FDA FDA deeming regulation proposals

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Katya

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Anybody hear of any juice-makers, for example, doing fundraising for this?


You know, something like, "For all purchases between now & ___, 10% of proceeds will be donated to CASAA to help keep vaping alive!"

No, but they should. There are plenty of vapers out there who have no idea what is going on. And vendors who seem to be strangely apathetic...
 

Katya

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1) tobacco products jurisdiction - anything derived from tobacco injested by consumers recreationally. (Not insecticides or some - say - fabric created from tobacco leaves intended to be used as clothing, etc.).

Now what is to prevent Nude Nicotine or Wizard Lab to label their nicotine base "Insecticide" ?

I'm not joking--this is a serious question.
 

salemgold

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No, but they should. There are plenty of vapers out there who have no idea what is going on. And vendors who seem to be strangely apathetic...

I know, right. That makes me wonder if they possibly could be that naive or are they seriously thinking that they may survive this?

Even if they are set up well, they are going to have to go through the application process and I just don't feel that is going to turn out well for very many if any. I would love to be wrong about that but, I really don't think so.
 

Sirius

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What does eGos mean? I think eGos = batteries, but you presumably don't mean that (?).

(I'm not sure it will be legal to trade nic juice once the 2-year window is closed. Fortunately I'm going nic free so I don't expect to have any. And frankly if I were inclined to do so, I woudn't be advertising it. Sooner or later water-soluble nic is going to become schedule II, methinks - after "medicalization" of course. That may be a good five years down the road. Or earlier.)

Incidently just because I'm a Dem, one is (=you are) free to conclude that I might be more inclined to bail someone else out. But I am not more inclined to ask anyone to bail me out. Just so we're clear about that :)

I hate bringing politics into it but..since you already did. :D
I'm diehard Libertarian and wished the two party system would go away. A more Libertarian form of government would mean less government in our lives. If we had that, we wouldn't even be discussing the FDA. lol
 

Sirius

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I know, right. That makes me wonder if they possibly could be that naive or are they seriously thinking that they may survive this?

Even if they are set up well, they are going to have to go through the application process and I just don't feel that is going to turn out well for very many if any. I would love to be wrong about that but, I really don't think so.

The only (vendors) that will survive will be those willing to pay big $'s to stay in business. It's a money thing and as I said before, big money is behind this. (BT Pharm)
 

DC2

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Now what is to prevent Nude Nicotine or Wizard Lab to label their nicotine base "Insecticide" ?

I'm not joking--this is a serious question.
I don't know how current this is, but...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

This document presents the Environmental Protection Agency’s (EPA’s or the Agency’s) decision regarding the reregistration eligibility of the registered uses of the active ingredient nicotine. The Agency conducted human health and environmental fate and effects risk assessments for nicotine non-food uses. The registrant of the sole remaining nicotine pesticide product requested the cancellation of its registration on February 25, 2008, to be effective on December 31, 2013, with existing stocks permitted to be sold by dealers and distributors for one additional year. The Agency has accepted this request in concept, and it is subject to notice and public comment. If public comment provides no information that causes the Agency to reconsider, the Agency may accept the cancellation request.

The assessment of risks for the pesticidal use of nicotine is unique in that much of the supporting data is drawn from the open literature, as opposed to studies conducted according to Agency guidelines, and the data that are available are not entirely wellmatched to anticipated routes of exposure and use patterns for the nicotine pesticide. The lack of more relevant data adds considerable uncertainty to the risk assessment and would necessitate that the Agency call-in data from a range of guideline studies. Ultimately, the process the Agency undertook to assess risks and formulate reregistration eligibility decisions was overtaken by the registrant’s request for cancellation. The Agency is finalizing this reregistration eligibility decision as a record of the database and methodologies that were used to assess nicotine and the Agency’s preliminary conclusions about the risks associated with its use.

The sole remaining nicotine registration, for which cancellation has been requested, is a Restricted Use Pesticide used on greenhouse ornamentals, including poinsettias, bedding plants, and chrysanthemums to control whiteflies, aphids, and thrips. Nicotine has been known for its pesticidal properties for centuries, and came into common use in the U.S. about sixty years ago. Production and usage are now quite limited.

