I'm not sure if PVs sold without nicotine will help that much. The FDA could just claim that the intended use is with the drug. True, people might not be using it for that, but the FDA could still probably use that to require product approval.
FDA approval?
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Mrkai,
Quick question, do you work for the FDA or are you just taking thier side?
Quick question, do you work for the FDA or are you just taking thier side?
For all practicle purposes, doesn't this all come down to 'A Piece Of The Action'? The Powers That Be just want their cut. And if they don't get it they will smash the new action out of existence. If they can use the government to accomplish this they will. If they have to buy up the patents and stick them in a vault, they will. If they can gain total control of the action and make all the profits for themselves, they will.
The hypocricy, for clear mind folks, is that tobacco is, due to legal presidence and the amount of $ envolved, exempt from being taken off the market. A new product hits the market that for the first time truly threatens the supremacy of the tobacco and pharma industries and the average Joe that benefits gets it in the shorts again.
I, for one, could care less what the FDA et.al. end up doing. I will buy ahead and make my own juice until my supply runs out. By that time I should be off the nicotine and will miss the hobby of vaping. But I seriously doubt that PV's will be permanently out of our lives. There are just too many people that love them and will come to love them as time goes on. And there is just too many dollars and potential dollars to be made in the future for the big players to kill this all together.
All the big palyers want is what they believe they are entitled to; their 'Piece Of The Action'.
The hypocricy, for clear mind folks, is that tobacco is, due to legal presidence and the amount of $ envolved, exempt from being taken off the market. A new product hits the market that for the first time truly threatens the supremacy of the tobacco and pharma industries and the average Joe that benefits gets it in the shorts again.
I, for one, could care less what the FDA et.al. end up doing. I will buy ahead and make my own juice until my supply runs out. By that time I should be off the nicotine and will miss the hobby of vaping. But I seriously doubt that PV's will be permanently out of our lives. There are just too many people that love them and will come to love them as time goes on. And there is just too many dollars and potential dollars to be made in the future for the big players to kill this all together.
All the big palyers want is what they believe they are entitled to; their 'Piece Of The Action'.
...do NOT work for the FDA, a Pharma company, a tobacco company...or any related industry, nor does my immediate family and, as far as I know, extended?
So then, why WOULD I even remotely be taking "their side"?
Well because I don't *see* it as their side
I am a pragmatist and have experience in dealing with companies and agencies that are authoritarian. I also have some experience working for whores of the Pharma industry
And well, my family is has journalists and lawyers...so I understand some subtle things.
Point one: The FDA is highly politicized right now.
Point two: While their study, and note that a study isn't by any means considered "scientific evidence" on the surface appears to be a hatchet job, as others have pointed out it pretty much admits that they didn't find a jillion chemicals o' doom in their testing.
Point three: The FDA has limited powers. Most people do not realize this because of mass hysteria and paranoia. Note that the FDA didn't ban e-Cigs, they issued a "Public Safety Theater" press release. States, which make laws, used this to ban eCigs. This is a fine point of fact that is also missed.
Point four: This is going to court, and in a court of law the rules are different. The FDA has to prove eCigs are medical devices *legally*...and quite frankly, without nicotine carts their case kind of is moot.
Furthermore, with the properly paid lawyers in place, the whole thing gets kicked back and the FDA is required to prove that they didn't find these problems in ONLY one shoddy brand...or even lot or shipment. In other words, they have to do it correctly
The FDA should reasonably be found to be negligent in *their* duties to *properly* do this, but given a "pass" due to a potential "Public Safety Concern".
In the meantime, we've got information that can help eCig consumer groups and Manufacturers: they know that at a minimum they need more accurate labeling.
The reason I seem to take the FDA "side" is because in honest debate, in the FDA's 103+ year history they've mostly got it right, and even in this case, they exposed one manufacture's flaws (they either should have know DEG was in the product or labeled it, regardless of levels/how safe it is said to be; we as consumers should know this stuff) and another's specious claims about smoking cessation (c'mon. really now. this is hardly proven and the general consensus is it makes not quitting something we can all "live with"...and *live* with). It shines a sharp light on the troublemakers so that we as consumers can deal with them.
They want our money.
The FDA only has jurisdiction here if they can prove within the scope of the law that personal vaporizers are medical devices.
Without a drug they are no more medical devices than sucking on flavored air.
Note that I previously explained why the *FDA* believed that had jurisdiction. This doesn't mean I'm on their side.
Moreso, I don't believe screaming from the rooftops that FDA is an Evil Front for Big <whatever> has anything to do with the evidence presented in a court of law
Nobody has argued that the stuff they tested was mislabel in several different ways. They've only argued that it isn't relevant.
