FDA FDA deeming regulation proposals

[stinkypete]

I may be way out of line here but I cannot help but think that they are shooting for a way to regulate/limit/TAX eliquids and devices. If the ecig industry made over 1 billion dollars or so (think thats what i read) thats money that the government has lost from tobacco. Im not a crazy conspiracy person or anything but I know the government does not want to miss out on taxable goods.

 

[propagandax]

How can you post health warning if you have no actual proof? Its mind boggling and riddled with confusion.

Sent from my Nexus 7 using Tapatalk

 

[Katya]

How can you post health warning if you have no actual proof? Its mind boggling and riddled with confusion.

Sent from my Nexus 7 using Tapatalk

You obviously don't care about the children.

They can. They are from the government and they are here to help.

 

[Jman8]

What I have read is not good for us or the industry as a whole, liquids as well as devices will fall under FDA's control, and there will be a lengthy, expensive application process to get approval for ANY product not on the market prior to February 2007.
This means 99.9% of what we currently use is affected by this, and if a vendor can afford to apply for approval of a liquid or device there application can be rejected for any reason that the FDA feels, almost all of your small vendors, and most of your medium vendors will not be able to get approval, this huge influx of devices and liquids we see now will be non existent, the FDA does not have the man power to approve everything we enjoy now in the 2 years till everything really kicks in, not to mention any new liquids and devices that aren't even out yet.
And this affects EVERY vaper and vendor, everyone needs to get involved or everything the vaping community has fought for will have been in vain.

How much do you see as the 'cost for applying for approval?'

I have my own opinions on this, based on information available (on this thread), but am curious what those who espouse what you are saying, see as the cost for applying.

 

[Schwiggiddy]

I'm not even sure these rules apply to devices that do not contain nicotine when they are sold. So all cartos attys Kayfuns etc would not be covered unless you sold them pre-filled. I challenge the FDA to prove a Kayfun or a T3S is a "tobacco product."

 

[Barbara21]

I admit - I'm totally confused.

I don't know what to think. I'm not a lawyer and the gobblety-.... language of the regulations makes my brain hurt.

In terms of *hardware* - batteries, cartos, atomizers, RDAs, RBAs, etc. (with the exception of pre-filled cartridges that contain nicotine liquid) - are they saying that any of these not on the market before 2007 have to be 'approved' before they can be sold?

(Haha - the forum edited my gobblety- 'g.o.o.k' reference. No, it wasn't racist, it's a common term. Definitely not meant to cause offense. )

 

[Dj Xy]

How much do you see as the 'cost for applying for approval?'

I have my own opinions on this, based on information available (on this thread), but am curious what those who espouse what you are saying, see as the cost for applying.

Submitting anything for FDA approval comes with a fee.

 

[Dj Xy]

I'm not even sure these rules apply to devices that do not contain nicotine when they are sold. So all cartos attys Kayfuns etc would not be covered unless you sold them pre-filled. I challenge the FDA to prove a Kayfun or a T3S is a "tobacco product."

Its does specify accessories used for the delivery of tobacco products (in this case eliquid) must be approved.
Right now even cigarette rolling papers must be approved, so what makes anyone think our devices will get different treatment.

 

[Gato del Jugo]

Here is an informative teleconference from CASAAs forum

https://www.youtube.com/watch?v=NaWLRIjc2AU

Thanks for the link..


I enjoyed the Q&A, which starts around 13:45...

 

[Gato del Jugo]

Two quick comments..


1.) At face value, the FDA seems to be pretty open, per their written proposal & teleconference, to how to go about all this, since there are a lot of moving parts in terms of vaping..

Question: Do you think they'll seriously take into consideration all submitted comments, which could have a positive impact on the final regulations? Or is this more or less pretty much pre-determined, and they're just blowing smoke up our bums to appease certain groups?


2.) It appears that the definition of vape equipment (e.g., PVs, toppers) as tobacco products to be regulated is pretty open-ended.. And seems to be quite a gray area with a lot of implied leeway of potentially skirting that definition... Sort of like how metal, glass, ceramic pipes & such can be used for loose tobacco (or other dried plant material) is also currently outside that definition & is not regulated by the FDA... Perhaps the vaping community/industry should try to follow that model so all our vape gear does not fall under regulation...

 

[Jman8]

Submitting anything for FDA approval comes with a fee.

