I thought the liquid was being tested in some shipments that were not seized. "They" -- "whoever" were taking samples of the liquid, repackaged, and then shipped. I thought I read that here? Maybe it was a BS post, but it makes sense. The only test needed is if it did indeed contain nicotine. That just strengthens the case against e-cigs for future litigation.
Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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We are a VERY tiny minority. Just a guess - 1% of smokers are vapers.
The Judge's delay in ruling on an emergency relief petition foretells the outcome.
The Judge's delay in ruling on an emergency relief petition foretells the outcome.
I guess that there is quite a few of us that "don't want to understand". My problem is that from banning aspect, I see only 2 ways for a non-artificial substance to be considered a "drug" or in the other words "controlled substance".
1) If a substance is a chemical compound where all natural sources of this compound are banned. E.g. THC is a controlled substance and marijuana that contains it is banned. ....... is a controlled substance and coca plants are banned.
2) If a substance is a chemical compound that is found in natural sources but in significantly lower concentration than the product that is offered on the market. E.g. penicillin is a controlled substance, fungus containing penicillin can not be banned. There are multiple examples of minerals, vitamins and other substances available in non-FDA-drug-tested concoctions that are controlled substances when offered in higher concentration.
Now nicotine based e-liquid doesn't fit either. Tobacco as its source is not banned, and the concentration of it is frequently less than that available in some dry tobacco leaves (up to 3-4% which would equal 40mg/g).
One might argue that nicotine is a drug by definition, since it affects body and brain chemistry, which is true, but any attempt to classify it as a controlled substance can be used in multiple other outrageous examples that contain "drugs". E.g. FDA could argue that it is not going to allow any new type of soda that contains caffeine, even though concentration of it might be lower than in coffee. Or they might make cane sugar based products only available as drug. Or sea salt for that matter.
What I constantly wonder is how come no one is bringing up the above example? Am I just wrong? Is there an example of a controlled substance, freely available in nature, with similar concentration, where artificially made alternative is considered a drug? FDA regulated product yes, but by all means not a drug, and therefore not subjected to different standards than the original.
It doesn't say anywhere on that site that it's been approved by the FDA. It says it's been tested by FTC standards, and that's about it.
Tujec--It is not a question of anyone being "wrong"--it is the law. Nicotine was already defined by litigation in the Nicotine Water case as being a drug subject to FDA regulation. Both SE and NJOY conceed that---they have to. We must move on with what the law is, not what we would like it to be. No matter how "creative" one can be, the case law on Nicotine is that it is a "drug".
And one really has to admit that Counsel for SE and NJOY were not really given a good fact pattern to work with here----No testing to submit to the Court, no attempt at anyone making any formal applications, the sale of a nicotine delivery product when the Court's have already concluded that Nicotine is a "drug" within the province of FDA regulation, ---the list goes on and on. Counsel really had no facts or evidence here to advance to the Court to make out a case for the e-cig.
TB is correct, that had the Manufactures chose to make formal applications and do the requistie studies for the FDA, then by now they might have been already approved or close to it. They chose not to.
Bottom line is the facts are the facts, the law is the law, and in this case, both the facts and the law do not give Judge Leon too much to hang his hat on for the e-cig to stand unregulated.
Sun
And one really has to admit that Counsel for SE and NJOY were not really given a good fact pattern to work with here----No testing to submit to the Court, no attempt at anyone making any formal applications, the sale of a nicotine delivery product when the Court's have already concluded that Nicotine is a "drug" within the province of FDA regulation, ---the list goes on and on. Counsel really had no facts or evidence here to advance to the Court to make out a case for the e-cig.
TB is correct, that had the Manufactures chose to make formal applications and do the requistie studies for the FDA, then by now they might have been already approved or close to it. They chose not to.
Bottom line is the facts are the facts, the law is the law, and in this case, both the facts and the law do not give Judge Leon too much to hang his hat on for the e-cig to stand unregulated.
Sun
Sun, many thanks for the response. Well I guess that since IANAL it allows for wishful thinking that laws would be logical.
But seriously, doesn't the case law, as it stands, open doors for FDA to raise the claim that any substance is a drug independent of its availability, and therefore ban random things at their will without congressional mandate? Wouldn't that allow them to ban any tobacco as well (unless they are specifically required by another law not to interfere)? Wouldn't that be enough to use as an argument to struck down the case law? If this seems ridiculous, please ignore, don't feel the need to respond to my rant.
Sun, many thanks for the response. Well I guess that since IANAL it allows for wishful thinking that laws would be logical.
But seriously, doesn't the case law, as it stands, open doors for FDA to raise the claim that any substance is a drug independent of its availability, and therefore ban random things at their will without congressional mandate? Wouldn't that allow them to ban any tobacco as well (unless they are specifically required by another law not to interfere)? Wouldn't that be enough to use as an argument to struck down the case law? If this seems ridiculous, please ignore, don't feel the need to respond to my rant.
Tvujec--There is a long history of tobacco and the law or rather should I say "lack there of" due to it being an idustury that drove an economy dating back to the infancy of our Country. Tobacco always has been a revenue maker for all concerned, be it the manufactures or the goverment. So much so that legistation or lack there of has been steared in it's favor---even up to today. Absent it's economic value, tobacco would have been banned many years ago. Such is not the case and it is hard to take tobacco and really compare it to most other products on the market.
You have to remember that the FDA is a product of Congress-- with the power to make codes and rules under the broad authority Congress granted it. The FDA is given broad latitude in perfoming their functions. Although the Courts are always available for advancing a cause of action against the a FDA for an abuse of it's discretion, the Court's in general give due deference to the FDA's expertise and usually defer to the FDA absent a blantant abuse of it's power.
