Vendors to spend how much for FDA PMTAs?

[Tommy-Chi]

I like Ahlusion, and I am just using them as an example here. I've ordered from them probably five times in the past and will order from them again and again over the course of time until they are no longer viable, should they decide not to remain open. I hope they decide to stay in business as long as they possibly can in the face of FDA regs. Business is going to change for every manufacturer, retailer in the vaping community.


RE-POSTS WELCOME

BY: @Tommy-Chi on ECF

Lets do a little review of how the FDA is going to effect Ahlusion given current, unmodified rules/regs.

They may have to kill their "Fully Customizable" and "Flavor Profiles" lines. Testing in light of FDA regs would be cost prohibitive.

Lines, ea with approx 6 different strengths (0, 3, 6, 12, 18, 24mg)
6 flavors, Elite Line (6 flavors * 6 different strengths = 36 PMTAs)
7 flavors, Custom Line, Aromatic (42 PMTAs)
4 flavors, Custom Line, Beverage (24 PMTAs)
2 flavors, Custom Line, Chocolate (12 PMTAs)
6 flavors, Custom Line, Cocktail (36 PMTAs)
3 flavors, Custom Line, Coffee (18 PMTAs)
5 flavors, Custom Line, Other (30 PMTAs)
36 flavors, Custom Line, dessert (216 PMTAs)
40 flavors, Custom Line, Fruit (240 PMTAs)
19 flavors, Custom Line, Tea (114 PMTAs)
17 flavors, Custom Line, tobacco (102 PMTAs)

PMTAs TO FILE = 870 PMTAs TOTAL

870 * $500,000 = $435,000,000 costs to file for PMTA with FDA for Ahlusion. Filing for a PMTA does not mean one is granted. If the product does not obtain the waiver, the product must be pulled from sale within the USA.

What to do in light of this situation:
* Join CASAA.
* Support your e-liquid vendors while they are here.
* Tell all of your manufacturers, vendors and retailers to join an established lawsuit to fight the FDA.
* Stock up! Buy vaping related devices, as well as flavors, pg/vg and nicotine base for yourself and learn how to use everything safely to make your own e-liquids in case the FDA regs are not overturned.

 

[bnrkwest]

The numbers are staggering, I really wonder if anyone will submit anything, the FDA rules are so ridiculous.

 

[Just Me]

I like Ahlusion, and I am just using them as an example here. I've ordered from them probably five times in the past and will order from them again and again over the course of time until they are no longer viable, should they decide not to remain open. I hope they decide to stay in business as long as they possibly can in the face of FDA regs. Business is going to change for every manufacturer, retailer in the vaping community.


RE-POSTS WELCOME

BY: @Tommy-Chi on ECF

Lets do a little review of how the FDA is going to effect Ahlusion given current, unmodified rules/regs.

They may have to kill their "Fully Customizable" and "Flavor Profiles" lines. Testing in light of FDA regs would be cost prohibitive.

Lines, ea with approx 6 different strengths (0, 3, 6, 12, 18, 24mg)
6 flavors, Elite Line (6 flavors * 6 different strengths = 36 PMTAs)
7 flavors, Custom Line, Aromatic (42 PMTAs)
4 flavors, Custom Line, Beverage (24 PMTAs)
2 flavors, Custom Line, Chocolate (12 PMTAs)
6 flavors, Custom Line, Cocktail (36 PMTAs)
3 flavors, Custom Line, Coffee (18 PMTAs)
5 flavors, Custom Line, Other (30 PMTAs)
36 flavors, Custom Line, Dessert (216 PMTAs)
40 flavors, Custom Line, Fruit (240 PMTAs)
19 flavors, Custom Line, Tea (114 PMTAs)
17 flavors, Custom Line, Tobacco (102 PMTAs)

PMTAs TO FILE = 870 PMTAs TOTAL

870 * $500,000 = $435,000,000 costs to file for PMTA with FDA for Ahlusion. Filing for a PMTA does not mean one is granted. If the product does not obtain the waiver, the product must be pulled from sale within the USA.

What to do in light of this situation:
* Join CASAA.
* Support your e-liquid vendors while they are here.
* Tell all of your manufacturers, vendors and retailers to join an established lawsuit to fight the FDA.
* Stock up! Buy vaping related devices, as well as flavors, pg/vg and nicotine base for yourself and learn how to use everything safely to make your own e-liquids in case the FDA regs are not overturned.

