FDA TVECA post table of contents for Deeming Final Rule

[navigator2011]

If you broil a steak at 500 degrees for 9 minutes, you'll get a nice medium well steak. If you broil it at 500 degrees for 30 minutes, you'll get a charred mess. This is what has been shown by the e-liquid testing done so far. There are no magic settings. It requires a person, in a situation, using their senses to determine what is and is not acceptable. Luckily, it is incredibly apparent when a certain configuration is not working properly.

The problem with a standard is, it assumes uniformity.

Now imagine that researchers broil the steak at 500 for 30 minutes, then conclude that all cooked steaks produce charred messes, then trumpet their finding all over the media, convince the public that broiling steak is going to kill them, and then cry out that we need to regulate or ban all steak cooking devices as well as conduct even more testing on raw meat to gain FDA approval for broiling. Kind of reminds me of this vapor fiasco.

 

[Kent C]

If you broil a steak at 500 degrees for 9 minutes, you'll get a nice medium well steak. If you broil it at 500 degrees for 30 minutes, you'll get a charred mess. This is what has been shown by the e-liquid testing done so far. There are no magic settings. It requires a person, in a situation, using their senses to determine what is and is not acceptable. Luckily, it is incredibly apparent when a certain configuration is not working properly.

The problem with a standard is, it assumes uniformity.

And some things need standards and some don't. I suppose it's pragmatic that communist rockets are standardized. How about standardizing religions, clothing, or the 1000's of cereals (vs. one or two in the old soviet bloc) that exist - and yeah, there are some standards - not to the extent discussed - and there is for pg, vg, nic and flavorings already.

@navigator2011

Right on - exactly what they did in the one study on coils. Pointed out clearly by 'our guys' studies.

 

[zoiDman]

Now imagine that researchers broil the steak at 500 for 30 minutes, then conclude that all cooked steaks produce charred messes, then trumpet their finding all over the media, convince the public that broiling steak is going to kill them, and then cry out that we need to regulate or ban all steak cooking devices as well as conduct even more testing on raw meat to gain FDA approval for broiling. Kind of reminds me of this vapor fiasco.

Not say'n that the Media and the Agenda Driven Individuals have Not Down EXACTLY what you just Outlined. Far from it. Seems like it is Done More Often that it is Not.

But there is a Difference between someone Wanting to do a Study Slanted towards making e-Cigarettes look Bad (Most of the Media, ANTZ Groups, etc) and someone Looking to do a Studies showing that there PMTA Application should be Approved (BT and BV).

The Whole Concept is Fundamentally Flawed. In Both Examples.

 

[Lessifer]

I apologize, I meant to say every .2 volts. That way you get a curve that can be measured.

And I agree, not every product needs to be tested. Just the different brands of chips. So every mod using a DNA40 doesn't need testing. Just the DNA40 (any mod will do). Same with the different Yihi chips, etc...

I also agree that it is not the nicotine that is the health problem, but the associated chemicals produced from any type of combustion. And vaping is not combustion. But is is also not technically vapor, either. It is aerosol. But since nicotine is derived from tobacco, and all other nicotine supplying products (ie. patches and gum) are regulated, what argument can you give to say e juice shouldn't be too? Patches and gum aren't tobacco leaves either. I know that e-cigs have a much better success rate than other methods, but that isn't enough of an argument. I would really like to know what these arguments are (no sarcasm. Not trying t be a no-it-all. I just haven't come across any that meet scientific standards).

I don't think that FDA should regulate how much power it supplied by any mod. But you do need to test the vapor that is produced from a variety of sources. That's simple scientific method. Trying to say that because my Mod X, using a tank Y, at Z watts doesn't produce harmful chemicals is not the same as saying all mods and tanks perform the same way at all power settings with all juices.

That's why there is always a debate about what new mods and chips are accurate and consistent. They don't all perform the same under different situations.

Again, the FDA is not who should be testing chip sets to determine if they produce the advertised voltage. That would be the Consumer Product Safety Commission I think? Not sure.

As for why not all nicotine containing products should be regulated under the Family Smoking Prevention and Tobacco Control Act, well, they're already not all under the same regulations. Nicotine gum/lozenges/patches/inhalers are not regulated as tobacco products. They are regulated as drugs, that's why nicorette can play TV ads.

It's not a scientific argument, it's not a scientific problem, it's a political/bureaucratic problem.

Most of the problems that vapers have with the deeming do not come simply from the fact that someone wants to regulate the industry, the problems arise due to the nature of the regulations that the FDA are attempting to apply.

 

[zoiDman]

BTW - TPSAC is a Body that seems to operate kinda Below the Radar when it comes to Most of these Discussions.

