FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

[tombaker]

My responses in quote boxes like this

Roger_Lafayette;13030810]

I. BELIEFS ABOUT WHAT CAN BE DONE IN THE NEAR FUTURE

Belief 1: The FDA's proposed rule may be challenged in court, prior to any action undertaken against a specific manufacturer, just as it was in Soterra. So this proposed rule can be stopped long before the two year "window" closes.
False
Federal Courts demand a "case or controversy" before hearing the merits of a claim, and this is often interpreted as requiring that a federal agency act or threaten to act against a particular party before the court will entertain a request to issue an order to the agency in the form of an injunction. In the Soterra case, the FDA had already acted. It seems extremely unlikely that the FDA regulations could be stopped by any entity that had not at least submitted a rejected application for market approval, or received a "cease and desist" letter from the FDA, or been on the receiving end of a product siezure.

Sottera decision and Court still exist, if the FDA would try and act the same way, without being inside of the bounds of the new law the court pointed to, Sottera could ask for relief, including asking for a temporay injunction until a final ruling, in whichever court is heard.

Belief 2: The FDA is simply putting foward a framework for negotiation and discussion. If we vapers get together, then organizations that represent us and/or the vaping industry can sit down with the FDA and offer them a series of "compromises," that may result in the FDA drafting a different proposed rule.
False
The FDA's "listening sessions" are over. The only thing that vapers can do right now to participate in the formal process is to submit comments during the period that will end in early July (although CASAA intends to request an extension, the FDA has the sole authority to decline this request). Once the comment period ends, the FDA will draft a final proposed rule that will go to the OMB. If OMB permits the final proposed rule to move forward, it will then be presented to the US Congress. While Congress has the authority to block the proposed rule, it must act affirmatively to do so. Without any such vote, the rule will become final. Furthermore, any such vote would be subject to a Presidential veto.

The comments are required by law, and the reading of them by the FDA is required. If they were to just ignore them completely, it would be a problem for the FDA in future court actions. If you really believe its pointless to comment, why bother to be waiting for language to get from CASAA. You have contradictory language in your own assessment.

Also the FDA is required to read all comments, I really wonder why people are waiting for any organization other than their own, to comment. A bunch of copy and paste comments will be equal to once of the same comments, from an organization that represents people, like the CASAA.

I see know downside to drafting individual comments, even if one was to get it “wrong”, a wrong comment does not displace a correct one. Each comment is unique, and if someone says and can show they are representing 14K individuals like the CASAA will, having each CASAA member saying the exact same thing, does not multiple the effect. They are expecting something like 200K comments, from organizations and individuals.

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II. BELIEFS ABOUT PRODUCTS SOLD WITHIN DIFFERENT TIME PERIODS

Belief 3: There are products available prior to Feb '07 which are "substantially equivalent" to products available now, such as unflavored nicotine base.
Almost certainly false
Anything available prior to Feb '07 would have to be tested and proven to be chemically identical to whatever is sold now. Furthermore it would need to be offered in identical quantity and packaging. No hardware solution available at that time (if one could be found) is in any way comparable to something that could likely be offered today.

The E-Cig existed in 2007 in America. The liquid inside would be the same, Food Grade Flavorings, a general classification of pre-approved known to be safe ingredients. A pallet that every food maker can work with, pre blessed by the FDA. PG/VG and Nicotine. Whatever extra chemicals were in the 2007 products are not needed. And deleting items from a predicate product is better for approval, than adding new ones.

Belief 5: As long as an application is submitted within the two-year window after the rule becomes final, the FDA will allow the product to remain on the market until the application is reviewed, which might take many years, given the history of tobacco cigarette applications and the number of applications submitted prior to that application.
Probably false
There are no enforceable rules regarding the order in which applications are reviewed. The FDA could choose to reject every single vaping product on the first day after the two-year window closes. At that point, the products could be immediately pulled from the market, meaning that the FDA has the right to sieze and destroy them at the manufacturer's expense.

