FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

[zoiDman]

I think you nailed it on the head and didn't know it. Could the WTA makers be
using proprietary extraction methods hence the hesitation to have their products
analysed? Just a thought. I have virtually no knowledge of the product other than
the name.
Mike

Don't Know what is in the Bottle they sell when they say it is WTA? Don't know How Much WTA is supposed to be in the bottle? I Don't Know how they make what the call "WTA"? And I Don't Know if their Process is Patented? Or even Patentable?

All I know is some people say it has Helped them to Quit. And others have said it was a Complete Waste of money.

 

[Robino1]

First they want you to buy from suppliers
selling materials that are compliant,

I don't see it that way. I see it as they have vendors that comply to a Standard they (the suppliers) set. If a consumer wishes to purchase from vendors that are members of AEMSA, then the consumer can purchase knowing that those vendors comply with those standards that they have set.

I don't see them forcing consumers to purchase from any of their member vendors.

All I know is some people say it has Helped them to Quit. And others have said it was a Complete Waste of money.

I guess it depends on the individual.

 

[skoony]

@Robino1 I meant they as in their own members. If as a member of AEMSA
I am required to buy from suppliers certified as having compliant products(raw materials),
why then test my product at multiple stages all the way through my production process.
There is nothing in the process that would change the materials from compliant to non
compliant. There isn't much that can go wrong in a process that has essentially two steps.
Measure and mix. My essential beef is some people take a process that's basically no
different than making Kool-Aid and with no difference in effort and safety and make a
full blown Cecil B. DeMilles production out of it. This sort of thing plays right into the
opposition's hands with no apparent benefit to me personally. I get nothing but the
sure fact that either my supplies are going to be severely restricted or unaffordable.

Regards
Mike

 

[zoiDman]

...

I guess it depends on the individual.

Exactly.

Just like some Need High Nicotine mg Levels to Quit. While others can Quit with Very Low Levels. And some need a 180W with a Quad Coil to get the Hit they want. And others are Fine with a 7W on a Clearo.

It just gets down to the Individual.

 

[AndriaD]

Don't Know what is in the Bottle they sell when they say it is WTA? Don't know How Much WTA is supposed to be in the bottle? I Don't Know how they make what the call "WTA"? And I Don't Know if their Process is Patented? Or even Patentable?

All I know is some people say it has Helped them to Quit. And others have said it was a Complete Waste of money.

People who say it's a waste of money are generally those who haven't yet fully quit, who are trying to find "a way to quit" -- which of course is just simply "stop lighting them." But those who have already quit, who've started experiencing bad cravings (or depression, or anxiety, etc) after the quitting is already done, those people nearly always benefit hugely from WTA. This is because WTA won't do a single solitary thing for PSYCHOLOGICAL addiction, but it's all kinds of wonderful for physical addiction, particularly for those who aren't terribly dependent on *nicotine* -- like ultra-light smokers for example -- those have little nicotine, but they do have the full alkaloid cocktail.

Andria

 

[zoiDman]

Like I said.

I have read that WTA has Worked for some people. And has Not Worked for Others.

My theory on Quitting Smoking is it Really Doesn't Matter what you try or do. Just keeping doing what Works. And Move On to something Different if what you are doing Doesn't.

If WTA Worked/Works for you, Great. And if it Didn't, well, that's OK also.

 

[snork]

The REAL elephant in the room is why NONE of the WTA manufacturers have tested their mix for DA and AP and posted same on their web site. Do their users care? Should they care? That fact is NOT about AEMSA but rather disclosure/transparency.

No, I do not care. I do not care if anybody thinks I should care. My vendor has been so transparent as to basically teach me how to do it and would probably set me up with the equipment if I wasn't so lazy that I'd rather pay him to do it for me.

 

[idahohermit]

No, I do not care. I do not care if anybody thinks I should care.

 

[SeniorBoy]

Rossum - Point taken and you are correct.

AEMSA is a science based "organization" and requires a molecular analysis of the final mix. This will certainly NOT disclose the extraction process for WTA or any of the specific %/components of the flavors used in the secret recipe. For example, a molecular analysis will not tell you that a given finished mix uses 4% of FA Banana and 2% of Caps VC. In simple terms, you get a long list of all of the chemicals used in the final mix and their levels. Then the reader determines which ones if any, pose a potential health risk, an avoidable risk, and which ones are currently safe for inhalation.

Speaking frankly and respectfully, the members of AEMSA have decided that using WTA in a given final juice mix is not permitted. They have no science on WTA which drives their decision. That's fine with me. No one is forcing any juice manufacturer/vendor to join AEMSA and many are currently thriving without joining. It's certainly understandable if they don't value the "badge" or lack the capital to pay the dues. Just tell your user base this, rather than diluting our collective efforts with regulators by saying the testing will compromise their secrets or creating unnecessary "drama" about who will meet with who. Of course, IMHO, this debate will be over sooner rather than later when (not if) the FDA's Final Rule is published in the Federal Registry.That means even more science and a very cumbersome and very exspensive PMTA procedure. Resulting in the obliteration of vaping from planet earth as we know it today.

IMHO, if the Vaping Community adopted a "same page" doctrine our collective efforts with regulators would be far more effective. My "same page" doctrine means that we don't need to agree on every single point but we evaluate the pluses and minuses and if we have more pluses then we support any "organization". In the case of AEMSA some might wish to read their Blog to see what actions they have taken which benefit all of us. I find the hypocrisy very disconcerting. For example, some folks wish to dwell in the past about what a given activist did to support smoking cessation, Dr. F gets raked over the coals for his scientific results by some because it's doesn't fit their own style. He is a scientist first. One "organization" tells it's users NOT to contribute to a scientific study. One organization thinks another is to controversial so they don't support them or they think they aren't doing enough to help our cause when in fact both organizations support the same issues. And I could list more.