Tobacco Products Scientific Advisory Committee

 

[Zabolee]

You're right about nicotine gum, lozenges, etc, being drugs. My mistake. But they are still regulated. I guess I just get the impression that many people don't want any regulations. That they aren't just against this one. That is what concerns me. I guess that makes this thread not the place for my arguments, since it is dedicated to this specific deeming.

Of course it's not the FDA's job to do the testing. They generally never test. But they can provide standards to meet. I, personally, don't see a problem with a little extra QA/QC

 

[Kent C]

The Cass Sunstein 'nudge force' is strong in here

 

[Lessifer]

You're right about nicotine gum, lozenges, etc, being drugs. My mistake. But they are still regulated. I guess I just get the impression that many people don't want any regulations. That they aren't just against this one. That is what concerns me. I guess that makes this thread not the place for my arguments, since it is dedicated to this specific deeming.

The idea of regulations or standards gets discussed here a lot, and there are many differing viewpoints. I'm not opposed to reasonable standards, but I couldn't tell you right now exactly what those standards SHOULD be.

What I do know is that applying regulations designed to keep the cigarette market stagnant is not conducive to the innovation and growth of a new market that holds no similarity to cigarettes.

 

[navigator2011]

... no similarity to cigarettes.

I think this, right here, is the keystone of the whole problem. There has been great effort to convince the general public that vaping = smoking.

 

[Alexander Mundy]

I mean something like calories per serving. At this setting on this build or better yet according to FDA/VSS(Vaping Safety Standard) VS- umptysquat125 this vape product produces this much A,B,C,D,....! THE SETTING OF THE STANDARD IS THE HARD PART! And with a standard other companies could be certified by such a standard to test products under that standard. I am a Machinist and my precision instruments have to be calibrated under things seamingly as silly as what temperature the room is, how long an item has to stay in that room per inch of max thickness, ect.... Then your supposed to measure parts in a similar fashion. this is because things change size the hotter or colder they get depending on many variables. That way when somebody in Russia makes a rocket part the mating part from China works together as designed. That way when somebody makes a juice somewere we have a baseline to compare it to!

Sure it can be done with a closed prefilled non adjustable system. But for open systems like RBAs there are too many variables and they are not simple XYZ multiple choice nor is it even totally understood (and may never be) yet how the variables (and how many) add up to a good vape or a foul acrolin tasting vape. Even such minute details as how much tension the wire is under during coiling, the type, shape, and density of the wick make a difference. Even assuming refillable carts or non rebuildable tanks were used then the eliquid used to fill can either choke you or make a smile come to your face. So to eliminate the variables that make exponentially huge results leaves the standard only applicable to itself. This is in my opinion exactly what the FDA wants and will stifle the many achievements that have been gained by the various curious individuals over the years and take us back to the day of someone wondering "What if I was to remove that bridge?".

 

[Alexander Mundy]

Can we have a market for those who believe extensive testing is a very good idea for consumers, and another market for those who are okay with testing as optional / not required and therefore okay obtaining non tested products?

Perhaps one day we will have that. The FDA market and the underground market.

Or perhaps we have it right now, with pre-FDA market and this post FDA market.

In the pre-FDA market I remember vapers bragging about how wonderful vaping was, how relatively safe it was and also recall seeing very few incidents of harm.

Gonna humor me when we get to the FDA market and incidents of harm go up, rather than down. Gonna humor me much, really.

Unfortunately no. But the idea of a table with the dozen or maybe 2 dozen FDA approved products and for those adventurous the rows of shelves of non FDA approved products sounds like a good compromise.

 

[haleysdadda]

Sure it can be done with a closed prefilled non adjustable system. But for open systems like RBAs there are too many variables and they are not simple XYZ multiple choice nor is it even totally understood (and may never be) yet how the variables (and how many) add up to a good vape or a foul acrolin tasting vape. Even such minute details as how much tension the wire is under during coiling, the type, shape, and density of the wick make a difference. Even assuming refillable carts or non rebuildable tanks were used then the eliquid used to fill can either choke you or make a smile come to your face. So to eliminate the variables that make exponentially huge results leaves the standard only applicable to itself. This is in my opinion exactly what the FDA wants and will stifle the many achievements that have been gained by the various curious individuals over the years and take us back to the day of someone wondering "What if I was to remove that bridge?".

THEN MAKE IT ABOUT CHEMICAL MAKEUP! COMPONENT %S! WHATEVER! JUST DON'T TAKE MY VAPE AWAY! DON'T Y'ALL THINK BY US BEING WISHY WASHY ABOUT VARIABLES XYZ WE MAY HAVE CAUSED OUR OWN PROBLEM? DO YOU REALLY THINK BT LET THE FDA OR WHOEVER SET THEIR STANDARDS? MAYBE WITH BT'S GUIDANCE! UGH! WE MUST COME TO AN AGREEMENT ON WHAT WE WANT SO WE CAN BRING A COHESIVE PLAN TO THE FDA! THAT ISN'T NECESSARILY ONE THAT EVERY LIKES IT MAY HAVE TO BE ONE THAT HURTS THE LEAST!

