm all for this too, but not sure if FDA-esque testing is what we want. We already saw the kind of "testing" the FDA was willing to push onto the general public in July of 2009.
 

CJsKee

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I'm all for this too, but not sure if FDA-esque testing is what we want. We already saw the kind of "testing" the FDA was willing to push onto the general public in July of 2009.

Actually, the FDA's tests of e-cigs were fine...it was the spin they spewed in the press release that was the problem!
 
I think it is very important that we encourage the FDA to stay out of regulating the hardware side of the business. The only part of the product they have any business regulating is the liquid that cntains nicotine. Used with a zero-nic liquid, an e-cigarette is nothing more than a novelty.

IMO, regulations for e-cigarette hardware should be based on regulations for tobacco accessories including pipes, lighters, and rolling papers and regulations for e-liquid could be based on rules for pipe or whole leaf tobacco as it is similarly sold by weight rather than unit.

ETA: The FDA should promulgate regulations for cigars, pipe tobacco, and other accessories first. ;)
 

Our House

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Actually, the FDA's tests of e-cigs were fine...it was the spin they spewed in the press release that was the problem!
Unless you're referring to the actual chemical level testing of the cartridges (which none of us really know about either way), the FDA's tests were NOT fine. In fact, they were completely pseudo-scientific. Just look at the study yourself.

• The "control" was not tested in areas it performed poorly, but ecigs were tested in those same areas.
• The quantities of "toxic" or "carcinogenic" chemicals found were not listed anywhere obvious.
• The testing was done in parts per billion to parts per trillion (normal science uses parts per million) -- a methodology that would even make tap water seem like a death wish.

...just to name a few issues.
 

CaptJay

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Seems like decent news to me - I only found out about this from a comment on one of the vendors sites lol. If they ban my flavors Ill just get candy flavors and add them myself; no biggie. Thanks to PV Ive been off the fags since Jan 2010 and I don't intend to go back - I'm even considering a time when I might not need nic-juice in the future. Hopefully the FDA will take their time over making too many decisions - no rush fellas :)
 

John Phoenix

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That's exactly what the FDA wanted and still wants, but the Dietary Supplement Health and Education of 1994 has kept that from happening - so far. Prior to 1994 they were regulated as food.

FDA is still fighting for control of supplements, herbals, etc., with no plans on stopping. In 1994 Pearson and Shaw took the FDA to court for rejecting valid, scientific health claims on supplement labels. Five years later a U.S. Court of Appeals affirmed the lower courts ruling for the plaintiffs on grounds it violates their First Amendment rights.

Believe it out not (easy to believe, really), the FDA actually argued it had the right to "protect consumers by suppressing scientific information it believes is too misleading for consumers to understand..."

I find this whole business funny. In the Bible Jesus told a man to wash in the Jordan River 7 times and he would be healed. The man washed and was healed. Another time Jesus made a mud ball with mud and spit and healed a mans blindness. Is Big Pharma going to snatch up the water in the Jordan or the mud and claim they are drugs?

Hippocrates ( father of the Hippocratic oath) said, " “Let food be your medicine, and medicine be your food.”. The Evil and Corrupt FDA under the guise of consumer safety has been allowed to scam the people and take away natural life giving substances then sell versions of them back to us at high prices. This practice should be outlawed and is very immoral and criminal. I agree with preventing harm, I do not agree with using it to take the peoples money and force us to get our "food medicine" from drug companies.

Personally I do not recognize the authority of the FDA to tell me what I can or cannot put in my body and why. I answer to a higher authority. In business I am forced to follow the Law no matter how wrong it is.
 

Mindfield

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I just read about this decision, and I have to say I'm really pleased to hear about it. Being in Canada though means that we're going to have to catch up to US regulations, as right now, Health Canada still has a moratorium on nicotine-containing E-liquids. I am hoping however that they will see the light and follow the FDA's lead. It's still no problem for me to get E-cigs and liquids, but the best placed to get liquids is still from the US (there are some decent places in Canada but none I have found yet that have the quality of some of the places in the US that I have found) and there is always this worry that my next shipment will get stopped at the border. I have delayed ordering the supplies to brew my own liquids in part for this reason.

With this decision, there is hope that Health Canada will lift the moratorium, at least while they work out the specifics, and then the places that went nic-free here will be able to carry proper nicotine liquids again. It may even help encourage the propagation of more E-cig vendors in Canada. One can only hope.

In the mean time though this is another battle won, and I couldn't be happier about it. I still wish the FDA would stay out of it, but I also have to admit that some regulation will be beneficial to the industry, as manufacturers would be held to the standards of the FDA to produce quality products. Just the same, I think this decision is a watershed moment for vapers that paves the way to a brighter future. As has been said numerous times there are still many battles to be fought, but one of the major ones has been won, and hopefully, with the number of vapers growing by the day, we will have a strong enough voice when the time comes to win the smaller battles that allow us to continue vaping the way we want to vape, flavours and all.
 

Mindfield

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At least people won't be able to use "the FDA is trying to ban them" anymore, and that's a good thing.

True enough. But the FDA's attempt to ban was just shady political posturing anyway while they tried to bring the devices and liquid under their Drug Delivery Device wing. Now that they've had the wind knocked out of those sails though, it's one less argument, however specious, to level against eCigs and their users.
 

kristin

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Unless you're referring to the actual chemical level testing of the cartridges (which none of us really know about either way), the FDA's tests were NOT fine. In fact, they were completely pseudo-scientific. Just look at the study yourself.

• The "control" was not tested in areas it performed poorly, but ecigs were tested in those same areas.
• The quantities of "toxic" or "carcinogenic" chemicals found were not listed anywhere obvious.
• The testing was done in parts per billion to parts per trillion (normal science uses parts per million) -- a methodology that would even make tap water seem like a death wish.

...just to name a few issues.

I think what CJ meant was that the FDA testing failed to find harmful levels of ANY chemicals or carcinogens (which was actually GOOD news,) yet the press release made it sound like they did, not that HOW they tested was "fine."

It's painfully obvious that if the FDA had been able to find any other potentially toxic chemicals (than what they announced) they would have included them in the press statement, even if they weren't at harmful levels either. So, that strongly indicates that what they reported in the press statement was the worst they could find (and those weren't even at harmful levels.)
 
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