I found this article on the webs and I worked in SC and NC for almost a year and got to meet and become friends with some of the B&M owners and workers.
FDA proposes strict regulations for vaping | Local News - WYFF Home
I just wanted to help people to understand exactly what the FDA is trying to do.
Because I'm not sure I even can see the big picture and I am hoping for others to chime in and shed some light on this.
This paragraph in the article is, to me, what people really need to understand,
The Food and Drug Administration, which regulates tobacco, wants to put some facts behind that trust. It's created a list of proposed regulations. According to the proposals, e-cigarettes and e-liquid must be reviewed by the FDA, products would have to contain a list of ingredients and health warning labels, and some products would require child-resistant packaging.
When i talk to people about this they say, "What's the big deal, they just want labels put on e-juice bottles"
I think it's a little more then that
so I got a few questions.
e-cigarettes and e-liquid must be reviewed by the FDA
Reviewed and Approved that should say.
Now the Reviewing part,
Am I understanding this right, when you want the FDA to approve something is that first you have to make it yours, like with a patent?
And is that for every flavor?
That's going to take some time and money for that if this is the case.
And if that is or isn't the case now you have to send the e-juice into the FDA, and is this for every flavor?
I did ask a worker at a local B&M and he told me it was going to cost in the ball park of $20,000 to $30,000 per flavor of juice to get FDA approval
Now if this is true is this a one time fee or is this annually?
So I wanted to find out just how much it was going to cost a B&M to send juice to the FDA and I did a google search on "cost to be reviewed by the FDA" and found this page,
PMA Review Fees
Which then directs me to this page,
MDUFA III Fees
First I have to ask am I on the right pages?
What application type would e-cigs and e-juice fall under?
This is important because if they claim e-cigs are a Medical Device then the Fee's go up.
"GRAS" is an acronym used by the FDA for the phrase Generally Recognized As Safe.
Shouldn't e-juice fall under GRAS, Since all the ingredients are already GRAS approved?
And if all the ingredients are already GRAS approved why do we have to send them in again
Just for the Annual Establishment Registration Fee is $3,646
And are they going to have to pay this fee PLUS the Application fee on every flavor of e-juice they make?
How many more Fee's are there going to be?
If the FDA puts e-cigs & juice in the same category as tobacco does that mean that them high tobacco taxes can now be added to their cost?
And how many months/years is it going to take for the FDA to test all these devices and juices?
If every B&M and company sends their Juices and Mods in to be tested that's going to take some time,
so can they still sale their merchandise while they wait?
This seems like no matter what this is going to cost a lot of time and money that most B&M's can't afford
Big Tobacco could easily afford this, maybe that's why they are jumping on the vape bandwagon?
I hope someone that knows more then me can help explain just how bad this can get for us
FDA proposes strict regulations for vaping | Local News - WYFF Home
I just wanted to help people to understand exactly what the FDA is trying to do.
Because I'm not sure I even can see the big picture and I am hoping for others to chime in and shed some light on this.
This paragraph in the article is, to me, what people really need to understand,
The Food and Drug Administration, which regulates tobacco, wants to put some facts behind that trust. It's created a list of proposed regulations. According to the proposals, e-cigarettes and e-liquid must be reviewed by the FDA, products would have to contain a list of ingredients and health warning labels, and some products would require child-resistant packaging.
When i talk to people about this they say, "What's the big deal, they just want labels put on e-juice bottles"
I think it's a little more then that
so I got a few questions.e-cigarettes and e-liquid must be reviewed by the FDA
Reviewed and Approved that should say.
Now the Reviewing part,
Am I understanding this right, when you want the FDA to approve something is that first you have to make it yours, like with a patent?
And is that for every flavor?
That's going to take some time and money for that if this is the case.
And if that is or isn't the case now you have to send the e-juice into the FDA, and is this for every flavor?
I did ask a worker at a local B&M and he told me it was going to cost in the ball park of $20,000 to $30,000 per flavor of juice to get FDA approval
Now if this is true is this a one time fee or is this annually?
So I wanted to find out just how much it was going to cost a B&M to send juice to the FDA and I did a google search on "cost to be reviewed by the FDA" and found this page,
PMA Review Fees
Which then directs me to this page,
MDUFA III Fees
First I have to ask am I on the right pages?
What application type would e-cigs and e-juice fall under?
This is important because if they claim e-cigs are a Medical Device then the Fee's go up.
"GRAS" is an acronym used by the FDA for the phrase Generally Recognized As Safe.
Shouldn't e-juice fall under GRAS, Since all the ingredients are already GRAS approved?
And if all the ingredients are already GRAS approved why do we have to send them in again
Just for the Annual Establishment Registration Fee is $3,646
And are they going to have to pay this fee PLUS the Application fee on every flavor of e-juice they make?
How many more Fee's are there going to be?
If the FDA puts e-cigs & juice in the same category as tobacco does that mean that them high tobacco taxes can now be added to their cost?
And how many months/years is it going to take for the FDA to test all these devices and juices?
If every B&M and company sends their Juices and Mods in to be tested that's going to take some time,
so can they still sale their merchandise while they wait?
This seems like no matter what this is going to cost a lot of time and money that most B&M's can't afford
Big Tobacco could easily afford this, maybe that's why they are jumping on the vape bandwagon?
I hope someone that knows more then me can help explain just how bad this can get for us
