Where can I watch this, as I click on the link it tells me the host has ended the session!
Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products
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Which is the part that has always concerned me. I would hope that an organization which wants to represent us (not just themselves as they would like to say, when you consider the impact such a presumptive AEMSA/FDA standards relationship forming would have), would encourage further exploration and development rather than lock the industry into a stagnant but safe book 'o rules.
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That's interesting! Unfortunately, the FDA doesn't categorize nicotine based on its source, only on its intended use. If it's used as a treatment for nicotine addiction, it's a drug that needs FDA-approval. If it's not used as a treatment, it's a (recreational) tobacco product (which, under FSPTCA, the FDA now has the power of deeming regulations for new tobacco products - they must be proven not to increase public health risks before they can be sold unless they are similar enough to products already sold.) The FDA (and probably Congress) would have to approve a whole new category (like "recreational nicotine") if companies start producing affordable nicotine products from non-tobacco sources that are not intended to be used as a treatment.
If I understand correctly, the FDA's power over eCig's is tied to the word, "Tobacco," the source of nicotine as we know it. It may be grasping at straws, but attorney's careers are made, or lost over the meaning of words. A common recreational substance has made recent headlines and is a concern, or as it now seems, not a concern for the federal government. Sometimes things are wishy-washy. I have no idea what the law has to say about 'nicotine.'
The FDA doesn't regulate nicotine, it regulates tobacco products and ecigs have been deemed a tobacco product. What they should be treated as is a suppliment. i.e. regulated only when proven to cause a public health risk as opposed to regulated until proven 'not' to cause a public health risk.
Right now we are guilty until proven innocent (tobacco product)
We want to be innocent until proven guilty (suppliment)
Right now we are guilty until proven innocent (tobacco product)
We want to be innocent until proven guilty (suppliment)
anyone find a video of this ? since the event is over i'd like to watch and see what the hubbub is all about
I'm sure one will pop up sooner than later. Give yourself some time, the hearing lasted all day.
I have my doubts that a substance known to be addictive might become a 'supplement.' The question for me remains, would "ecigs" still be deemed a 'tobacco product' if the nicotine in them came from somewhere other than from 'tobacco' plants? Yes, yes...grasping at straws and trying to make a career for some crafty would-be attorney.
That "other" movement is further proof that trying to swim upstream, by trying to "fight" the FDA et. al. for the right to use e-cigarettes, will not work. If we can figure out a way to suggest cooperation- whether it be through reasonable regulation or industry standards, taxes, licensing, etc. or a combination of those ideas- we'll live to see the day when e-cigarettes will have gained legitimacy. That, and we also will need some great PR and more money from the industry...
On the same topic, and while this is mildly-taboo - the use of e-cigarettes has expanded out of the realm of nicotine, using the same concept of vaporizing a fluid suspension, in that "other" movement that's gained ground lately. There is also lots of research money being poured into refining and researching the e-cigarette for said industry, and on health effects, etc. Unfortunately, though, there are not many places where discussion of the topic is even allowed (...certainly not here in any explicitly obvious capacity), so it remains virtually a secret to most everyone except those in the know. The product acquisitions being made are staggering- one company I communicate with in china reported sales of over 100,000 atomizer units (designed specifically for "industry X", using standard 510 connection and ceramic/coil technologies similar to what we use) per month. Just an interesting side note for those who aren't aware.
I'm sure lots of people here want to see "e-cigarettes" remain a term and product exclusively used for nicotine, and no matter where you stand on the issue, the info above may be useful. I have much more info, and if anyone involved in the Vaping movement has any specific questions, I would be happy to answer them by PM, but as I said above it is not permitted explicitly in forums on ECF.
Sorry -- but I find this a bit scarey that CASAA seems to be indicating that "taxes" should not be a concern. Surely, part of the job is insuring that e-liquid not be taxed at levels that have been proposed for ALL tobacco products....except the illusive cigars. As I recall, there have been several proposed legislation attempts in 2012. There are surely more to come in 2013.
From how things have progressed nationwide with some areas banning the use of E-cigs, I am far from seeing a trust that our legislators give a hoot about harm.
CASAA had been great and deserves respect and support. There is a lot of work to do.
Just received this email from the FDA:
In answer to some of the previous questions:
Today, the presentation was only viewable in real time. If you tuned in during one of the breaks, you saw nothing going on. It would have been nice if they posted some type of sign that let folks know the meeting would be continuing at X:XX time.
The webcast video will be posted on the FDA web site when they are good and ready. My guess would be that it might take a few weeks, considering the holidays coming up.
The video filmed by Linc Williams (simultaneously) will be ready for posting after he has edited the raw footage. When it is ready, we will be posting his videos on the CASAA site.
As for the topic of the meeting and whether it was about e-cigarettes...
Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Comments
Keep in mind that two different divisions of the FDA regulate the nicotine products made by Big Pharma (the Center for Drug Evaluation and Research, aka CDER) and tobacco products (The Center for Tobacco Products aka CTP.
One of the points I made in my presentation is that the Tobacco Act calls for a "fast track" for approval of the products regulated by CDER that could be considered "breakthrough products" or "innovative". That is under Section 918 of the tobacco act.
