Njoy response to FDA
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I just posted some hair-raising information about Chantix. Title "And the winner is...Chantix" in the Health and Medical Issues/Other Alternatives/Miscellaneous forum.
http://www.e-cigarette-forum.com/forum/miscellaneous/28692-winner-chantix.html#post443366
Does anyone have a direct link to these requirements? It would be greatly appreciated. I know I did look for some and found a document from the CDC regarding their tobacco Testing Facility and what they do.
Suggestion... I too have been "warned" by one friend already about my "deadly e-cig".. I had already thought this might happen..There was no way I was going to stand there and try to list how the FDA lied multiple times by ommission etc...(besides, I get too worked up! lol..Which would make most people turn off listening pretty quick)
In post #18 of this thread Lacey posted a link > The Rest of the Story: tobacco News Analysis and Commentary
It is a very serious commentary addressing everything that the FDA left out and very easily understood.. I picked out several very good points and printed them off ( explains it way better then I ever could)...
When my friend approached me.. I just smiled, pulled it out of my purse and said, " they lied by ommission..It's all about money (shrug)...If you're truly worried about me read this and give me a call later"...End of story...Well, until she called me later...She started the conversation with " Wow, unbelievable..I had no idea.....
I now don't leave the house without a few copies..And if it weren't against the law..I'd be shoving them in mailboxes lol
edit> holy smokes Sun, that's the longest post I have ever seen! lol
In post #18 of this thread Lacey posted a link > The Rest of the Story: tobacco News Analysis and Commentary
It is a very serious commentary addressing everything that the FDA left out and very easily understood.. I picked out several very good points and printed them off ( explains it way better then I ever could)...
When my friend approached me.. I just smiled, pulled it out of my purse and said, " they lied by ommission..It's all about money (shrug)...If you're truly worried about me read this and give me a call later"...End of story...Well, until she called me later...She started the conversation with " Wow, unbelievable..I had no idea.....
I now don't leave the house without a few copies..And if it weren't against the law..I'd be shoving them in mailboxes lol
edit> holy smokes Sun, that's the longest post I have ever seen! lol
Thanks Sun! I will go through it. Just skimming... three things popped out immediately that I don't think I saw in their own report!
Razor - Great idea! Everyone should do that! Have your ammo ready for them to educate themselves. Far easier than preaching.
Razor - Great idea! Everyone should do that! Have your ammo ready for them to educate themselves. Far easier than preaching.
The FDA's testing that resulted in the carcinogen and contamination findings was never said to be equivalent to testing needed for approval of a new drug. I don't see any reason to compare these tests and requirements.
Lacey, Sun's post is why companies have lawyers to meet requirements of the law. If they don't, they get cited for sale of unapproved new drugs and devices.
And of course a comparison to tobacco cigarettes was not and will not be done. These aren't tobacco products in the FDA's eyes. They are drug products, no different that the current NRT products that are FDA approved after rigorous testing and review. Who cares how an e-cig stacks up against a tobacco cigarette if the comparison has no worth; it's apples-to-oranges to regulators. We can stop calling for comparisons.
One other off-key note here: Chantix has no place in this discussion of test results and what must be done to get acceptance.
Lacey, Sun's post is why companies have lawyers to meet requirements of the law. If they don't, they get cited for sale of unapproved new drugs and devices.
And of course a comparison to tobacco cigarettes was not and will not be done. These aren't tobacco products in the FDA's eyes. They are drug products, no different that the current NRT products that are FDA approved after rigorous testing and review. Who cares how an e-cig stacks up against a tobacco cigarette if the comparison has no worth; it's apples-to-oranges to regulators. We can stop calling for comparisons.
One other off-key note here: Chantix has no place in this discussion of test results and what must be done to get acceptance.
TB - Interesting... I found a study that was done that compares all new tobacco products, the nrt's and cigarettes. The patch and the gum both had nsta's in them and believe it or not, at higher rates than the disolvable losenges. Granted, one disolvable didn't have any tobacco in it so that would probably be why, but it's an interesting study none-the-less.
The other issue with the study is that they didn't give any numbers. So, you can't even use the study as presented by the FDA in comparison to any study that has been done as it really doesn't present their findings.
Oh... and all other studies I have, currently I have four that range from cigarettes to NRT's, all are done in ppm's vs. ppb's.
Just some interesting things I have run across.
The other issue with the study is that they didn't give any numbers. So, you can't even use the study as presented by the FDA in comparison to any study that has been done as it really doesn't present their findings.
Oh... and all other studies I have, currently I have four that range from cigarettes to NRT's, all are done in ppm's vs. ppb's.
Just some interesting things I have run across.
Noted.