My guess is to stock up.

 

[440BB]

Watching a small business grow based on high quality and customer service, Ahlusion is an example of the American Dream being fulfilled. Seeing this likely to be killed by these regs saddens me. Good people there, hope they can somehow pull through.

 

[bnrkwest]

I hope at least Ahlusion will sell flavors if they get out of the vape biz.

 

[satchvai]

The scary thing is $500k is a very conservative estimate for the cost of a PMTA application.

 

[Yiana]

Putting into perspective may make more people realize what these regs really mean. They are not around.

 

[tj99959]

PMTAs are nothing more than a money grab by the FDA.

 

[mattiem]

The american dream of owning your own company, selling a good product, putting others to work, living a comfortable life has turned into a nightmare for so many This corporate run government we find ourselves living under is both heartbreaking and maddening. So many folks have been the frog on the pot of water and they still don't realize that they are slowly being boiled alive.

I don't now what it is going to take to open the eyes of the ones that aren't paying attention. For some it has been the slow demise of vaping. I still had my eyes partially closed when they came after smokers with a pitchfork. They were wide open long before they came after vaping. I have tried to fight the good fight but it seems the corporations have gotten so big it is going to take something drastic to stop them. If something drastic doesn't happen and happen soon I feel we are in for some very very dark days. Yes, I am that paranoid.

 

[OlderNDirt]

I could see a possibility that they (or anybody else) could only provide a flavor in choice of two nic levels, 0 and 24. You buy however many 0 nic bottles needed to cut the 24nic to your level.

Now the bad news. Even doing that, there are still 2 PMTA's for each flavor and I'm not even going to bother with the math on Tommy-chi's post. Let's just say fewer flavors. And just for good measure, how many vapers having to combine different nic level juices (IE, mixing) will take the next step to DIY? Or as brnkwest commented, they end up just selling flavors.

I never watched those "prepper" shows on tv cause I thought they were either crazy, or at least well on their way there. But my order is on its way.....I am now officially a "vape prepper!"

 

[Yiana]

The american dream of owning your own company, selling a good product, putting others to work, living a comfortable life has turned into a nightmare for so many This corporate run government we find ourselves living under is both heartbreaking and maddening. So many folks have been the frog on the pot of water and they still don't realize that they are slowly being boiled alive.

I don't now what it is going to take to open the eyes of the ones that aren't paying attention. For some it has been the slow demise of vaping. I still had my eyes partially closed when they came after smokers with a pitchfork. They were wide open long before they came after vaping. I have tried to fight the good fight but it seems the corporations have gotten so big it is going to take something drastic to stop them. If something drastic doesn't happen and happen soon I feel we are in for some very very dark days. Yes, I am that paranoid.

It really is that bad and you are not that paranoid. I'd say you were in denial if you were not feeling "paranoid"

 

[Tommy-Chi]

To tell the truth, I knew the numbers were "big" but I did not know how big until I sat down and did the math for one manufacturer.

There is NO, NONE, as in ZERO chance that we see any e-liquid manufacturer remain viable after the FDA process moves forward. The reason is that even if they wanted too, none have $435 million to $1 billion in cash reserves to move forward.

It should be against the law to write regulations that kill an entire industry for no legitimate reason.

 

[mattiem]

To tell the truth, I knew the numbers were "big" but I did not know how big until I sat down and did the math for one manufacturer.

There is NO, NONE, as in ZERO chance that we see any e-liquid manufacturer remain viable after the FDA process moves forward. The reason is that even if they wanted too, none have $435 million to $1 billion in cash reserves to move forward.

It should be against the law to write regulations that kill an entire industry for no legitimate reason.

Problem being, the ones that write the regulations are the same ones that make the laws or least they pay the ones that make the laws.

 

[satchvai]

To tell the truth, I knew the numbers were "big" but I did not know how big until I sat down and did the math for one manufacturer.

There is NO, NONE, as in ZERO chance that we see any e-liquid manufacturer remain viable after the FDA process moves forward. The reason is that even if they wanted too, none have $435 million to $1 billion in cash reserves to move forward.

