FDA Was nic base available pre 2007?
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What does it mean? I'm not sure what is required for "equivilant".
Another question. If someone wanted to refill their cartridge in 2006, would they have been able to buy 12% nicotine, even if it was unflavored, and do it? Or would they have had to buy 100% and dilute it themselves?
Here's a blog from 2006; 2006 December | e-Cigarettes - Electronic Cigarettes
Here's DIY mentioned in 2007 http://www.e-cigarette-mart.com/cms/why-choose-e-cigarette-in-english-t105
Heavens Gifts was mentioned as a supplier in the first blog (2007). I wonder if they have a record of products from that year.
Another question. If someone wanted to refill their cartridge in 2006, would they have been able to buy 12% nicotine, even if it was unflavored, and do it? Or would they have had to buy 100% and dilute it themselves?
Here's a blog from 2006; 2006 December | e-Cigarettes - Electronic Cigarettes
Here's DIY mentioned in 2007 http://www.e-cigarette-mart.com/cms/why-choose-e-cigarette-in-english-t105
Heavens Gifts was mentioned as a supplier in the first blog (2007). I wonder if they have a record of products from that year.
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Very interesting blog, great find!!! Browsing around I found a study from March 2006....
The original...
http://www.aerzteinitiative.at/RuyanGutachten.pdf
And the same translated....
https://translate.google.com/translate?sl=auto&tl=en&js=y&prev=_t&hl=en&ie=UTF-8&u=http%3A%2F%2Fwww.aerzteinitiative.at%2FRuyanGutachten.pdf&edit-text=&act=url
The original...
http://www.aerzteinitiative.at/RuyanGutachten.pdf
And the same translated....
https://translate.google.com/translate?sl=auto&tl=en&js=y&prev=_t&hl=en&ie=UTF-8&u=http%3A%2F%2Fwww.aerzteinitiative.at%2FRuyanGutachten.pdf&edit-text=&act=url
Once you find your 'predicate' product, you will need to prove to FDA that it was commercially marketed as of 2/15/07. Here's a snip from their guidance on this question
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM334750.pdf
Then you have to prove your product is practically identical to the predicate with a side by side table showing each characteristic and the levels in yours vs. theirs.
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf
Here's a question/answer given in another guidance document to back up my 'practically identical' assertion
http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM271239.pdf
Another question from same document:
So once you find your predicate product, apparently you will need to contact them and get information from them regarding 'dated proof of sale ON 2/15/07, characteristics, including exact levels, of that exact product, and find out the original suppliers they used and make sure yours are the same as well.
I've been watching this effort w/ some interest, hoping against hope ...
Not to be too picky about it, but the "on Feb 15 '07" language means "as of" ... i.e. it was still on the market.
It's also worth noting that the FDA is not exclusively in charge of the standards of proof here.
For ex., if they demanded an original bill of sale printed on purple paper, they would presumably be exceeding their scope of authority under the statute.
Me too - I hope something can be found.
And I don't think we can dismiss the picky part of the date. They clearly state that proof must be dated. So, if one could only find an invoice of sale dated 12/20/06, I could easily see them saying, but how do we know they were still in business 2 months later? I clearly interpret their word 'on' or even 'as of' to mean "Show us that it bridged the before/after date of 2/15/07.", and that you could not compare to a product that was sold in 2005 and went out of business before 2/15/07.
While I hope we will be able to have access to nicotine base as a "predicate product", I don't hold out much hope. From all I've read, the FDA's definition of "substantial equivalent" tobacco products is what most people would say is "demonstrably identical".
As a ray of hope, they do state that genetically modified food crops are "substantial equivalent" to their non-genetically engineered counterparts.
As a ray of hope, they do state that genetically modified food crops are "substantial equivalent" to their non-genetically engineered counterparts.
No doubt thanks to the "revolving door" folks such as Michael R. Taylor, Deputy Commissioner for Foods at the FDA..
Michael R. Taylor - Wikipedia, the free encyclopedia
And he is far from being the only one who hops between the FDA & certain large industries, including BP & BT...