Using the limited available data, EPA has assessed the human health risks for the remaining nicotine registration and has concluded that risks for workers both during and after application, and for consumers of plants from treated greenhouses and members of the public who might be exposed to nicotine residues in treated greenhouses, are potentially of concern. Nicotine is not used on any food and feed crops so dietary risks have not been assessed. Because nicotine is used in greenhouses only, drinking water and ecological risks were not assessed for this use pattern, although the Agency did assess the ecological risks associated with another nicotine product used outdoors to repel vertebrate pests of ornamentals which has since been cancelled. The ecological risk assessment and an assessment of episodic ingestion of the nicotine repellant product are posted to the nicotine docket, as are the technical documents supporting the human health risk assessment for the nicotine greenhouse use.
 

tombaker

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I know, right. That makes me wonder if they possibly could be that naive or are they seriously thinking that they may survive this?

Even if they are set up well, they are going to have to go through the application process and I just don't feel that is going to turn out well for very many if any. I would love to be wrong about that but, I really don't think so.

I think the industry and vendor response welcoming the new regulations, is probably more of an indicator that they are NOT naive, and they think they will indeed thrive and survive. A small juice maker like Apollo E-Cigs is talking about its super clean manufacturing process, already built and running, and is happy with the Regs, as so with Njoy and V2, and Johnson Creek, the grand-daddy of Juice makers.

ECBlend which I consider a small player, (a big small, not tiny) is also happy with the Regs.

So we have on one hand, the industry, and their lawyers and compliance officers looking at it, saying we are good to go. I am not sure what your logic is, but I don't think it will push off the weight of the other side off the scale. They have mass.

Have you seen anyone in the industry, someone who will have to deal with the FDA themselves actually, the businesses themselves only....who has come out against the Regulations? I have not seen a business complaining.

Link me up if we have any Juice or Hardware Companies who are publishing concern. I have seen CASAA, but I am really looking at the people who pay their bills with the business of E-Cigs, because they are the most vested into the outcome. The 10 Million dollars per single product application....well it seems the entirety of E-Liquid industry.....does not see that as being the case. I don't think Johnson Creek are a bunch of buffoons or anything, or Apollo, I think they have good knowledge of their businesses.

How could they possibly not know what to expect, most have been in meetings with the FDA over time.

But right now, if we have the industry vs your quote above, I gotta think the industry has it right. Make sense?
 
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I think the industry and vendor response welcoming the new regulations, is probably more of an indicator that they are NOT naive, and they think they will indeed thrive and survive. A small juice maker like Apollo E-Cigs is talking about its super clean manufacturing process, already built and running, and is happy with the Regs, as so with Njoy and V2, and Johnson Creek, the grand-daddy of Juice makers.

ECBlend which I consider a small player, (a big small, not tiny) is also happy with the Regs.

So we have on one hand, the industry, and their lawyers and compliance officers looking at it, saying we are good to go. I am not sure what your logic is, but I don't think it will push off the weight of the other side off the scale. They have mass.

Have you seen anyone in the industry, someone who will have to deal with the FDA themselves actually, the businesses themselves only....who has come out against the Regulations? I have not seen a business complaining.

Link me up if we have any Juice or Hardware Companies who are publishing concern. I have seen CASAA, but I am really looking at the people who pay their bills with the business of E-Cigs, because they are the most vested into the outcome. The 10 Million dollars per single product application....well it seems the entirety of E-Liquid industry.....does not see that as being the case. I don't think Johnson Creek are a bunch of buffoons or anything, or Apollo, I think they have good knowledge of their businesses.

How could they possibly not know what to expect, most have been in meetings with the FDA over time.

But right now, if we have the industry vs your quote above, I gotta think the industry has it right. Make sense?

THen again, the industry people are likely no more experts on government regulations and laws than most here. I tend to think most government regulatory services are a bad thing. This market should only require minmal regulation by way of making sure the juices are "safe", but this is the same government that allows who knows what in our foods etc. so really, we don't need this at all. It's pretty simple.
 

