FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development
So are they going to disqualify themselves, seeing as how they manipulated their own study?
FDA can disqualify those who manipulate data
- Thread starter ashdaburned
- Start date
- th_trl_thread_readers 0
- Status
So are they going to disqualify themselves, seeing as how they manipulated their own study?
We don't know they manipulated anything. That's speculation. We do know that they spun their data for the media, but that doesn't mean they manipulated it. In fact, their actual study was pretty much in line with the New Zealand study. It's how they presented it that's an issue.
Ashda--In the middle of the pendency of Federal Litigation----there was no manupulation---no one in their right mind is going to do that when they are right in the middle of a DC Fedreal Court Case-- Sorry, but that is way to much of a strech for me to buy.
Sun
Naming this thing an e cig was the biggest mistake ever.
Something like Personal Aroma Enhancing Atomizer. The PAEA
Then started off with just 0 nic flavors and ween them in or have them available seperate from the nic liquids........
Wonder how long it would have taken the FDA to take notice?
The stigma that goes with a cigarette or smoking is always negative except to the smoker. Many want to quit but will alway be judged by the holier than thows even after they do.
Vaporer
Something like Personal Aroma Enhancing Atomizer. The PAEA
Then started off with just 0 nic flavors and ween them in or have them available seperate from the nic liquids........
Wonder how long it would have taken the FDA to take notice?
The stigma that goes with a cigarette or smoking is always negative except to the smoker. Many want to quit but will alway be judged by the holier than thows even after they do.
Vaporer
Eric--If they were not involved in litigation, then it "might" be worth a "look"--but when you are up in that Fereral Court, you just do not pull that--unlike the State Courts that are a little less stringint with perjury, in Fereal Court you are going down and going down hard if you tried to manipulate in anyway discoverable evidence. Remeber, during the trial stage of this case, the people who actually conducting that study will be called and they already know that. So the tests were what they were, you can bank perjury on it.
Sun
I'm speaking in terms of all suppliers.
The FDA did not present their press release as a warning so much as an all out attack on the product and our marketing strategies.
The FDA did not present their press release as a warning so much as an all out attack on the product and our marketing strategies.
I understand that Sun. However there are manipulations done in that report. Not properly using a control substance. Something which BTW is taught in 6th grade science. Regardless of knowing the outcome it is still supposed to be tested. As well as placing a NMT 0.5% which is a different format from what was used for the e-cig.
They also didn't even fully test all the products becuase they were already opened? Surely with 50 shipments stopped they could get enough to test. And if not, just go to the local kiosk.
Besides i think most here know that this report will get thrown out if it goes to trial. Which it won't. Like you said in the dockets. The judge doesn't have much to go against the FDA. And this report has little bearing on the case at hand.
*Edit* Also realized this appearently only goes for clinical trials. Not lab tests apperantly.
They also didn't even fully test all the products becuase they were already opened? Surely with 50 shipments stopped they could get enough to test. And if not, just go to the local kiosk.
Besides i think most here know that this report will get thrown out if it goes to trial. Which it won't. Like you said in the dockets. The judge doesn't have much to go against the FDA. And this report has little bearing on the case at hand.
*Edit* Also realized this appearently only goes for clinical trials. Not lab tests apperantly.
Last edited:
Eric--it is much deeper then that and a very good tactical move by the FDA--they baited njoy to counter with test results showing the product is relativley safe and has the potentail to be approved. Now SE and NJOY can not argue the second prong of Brown. The dictum in Brown said the FDA could not have jurisdiction over traditional tobacco prodcts because they are too dangerous on their face to be regulated and the FDA would be forced--with the mission they are charged with, to ban them. NJOY just shot themselfs in the foot by showing the e-cig has the potiental to be a safe product, thereby putting it in the hands of the FDA for regulation.
