I suppose Halo's big enough that they expect to submit PMTAs and believe they have some chance of eventually getting them approved. If I were in their shoes, I'd be putting a positive spin on the situation too, lest their investors decide to jump ship.
FDA TVECA post table of contents for Deeming Final Rule
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I started with their Triton bits and their juice not quite two years ago. It showed me the potential of vaping and got me from 2 PAD to almost (but not quite) none. A few days later, I bought better gear and better juice locally and that got me over the hump.
Up until very recently, all of Halo's juice was rather heavy on the PG, which I quickly found I didn't care for. They've recently introduced higher VG versions of a bunch of their classic flavors, I and think some other, more modern flavors as well. But I have no interest in trying them at this point.
Up until very recently, all of Halo's juice was rather heavy on the PG, which I quickly found I didn't care for. They've recently introduced higher VG versions of a bunch of their classic flavors, I and think some other, more modern flavors as well. But I have no interest in trying them at this point.
Also, their best sellers have always been tobacco and menthol flavors. Actually, when I first ordered from Halo in 2010, that's all they carried. They added some dessert flavors over the years, like Malibu and Belgian Chocolate, but I suspect they could stay in business without them.
Halo makes wonderfully clear and clean juices; I like their menthols, can't stand their "purity" tobacco base. Some people love it--to me their tobaccos taste like Pine Sol mixed with ginger tea.
Halo is a remarkable business model and like many, they were my second stop in my vaping journey. I've always held a large amount of affection for them, which may explain my disappointment, when I read their "spin" as others have noted. After their merger they are part of a huge player. For your reading pleasure:
"Leading E-Cigarette And Regulatory Expert Joins Nicopure Executive Team
TAMPA, Fla., Aug. 4, 2015 /PRNewswire/ — Nicopure Labs, LLC, the leading e-liquid and vaping device manufacturer of Halo, eVo, Triton and G6 brands, today announced the appointment of Patricia I. Kovacevic as General Counsel and Chief Compliance Officer.
With extensive U.S. and international electronic cigarette and tobacco experience, Kovacevic held senior legal and compliance positions at Philip Morris International, Lorillard and ITG Brands. Kovacevic was instrumental in securing the first ever premarket approvals for newly regulated tobacco products by the Food and Drug Administration. Reporting to Nicopure Labs, LLC’s founders, Jeffrey Stamler andJason Del Giudice, Kovacevic will assume responsibilities for the company’s global legal affairs, regulatory and compliance matters, as well as public policy engagement."
Source
From their attorney:
"During a recent meeting I attended, Mitch Zeller, the FDA’s Director of the Center for Tobacco Products, briefly discussed a bill introduced in Congress earlier in the year, which he did not seem to believe had great chances at success. That bill intended to change the grandfather date for newly regulated products such as e-cigarettes and liquids. Director Zeller conveyed that changing the grandfather date would substantially limit the goals of the Tobacco Control Act. It’s anyone’s guess, therefore, if FDA will consider changing that date."
Source
HA!
"Leading E-Cigarette And Regulatory Expert Joins Nicopure Executive Team
TAMPA, Fla., Aug. 4, 2015 /PRNewswire/ — Nicopure Labs, LLC, the leading e-liquid and vaping device manufacturer of Halo, eVo, Triton and G6 brands, today announced the appointment of Patricia I. Kovacevic as General Counsel and Chief Compliance Officer.
With extensive U.S. and international electronic cigarette and tobacco experience, Kovacevic held senior legal and compliance positions at Philip Morris International, Lorillard and ITG Brands. Kovacevic was instrumental in securing the first ever premarket approvals for newly regulated tobacco products by the Food and Drug Administration. Reporting to Nicopure Labs, LLC’s founders, Jeffrey Stamler andJason Del Giudice, Kovacevic will assume responsibilities for the company’s global legal affairs, regulatory and compliance matters, as well as public policy engagement."
Source
From their attorney:
"During a recent meeting I attended, Mitch Zeller, the FDA’s Director of the Center for Tobacco Products, briefly discussed a bill introduced in Congress earlier in the year, which he did not seem to believe had great chances at success. That bill intended to change the grandfather date for newly regulated products such as e-cigarettes and liquids. Director Zeller conveyed that changing the grandfather date would substantially limit the goals of the Tobacco Control Act. It’s anyone’s guess, therefore, if FDA will consider changing that date."
Source
HA!
Some people love it--to me their tobaccos taste like Pine Sol mixed with ginger tea.
and here's the crux of the matter - taste is so subjective we really need to have most of the e-juice manufacturers survive whatever is coming down the pipe line
The FDA will not change the date. If they wanted to change the date, they would have done so a long time ago. Only Congress can make them change the date, but both bills changing the grandfather date aren't making any progress at all.