The problem is, for the FDA it *is*. It is part of their mission. To keep "snake oil" away from you. Mostly, they get it right.
The other argument against the evidence as been "well it isn't dangerous".
No, not this time. Maybe next time. That is part of their job, too.
No one has argued against the evidence that SmokingA have marketed their product as a smoking cessation aid. They've just noted that they are a bunch of tools.
Basically, I guess at the end of the day, I am more upset at the industry, and in some ways, consumers, than I am at the FDA...because at least the FDA was doing their job. Even if that job at this point appears to be specious, at best.
The industry made no genuine effort to police itself early, to form any sort of standards body, etc. Instead they went for a quick RoI and in the process put their customers and ultimately, their businesses in jeopardy.
Which is really sad because as we all know...they have a MUCH BETTER PRODUCT.
-K
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...with myriad other products, from hookas to guns. If there is a clearly defined legal use for something the manufacturers get Safe Harbor from customers violating the law.
As far as I know, you can walk into stores in pretty much all sorts of cities and buy things that people use for tobacco enjoyment that I can't imagine anyone using them that way...but my imagination isn't the law.
Nor is the FDA's
-K
It takes a law to make something not legal or at least lawful jurisdiction to stop sales.
That is to say, the FDA can impose an import ban, but a law is required to make sale, manufacture illegal.
This is why depending on where you live, we can all still buy this stuff
Have any states outlawed the *possession* of PV's or just the *sale*?
The law is very intricate...this is why there are so many "criminals" about
-K
This is an excellent point. And makes all this even more scary. To me it indicates an organized network of lobbyists that had knowledge of the "Public Safety Theater" press release before its release to begin working state legislators to start writing those laws. Follow the money!
I'm still missing something here. If the manufacturer does not claim that the product treats anything then why does it have to go to clinical trials?
Yes, if E-cigs are marketed as a TREATMENT for smoking they will legally deserve this scrutiny, but that is easily avoided by "This product is not intended to treat any illness. These statements have not been evaluated by the FDA." yada yada.
Lots of vitamin and herbal supplements are available, and they do not have to go through clinical trials because they are not controlled substances. Nicotine itself is not a controlled substance.
The idea that we should require FDA clinical trials for every new product that comes to market is laughable. Just look at all the foreign cigarettes brands that are on the market, can you tell me that they all went through clinical trials? Can you even tell me that the FDA routinely tests them with the stringency they currently want to apply to E-cigs? No! Because the FDA does not have authority yet to regulate tobacco products. That may change soon, but to my knowledge the FDA tobacco regulation bill has not been signed yet.
Wake up people. I don't mind if e-cigs get regulated, but if so they should be regulated with the same laws that control cigarettes and not prescription drugs. There is nothing here that the FDA should have the authority to 'disapprove' or 'approve'. The fact that so many people on this forum are oblivious to the governments legal boundaries is scary. A right unused is a right lost.
Yes, if E-cigs are marketed as a TREATMENT for smoking they will legally deserve this scrutiny, but that is easily avoided by "This product is not intended to treat any illness. These statements have not been evaluated by the FDA." yada yada.
Lots of vitamin and herbal supplements are available, and they do not have to go through clinical trials because they are not controlled substances. Nicotine itself is not a controlled substance.
The idea that we should require FDA clinical trials for every new product that comes to market is laughable. Just look at all the foreign cigarettes brands that are on the market, can you tell me that they all went through clinical trials? Can you even tell me that the FDA routinely tests them with the stringency they currently want to apply to E-cigs? No! Because the FDA does not have authority yet to regulate tobacco products. That may change soon, but to my knowledge the FDA tobacco regulation bill has not been signed yet.
Wake up people. I don't mind if e-cigs get regulated, but if so they should be regulated with the same laws that control cigarettes and not prescription drugs. There is nothing here that the FDA should have the authority to 'disapprove' or 'approve'. The fact that so many people on this forum are oblivious to the governments legal boundaries is scary. A right unused is a right lost.
If the FDA *does* win this round they have more than a few things they can do within the scope of the law to have prosecuted anyone that tries to circumvent any restrictions they place on these products.
It is a bit of legal finery that I am not qualified to discuss but the gist would be that while a law doesn't say such and so is illegal, a law does say the FDA has the authority to tell you that no one can send it here nor sell it to anyone
It is based on the Food and Drug Act of 1938 and its many power-expanding amendments.
-K
Smoking cessation via the drug nicotine is Nicotine Replacement Therapy and is in the scope of the FDA's powers.
As I have pointed out in this thread and others have in the SA vs FDA thread, some marketers crossed the line you mentioned and there is no putting the toothpaste back into the tube at this point. "If" is no longer a question. Someone has already done this and was the catalyst for FDA involvement.
