FDA FDA regulations and the impact on small juice vendors | another side

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Stosh

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Wouldn't this be highly dependent on who is proposing to do the inspections and to what end? Would you want organization that claims vegan lifestyle is above all others inspecting a steak house? ....?

I would be OK with that if they were required to eat a serving of each item on the menu as part of their inspection....:laugh:
 

AndriaD

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I wonder what would happen if COFFEE were substituted for ELECTRONIC CIGARETTES in the legislation? The coffee party would rise up and overturn the evil politicians. It happened with tea over taxation.

Or what about... ......? can you just IMAGINE if you threatened to make that stuff even more expensive than it is? Middle-aged and older men (the ones with power and money!) would have a connimption fit and overthrow the entire gov't!!

Andria
 

Bob Chill

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There's a big difference between inspecting a place occasionally and requiring said place to file an application for "Product Approval" (at a 6-figure cost) for every item on their menu. The former is what restaurants are subject to. The latter is what the FDA appears to be proposing as a requirement for juice manufacturers.

This is really the issue at hand and one that makes little sense if each flavor requires approval. It's completely redundant and stupid for lack of a better term. The ingredients in juice are already approved for consumption. Approval should be a level above the mixers themselves just like all other consumables that are assembled at the retail level.

The grey area boils down the the flavors themselves. That has always been and remains to be the wildcard because there is an obvious difference between inhaling and eating. If flavors can be approved for inhalation at the manufacturer level and the regs have a max nic content for finished product then the only other thing that is necessary is commercial kitchen standards for the mixers.

It really is as simple as that in my mind. And it should be in everyone else's. Especially the decision makers. If each recipe from each vendor needs separate approval then IMO the regulations are nothing more than a ruse to eliminate the small guys and hand it over to the big guys. It wouldn't shock me if that was the case but it would certainly disgust me.

But if unflavored nic juice is allowed to be sold then the loophole to access to flavors is enormous. DIY is really easy. As simple as making a mixed drink once you have a recipe you like.
 

zoiDman

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Here is Something that another Member Posted in another thread that is kinda Interesting...


Let's not try to dismiss everything that doesn't agree with our preferred position that vaping is harmless. :)

Vaping is tobacco harm reduction, not elimination. There are certain risks, not all of them are known or have been thoroughly studied. I trust Dr. Farsalinos and his research--and even he warns about possible risks.

To the OP--if you want to minimize your risks while further studies are being conducted, vape at lower wattages and avoid dry hits, don't overheat your coils and eliquids, and try to vape clear, clean juices with as little flavoring as possible. Also, if you could learn how to vape without inhaling, or inhaling deeply, like one would smoke a pipe or a cigar, that would probably cut your risk to zero.

Here's Dr. Farsalinos's response to the study about formaldehyde in vapor (discussed in the NYT article, among other places).

Formaldehyde release in ecigarette vapor The New York Times story explained in detail

Dr. Farsalinos also recently found diacetyl and related diketones in 69% of eliquids he randomly tested. The paper will be published soon.

https://soundcloud.com/vp-live/smoke-free-radio-episode-3

Summary:
Out of 159 liquids tested, 69% of liquids were found to contain diacetyl. Even from vendors that claimed their e-liquids were diacetyl free. The levels of diacetyl found were not discussed.

In a Completely Unregulated Market, how does Someone who does Not Want to Inhale Diacetyl insure that they are Not?

Regulations are to Me, a Double Edged Sword. In that I can see how Regulations will Benefit Vapers in Many Ways. But I also see how Regulations will be Used to Subvert the e-Cigarette Market also.

It's Very Much a Catch 22. On One Side we Need Them. On the Other Side we Don't.
 

wv2win

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This is really the issue at hand and one that makes little sense if each flavor requires approval. It's completely redundant and stupid for lack of a better term. The ingredients in juice are already approved for consumption. Approval should be a level above the mixers themselves just like all other consumables that are assembled at the retail level.

The grey area boils down the the flavors themselves. That has always been and remains to be the wildcard because there is an obvious difference between inhaling and eating. If flavors can be approved for inhalation at the manufacturer level and the regs have a max nic content for finished product then the only other thing that is necessary is commercial kitchen standards for the mixers.