I think you are being purposefully naïve here. If the FDA could just reject applications, without any basis, they would do so for Analogs and Traditionals. You pretend the FDA can act without redress, as if Sottera was not possible. Your scenario would have the FDA locked into tons of legal cases for injuctions against FDA actions, which they would loose.

Maxwell its as if you are trying to play Checkers with someone who you want to pretend does not need to follow the rules of Checkers. Nation of Laws thing.

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III. BELIEFS ABOUT COSTS OF THE APPLICATION PROCESS AND THE REGULATORY FRAMEWORK

Belief 6: The costs of an application might be as little as a few thousand dollars, or perhaps a few tens of thousands of dollars.
False
No credible person who has looked at this process has suggested that it will cost less than several hundred thousand dollars (at a bare minimum) to do all the necessary studies and analyses of the product's effect on tobacco product usage behavior as well as fulfill the additional standards. Some estimates are as high as $10M. The FSPTCA statutory framework was specifically set up by Congress to deter big tobacco companies from marketing new varieties of tobacco cigarettes, so the barriars placed in their path will be very similar to those facing any e-liquid or vaping equipment manufacturer.

If you think that the cost of an application to understand 3 categories (E-Liquid) is going to take as much work as 4000+ inhaled items, I think you are just playing games. Nicotine taken to the lungs and body is the essential element of a Tobacco product. If you are talking levels never seen by Analogs that is one thing, if you are 2.4 and below, it the same element, different delivery, to the same human.

I think you are pretending intentional or not, that E-Cigs are bad for health, and that they are not able to be shown as safe. To this I think you are wrong. Saying that each application will take 10 Million dollars, is a fantasy, plucking numbers out of the air, and selling it as if certainly true.

You also want to pretend that the 3500 products which already have their applications in, and are being sold, all took 10 Million Dollars each to apply for. Silly. And you ignore that the FDA is still allowing 3500 products to be sold.

You ignore there is no application fee also. The cost of putting out something, that they would have to reject, is almost nothing. What makes you think that 3500 applications for currently being sold items, are nothing more that cut and paste….you don’t know, I don’t know the contents of 3500 documents either…..but we both know 1 thing, all those products are being sold today. Still. 500 items not being sold at the deadline, in limbo, sure…so I would suggest if you have product, get it out before the 2 year grace period for complance starts.

IV. BELIEFS ABOUT THE REQUIRED NUMBER OF DISTINCT APPLICATIONS

Belief 9: There will be one approval process for each flavor of e-liquid, which can then be used by other manufacturers.
False
If the history of the tobacco cigarette approval process is any guide, even the smallest variation in chemical composition or manufacturing standards between two e-liquids will require an individual application to be submitted for each. That includes, but is not necessarily limited to variations in nicotine content, package size, VG/PG ratios, and almost certainly packaging and even labelling.

The Family Tobacco act is actually pointed a lot to the precious children of the world, who cease being precious at the age of 18. Stuff like marketing to kids, advertising with Joe Camel cartoons in Magazines, the look of the package count for kiddies.

A nondescript bottle of juice, with some warnings is what E-Liquid looks like, so feel free to worry and worry about packaging.

Might as well put a large Skull and Bones with a Warning Contains nicotine on all the bottles, just to be sure its not kid friendly.

Belief 10: Hardware (vaping equipment) is not affected, so long as it doesn't contain nicotine, and/or isn't sold with nicotine as part of a "kit."
False
Any "component or part" of a "regulated tobacco product" is covered under the act, and the FDA has indicated that the standard is "intended or anticipated for use." While this approach would also theoretically cover rubber O-rings or 186xx batteries that are used for many other types of products, no one anticipates that the FDA will declare those items to be regulated "components or parts" of tobacco products. However anything that's unique to vaping and essential to a particular usable configuration of a regulated "tobacco product" (e.g. a drip tip) will likely be covered. This means it will require a separate application if it is sold separately. As with e-liquid and tobacco cigarettes, the smallest variations in manufacturing, composition, size, shape, color, and so forth will each yield the requirment for a separate application.

