Deeming Regulations have been released!!!!

[HazyShades]

oh hellzbellz...

ridiculous.

Ain't it though? My old lady asked me why the FDA doesn't prohibit
Canola oil. With all due respect to our northern friends (LOL)
rape oil is bad for ya! It used to be used to grease ship rigging in WWII
'cause it stays forever..Ok, they process it so it doesn't kill us outright
but still it stays in your gut a looooooong time...but it's perfectly cool with the FDA.

So yeah, Mrs Classwife there's coming and somebuddy ain't playing fair

Regards,
Hazy

 

[Lessifer]

A lot will depend on how FlovorArt Markets/Advertises their Products.

I go to the LorAnn web site and I don't see any references to e-Cigarettes. Just a bunch of stuff say'n that you can make Yummy Cakes and Candies.

What's the Big Deal with Yummy Cakes and Candies? Nothin. Right?

I believe it was the CEO of flavourart on one of the podcasts who said that they have dedicated the company to vapor products. They're actually actively involved in crafting the new regulatory framework that will be put in place in Canada. Now, I don't know if that means that they will actually be filing PMTA's, or if they will just sell their products to manufacturers. If you go to their website now, there's an age verification on the landing page.

 

[crxess]

How many of us look out the window waiting for the mailman to deliver our vapemail? I hadn't done that since I was a kid.

My grand daughter brings in the mail after school.
She has gotten me twice in a week..........Handing me Packages of stuff I forgot I ordered.

 

[crxess]

I believe it was the CEO of flavourart on one of the podcasts who said that they have dedicated the company to vapor products. They're actually actively involved in crafting the new regulatory framework that will be put in place in Canada. Now, I don't know if that means that they will actually be filing PMTA's, or if they will just sell their products to manufacturers. If you go to their website now, there's an age verification on the landing page.

I would suppose their first goal, in the US, would be Filing to the Master File for all their(TESTED) Flavors. This could leave manufacturers in a Bind down the road.
Any Flavor tested and modified to meet FlavourArt standards would result in New Products.

 

[zoiDman]

I believe it was the CEO of flavourart on one of the podcasts who said that they have dedicated the company to vapor products. They're actually actively involved in crafting the new regulatory framework that will be put in place in Canada. Now, I don't know if that means that they will actually be filing PMTA's, or if they will just sell their products to manufacturers. If you go to their website now, there's an age verification on the landing page.

Yeah... Now that is Problematic. And probably is something that he Wishes he could take back.

If FlavorArt is selling just to e-liquid Manufactures, no problem. But if FlavorArt is going to sell to the End User, well, that could be an Issue.

In the USA that is.

 

[bigdancehawk]

Did you at least listen to the bigshot lawyer or are you so sure of your own opinion
that his opinion doesn't matter?

No, you win. I don't need or have to win.
See, I'm not arguing here. Are you?
I'm concerned with whether I'll be able to vape in the future
and trying to understand the possible alternatives to just
bowing my head to a corrupt system, I'm not trying to impress anybody with my knowledge or one-up-man-ship. As far as I'm concerned we're all vapers in back of a bus,
even the vaping lawyers...

So...I insist, you win..You need to win.

You said, "An injunction might not be a good thing anyway."
I replied, "A injunction would virtually guarantee a win for the plaintiff(s) at the district court level." I said I couldn't tell if you were being sarcastic.
You then said, "Listen to the bigshot lawyer FDA expert.
It might not be the correct course according to him."

I wasn't sure who you were talking about. I thought you might be making a sarcastic remark about me. If by "bigshot lawyer" you mean the guy who did the over one hour long interview linked previously in this thread, I listened to all of it.

I think there may be a misunderstanding and you may be confusing me with someone else. In any case, the "bigshot" lawyer never said that going for an injunction might not be the correct course of action, so I don't know where you're getting that. I strongly suspect that the "bigshot" lawyer would do cartwheels and drinks would be on him if he could get an injunction.

 

[Spazmelda]

I just did a google search, and it looks like these heat-not-burn devices may still be in development. Perhaps not for the US market though- it appears there have been some launches in other countries. One thing I found that I didn't know was that Imperial Tobacco acquired the original e-cigarette patents from Hon Lik. In this article, they were pooh-poohing Phillip Morris' heat and burn device as less safe than electronic cigarettes.