It really is as simple as that in my mind. And it should be in everyone else's. Especially the decision makers. If each recipe from each vendor needs separate approval then IMO the regulations are nothing more than a ruse to eliminate the small guys and hand it over to the big guys. It wouldn't shock me if that was the case but it would certainly disgust me.

But if unflavored nic juice is allowed to be sold then the loophole to access to flavors is enormous. DIY is really easy. As simple as making a mixed drink once you have a recipe you like.

Then you should be disgusted because that is EXACTLY the purpose of these regulations. They know when cig-a-likes with sealed carts are the only option left standing, the threat to BP, BT and government sin tax revenue will have been eliminated.

I hope you and all informed vapers have not only joined CASAA by now, but are actively supporting CASAA, both financially and by taking action as called for.
 

Bob Chill

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Here is Something that another Member Posted in another thread that is kinda Interesting...




In a Completely Unregulated Market, how does Someone who does Not Want to Inhale Diacetyl insure that they are Not?

Regulations are to Me, a Double Edged Sword. In that I can see how Regulations will Benefit Vapers in Many Ways. But I also see how Regulations will be Used to Subvert the e-Cigarette Market also.

It's Very Much a Catch 22. On One Side we Need Them. On the Other Side we Don't.

It could be as simple as approving the flavors at the manufacturer level. There aren't even that many manufacturers for our purpose. 95% of premix is flavored from a half dozen or so flavor manufacturers.
 

Bob Chill

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Then you should be disgusted because that is EXACTLY the purpose of these regulations. They know when cig-a-likes with sealed carts are the only option left standing, the threat to BP, BT and government sin tax revenue will have been eliminated.

I hope you and all informed vapers have not only joined CASAA by now, but are actively supporting CASAA, both financially and by taking action as called for.

I completely agree. A small part of my brain wants to believe that a reasonable approach (like some of the ones hinted at in the proposal) will prevail. But I wouldn't bet a dollar at 100-1 odds on it.

I joined and donated to CASAA shortly after I joined the forum. It should be a requirement for US members IMO. It's all we got. Complacency is a losing proposition on this issue.
 

zoiDman

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It could be as simple as approving the flavors at the manufacturer level. There aren't even that many manufacturers for our purpose. 95% of premix is flavored from a half dozen or so flavor manufacturers.

I'm Confused.

Are you saying that the FDA should Apply Regulations to people who make Food Flavorings on the Chance that they Might be Used in an e-Liquid?
 

wv2win

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I completely agree. A small part of my brain wants to believe that a reasonable approach (like some of the ones hinted at in the proposal) will prevail. But I wouldn't bet a dollar at 100-1 odds on it.

I joined and donated to CASAA shortly after I joined the forum. It should be a requirement for US members IMO. It's all we got. Complacency is a losing proposition on this issue.

Well stated, Bob and excellent suggestion!
 

Jman8

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If each recipe from each vendor needs separate approval then IMO the regulations are nothing more than a ruse to eliminate the small guys and hand it over to the big guys. It wouldn't shock me if that was the case but it would certainly disgust me.

But if unflavored nic juice is allowed to be sold then the loophole to access to flavors is enormous. DIY is really easy. As simple as making a mixed drink once you have a recipe you like.

Then you should be disgusted because that is EXACTLY the purpose of these regulations. They know when cig-a-likes with sealed carts are the only option left standing, the threat to BP, BT and government sin tax revenue will have been eliminated.

I hope you and all informed vapers have not only joined CASAA by now, but are actively supporting CASAA, both financially and by taking action as called for.

IMO, joining CASAA doesn't lessen the current level of frustration / disgust around proposed regulations. And plausibly increases it. How does it increase it? Because it magnifies the rationale that the purpose for these particular proposed regulations is to eliminate small vendors and hand industry over to big guys. Not that CASAA can do that all on its own, but joining right now, without the clear roadmap going forward, can currently lead to frustration in that there may be no way around this. IOW, it is plausibly setting one up for false hope.

I am current member of CASAA and proud member at the level of combatting local / state issues. Track record there is decent to very good. When issue pops on the radar at that level, the CTA is thorough, delivering confidence in how to transverse the game that opposition is up to. And at that level the FDA is absent and our very vocal opposition is arguably more unified. And arguably more deceptive in their tactics. Yet, we as consumers in the game have a clear role to play and when we play as an organized group, we fare well.