Here is where you are so very wrong. A battery source, replaceable Cell or integrated, with a Standard Connector. Can not be regulated by the FDA. Period. If it attached to a disposable with a Nic Cart installed. Yes. If sold as a Kit, Yes.

Tanks, APV of any type, battery sources, all have application far outside of Nicotine. AND THE FDA SAYS IT ONLY HAS DOMAIN OVER TOBACCO BASED NICOTINE.

The paraphernalia of Tobacco Products is out of scope. E-Liquid is the Tobacco Product. A disposable is a finished product. APV hardware and Clearos, are nothing but personal humidifiers. If water is used in Nic-Liquid, is water then also a tobacco product?

You are acting as if raw materials of manufacturing can be regulated. Its silly. You are acting like the entire MSDS system does not even exist.

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V. BELIEFS ABOUT OTHER "WORKAROUNDS"

Belief 12: A group of manufacturers can submit an application for high-strength e-liquid "base," which would then be used by the customer to create various flavorings. By pooling their resources, this consortium would have have the economic ability to satify the application standards and pursue any needed post-rejection litigation.
Probably false
The FDA is free to reject this application on the first day after the 2-year "window" expires, thus making the product illegal. That means the ROI for the investment involved in submitting the application will be zero until a court intervenes. It might be years before any litigation was concluded successfully for the manufacturers, thus making this an extremely risky prospect. It's not clear what the market would look like for e-liquid, particularly if vaping equipment hadn't been sold for many years prior to any eventual positive outcome in the courts. There are also other issues, such as the base composition ratio between PG and VG, and whether nicotine of that strength could be safely handled by consumers and result in an e-liquid that's also strong enough. Last but not least, any sellers of flavorings that were "intended or anticipated for use" with a "covered tobacco product" (i.e. the high-strength e-liquid) might be in exactly the same situation as vaping equipment manufacturers, i.e. they would be selling a "component or part" of a "tobacco product." This entire strategy is fraught with risks that are difficult to assess at best.

Flavorings are is a category. Much like in Food, the are a known set of accepted as Safe items. Next time you eat some food, tell me all the items which are within the term “Artificially Flavored” The artifical flavorings are a pallet of items that Big Food gets to use, they don’t have to apply for usage on each product they make.

Flavorings are heated in Vaping, they are incinerated in Smoking, that is not comparable. Have you looked at a MSDS before?

Belief 13: Anyone will be free to do so for their own use until laws are passed against "nicotine paraphernalia"

And we are free to use toothpicks until they ban those too….about as significant of a fear, considering both are without president. Are you saying they are about to create laws to ban Tobacco Pipes? If some of your fears were so easily possible, it would have been done with Analogs.

Belief 15: There is no way that the FDA can successfully keep vapers from accessing nicotine and/or vaping equipment on the black market. Besides, all federal agencies are prohibited from drafting regulations that create black markets.
Hard to evaluate
Many existing prescription drugs are sold on the black market. As with all black markets, any given person's experience will likely vary from that of others'.

Nicotine is a being sold in raw form because it is legal to do so. If it was not legal, they could not do it. For the FDA to do as you say, they need a bunch of new laws, that are not written, or proposed. They would need a law banning nicotine.

And that is my concern about much of what you proclaim, you need new laws, new rules, new ways of looking at items already controlled by law and the FDA, you pretty much need a conspiracy theory of new legislations, about to be drafted and set in stone. Ohhh but look what the FDA tried to do in 2009. oooooooohhhhh just look at that. From 2009-2013, what would you say would be the state of the health of the Vaping world?
If they have these incredible powers, and they are out to get you, and your vape, how is it that Sottera won, how is it that with all the same laws on the Books, signed into law, that the FDA did not just go gang busters in 2010 or 2012, or even 2013.

