Deeming Regulations have been released!!!!

[StormFinch]

But try finding an example. I couldn't, when I tried.

Part of the reason it's hard to find an example is that PG is considered as an inactive ingredient in pharmacology. It doesn't even have to be listed.

It's really too bad that Nicorette Quickmist hasn't been sold here, since it's basically e-liquid with a handful of other ingredients.

 

[StormFinch]

I do remember reading the ingredients on my daughter's asthma inhaler about 5 years ago and it contained PG. I didn't know they discontinued it. Maybe not in inhalers but certainly is still used in a lot of meds such as these:

Propylene Glycol (Inactive Ingredient) - Drugs.com

Don't hold me to it, but I believe that might have had something to do with the change in propellants in 2012. They had to move away from CFCs.

 

[The Ocelot]

One would think the intravenous delivery would have more of a health impact.

Diazepam Injection Description

Each mL of this sterile injection contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.

 

[nicnik]

PG might still be used in some nebulizers. I think that was revealed in a fairly recent discussion, here. But it definitely used to be used in them.

 

[Robert Cromwell]

From a visual perspective:

But keep calm and do not panic?

 

[rosesense]

Ocelot, I am sure you are right about injectibles.

What amazes me is all this regulation for something they say might be harmful while all the commercials advertising various prescription drugs list so many possible side effects, including death. Brainless..

 

[Bruce C]

So, for me, the key word here is "products". I'm taking that to mean nic and hardware also, no?
(leave it to this government to drop a 499 page purposefully confusing and frustrating document. And I'm absolutely sure it's intended to be that way to further their agenda. After all, vapers are just idiots who don't know what's going on, so the more words and complications we use the more we'll baffle them and get our monopoly and taxes. I am so sick of this government forcing THEIR agenda on us and having very little power to counter it. I'm 64 years old and I'm sad and frustrated that this is NOT the country I grew up in. My father, rest his soul, fought at Normandy Beach on D-Day to help make this country what it was. Which was free. But this admin is stripping that away. Very sad to see that happen)

That's too funny, jmur. I'm 61 and my father landed at Normandy as one of Patton's tank commanders (with those tank snorkels that were such a huge fail being too short, good idea poor execution), and served under Patton for most of WW2. I wonder if they knew each other?

 

[nicnik]

One would think the intravenous delivery would have more of a health impact.

Diazepam Injection Description

Each mL of this sterile injection contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.

No one gets injected with that every day. I think the intravaneous Diazepam use is for sedating for surgery, colonoscopy, etc...

 

[rosesense]

So far, I have heard of several groups that have formed to tackle this. Wouldn't it be more prudent to use one main group instead of splitting all over the place?

I hope someone takes on the task of following the money, that is what will get our point across to the public, I think.

 

[jmur]

That's too funny, jmur. I'm 61 and my father landed at Normandy as one of Patton's tank commanders (with those tank snorkels that were such a huge fail being too short, good idea poor execution), and served under Patton for most of WW2. I wonder if they knew each other?

You know, I wouldn't be surprised.
My thanks to your Dad too, for fighting for our freedoms. It's never forgotten what their generation did.

 

[nicnik]

But keep calm and do not panic?

And then many people are saying, it'll cost way more than Zeller's sevearl hundred thousand dollars per product. More like two million.

 

[lauragal]

In 2015, the FDA issued 16,924 "Warning Letters" to cig retailers, stating that they'd been caught violating some regulation. Mostly it's selling to a minor, but this also can include carrying an un-approved product.

in 2015, the FDA issued 3799 "Civil Money Penalties" which is what you get if you are caught again. Mostly for $250 (see below for escalating fines)

In 2015 they issued 8 "No Sale Orders". That can follow 5 violations - but each visit they usually write you up for several violations, so they can stop you from selling tobacco after watching you do something against regs just twice: 1 - selling to a minor and 1 - Failing to verify age. That's two violations. Who knows what they'll do if your stores full of unapproved e-liquid?