Sun
It wouldn't matter now anyways becuase now they have the authority to regulate tobacco. Which completely invalidates the Brown case. Honestly i think the best thing to do is fight for them to stay on the market. try like heck to settle with the stipulation that they;
1. stay on the market
2. Immediate regulation concerning the DEG.
3. and do not become smoke cessation products.
I'm sure that there is more that should be in there, but I'm not going to go further than that.
1. stay on the market
2. Immediate regulation concerning the DEG.
3. and do not become smoke cessation products.
I'm sure that there is more that should be in there, but I'm not going to go further than that.
Ashdaburned, you're right, they have the authority to regulate tobacco, but not ban it.
Electronic Cigarettes are absolutely a tobacco product, just as Snus is, and they both incorporate a new method for which the desired effect is delivered.
Just as Snus is wrapped in cloth and soaked in glycerol and PG, the e-liquid's nicotine is delivered by way of PG vapor. Not to mention all ingredients in ecigs are present in tobacco, just in different amounts.
The electronic cigarette itself could definitely be considered a delivery device, but is no more a delivery device than a tobacco pipe, but that it is composed of certain parts and tools. And I know I've read numerous posts stating, "The tobacco pipe argument doesn't apply to the electronic cigarette device," though I, personally, think it does. The only way it doesn't is if the Electronic Cigarette is, in fact, a drug, and not a tobacco product, and this conclusion has not yet been presented as fact and will not until the Judge makes his decision. Another thing to consider is the Tobacco Vaporizer, which is really just a larger atomizing device that burns much hotter. On a side note, I would liken the e-cig charger to a cigar cutter or cigarette roller, the carts to cigarette filters, and the atomizer to a lighter.
Now, to get back to my point... I was hoping for some worthwhile feedback on the notion that myself and other suppliers might be able to band together and file a lawsuit against the FDA for business slander and libel.
Electronic Cigarettes are absolutely a tobacco product, just as Snus is, and they both incorporate a new method for which the desired effect is delivered.
Just as Snus is wrapped in cloth and soaked in glycerol and PG, the e-liquid's nicotine is delivered by way of PG vapor. Not to mention all ingredients in ecigs are present in tobacco, just in different amounts.
The electronic cigarette itself could definitely be considered a delivery device, but is no more a delivery device than a tobacco pipe, but that it is composed of certain parts and tools. And I know I've read numerous posts stating, "The tobacco pipe argument doesn't apply to the electronic cigarette device," though I, personally, think it does. The only way it doesn't is if the Electronic Cigarette is, in fact, a drug, and not a tobacco product, and this conclusion has not yet been presented as fact and will not until the Judge makes his decision. Another thing to consider is the Tobacco Vaporizer, which is really just a larger atomizing device that burns much hotter. On a side note, I would liken the e-cig charger to a cigar cutter or cigarette roller, the carts to cigarette filters, and the atomizer to a lighter.
Now, to get back to my point... I was hoping for some worthwhile feedback on the notion that myself and other suppliers might be able to band together and file a lawsuit against the FDA for business slander and libel.
Another quick question.
If I was to develop a cylindrical mechanism that was placed at the forefront of the mouth (much like a straw, but larger) and had a grating device that ground up pills when activated(i.e. aspirin, ibuprofen, etc.) so as to turn the pill into a powder for quicker absorption, do you believe such a device would be under such scrutiny? No.
Edit: Granted, if I marketed it initially as a "crack grinder" or "oxycotton crusher" such scrutiny might apply. However, if someone else was to market such a device as a "candy grater" I highly doubt they'd receive any trouble at all whatsoever. Which should also apply to intended use of the ecig as well. If it's called a Personal Vaporizer, it's use is not intended for anything specific, but to vaporize things for personal use.
If I was to develop a cylindrical mechanism that was placed at the forefront of the mouth (much like a straw, but larger) and had a grating device that ground up pills when activated(i.e. aspirin, ibuprofen, etc.) so as to turn the pill into a powder for quicker absorption, do you believe such a device would be under such scrutiny? No.