In the case of e-cigs, the Court has been given a devise that delivers nicotine---No data, no standards, no manufactuing specifications, no scientific studies to show in any way that it is safe. The FDA is arguing to the Court, that this is a product that needs to go though its approval process before it is imported, sold, and marketing. Just look at what SE and NJOY are asking the Judge to do?
All of us here for the most part think that the e-cig is safe, and surely safer then cigarettes which are known killers. But that kind of unsupported thinking just has no merit when it comes to meeting the burden of proof showing the Court that the FDA abused its discretion. The pleadings advanced by SE and NJOY, really do not give Judge Leon much to work with.
Sun
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Mixmaster51
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Sun,
As far as the case law is concerned and the interpretation. You are exactly right. No matter how bitter of a pill, no pun intended, that it is for us to swallow. We are going to have to face some very hard facts. We are going to lose. The question is and one we should all be focusing our collective energies on right now is where do we go from here.
Mixmaster51
As far as the case law is concerned and the interpretation. You are exactly right. No matter how bitter of a pill, no pun intended, that it is for us to swallow. We are going to have to face some very hard facts. We are going to lose. The question is and one we should all be focusing our collective energies on right now is where do we go from here.
Mixmaster51
Sun,
As far as the case law is concerned and the interpretation. You are exactly right. No matter how bitter of a pill, no pun intended, that it is for us to swallow. We are going to have to face some very hard facts. We are going to lose. The question is and one we should all be focusing our collective energies on right now is where do we go from here.
Mixmaster51
<sigh> I tend to agree. Even if they don't ban e-cigs but rather force them to adhere to the rigorous approval process it leaves us high and dry for the immediate future. It could take a couple years to get approved. I just can't imagine all the current vapors tossing their e-cigs and juice and saying, "Oh well, will try again in a couple years, back to analogs."
CoderGuy
Since all of us have been vaping for anywhere from weeks to years, why couldn't WE all be included in a "study group" and asked to provide testimony as to our health concerns on cigs vs. on vape?
We have a ready-made, motivated test pool of human guinea pigs right here on this forum. The majority of us would be glad to contribute to the effort, even if only to guarantee the right to continue vaping for the length of the study. Why not commission an eight or ten-year study, and LET US SIGN UP FOR IT?
~~Cheryl
We have a ready-made, motivated test pool of human guinea pigs right here on this forum. The majority of us would be glad to contribute to the effort, even if only to guarantee the right to continue vaping for the length of the study. Why not commission an eight or ten-year study, and LET US SIGN UP FOR IT?
~~Cheryl
Cheryl: That won't work. That's not what is needed and would be an exercise in futility. For drug approval, clinical trials are needed. Then peer-review must be done on the results, then applications for approval made, then the applications studied, then determination .. approval, rejection, or more study. It takes time. And lots of money. And users can't initiate the study. Deal with reality. Don't fantasize end runs around the law. It will only lead to trouble. Your idea has been suggested many times over the past year. Sorry, but that's the truth.
Sun and TB,
Im not an expert in this matter, but trying to do some research on FDA procedures and classifications. FDA has made it clear that they consider e-cigarettes drug/device combo. As such, it is required to go through an approval process. The consensus here is that its long and costly proposition
I dont think it is. As device/drug combo it falls under 510(k) and must follow approval guidelines established in CODE OF FEDERAL REGULATIONS, TITLE 21. There multiple options for a path to an approval, but the one that caught my eye is:
Premarket Notification, 510(k) - 21 CFR Part 807 Subpart E
Sec. 807.92 Content and format of a 510(k) summary.
Like I said, Im not an expert but I do not see a reason why SE/NJOY cant file 510(k) claiming its equivalency to a cigarette and seek the approval based on better alternative. I would like to hear you thoughts...
Im not an expert in this matter, but trying to do some research on FDA procedures and classifications. FDA has made it clear that they consider e-cigarettes drug/device combo. As such, it is required to go through an approval process. The consensus here is that its long and costly proposition
I dont think it is. As device/drug combo it falls under 510(k) and must follow approval guidelines established in CODE OF FEDERAL REGULATIONS, TITLE 21. There multiple options for a path to an approval, but the one that caught my eye is:
Premarket Notification, 510(k) - 21 CFR Part 807 Subpart E
A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by the FDA to be substantially equivalent.
Sec. 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall contain the following information:
(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process;
(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;
(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k)
(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process;
(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;
(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k)
Like I said, Im not an expert but I do not see a reason why SE/NJOY cant file 510(k) claiming its equivalency to a cigarette and seek the approval based on better alternative. I would like to hear you thoughts...
"Nicotine "drugs" as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). Section 503 drugs must be compounded based on the receipt of valid prescription orders from licensed practitioners."
This was the FDA's statement on Nicotine Water and Nicotine Lollypops when they where banned.
Sun
This was the FDA's statement on Nicotine Water and Nicotine Lollypops when they where banned.
Sun
Ruyan did do testing, but not specific to the requiste studies that are required to be submitted to the FDA nor did Ruyan make application.
You must remember that that the application and approval process of any product that comes before the FDA is a compex with many guidelines and studies that must conform to those set by the FDA.
Sun
Nicotine is, but the e-cig and no-nicotine e-liquid HAS not been classified by FDA, or any other agency for that matter. Am I correct in my assumptions or am I missing something?
So correct me if I am wrong (and I may very well be) but cigarettes, cigars, snuff, chew, snus, etc. are all not FDA approved either are they? Even with this new multi-million dollar waste of money bill they just passed they aren't going to "approve" these products, just do things like "limit advertising", "reduce flavors", "make it more difficult for children to acquire", "regulate the amount of nicotine in the products". Right?
CoderGuy
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