I remember that.When JC was partnered with Blu, they were all about welcoming our FDA overlords. Now? Not so much.
Deeming Regulations have been released!!!!
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How about then making supporting the FDA in its past, current, and future rampage unpalatable ?
We don't need to throw dirt. We just need to point at the pile, or maybe even rub some pols noses into it:
FAERS Reporting by Patient Outcomes by Year
It's their very own data.
And the blue bar ( which shows cases called 'serious' - i.e. not dead , providing never ending income for BP for treating what they botched up in the first place ) is steadily rising. What is the FDA doing ??!!
Caring for the Americas health ? Or running some clandestine euthanasia program ?
The yearly body count tops American casualties of the Korean and Vietnam Wars combined.
A 9-11 roughly every ten days - from FDA-approved drugs.
If any of these crazed outfits wreaking havoc in the Middle East and elsewhere would rack up so many US citizens, the military would come down on them with everything at their disposal, including the kitchen sink.
Make THAT clear to the public.
Make it clear to the 'so-called' representatives is failing abysmally on its designated task.
It will be quite interesting to see Califf's response to Sen. Johnson's letter, linked above. He gave them two weeks. Among other questions, he asks (paraphrasing): How many businesses will have to shut down? As the FDA claims it lacks "sufficient data" to determine the effect of e-cigarettes on public health, explain why these regulations aren't premature?Looks like Johnson's Creek is having second thoughts about "welcoming FDA regulation". And, I guess this answers my question as to whether they got cut out of the whole Blu loop when it was sold or not.
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I won't argue that point, but it doesn't really matter either way.Sugar_and_Spice said:
The more the FDA actually does control Big Tobacco...
The more they would want Big Tobacco to control recreational usage...
They are only killing OUR industry.
The future of vaping is being handed to Big Tobacco, if there is any future.
Well, they shouldn't actually be taxing either, but yeah.
They need a villain for the ANTZ to rally against.
The ANTZ are the minions that keep the public frothing at the mouth against us.
There is an entire list of benefits of nicotine usage which grows by the month.
But there are no nicotine-based drugs yet to take advantage of that.
"Yet" being the keyword here.
The path must be cleared first, and electronic cigarettes stand in the way.
The only "healthy" alternative for nicotine usage must be Big Pharma offerings.
That's the thing that has kept me optimistic for a couple years. I stated several years ago that the opponents to the ecig industry have been scrambling all over the place trying to find the "smoking gun". All they could ever come up with was misinformation and using flawed/dated studies. It's not like the ecig industry is really that new. It's been around nearly 10 years and there are current users who have been at it for 7 years. You would think it would be easy to document acute affects if there were any, right? If you smoke for 7 years it's pretty easy for any doctor to tell.
Since they couldn't find ANYTHING worthy of documenting clear and present danger or acute effects, they had to go on a propaganda campaign to sway public opinion and falsely "create danger". Now the defense is "insufficient data". lol. Which is partly true because long term effects won't be known until we have long term users. But we do have data for short term use. And data that clearly backs up magnitudes of lower harm. But that somehow got conveniently ignored during the comment period.
Things are getting noisy now. Backlash is slowly gaining momentum. It's going to be a cage match for sure. We can only hope in the end that the FDA takes an embarrassing beat down. If they don't then we do...lol
Ah, a breath of fresh air for a change.... a Senator with some pull actually asking the questions that need to be asked of the FDA. Thanks for sharing that.Looks like Johnson's Creek is having second thoughts about "welcoming FDA regulation". And, I guess this answers my question as to whether they got cut out of the whole Blu loop when it was sold or not.
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EDIT: I believe the Senator was representing Johnson Creek because they are based in Wisconsin, the state Senator Johnson represents.
I'm gonna let the Senator know of my appreciation for his efforts.
Contact | Homeland Security & Governmental Affairs Committee
Contact | Homeland Security & Governmental Affairs Committee
This is very promising! We need the names of members on this committee!
Oh... About the Senate Committee on Homeland Security & Governmental Affairs | Homeland Security & Governmental Affairs Committee
Oh... About the Senate Committee on Homeland Security & Governmental Affairs | Homeland Security & Governmental Affairs Committee
I see it's already been shared but I'll post it again.
Sen Johnson (R-Wis) demands answers from FDA RE deeming
Possibly the start of a congressional review?
Sen Johnson (R-Wis) demands answers from FDA RE deeming
Possibly the start of a congressional review?
Sweet- Rob Portman is one of my Senators and I just mailed off a letter to him today. Wish I'd known about this first, but that's okay...