I'm not inferring that if you find fault and or disagree with a given "organizations" scientist, or activist's policy's, procedures, or methods, that you should not voice your thoughts. Just do it privately, respectfully, professionally, and include relevant details. I've certainly done this on a couple of occasions and have always found the exchange to be productive, even if we agreed to disagree. I've also received a few very critical emails myself concerning my own Blog posts and if the sender is serious the exchange begins in a respectful and professional manner. These exchanges have also been productive and helped my own perspective.

Good luck to all and happy vaping using any juice you wish.

 

[schatz]

For me it's only $36.00 per shot for 1 year equaling 4 shots, I think it is. I know the serious cancer fighting medications would be out of reach for me with the insurance.

What shot are you referring to, inquisitive minds would like to know.

 

[oplholik]

What shot are you referring to, inquisitive minds would like to know.

The cancer I have is the less aggressive, slow growing cancer, which according to the Dr. can be taken care of with hormone blocking shots.
Side effects, hot flashes. Jeesh. But I'll deal with that.

 

[Jman8]

If any think, for even a fraction of a second, that the FDA will allow WTAs without THIER evaluations and approval of comprehensive molecular analysis - well, then those who think that way have not looked at the NPRM, TCA PMTA process or any of the currently proposed regulatory approaches and/or real discussions. PMTA demands thousands of hours of science and hundreds of thousands - if not millions - in cost PER SKU (yes, that means each and every e-liquid/product).

I'm trying to use fractions of a second to determine how long AEMSA will survive post FDA deeming. Current Vegas odds are 1 year for the over/under.

 

[schatz]

The cancer I have is the less aggressive, slow growing cancer, which according to the Dr. can be taken care of with hormone blocking shots.
Side effects, hot flashes. Jeesh. But I'll deal with that.

No kidding good luck. Check out black seed oil or novella sativa it can't hurt,anything to boost immune system.

 

[snork]

I'm trying to use fractions of a second to determine how long AEMSA will survive post FDA deeming. Current Vegas odds are 1 year for the over/under.

How naïve was it that a puny little trade organization could think it would be the standard bearer for all that was right in vaping before the behemoth of deeming?

 

[skoony]

I have no personal issues with AEMSA. It's admirable they are trying to make standards.
My problem is you do not need many standards for something as easy and safe to make as e-juice.
The manufacturing process is two steps. Measure and mix. Buy certified food grade
PG/VG and flavorings and pharmaceutical grade nicotine. Use a clean facility with
clean equipment and clean up when your done. As far as all the testing is concerned
if there was something "known" to be causing harm when vaped by all means test
for it. Complete molecular analysis is overkill unless you suspect your certified
suppliers of not being on the up and up.
Also consider that until the deeming regulations are released no one knows what
the requirements will be. My guess FDA will require about 10 to 20 more testing
procedures roughly 50 to 100 times more difficult to complete using AEMSA
standards as a baseline.

Regards
Mike

 

[MacTechVpr]

I have no personal issues with AEMSA. It's admirable they are trying to make standards.
My problem is you do not need many standards for something as easy and safe to make as e-juice.
The manufacturing process is two steps. Measure and mix. Buy certified food grade
PG/VG and flavorings and pharmaceutical grade nicotine. Use a clean facility with
clean equipment and clean up when your done. As far as all the testing is concerned
if there was something "known" to be causing harm when vaped by all means test
for it. Complete molecular analysis is overkill unless you suspect your certified
suppliers of not being on the up and up.
Also consider that until the deeming regulations are released no one knows what
the requirements will be. My guess FDA will require about 10 to 20 more testing
procedures roughly 50 to 100 times more difficult to complete using AEMSA
standards as a baseline.

Regards
Mike

Ridiculous, exactly. What are we gonna be running molecular analysis for the hot dog stand at the game? Crikey. But believers in the theology of equality would swear this is for all of our own good. The games afoot skoon. The filthy stench and ooze of federal mandate has slimed its way down to the states. The pretense of process, of passing laws and objects created by others in dark smokey rooms to be glibly endorsed. A nod to the MSA masters. Gone the regulatory reaping sickle, now the hammer. We'll know what it means when we pass it. It is deemed. They're banning us.

G'luck.

 

[zoiDman]

Like I said Earlier. I think all the Rhetoric surrounding AEMSA is Stupid.

If you make e-Liquids, and Like and Want to Fully Comply with what AEMSA has set forth, then Great - Join AEMSA.

If you Don't - Then Don't Join AEMSA.
If you use e-Liquids, and you Like what AEMSA Member's e-Liquids Offer, then Great - Buy e-Liquids from AEMSA Members.

If you Don't - Then Don't.

It's Funny to read all the Hype when AEMSA name is Mentioned. Especially from those who are so Vocal about Free Markets.

 

[MacTechVpr]

Good point. Free market standard setting is the model of efficacy; but, voluntary is the operative word for consumer and maker in a truly free market.

G'luck.

 

[DC2]

If you make e-Liquids, and Like and Want to Fully Comply with what AEMSA has set forth, then Great - Join AEMSA.

If you Don't - Then Don't Join AEMSA.

I was under the impression that AEMSA formed, in part, with the hope of becoming the standards that the FDA would adopt. It is from that perspective that I have a problem with the explicit exclusion of WTA as currently written into those standards.

 

[MacTechVpr]

I was under the impression that AEMSA formed, in part, with the hope of becoming the standards that the FDA would adopt. It is from that perspective that I have a problem with the explicit exclusion of WTA as currently written into those standards.

It is a collaborative partnership with the FDA as I understand too. G'luck.