Deeming Regulations have been released!!!!

[borno]

Here's an email I got from river supply. I looks like they are giving it a go, and offering to help others, but I don't know if it is going to effect flavors or nik solution.

Good afternoon, I hope everyone is doing well and staying safe. First, thank you for being a River Supply Co client. I appreciate all of you and wanted to reach out personally to give an update on the current status of River Supply Co.



I am proud to share that we have been busy pursuing all of our benchmarks, even in the face of these uncertain times, and have no plans to slow down. Below you will find what we have been up to, and what you can expect on the horizon.



We have completed the following actions:

• tobacco Master Files
• Environmental Assessment
• ISO 9001 Certification and follow up audits
• cGMP Certification and follow up audits
• Complying with all STAKE Act requirements
• Complying with all Age Verification requirements

The following items are currently in process:

• Drug Master Files (Two weeks away from completion.)
• Nicotine Stability Study (First round will be in mid-September with results every quarter.)
  
• Cleanroom expansion from 2,400 sq. ft to 3,840 sq. ft (Four weeks away from completion.)
• Lab expansion, adding three more HPLC machines (Two weeks away from completion.)
  
• ISO 17025 certificate to validate our testing methods (Eight weeks away from completion.)

Our goal is to be a supportive resource as much as a quality supplier. This effort is to ensure we are compliant on all levels and can help those making their way through PMTA’s. Please feel free to reach out if you need TMPF information for your application.



Thank you,



Grant Boatman

 

[Bronze]

Here's an email I got from river supply. I looks like they are giving it a go, and offering to help others, but I don't know if it is going to effect flavors or nik solution.

Good afternoon, I hope everyone is doing well and staying safe. First, thank you for being a River Supply Co client. I appreciate all of you and wanted to reach out personally to give an update on the current status of River Supply Co.



I am proud to share that we have been busy pursuing all of our benchmarks, even in the face of these uncertain times, and have no plans to slow down. Below you will find what we have been up to, and what you can expect on the horizon.



We have completed the following actions:

• Tobacco Master Files
• Environmental Assessment
• ISO 9001 Certification and follow up audits
• cGMP Certification and follow up audits
• Complying with all STAKE Act requirements
• Complying with all Age Verification requirements

The following items are currently in process:

• Drug Master Files (Two weeks away from completion.)
• Nicotine Stability Study (First round will be in mid-September with results every quarter.)
  
• Cleanroom expansion from 2,400 sq. ft to 3,840 sq. ft (Four weeks away from completion.)
• Lab expansion, adding three more HPLC machines (Two weeks away from completion.)
  
• ISO 17025 certificate to validate our testing methods (Eight weeks away from completion.)

Our goal is to be a supportive resource as much as a quality supplier. This effort is to ensure we are compliant on all levels and can help those making their way through PMTA’s. Please feel free to reach out if you need TMPF information for your application.



Thank you,



Grant Boatman

Looks like they are about one more rule away from being regulated out of existence.

 

[borno]

Looks like they are about one more rule away from being regulated out of existence.

You may be right, I think I'll get a few more of my favorites on order just in case.

 

[stols001]

Whelp I know ONE person that does not know the answer. It's okay @ENAUD it's entirely on topic, if only you knew the answer.

I'm really sorry that you had to crash a train and all, but if you asked me I might just tell you. No need for wanton destruction. LOL.

Anna

 

[ENAUD]

 

[ENAUD]

Whelp I know ONE person that does not know the answer. It's okay @ENAUD it's entirely on topic, if only you knew the answer.

I'm really sorry that you had to crash a train and all, but if you asked me I might just tell you. No need for wanton destruction. LOL.

Anna

Totally off topic, and its always a good time for a train wreck

 

[Kent C]

Totally off topic, and its always a good time for a train wreck

Not so off topic...

 

[ENAUD]

The real train wreck is only a couple weeks from now...

 

[newyork13]

I will say this until I'm blue in the face. Actually, just checked a mirror, and I'm blue in the face, which I've read is a symptom of coronavirus. Oh well, sweet corona, come to me sweetie. Good grief, more bull from them.
Anyway, saying it again until I'm blue in the face, I'm not a Republican nor a Trump fanboy. But, it's clear to me that the Democrats will hurt vaping even more (Kamala lambasted Trump for not banning all flavored juices; Pelosi's bill a few months ago would have been a disaster.)
The thing about Trump is that on the one hand he's a puritan of sorts (never drank never smoked no women [scratch the last one LOL]), but I do think he's against regulations generally and against actions which will be economically harmful, even if to a relatively small part of the economy such as the vaping industry.
If Biden wins, then hang it up. If Trump wins there is a chance.