The FDA has constantly presented themselves as a "science-based organization". The fact that they claimed "insufficient data" should have been enough for them to take a pause to collect that data before issuing draconian regulation.
To simply say, "We're going to ban vapor products because we just don't have any evidence either way to the public health impact" is just simply not scientific. Its political pandering.
I, too, am very interested to see what becomes of this. At a minimum, it forces them to come to the table and be accountable to a pretty powerful Senate committee.
Maybe we should mail the good senator a hardcopy of the RCP report.
Or at least the relevant summaries or the chapters that matter as these seem to have been formulated especially for people who need data concise and condensed.
Though the way he posed his questions and requests for clarification to the FDA, I suspect he's got a copy already
Or at least the relevant summaries or the chapters that matter as these seem to have been formulated especially for people who need data concise and condensed.
Though the way he posed his questions and requests for clarification to the FDA, I suspect he's got a copy already
I still think there is merit to the idea that the fact FDA was not allowed to treat e-cigs as a drug product (per the Judge Leon ruling), yet issued deeming regs that essentially require pharma model testing, could be used as a very valid argument against. This was brought to mind again today when I was watching Siegel's interview with uh... Whitecloud(?).
I must be misunderstanding this bit below from that page. Can they really be basing fees on a revenue target?
Well done.Below is my comment and response to the FDA. I know it doesn't solve anything but I feel better when I do it.
Lumping vaping and smoking into the same bucket is completely illogical. Combustion and smoke is the real killer and everybody including elementary school students knows this. Nicotine consumption is already approved for long term use and is scientifically proven by numerous studies to be about as harmful as caffeine. And appears to have cognitive benefits and may prove to be a treatment for certain cognitive diseases. The science behind nicotine itself goes back many years and is completely ignored on this issue. All we see is nicotine = sickness and death. I'm not an idiot and don't appreciate being treated like one. The only sensible regulation would be to create a new class of recreational product and have regulations focused on the actual harm of the product. But that isn't what happened. Not even close. We're staring down the barrel of a modern day health miracle. One that has been sought after for decades. The end of smoking. And what do we get? Our voices silenced, the truth twisted, completely biased propaganda, our future compromised, another freedom taken away, and all in the name of what? Money, corruption, and crony capitalism.
Bob- Any product wishing to enter the market as a cessation tool is required to show both effectiveness and safety before being approved as a drug or device by FDA - and e-cigarettes have not yet passed that basic test. Regulations are not a ban, but give us the ability to further evaluate and assess the impact of e-cigarettes on the health of both users and non-users, and regulate the products based on the most current scientific knowledge.
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I think I need to make my point more clear based on your response. I wasn't implying that ecigarettes should be lumped into the treatment/medical bucket. I was simply stating that nicotine itself does not pose any credible health risk and the FDA already approved it as such. It is no more harmful to the human body than caffeine. It's a proven scientific fact that has been around for many years.
My main point was that the FDA's approach is lumping cigarettes (smoke) and ecigarettes (vapor) into the identical regulatory bucket. That's not even apples to oranges. It's apples to boulders. The only sensible approach is to create a new class of recreational product (note recreational) that will ultimately replace combustible cigarettes in the United States. That is a health miracle without even requiring any medical treatment, prescriptions, mind altering pharmaceuticals, or ineffective nicotine replacement therapy. But that's not what big businesses want. Not at all. Because it would cost billions in profits to both the tobacco and pharmaceutical companies. Not one single sensible concession was made with the deeming regulations when comparing vapor to smoke.
The regulations are artfully crafted (in every possible way) to completely destroy the industry. How can you honestly say that ANY small business stands ANY chance at affording and/or succeeding the PMTA process? I read up on what Swedish Match and their 100,000 pages of application had to go through. The regulations as written are quite heavy handed and draconian. I feel sorry for the tens of thousands of jobs that will be lost in the next 2 years. And even worse for the increased harm caused by not having a viable recreational alternative to packs of cigarettes sitting on the shelves in millions of stores.
All data currently coming out is proving that ecigarettes are in fact 95 to possibly 100% safer than combustible cigarettes. From undeniably credible sources like the Royal College of Physicians no less. But instead they are being treated as carbon copies of each other. The more I think about it the more insane it looks. Until I think about tobacco and pharmaceutical special interests. Then it becomes pretty clear.
IMO, it would hurt more than help, even if it wouldn't create an ecf mess. There'd be other collateral damage.
No pause in access to vaping help and info, please. None.
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