Phillip Morris Smokeless Cigarette Not as Safe as E-Cigarettes, Big Tobacco Researcher Says | E-Cigarette Reviews and Rankings

I do think they are still on the board, especially now with e-cigs in the picture. They were developing them in the late 80s though, as I mentioned, way before e-cigs were around and the regulatory hurdles were not worth the effort according to my professor. He was very disturbed by this as I recall, had spent a lot of time and dedication on the project, hoping to help people. I would think they'd not be as safe as vapor products since they do heat real tobacco not just nicotine solution. He took one apart and showed us, there was sort of a tobacco-ey stuff in them (looked to be chopped finer than regular tobacco), and I think he told us there was some other substance in them that made the visible vapor though. It was a while ago. Wish I remembered better.

 

[Lessifer]

I would suppose their first goal, in the US, would be Filing to the Master File for all their(TESTED) Flavors. This could leave manufacturers in a Bind down the road.
Any Flavor tested and modified to meet FlavourArt standards would result in New Products.

I don't understand what you mean.

I believe their intention, at least for the Canadian market, is that they have the individual flavoring components tested and approved, and then anyone who wants to combine those into something else is good. You know, a common sense approach to this kind of thing. Not sure what the plan is for the US market, but he did say they would be working on master files and hopefully manufacturers could reference those for the flavors.

 

[beckdg]

I'll tell you, common folk like me have stood by the last few years and signed petitions and such and supported organizations and that has ended in the worst case results. Now, you'll be seeing us taking action in ways that may not be liked, but it's all we have left. See ya on the streets...

Show me the money.

Tapatyped

 

[zoiDman]

I believe it was the CEO of flavourart on one of the podcasts who said that they have dedicated the company to vapor products. They're actually actively involved in crafting the new regulatory framework that will be put in place in Canada. Now, I don't know if that means that they will actually be filing PMTA's, or if they will just sell their products to manufacturers. If you go to their website now, there's an age verification on the landing page.

BTW - Why would a Flavoring Company consider doing a PMTA? I mean, what chance would there be of getting it Approved?

Because there is No Way they could show anything because there is No Way they could include Every Possible use/condition that an end user might use the Flavor with.

Just seems like a Big Waste of Money.

 

[bigdancehawk]

Wrong. Most isn't "all". Specify. Which market, where?
Most nicotine to be used for ecigs
is indeed tobacco derived but not all nicotine on the market is derived from tobacco.
See: Synthetic Nicotine | Spectrum
Synthetic nicotine, often used in bug spray and in some nicotine lozenges marketed for smoking cessation, is much more expensive than naturally extracted nicotine
which is one reason why it isn't used in ecig juice. However some ecig juice vendors have
used or are said to have used some synthetic nicotine in some of their products.

In this thread: Synthetic Nicotine - Is there really such a thing?
Rolygate states:
"We know of one supplier who claims to use only synthetic nicotine in their cartos. They pay $1,800 per barrel for their nic, when standard natural nic of very high purity is $300 per barrel or less. The reason they use it is apparently to ensure it is of the highest quality and contains no pesticides, carcinogens or any other contaminants.

It is of course very expensive. However this supplier (a major name) only sells cartomizer ecigs, and to the 'new buyer' market. Their product is very expensive indeed, around $150 or more for a starter kit - you know the type. Therefore I guess the nic cost is not a huge factor; also like many suppliers in that market their 'high strength' cartos are what others would consider medium or low. I can easily see that whatever the cost of their nic, it would be absorbed without issue, due to the price of the end product. The ability to claim ultra-high purity, and for that to be provable on analysis, would be a good selling point especially in that market.

This was unfortunately told me in confidence so I can't say any more on the subject."

Yep, I stand corrected. There does seem to be one manufacturer using synthetic nicotine, albeit in small quantities, in a $150 starter kit.

 

[Mazinny]

I can't see how FlavourArt has done much (if any) testing towards a PMTA application.

I'm thinking maybe you meant getting their Master File info worked out?
That would allow liquid manufacturers to continue to use their flavors for now.

No i meant the toxicity testing they were doing in anticipation of Eurozone regulations. I would think some of that would apply to PMTA as well.

The project “ClearStream Onward” » ClearStreamOnward

 

[Lessifer]

BTW - Why would a Flavoring Company consider doing a PMTA? I mean, what chance would there be of getting it Approved?

Because there is No Way they could show anything because there is No Way they could include Every Possible use/condition that an end user might use the Flavor with.

Just seems like a Big Waste of Money.

No argument here. So I guess, if you DIY and use flavourart flavorings, stock up now, because they may not be available to consumers in the future?

 

[HazyShades]

Listen to the bigshot lawyer FDA expert.
It might not be the correct course according to him."

I wasn't sure who you were talking about. I thought you might be making a sarcastic remark about me. If by "bigshot lawyer" you mean the guy who did the over one hour long interview linked previously in this thread, I listened to all of it.