Section 911 of the law called for the tobacco side of FDA (CTP) to come up with a plan for approval of "modified risk tobacco products (MRTPs)." There was no requirement for these to be "fast tracked," so the regulatory guidance that the CTP issued for approval of MRTPs was so detailed and complex that it would take years and cost millions for any products to be considered MRTP.
So think about that. Yes, we didn't want the FDA to regulate e-cigarettes as drugs because that approval process takes so long and costs so much. But if being a regulated as an "innovative" or "breakthrough" product by CDER means that you can get on a fast-track, might that not be preferable to the MRTP process that CTP decided to lay out?
We don't know for sure where all this is going, but we need to keep all our options open, and educate both sides of the FDA on the benefits of Tobacco Harm Reduction.
In answer to some of the previous questions:
Today, the presentation was only viewable in real time. If you tuned in during one of the breaks, you saw nothing going on. It would have been nice if they posted some type of sign that let folks know the meeting would be continuing at X:XX time.
The webcast video will be posted on the FDA web site when they are good and ready. My guess would be that it might take a few weeks, considering the holidays coming up.
The video filmed by Linc Williams (simultaneously) will be ready for posting after he has edited the raw footage. When it is ready, we will be posting his videos on the CASAA site.
As for the topic of the meeting and whether it was about e-cigarettes...
Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Comments
Keep in mind that two different divisions of the FDA regulate the nicotine products made by Big Pharma (the Center for Drug Evaluation and Research, aka CDER) and tobacco products (The Center for Tobacco Products aka CTP.
One of the points I made in my presentation is that the Tobacco Act calls for a "fast track" for approval of the products regulated by CDER that could be considered "breakthrough products" or "innovative". That is under Section 918 of the tobacco act.
Section 911 of the law called for the tobacco side of FDA (CTP) to come up with a plan for approval of "modified risk tobacco products (MRTPs)." There was no requirement for these to be "fast tracked," so the regulatory guidance that the CTP issued for approval of MRTPs was so detailed and complex that it would take years and cost millions for any products to be considered MRTP.
So think about that. Yes, we didn't want the FDA to regulate e-cigarettes as drugs because that approval process takes so long and costs so much. But if being a regulated as an "innovative" or "breakthrough" product by CDER means that you can get on a fast-track, might that not be preferable to the MRTP process that CTP decided to lay out?
We don't know for sure where all this is going, but we need to keep all our options open, and educate both sides of the FDA on the benefits of Tobacco Harm Reduction.
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Sorry - I didn't mean it that way. It SHOULDN'T be taxed at the same rate, but you are correct - that doesn't mean they won't try - but we fight them every time. CASAA helped stop a 70% tax on e-cigarettes in Hawaii and one other place that escapes my memory right now - fighting unreasonable taxation proposals is definitely something CASAA does!
Actually, Lou, from AEMSA was the one that suggested I should make an appearance. After all, the entire point of the vaping speakers is to push to extend THR TO E-CIGS.
Apparently you didn't watch much
Overall I was quite pleased with everybody who presented. In fact I was surprised that even some of those who I expected to somehow discount or deride electronic cigarettes seemed finally to admit their value.
I was quite educated, not so much by the presenters but by the panel and their questions. It's astounding how people can be so narrow minded. No imagination, their world is a box. I know their box is dictated by the law, but you'd think just as human beings they would take the opportunity to be curious, to expand their lives. Maybe that comes at the after party.
I was quite educated, not so much by the presenters but by the panel and their questions. It's astounding how people can be so narrow minded. No imagination, their world is a box. I know their box is dictated by the law, but you'd think just as human beings they would take the opportunity to be curious, to expand their lives. Maybe that comes at the after party.
Actually, Lou, from AEMSA was the one that suggested I should make an appearance. After all, the entire point of the vaping speakers is to push to extend THR TO E-CIGS.
Apparently you didn't watch much
Thank you sir. I enjoyed your perspective.
It was a long session, I didn't watch the whole thing either. I wonder who watched the whole thing after all some of users of nicotine products are self-medicating for things like ADHD
It was a long session, I didn't watch the whole thing either. I wonder who watched the whole thing after all some of users of nicotine products are self-medicating for things like ADHD
I would have watched the whole thing, but I had to go pick up my Ritalin perscription.
I'm fairly certain that by not being classified as an NRT we were able to escape a ban the last time when NJoy went to court, yes? I don't want people classifying e-cigs as an NRT, because it's not. Strict NRT's are used to quit nicotine dependency, and while some users use e-cigs to that end, many do not and that's not the purpose of e-cigs. I, for one, do not see this as a means to quit in the immediate future. It's a way for me to continue to enjoy nicotine while enjoying the health benefits of NOT smoking. It's like Bill said, no this is not a safe alternative to smoking but, like smokeless, it IS a SAFER alternative to smoking. Anyone who's made the switch can vouch for that. And while using an e-cig, i did not go through DT's or have personality altering mood swings. That alone is enough to convince me, and thousands of others.
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