Congressional action on electronic cigarette regulations may save vapers

[Jman8]

Any victory after many months, or years, of limbo (at best) and seemingly being ignored (at least) - is great news. This strikes me as monumental news.

Seemed like the whole shindig presented in the video was underwhelming in their understanding of all the points we have constantly discussed. IMO, they are a good 3 to 5 years behind where a knowledgeable politically aware vaper is. I don't expect them to get the nuanced points, but the main points appear to be lacking.

Amendment is squarely going after kids as the deeming does. I hate that. I hope it backfires. I hope kids see it as even more cool and try it out. I feel confident that will happen. I feel the more zealous FDA gets on that issue, the more kids will be attracted to the product due to the cool factor. I have little sympathy for anyone that supports such a strong prohibition on minors and then acts all surprised if minors use/continue to use. Always up for that debate, but usually ends up being one side appealing to emotion and little to no facts to back up their feeble concerns.

I say all that because the amendment is huge news on the grandfather date, but does leave me wondering how bad FDA will tackle certain things. Not to mention the zealots in FDA or who influence FDA aren't going to take kindly to this amendment. They'll likely overreact and I think a whole bunch of flavors could be nixed and many political types (who are not so versed in vaping rhetoric or politics) will feel this was a big enough battle to warrant a sacrifice in a whole lot of flavors that are 'probably aimed at kids anyway.'

And with all that said, I'm around 25% ecstatic by the passing of this amendment. Easily the best news I've heard on vaping in awhile, that rises to this level of significance. But 75% of me is still concerned at the voodoo the FDA / ANTZ will do as a result of this setback to their efforts. Obviously, the fight is not over, but I hope we get a week (or years) to enjoy this victory.

Oh, and very glad I didn't hear the words "online sales" during the video, but admittedly I skipped over some of the nonsense Dems were prattling on about.

 

[skoony]

@Jman8 I am thinking along the same line when it comes to all this advertising
to children hocus pocus. Although I do believe restricting advertising to adult
venues is appropriate it does nothing to address the issue of the ongoing and
relentless advertising campaigns directed at our children with the sole purpose
of making sure every child in America knows what these products are and they
are deliberately made for them.



Regards
Mike

 

[Jman8]

@Jman8 I am thinking along the same line when it comes to all this advertising
to children hocus pocus. Although I do believe restricting advertising to adult
venues is appropriate it does nothing to address the issue of the ongoing and
relentless advertising campaigns directed at our children with the sole purpose
of making sure every child in America knows what these products are and they
are deliberately made for them.



Regards
Mike

IMO, once they get one flavor, it'll literally be a slippery slope. If the argument will be something like, "only a kid would be attracted to cookie dough flavor, that's why it needed to be removed from the market..."

...Then replace "cookie dough" with 99% of the flavors currently available, and voila, flavors are gone. To me, whatever flavors they go after, us adults need to claim we thoroughly enjoy it. Cause unless you've vaped that and know for sure you hate it, then chances are it is a flavor you would probably enjoy.

As if from their perspective it's actually about the flavors. Hint: it's not.

 

[MacTechVpr]

@Jman8 I am thinking along the same line when it comes to all this advertising
to children hocus pocus. Although I do believe restricting advertising to adult
venues is appropriate it does nothing to address the issue of the ongoing and
relentless advertising campaigns directed at our children with the sole purpose
of making sure every child in America knows what these products are and they
are deliberately made for them.



Regards
Mike

I agree, I think the State of California has done a great job. An excellent model.

Good luck.

 

[bigdancehawk]

IMO, once they get one flavor, it'll literally be a slippery slope. If the argument will be something like, "only a kid would be attracted to cookie dough flavor, that's why it needed to be removed from the market..."

...Then replace "cookie dough" with 99% of the flavors currently available, and voila, flavors are gone. To me, whatever flavors they go after, us adults need to claim we thoroughly enjoy it. Cause unless you've vaped that and know for sure you hate it, then chances are it is a flavor you would probably enjoy.

As if from their perspective it's actually about the flavors. Hint: it's not.

It's not about the flavors, but mostly it's the names and the packaging that give these attacks a semblance of credibility. If you call your product something like Fruit Loops, Cotton Candy or Captain Crunch, you'll invariably be accused of shamelessly marketing to children. If you call the same exact thing something like Ostrich ..., nobody will say a word.

Edit: This site takes offense at a three letter word referring to the rearward portion of the critter.

 

[Kent C]

If you call the same exact thing something like Ostrich ..., nobody will say a word.

Edit: This site takes offense at a three letter word referring to the rearward portion of the critter.

Thoroughly debunking your argument.

 

[zoiDman]

...

Edit: This site takes offense at a three letter word referring to the rearward portion of the critter.

The Azz End?

 

[skoony]

It's not about the flavors, but mostly it's the names and the packaging that give these attacks a semblance of credibility. If you call your product something like Fruit Loops, Cotton Candy or Captain Crunch, you'll invariably be accused of shamelessly marketing to children. If you call the same exact thing something like Ostrich ..., nobody will say a word.

