FDA approval?
- Thread starter SquirrilahFish
- Start date
- th_trl_thread_readers 0
-
- Tags
- volcano
- Status
The suit is on track to be settled this month and the FDA will then probably have the authority to ban them nationwide if the outcome goes as expected.
I dont understand how that works, I thought the court battle was over illegailly seized shipments, how can the fate of all ecigs be hindered on the outcome of 2 companies, that doesn't make sense
Ecig are classified by the FDA as a Medical Device, and an unapproved one at that. to get proper Approval or even registered, a company (s) would have to spend Millions , yes millions of dollars and years of testing before the FDA would even blink an eye to say if they are approved or registered. Even if the court case goes in our favor, that is just the shipping issue, not the position to legally sell in the US.
millions huh, what is that bribe money, ****ing government
im moving too. . . . . oh wait there's no where free anymore, Sweden?
im moving too. . . . . oh wait there's no where free anymore, Sweden?
FDA's regulatory maze is called a pre-market approval (a.k.a. PMA). In order to gain PMA, you need to do the following:
(a) Conduct lab experiments and research to prove that your device does what you say it does and that it can advance medicine, in the end.
(b) With your experimental data to back up your claims, apply to the FDA for an Investigational Device Exception (IDE). This gives you limited approval to use the device on an experimental basis in order to ...(c) Conduct clinical trials to show that your device is safe (causes no harm) and effective (is at least as good, if not better, than already-existing products on the market). (d) Using the positive results from the clinical trials.
PMA takes several years and millions of dollars. Only undertake it if you have the financial backing and patience to undergo many delays, problems, and bills.
(a) Conduct lab experiments and research to prove that your device does what you say it does and that it can advance medicine, in the end.
(b) With your experimental data to back up your claims, apply to the FDA for an Investigational Device Exception (IDE). This gives you limited approval to use the device on an experimental basis in order to ...(c) Conduct clinical trials to show that your device is safe (causes no harm) and effective (is at least as good, if not better, than already-existing products on the market). (d) Using the positive results from the clinical trials.
PMA takes several years and millions of dollars. Only undertake it if you have the financial backing and patience to undergo many delays, problems, and bills.
So what's really going to happen here? The sale of e-liquid, e-cigarette parts, etc. and the ability to vape in the U.S. is likely to all become "illegal?" Meaning no more e-liquid, no more buying replacement atomizers, no more vaping?
I'm not 100% certain I follow everything the FDA is trying to "ban." I can understand banning an import of devices from China... but is this at the point where it is now banning the entire concept of e-cigarettes?
I'm not 100% certain I follow everything the FDA is trying to "ban." I can understand banning an import of devices from China... but is this at the point where it is now banning the entire concept of e-cigarettes?
In short, it's a system to ensure monopoly by a handful comapnies that swap chairs with the FDA.
I think it's mostly a system to ensure return of investment(or any profit for that matter) to big pharma and small part of it is to ensure safety and effacy of products. Problem with products containing nic is that no one actually developed it as a drug or has any pending investments on it.
i think we know why this is happening, what im wondering, is will the case between Njoy and FDA, determine a outcome for all ecigs, and are they any ecig companies working with the FDA to keep there products on the market?
This is the part that confuses me a bit.
If the suit is just SE and NJoy suing the FDA over held shipments, and not the legality of e-cigs, then why hasn't the FDA issued a ban on them already? This suit really has nothing to do with the e-cigs being legal or not. Why can we buy them now, and not after the suit if (when) the FDA wins?
Either way, I'm stocking up what little I can.
How are e-cigs categorized as drugs? Are cigarettes categorized as drugs? This is the issue which confuses me the most.
There are a million different ways to get caffeine into your body and the FDA doesn't care. Maybe we can get e-cigs categorized as a food.
There are a million different ways to get caffeine into your body and the FDA doesn't care. Maybe we can get e-cigs categorized as a food.
The FDA and such have to know that banning them will only cause a black market for them. It is well known prohibition doesn't work. I half expect taxing and regulation to "nicotine" in addition to tobacco at some point in the future.
Last edited:
Why do electronic cigarettes HAVE to be approved as a "medical device"? I understand that some companies have been making reckless claims regarding it as a quit-smoking tool, but if its "intended purpose," as the FDA would say, is determined to be use as an alternative to smoking cigarettes, then what does that have to do with medicine?
Is there an alternative route to the "medical device" billion-dollar investment? Does the FDA have anything in place to evaluate these for safety alone with no intention to treat a disease?
