Independent lab analysis of FDA study

[Territoo]

I came across this a few weeks ago, but cannot recall if the link was ever posted here. If this a redundant thread, I apologize.

After the FDA released their report, njoy hired a third party lab to analyse the study, including data collection method and conclusions. They found a lot of flaws with the study and the conclusions the study made. Now, some may claim that since njoy paid this lab, that the analysis is biased in favor of njoy. However, these independent labs maintain their reputation by being unbiased. If the report had been unfavorable for Njoy they would have said so, and Njoy would have chosen not to release the results.

http://www.njoythefreedom.com/contactcommerce/images/press_releases/Response to the FDA Summary.pdf

 

[a2dcovert]

Thanks for sharing Territoo. It's too bad that this will never see the light of day in the matter before the court in the current case. It will be one small step for future negotiations though.

Kevin

 

[ladyraj]

Unfortunately, it appears this anaysis is of the FDA report with differing opinions (and other study findings) of the presented conclusions versus a truly independent lab analysis of carts and simulated vaping. Am I misreading the report?

This is considered a historical analysis to point out the flaws in the FDA report and has far less power than an independent analysis of product that would rival the FDA's lab report.

 

[Territoo]

Unfortunately, it appears this anaysis is of the FDA report with differing opinions (and other study findings) of the presented conclusions versus a truly independent lab analysis of carts and simulated vaping. Am I misreading the report?

This is considered a historical analysis to point out the flaws in the FDA report and has far less power than an independent analysis of product that would rival the FDA's lab report.

I wouldn't say far less. Any scientific study must meet peer review to hold any water. An analysis (peer review) isn't quite as good as an independent study, but it's a lot quicker and we can hope these studies are being conducted now. However, it does make the FDA study much less powerful, since it couldn't hold up to peer review. Keep in mind much of what is written in scientific journals is not new studies but reviews of previous work. To date, the FDA's findings have not been duplicated (another criteria for it to carry any weight) and have not been reviewed w/ the reviewer concurring w/ the method and conclusions.

This report from Exponent not being original research is not a step backwards for us, its knocking the FDA off of its alleged step forward.

The FDA jumped the gun in attempts to enforce policy based on a study using a small sample of available products, not using multiple samples of the products that were used (only one cart at each nic level from each company), that hasn't been repeated and hasn't stood up to peer review. Very unscientific, but very political.

 

[Territoo]

Thanks for sharing Territoo. It's too bad that this will never see the light of day in the matter before the court in the current case. It will be one small step for future negotiations though.

Kevin

I'm sure that Njoy will be submitting this report, in fact probably did during the hearing.

 

[a2dcovert]

I hope you are right. Unfortunately this case is not about the integrity of the FDA or their test data. It is about their jurisdiction over the product. Since there has been no official data submitted to the FDA they are free to draw their own conclusion. I think that is going to be the bottom line, unless the judge finds that our products can be considered tobacco products, the FDA was proper in classifying them as a new untested drug therefore was acting within the scope of their jurisdiction to block their sale.

Then it will be up to someone with deep pockets to comply with the standard product submission rules. I'm sure that is possible but it will be an expensive and lengthy process.

Kevin

 

[Vex444]

Im sure there in development as we speak. If these are banned the law dose'nt go into effect till Jan 1st and by then Im sure there will be alternatives. ok Hope there will be.

 

[a2dcovert]

Im sure there in development as we speak. If these are banned the law dose'nt go into effect till Jan 1st and by then Im sure there will be alternatives. ok Hope there will be.

I would expect that if the FDA is found to be operating properly they will immediately resume enforcing their original position. The only reason the shipments are going through right now is they are waiting on verification of their jurisdiction.

Kevin

 

[MrKai]

Im sure there in development as we speak. If these are banned the law dose'nt go into effect till Jan 1st and by then Im sure there will be alternatives. ok Hope there will be.

The case is being decided under *current* law and if the judge finds for the Defendant (remember, the FDA is being sued here...which is even worse, because the burdon of proof is on SE/NJOY...) then the "ban" is instant and permanent unless a law is passed granting an exception or the product is proven to be safe.

It really, at the end of the day, is that simple. No one will be able to sell this stuff without being in violation of long established, court-held Federal Statute.

-K

 

[MrKai]

I would expect that if the FDA is found to be operating properly they will immediately resume enforcing their original position. The only reason the shipments are going through right now is they are waiting on verification of their jurisdiction.

