FDA and bringing new vaping products to market

[mightymen]

IMO: if they think the vaping market is X billion dollars a year and it will stay that way SUPRISE.


It was the availability of products and easy in which to buy them that at local vaping shops and online that allowed the market to grow. With added cost to each product and fewer choices in delivery systems and flavors and less places to shop, I expect very few new vapors in the long run and those that are here now will be going DIY and stocking up on everything. It only makes sense if they're going to push this as quit smoking device and jack the price way up. After all we are the proof that it is really possible to stop smoking while vaping. It's just that it will cost a hell of a lot more than it does now. Long run they most likely want to make a one billion market into a 10 billion market by keeping people vaping. Taken one habit(Cigs) and turning into a less risky habit(E-Cigs). JUST MY TWO CENTS.

 

[Rickajho]

OK.

But JSYK, the interjection of "Intended Use" wording by the FDA has Closed any of the "Loopholes" that many have suggested a Deeming Rule Set may have.

That is, Unless I am Mis-Understand your use of the word "Loophole".

That's exactly my point - "intended use" - it's ambiguous, it overreaches, it's vague. Last I checked we don't have a feudal Monarchy going on here and I don't accept this concept that we have a government agency that gets to make up definitions (if you can even call them definitions) and rules that only Mary Queen of Scots could get away with.

Whether that's a legal pot to pee in - we'll see. "Intended use" seems incredulous.

 

[mightymen]

I Don't think you should be Troubled by the references to "Closed System" Cartridges. I think it Should Scare the Hell Out of You!

Exactly say good bye to the refill bottles it will be limited flavors in a cartridge which mean available from few manufactures - NO CLONES because clones will not be approved by FDA and limited choices on wicking material and coils. RDA, RBA, tanks say good bye to them not possible to be a closed system that is refillable or able to be re-wicked or re-coiled - to damn expensive to replace.

Think we can buy stuff outside of the country. Customs - each package has to be marked what is in it and the value. Says e-cigs on it, it will never get past customs without being opened - bye bye.

 

[zoiDman]

That's exactly my point - "intended use" - it's ambiguous, it overreaches, it's vague. Last I checked we don't have a feudal Monarchy going on here and I don't accept this concept that we have a government agency that gets to make up definitions (if you can even call them definitions) and rules that only Mary Queen of Scots could get away with.

Whether that's a legal pot to pee in - we'll see. "Intended use" seems incredulous.

Oh Don't get me Wrong. I feel that as Worded, the "Intended Use" concept is a Complete Over-Reach.

I'm just not sure How Much it can be Challenged until the FDA Actually uses it? And to what Extent they Use it?

 

[Rickajho]

This is why I stopped playing in these discussions. I'm not jumping on the WE'RE ALL GONNA DIE circular bandwagon.

What do you think customs is going to do with all those itty bitty packages? The hundreds of thousands that arrive in this country every day? They can't even keep on top of the random shipping container inspections at loading docks they are supposed to be doing already - illicit drugs and terrorism and all that jazz. How much priority will a 2 ounce package from FastTech get in the customs rumba line?

 

[zoiDman]

Exactly say good bye to the refill bottles it will be limited flavors in a cartridge which mean available from few manufactures - NO CLONES because clones will not be approved by FDA and limited choices on wicking material and coils. RDA, RBA, tanks say good bye to them not possible to be a closed system that is refillable or able to be re-wicked or re-coiled - to damn expensive to replace.

Think we can buy stuff outside of the country. Customs - each package has to be marked what is in it and the value. Says e-cigs on it, it will never get past customs without being opened - bye bye.

It's Worse that that MM.

Because something like the RJ Reynolds VUSE has a Proprietary Connector. So it Isn't going to Screw onto your Mod. Or any other Mod but a Vuse.

And the Cartridge is "Chip Enabled" just like many Ink Jet Cartridges. So even if you Do cut the cartridge open to try and Re-Fill/Re-Wick it, when the Chip says the Cartridge is Empty, it Won't Fire anymore.

BTW - Good to see you again MM. Have you been keeping "The One Who Shall Not Be Mentioned" in-line?