For you to be right in most everything you say above (not everything) you have to explain why all of this has not happened already. And why now, the FDA by most assessments won’t have a chance of doing anything until 2018, all of your theories of Doom. And by 2018, at current pace, without accelerating, it will be a 32 Billion dollar industry.

So Maxwell, to put it in a single sentence.

Your theory:
Is the FDA is going to let E-Cigs grow to an 32 Billion dollar industry in 2018, to then attempt (actually you say not attempt, you say they just get to) to shut it all down like a light-switch, poof, only Sottera and a few others remain at best.

Because it makes SO much sense to let it grow to a huge large size in 2018, just to then stop it in its tracks.

Prrrooooo HO Beatchin be a coming in 2018. Right about when Global Warming causes the Sky to Fall too.

 

[Roger_Lafayette]

<snip>

I am going to ignore your responses that I regard as incoherent or nonsensical. Although I will flag them as such, with the bolded blue acronym "IoN".

The indicated numbers refer to the belief sequence numbers in my original post (and thus reference your replies as well).

***

1) IoN - you appear to completely misunderstand Soterra.

2) IoN - I said that vapers can participate in the formal process via comments. I'm not sure what you're adding or trying to say there.

3) The entirety of a new product has to be substantially eqivalent to the entirety of the older one. It's not as if a manufacturer of (say) a tobacco cigarette could say that the filter of a new cigarette is substantially equivalent to a "grandparented" tobacco cigarette, and then stick it on the remainder of another "grandparented" tobacco cigarette, in order to create a new (supposedly) SE tobacco cigarette. Or pick and choose from the chemicals in a "grandparented" tobacco cigarette, and then argue that a new allegedly-SE tobacco cigarette uses a subset of them. Under your interpretation of SE, every new tobacco cigarette is SE to "grandparented" tobacco cigarettes as long as it contains no new chemicals. That's not how it works.

5) I am not assuming that the FDA can reject applications without redress. Only that they may do so at a time of their own choosing, and in any sequence they please. Once they reject an application after the 2-year window is closed, then things get tied up in the courts for years - plus the FDA can also immediately sieze and destroy the product at the manufacturer's expense. Unless a manufacturer can persuade a court to issue a preliminary injunction, the product must stay off the market until the merits are heard. Even if a manufacturer wins on the merits in Federal District Court, the court may stay the ruling on appeal, thus potentially keeping the product off the market for a few more years.

6) The $10M upper bound for applications comes from the VPLive round table (Bill G., I believe). You can take it up with him. Although I will mention in passing that the application process and standards which are present in the language of the FSPTCA and its legislative history clearly reflect the intent on the part of Congress to make it difficult for BT to introduce new types of tobacco cigarettes.. It is this underlying context that applies to all applications from vaping manufacturers, whether for e-liquid or equipment.

9) IoN

10) I refuse to debate this "component or part" issue with you any further. We've been talking about this for almost ten days now. It's pointless to keep discussing it.

12) I didn't say that the "component or part" of the FDA's jurisdiction could be used to ban all flavorings. Just those which are "intended for use" in a covered tobacco product. C.f. the equipment discussion above. I won't discuss this with you any more, either.

13) If vaping becomes "medicalized" (available only by prescription), then vaping devices will become medical devices that can only be posessed with a prescription. That was my only point.

15) IoN

***

I confess that my patience for your difficult-to-parse sentences and convoluted arguments is not infinite.

For example, stuff like this is just gibberish:

Prrrooooo HO Beatchin be a coming in 2018. Right about when Global Warming causes the Sky to Fall too.

I put you on "ignore" in another thread. And that's where you're going in this one too, until you can do a better job of making coherent arguments and writing prose that I can read more easily. I might have a little sympathy for you on the latter point if I thought you weren't a native speaker of English.

 

[aikanae1]

Why not? FDA has already proclaimed that genetically modified foods are safe.