• I. in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer;
• II. in the case of a second violation within a 12-month period, $250;
• III. in the case of a third violation within a 24-month period, $500;
• IV. in the case of a fourth violation within a 24-month period,$2,000;
• V. in the case of a fifth violation within a 36-month period, $5,000; and
• VI. in the case of a sixth or subsequent violation within a 48-month period, $11,000 as determined by the Secretary on a case-by-case basis.
• o Violations of other FDCA requirements relating to tobacco products. In general, penalties for violating other FDCA requirements relating to tobacco products may not exceed $15,000 for each violation or $1,050,000 for all violations adjudicated in a single proceeding.

Ah well, that's good, they can only ding a vape shop for about $1 million at a time then.

Still cheaper than paying $300,000 for a PMTA (or whatever the alphabet letters are??!).

 

[nicnik]

So far, I have heard of several groups that have formed to tackle this. Wouldn't it be more prudent to use one main group instead of splitting all over the place?

I hope someone takes on the task of following the money, that is what will get our point across to the public, I think.

I think some of the biggest groups have been working on combining their efforts.

I agree about the money, but some people react like what they are hearing is the product of the mind of an addict, and use that as an excuse to disregard it, even if they believe that influence peddling is out of control. Believing us should fit right in with their beliefs, but they don't want to believe.

 

[Lessifer]

I'm not going to, either, and haven't been, but I've been supportive of people that use some of TC's lies to make the comparison to smoking even better than it is, which happens to be way more than enough, without disortion. Sometimes I tried to separate out the lies from my support, but usually not.

I get torn over that. I don't feel right supporting, or not supporting.

It's one of the problems for all being on the same page, but not the only.

Yup, I've been guilty of that too, usually for expediency though, not for effect.

Not only that, it hurts smokers, and we know they don't need that.

And yup, the last thing I want to become is a preachy ex smoker. I will fight for your right to choose an alternative, and for you to be able to choose smoke instead.

It's hard to not use some of their stuff, that I believe is lies, but I don't have fully accepted proof.

I will not perpetuate lies that nicotine is harmful when not abused, or that quitting should be our goal, or that there is anything about vaping that people need to be protected from.

I'm also not rude about how I vape in public.

And then many people are saying, it'll cost way more than Zeller's sevearl hundred thousand dollars per product. More like two million.

I believe there is a section that says that the 1500 hours is for a firm that is experienced in dealing with this type of application(i.e. BT), but an inexperienced firm could expect up to 5000 hours or more. That's why I used the 5000 hour number.

 

[nicnik]

Still cheaper than paying $300,000 for a PMTA (or whatever the alphabet letters are??!).

So, who wants to do the math, and see how many violations until $300,000?

 

[nicnik]

Yup, I've been guilty of that too, usually for expediency though, not for effect.

Good way to put it. Me too.

 

[Lessifer]

