Is it possible that the "statement" everyone is banking on to be truth was actually misread? And that the form letter was intended to alert those who are marketing this as an NRT and labeling it as an NRT in their documentation (manuals) to stop?
Why shouldn't the FDA interfere?
- Thread starter Bellinghamster
- Start date
- th_trl_thread_readers 0
- Status
Is it possible that the "statement" everyone is banking on to be truth was actually misread? And that the form letter was intended to alert those who are marketing this as an NRT and labeling it as an NRT in their documentation (manuals) to stop?
Great post, Kate.
In virtually every Disman post, he uses an advertising technique known as the "straw man." Set up a diversion to distract attention from the only issue at hand. Let me set one up:
An electronic cigarette is a device to help smokers avoid smoking tobacco cigarettes. Some smokers, in trying to avoid real cigarettes, chew on toothpicks or suck Life Savers. But surely no one thinks the FDA should force the makers of toothpicks and Life Savers to conduct studies on the long-term effects of their use. So why pick on the electronic cigarette?
There you have it! Perfect logic, right? WRONG. The only issue is the electronic cigarette. It is never about tobacco cigarettes, or Life Savers, or Corn Flakes or a dozen other diversions used in Straw Man arguments. It's a very old advertising technique -- and it surely works for some, doesn't it?
The only issue the FDA has is the safety and efficacy of the electronic cigarette, its components and liquid. Everything else is irrelevant. In dealing with a new drug, the "free market" cannot provide assurances the common good demands. Only testing can provide scientific assurance of safety -- and that's what the FDA needs.
In virtually every Disman post, he uses an advertising technique known as the "straw man." Set up a diversion to distract attention from the only issue at hand. Let me set one up:
An electronic cigarette is a device to help smokers avoid smoking tobacco cigarettes. Some smokers, in trying to avoid real cigarettes, chew on toothpicks or suck Life Savers. But surely no one thinks the FDA should force the makers of toothpicks and Life Savers to conduct studies on the long-term effects of their use. So why pick on the electronic cigarette?
There you have it! Perfect logic, right? WRONG. The only issue is the electronic cigarette. It is never about tobacco cigarettes, or Life Savers, or Corn Flakes or a dozen other diversions used in Straw Man arguments. It's a very old advertising technique -- and it surely works for some, doesn't it?
The only issue the FDA has is the safety and efficacy of the electronic cigarette, its components and liquid. Everything else is irrelevant. In dealing with a new drug, the "free market" cannot provide assurances the common good demands. Only testing can provide scientific assurance of safety -- and that's what the FDA needs.
The only other options I can see is to get it classified as homeopathic or as a tobacco product. Tobacco product might work since theyre currently pretty much untouchable right now. But, if congress gives the fda power over tobacco, that will change.
1. The nicotine strength we need eliminates hope of this being homeopathic. I, for one, am not interested in sucking on impotent vapor.
2. It is not a tobacco product by the government's definitions. Those are carefully spelled out in legal language. E-cigs don't qualify.
Neither is an option.
The only option beyond the undesirable approval process, and its delays, is that these are indeed personal vaporizers. Marketing might have eliminated any hope of pleading this, but a case could be argued that these have been misnamed as "cigarettes" and are more properly "personal vaporizers" with a myriad of potential uses, including recreational vaping.
And that would be true.
2. It is not a tobacco product by the government's definitions. Those are carefully spelled out in legal language. E-cigs don't qualify.
Neither is an option.
The only option beyond the undesirable approval process, and its delays, is that these are indeed personal vaporizers. Marketing might have eliminated any hope of pleading this, but a case could be argued that these have been misnamed as "cigarettes" and are more properly "personal vaporizers" with a myriad of potential uses, including recreational vaping.
And that would be true.
Not to be a d.ck, but that's not what a straw man is. A straw man is the manipulation of the initial argument and then arguing against the manipulation.
He used numerous analogies which is it's own distinct type of fallacy.
Thanks. Back in college advertising classes, we studied a number of different ways to divert from the central issue. I thought his tactics perfectly fit what I remember of the "straw man" technique, but I bow to more current knowledge. Thanks.
At least the irrelevance is recognized!