One thing is for sure... when you compile some of the other studies that have been done evaluating NSTA's across the board, it is amazing that some of the products that are classified as tobacco products are even classified as such.
Wow. Could you imagine that from all of this, there could be a serious revamping of how things are classified? With the FDA having control now of tobacco, it could be feasible to review all of the studies, create another classification, and reclassify everything! But, that falls into the tobacco harm reduction philosophy and that is definitely wishful thinking.
Just out of curiosity, who determines the "intended use" of a product...the FDA, the manufacturer, or the users?
It seems like they're using "intended use" differently in the court case than they do for NRTs.
Lacey, I do believe you'll find that Ariva and Stonewall dissolvables have the lowest TSNA content of any tobacco product. And, yes, they are pure powdered tobacco, processed very differently from tobacco to be smoked, and now grown with seeds especially created for low TSNA yields. I am totally addicted to my Stonewalls.
The TSNA levels found for e-cigs are comparable to snus, which has a long and safe history in Sweden. From my research, I've concluded that e-smoking is a relatively (important word) safe way to obtain my nicotine. Nothing is 100% safe for nicotine addicts, but e-smoking ranks among the least dangerous ways to obtain nicotine.
I would defy the FDA to say e-smoking is MORE dangerous than approved NRT products. Not so. It's about the same, in all honesty. And certainly far safer than combusting tobacco and inhaling it.
In the final analysis, that's what is on our side. But the sad truth is that our guys (manufacturers) didn't follow the regulatory rules. I've said before that e-smoking is the future of smoking, but this is that "speed bump" many foresaw that will delay mass adoption until approved devices and liquids come to market.
The TSNA levels found for e-cigs are comparable to snus, which has a long and safe history in Sweden. From my research, I've concluded that e-smoking is a relatively (important word) safe way to obtain my nicotine. Nothing is 100% safe for nicotine addicts, but e-smoking ranks among the least dangerous ways to obtain nicotine.
I would defy the FDA to say e-smoking is MORE dangerous than approved NRT products. Not so. It's about the same, in all honesty. And certainly far safer than combusting tobacco and inhaling it.
In the final analysis, that's what is on our side. But the sad truth is that our guys (manufacturers) didn't follow the regulatory rules. I've said before that e-smoking is the future of smoking, but this is that "speed bump" many foresaw that will delay mass adoption until approved devices and liquids come to market.
Our House--the maufacture proposes it and the FDA reviews it and either agrees and approves or denies.
The FDA defines Intended Use as:
The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, or a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)
Sun
Of course you know my next question:
Why is it the FDA keeps insisting that NJOY's device is a smoking cessation product despite NJOY's vehement claims (and labels, and sales pitches, and website, etc.) to the contrary?
Why should a few bad apples spoil the bunch? If Nissan dealers said their cars can help you quit smoking, should all brands of cars be removed from the market by the FDA because of "intended use"?
See my post above.
If the manufacturers aren't marketing their products as or intending their products to be "smoking cessation" devices, then why would they go through many hundreds of thousands of dollars and many years of "smoking cessation" regulation?
Our House --the FDA is not insisting that the e-cig is an NRT--they never have. They are stating that the e-cig is a device that delivers nicotine and nicotine is a "drug" that needs to be regulated.
Sun
It is really up to us.
People don't seem as motivated as they should be and I think it's because they don't think it will happen in full force.
I suggest you take a look at current events with republicans combating the .... out of health care reform if you don't think that this will happen.
Politics suck!!!!!!!!!!!!!!!!!!!!!
People don't seem as motivated as they should be and I think it's because they don't think it will happen in full force.
I suggest you take a look at current events with republicans combating the .... out of health care reform if you don't think that this will happen.
Politics suck!!!!!!!!!!!!!!!!!!!!!
oops, yeah, meant nitrosamines. Had a dyslexic moment, apparently
Not true. Lacey and I were just discussing yesterday in another thread about how the FDA's attorney stated that ALL seized shipments were being marketed by the manufacturers as smoking cessation devices. I don't have the link handy, but Lacey should remember the statement and our convo. It was a blatant, bold-faced lie on the FDA's part since NJOY NEVER EVER makes a cessation claim on their products (which is why they jumped on board this case to begin with).
Is there or has there ever been a case where nicotine is regulated outside of NRT's? It wasn't a "drug" that needed regulation in its most prevalent form of tobacco smoking (maybe it is now since the bill, I don't know), and it certainly isn't isn't a "drug that needs to be regulated" when it appears in other forms such as eggplant, potatoes, tomatoes, etc.
Suppose you wanted to make a (non-NRT) nicotine pill for people to use indefinitely. What process would you go through to get it approved, if not "smoking cessation"?
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