You seemed to be confused as to how this flavor thing works.
It doesn't mater what you call it or how attractive the labeling may
be. The mere fact that it is a flavor a child might like is de facto
deliberate marketing to children. It is also considered deliberate
with malice an aforethought. The fact one makes flavors makes
one guilty.

Regards
Mike

 

[bigdancehawk]

You seemed to be confused as to how this flavor thing works.
It doesn't mater what you call it or how attractive the labeling may
be. The mere fact that it is a flavor a child might like is de facto
deliberate marketing to children. It is also considered deliberate
with malice an aforethought. The fact one makes flavors makes
one guilty.

Regards
Mike

Thanks for straightening me out. However, I didn't hear Jay Rockefeller saying, "Ummm, this stuff you call Vulture Breath tastes like cotton candy. You evil people are marketing to children! You should be ashamed. How can you sleep at night?" Rather, it was the name alone that proved it to his satisfaction and he worked himself up to a high state of outrage. I thought he might burst a blood vessel. Which would have been so unfortunate.

 

[bigdancehawk]

The Azz End?

There, you have it.

 

[MacTechVpr]

It don't matter whatcha call it, it'll be flavors are for children one day and adults don't smoke Fruit Loops the next. It's intended use and purpose that they mangle indiscriminately. Nice debate tho. Good luck.

 

[Jman8]

I had a low level vendor one time make me a flavor he called "Apple Jacks." Tasted just like Apple Jacks. Was perfect level of sweetness with no overpowering cinnamon notes to it. He's no longer in business. I've been flavor chasing that for over 2 years. If I tell vendors about it, the only thing that makes sense is "Apple Jacks." Cause 'Apple and Cinnamon' I get that anyone can mix that. But apparently, there was only 1 person on the planet that could make an Apple Jacks flavor. Which targeted the kid in me, and I so loved it.

 

[nicnik]

I had a low level vendor one time make me a flavor he called "Apple Jacks." Tasted just like Apple Jacks. Was perfect level of sweetness with no overpowering cinnamon notes to it. He's no longer in business. I've been flavor chasing that for over 2 years.

So sorry for your loss. Good luck with your search!

 

[MacTechVpr]

I had a low level vendor one time make me a flavor he called "Apple Jacks." Tasted just like Apple Jacks. Was perfect level of sweetness with no overpowering cinnamon notes to it. He's no longer in business. I've been flavor chasing that for over 2 years. If I tell vendors about it, the only thing that makes sense is "Apple Jacks." Cause 'Apple and Cinnamon' I get that anyone can mix that. But apparently, there was only 1 person on the planet that could make an Apple Jacks flavor. Which targeted the kid in me, and I so loved it.

Here, have you tried @Bill's Magic Vapor's Apple Jacks?

Apple Jacks
Apple - 7%
Cinnamon Sugar Cookie - 7%
Cotton Candy - 3%
Belgian Waffle - 2%
Dulce de Leche - 1%
​

We grieve for such loss of innocence.

Good luck.

 

[Instant_GMP]

So my company works in regulation, we're all ex-pharmaceutical quality people and now we make software to help companies comply with various regulations. We work with a number of vape companies, and help translate FDA speak to companies and consumers.

The main concern from the FDA's standpoint is consumer safety. Almost all industries that produce things that are consumed by humans and animals have to follow manufacturing standards that vary. In pharma, there's numerous clinical trial phases and even once you get to market there's different phases.

So if (more so "when") the FDA classifies vape liquids as tobacco, there's a bunch of written standards that must be followed (bottled with child seal, warnings, etc) and various minimums that manufacturers have to meet (ingredients have to be test and certified for purity and potency from a vendor). I would recommend reading up on good manufacturing practices (GMP).

What seems to be really controversial is the predicate device wording. The tobacco lobbyists are pushing to get it so that vape companies have to conduct trials and toxicity studies/reports, which is prohibitively expensive. In addition, they'd have to file tons of regulatory paperwork such as a pre-market application. That takes lots of time, and since this would be new for the FDA, likely lots of time. In medical devices, it can take about 18 months for someone to clear a review panel. That's why medical device and pharma companies get that sweet venture capital money. Only large companies would be able to produce those studies and reports, thus weeding out small to mid-size companies.

The FDA is willing to say that's not necessary, and set a minimum date. Thus, grandfathering in everyone. Going forward, companies would have to say that next iterations of their e-cig devices would need to be compared to that predicate device (the first one) and illustrate how it's better/safer.

It wouldn't stop the production of delicious sounding flavors. Heck, we have clients that have similar sounding products and they've passed audits.

 

[skoony]

So my company works in regulation, we're all ex-pharmaceutical quality people and now we make software to help companies comply with various regulations. We work with a number of vape companies, and help translate FDA speak to companies and consumers.

The main concern from the FDA's standpoint is consumer safety. Almost all industries that produce things that are consumed by humans and animals have to follow manufacturing standards that vary. In pharma, there's numerous clinical trial phases and even once you get to market there's different phases.

