FDA TVECA post table of contents for Deeming Final Rule

[Outcast]

Might want to Double Check that Math.

Did I mess up may have lol


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[Katya]

Page 7, Lines 253 ~ 271


2. ENDS Retailers Who Mix or Prepare Their Own E-Liqlljd.~ or Create or
Modify Acrosoiidng Apparatus ji-om VariOliS Componerus


An ENDS retail establishment that mixes and/or prepares combinations of liquid nicotine,
flavors, and/or other liquids for direct sale to consumers for use in ENDS or creates or modifies
aerosolizing apparatus for direct sale to consumers for use in ENDS (sometimes known as a vape
shop) meets the defmition of .. tobacco product manufacturer" in section 900(20)6 of the FD&C
Act (21 U.S.c. 387(20» and the combinations il mixes and/or prepares are "new tobacco
products" within the meaning of section 91 O(a)( 1). Section 91 O(a)(1 ) defi.nes a '"' new tobacco
product" as "any tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 1 S, 2007," or '"any modification
(including a change in design, any component. any pan. or any conslituent. including a smoke
constituent. or in the conlent. delivery or fonn of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed in the Uni ted States
after February 15, 2007." Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers.

---

Note: Sorry if some words are Wacked. The OCR Software I used on the Original PDF isn't the Greatest.

"Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers."

That would mean zero nic liquids, too, correct?

 

[Kent C]

But the intro sections on definitions starts off with - if a product is sold specifically for or reasonably intended for use with.

Did they define "reasonably" or what efforts would be made to ensure that?

There's case law on that btw.... which is specifically to what they are referring in some parts of the doc. I listed the handful of cases in earlier posts - one of them involved nitrous oxide and balloons. The sale of balloons were restricted (in certain areas) because they could be used for that.

Anyway, I hope you're right.

 

[squee]

That would mean zero nic liquids, too, correct?

Not what's quoted but yes. There's another section that specifically mentions 'nic-free and zero-nic' as being regulated the same, as they're still intended for inhalation

 

[Katya]

Did I mess up may have lol


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Per my calculations, 1 liter of 100 mg/ml nicotine base should last me about 5.5 years (at 4-5 ml per day, 10-12 mg/ml, roughly).

 

[puffon]

You would think China would be putting some pressure on our government.
US owes them $billions, their economy is not in great shape now. Many of their factories will be shuttered.

 

[zoiDman]

"Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers."

That would mean zero nic liquids, too, correct?

I'm not sure How to Interoperate 0mg right now.

The OCR Software did such a So-So job of converting the PDF, I'm having a hard time Searching.

I did see this on Page #6


212 ... For the purposes of this guidance document, liquid nicotine and nicofille-
213 containing e-liquids (i.e .. liquid nicotine combined with colorings, flavorings, and/or potentially
214 other ingredients) are generally referred to as e-liquids. Liquids that do not contain nicotine or
215 other material made or derived from tobacco but that are intended or reasonably expected to be
216 used with or for the human consumption of a tobacco product also are referred to as e-liquids for
217 the purposes of this guidance document. For example, where a "zero nicotine" or "nicotine free"
218 e-liquid is imended or reasonably expected to be mixed with liquid nicotine. that e-liqu.id may be
219 a component or pan of a tobacco product and subject to FDA' s tobacco control authorities. FDA
220 considers such e-Liquids to be a tobacco product even if sold separately from an aerosolizing
221 apparatus.

 

[Katya]

You would think China would be putting some pressure on our government.
US owes them $billions, their economy is not in great shape now. Many of their factories will be shuttered.

Right.

But there's a new global assault on vaping started by the WHO.

http://www.forbes.com/sites/sallysa...he-world-health-organization-on-e-cigarettes/

 

[Stephen1520]

Sen. Ted Cruz (R-TX), Sen. John Cornyn (R-TX), Rep. Blake Farenthold (R-TX)

All notified of my position (for what it's worth)!

 

[Outcast]

Per my calculations, 1 liter of 100 mg/ml nicotine base should last me about 5.5 years (at 4-5 ml per day, 10-12 mg/ml, roughly).

Ya I'm going to get 2l thy say it's good 6+ years as vg In the freezer I'm going to put it in glass and store in my chest freezer in the bacment


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[MattVid]

Hmmm, I guess I am in the minority on here. Still reading through the full PDF (thanks for pointing out the link, didn't get that far into the thread yet ). But I don't see all of this as that out of line.