I just find it hard to believe that every legal drug must have a medical intent in mind.
Is there an alternative route to the "medical device" billion-dollar investment? Does the FDA have anything in place to evaluate these for safety alone with no intention to treat a disease?
I just find it hard to believe that every legal drug must have a medical intent in mind.
If I understand it correctly, Njoy and SE sued stating that the FDA did not have the authority to confiscated and stop their products as they are not medical devices. When the judge rules that the FDA is correct and can confiscate them, he is in essense agreeing with the FDA's opinion on PV's as medical devices. Once that happens, the FDA will ban them nationwide and there will be financial and criminal consequences for suppling them. So, if a black market does come into existence, which may be doubtful since 98% of everything comes from China and they don't need the US market to make a profit, the $15 cost for a small device battery will go up to $50-$100 IMO.
Then, in 2-4 years, Pfizer will come out with a personal vaporizer requiring a perscription, prefilled carts only, 2mg and 4mg carts only and the device will cost $200 and the cartridges will cost $4 each and they will taste like a POS.
And ASH and the FDA will act like they saved us poor misguided addicts from ourselves. And Pfizer will pump more money into the ASH accounts and many top FDA personal will leave the government and get good jobs with Pfizer.
Last edited:
...for those that wish to have a serious debate/discussion about this, and how this can have an effective positive outcome (and I do NOT TRUST NJOY not to blow this without *strong consumer pushback) is this:
(I will list the irrefutable *facts* here, devoid of emotion, and welcome correction of these facts
1. Nicotine in non-plant, purified, extracted or synthetic form (nicotine is found naturally in some nighshade family plants, specifically tobacco for our purpose) is a pharmaceutical drug, a powerful highly addictive pharmaceutical drug that in pure form is highly toxic and can kill on contact, and in this form is a drug/pharmaceutical regulated by the USFDA. With new laws passed, in cigarette form, it is also regulated by the USFDA.
2. The FDA has jurisdiction over this pharmaceutical drug and the way it is used/administered.
3. One of the approved uses is as an inhalent in vapor, specifically for smoking cessation, at regulated amounts. These are Medical Devices.
4. some e-Cigarette devices are sold/shipped/marketed with nicotine.
5. e-Cigarette devices atomize nicotine-bearing liquid into a vapor for inhalation.
How can it be any less clear how and why the FDA has jurisdiction here, where the problem lies and what can be done to resolve the issue and keep Personal Vaporizers on the market? I mean really, is it that hard to see what the solution is? Are these companies and their vocal proponents *so arrogant* that they don't know how to "play the game"?
If anyone needs me to spell it out further I will by all means be happy to, but I think a clear, interim solution is apparent
-K
(I will list the irrefutable *facts* here, devoid of emotion, and welcome correction of these facts
1. Nicotine in non-plant, purified, extracted or synthetic form (nicotine is found naturally in some nighshade family plants, specifically tobacco for our purpose) is a pharmaceutical drug, a powerful highly addictive pharmaceutical drug that in pure form is highly toxic and can kill on contact, and in this form is a drug/pharmaceutical regulated by the USFDA. With new laws passed, in cigarette form, it is also regulated by the USFDA.
2. The FDA has jurisdiction over this pharmaceutical drug and the way it is used/administered.
3. One of the approved uses is as an inhalent in vapor, specifically for smoking cessation, at regulated amounts. These are Medical Devices.
4. some e-Cigarette devices are sold/shipped/marketed with nicotine.
5. e-Cigarette devices atomize nicotine-bearing liquid into a vapor for inhalation.
How can it be any less clear how and why the FDA has jurisdiction here, where the problem lies and what can be done to resolve the issue and keep Personal Vaporizers on the market? I mean really, is it that hard to see what the solution is? Are these companies and their vocal proponents *so arrogant* that they don't know how to "play the game"?
If anyone needs me to spell it out further I will by all means be happy to, but I think a clear, interim solution is apparent
-K
Last edited:
...for those that wish to have a serious debate/discussion about this, and how this can have an effective positive outcome (and I do NOT TRUST NJOY not to blow this without *strong consumer pushback) is this:
(I will list the irrefutable *facts* here, devoid of emotion, and welcome correction of these facts
1. Nicotine in non-plant, purified, extracted or synthetic form (nicotine is found naturally in some nighshade family plants, specifically tobacco for our purpose) is a pharmaceutical drug, a powerful highly addictive pharmaceutical drug that in pure form is highly toxic and can kill on contact, and in this form is a drug/pharmaceutical regulated by the USFDA. With new laws passed, in cigarette form, it is also regulated by the USFDA.