I hate the prospects of monsanto entering the nic market, but there's some merit to the idea.

 

[DC2]

IoN

I like that!

 

[Dave_in_OK]

What I want to know is what is the TAX benefit of the proposed rules! Will BT and BP keep or increase their profits yes but the Federal, State, and City governments will be the biggest winners. I know that the FDA isn't required to shows this as it falls under the IRS however IMO it is the only reason for the Deeming rules. And I would like CASAA to try and cover it if at all possible.

 

[wv2win]

Roger, I can't speak to the accuracy of your analysis, but I appreciate your effort. My guess is your analysis is at least 90% on the mark which means every one who vapes had better band together and exert whatever pressure we can to our elected officials. I am holding off until we receive more direction from CASAA.

Something tells me it is not a coincidence that the two year window expires before we have a chance to have a new administration that is not hell bent on destroying our ability to vape, as the current administration is trying to do.

 

[Roger_Lafayette]

Roger, I can't speak to the accuracy of your analysis, but I appreciate your effort. My guess is your analysis is at least 90% on the mark which means every one who vapes had better band together and exert whatever pressure we can to our elected officials. I am holding off until we receive more direction from CASAA.

Something tells me it is not a coincidence that the two year window expires before we have a chance to have a new administration that is not hell bent on destroying our ability to vape, as the current administration is trying to do.

You see this as an exclusively partisan issue. Republicans are all good, Democrats are all bad. It's as simple as that, isn't it?

I'd be happy (at least as a vaper) to have a Democrat who thinks like Gov. Dayton or Gov. Shumlin in office in 2017. A whole lot better than one who thinks like Gov. Christie or Gov. Kasich. Or Snyder, for that matter.

This is about vaping, not politics. Chances are pretty good that we're going to be fighting this battle under any new administration, because the forces involved here are bigger than the parties and are very influential in both of them.

 

[StormFinch]

Here is where you are so very wrong. A battery source, replaceable Cell or integrated, with a Standard Connector. Can not be regulated by the FDA. Period. If it attached to a disposable with a Nic Cart installed. Yes. If sold as a Kit, Yes.

Tanks, APV of any type, battery sources, all have application far outside of Nicotine. AND THE FDA SAYS IT ONLY HAS DOMAIN OVER TOBACCO BASED NICOTINE.

The paraphernalia of Tobacco Products is out of scope. E-Liquid is the Tobacco Product. A disposable is a finished product. APV hardware and Clearos, are nothing but personal humidifiers. If water is used in Nic-Liquid, is water then also a tobacco product?

You are acting as if raw materials of manufacturing can be regulated. Its silly. You are acting like the entire MSDS system does not even exist.

I'm only going to do this once and relatively quickly, so no one should expect a long, drawn out debate.

Although things like wick, wire and rubber O rings would almost certainly be considered raw materials and not components, lawyers well versed in FDA regulation, and at least one who works regularly with both food and tobacco companies to get their companies' product through said regulation, don't agree with your belief that tanks, batteries (in the form of sealed units) etc won't be covered as components. Until you can put forth any training you have to make you an expert in the FDA regulatory arena, I'm personally going to ignore the strange preoccupation you have with trying to convince everyone they're wrong.

This is an interview with Azim Chowdhury, attorney at Keller Heckman who's specialty is FDA regulation and he covers most of the points brought up in this sub-forum in it. https://soundcloud.com/vp-live/smoke-free-radio-episode-2

 

[GaryInTexas]

You see this as an exclusively partisan issue. Republicans are all good, Democrats are all bad. It's as simple as that, isn't it?

I'd be happy (at least as a vaper) to have a Democrat who thinks like Gov. Dayton or Gov. Shumlin in office in 2017. A whole lot better than one who thinks like Gov. Christie or Gov. Kasich. Or Snyder, for that matter.

This is about vaping, not politics.

