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

[vapero]

I know there is a lot of talk saying that the FDA will drive out of business the small mixers but I don't think this is a real problem... let's look around on a different business...

alcohol

you do need some kind of testing if you are making a high proof alcohol like tequila vodka or something similar (right?)
but bars just need a license to sell alcohol, they don't have to test their piña colada or their whiskey sour they just use previously tested spirits and mix them with innocuous ingredients.

so wouldn't it be true to juice mixers? don't they just need to acquire previously tested ingredients and mix to their liking just like any bar, nightclub or pub in the world?????

 

[Tinkiegrrl]

They already use only FDA approved ingredients for the most part. The regulations require that the specific mixes be registered with them for the purpose of vaping.

 

[novamatt]

Here's an explanation straight from the mouth of one of our forum suppliers, Clark from Nicoticket. Hopefully this will make more sense.

There's two "pathways" to get any specific product "approved by the FDA"

1) Substantial equivalence: Essentially, we would need to submit that a product we intend to get approved is "equivalent" to a product that existed before February of 2007. Problem - no such product exists.

2) Pre-market Tobacco Application (PMTA) - Estimated cost... 1-1.5million per SKU. Take Custard's Last Stand for example... CLS in 0,6,12,18 - in 15ml, 30ml, 50ml bottles = 12 SKUs. So, the cost to keep a product like CLS alive... somewhere between 12-18million in research, development, testing, etc. THEN - take into consideration that since the inception of the PMTA pathway, approx 20 or so have been submitted and exactly ONE has been approved (a minor change to an existing product). So, net-net - a business like Nicoticket invests millions of dollars to submit an application for which no defined set of application guidelines exists. Even the FDA doesn't know what information they want (or how much). Who wants to invest all that money to submit an application that (in all likelihood) will be denied for "insufficient information?"

So it's going to cost a juice vendor millions and millions of dollars to get their products approved for sale, IF the FDA decides to approve it, and the odds are against approval. Most of these juice vendors are really small companies who don't make enough money in a year to file a single application, much less 12 per flavor.

 

[wrath186]

That scenario is entirely possible, but unlikely. IMHO, the ingredients in ejuice already have FDA approval, including nicotine. Secondly, putting a rigiorous approval process in place would definitely kill the industry entirely as no one would be able to afford it. It would also make it cost prohibitive for those tobacco manufacturers that are, or are looking to acquire an ecig company like Blu. Thirdly, it makes more economic sense to regulate the juice industry to certain standards for purity and safety purposes and taxation.

It makes no sense to kill and obviously growing and highly profitable industry with an over cautious approval process. Especially when it can be a new cash cow for BT and a source of tax revenue for the government. Just my opinion though.

 

[novamatt]

That scenario is entirely possible, but unlikely. IMHO, the ingredients in ejuice already have FDA approval, including nicotine. Secondly, putting a rigiorous approval process in place would definitely kill the industry entirely as no one would be able to afford it. It would also make it cost prohibitive for those tobacco manufacturers that are, or are looking to acquire an ecig company like Blu. Thirdly, it makes more economic sense to regulate the juice industry to certain standards for purity and safety purposes and taxation.

It makes no sense to kill and obviously growing and highly profitable industry with an over cautious approval process. Especially when it can be a new cash cow for BT and a source of tax revenue for the government. Just my opinion though.

What I posted above is based on the regulations that are on the table right now under the deeming proposal. This is how the FDA has stated they want to regulate e-cigarettes. They're under a huge amount of pressure from well-funded interests like big tobacco and the pharmaceutical industry, who are both losing customers in large numbers to vaping, and uneducated politicians who read the same media we do - e-juice is poison, vaping releases formaldehyde, it's a gateway to smoking, flavors are for kids, etc. Additionally, the head of the FDA is a big vocal proponent of the idea that e-cigarettes get kids into smoking.

You're right that regulating this way doesn't make any sense. I'd like to see something like how restaurants are regulated. But this is what's being suggested by the people who get to decide, which makes it quite a bit more likely than one would think it would be. That's why it's so important that we all get on CASAA's mailing list and take the actions they recommend to fight for fair and reasonable regulations and oppose the terrible ones.

 

[zoiDman]

They already use only FDA approved ingredients for the most part. The regulations require that the specific mixes be registered with them for the purpose of vaping.

Unfortunately, the Flavorings that are used in Flavored e-Liquids are FDA Approved as a Food Additive to be Eaten, but Not FDA Approved to be Vaporized and then Inhaled.

 

[Vaslovik]

Secondly, putting a rigiorous approval process in place would definitely kill the industry entirely as no one would be able to afford it.

Frankly I think that's the whole idea. The FDA is really nothing more than the tool of BT and BP, and it wouldn't be the first industry they destroyed, look what the FDA did to the dietary supplements industry.