Fair enough. My larger point is that there are many ways to prove that a product s/b grandparented under the language of the statute. The FDA can't say that people have to jump through hoop A versus hoop B. I believe the statutory language is "marketed as of 2/16/7" or something like that (hmm, I think it's exactly that). Even a web page pulled off of a properly-authenticated server backup tape might do. FDA might refuse to accept this as evidence. But then I think it could go to an administrative law judge, and from there could be appealed to a federal district court. Congress didn't say "marketed as of 2/16/7, according to the FDA" in the statute.
Given the amount of money potentially at stake here, it's probably worth it to go to court if the only issue is proof of facts. If the disagreement is over the exercise of discretion which congress granted to the FDA, for example to make some complex determination about public health costs and benefits ... then the situation becomes much iffier. Now you're asking a court to step in and substitute its own judgement for the FDA's on a tricky policy issue.
That's a far cry from proving a simple real-world fact which is probably not open to much quibbling.
This is a point made in the VPLive round table discussion - namely that some of the nic juice woud have to be extracted (hopefully from a freezer) and tested. Then the new manufacturing process/product would have to be virtually identical according to whatever standards there are for such things. I saw a SE application once for tobacco cigarettes on (?) Glantz's blog, and they were measuring them down to a fraction of a millimter. I got the impression that the slightest variation in somethinig like the filter length would be enough to change the result.
On the other hand, that doesn't mean that the statute requires such precision. Let's face it, no one really knows what Congress had in mind by the term. You could go back in time and assemble every one of them who voted for it, and they wouldn't know, either.
My best guess is that this has to do with the health costs to society. In other words if a variation appeared to have no health impacts, then minor differences would be acceptable. Once again, we're talking about litigation.
I think finding the testable frozen nic. juice and authenticating it would be job #1. Can't go anywhere w/o that.
It appears Ruyan was commercially imported into the US starting in 2006. Would it make sense for Njoy to file for SE? The products were pretty bad then. Commercials from 2008 show them bigger than a cigar. I'm not so sure this would be of much use other than for the nic (RY4).
The FDA did those tests back in 2009 showing harmful chemicals in a couple. Would that also need to be duplicated (sounds like a yes IMO)?
It appears people were "dripping" but it seems they were ordering from Chinese websites - those sites were in english and USD - is that enough to satisfy the definition of commercially marketed?
I thought the Feb 2007 date was based on the day that an agreement was reached. Obviously upon signing in 2009 would have been a better date. Ecigs is the only category that would be changed by using a later date - one of the reasons this sounds so discriminatory to me.
Just the fact the FDA says it's unlikely ecigs will find a SE product, over and over, leans me towards the possibilty it's out there and we can find it. That's just the way they do it. "Science based" = science not required, down is up, etc.
The FDA did those tests back in 2009 showing harmful chemicals in a couple. Would that also need to be duplicated (sounds like a yes IMO)?
It appears people were "dripping" but it seems they were ordering from Chinese websites - those sites were in english and USD - is that enough to satisfy the definition of commercially marketed?
I thought the Feb 2007 date was based on the day that an agreement was reached. Obviously upon signing in 2009 would have been a better date. Ecigs is the only category that would be changed by using a later date - one of the reasons this sounds so discriminatory to me.
Just the fact the FDA says it's unlikely ecigs will find a SE product, over and over, leans me towards the possibilty it's out there and we can find it. That's just the way they do it. "Science based" = science not required, down is up, etc.
Bought a liter of nic 100mg/ml. Cutting it to 12.5% will render roughly 2 gallons. At 2 mls per day that's over ten years worth. I don't know if it will last that long , but it will at least give me some more quality years to live. Keeping it in a deep freeze with the proper bottles should slow down degradation quite abit. I figure this to be a long battle with The FDA. After all, ultimately, we ARE fighting BT. I see this as war between my enfisema and them. 47 years of analogs and finally I found something that saved my life!!!!......Hey...when your life's on the line you have to get creative.... Even if it were sold VIA a doctors prescription at least it would be available....
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I'm betting that if any remaining nic base exists, it's in Njoy's freezer. They could have the monopoly.
A lot of that is assuming that's what required for "equilvenlcy". My searches are in no way exhaustive. I have read about a couple of websites people were ordering from. People were definatley dripping before 2007.