I won't speak for wv2win but this administration is bad bad bad. Regardless of party affiliation, this particular administration has taken a huge step in removal of individual rights and freedom. Any change in leadership can only be better as this one is absolutely pitiful.

 

[wv2win]

You see this as an exclusively partisan issue. Republicans are all good, Democrats are all bad. It's as simple as that, isn't it?

I'd be happy (at least as a vaper) to have a Democrat who thinks like Gov. Dayton or Gov. Shumlin in office in 2017. A whole lot better than one who thinks like Gov. Christie or Gov. Kasich. Or Snyder, for that matter.

This is about vaping, not politics. Chances are pretty good that we're going to be fighting this battle under any new administration, because the forces involved here are bigger than the parties and are very influential in both of them.

First, I never stated, Democrat or Republican. Personally, I'm an Independent. On this issue, I don't care which party is in power, as long as they do not subject us to "nanny-state" policies/laws that reaches into my home and deprives me of my ability to make decisions for myself as to how I lead my life, that is not harming others!!!

Second, vaping IS a POLITICAL issue ONLY because THIS administration made it one. My issue is with THIS administration and any politician that advocates controlling my life on activities that are not harming others. If this administration were of the other party, I would be just as vehemently opposed to their desire to control my life.

 

[Roger_Lafayette]

I won't speak for wv2win but this administration is bad bad bad. Regardless of party affiliation, this particular administration has taken a huge step in removal of individual rights and freedom. Any change in leadership can only be better as this one is absolutely pitiful.

I won't argue with you about whether this sucks. Although I'm not sure that a new administration will be less in the pockets of all the forces allied against us. We are fighting BP, BT, BV, and the entire Government-Industrial Tobacco Control Complex.

Only the long-term growth in vapers, our ability to organize, and future better health statistics will save us. President Christie? Not likely to be any better than President (HR) Clinton. Actually BP is fairly influential in NJ, which may explain Christie. Although they also have a big role to play in Gov. Dayton (D)'s MN. There are still a few folks like him and Gov. Shumlin (D-VT) who are willing to stand up for rationality. Unlike Durbin and his ilk (who are also all Ds).

It will be very interesting to see whether the national GOP takes a position on this. So far, they've let the nat'l Dems get all the headlines, and gov.s like Dayton, Christie, Kasich, and Shumlin have mostly been buried under the media radar.

 

[Roger_Lafayette]

First, I never stated, Democrat or Republican. Personally, I'm an Independent. On this issue, I don't care which party is in power, as long as they do not subject us to "nanny-state" policies/laws that reaches into my home and deprives me of my ability to make decisions for myself as to how I lead my life, that is not harming others!!!

Second, vaping IS a POLITICAL issue ONLY because THIS administration made it one. My issue is with THIS administration and any politician that advocates controlling my life on activities that are not harming others. If this administration were of the other party, I would be just as vehemently opposed to their desire to control my life.

Excellent. We're agreed then. Let the partisan bashing at ECF cease as of this moment

 

[Nate760]

I won't speak for wv2win but this administration is bad bad bad. Regardless of party affiliation, this particular administration has taken a huge step in removal of individual rights and freedom. Any change in leadership can only be better as this one is absolutely pitiful.

Neither of the major parties is less hostile to individual liberty than the other. They just have different priorities about what you shouldn't be allowed to do with your own body.

 

[GaryInTexas]

Neither of the major parties is less hostile to individual liberty than the other. They just have different priorities about what you shouldn't be allowed to do with your own body.

I made no such claim either. I will not vote for any candidate regardless of party that does not support individual freedoms. Some of the R's mentioned above will not get my vote ever. I do know who has had their hand the deepest in my pockets the last few years. I know which party is now reaching deeper for even more.

 

[wv2win]

Excellent. We're agreed then. Let the partisan bashing at ECF cease as of this moment

The only politicians that I "bash" are those who want to control a citizen's activities that do no harm to others. To this point, they all appear to be of a particular political philosophy. (notice I did not say party). If some politician of a different political philosophy comes out against vaping or like activities that does not harm others, I will "rant" against them as well.