At the national level, with these federally proposed regulations, that our very vocal opposition has expressed own level of disgust at, we haven't managed to change a thing since 4/24/14. Which isn't too bad as reality is that at the federal level, nothing has impacted the market since 4/24/14. It's all a big 'wait and see' game, where consumers are clearly standing on outside looking in.

Yet, I as consumer feel confident going forward. I've expressed several times, in several threads why I have this confidence around federal regulations. The ruse is yet to play out, and if/when it does, I see more than one way that could go down with a vocal minority of (10,000+) consumers in the mix.

We currently are on the side that is winning, have the momentum, have backing from science and yet in face of federally proposed regulations display defeatist attitude every chance we get. Someone like me comes along to challenge that, and seemingly it is best to organize around those messages to downplay them, noting them as false hope and unrealistic in light of what we are up against.

Knowing (or thinking you know) that the current proposed regulations have no other purpose than to hand industry over to big players in the game is a ruse of another sort. With certainty in that position and nothing to swing it back in favor of consumers, it (currently) offers no hope to change the narrative and change the direction of what we are up against. The ruse being that if we join an organized group, that'll somehow change things for either the individual or for the collective group of individuals, when certainty of the organization is there is no benefit to us in these regulations and what's being done at federal level.

I can safely and proudly encourage consumers to join CASAA because of mobilization efforts that happen at local / state level, and do matter. But as a rally cry for what we consumers face with FDA proposed regulations, I find it currently impossible to advocate to a fellow consumer to join CASAA. Especially if said individual has confidence or positive attitude in the fight that is in store for all vapers going forward in light of deeming regulations and future of vaping in America. Legal or otherwise.
 

Bob Chill

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I'm Confused.

Are you saying that the FDA should Apply Regulations to people who make Food Flavorings on the Chance that they Might be Used in an e-Liquid?

Not exactly. I'm saying that the manufacturers get a lineup of flavors approved for vaping. Otherwise it's a complete redundant fiasco at the mixing level. Store A's Grape Explosion would go through a rigorous and expensive approval process and Store B's Fancy Grape Surprise would go through a rigorous and expensive approval process...but they are both using the exact same flavor from the same company. It makes no sense. The baker analogy is a good one. All they need to do is use FDA approved ingredients and bake away. They don't have to get their new cookie tested for anything. There's no reason for it.

Flavor manufacturers should be racing to figure it out. Manufacturers also have the pockets and knowledge to get through the process. They already had to for consumption approval. Juice is pretty low tech and uncomplicated. It only has 4 components.
 

zoiDman

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Not exactly. I'm saying that the manufacturers get a lineup of flavors approved for vaping. Otherwise it's a complete redundant fiasco at the mixing level. Store A's Grape Explosion would go through a rigorous and expensive approval process and Store B's Fancy Grape Surprise would go through a rigorous and expensive approval process...but they are both using the exact same flavor from the same company. It makes no sense. The baker analogy is a good one. All they need to do is use FDA approved ingredients and bake away. They don't have to get their new cookie tested for anything. There's no reason for it.

Flavor manufacturers should be racing to figure it out. Manufacturers also have the pockets and knowledge to get through the process. They already had to for consumption approval. Juice is pretty low tech and uncomplicated. It only has 4 components.

Gotcha...

The Only Hitch I see in this Is Chemical Interactions.

Say I determine what the GRAS Max level of Exposure is for a Cherry Food Flavoring. And then I do the Same for a Cola Flavor.

Does that then Imply that if I Mix the Two Flavorings Together that the GRAS Max Levels will Remain the Same? Or Can New Chemical Compounds be Formed which May Have a Lower GRAS Level of Exposure.

I'm with you on a Reasonable Approach would be that Once a Single Food Flavoring has a GRAS Max Exposure Level set that Anyone should be able to Use that Single Flavor at the Same or Lower Levels and not have to Do a Study on Safety.
 

Bob Chill

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Gotcha...

The Only Hitch I see in this Is Chemical Interactions.