 

[AgentAnia]

I know there is a lot of talk saying that the FDA will drive out of business the small mixers but I don't think this is a real problem... let's look around on a different business...

alcohol

you do need some kind of testing if you are making a high proof alcohol like tequila vodka or something similar (right?)
but bars just need a license to sell alcohol, they don't have to test their piña colada or their whiskey sour they just use previously tested spirits and mix them with innocuous ingredients.

so wouldn't it be true to juice mixers? don't they just need to acquire previously tested ingredients and mix to their liking just like any bar, nightclub or pub in the world?????

Your analogy needs tweeking. What would equate w/ bartenders selling a mixed drink vs. liquor companies selling liquor in bottles would be a vape lounge filling your tank w/ its own mixture for on-site consumption vs. eliquid companies selling bottles of eliquid. (As far as I know, no vapor lounge offers that service, but it's an intriguing idea! and not addressed in the deemings, AFAIK.)

 

[Zealous]

So, then are the flavoring manufacturers required to get approval for their flavorings as flavorings that are safe to vape (ie Flavor Art, etc.) or is it the people who actually have used those flavorings to make a particular flavor eliquid that need to get the approval (ie whomever makes custards last stand). And if the flavoring manufacturers have gotten X flavors approved to be used for eliquid wouldn't it be true that anyone who used those approved flavors for their eliquid would not have to get this approval again since the flavorings already were approved before?

I'm just not sure why I"m reading a lot about what someone who makes a certain flavor eliquid would have to do but I have not heard anything about what those people who produce those flavorings might be required to do.

 

[twgbonehead]

So, then are the flavoring manufacturers required to get approval for their flavorings as flavorings that are safe to vape (ie Flavor Art, etc.) or is it the people who actually have used those flavorings to make a particular flavor eliquid that need to get the approval (ie whomever makes custards last stand). And if the flavoring manufacturers have gotten X flavors approved to be used for eliquid wouldn't it be true that anyone who used those approved flavors for their eliquid would not have to get this approval again since the flavorings already were approved before?

I'm just not sure why I"m reading a lot about what someone who makes a certain flavor eliquid would have to do but I have not heard anything about what those people who produce those flavorings might be required to do.

Under the proposed regulations, a vendor would have to file a separate application for:
Every flavor
in Every Nic. Concentration
in Every PG/VG mix
with Every combination of extra flavor shots.

It's completely irrational and unworkable, as by the FDA's own estimate it will cost an average of $334,000 per product.

Think about what it would cost to register all the products available on this one page:
Build Your Own E Juice - Mt Baker Vapor - Electronic Cigarettes

Basically the FDA is hell-bent on completely eliminating the independent juice market, and cutting it down to perhaps 2 flavors at 3 strengths, all manufactured by BT.

 

[zoiDman]

So, then are the flavoring manufacturers required to get approval for their flavorings as flavorings that are safe to vape (ie Flavor Art, etc.) or is it the people who actually have used those flavorings to make a particular flavor eliquid that need to get the approval (ie whomever makes custards last stand). And if the flavoring manufacturers have gotten X flavors approved to be used for eliquid wouldn't it be true that anyone who used those approved flavors for their eliquid would not have to get this approval again since the flavorings already were approved before?

I'm just not sure why I"m reading a lot about what someone who makes a certain flavor eliquid would have to do but I have not heard anything about what those people who produce those flavorings might be required to do.

It is Going to be the People who Make Flavored e-Liquids. And NOT the OEM of the Flavor.

 

[novamatt]

So, then are the flavoring manufacturers required to get approval for their flavorings as flavorings that are safe to vape (ie Flavor Art, etc.) or is it the people who actually have used those flavorings to make a particular flavor eliquid that need to get the approval (ie whomever makes custards last stand). And if the flavoring manufacturers have gotten X flavors approved to be used for eliquid wouldn't it be true that anyone who used those approved flavors for their eliquid would not have to get this approval again since the flavorings already were approved before?

I'm just not sure why I"m reading a lot about what someone who makes a certain flavor eliquid would have to do but I have not heard anything about what those people who produce those flavorings might be required to do.

The flavorings are FDA approved for their intended purpose, which is in foods (usually candy). The FDA is looking specifically at eliquid. They don't care if the individual ingredients have been approved or not - they care about the final product. To them, each juice (and each size that juice is sold at) is a new product that requires its own individual approval.

You're not hearing what flavor manufacturers are required to do because they're not required to do anything. The FDA doesn't care about them.

 

[Zealous]

Under the proposed regulations, a vendor would have to file a separate application for:
Every flavor
in Every Nic. Concentration
in Every PG/VG mix
with Every combination of extra flavor shots.

It's completely irrational and unworkable, as by the FDA's own estimate it will cost an average of $334,000 per product.

Think about what it would cost to register all the products available on this one page:
Build Your Own E Juice - Mt Baker Vapor - Electronic Cigarettes

Basically the FDA is hell-bent on completely eliminating the independent juice market, and cutting it down to perhaps 2 flavors at 3 strengths, all manufactured by BT.

