FDA Kangertech Response to FDA
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Actually found it on Reddit--they sure are fast to post the latest information.
I am enjoying their subtank, it just works. I have 5 and just ordered 4 more from the classifieds for back-up! I like that I can, when, and if, they stop selling, I can use the rebuildable part and just keep on vaping. Kanger rules!
No Chinese manufacturer will consider applying for product approvals. Nothing I buy will be submitted for approval. I wish that all the manufacturers, without exception, would stand together and promise not to submit applications. 99% of them don't have the option anyway.
I'm not sure I would go that Far.
Because if it is Only BT and maybe a BV doing PMTA's, someone like Kanger might see a Large Market Share that could be Captured.
But I agree, they probably aren't going to probably do PMTA's on Anything that You or I (or Most Current Vapers) would want to use.
I wonder what percent of all vaping hardware sales are to the US market. Americans have lots of money to spend but are only 4% of the world's smokers. It's possble to have a first class vape for an annual cost that's substantially less than the least expensive quality cigarettes in the world (Cambodia). There is no place where vaping doesn't have a substantial cost advantage over smoking. The hardware manufacturers will simply move on to greener pastures. The US is not worth the bother. We aren't so special.
That is a Good Question.
I'm not sure what Percentage the US might have? But It Wouldn't surprise me if the US was the Largest Market.
But that could well have just Changed.
I could see Kanger maybe doing a PMTA for a Closed System setup to compete against BT's offerings. But there is No Way they are going to Invest BIG Bucks in our Crocked FDA Approval System for all but 1 or 2 of their New Products.
The approval process is a sucker's game. No matter what an application contains it can be denied for any reason or no reason at all. God doesn't give reasons for the commandments.
Folks, I follow start-up biotechs and their battles with the FDA.
There essentially isn't a filing fee with the FDA.
The monetary killer is all the testing and documentary evidence you have to file with the FDA. That's where the big bucks get spent. The applicant pays 100% of that.
And the FDA doesn't do any testing itself on NDAs (and, for vaping, PMTAs). That's all up to the company applying for FDA approval. Here's the basic process:
1. The company files a new drug application (NDA) with the FDA.
2. The FDA then discusses acceptable testing designs (yes, plural for NDAs), from phase I through phase III with the company.
3. The company then tests the new drug, according to the agreed-upon testing protocols, from phase I through phase III. The drug has to pass on each of the phases, some of which are divided into two or more sub-phases.
4. Once the new drug has passed through all the FDA-mandated tests, then there is an advisory committee meeting or meetings to discuss the findings and possible impact on patients and the nation's health in general.
5. The FDA is not bound by the committee's or committees' vote(s).
There's one drug-delivery system I've been following for quite a few years. It seemed like such a slam-dunk that I even invested in the company. More on that in the next post.
There essentially isn't a filing fee with the FDA.
The monetary killer is all the testing and documentary evidence you have to file with the FDA. That's where the big bucks get spent. The applicant pays 100% of that.
And the FDA doesn't do any testing itself on NDAs (and, for vaping, PMTAs). That's all up to the company applying for FDA approval. Here's the basic process:
1. The company files a new drug application (NDA) with the FDA.
2. The FDA then discusses acceptable testing designs (yes, plural for NDAs), from phase I through phase III with the company.
3. The company then tests the new drug, according to the agreed-upon testing protocols, from phase I through phase III. The drug has to pass on each of the phases, some of which are divided into two or more sub-phases.
4. Once the new drug has passed through all the FDA-mandated tests, then there is an advisory committee meeting or meetings to discuss the findings and possible impact on patients and the nation's health in general.
5. The FDA is not bound by the committee's or committees' vote(s).
There's one drug-delivery system I've been following for quite a few years. It seemed like such a slam-dunk that I even invested in the company. More on that in the next post.
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Opioid addition is a serious problem in this country. But there are two drugs which fairly effectively block opioid addiction, methadone and buprenorphine. Both of these drugs are also subject to widespread abuse. In fact, buprenorphine is the single most abused drug in the nation's prisons.