Kevin

This isn't at all about what people seem to think it is here, which is kind of odd to me as it is all a matter of public record, the whole sad tale

-K

 

[HaploVoss]

I realize that there is law, and there is the FDA, and what is done is done. But has anyone really stopped to carefuly READ the FDA report... then carefully READ this report? It seriously is insane. If any drug company tried to hand the FDA a summary like the one they did themselves here, and say 'See? It's all good.' The FDA would laugh in their faces and say yeah nice try come back tomorrow.

That is my main complaint is that there was absolutely no scientific ethic involved in this 'testing'. The control was not a control - it was something to compare it to. If it were a real control, it would have been tested in all the same manners, etc.

I'm sick of the debate. The FDA screwed up the tests, and they actually screwed them up really badly. I am really surprised that it has not been thrown out for a 'do-over' so to speak. Whether it would be for the better or worse is not my point... just based on the initial reports from both sides -> everyone needs to be sent back home for a time out and get it done right first.

My .02
- Hap

 

[MrKai]

Whether it would be for the better or worse is not my point... just based on the initial reports from both sides -> everyone needs to be sent back home for a time out and get it done right first.

My .02
- Hap

$1.00, HaploVoss. But then again, the principals involved, and I am willing to include the FDA in this, are ALL suspect at this point; FDA, NJOY, SE are all responsible of showing us, front and center the worst possible handing of an invention that *could possibly be proven* to save millions of lives.

As far as I know (I think SunVap could add to this quickly or we can go over that thread to find it) they aren't arguing the validity of the data strongly; I believe this is being done via amicus filings because someone must have hinted how incompetent their legal team is

That...or it isn't directly relevant to the case. I am told by those who know that Federal Judges really, really hate having their time wasted with immaterial, spurious arguments so it may in fact be a sound legal strategy to not poke holes in the FDA's data (directly) unless/until they have to...but the FDA isn't removing something from the market that was deemed safe ("Hey! This is perfectly safe and your data saying otherwise is bogus!") and then found *not* to be...they assert that we never even got to the "proven safe" ("How do we know this is saf in the first place? Have you proven it?") point...

Understand?

Things like this are *exactly why* laypersons are always urged to seek council by judges when they show up in court without them

-K

 

[HaploVoss]

$1.00, HaploVoss. But then again, the principals involved, and I am willing to include the FDA in this, are ALL suspect at this point; FDA, NJOY, SE are all responsible of showing us, front and center the worst possible handing of an invention that *could possibly be proven* to save millions of lives.

As far as I know (I think SunVap could add to this quickly or we can go over that thread to find it) they aren't arguing the validity of the data strongly; I believe this is being done via amicus filings because someone must have hinted how incompetent their legal team is

That...or it isn't directly relevant to the case. I am told by those who know that Federal Judges really, really hate having their time wasted with immaterial, spurious arguments so it may in fact be a sound legal strategy to not poke holes in the FDA's data (directly) unless/until they have to...but the FDA isn't removing something from the market that was deemed safe ("Hey! This is perfectly safe and your data saying otherwise is bogus!") and then found *not* to be...they assert that we never even got to the "proven safe" ("How do we know this is saf in the first place? Have you proven it?") point...

Understand?

Things like this are *exactly why* laypersons are always urged to seek council by judges when they show up in court without them

-K

I can see your point, however that underscores my point as well... since there has been no approval / disapproval of this product or these products as of yet, and the FDA decided that it was high time someone said something about it and wanted some results - well they went and screwed the pooch didn't they? All they had to do, just like they do with sooooo many other products that hit the market... is simply contact the manufacturers in question and start the ball rolling.

Instead they just grabbed up some samples, ran some tests, and shouted 'PHAIL! BAN THEM!' more or less. (I have an image of a huge red-faced Whig with a gigantic gavel... lol - anyway...)

Basically at this point it is 6 of one, half a dozen of the other. No matter what the outcome, I believe PV's are inevitable because it is quite obvious from the reports and respective reports on said report, that the harm level is equal to or less than most NRTs on the market. Therefore at some point, even if they do place a ban on them, someone will be able to go ahead and make one 'according to standards' at some point yes?

Take care,
- Hap

 

[Sun Vaporer]

$1.00, HaploVoss. But then again, the principals involved, and I am willing to include the FDA in this, are ALL suspect at this point; FDA, NJOY, SE are all responsible of showing us, front and center the worst possible handing of an invention that *could possibly be proven* to save millions of lives.