 

[zoiDman]

This is why I stopped playing in these discussions. I'm not jumping on the WE'RE ALL GONNA DIE circular bandwagon.

What do you think customs is going to do with all those itty bitty packages? The hundreds of thousands that arrive in this country every day? They can't even keep on top of the random shipping container inspections at loading docks they are supposed to be doing already - illicit drugs and terrorism and all that jazz. How much priority will a 2 ounce package from FastTech get in the customs rumba line?

Just curious. What form of Payment did you Use on your Last Fasttech Order?

 

[mightymen]

It's Worse that that MM.

Because something like the RJ Reynolds VUSE has a Proprietary Connector. So it Isn't going to Screw onto your Mod. Or any other Mod but a Vuse.

And the Cartridge is "Chip Enabled" just like many Ink Jet Cartridges. So even if you Do cut the cartridge open to try and Re-Fill/Re-Wick it, when the Chip says the Cartridge is Empty, it Won't Fire anymore.

BTW - Good to see you again MM. Have you been keeping "The One Who Shall Not Be Mentioned" in-line?

Forum ignore function works when applied self discipline is required though.

Anyway that was my point unless supreme court overturns this garbage we are screwed. The market will take a nose dive unless the community of manufactures state side all gets together and remove E-cigs and nicotine from the wording and wait until FDA challenges it and it goes to the supreme court and evidence shows the product is not under FDA control to be regulated as a cig or smoking device. That's going to take money and time plus and FDA Hitler patrol will be closing business down or at least attempting to and imposing heavy fines. I don't see china or anyone outside of the country investing the money or time. China might rename products and leave the rest up to us. Forget about juice which has nicotine in it, still will be under FDA control. We will be able to get all the concentrated flavors, PG/VG, wicks, wire we want but everything else big problems. Nicotine could be a horror story also just a matter of bill or regulation that classifies nicotine as a controlled substance. With the way people’s minds are working these days doesn't seem impossible anymore to me.

 

[mightymen]

This is why I stopped playing in these discussions. I'm not jumping on the WE'RE ALL GONNA DIE circular bandwagon.

What do you think customs is going to do with all those itty bitty packages? The hundreds of thousands that arrive in this country every day? They can't even keep on top of the random shipping container inspections at loading docks they are supposed to be doing already - illicit drugs and terrorism and all that jazz. How much priority will a 2 ounce package from FastTech get in the customs rumba line?

No priority at all. They'll get dumped in a bin and when more people get hired they might look at it someday and if it meets FDA regulation you'll get it if not you might get a fine but NO package.

 

[zoiDman]

Forum ignore function works when applied self discipline is required though.

Anyway that was my point unless supreme court overturns this garbage we are screwed. The market will take a nose dive unless the community of manufactures state side all gets together and remove E-cigs and nicotine from the wording and wait until FDA challenges it and it goes to the supreme court and evidence shows the product is not under FDA control to be regulated as a cig or smoking device. That's going to take money and time plus and FDA Hitler patrol will be closing business down or at least attempting to and imposing heavy fines. I don't see china or anyone outside of the country investing the money or time. China might rename products and leave the rest up to us. Forget about juice which has nicotine in it, still will be under FDA control. We will be able to get all the concentrated flavors, PG/VG, wicks, wire we want but everything else big problems. Nicotine could be a horror story also just a matter of bill or regulation that classifies nicotine as a controlled substance. With the way people’s minds are working these days doesn't seem impossible anymore to me.

Yeah... I foresee a Challenge going to the SC.

And that is what makes this Circus (I mean Presidential Election) Very Important. Because the Next President will be presenting 2 Nominees to sit on the Highest Court.

And whoever gets to the SC, and the Balance or Majority that they provide, it will be that way for Long Time.

 

[mrZoSo]

I was wondering about this and what it does to Imeo producing new mods and selling in the US. Not very promising.
The FDA has set the date of Aug. 8th, 2016 as a deadline for bringing new vaping products to market. After this date FDA approval will be needed, likely a very expensive and and lengthy procedure.