At least the irrelevance is recognized!
likewise, a low limit would destroy the entire reason for use for myself.
but legal definitions can be changed. (ie: in oklahoma a tobacco product is legally defined as including any tobacco substitute, at least in regards to tobacco resale licensing laws). I'm still not sure if that would be a good way to push for, though.
very correct. I guess my biggest concern is that even as a personal vaporizer it may still end up being required to be tested, being required to prove that the liquids are safe, etc. And, if the liquids turn out to not be entire safe, possibly resulting in a banning of the product. Even if the liquid is not entirely safe, I'd still prefer to have the choice of selecting it instead of a cigarette.
Everyone needs to get a grip on reality A little research would calm everyone's nerves on this issue The United States Supreme Court has already ruled on the FDA's ability to regulate tobacco.
I know is is long but it is plain and simple.
The Supreme Court rules that the FDA has no authority to regulate tobacco - FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S.2000)
No product is more closely intertwined with the history of the United States than tobacco. From early colonial days, tobacco was a major export. In some colonies, tobacco was legal tender and the colonies paid their own debts in tobacco, at governmentally recognized rates denominated in pounds and barrels and hogsheads. During the revolutionary period, tobacco was valued more highly than continental money - Wharton v. Morris 1 U.S. 125, 1 Dall. 125, 1 L.Ed. 65 (Mem) Pa. Apr Term 1785. During this long history, the federal government's regulation of the health effects of tobacco have only been before the United States Supreme Court in one previous case, Cipollone v Liggett Group, Inc. 505 U.S. 504 (US 1992), which dealt with whether Congressional regulation of tobacco advertising and promotion preempted state tort claims against cigarette manufacturers.
FDA v. Brown & Williamson arose from the FDA's assertion of authority over the production and sale of cigarettes. This was based on finding that nicotine was a drug and that cigarettes were thus a drug delivery system. The FDA proposed to regulate cigarettes as a hybrid involving both a drug and a medical device. The FDA proposed rules through notice and comment rulemaking and when these rules were finalized, Brown & Williamson moved to have them enjoined because they exceeded the FDA's statutory authority. The District Court found most of the rules valid, but held that some exceeded the FDA's authority. The 4th Circuit reversed, finding that the FDA had no authority to regulate tobacco. The United States Supreme Court accepted cert., and announced its ruling in this case.
The question before the court was simple: does the Food Drug and Cosmetics Act (FDCA), as amended, give the FDA the legal authority to regulate tobacco? The court reviewed using classic administrative law precedents, beginning with the two-step analysis from Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). The first step of Chevron is to determine whether the plain language of the statute allows the agency's action. If that statute is silent on the matter at issue, then the second step is to determine if the agency's assertion of authority is permissible under the statute, considering the plain language of the statute, possible conflicting statutes, and relevant constitutional limitations.
Ironically, the majority opinion and the dissent agreed on the basic issue that tobacco is an extremely dangerous product that should be regulated: "This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use." The importance of tobacco regulation drove the majority to conclude that if Congress intended for the FDA to regulate tobacco, it should say so. In contrast, the dissent believed that tobacco regulation is so important that the FDA should have the right to regulate tobacco unless Congress forbids it that right. Jurisprudentially, the case is interesting because the judges reverse their usual roles. Scalia, who usually demands that the court look only to the words of the statute, signs on without separate comment to a majority opinion steeped in legislative history. Breyer, who usually cares more about what Congress thought about than what it wrote, dissents because the court ignores the plain meaning of the statute and delves into the morass of congressional intent.
Both the majority and the dissent concede that congress has been silent as regards the FDA's authority to regulate tobacco. The only mention of the FDA by congress in regard to tobacco was a statement that a particular labeling regulation did not affect the FDA's authority over tobacco, whatever it might be. At the same time, both the majority and dissent agree that the plain language of the FDCA seems to give the FDA the authority to regulate nicotine, and, through that, cigarettes. The problem with this plain reading is that for nearly 50 years the FDA denied that the FDCA gave it authority over tobacco. While agencies may change their minds as politics change, such a shift undermines their claim for deference because of their expertise in the subject. The majority focuses on history of tobacco regulation by Congress and finds that Congress has passed tobacco regulations six times since 1965. During this period Congresses accepted the FDA's assurance that it had not jurisdiction over tobacco and in none of these laws did it give any power to the FDA to regulate tobacco. Since tobacco regulation is such an important issue, this failure to give authority to the FDA in previous tobacco regulatory law convinces that majority that Congress could not have intended such an important task to fall the FDA through inadvertence.