It should be against the law to write regulations that kill an entire industry for no legitimate reason.

I had a small juice company (mods, I'm out of business so don't freak) and closed down. Not only are the FDA regs onerous but you have to deal with local and state regs as well. I would have had to register with the ATF as well as deal with the local health department concerning manufacturing processes. And that is only a start. If I'd decided to stay in business, after August 8, I couldn't have changed base or nicotine vendors or anything on my packaging, including the size of my font. If I had the capital to pursue the PMTA process, I wouldn't. I'd take it and invest in advocacy efforts instead. I don't see any open system devices being approved as things stand currently.

 

[Tommy-Chi]

I had a small juice company (mods, I'm out of business so don't freak) and closed down. Not only are the FDA regs onerous but you have to deal with local and state regs as well. I would have had to register with the ATF as well as deal with the local health department concerning manufacturing processes. And that is only a start. If I'd decided to stay in business, after August 8, I couldn't have changed base or nicotine vendors or anything on my packaging, including the size of my font. If I had the capital to pursue the PMTA process, I wouldn't. I'd take it and invest in advocacy efforts instead. I don't see any open system devices being approved as things stand currently.

The ATF... yea, I was a little astounded when you said that but then I remembered they're the *T*. I agree 100%. After seeing the numbers I don't think the market will be here unless some huge change is made.

The numbers are one heck of a reality check.

 

[subwayaznm]

That would be quite sad if that is what it came to. I've ordered a large order to hold me over for awhile since I like their custom blends so much. A few 60 mil bottles

 

[Vandal]

I could see a possibility that they (or anybody else) could only provide a flavor in choice of two nic levels, 0 and 24. You buy however many 0 nic bottles needed to cut the 24nic to your level.

Now the bad news. Even doing that, there are still 2 PMTA's for each flavor and I'm not even going to bother with the math on Tommy-chi's post. Let's just say fewer flavors. And just for good measure, how many vapers having to combine different nic level juices (IE, mixing) will take the next step to DIY? Or as brnkwest commented, they end up just selling flavors.

I never watched those "prepper" shows on tv cause I thought they were either crazy, or at least well on their way there. But my order is on its way.....I am now officially a "vape prepper!"

I guess I kind of felt the same about preppers. However, I've been changing my mind about that over this past year. Since May, that change has accelerated. What has happened to vaping has opened my eyes for sure, as I explore the effects of government overreach in other areas of the lives of US citizens.

Stockpiling vaping supplies is my first experience with prepping. I have mixed feelings about it. The good: I am prepared for any eventuality. The bad: that I must be prepared for any eventuality.

 

[satchvai]

I guess I kind of felt the same about preppers. However, I've been changing my mind about that over this past year. Since May, that change has accelerated. What has happened to vaping has opened my eyes for sure, as I explore the effects of government overreach in other areas of the lives of US citizens.

Stockpiling vaping supplies is my first experience with prepping. I have mixed feelings about it. The good: I am prepared for any eventuality. The bad: that I must be prepared for any eventuality.

I understand. My last few vape orders have been for quality Allen wrenches, replacement screws, 510s and glass replacement tanks for various attys. Things I never would have thought to order previously I am now because they really may not be available at a later date. (Sans the screws and wrenches)

 

[Lessifer]

To tell the truth, I knew the numbers were "big" but I did not know how big until I sat down and did the math for one manufacturer.

There is NO, NONE, as in ZERO chance that we see any e-liquid manufacturer remain viable after the FDA process moves forward. The reason is that even if they wanted too, none have $435 million to $1 billion in cash reserves to move forward.

It should be against the law to write regulations that kill an entire industry for no legitimate reason.

Unless that company doesn't offer different pg/vg blends, you left out a whole set of variations.

 

[DC2]

I have a very hard time seeing even Halo submitting a PMTA.
And by that I mean even ONE of them.

Not only is there the cost of doing so to consider...
There is the fact that what the FDA is asking for is nearly impossible to provide..

And all that, without even getting into the fact that the FDA doesn't have to approve.
Anyone got $500,000 to spend on a lottery ticket?

In a just world the courts will blast the Demon Regulations out of the water.
And honestly, I do believe that is what will happen.

Not that I'm trying to imply the world is just.
Just that that is how screwed up the Demon Regulations truly are.