Aug. 8th 2016 is when the Deeming Regulations go into effect.
HR2058 was to try and change the predicate date to Aug 8th, but HR2058 is pretty much dead.
Predicate date is any product on the market since 2007, will have to go through the new regulations.
The Cole/Bishop Amendment is what is important now. It also moves the predicate date but adds fair regulations and also aims at bipartisanship support.

Phil Busardo and Dimitris Agrafiotis have a great informative video about the new FDA regulations, I suggest everyone should watch. They start talking about it at 13:30. It's a long video but so worth watching!

any idea about the money they are needed to file a PMTA and approved by fda zoi?

Just an example: an E-liquid line with 4 juice flavors has 3 nicotine levels. The minimum cost for just having the e-juice application is 4 (flavors) x 3 Nicotine levels = 12 applications x 330,000usd = $3,960,000 USD! And this is the cost just for the e-liquid line.
Accessories such as 18650 batteries, coil replacements, etc all would have separate $330,000 FDA fee.
Note: =$330k was the initial estimate from the FDA.
The actual fee has yet to be officially released. With lawyers fees, testing fees, etc., each application is estimated to cost more around $500k per application.

 

[imeothanasis]

lol

It becomes more like a joke

 

[mrZoSo]

It sure does, but it's not.
Very few companies can afford that. So, whats that leave, 'big tobacco' and taxes on top.
Greed is such an ugly thing!

 

[imeothanasis]

The amount is very big and yes, only very very few companies can handle this amount of money Mr. Also they will always sell the same juices, so innovation in juices will be gone too.

I have a great thought that will change things, really. FDA will look with their mouth open in a while I hope

 

[mrZoSo]

Maybe you should get that idea to the FDA very soon. These regulations are what they are, and FINAL.
If nothing is done by Aug 8th and the Cole/Bishop Amendment doesn't go through, the vaping industry as a whole, is pretty much screwed.
Maybe you should get in touch with Dimitris Agrafiotis, he's very involved in the advocacy!!

 

[AdamAnd]

The amount is very big and yes, only very very few companies can handle this amount of money Mr. Also they will always sell the same juices, so innovation in juices will be gone too.

I have a great thought that will change things, really. FDA will look with their mouth open in a while I hope

The only thing that is the problem is the nicotine everything else can be bought separate i.e. PG, VG , Flavours
Sell them seperate in the right protions then leave the mixing to me LOL

 

[mrZoSo]

The only thing that is the problem is the nicotine everything else can be bought separate i.e. PG, VG , Flavours
Sell them seperate in the right protions then leave the mixing to me LOL

If that was the case, no one would be worrying about the new regulations.
Wish it was that easy though.

 

[zoiDman]

lol

It becomes more like a joke

Yeah... Kinda Crazy isn't it.

But didn't we Know it was Coming? Didn't we know from Previous FDA Docs that it could be this Bad? Where was the Concern 2 years ago?

The Reality of the Situation is the Vast Majority of people who use an e-Cigarette don't even Know what is Facing them. And why is That? Did OEM's/Retailers do their part in Providing Information to those who Vape?

I today got a e-Mail from a e-Cigarette/e-Liquid Retailer. Nice Glossy Pictures of the Latest RTA. And Cool descriptions of some "Juice" that is all but Guaranteed to be your Next ADV. And if I buy some amount I can even get Free Shipping.

That's Just Great.

But No Mention the FDA "Deeming". No Mention of groups like SFATA or CASAA. No Links to an Advocacy/Information Page on their Website. Because they Don't have one.

 

[mrZoSo]

I agree. You're now going to see a pretty big influx of "sales". Alot of companies are going to try and get what they can before they get closed up, because they did nothing a while back.

 

[mrZoSo]

It would be real nice to see GG help support the fight against the FDA.
After all, it's not just about product innovation and sales, which would be stifled if these regulations go through, but also giving a chance for current smokers to make the switch to vaping and save lives. If the regulations go through with no changes, the majority of these future vapors, will be too discouraged to even try.
Maybe one of these groups would work:
Vaping Advocacy and Trade Organizations