If politicians from every political philosophy had stayed out of the vaping business, as they should have, we would not be at this point.

 

[Roger_Lafayette]

The only politicians that I "bash" are those who want to control a citizen's activities that do no harm to others. To this point, they all appear to be of a particular political philosophy. (notice I did not say party). If some politician of a different political philosophy comes out against vaping or like activities that does not harm others, I will "rant" against them as well.

If politicians from every political philosophy had stayed out of the vaping business, as they should have, we would not be at this point.

Not all of them should be staying out of the vaping business.

Gov. Dayton (D) single-handedly stopped MN's clean indoor (and outdoor) air act from being extended to cover vaping. We wouldn't want him to be neutral, would we?

It also appears as if Gov. Shumlin (D-VT) is going to single-handedly stop VT's proposed vaping tax.

There are also some very helpful NJ legislators (Ds too) who have given Christie's proposed tax a very hard time such as Assembly budget chair Schaer (a vaper, it is said).

We should eschew our enemies

But also be grateful for our friends We need all of those we can get.

 

[tombaker]

Roger the FDA can not do anything until 2018, so why would they just let the industry double in size each year for another 4 years, and then attempt to create prohibition, like yourself and others are terming it. You have to think the FDA is just doing a dance until 2018. As if the FDA has nothing better to do.

Roger_Lafayette;13040116]

3) The entirety of a new product has to be substantially eqivalent to the entirety of the older one. It's not as if a manufacturer of (say) a tobacco cigarette could say that the filter of a new cigarette is substantially equivalent to a "grandparented" tobacco cigarette, and then stick it on the remainder of another "grandparented" tobacco cigarette, in order to create a new (supposedly) SE tobacco cigarette. Or pick and choose from the chemicals in a "grandparented" tobacco cigarette, and then argue that a new allegedly-SE tobacco cigarette uses a subset of them. Under your interpretation of SE, every new tobacco cigarette is SE to "grandparented" tobacco cigarettes as long as it contains no new chemicals. That's not how it works.

SE specifically list out reducing or eliminating an ingredient as grounds for granting SE. Or even exemption to the SE requirement. Whatever basis you are using to say that early generation of E-Liquid are not equivilent to later version sold today, is left unsaid. The core elements of each juice are equivilent to ever other, with the difference being the flavorings, and the Ratio of PG/VG. The rest of the juice is the artistry of cooking. But the elements are the same.

Your insistence that early E-Juice is radically different from today's Juice, is without any support.

5) I am not assuming that the FDA can reject applications without redress. Only that they may do so at a time of their own choosing, and in any sequence they please. Once they reject an application after the 2-year window is closed, then things get tied up in the courts for years - plus the FDA can also immediately sieze and destroy the product at the manufacturer's expense. Unless a manufacturer can persuade a court to issue a preliminary injunction, the product must stay off the market until the merits are heard. Even if a manufacturer wins on the merits in Federal District Court, the court may stay the ruling on appeal, thus potentially keeping the product off the market for a few more years.

The FDA can not just rip and destroy legally being sold products off the shelves, and then destroy them. Products introduced this year will be legally being sold, and all the way up until 4 years from now, products can be introduced. 4 years is the 2 years the FDA has from the final approval. Right now legislative wonks are saying the final approved version is most likely 2 years away.

You are saying the FDA can just do nothing with the applications, wait until the clock strikes midnight, and then start ripping products off the shelf. By doing this you are saying they can reject applications without cause, consideration, or response back to the company submitting the application. I just think you are naive to think the FDA would just act like that in 4 years time, when a court will overturn them. Sottera hurt the FDA's authority significantly, and you are saying they will just make that mistake and more, again and again. You don't understand the politics or the courts.