Say I determine what the GRAS Max level of Exposure is for a Cherry Food Flavoring. And then I do the Same for a Cola Flavor.

Does that then Imply that if I Mix the Two Flavorings Together that the GRAS Max Levels will Remain the Same? Or Can New Chemical Compounds be Formed which May Have a Lower GRAS Level of Exposure.

I'm with you on a Reasonable Approach would be that Once a Single Food Flavoring has a GRAS Max Exposure Level set that Anyone should be able to Use that Single Flavor at the Same or Lower Levels and not have to Do a Study on Safety.

It gets awful complicated pretty quick. Good points. And then there is the entire subject of inhalation of the flavorings and the long term effects. Those questions can only be answered with time and we don't have that luxury anymore. It's all a leap of faith of sorts. None of us are 100% what we are doing is as safe as we think it is. And I'm not a chemist, scientist, or doctor so there isn't much I can do but accept the risk of choice and accept consequences if there are any.

Since the vast majority of us are ex-smokers it's pretty easy to make the choice and understanding there could be risk. But now that regulations are coming into play, the decision makers aren't just thinking about ex smokers. They are thinking about everyone because there will be plenty of people who never smoked but start vaping over time. It's happening now already and will pick up steam. My daughters are in high school and said they know a bunch of kids who are using ecigs that never smoked. Hardly a surprise. Of course we could argue that they would have smoked and chose a lesser harm path. But since ecigs don't make you stink and you can stealth use them anywhere, it's pretty appealing to curious kids. You can't smoke cigarettes and go undetected. But you can with ecigs. I personally don't care at all. Kids will always be kids. Ecigs are probably at the near bottom of my list of worries for my kids.
 

zoiDman

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It gets awful complicated pretty quick. ...

It Does.

And when One Does the Permutations and Combinations for all the Food Flavors that are Available, the Numbers are Staggering.

And the Potential for Unwanted Chemical Reactions would be Hard to Determine in Totality.
 

Kent C

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It gets awful complicated pretty quick. Good points. And then there is the entire subject of inhalation of the flavorings and the long term effects. Those questions can only be answered with time and we don't have that luxury anymore.

Actually, all MSDS (Material safety data sheets) I've seen have inhalation data (as well as ingestion, contact, etc.) and have been done for decades - usually for workers in factories that make flavorings (and PG and VG as well - GRAS on both). And it isn't like there hasn't been other inhalation products before ecigs. Most of the FDA/OSHA/CDC docs you'll find on inhalation of flavors deals with diacetyl and acetaldehyde.
 

wv2win

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Jman, it sounds like you are saying that CASAA hasn't done enough or been aggressive enough on the federal level. If that is what you are saying, then I can understand your concern. Unless I missed it, I've been disappointed that we never received a summary of CASAA's meeting with the FDA.

Although unless you are recommending just individual action, I'm not aware of any other organized consumer advocacy option. I haven't seen any concrete action by SAFTA, either. I would presume they have a larger budget.
 

DC2

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Jman, it sounds like you are saying that CASAA hasn't done enough or been aggressive enough on the federal level. If that is what you are saying, then I can understand your concern. Unless I missed it, I've been disappointed that we never received a summary of CASAA's meeting with the FDA.

Although unless you are recommending just individual action, I'm not aware of any other organized consumer advocacy option. I haven't seen any concrete action by SAFTA, either. I would presume they have a larger budget.
CASAA provided the presentation they gave to the FDA.

The reason that there is no summary of the meeting is because it wasn't really a meeting.
It was a listening session where CASAA talks and the FDA sits there and shakes it's head and says nothing.

Other than that, I agree.
I don't know where Jman8 is heading with his last post.
 

Kent C

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CASAA provided the presentation they gave to the FDA.

The reason that there is no summary of the meeting is because it wasn't really a meeting.
It was a listening session where CASAA talks and the FDA sits there and shakes it's head and says nothing.

Other than that, I agree.
I don't know where Jman8 is heading with his last post.

I'd like to know what was said. The reason why I've stated in earlier posts about 'consumer groups'.... and their history. Not saying CASAA conforms with that, but see http://www.e-cigarette-forum.com/fo...economic-impact-analysis-35.html#post13278613
 
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