The majority also looks at the logic of the FDCA and what it would mean to regulate tobacco under it. The FDCA gives the FDA the power to assure that drugs and medical devices in interstate commerce are safe and effective. The Act clearly deals with therapeutically valid drugs and devices and seems to leave no room for the sale of substances such as tobacco that have no therapeutic value. (Ignoring the very limited therapeutic role for nicotine itself.) The dissent disagrees, reading into the FDCA a cost benefit analysis based on allowing bad substances because not having them will be worse. Under this analysis, the FDA would not ban tobacco because of the potential risks of smuggling and other tobacco- related illegal activity. The dissent does not discuss that this particular theory has been completely rejected in American drug policy, with its focus on prohibition except for very strictly controlled medical use. Short of methadone clinics, there is no useful analogy for the dissent to draw on.
The core of the majority's reasoning is that Congress is aware of the need to regulate tobacco as evidenced in the other tobacco regulations it has passed and that tobacco regulation is very complex and not well-suited to the provisions of the FDCA. The majority opinion is a call to Congress to step in and pass a law clearly stating its views on further regulation of tobacco. The dissent would prefer to allow the FDA to proceed, thus forcing Congress to act if it disapproves of the FDA position. Given that this case is a close call, both of these views are supportable under traditional administrative law jurisprudence. The court's choice is a political one, and it implicitly recognizes this by pushing the decision back to Congress. Since the court found that the FDA had no authority over tobacco, all of the FDA regulations affecting tobacco are now voided. The FDA's retains it's authority to regulated nicotine, which does have some therapeutic uses beyond its use as an anti-smoking agent, but it cannot use this authority to regulate tobacco products. It is not clear what role the FDA has as regard to "smokeless" cigarettes, which are very clearly a nicotine delivery device and do not involve the a traditional use for tobacco. This opinion does not affect state level regulation of tobacco, to the extent that it does not conflict with other state laws, nor does it affect the FTC and other agencies that do have statutory authority over tobacco.
All of you who are going in circles over this - you can stop
I know is is long but it is plain and simple.
The Supreme Court rules that the FDA has no authority to regulate tobacco - FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S.2000)
No product is more closely intertwined with the history of the United States than tobacco. From early colonial days, tobacco was a major export. In some colonies, tobacco was legal tender and the colonies paid their own debts in tobacco, at governmentally recognized rates denominated in pounds and barrels and hogsheads. During the revolutionary period, tobacco was valued more highly than continental money - Wharton v. Morris 1 U.S. 125, 1 Dall. 125, 1 L.Ed. 65 (Mem) Pa. Apr Term 1785. During this long history, the federal government's regulation of the health effects of tobacco have only been before the United States Supreme Court in one previous case, Cipollone v Liggett Group, Inc. 505 U.S. 504 (US 1992), which dealt with whether Congressional regulation of tobacco advertising and promotion preempted state tort claims against cigarette manufacturers.
FDA v. Brown & Williamson arose from the FDA's assertion of authority over the production and sale of cigarettes. This was based on finding that nicotine was a drug and that cigarettes were thus a drug delivery system. The FDA proposed to regulate cigarettes as a hybrid involving both a drug and a medical device. The FDA proposed rules through notice and comment rulemaking and when these rules were finalized, Brown & Williamson moved to have them enjoined because they exceeded the FDA's statutory authority. The District Court found most of the rules valid, but held that some exceeded the FDA's authority. The 4th Circuit reversed, finding that the FDA had no authority to regulate tobacco. The United States Supreme Court accepted cert., and announced its ruling in this case.