6) The $10M upper bound for applications comes from the VPLive round table (Bill G., I believe). You can take it up with him. Although I will mention in passing that the application process and standards which are present in the language of the FSPTCA and its legislative history clearly reflect the intent on the part of Congress to make it difficult for BT to introduce new types of tobacco cigarettes.. It is this underlying context that applies to all applications from vaping manufacturers, whether for e-liquid or equipment.

You got a 10 Million dollar theory of application cost, base upon someone who you are not too sure of who said it, plucked the number out of the air. You think that a product with 4000 ingredients has the same amount of data and application process, as one with 4.

And thank you for confirming you don't understand the purposes, uses, and reliance on MSDS sheets.

9) IoN

10) I refuse to debate this "component or part" issue with you any further. We've been talking about this for almost ten days now. It's pointless to keep discussing it.

I have fond that a person without the facts, when confronted with facts, often will refuse to discuss it further. That you don't want to explain why a Clearomizer used for a non-Tobacco product, will be restricted for all usage, because someone can vape Nicotine, is evidence you are not using the best known facts or information. It makes sense you don't want explain it to anyone. But you present your believe that every Tank can be used with Nicotine, therefore all Tanks will be regulated. Don't let the facts get in the way of a great story.

12) I didn't say that the "component or part" of the FDA's jurisdiction could be used to ban all flavorings. Just those which are "intended for use" in a covered tobacco product. C.f. the equipment discussion above. I won't discuss this with you any more, either.

You missed the point. The only difference between Cherry vs RY4 juices are the flavoirngs. The Flavorings are essentially the same to the FDA, because they come from a list of foodsafe ingredients. FDA said flavoring rules don't apply to non-Cigarettes. You want to think that Flavor by itself is a new product, and that Provari batteries are now Tobacco products...but most importantly you don't want to explain such notions. You are free to present items as fact when you can not support them, you don't need to respond to me too.

13) If vaping becomes "medicalized" (available only by prescription), then vaping devices will become medical devices that can only be posessed with a prescription. That was my only point.

How on earth after the FDA lost Sottera you think that E-Cigs are going to become medical devices is beyond me, even the FDA conceded that after lossing the 2nd appeal.

Roger, its Okay if you don't want to have any challenge to the way you see it.

 

[Vaslovik]

The FDA is a fascist criminal organization period. I've followed their activities long enough to know what they are and how they operate. This deeming proposal is just the thin edge of the wedge. They serve powerful private interests, and NOT the public interest. They don't care one whit about our health or rights, they are all about the money and their corporate buddies.

 

[Nate760]

The FDA is a fascist criminal organization period. I've followed their activities long enough to know what they are and how they operate. This deeming proposal is just the thin edge of the wedge. They serve powerful private interests, and NOT the public interest. They don't care one whit about our health or rights, they are all about the money and their corporate buddies.

The next time the FDA makes a decision motivated by a genuine concern over public health will be the first time.

 

[Roger_Lafayette]

Roger, its Okay if you don't want to have any challenge to the way you see it.

All of this was already debated at length right here: http://www.e-cigarette-forum.com/fo...rs-before-any-action-possible-under-regs.html

[Among other threads, BTW.]

I'm not going to waste my time picking through the stuff you're repeating all over again, just to see if I can manage to somehow tease out some new smidgen of a nuance or variation regarding a point that you've made here on ECF many times before.

My views are basically no different than those expressed on the VPLive round table, although in my original post I was a little more specific about certain issues, and went to the trouble of collecting all of these misconceptions into one organized and (hopefully) relatively concise format.

For you, it seems that every thread is a brand new start - a fresh opportunity utterly unblemished by the past, to make the same old tired and roundly-refuted points all over again.

It's as if the last 10 days of back-and-forth on this forum have never happened, the VPLive round table discussion never occurred, and many other instances in which views on these issues have been expressed by folks (who are much smarter and better-informed than Yours Truly) have also been banished from memory.

Ever seen the movie "Groundhog Day?"