While many wish to point a finger and FDA Conspiracies and the like, at the end of the day really, the blame falls to the industry for NOT being more proactive *before* the light was cast upon them. They took a gamble, didn't police their own (securing exclusivity from china manufactures, public awareness campaigns, trade association and a myriad other things). Greed and a quick buck from some "clever" marketers hoping to get a slice of that Fact Big Tobacco and Big Pharma pie by by sucking up a chunk of their customer base while not playing by those same rules they had to, as specious as they can be, played a heavy hand in this.
Some ...... in Florida thought they could play a game they didn't have uniform for, namely by claiming their product *could* be used to cure or treat a medical condition: nicotine addiction.
These people are in *business* and tried/are trying to grow from cottage industry to mainstream and don't even have proper labeling standards, submitted nothing to the FDA, which has jurisdiction over practically everything that goes into humans (except...other humans) in this country and quite frankly, have screwed the pooch it appears at this point to the detriment of themselves and millions of Americans they could have helped.
Unless some serious political engineering happens in the Legislative and Executive branches, based on voices ringing out in the ways they can hear or something else miraculous it if likely not going to go well.
And all the tinfoil at Reynolds won't make a bit of difference.
Stock up, quit or just get your nic from some other source are all the options that look likely at this point. See the SA vs FDA thread for more insight into this; I believe one of the members there is following this "on the ground" in some fashion and appears to have some legal background.
-K
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They are food. If or not a chemical or drug is a controlled substance has nothing to do with clinical trials or if it passes FDA muster. There are 180 drugs/chemicals that can be mixed in like 10K different ways and sold, according to FDA rules, if properly made, labeled, sold and marketed according to regulation without clinical trial and are sold to treat a whole host of ills and symptoms.
While nicotine is not a Controlled Substance in the sense that an illicit drug is, it is a poison in chemical form and, as such, is regulated.
While people are making claims that "eCigs" are being treated unfairly, if you look at the situation rationally and legally, they really aren't.
Now the case that they are being portrayed *unfavorably* is certainly valid, but you can pretty much blame this on the slipshod way the industry has handled the product.
*NOW* they want to work with Congress and the FDA. *Now* they want to (have the chance to) "do things right"...even though someone has crossed the line.
They could have done it a year ago.
Understand?
-K
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I just discovered that NIClite successfully registered as a "Homeopathic Nicotinum Complex Formula". What is to stop anyone from following the pattern of NIClite with the difference being that the nicotinum complex would be dissolved in PG or Glycerin instead of water like NIClite?
Lots of food additives are poison in their chemical forms. Caffeine for example can kill you.
<tried to post the Caffine MSDS>
Lots of food additives have to be handled with hazmat suits in their pure form, but that doesn't cause the FDA to force clinical trials on all food containing them. See: SODIUM METABISULFITE MSDS
It's very nasty stuff, but you eat it. If e-liquid needs to be stringently regulated with it's low concentration of nicotine then we should also regulate every other product on the market that contains something that is poisonous in its pure form. This is a simple double standard.
So it's really all the other products on the market that are being treated unfairly? Yes, e-cigs are a new way of administering nicotine, but casual nicotine use has been around FOREVER. The only leg the FDA has to stand on is the method for administering nicotine which is new. E-cigs are not food, and they are not cigarettes. This makes them a 'nothing' so how the laws apply to them is still up for grabs, and the FDA is trying to make them a drug.
So, what you conclude with says, 'yes, chayce is right, but the FDA is trying to fix that.'
Well thanks. I knew I was right.
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Look at the ingredients for that product. Note too that NICLite had similar problems
Note that they were worked out. More importantly, note that NICLite is essentially 8oz of water with 4mg of nicotine (if that; it is registered as homeopathic and the math they use is...interesting. Still looking for actual label info) in the whole bottle
-K
*Edit: I checked this; it is sold as 4mg nicotine in either 8 or 16oz bottles.
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All of your red herrings aside...
eCigs have been advertised as a smoking cessation aid, in the form of an electronic device, without disclaimer, testing or PRIOR FDA approval.
You can argue anything you want, but that chayce is fact. That is the legal heart of the matter, not the incidental, anecdotal,it-isn't-fair-I-want-a-pony argument many are trying to float.
Every single thing you mentioned, if put into anything in greater than accepted as safe amounts for human ingestion, GRAS or not, then marketed and sold as a treatment or cure for anything would have the same issue.
Period. Since you are floating a non-fact-based scenario, it is up to you to provide facts to back it up. Or not. You would do better to not make feeble attempts to inverse my arguments...I'm not that guy
-K
I have yet to see an add featuring e-cigarettes as a smoking cessation aid. I have seen adds claiming they were safer smoking alternatives, but that claim alone should not be enough to get the wrath of the FDA. There are also herbal smoking cessation remedies that are marketed as such and apparently get away with it (perhaps due to the fact that they contain no nicotine.).