Yeah, and if the bill did go to Obama, I believe he has said that he would veto it. So, no hopes of that happening.
Yeah, and if the bill did go to Obama, I believe he has said that he would veto it. So, no hopes of that happening.
Which is why, as God is my witness, I will never vote for any of these Democrats, ever!!! And I'll be adding some Republicans to that list, too--maybe a lot of them. I have heard it said that "vaping is just one issue," as though there are other more important issues around which we should cast our votes. Well, since I think vaping is probably saving my life, I think that's a pretty important issue, and therefore I say vaping is MY issue. At present, when it comes to the Democrats, I just give up and rest my case.
As for the Republicans? Well ... the ball is in their court ... for now.
So glad you noticed that not so clever obfuscation from the Halo General Counsel. CONGRTATS! It's not like I could find numerous quotes from uncle Mitch Zeller which effectively say...we can't change it. Only Congress can change it.
Smarter minds than my own are telling me that the Bills to change the Grandfather date must be "ripe" and IMHO this means the politico types want to see the final rule first, then it's a matter of if and when they decide to move. More traction? Better PR? More bribes? More time on Cable TV? I share your frustration and I would term my current state of mind (which has always been debatable) /lol as not very optimistic.
Let's all try and have a happy weekend and prepare for Turkey day.
I could, but I'm too busy right now. I heard him saying in an interview that the FDA "has no power to change the date" even though he himself understands that that date is very "problematic."
Bloody weasel.
Only OMB/OIRA can save us now--they can still reject the whole deeming proposal package as too costly and too overreaching. At least that's how I see it.
There are many quotes out there but it is written right in the deeming doc itself:
"Based on initial information FDA has gathered and received from industry, many tobacco products we are proposing to deem that are currently being sold may not be “grandfathered” tobacco products because many were not commercially marketed or modified until after February 15, 2007. We understand that this may be particularly true in the case of e-cigarettes and similar novel products. Moreover, new products that come on the market in the future would never be grandfathered tobacco products because they would be coming on the market after February 15, 2007. We do not believe that we have the authority to alter or amend this grandfathering date, which is set by statute."
And:
In the originally introduced Tobacco Control Act legislation in 2004 (negotiated and agreed to by Phillip Morris, the Center for Tobacco Free Kids’ Matt Myers and then Glaxo Smith Klein lobbyist Mitch Zeller), the grandfather date was set at June 30, 2003. When the legislation was reintroduced in 2005, the grandfather date was then changed to February 15, 2005, and later to February 15, 2007 when it was reintroduced in 2007, which remained when the legislation was reintroduced, again, in 2009; probably in an attempt to ban several recently introduced smokeless tobacco products by Reynolds.
What is the Grandfather Date of the Tobacco Control Act & How Will it Impact the Vapor Industry? - SFATA | Smoke Free Alternatives Trade Association
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As far as I know, the President has never mentioned the Cole bill - he hasn't been asked about it. And since it's been sitting in the house with no action being taken on it for over 6 months, I can't see why he would mention it.Yeah, and if the bill did go to Obama, I believe he has said that he would veto it. So, no hopes of that happening.
The question is: why has it been sitting for over 6 months with no action being taken on it?
There are many bills sitting in committees, many longer than 6 months. The one bill, that Obama has promised to veto - because it has less spending than what he recommended - is the Agricultural Bill H.R. 3049 - which also has the final rule grandfather date. That is on what is called the Union Calendar (no.153) which tends to reach the floor faster than other calendar bills. How soon, no one knows. But likely has a better chance, sans some real push on H.R. 2058 by Rep. Cole and the other 30 co-sponsors (all Republicans, btw*), of coming to a vote and sent to the Senate.
*Cosponsors - H.R.2058 - 114th Congress (2015-2016): FDA Deeming Authority Clarification Act of 2015
.. in case people spot their representative and want to send off an email. I've already contacted all of them.
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Guessing this will be posted here at ECF soon. Latest Urgent CTA
CASAA: FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation
CASAA: FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation
It has. JustJulie started a Thread about 9:30am today.
URGENT: FDA Call to Action: Submit Comments on FDA's Proposed Intended Use Regulation
But Thank You Salem for bring it to People's Attention who might not be aware of it.
i haven't seen anywhere that he said he would veto them. where's your source/reference for that?Yeah, and if the bill did go to Obama, I believe he has said that he would veto it. So, no hopes of that happening.
I wouldn't know where to find it, just don't remember where I saw it, probably in a thread on ecf somewhere. I read so many of these threads it just kinda all comes together.
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