 

[stols001]

Right. You shouldn't be wasting your trains NOW, you should be saving them for the big DAAAAYYYYY which is the day (if all goes as planned) I will IRONICALLY have the most amount of money I will ever have made in one day (house closing) and NO ability to spend it.

So just you stop bossing me around Mr. Man.

Okay so Douglas Adams was at a "book signing" back when those were a mandatory thing. He looked MISERABLE and he probably was, and he read a chapter from his new book and I was NOT enthusiastic (see my other post you found so funny) and he explained that like a friend of his had bet him that he could not start a chapter with the sentence "Ford Prefect (the alien who had an ill advised understanding of the names of people and of cars) hit the ground running."

He did it. He did not look happy about it, and also like he read the Chapter in a monotone and did not look up or interact he was like, "Shove book here, spell your name, nicely queued and thank you," and on your merry way you went.

The only writer who I can think of who was ACTUALLY more miserable was David Foster Wallace and he killed himself but that was from a pre existing depression consisting of like being smarter than all other humans combined. Douglas Adams Dropped dead of a heart attack at age 50 after his newly hedonic lifestyle and NONE of his fans would talk to him about "The Hitchhiker's Guide to the Galaxy" which is EXACTLY how he wanted it. I am pretty sure.
The reference was to Mac being an alien recently touching down to earth. Are we happy now? Are we happy and all knowing what is going on? Are we ALLL Hoopy Froods?

Anan

Anna

 

[Katya]

Not so off topic...

The real train wreck is only a couple weeks from now...

I'm really curious. Of course I'm angry, sad, and disappointed, but I'm also morbidly curious. What is really going to happen on September 9th? The day after? Anyone?

 

[stols001]

Absolutely no one has any idea I don't think.

I would hope an ecig mafioso you know pops up right away. I have my derringer in my stocking ready I have always wanted to run a mafia cell and like, it's way cooler when you can run (even in heels) not dragging ones oxygen tank behind one.

So I'm thinking the big Head Boss is gonna call me and say, "NAME WITHHELD UPON REQUEST" we have been needing your services in "LOCATION WITHHELD UPON REQUEST" for some time now so glad you got here in time."

Anna

 

[zoiDman]

.

 

[zoiDman]

... The day(s) after? Anyone?

I think there is going to be a Surge of New ECF Members posting in the New Members Section asking... "What is Going On?'

 

[Katya]

I think there is going to be a Surge of New ECF Members posting in the New Members Section asking... "What is Going On?'

Heaven have mercy on us...

 

[Seiggy]

I don't know, but I think come 09/10 we will some online stores close or quit selling to US customers. Some will stay operating as normal until told to stop. FDA will take awhile to deal with the logistics of enforcement/letters, etc. The questions I would have, where is the list of submitted PTMA devices, etc.? What can a retailer still sell within the US until FDA approves or NOT? This is from my knowledge which is very little or non-existent. I would hope retailers have something that lets them know what they can or can not sell within the USA.

 

[ENAUD]

I'm really curious. Of course I'm angry, sad, and disappointed, but I'm also morbidly curious. What is really going to happen on September 9th? The day after? Anyone?

We'll find out soon enough. Some vendors are already sending out emails announcing their closures, maybe some will be defiant and continue on until forced otherwise, maybe FDA will be lax in enforcement. it is game on time...let the cards fall where they will.

 

[borno]

You may be right, I think I'll get a few more of my favorites on order just in case.

I guess I waited too long, The pre-made e-juice is no lomger on the website.

 

[somdcomputerguy]

The real train wreck is only a couple weeks from now...

17 days..

 

[mikepetro]

More-so I think, start out with a few flavors to see if the PMTA will fly. They are quite expensive to do, especially when the benchmark to pass has not been clearly communicated.

Below is the FDA's estimate of a PMTA cost, which most of the industry considers to be very underestimated.

Now, remember you need one PMTA for each flavor AND nic concentration.

So if an ejuice company submitted 3 flavors at 3 different strengths, you would need to multiple the numbers below by 9.

How many ejuice companies have >$10 million to be able to throw at this, with no guarantee of getting approved???