I am sure e-cigarette/vaping/e-juice/etc. companies are making tons of money because they are not needing to follow any regulations what so ever. Apparently, the government is there to watch out for our own well being, welcome to the United States (even though, they could care less about other things ... but that is another discussion entirely). This isn't the first drug/product needing to go through all of this ... I work in the electronics industry, working with all sorts of products, from IT, to industrial, to military, to medical. I am very familiar with looking through all this regulatory documentation and testing these products.

I mean, look at what they are wanting to know/shown with the products:
E-Juice:
-The ingredients list (isn't that good for us?)
-Chemical analysis, and what is really in it, is it harmful to people (why would anyone be opposed to this?)
-Labeling on bottles (90% of it already seems there from the juice I buy)
-Further scientific and research/clinical studies on the long term effects (how is more information and data a bad thing?)

Box Mods/Vape Pens/Atomizers/etc.
-Safety information on the batteries, power levels, short circuit protection, etc. (most all of this is already there)
-More labeling stuff, a pain, sure, but not a huge deal.
-More studies on vaping in general with consumption of cigarettes/going back to smoking/starting smoking/etc. There is A LOT of information about this already, which we/they can use.

Honestly, I would love to get more information on vaping in general, as it is still a rather new thing. Sure there are a lot of studies out there, but all of these can be analyzed and used to get the FDA approval.

I find it humorous that cigarettes lacked all of this study to begin with, and now look where we are at with those. Is it not reasonable to have a similar request for something that is replacing a cigarette? Every other product under the sun goes through the same scrutiny, especially if it has anything to do with going in the human body.

I think my only concern is increase in cost, but it is a little early to get jazzed up about that. I guess, I can't say I am totally opposed to this, as it seems pretty rational to me. I will just have to see where everything stands after the dust settles.

Don't get me wrong, I am not one to support the government and them telling me what to do. But they already act that way, and have done for some time, this doesn't seem like much of a blind side to me. Looks like pretty typical regulation for any new product to enter the market.

 

[FlamingoTutu]

But this is absurd. Are they seriously going to regulate cotton balls?

They are deploying half a million Umpa Lumpas to stand on Wal-Mart conveyer belts and grill customers about why they are buying VG and cotton balls. Look him straight in the face (avoid giggling) and tell him you use it wipe your derrière because it’s soft. You’ll never be asked again, guaranteed.

 

[Kent C]

Note: Sorry if some words are Wacked. The OCR Software I used on the Original PDF isn't the Greatest.

At least it didn't capitalize every third word just kidding.... Thank you - not kidding

 

[Katya]

They are deploying half a million Umpa Lumpas to stand on Wal-Mart conveyer belts and grill customers about why they are buying VG and cotton balls. Look him straight in the face (avoid giggling) and tell him you use it wipe your derrière because it’s soft. You’ll never be asked again, guaranteed.

Thank you, love! I needed a laugh!

 

[Kent C]

Hmmm, I guess I am in the minority on here.

I hope so.

 

[Rabbit Slayer]

See here: http://tveca.com/tveca_docs/drp_redacted.pdf

Troublingly there's a new section on flavors, and intriguingly one on Vape Stores.

I'm hearing from my sources that this is worse than the original.

Who are your sources and how do we know we can trust what they are saying it accurate?

 

[zoiDman]

"Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers."

That would mean zero nic liquids, too, correct?

BTW - Could this Wording be Applied to a Retailer who would like to Sell a Bottle of Mixed Flavorings for an End User to DIY themselves.

Page #6

217 ... For example, where a "zero nicotine" or "nicotine free"
218 e-liquid is imended or reasonably expected to be mixed with liquid nicotine. that e-liquid may be
219 a component or pan of a tobacco product and subject to FDA' s tobacco control authorities. FDA
220 considers such e-Liquids to be a tobacco product even if sold separately from an aerosolizing
221 apparatus.

The Reason I asked is that some Owners/Retailers are Hoping that even if they can Not Sell e-Liquids that contain Nicotine, that they would be Able to Sell a Bottle of Mixed Flavorings that an End User could put into Unflavored.

 

[skoony]

Hmmm, I guess I am in the minority on here. Still reading through the full PDF (thanks for pointing out the link, didn't get that far into the thread yet ). But I don't see all of this as that out of line.

