Deeming Regulations have been released!!!!
- Thread starter Oliver
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It might be a tiny bit better than just the 3 month extension. The reason offered (from what I've read, which was somewhere legit, just can't put my finger right on it) was to allow the incoming administration, namely Gottlieb and Price an opportunity to review implementation of the regulations. I have a feeling the Center for Tobacco knows some changes are coming, and a little cover my .... activity may be in play. Which is fine by me as legislative changes are sure taking a long time to get anywhere, and the federal court lawsuit remains in limbo.
Edit: Found it FDA gives e-cigarette makers a reprieve
Ah, oops. I just read up and see @Fozzy71 already referenced this announcement. Sorry I'm late to the game. Again.
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I am also curious how Dr. Siegel got hold of these results. I can't imagine CA Dept. of Health publicizing these results. If there's any mention of these studies at all, it would probably be a headline stating " detectable levels of formaldehyde found in the air of vapeshop. formaldehyde is a known carcinogen blah blah blah.... " .
Did anyone see the webinar on legislative strategy to support vaping?
Yeah, i missed the first 15 minutes, but i listened to the final 45 minutes. There was no video, and only VTA members could ask questions, so i was in listen mode only.
- They emphasized how important the 3 month extension was for a lot of vape shops, and took credit for the letter to Tom Price signed by 2000 vape shop owners, which they felt was instrumental in the FDA granting the extension. They urged vapeshop owners to be more active ( which i assume would include signing up and paying dues to VTA
)- They haven't lost hope re Cole/Bishop and they think they are getting closer. They claim they have converted a number of representatives including a few Democrats.
- They claim they have made significant administrative inroads and are in constant contact with Secretary Price staff, but it seems they haven't been able to extract what Price's position is. They think the ultimate decision will be made by Gottlieb though, and Price will be on board with whatever Gottliebs FDA decides. They are optimistic that Gottlieb really gets the concept of harm reduction.
- They were careful to thank Duncan Hunter for his pro-vaping stance, but didn't think his bill has a real chance of getting traction, and they thought it would be stuck in committees for the next eighteen months.
Imo, this was really designed to impress on business owners how important lobbying is, and how they would benefit by joining VTA.
Yeah, i missed the first 15 minutes, but i listened to the final 45 minutes. There was no video, and only VTA members could ask questions, so i was in listen mode only.
- They emphasized how important the 3 month extension was for a lot of vape shops, and took credit for the letter to Tom Price signed by 2000 vape shop owners, which they felt was instrumental in the FDA granting the extension. They urged vapeshop owners to be more active ( which i assume would include signing up and paying dues to VTA
- They haven't lost hope re Cole/Bishop and they think they are getting closer. They claim they have converted a number of representatives including a few Democrats.
- They claim they have made significant administrative inroads and are in constant contact with Secretary Price staff, but it seems they haven't been able to extract what Price's position is. They think the ultimate decision will be made by Gottlieb though, and Price will be on board with whatever Gottliebs FDA decides. They are optimistic that Gottlieb really gets the concept of harm reduction.
- They were careful to thank Duncan Hunter for his pro-vaping stance, but didn't think his bill has a real chance of getting traction, and they thought it would be stuck in committees for the next eighteen months.
Imo, this was really designed to impress on business owners how important lobbying is, and how they would benefit by joining VTA.
Thanks for listening and reporting on what you heard. The waiting to know what will happen is driving me crazy! I never took the Deeming seriously until last May, so I've been waiting a lot less longer than most people who post here. It really stinks, and trying to express myself about this without four letter words stinks even more!
I don't know, i just checked their website and it's not there. I wouldn't call it a podcast per se, it was more like a conference call that i could listen in on. When you registered, you were given a link, with two options ; a phone number to call to listen in , or a sotware to download to listen in on your computer.
I just got an email with registration info for their next webinar on Friday re Indiana SB1 :
Registration
May 3, 2017
Vapor News and Views
News and views on vapor tax and regulatory issues from across the United States. The best way to stay up to date with what's happening in Washington and in your state capitol.
Folks,
It was a gallant effort but at the end of the day, Democrat leaders held their party strong to prevent Cole-Bishop from being a part of the FY17 spending package. A day later the FDA delayed filing deadlines by 3 months. So, what's next and will this industry meet its demise or not? Read on!
--
Paul Blair
Strategic Initiatives Director
Americans for Tax Reform
What Happened with Cole-Bishop?
Despite the GOP controlling the House, Senate, and White House, Democrats still had a hand to play in all omnibus budget decisions. With a 60-vote requirement in the Senate for a spending package, Republicans needed every one of their members and eight Democrats to sign off on something like Cole-Bishop to be a part of the omnibus. House Minority Leader Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) said from day one that Trump’s and many of the Republicans' priorities were a non-starter for their entire caucus and would encounter unanimous opposition, leading to a government shutdown if any of them were included and any Republicans also caved. In not achieving many Trump/GOP objectives in the budget, Democrats were willing to support it, some Republicans broke away, and on policy provisions the bill moved Left. This meant GOP leadership needed more and more Democrats who could and did demand more pounds of flesh. Cole-Bishop was just that.