Oh stop being so sensitive, you're acting like a lawyer for chrissake.
The bigshot was the guy in the interview and if you hadn't been so
into finding fault and arguing like lawyers like to do
you would have understood my words instead of getting your drawers bunched up thinking
I was calling you a bigshot.
Why would I do that? You're the dude being hostile.
I don't know you and seriously doubt that a semi retired Missouri lawyer
is a bigshot..so relax.
I admitted my limited knowledge in conversation with Lessifer
and if you'd read the whole thread you'd have seen that.

But you accused me in a hostile manner of not knowing process
when I have a shield that proves different, and you had plenty of opportunity
to educate us about the law and your experience as an attorney
but instead did not.

If you listen to the interview with an open mind
you'll see that the attorney being interviewed is indeed a BIGSHOT
as far as his experience in dealing with the FDA
and you'll hear the interviewer propose or ask about filing injunctions
to which the attorney responds in an evident negative manner.

Now, like I told you last night, you win.
I'm not out to prove anything and you can say what you will.
I'll not entertain you any longer
because of my great consideration for my fellow man
and a perverse sense of professional courtesy...

bye

 

[Mazinny]

Why would FlavorArt need to do a PMTA?

Do they sell a "Finished" or "Covered" Tobacco Product? I thought they just Sold Flavorings?

They sell finished liquids in Europe. Also the testing they do on their flavors will be needed for the vendors selling liquid using their flavors ( if they can afford PMTA ). If i were them, i would rush the finished eliquids to the U.S. market prior to Aug 8, 2016.

 

[Lessifer]

BTW - Why would a Flavoring Company consider doing a PMTA? I mean, what chance would there be of getting it Approved?

Because there is No Way they could show anything because there is No Way they could include Every Possible use/condition that an end user might use the Flavor with.

Just seems like a Big Waste of Money.

You know, I just had a thought. Maybe not for FA, but for Lorannes or capella, it's entirely possible that many of their products were marketed prior to February 2007, possibly FA too. Can a component be grandfathered?

Just had another thought, this whole thing is so ridiculous...

 

[Mazinny]

No argument here. So I guess, if you DIY and use flavourart flavorings, stock up now, because they may not be available to consumers in the future?

I don't follow, how could FDA stop sale of food flavoring in U.S.A. Just because some consumers and vendors use that same food flavoring in tobacco products ?

 

[Lessifer]

Oh stop being so sensitive, you're acting like a lawyer for chrissake.
The bigshot was the guy in the interview and if you hadn't been so
into finding fault and arguing like lawyers like to do
you would have understood my words instead of getting your drawers bunched up thinking
I was calling you a bigshot.
Why would I do that? You're the dude being hostile.
I don't know you and seriously doubt that a semi retired Missouri lawyer
is a bigshot..so relax.
I admitted my limited knowledge in conversation with Lessifer
and if you'd read the whole thread you'd have seen that.

But you accused me in a hostile manner of not knowing process
when I have a shield that proves different, and you had plenty of opportunity
to educate us about the law and your experience as an attorney
but instead did not.

If you listen to the interview with an open mind
you'll see that the attorney being interviewed is indeed a BIGSHOT
as far as his experience in dealing with the FDA
and you'll hear the interviewer propose or ask about filing injunctions
to which the attorney responds in an evident negative manner.

Now, like I told you last night, you win.
I'm not out to prove anything and you can say what you will.
I'll not entertain you any longer
because of my great consideration for my fellow man
and a perverse sense of professional courtesy...

bye

Not getting into the argument here, but if it's the interview I'm thinking of, I THINK the potential negative with the injunction is if the judge decides NOT to grant it, which would mean that the judge does not think you stand a decent chance of winning. That was my lay interpretation at least.

 

[Lessifer]

I don't follow, how could FDA stop sale of food flavoring in U.S.A. Just because some consumers and vendors use that same food flavoring in tobacco products ?

That's the point, FA markets their products as e-liquid flavorings. Making it a tobacco product component, which I believe would require a PMTA. The other flavoring companies don't market their products that way.

 

[Mazinny]

You know, I just had a thought. Maybe not for FA, but for Lorannes or capella, it's entirely possible that many of their products were marketed prior to February 2007, possibly FA too. Can a component be grandfathered?

Just had another thought, this whole thing is so ridiculous...

Lots of speculation going on, some educated, some not. I doubt the FDA know themselves how they will deal with each and every issue emanating out of these nonsensical regs. They'll be winging it for the most part, i assume, or as they word it, "cthe decision will be made on a case by case basis "