Then your argument that nicotine is a poison and must be controlled is also invalid. Thanks. Alcohol if abused can kill you easily, but that doesn't mean we can't buy it. Caffeine is in the same boat. If nicotine levels in e-cigarettes were beyond safe levels then I would applaud the FDA's actions, but as of yet I have seen no evidence. Check for yourself: google 'nicotine overdose' you will get a lot of hits, but no e-cig overdoses. In fact there are very few actual overdoses. Mostly just people asking questions.
Non fact based argument? The basis of your argument is that nicotine is poison and must be controlled which is a non fact. You then state that smoking cessation aids must also be controlled which hinges on e-cigarettes being a treatment for smoking. Another non fact.Period. Since you are floating a non-fact-based scenario, it is up to you to provide facts to back it up. Or not. You would do better to not make feeble attempts to inverse my arguments...I'm not that guy
The only fact here is that the FDA is trying to control anything with nicotine in it. Cigarettes are next. This is not due to an inherent danger with nicotine but a social unpopularity of cigarettes.
Forgive me
But your post stinks of herring.
You haven't seeing any ads claiming smoking cessation is not relevant. The ads have been made, SA staff have made these claims at retail and even THEY are not debating this.
They did it. Why are you debating this?
-K
They did it. Why are you debating this?
-K
Doesn't matter if *you* have seen this. Smoking Anywhere has done it. They made a claim that opened the whole can of worms. They claimed that eCigs are a stop smoking aid and at their retail outlets have even distributed sales media for sellers explaining how this could be done by progressively stepping down the cart strength.
Sorry. This is a known fact. By doing this, they crossed the line...jumped the fence right into the FDA's front lawn. They are still doing this in MD and Northern Virginia...*literally the FDA's Neighborhood* as of the last 10 days.
It isn't *my* argument. It is a state ment of fact and reality. There is nothing you can put nicotine into for human consumption or ingestion that doesn't come under the USDA or FDA jurisdiction and isn't subject to monitoring, labeling restrictions and approved/indicated use guidelines.
Why...are you arguing *against* this? This is fact.
What are you thanking me for? Are you really this misinformed? The issue here isn't about "if or not you can buy" anything...it is if or not it is regulated, or can be, in this case, by the FDA.
You...are aware of what we are *actually* discussing...are you not?
Every single example you posited, AGAIN, is subject to FDA regulation when sold or marketed outside of the allowed scope, especially if as a medicine or drug for a non-indicated use...including nicotine as a *treatment* for anything.
If I tried to sell caffeine in an inhaler as a cancer treatment, mixed with alcohol, I'd have the exact same problem.
Do you understand this?
Do you even understand the function of the FDA? It isn't to pick on eCigs
it is..
Perhaps you are confusing "controlled" and "regulated"? When you say controlled are you using it in the sense of a CDS?
I see what you are doing here. Let me help you. Stop turning my *specific* examples into *general ones* and you'd do a hell of a lot better.
I did NOT say "smoking cessation aides must also be controlled". Please do NOT attribute things to me that I have not stated
That may be a general case, but in THIS PARTICULAR CASE they are specifically talking about a product that was marketed and presented as a smoking cessation aid that uses a drug that when used IN THIS MANNER falls under their jurisdiction and requires FDA approval.
And no amount of self-deluding pretzel logic you throw at it changes the MATERIAL FACTS of this case.
This speaks volumes. Do you know what a Red Herring logical fallacy argument..is, chayce?
-K
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Wouldn't this also mean that buying a pipe or papers from a smoke shop should be illegal?
Obviously no one is using those for smoking tobacco!
This topic outrages me and upsets me greatly. I hope they don't ban any part of this amazing product. I have stopped smoking cigarettes and i do not ingest nicotine anymore because of this product!!!
Hopefully the gov't looks out for the people in this case, not the tobacco industry (which is killing us by the way)
Obviously no one is using those for smoking tobacco!
This topic outrages me and upsets me greatly. I hope they don't ban any part of this amazing product. I have stopped smoking cigarettes and i do not ingest nicotine anymore because of this product!!!
Hopefully the gov't looks out for the people in this case, not the tobacco industry (which is killing us by the way)
Wouldn't this also mean that buying a pipe or papers from a smoke shop should be illegal?
Obviously no one is using those for smoking tobacco!
This topic outrages me and upsets me greatly. I hope they don't ban any part of this amazing product. I have stopped smoking cigarettes and i do not ingest nicotine anymore because of this product!!!
Hopefully the gov't looks out for the people in this case, not the tobacco industry (which is killing us by the way)
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