2. The FDA has jurisdiction over this pharmaceutical drug and the way it is used/administered.
3. One of the approved uses is as an inhalent in vapor, specifically for smoking cessation, at regulated amounts. These are Medical Devices.
4. some e-Cigarette devices are sold/shipped/marketed with nicotine.
5. e-Cigarette devices atomize nicotine-bearing liquid into a vapor for inhalation.
How can it be any less clear how and why the FDA has jurisdiction here, where the problem lies and what can be done to resolve the issue and keep Personal Vaporizers on the market? I mean really, is it that hard to see what the solution is? Are these companies and their vocal proponents *so arrogant* that they don't know how to "play the game"?
If anyone needs me to spell it out further I will by all means be happy to, but I think a clear, interim solution is apparent
-K
MrKai,
I appreciate your clarification, thank you. I do see where the FDA is coming from in all this.
However, i still have that nagging question in my mind as to whether or not every drug has to have proven medical benefit to be legal in the united states.
To beat a dead horse, the steps of drug approval are (VERY generally speaking):
1) Prove it is not lethal or otherwise extremely toxic (usually done on animals)
2) Prove it is safe enough for human consumption (limited human trials here)
3) Prove it is effective for its intended medical purpose (human trials on those with said medical condition)
Initially, the drug will be marketed only by the company that patented the drug and conducted the trials, and by prescription only. Later, the FDA will evaluate and allow the potential for generics. Later still, if the drug is determined to be safe enough in patient-controlled doses, it may be available over-the-counter.
With the dead horse now successfully beaten, if a drug is clearly NOT intended to treat any medical condition by its very nature, does the FDA have any clause for going through only steps 1 and 2, skipping step 3 entirely and simply not ever marketing itself as a medical device?
I would like to make it clear that i KNOW i am stepping outside the bounds of reality as far as the e-cig case is concerned; the FDA already made it excruciatingly clear what its position is on that. I simply would like to know if its ever been done before, if its possible, or is there any clause in the laws governing the FDA which render this impossible?
I am just wondering if its possible, under current law, for a recreational drug other than alcohol or tobacco to be legal.
And yes, my curiosity kills me every day
I still think separating the device from the drug might be the key to legalization. Many vapers do their own refilling anyway, and the PV itself doesn't have to be used with nicotine in particular. Other medications can be delivered, some manufacturers are even delivering vitamins via vapor, and anti-nausea or anti-pain meds could be administered through vaping where its legal and it would minimize sidestream effects. Any of those additives can and should be evaluated for its safety and efficacy as an inhalant, but they should be on their own merit.
The personal vaporizer itself needs a completely different set of quality assurance standards. The FDA used the fact that Njoy and SmokingEverywhere sell starter kits with the hardware and the cartridges as a single retail product as justification for classifying it as a new drug/deliver combo. The only reason the FDA has jurisdiction and the ability to claim that this combo is "untested"--even though every element of an e-cigarette has been tested separately--is by viewing it as a combo. But even that logic, IMO, is flawed. If Kellogg puts a souvenir spoon in boxes of Raisin Bran does it need to undergo FDA certification as a new food/device combo? If Jagermeister comes with a promo shot pourer, is that a new drug/device combo too?
The personal vaporizer itself needs a completely different set of quality assurance standards. The FDA used the fact that Njoy and SmokingEverywhere sell starter kits with the hardware and the cartridges as a single retail product as justification for classifying it as a new drug/deliver combo. The only reason the FDA has jurisdiction and the ability to claim that this combo is "untested"--even though every element of an e-cigarette has been tested separately--is by viewing it as a combo. But even that logic, IMO, is flawed. If Kellogg puts a souvenir spoon in boxes of Raisin Bran does it need to undergo FDA certification as a new food/device combo? If Jagermeister comes with a promo shot pourer, is that a new drug/device combo too?
Last edited:
This seems to be key to me too. How would the FDA have jurisdiction over the sale of a PV that comes with carts that have 0 mg Nicotene juice? Would it be that PG juice still would need to be regulated for purity standards? Or not since PG is already in lots of foods?
The fact that PVs and Nicotene are not the same thing and not permanantly linked to each other needs to be emphasized imo.
- Status
Similar threads
- Locked
