FDA FDA Regulations on E-liquid. Sealed or refillable?

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Rossum

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The regulations don't specify things either way. Bottom line with the regs as they currently stand is that if a product's manufacturer hasn't filed a PMTA by 8/8/18, that product can no longer be sold in the US, and if the FDA hasn't approved the PMTA within a year, the product must also be withdrawn. Since the cost of preparing a PMTA is six figures at a minimum, it's doubtful that very many will be filed, particularly since there's no guarantee that any will be approved at all. However, speculation is that a sealed, closed system has a better chance of approval than an open one that could be used with any e-liquid, or an e-liquid that could be used in any device.
 
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viperyuan

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The regulations don't specify things either way. Bottom line with the regs as they currently stand is that if a product's manufacturer hasn't filed a PMTA by 8/8/18, that product can no longer be sold in the US, and if the FDA hasn't approved the PMTA within a year, the product must also be withdrawn. Since the cost of preparing a PMTA is six figures at a minimum, it's doubtful that very many will be filed, particularly since there's no guarantee that any will be approved at all. However, speculation is that a sealed, closed system has a better chance of approval than an open one that could be used with any e-liquid, or an e-liquid that could be used in any device.
THX bro
According to the FDA, whether there is still no specified regs about the maximum nicotine in the E-liquid? JUUL has already reached 50mg. OMG
 

Rossum

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THX bro
According to the FDA, whether there is still no specified regs about the maximum nicotine in the E-liquid? JUUL has already reached 50mg. OMG
So what? Vuse is 48, and some of NJOY's products were 45. But keep in mind that all of these are very low-power devices with a highly restrictive draw. You need that kind of nicotine level if device like those are going to be a satisfying alternative to smoking "full flavor" cigarettes. I think the FDA probably understands this and probably believes (IMO rightfully so) that tootle-puffing 50mg at 5 watts is likely safer than DL-huffing 3mg at 100+ watts.
 

viperyuan

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So what? Vuse is 48, and some of NJOY's products were 45. But keep in mind that all of these are very low-power devices with a highly restrictive draw. You need that kind of nicotine level if device like those are going to be a satisfying alternative to smoking "full flavor" cigarettes. I think the FDA probably understands this and probably believes (IMO rightfully so) that tootle-puffing 50mg at 5 watts is likely safer than DL-huffing 3mg at 100+ watts.
FDA is really hesitating LOL
 

Tomasius74

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Hi, does anyone know the FDA regulations on E-liquid?Does e-liquid can be refillable or must be sealed in a container, like JUUL, and could not be opened?

THX

I believe that the deeming rule true purpose is to transfer vaping industry to Big Tobacco companies, I fear that by 2019 you'll see only closed systems and the e-cigs that use real tobacco like IQOS

A friend of mine works at PM and said that IQOS is going to be launched in Mexico. Because vaping here is in a gray area in which it is not regulated but at the same time banned by the health authorities , I guess that PM will move for a tailored regulation in which the only approved vaping products will be theirs




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Rossum

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I believe that the deeming rule true purpose is to transfer vaping industry to Big Tobacco companies, I fear that by 2019 you'll see only closed systems and the e-cigs that use real tobacco like IQOS

A friend of mine works at PM and said that IQOS is going to be launched in Mexico. Because vaping here is in a gray area in which it is not regulated but at the same time banned by the health authorities , I guess that PM will move for a tailored regulation in which the only approved vaping products will be theirs
BT and BG would both be happy with that solution. :mad:
 

ENAUD

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Whatever the end result, it's all about money & control. The FDA, BT, BP & BG could care less about my health, your heath or the public's health. Well, there is that one guy in the back office down in the basement that cares, but he's long forgotten, much like us... :cool:
I think they took that guys red stapler away from him last week too.
 

KODIAK (TM)

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It seems to me that the Heat-not-Burn realm should be ripe for DIY modding...
Yes. It's called Vaping. :)

If the FDA approves Big Tobacco's iQOS here in the U.S. they have some serious explaining to do regarding this industry. Of course the firmware used to upgrade a device is now tobacco so what the hell do I know?
 
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