So then...hm. A company like Wizardlabs can't get certain PG/VG mixes approved & all their flavorings & then since they are approved anyone who uses them is using approved products?

I get what you're saying & YEA it's dumb as hell. I just don't understand how they can make the eliquid vendors get every product approved like that & not accept the company who provides the ingredients for those eliquids getting approval for the ingredients instead. (and when I say "approval" I mean approval to use those products in eliquid. I'm aware they are approved by the FDA to be used in other ways).

I mean, I'm sure Wizardslabs wouldn't want to take on that expense either. However for them to do it it would mean they would be able to service a number of eliquid vendors by having approved ingredients so there would be some motivation on their part to do it if it were required. But yea, it's totally not worth it for someone to invest that much money for 1 flavor of eliquid.

 

[Zealous]

The flavorings are FDA approved for their intended purpose, which is in foods (usually candy).

Yea I know they're not currently approved for being heated & vaped. I'm saying if they were approved for this use.

 

[zoiDman]

So then...hm. A company like Wizardlabs can't get certain PG/VG mixes approved & all their flavorings & then since they are approved anyone who uses them is using approved products?

...

WL, or Anyone else, can continue to Sell Food Flavorings. Just as long as the Flavorings are not Advertised as to be Added to make e-Liquids, Why Wouldn't they be able to sell them?

Food Flavorings have been Sold for a long time Before e-Cigarettes were first thought of. And they will be Sold long after whatever the FDA Decides to do.

 

[AndriaD]

Under the proposed regulations, a vendor would have to file a separate application for:
Every flavor
in Every Nic. Concentration
in Every PG/VG mix
with Every combination of extra flavor shots.

It's completely irrational and unworkable, as by the FDA's own estimate it will cost an average of $334,000 per product.

Think about what it would cost to register all the products available on this one page:
Build Your Own E Juice - Mt Baker Vapor - Electronic Cigarettes

Basically the FDA is hell-bent on completely eliminating the independent juice market, and cutting it down to perhaps 2 flavors at 3 strengths, all manufactured by BT.

And THAT is what makes no sense... they want to kill an entire thriving industry, in this era of a struggling, limping economy? Instead of doing what they can to SUPPORT the thriving industry, so as to create jobs, create bigger markets, create more tax money for themselves?

Cutting off their noses to spite their faces much???

Andria

 

[Kemosabe]

Unfortunately, the Flavorings that are used in Flavored e-Liquids are FDA Approved as a Food Additive to be Eaten, but Not FDA Approved to be Vaporized and then Inhaled.

how about if e-juice companies all just started selling no-nic mixes. these can be sold as aromatics, food flavors, or something of the like. no mention of vaping. heck, they could even be sold as perfume.
we, as consumers would buy our nic from one of the few companies that can afford to purchase the permit and mix it with the no-nic. essentially DIY, yet we would have pre-made recipes and wouldnt need to futz around making our own recipes (which, if you're like me, taste pathetic because i for the life of me cant come up with my own super tasty recipes like vendors do).

 

[zoiDman]

how about if e-juice companies all just started selling no-nic mixes. these can be sold as aromatics, food flavors, or something of the like. no mention of vaping. heck, they could even be sold as perfume.
we, as consumers would buy our nic from one of the few companies that can afford to purchase the permit and mix it with the no-nic. essentially DIY, yet we would have pre-made recipes and wouldnt need to futz around making our own recipes (which, if you're like me, taste pathetic because i for the life of me cant come up with my own super tasty recipes like vendors do).

If something Doesn't have Nicotine which was Derived from Tobacco Leaves, and if they Make no Claim about Quitting Smoking or Health Benefits, there Isn't Much the FDA can Do about it.

 

[Zealous]

WL, or Anyone else, can continue to Sell Food Flavorings. Just as long as the Flavorings are not Advertised as to be Added to make e-Liquids, Why Wouldn't they be able to sell them?

Food Flavorings have been Sold for a long time Before e-Cigarettes were first thought of. And they will be Sold long after whatever the FDA Decides to do.

Yes I know they have. That's not what I'm saying. What I'm saying is why won't the FDA accept them getting approval for those certain ingredients & mixes specifically FOR using with ecigarettes.

However I think that Kemosabe's way of thinking is probably the way it will go & they will just market the mixes as something else to avoid such nonsense.

 

[fraychek]

how about if e-juice companies all just started selling no-nic mixes. these can be sold as aromatics, food flavors, or something of the like. no mention of vaping. heck, they could even be sold as perfume.
we, as consumers would buy our nic from one of the few companies that can afford to purchase the permit and mix it with the no-nic. essentially DIY, yet we would have pre-made recipes and wouldnt need to futz around making our own recipes (which, if you're like me, taste pathetic because i for the life of me cant come up with my own super tasty recipes like vendors do).

Because right now the FDA has classified no nic e-liquids as tobacco products. Probably wouldn't hold up in court, but that would be a lengthy process.