Sirius

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And on a political note: ;)

Rasmussen Poll shows 53% think neither Democrats nor Republicans represent the American people.
WASHINGTON - According to ballot access expert Richard Winger, Libertarian Party voter registration in the U.S. has grown 11.4% since late 2012. Registration in all other nationally-organized parties has decreased.
https://www.lp.org/

.....this may just be the news we are hoping for. Limit the government. Limit the FDA from regulation of e-cigs.
 

mkbilbo

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Oh great this thread has now been exposed, sigh.

Hmmm, should I leave my coat hanging?

For now, FDA if u can hear me I'm very concerned about your deeming regulations inre to ecigs, can u please have some compassion and allow us to Vape peacefully and freely. TY.

Exposed?

Wait, is it having that dream where you're in school naked?
 

mkbilbo

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I think the industry and vendor response welcoming the new regulations, is probably more of an indicator that they are NOT naive, and they think they will indeed thrive and survive. A small juice maker like Apollo E-Cigs is talking about its super clean manufacturing process, already built and running, and is happy with the Regs, as so with Njoy and V2, and Johnson Creek, the grand-daddy of Juice makers.

ECBlend which I consider a small player, (a big small, not tiny) is also happy with the Regs.

So we have on one hand, the industry, and their lawyers and compliance officers looking at it, saying we are good to go. I am not sure what your logic is, but I don't think it will push off the weight of the other side off the scale. They have mass.

Have you seen anyone in the industry, someone who will have to deal with the FDA themselves actually, the businesses themselves only....who has come out against the Regulations? I have not seen a business complaining.

Link me up if we have any Juice or Hardware Companies who are publishing concern. I have seen CASAA, but I am really looking at the people who pay their bills with the business of E-Cigs, because they are the most vested into the outcome. The 10 Million dollars per single product application....well it seems the entirety of E-Liquid industry.....does not see that as being the case. I don't think Johnson Creek are a bunch of buffoons or anything, or Apollo, I think they have good knowledge of their businesses.

How could they possibly not know what to expect, most have been in meetings with the FDA over time.

But right now, if we have the industry vs your quote above, I gotta think the industry has it right. Make sense?


Given Johnson Creek's response, they can't possibly believe the regs mean every, single flavor has a separate registration. I doubt even they could stay in business then.

Or they're wrong?

Or they figure they can make The One Approved Juice for tobacco owned vape like Blu (who they have an exclusive contract of some kind)?
 

mkbilbo

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No, but they should. There are plenty of vapers out there who have no idea what is going on. And vendors who seem to be strangely apathetic...

That would be up to us to enforce by telling our regular vendors that our money goes to non-apathetic businesses.

Oh... hey...

"Look for the CASAA label!..."

(No, I can't sing. The judge was adamant on that point.)
 

Sirius

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Given Johnson Creek's response, they can't possibly believe the regs mean every, single flavor has a separate registration. I doubt even they could stay in business then.

Or they're wrong?

Or they figure they can make The One Approved Juice for tobacco owned vape like Blu (who they have an exclusive contract of some kind)?

Ha! Wouldn't that be something? Every vendor with just one flavor. That way when we go to their site we wouldn't act like a cross eyed dog in a hubcap factory trying to pick juices. AV with just Bobas or Gorilla. Ahlusions with only Smooth Criminal..ect. ect. lol :D
 

mkbilbo

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Ha! Wouldn't that be something? Every vendor with just one flavor. That way when we go to their site we wouldn't act like a cross eyed dog in a hubcap factory trying to pick juices. AV with just Bobas or Gorilla. Ahlusions with only Smooth Criminal..ect. ect. lol :D

Nope! No flavors! Because of the chiiiiiilllllllldddrrrrrrrrriiiiiiinnnnn!!!

You'll have FDA approved plain and you'll like it citizen!

(Also, the chocolate rations have been increased!)
 

Thundernoggin

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I'd like some clarification on this as well.

I don't think Johnson Creek are a bunch of buffoons.....Make sense?

I doubt they have anything to worry about. If this all goes as it usually does we will all get screwed over and big tobacco will score another win. Cigalikes for everyone while Lorillard and Johnson Creek laugh all the way to the bank.
 
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