So if (more so "when") the FDA classifies vape liquids as tobacco, there's a bunch of written standards that must be followed (bottled with child seal, warnings, etc) and various minimums that manufacturers have to meet (ingredients have to be test and certified for purity and potency from a vendor). I would recommend reading up on good manufacturing practices (GMP).

What seems to be really controversial is the predicate device wording. The tobacco lobbyists are pushing to get it so that vape companies have to conduct trials and toxicity studies/reports, which is prohibitively expensive. In addition, they'd have to file tons of regulatory paperwork such as a pre-market application. That takes lots of time, and since this would be new for the FDA, likely lots of time. In medical devices, it can take about 18 months for someone to clear a review panel. That's why medical device and pharma companies get that sweet venture capital money. Only large companies would be able to produce those studies and reports, thus weeding out small to mid-size companies.

The FDA is willing to say that's not necessary, and set a minimum date. Thus, grandfathering in everyone. Going forward, companies would have to say that next iterations of their e-cig devices would need to be compared to that predicate device (the first one) and illustrate how it's better/safer.

It wouldn't stop the production of delicious sounding flavors. Heck, we have clients that have similar sounding products and they've passed audits.

What I do not understand is if one knew and understood how the product is made,the ingredients it is
made out of and the simplicity of the devices made to use it what in the world is all the hub bub about?
If one gets the percentage of nicotine right the worst that can happen is you get bad tasting juice.
All the ingredients in the juice are already made to exacting quality controls and government
standards if the labeling on the raw ingredients is to be believed. Is it not up to the suppliers
of the raw materials to guarantee there products are what they present them to be?
The vendors and end users should be left completely out of the picture.

Regards
Mike

 

[DC2]

The FDA is willing to say that's not necessary, and set a minimum date.

There is no evidence the FDA is willing to say that.
And in fact they have already said they don't think they CAN say that.

This is a Congress attempting to force the issue.

It wouldn't stop the production of delicious sounding flavors. Heck, we have clients that have similar sounding products and they've passed audits.

Not on the face of it.

But the FDA will almost certainly stamp out flavors.
Zeller has already implied as much in a PBS interview.

This is not the medical device arena.
This is the tobacco arena.

 

[Instant_GMP]

What I do not understand is if one knew and understood how the product is made,the ingredients it is
made out of and the simplicity of the devices made to use it what in the world is all the hub bub about?
If one gets the percentage of nicotine right the worst that can happen is you get bad tasting juice.
All the ingredients in the juice are already made to exacting quality controls and government
standards if the labeling on the raw ingredients is to be believed. Is it not up to the suppliers
of the raw materials to guarantee there products are what they present them to be?
The vendors and end users should be left completely out of the picture.

Regards
Mike

For the FDA, it boils down to that the manufacturer verifies what the vendor claims. That's when you get to collect certificate of analysis (CoA) like pokemon. Then you have to do your own in-house verification. It's to mitigate risk. If a batch has to be recalled, the FDA comes and reads the documentation. They clear you, and go after the vendor. But if you didn't do your own verification, you get roped into fines and possible litigation. It's a CYA.

It leads to a lot of paperwork of people signing off on things that other people have written or signed off on. As pharma people, we're used to the two signature requirements for official manufacturing documents.

One of the big things happening in the dietary supplements industry is that the FDA is going after firms overseas (China), that supply ingredients that are not what they claim to be, or there are issues with the strength (too little, too much).

But the major thing is that the juice was made in a clean facility and from legit ingredients.

 

[Instant_GMP]

There is no evidence the FDA is willing to say that.
And in fact they have already said they don't think they CAN say that.

This is a bunch of Reb, attempting to force the issue.


Not on the face of it.

But the FDA will almost certainly stamp out flavors.
Zeller has already implied as much in a PBS interview.

This is not the medical device arena.
This is the tobacco arena.

Yes you're right, I mixed them up with Tom Cole's proposed legislation. Currently the FDA is trying to fend off tobacco lobbyists saying "hey! they have to do the expensive and resource intensive stuff we had to do!". Good catch. You caught me between cups of coffee.

 

[skoony]

For the FDA, it boils down to that the manufacturer verifies what the vendor claims. That's when you get to collect certificate of analysis (CoA) like pokemon. Then you have to do your own in-house verification. It's to mitigate risk. If a batch has to be recalled, the FDA comes and reads the documentation. They clear you, and go after the vendor. But if you didn't do your own verification, you get roped into fines and possible litigation. It's a CYA.

It leads to a lot of paperwork of people signing off on things that other people have written or signed off on. As pharma people, we're used to the two signature requirements for official manufacturing documents.

One of the big things happening in the dietary supplements industry is that the FDA is going after firms overseas (China), that supply ingredients that are not what they claim to be, or there are issues with the strength (too little, too much).

But the major thing is that the juice was made in a clean facility and from legit ingredients.

Why? What for? As of now there isn't any indication aside from abusing or misusing
the product that it is causing harm to otherwise healthy individuals.
At this point I see no reason for any government interference on the domestic end
of the industry. Us vapers here in the US are doing just fine. I am not hearing any
complaints.

Regards
Mike