Edit: Granted, if I marketed it initially as a "crack grinder" or "oxycotton crusher" such scrutiny might apply. However, if someone else was to market such a device as a "candy grater" I highly doubt they'd receive any trouble at all whatsoever. Which should also apply to intended use of the ecig as well. If it's called a Personal Vaporizer, it's use is not intended for anything specific, but to vaporize things for personal use.
Last edited:
If not "manipulation", then perhaps "selective data" would be more fitting. I absolutely love my nicotine fog with my morning, noon, and evening coffee! Me BAD 
Last edited:
I'm speaking in terms of their stating we are marketing our products to children. With no proof!
They did not at all manipulate data, but absolutely performed the tests out of sync with anything the worthwhile scientific community would deem acceptable. What they did do, however, is attack the electronic cigarette industry and our product, and boasted we market to children and gave the impression that none of us provide quality controlled products based on the outcome of test samples taken on only TWO suppliers. They also made no mention of the manufacturers.
They did not at all manipulate data, but absolutely performed the tests out of sync with anything the worthwhile scientific community would deem acceptable. What they did do, however, is attack the electronic cigarette industry and our product, and boasted we market to children and gave the impression that none of us provide quality controlled products based on the outcome of test samples taken on only TWO suppliers. They also made no mention of the manufacturers.
There's only one thing i know.
I have stopped smoking analogs.
I truly know that vaping is an effective way to stop analogs.
It was a good thing for me.
I have stopped smoking analogs.
I truly know that vaping is an effective way to stop analogs.
It was a good thing for me.
The whole "marketing to children" thing is nonsense, I don't care if e-liquid comes in pink bubble-gum / watermelon flavour...
I'm 43 my Lady is 44 and we grew up with wacky flavours including fried chicken flavoured potato chips, coca-cola tasting bubble-gum etc. and we STILL like stuff like that!
never mind all these mini cigars chocolate, grape and so on...
cheers
I'm 43 my Lady is 44 and we grew up with wacky flavours including fried chicken flavoured potato chips, coca-cola tasting bubble-gum etc. and we STILL like stuff like that!
never mind all these mini cigars chocolate, grape and so on...
cheers
Snuggle--it may be "nonsense" but it is addressed right in the new legislation that was passed. As stated:
TOBACCO & YOUTH
Will FDA raise the minimum age to purchase tobacco products?
As required by the bill, an expert panel will be convened to conduct a study on the public health implications of raising the minimum age to purchase tobacco products. The results of this study are to be submitted to Congress.
What will FDA do to curb tobacco use among children and adolescents?
FDA will employ many effective public health strategies to reduce the burden of illness and death caused by tobacco products. One of the first items aimed at reducing tobacco use among children and adolescents will be to reissue the 1996 regulation aimed at reducing young peoples access to tobacco products and curbing the appeal of tobacco to the young. When this becomes effective, a number of measures will take effect, including:
- Tobacco manufacturers may no longer sponsor athletic, and entertainment events using tobacco product brand names and logos;
- Tobacco manufacturers may no longer sell or give away clothing or other items which bear the brand name or logo of a tobacco product; and
- Tobacco manufacturers will no longer be able to distribute free samples of cigarettes, and free samples of smokeless tobacco will be allowed only in adult-only facilities
Naming this devise an as "E-Cigarette" was sheer GENIUS and perfect timing! It's the number one reason that you're using one right now. It's the name that initially attracted attention to the product.
If the Chinese inventor(s) would have given it a RIDICULES name like your example, it would have NEVER attracted USER attention world-wide.
You wouldn't even know that this thing existed if it wasn't for the name, its marketing scheme/gimmick and the steady increase in the costs of smoking tobacco!
Honestly....Would you even think to look at a "Personal Aroma Enhancing Atomizer"?
Of course not! Cuz it sound like a potpourri machine and not a nicotine inhaler.
- Status
Similar threads