I am sure e-cigarette/vaping/e-juice/etc. companies are making tons of money because they are not needing to follow any regulations what so ever. Apparently, the government is there to watch out for our own well being, welcome to the United States (even though, they could care less about other things ... but that is another discussion entirely). This isn't the first drug/product needing to go through all of this ... I work in the electronics industry, working with all sorts of products, from IT, to industrial, to military, to medical. I am very familiar with looking through all this regulatory documentation and testing these products.

I mean, look at what they are wanting to know/shown with the products:
E-Juice:
-The ingredients list (isn't that good for us?)
-Chemical analysis, and what is really in it, is it harmful to people (why would anyone be opposed to this?)
-Labeling on bottles (90% of it already seems there from the juice I buy)
-Further scientific and research/clinical studies on the long term effects (how is more information and data a bad thing?)

Box Mods/Vape Pens/Atomizers/etc.
-Safety information on the batteries, power levels, short circuit protection, etc. (most all of this is already there)
-More labeling stuff, a pain, sure, but not a huge deal.
-More studies on vaping in general with consumption of cigarettes/going back to smoking/starting smoking/etc. There is A LOT of information about this already, which we/they can use.

Honestly, I would love to get more information on vaping in general, as it is still a rather new thing. Sure there are a lot of studies out there, but all of these can be analyzed and used to get the FDA approval.

I find it humorous that cigarettes lacked all of this study to begin with, and now look where we are at with those. Is it not reasonable to have a similar request for something that is replacing a cigarette? Every other product under the sun goes through the same scrutiny, especially if it has anything to do with going in the human body.

I think my only concern is increase in cost, but it is a little early to get jazzed up about that. I guess, I can't say I am totally opposed to this, as it seems pretty rational to me. I will just have to see where everything stands after the dust settles.

Don't get me wrong, I am not one to support the government and them telling me what to do. But they already act that way, and have done for some time, this doesn't seem like much of a blind side to me. Looks like pretty typical regulation for any new product to enter the market.

Of course it will be easy as pie. If I make an EGO type battery I would have scientifically
prove using every clearo that would fit in all resistance settings using every combination
of PG/VG/nicotine and flavoring combinations using a sliding scale as the voltage on
the battery drops the precise amount of every chemical being delivered per puff in
parts per million or better.
Piece of cake.
Regards
Mike

 

[Katya]

This is the reply I got from my congressman:

Dear Ms. Reeves,

Thank you for writing in and sharing your concerns about the Food and Drug Administration's (FDA) proposed rule for new tobacco products and H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate the opportunity to hear from you.

In April 2014, the FDA released a draft rule that proposes stricter regulations on pipe tobacco, cigars, nicotine gels, water pipe tobacco, hookah, and e-cigarettes. The proposed rules would require manufacturers to register products and ingredients with the FDA, garner FDA approval before marketing new products, and utilize science-based evidence before making direct or implied claims of product benefits.

In the proposed rule, the FDA laid out two different paths for the consideration of new tobacco products. If a new tobacco product has the same characteristics as a tobacco product that was commercially marketed before February 7, 2007, it would not be subject to a new approval process. If the product does not have the same characteristics as a tobacco product sold by that date, the producer would have to apply with the FDA for a premarket product review of new tobacco products. This could only be avoided if the FDA finds that the products do not raise different questions of public health.

If the FDA finalizes this rule, it is anticipated that new vapor product manufacturers, including those of electronic cigarettes, would have to attempt to have their products qualified as having the same characteristics as other products (also known as "substantial equivalence"). I've heard from some folks who are concerned this would increase the regulatory burden for manufacturers of new tobacco products and limit the ability of consumers to purchase them.

In response to concerns about the impact of this proposed rule on small businesses, Rep. Tom Cole (Okla.) introduced the FDA Deeming Authority Clarification Act of 2015. This legislation would move the deeming regulation date (i.e., the date from which products would have to demonstrate substantial equivalence) from 2007 to 2015. This legislation has been referred to the House Committee on Energy and Commerce, where it is pending a hearing. Though I do not sit on this committee, if this issue does come before the full House for a vote, I will take your thoughts into account.

"if this issue does come before the full House for a vote, I will take your thoughts into account."

Not good. If it doesn't, we're screwed. If it doesn't pass, we're screwed. We're screwed.

 

[zoiDman]

Who are your sources and how do we know we can trust what they are saying it accurate?

TVECA is Reputable.

But Until something comes out of a High Level Domain that ends in .gov, I would consider all this to be "Reference Only".