Those old commercials are a trip.
A lot of that is assuming that's what required for "equilvenlcy". My searches are in no way exhaustive. I have read about a couple of websites people were ordering from. People were definatley dripping before 2007.
Those old commercials are a trip.
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I'm fairly certain nic base will be passed. However, I do believe it will be the first thing taxed and taxed big------by the mg I'm sure.
I'd almost bet BT will get it passed and monopolize on it.
But.... I was just thinking. Isn't nic base already FDA approved?
I need to go research this.
But.... I was just thinking. Isn't nic base already FDA approved?
I need to go research this.
Interesting, FDA doesn't have taxing power, but there's already legislation to tax tobacco products. Now the FDA makes eliquid a tobacco product, but there's no equivalency or levels to tax eliquid. In a nutshell, one big mess....
What a tangled web we weave, when first we practice to decive
Interesting, FDA doesn't have taxing power, but there's already legislation to tax tobacco products. Now the FDA makes eliquid a tobacco product, but there's no equivalency or levels to tax eliquid. In a nutshell, one big mess....
What a tangled web we weave, when first we practice to decive
Absolutely. But this is the first stepping stone to tax them, and heavily. How hard would it be to impose a tax per mg of nic liquid? I'm sure they'll figure a way to ensure they get their piece of the pie...
I'm curious about something. We know there's a nicotine inhalor already on the market in the Pharmaceutical industry. I know its separate than tobacco, but that would still mean nicotine was approved as a liquid to be inhaled in a PG base. I know it needs a prescription, but... I wonder if there's a way to correlate it??? Surely there were studies done prior to this device being approved. So I'm wondering, could those studies/tests be used to bring nicotine base to the market much cheaper...it would save thousands of dollars in testing/studies.
1) Nic inhalers are a totallly different technology - they don't use heat. And remember the entire product has to be on the market pre-'07. No "cutting and pasting" as it were. Besides nic inhalers are on the market as medical devices, not tobacco products.
2) Taxing is usually done in the vaping context by wholesale price %. At least that's how it's been proposed in the states that are looking at it (VT, NJ, OH who else?) and MN which already does it (?).
3) NJOY's e-liquid wouldn't do us any good anyway since they're already going to do an application for their own cigAlikes. I was hoping for someone else's e-liquid, i.e. something sold separately to vapers. Guess that one's a bust.
4) Oh and on the studies used to get nic inhalers approved - these are the wrong kind of studies for a new product application, at least they aren't the whole ball of wax. New OTC products have to be studied for their effect on tobacco product use - cessation by adults, uptake by minors, continued tobacco product use (i.e. discouraging smokers from quitting), etc.
So-o is this the end of this thread/quest/idea
2) Taxing is usually done in the vaping context by wholesale price %. At least that's how it's been proposed in the states that are looking at it (VT, NJ, OH who else?) and MN which already does it (?).
3) NJOY's e-liquid wouldn't do us any good anyway since they're already going to do an application for their own cigAlikes. I was hoping for someone else's e-liquid, i.e. something sold separately to vapers. Guess that one's a bust.
4) Oh and on the studies used to get nic inhalers approved - these are the wrong kind of studies for a new product application, at least they aren't the whole ball of wax. New OTC products have to be studied for their effect on tobacco product use - cessation by adults, uptake by minors, continued tobacco product use (i.e. discouraging smokers from quitting), etc.
So-o is this the end of this thread/quest/idea
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1) Nic inhalers are a totallly different technology - they don't use heat. And remember the entire product has to be on the market pre-'07. No "cutting and pasting" as it were. Besides nic inhalers are on the market as medical devices, not tobacco products.
2) Taxing is usually done in the vaping context by wholesale price %. At least that's how it's been proposed in the states that are looking at it (VT, NJ, OH who else?) and MN which already does it (?).
3) NJOY's e-liquid wouldn't do us any good anyway since they're already going to do an application for their own cigAlikes. I was hoping for someone else's e-liquid, i.e. something sold separately to vapers. Guess that one's a bust.
So-o is this the end of this thread/quest/idea
Hmmm. Yeah it's a bust.
Anxiously awaiting what CASAA has come up with.
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