The question before the court was simple: does the Food Drug and Cosmetics Act (FDCA), as amended, give the FDA the legal authority to regulate tobacco? The court reviewed using classic administrative law precedents, beginning with the two-step analysis from Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). The first step of Chevron is to determine whether the plain language of the statute allows the agency's action. If that statute is silent on the matter at issue, then the second step is to determine if the agency's assertion of authority is permissible under the statute, considering the plain language of the statute, possible conflicting statutes, and relevant constitutional limitations.
Ironically, the majority opinion and the dissent agreed on the basic issue that tobacco is an extremely dangerous product that should be regulated: "This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use." The importance of tobacco regulation drove the majority to conclude that if Congress intended for the FDA to regulate tobacco, it should say so. In contrast, the dissent believed that tobacco regulation is so important that the FDA should have the right to regulate tobacco unless Congress forbids it that right. Jurisprudentially, the case is interesting because the judges reverse their usual roles. Scalia, who usually demands that the court look only to the words of the statute, signs on without separate comment to a majority opinion steeped in legislative history. Breyer, who usually cares more about what Congress thought about than what it wrote, dissents because the court ignores the plain meaning of the statute and delves into the morass of congressional intent.
Both the majority and the dissent concede that congress has been silent as regards the FDA's authority to regulate tobacco. The only mention of the FDA by congress in regard to tobacco was a statement that a particular labeling regulation did not affect the FDA's authority over tobacco, whatever it might be. At the same time, both the majority and dissent agree that the plain language of the FDCA seems to give the FDA the authority to regulate nicotine, and, through that, cigarettes. The problem with this plain reading is that for nearly 50 years the FDA denied that the FDCA gave it authority over tobacco. While agencies may change their minds as politics change, such a shift undermines their claim for deference because of their expertise in the subject. The majority focuses on history of tobacco regulation by Congress and finds that Congress has passed tobacco regulations six times since 1965. During this period Congresses accepted the FDA's assurance that it had not jurisdiction over tobacco and in none of these laws did it give any power to the FDA to regulate tobacco. Since tobacco regulation is such an important issue, this failure to give authority to the FDA in previous tobacco regulatory law convinces that majority that Congress could not have intended such an important task to fall the FDA through inadvertence.
The majority also looks at the logic of the FDCA and what it would mean to regulate tobacco under it. The FDCA gives the FDA the power to assure that drugs and medical devices in interstate commerce are safe and effective. The Act clearly deals with therapeutically valid drugs and devices and seems to leave no room for the sale of substances such as tobacco that have no therapeutic value. (Ignoring the very limited therapeutic role for nicotine itself.) The dissent disagrees, reading into the FDCA a cost benefit analysis based on allowing bad substances because not having them will be worse. Under this analysis, the FDA would not ban tobacco because of the potential risks of smuggling and other tobacco- related illegal activity. The dissent does not discuss that this particular theory has been completely rejected in American drug policy, with its focus on prohibition except for very strictly controlled medical use. Short of methadone clinics, there is no useful analogy for the dissent to draw on.
The core of the majority's reasoning is that Congress is aware of the need to regulate tobacco as evidenced in the other tobacco regulations it has passed and that tobacco regulation is very complex and not well-suited to the provisions of the FDCA. The majority opinion is a call to Congress to step in and pass a law clearly stating its views on further regulation of tobacco. The dissent would prefer to allow the FDA to proceed, thus forcing Congress to act if it disapproves of the FDA position. Given that this case is a close call, both of these views are supportable under traditional administrative law jurisprudence. The court's choice is a political one, and it implicitly recognizes this by pushing the decision back to Congress. Since the court found that the FDA had no authority over tobacco, all of the FDA regulations affecting tobacco are now voided. The FDA's retains it's authority to regulated nicotine, which does have some therapeutic uses beyond its use as an anti-smoking agent, but it cannot use this authority to regulate tobacco products. It is not clear what role the FDA has as regard to "smokeless" cigarettes, which are very clearly a nicotine delivery device and do not involve the a traditional use for tobacco. This opinion does not affect state level regulation of tobacco, to the extent that it does not conflict with other state laws, nor does it affect the FTC and other agencies that do have statutory authority over tobacco.