Now this hurts all of us. The littlest to biggest companies who make and sell vaping materials in all categories. If the manufacturers have huge meetings/conferences scheduled to meet with FDA etc., what about the faces behind them (US)...isn't there any way we can demand that our faces and voices be heard as well? This affects many of us having no expectations from vaping. I liked smoking. Had surgeon tell me I had to quit or no surgery, no surgery I'd have been paralyzed! So they put me on chantix got sicker than a dog still have side effects, had surgery went back to smoking just can't taste certain things, tolerate certain smells or tastes can't drink coffee or I'll get sick.
Started vaping 2 yrs ago basic pen style started at 24 mg, then tasted it out of a bomber mod. BAM put down 24 mg to 6 and now at 3 mg if the juice is only available in zero I'll take it. I have intense debilitating pain I need something to do. I don't need the nicotine as much as an escape from pain. Vaping got me to quit!!! Now my bones aren't falling apart as fast, I'm not putting poison in my lungs I can breathe. Now when I'm hurting I smile with my mod and great juices relax and smile, it gets me through another day, without smoking cigarettes.
I tried patches you name it. THE ONLY WAY I QUIT OR COULD QUIT IS VAPING!!!
I'm a face with a successful story because I Vape.
Don't we have the right to rally, protest and be SEEN AND HEARD!!!
Big tobacco, government, hospitals, FDA and pharmaceutical companies would rather see us try to find a way to pay for chemotherapy, hospital visits and let us slowly die!
I fought harder than I should have had to with my health and I am more than willing ready and waiting to fight to keep my vaping rights! Which affects my health.
There has to be a way we can demand were heard and ask the people with the best success stories to bravely stand up and look them in the eyes and tell their stories.
My personal experiences have taught me that I had to be educated and proactive in my health care and I honestly had to scream fight and go over big shots heads to be heard. When they wouldn't approve a bone stimulator. I went to the corporate office of my insurance company white as a ghost gnarly looking crawl walking in and calmly said I wasn't leaving until it was approved....They had to SEE ME to HEAR ME! (not to mention other people they insured saw me). Yes, I was approved quite quickly. Lol
This is no different, it's easier to push people down when you can't see them because were faces without names or stories right now. I'm sorry but no matter how many letters we write or petitions we sign, we are invisible. And I know so many of you have put your hearts into trying with all you had to make a difference, please don't think we all thought it would help!! They place those papers in closets.
There has to be a way we can request having the right to speak peacefully and respectfully with them, can't we set up a few conventions like the manufacturers are, so all of us can afford to go so "We the People" get to meet with the same people who are going to shut this all down!
Having to see our faces and hearing many stories has a profound affect on any human being no matter how big they are or what job title they have. I know I didn't go up against the FDA, but I went head to head with doctors, surgeons, insurance companies.
Believing in yourself, knowing yourself and educating yourself about protecting your life, your health means something!!! We don't have the 2 yrs we thought
we had. This is a big group, strength in numbers!!!
So let's find a way to be seen and heard at a professional factual level. When your calm and collected and speak with passion and factual information your on the same level as them.
Those are just their jobs, ultimately they are just people like us. When you don't yell swear or scream .. YOU REALLY ARE HEARD!! We would have faces at these conventions, we could help end lung cancer from killing not just ourselves but our children and so on. Unfortunately, I am only educated in family and traffic laws, but having an open convention with adult respect and behavior with them "could" make a difference??
Just a thought! Have a great night. keepcalmvapeon

Thank you for sharing your story!

CASAA is the consumer advocacy group that is the biggest, and has been around the longest. They did have closed meetings with the FDA, just like the industry people did, and they were our voice. I truly believe that they did their best, I just don't believe the FDA was ever going to do things differently. Our fight now seems to be in the courts and with congress. So join the groups that you can, participate however you can, and prepare yourself for a tough ride if you haven't already.

 

[The Ocelot]

But keep calm and do not panic?

Don't panic, but explore other business opportunities.

My example was for 21 bottles, not 21 flavors.

Suicide Bunny has 13 flavors on their site, available in 5 nic levels

13 flavors at 0mg, 3mg, 6mg, 12mg, 18mg (The FDA will probably count the 0mg due to intended use)
50/50 pg/vg for all
That's 65 PMTAs
97,500 hours (65x1500) of prep time (per Zeller)
$19,500,000 (If Zeller's "several thousand dollar" per application estimate is $300,000.00)

Buh-bye bunny...

If they decided to just produce Suicide Bunny and Mother's Milk in 0mg and 18mg (people could dilute to make their own nic level) it would be more manageable, but still 6,000 hours and $1,200,000.00

 

[Robert Cromwell]

After browsing this: Dropbox - VTA Guidance - Deeming Compliance Calendar - FINAL.pdf

I Predict that 12-31-16 will pretty much be the end of vaping as we do now in the USA.
UNLESS rules are changed.

And most things will become unavailable before then.

 

[Robert Cromwell]

Don't panic, but explore other business opportunities.

My example was for 21 bottles, not 21 flavors.

Suicide Bunny has 13 flavors on their site, available in 5 nic levels

13 flavors on 0mg, 3mg, 6mg, 12mg, 18mg (The FDA will probably count the 0mg due to intended use)
50/50 pg/vg for all
That's 65 PMTAs
97,500 hours (65x1500) of prep time
$19,500,000 (If Zeller's "several thousand dollar" per application estimate is $300,000.00)

Buh-bye bunny...

If they decided to just produce Suicide Bunny and Mother's Milk in 0mg and 18mg (people could dilute to make their own nic level) it would be more manageable, but still 6,000 hours and $1,200,000.00

In addition ejuice must be tested throughout the shelf life of the product.
So no juice can be test complete in less time than it's shelf life.