As far as I know (I think SunVap could add to this quickly or we can go over that thread to find it) they aren't arguing the validity of the data strongly; I believe this is being done via amicus filings because someone must have hinted how incompetent their legal team is

That...or it isn't directly relevant to the case. I am told by those who know that Federal Judges really, really hate having their time wasted with immaterial, spurious arguments so it may in fact be a sound legal strategy to not poke holes in the FDA's data (directly) unless/until they have to...but the FDA isn't removing something from the market that was deemed safe ("Hey! This is perfectly safe and your data saying otherwise is bogus!") and then found *not* to be...they assert that we never even got to the "proven safe" ("How do we know this is saf in the first place? Have you proven it?") point...

Understand?

Things like this are *exactly why* laypersons are always urged to seek council by judges when they show up in court without them

-K

K---You are right on point---the "saftey" of the e-cig has no bearing on the legal argument of whether or not the FDA has jurisdiction over them. Jurisdiction is what is in issue-------save the saftey data for the approval process when a Manufacturer actually steps up and makes application and provides the requisite studies and either gains approval, or at that point, if the e-cig is deemed to be as safe as claimed, then file suit against the FDA for withholding approval. As it stands now the cart is before the horse.


Sun

 

[MrKai]

All they had to do, just like they do with sooooo many other products that hit the market... is simply contact the manufacturers in question and start the ball rolling.

This is NOT what they do for things deemed to be *drugs*. They do this for *food* products and where in their jurisdiction, cosmetics.

The SOP for *drugs* that are *unproven* is *not* to say "hey buddy, want to put the right thing on the bottle, please?"

Everything in pill and liquid form in a bottle isn't a drug/regulated as a drug.

With drugs, or things that make medical claims the process is in fact the *inverse*...you are not allowed to sell it until you prove it does what YOU claim it does. The burden of proof lies on the shoulders of the claimant.

-K

 

[Our House]

K---You are right on point---the "saftey" of the e-cig has no bearing on the legal argument of whether or not the FDA has jurisdiction over them.

Then the "danger" also has no bearing on the legal argument either. It works both ways.

The FDA has no business launching a smear campaign based on the "test results" from a 2.5 month old pseudo-scientific study while there is a pending court case...especially since the test just happened to have been conducted against the two parties involved in the case.

IMO (and I'm obviously not a lawyer), that political move completely undermines Judge Leon's efforts.

 

[Sun Vaporer]

Then the "danger" also has no bearing on the legal argument either. It works both ways.

The FDA has no business launching a smear campaign based on the "test results" from a 2.5 month old pseudo-scientific study while there is a pending court case...especially since the test just happened to have been conducted against the two parties involved in the case.

IMO (and I'm obviously not a lawyer), that political move completely undermines Judge Leon's efforts.

I really do not know how to expain it to you other then you are comparing apples to oranges---the safty of a product and any testing that the FDA did is simply not relevent to the legal issue of jurisdiction. Saftey has no weight or bearing on the issue at all. So you really are looking for something that does not exsist.

Sun

 

[kinabaloo]

"Some governments define the term drug by law. In the United States, the Federal Food, Drug, and Cosmetic Act definition of "drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals."[11] Consistent with that definition, the U.S. separately defines narcotic drugs and controlled substances, which may include non-drugs, and explicitly excludes tobacco, caffeine and alcoholic beverages" - Drug - Wikipedia, the free encyclopedia

So, aside from a few specific exclusions, notably tobacco, everything that is not food is caught in the definition of drug; it's truly a catch-all. It's about maintaining monopolies. The problem is that the FDA and BP is virtually the same thing. This situation needs a radical overhaul and the legalities of definitions and jurisdiction needs a re-think. The current system is deeply flawed and does not properly work in the public's interest.

 

[Sun Vaporer]

SEC. 201. [21 U.S.C. 321] defines a drug and clears that ambiguity:

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Sun

 

[kinabaloo]

Sun - nicotine could be seen as a natural substance and e-juice as a solution of that extract; but it's not a dietary article, so as the law stands that would seem to be a dead-end. But it will be pursued I suspect and who knows might be successful.

As i see the current situation, the PV is clearly not used exclusively as a drug delivery device; nicotine containing juice will be seen as a drug by the FDA unless it can get into the tobacco category - or a new class of reduced harm tobacco alternatives.

Nicotine is no more dangerous than, say, aspirin (another natural extra with some beneficial properties). It is not so much that being classed as a drug would neceassrily be bad (aspirin is cheap and easily available) but that the indications are that the FDA is not going to evaluate it fairly; though as Mr K said, it could be challenged if that becomes the case.

Incidentally, aspirin is widely thought as one of the safest drugs, and relative to other medical drugs that is true; but it is still a big killer in fact. So there are good grounds for saying that nicotine is far safer than aspirin; only the handling presents a significant danger, but there are relatively simple ways to minimise that (such as valved containers).