Titan Pharmaceuticals came up with the idea of making buprenorphine essentially non-abusable by changing its method of administration. Instead of using daily pills or sublingual dissolving "pads," Titan came up with making little, implantable tubes loaded with buphrenorphine, like Norplant. (Norplant is an implantable contraceptive in wide use throughout the world, except in the U.S.) The little tubes have to be inserted by a physican, since they go deep under the skin. They're not removable except by a doctor. They last for about six months, then they have to be replaced.
Titam's delivery system, which they call Probuphine, seems to be a slam-dunk. The drug itself is effective and has been used to control opioid addiction for 15 years. The delivery method has been in use for over 50 years and has a good record.
Titan expensively jumped through all the FDA hoops: phases Ia and Ib, II, IIIa and IIIb. The advisory committee overwhelmingly approved it, with a vote of something like 19-4.
The FDA bounced it.
Titan was pretty much out of money, so they had to partner with another firm, Braeburn, which demanded and got a huge chunk of potential Probuphine revenue, should it pass.
So, Titan and Braeburn then brewed up another test protocol, with kibbitzing by the FDA. The test successfully met all goals, and had another advisory committee hearing. Once again Probuphine passed by an overwhelming majority.
Months and months later, Titan is still waiting for the FDA to rule.
This is what any hardware or eliquid PMTA faces. Or worse.
Titan Pharmaceuticals came up with the idea of making buprenorphine essentially non-abusable by changing its method of administration. Instead of using daily pills or sublingual dissolving "pads," Titan came up with making little, implantable tubes loaded with buphrenorphine, like Norplant. (Norplant is an implantable contraceptive in wide use throughout the world, except in the U.S.) The little tubes have to be inserted by a physican, since they go deep under the skin. They're not removable except by a doctor. They last for about six months, then they have to be replaced.
Titam's delivery system, which they call Probuphine, seems to be a slam-dunk. The drug itself is effective and has been used to control opioid addiction for 15 years. The delivery method has been in use for over 50 years and has a good record.
Titan expensively jumped through all the FDA hoops: phases Ia and Ib, II, IIIa and IIIb. The advisory committee overwhelmingly approved it, with a vote of something like 19-4.
The FDA bounced it.
Titan was pretty much out of money, so they had to partner with another firm, Braeburn, which demanded and got a huge chunk of potential Probuphine revenue, should it pass.
So, Titan and Braeburn then brewed up another test protocol, with kibbitzing by the FDA. The test successfully met all goals, and had another advisory committee hearing. Once again Probuphine passed by an overwhelming majority.
Months and months later, Titan is still waiting for the FDA to rule.
This is what any hardware or eliquid PMTA faces. Or worse.
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I propose it will be far worse.
Back in 2009, when the FDA was given oversight over tobacco products, the entire PMTA process was designed to make it very, very difficult to introduce new tobacco products into the market. The bar was set exceptionally high to prevent BT from introducing new and novel products. The goal was to freeze the market for cigarettes and chewing tobacco, not grow it.
This is very different than NDAs, where the protocol is well-defined in 21CFR and the FDA does not have an interest in halting/freezing the market, simply an interest in ensuring that new pharmaceutical product is safe, effective, and manufactured properly (in theory, anyway... we know how well that seems to be working lately).
Not to mention that large pharmaceutical companies have entire departments to manage the FDA for NDAs and ANDAs (for generics) and to deal with FDA audits....not to mention staff to handle developing the NDAs, clinical trials, etc. This is something a small eliquid manufacturer doesn't have.
A stupid question from boring south Africa.
Will the fda impose the same regulations accross the board to other industries? Will coke and other companies need to register each product under these same regulations ?
When will a world wide petition be started?
Why would a small e liquid manufacturer need to register already registered product components just the combination is different and possibly the same combination is found in food products less the nic?
Will the fda impose the same regulations accross the board to other industries? Will coke and other companies need to register each product under these same regulations ?
When will a world wide petition be started?
Why would a small e liquid manufacturer need to register already registered product components just the combination is different and possibly the same combination is found in food products less the nic?
Hi, Dean, from not-so-boring South Africa! That's one beautiful country.
The Deeming Regulation only applies to tobacco products. Other products are regulated by other FDA regulations, or are regulated by other alphabet-soup agencies.
The Deeming Regulation only applies to tobacco products. Other products are regulated by other FDA regulations, or are regulated by other alphabet-soup agencies.
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