 

[Ceskam21]

Hey i'm new here and dont know if this has been mentioned before... but very serious question. It seems that most of this regulation and rule is in direct response to it containing nicotine and not the novelty aspect.. what if all Juice was made with 0% nictoine to avoid tobacco taxing and regulation and leave it up to the consumer to buy portioned nics or mix themselves? isn't there some kind of loop-hole that will allow us to fall back on? especially if flavoring is deemed to be banned which is absurb and what makes vaping so successful in my eyes.. as most of us know that cigarettes were not enjoyable but this is... serious answers please

 

[Jman8]

Not say'n that the Media and the Agenda Driven Individuals have Not Down EXACTLY what you just Outlined. Far from it. Seems like it is Done More Often that it is Not.

But there is a Difference between someone Wanting to do a Study Slanted towards making e-Cigarettes look Bad (Most of the Media, ANTZ Groups, etc) and someone Looking to do a Studies showing that there PMTA Application should be Approved (BT and BV).

The Whole Concept is Fundamentally Flawed. In Both Examples.

Oh great, everyone that studies eCigs is now ANTZ.

 

[puffon]

WE MUST COME TO AN AGREEMENT ON WHAT WE WANT SO WE CAN BRING A COHESIVE PLAN TO THE FDA!

The FDA has formed their own plan, whether we like it or not.
In a few months or sooner, we will know the plan.........

 

[Jman8]

Hey i'm new here and dont know if this has been mentioned before... but very serious question. It seems that most of this regulation and rule is in direct response to it containing nicotine and not the novelty aspect.. what if all Juice was made with 0% nictoine to avoid tobacco taxing and regulation and leave it up to the consumer to buy portioned nics or mix themselves? isn't there some kind of loop-hole that will allow us to fall back on? especially if flavoring is deemed to be banned which is absurb and what makes vaping so successful in my eyes.. as most of us know that cigarettes were not enjoyable but this is... serious answers please

Challenging to give serious (and accurate) answers when FDA hasn't been entirely forthcoming with what they will in fact do via regulations.

From my understanding if a business is selling/distributing Juice with 0 nic, and NOT marketing themselves as product is intended for use for recreational vaping, then they would likely be the loophole you are thinking of. But if say a business sells that and sells nicotine separately, they might think they have a loophole, but I'm thinking they'll get nailed, and fast. The business that sells 0 nic juice, and does not sell nic separately, and is marketing it as product for recreational vaping would plausibly be subject to FDA regulations, based entirely on their marketing.

 

[Kent C]

what if all Juice was made with 0% nictoine to avoid tobacco taxing and regulation and leave it up to the consumer to buy portioned nics or mix themselves? isn't there some kind of loop-hole that will allow us to fall back on?

Some interpret the deeming to say that 0% nicotine would be included. Not all agree but the wording is pretty precise. As far as 'loop holes' the deeming isn't in effect as yet and it has been indicated at the FDA that the deeming is 'just a start'. If there is 'loop holes' they'll close them. As written, I don't see any loopholes.

Welcome to ECF!!

 

[zoiDman]

Hey i'm new here and dont know if this has been mentioned before... but very serious question. It seems that most of this regulation and rule is in direct response to it containing nicotine and not the novelty aspect.. what if all Juice was made with 0% nictoine to avoid tobacco taxing and regulation and leave it up to the consumer to buy portioned nics or mix themselves? isn't there some kind of loop-hole that will allow us to fall back on? especially if flavoring is deemed to be banned which is absurb and what makes vaping so successful in my eyes.. as most of us know that cigarettes were not enjoyable but this is... serious answers please

The Flavorings would be No Problem. But where would we Get the Nicotine from?

 

[DC2]

The Flavorings would be No Problem.

Well, the diketone-free flavorings would be a problem under the "intended use" farce.
Because they are OBVIOUSLY intended for vaping use.

 

[zoiDman]

Some interpret the deeming to say that 0% nicotine would be included. Not all agree but the wording is pretty precise. As far as 'loop holes' the deeming isn't in effect as yet and it has been indicated at the FDA that the deeming is 'just a start'. If there is 'loop holes' they'll close them. As written, I don't see any loopholes.

Welcome to ECF!!

I think If or When the FDA tries to Restrict the Sale of 0mg, that would be when a Very Realistic Legal Challenge will take place.