All of you who are going in circles over this - you can stop
KK--Hardly going around in Circles here. I do not care about the plight of tobacco--as you state --or devices have nothing to do with tobacco and the FDA has jurisdiction to regulate them. The plight of Nicotine Water is much more on point in the instant case and that took years to settle--So we are not going around in circles here as the FDA has stated alreadt stated that these devices are illegal to sell---Sun
See timeline on the plight of Nicotine Water--
Nicotine Water
The FDA have said eliquid is a drug that needs approval before use but they've tolerated sales for a while now.
In Australia eliquid has been classed as a poison for regulation. Although it's not legal to use they are not enforcing the laws on private use. The FDA might take the same line.
In the UK the Poisons Act was tried and ruled out. Medical and healthcare regulators have said it's not their issue unless claims are made about NRT or health and they've told traders not to use that sort of marketing language. Presumably it's going to be classed as a new drug here too if those claims continue to be made but until then they are not making a fuss. It looks like unless a big scandal breaks (like a death from poisoning or something) they're not taking an active role although they could if they chose to for the same reasons as the FDA.
I suppose it boils down to what tips the authorities over the edge to do something. They can justify action but can also justify non-action because without health or NRT claims nothing is clearly their problem.
Marketing, manufacturing and trading standards won't be enforced unless the FDA says it's their issue. If they do take it on as a responsibility of theirs then the first thing they will have to do is to stop distribution until safety criteria (testing, trials, etc) are met.
In Australia eliquid has been classed as a poison for regulation. Although it's not legal to use they are not enforcing the laws on private use. The FDA might take the same line.
In the UK the Poisons Act was tried and ruled out. Medical and healthcare regulators have said it's not their issue unless claims are made about NRT or health and they've told traders not to use that sort of marketing language. Presumably it's going to be classed as a new drug here too if those claims continue to be made but until then they are not making a fuss. It looks like unless a big scandal breaks (like a death from poisoning or something) they're not taking an active role although they could if they chose to for the same reasons as the FDA.
I suppose it boils down to what tips the authorities over the edge to do something. They can justify action but can also justify non-action because without health or NRT claims nothing is clearly their problem.
Marketing, manufacturing and trading standards won't be enforced unless the FDA says it's their issue. If they do take it on as a responsibility of theirs then the first thing they will have to do is to stop distribution until safety criteria (testing, trials, etc) are met.
That same post was made in the News thread ... Arrrrgh. Thanks for clueing him in, Kate.
I am finding this to be true sadly. But... there is still hope for the lobela inflata as it can be 3X to be OTC. So... we are going to whip up a homebrew concoction and see if that does the trick.
I was under the impression the lobelia blocks nicotine receptors in the brain, rather than being a possible replacement for nicotine. Am I missing something?
I have a pharmacist friend who is going to look into this as I am not a chemist at all. However it is my understanding that lobelia offers a similar reaction as nicotine, just not as strong.
Lobelia inflata - Wikipedia, the free encyclopedia
I love Roald Dahl! My favorite is still James and the Giant Peach.
Well if it does the trick, I will slap a cute little label on it and ship you some so you can give it a test drive! Apparently, you can get lobelia pretty easy. We shall see because that would be freaking awesome! (It sounds to good to be true so it probably is... oh well... you know me... ride the idea till it dies.)
Well if it does the trick, I will slap a cute little label on it and ship you some so you can give it a test drive! Apparently, you can get lobelia pretty easy. We shall see because that would be freaking awesome! (It sounds to good to be true so it probably is... oh well... you know me... ride the idea till it dies.)
Wow. That's all I can say anymore. Just wow. I've been personally attacked at least 3 times now.....quit responding all emotional.
Incredible.
Oh, and I did supply the link well before your reply.
"Hiding behind corn flakes"....I don't understand why people can't equate that what they're requesting of e-liquid is beyond what we request from our food.
Go eat another Big Mac....maybe you'll feel better.
Wow...so, questioning why somebody would hold e-liquid to a higher standard there everything else is a straw man tactic? Seriously?
You want to question things....unless the questioning goes against your own personal agenda. Then it's insulting...and then the insults fly towards the person bringing up the questions?
Just...WOW! You guys are awesome! You act just like the anti-smoking people....oh wait, they're people too.
Last edited:
- Status
Similar threads