Okay, but that doesn't address it as costly.

Let's say it costs a small business, $50 per application for 'major components' (i.e. battery kit). Is that costly?

I'm already anticipating people's responses of thinking this could be costly if company has umpteen hundred different components, but really I'm just trying to determine what people think is 'too costly.'

 

[Gato del Jugo]

I'm not even sure these rules apply to devices that do not contain nicotine when they are sold. So all cartos attys Kayfuns etc would not be covered unless you sold them pre-filled. I challenge the FDA to prove a Kayfun or a T3S is a "tobacco product."

If what the FDA is saying is to be taken at face value, then it sounds like if they hear enough / convincing enough arguments that vape gear (PVs, toppers) shouldn't fall under the definition of regulated tobacco products, then that could sway their decision not to include them.. and instead just go after stuff like non-zero nic pre-filled cartridges & non-zero nic bottled liquid...


But, maybe I'm just being too naive / optimistic...

 

[Jman8]

I admit - I'm totally confused.

I don't know what to think. I'm not a lawyer and the gobblety-.... language of the regulations makes my brain hurt.

In terms of *hardware* - batteries, cartos, atomizers, RDAs, RBAs, etc. (with the exception of pre-filled cartridges that contain nicotine liquid) - are they saying that any of these not on the market before 2007 have to be 'approved' before they can be sold?

In my understanding of proposal and related news from today, they are saying anything not on the market before 2007 needs approval. And, more importantly, asking for comment on that, plus asking for comment on their additional proposal that allows for 2 year grace period to get all products approved, or rather reviewed, that are in the market now.

And they are saying, after 2 years, new products can be approved, but cannot be marketed until they have been approved. In the grace period, they are saying they won't enforce a ban on any products under review.

 

[Jman8]

At face value, the FDA seems to be pretty open, per their written proposal & teleconference, to how to go about all this, since there are a lot of moving parts in terms of vaping..

Question: Do you think they'll seriously take into consideration all submitted comments, which could have a positive impact on the final regulations? Or is this more or less pretty much pre-determined, and they're just blowing smoke up our bums to appease certain groups?

I think (don't know) that they, being government types, feel it is their duty and service to take all comments into consideration, and let that influence the actual legal regulations they put into place. Emphasis on all. Yet, I think they will give higher value to comments that are better written (organized with a layout), and that cite supporting references for massive claims (i.e. eCigs save lives).

 

[215Z]

Okay, but that doesn't address it as costly.

Let's say it costs a small business, $50 per application for 'major components' (i.e. battery kit). Is that costly?

I'm already anticipating people's responses of thinking this could be costly if company has umpteen hundred different components, but really I'm just trying to determine what people think is 'too costly.'

[misinformation deleted. i don't see any fee listed for Premarket Tobacco Application. There is also a "substantial equivalence report" alternative]

 

[JackInCali]

Fees are right here, no need to speculate:
PMA Review Fees
We get the "small business" fee schedule with a first-submission freebie.

So am I reading that right? $64,000 to put out a brand of e juice or APV? Which could subsequently be denied without a refund?

 

[Tom Servo]

So am I reading that right? $64,000 to put out a brand of e juice or APV? Which could subsequently be denied without a refund?

If I'm reading things right, the hardware isn't affected:

For purposes of this part, FDA considers any loose tobacco, including pipe tobacco, and the nicotine in e-cigarette cartridges to be within the definition of "covered tobacco product." FDA proposes to treat covered tobacco products in a manner consistent with FDA's treatment of cigarettes and smokeless tobacco throughout part 1140. In current part 1140, FDA imposes restrictions on cigarettes and smokeless tobacco, but not on the components, parts, and accessories of such products. [p. 131]

Still, the approval process for liquid is going to be very problematic.

 

[Killaq2188]

So will they be changing the fees for the forms due to creating new regulations on e-cigs?

 

[Gato del Jugo]

Fees are right here, no need to speculate:
PMA Review Fees
We get the "small business" fee schedule with a first-submission freebie.

Not sure e-liquid is considered a medical device...

 

[Katya]

Fees are right here, no need to speculate:
PMA Review Fees
We get the "small business" fee schedule with a first-submission freebie.

Not sure:

"First premarket approval submission (PMA) from firms with
gross receipts or sales ≤ $30 million--fee is waived. "