From the Democrat House Appropriators, taking pride in killing the effort to modernize the predicate date.
Look, there are Democrat allies in this fight and there has been a growing and successful effort by businesses and consumers to expand the coalition of Congressional supporters. That being said, it's silly to ignore the fact that GOP House and Senate leadership and GOP caucus would have made this happen if Democrats weren't empowered to derail the effort. The anti-vaping tobacco control extremists (leaders) in the Democrat party are the reason we've yet to succeed on a legislative front.
The Time for Administrative Action is Now
One day after GOP and Democrat leaders rolled out the FY17 budget that did not include the Cole-Bishop language to rein in part of the FDA's overreach, the FDA (essentially) delayed all future filing deadlines by 90 days. The extension pertains to major deadlines such as manufacturer submission of future warning label plans, registration and listing, health documents, Substantial Equivalence (SE) exemption requests and applications, Premarket Tobacco Product Applications (PMTAs), and Harmful and Potentially Harmful Constituent reports. Check out this article from Cigar Aficionado for a more thorough explanation.
"This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court,” stated Lindsay R. Tobias, an FDA policy analyst.
This is a temporary stay of execution but my hope is that it's a sign of what's to come. Once Dr. Scott Gottlieb is confirmed as the next Commissioner of the FDA, it will be of the upmost importance that HHS/FDA immediately delay all future deadlines even further, by at least two years. His confirmation may come as soon as mid-May and this isn't an issue he or Secretary Price are unfamiliar with. There's no learning curve on this issue, as numerous organizations and businesses have already put in that effort. This is plain and simple. As the FDA devises more appropriate guidelines for the industry, it must give Congress more time to figure out a short and longer term solution to the unworkable nature of the Tobacco Control Act's regulatory requirements for the vapor industry.
The Future isn't Filled with Binary Choices
There's been a lot of chatter recently about a number of alternative approaches to preventing Prohibition Day from hitting the vapor industry and its millions of U.S. consumers. Cole-Bishop, as part of the FY17 budget, obviously was the first and most important element of this fight. So let's examine other and future options:
In order of priorities, given the political reality associated with how Congress currently functions, the path forward is relatively clear but not entirely binary. CB language needs to get into the FY18 budget, simply because it's must-pass legislation. H.R. 1136 helps with that effort because it gets folks on the record early. The Hunter bill is a good start for the ongoing conversation about where the regulatory discussion heads next. It forces questions such as, "Is the Tobacco Control Act's current regulatory structure most appropriate for the regulation of vapor products?" and "Can hesitant activists at the Center for Tobacco Products be trusted to ever approve innovative 'tobacco' products in a timely and non-burdensome way?" As of now, the answer to both questions is no.
But our legislative options going forward aren't limited; they're open-ended. I remain optimistic that we'll achieve success.
If you think this email was informative please do forward to friends or colleagues who might be interested in Vapor News and Views! They can subscribe by clicking here.
And if you can't get enough... If you crave even more exclusive information... If want to know more about what's going on in Washington and around the country, get your premium content even quicker with a subscription to Vapor News and Views Pro by emailing me at pblair@atr.org
Paul Blair | Americans for Tax Reform | 202-785-0266 | pblair@atr.org | www.atr.org
Vapor News and Views
News and views on vapor tax and regulatory issues from across the United States. The best way to stay up to date with what's happening in Washington and in your state capitol.
Folks,
It was a gallant effort but at the end of the day, Democrat leaders held their party strong to prevent Cole-Bishop from being a part of the FY17 spending package. A day later the FDA delayed filing deadlines by 3 months. So, what's next and will this industry meet its demise or not? Read on!
--
Paul Blair
Strategic Initiatives Director
Americans for Tax Reform
What Happened with Cole-Bishop?
Despite the GOP controlling the House, Senate, and White House, Democrats still had a hand to play in all omnibus budget decisions. With a 60-vote requirement in the Senate for a spending package, Republicans needed every one of their members and eight Democrats to sign off on something like Cole-Bishop to be a part of the omnibus. House Minority Leader Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) said from day one that Trump’s and many of the Republicans' priorities were a non-starter for their entire caucus and would encounter unanimous opposition, leading to a government shutdown if any of them were included and any Republicans also caved. In not achieving many Trump/GOP objectives in the budget, Democrats were willing to support it, some Republicans broke away, and on policy provisions the bill moved Left. This meant GOP leadership needed more and more Democrats who could and did demand more pounds of flesh. Cole-Bishop was just that.
From the Democrat House Appropriators, taking pride in killing the effort to modernize the predicate date.
- "The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review. The House provision would have exempted e-cigarettes, little cigars, cigarillos, hookah, cigars and other products from the Tobacco Control Act’s pre-market review requirement, allowing products to escape regulations and requirements that Congress enacted to protect the public health from the nation’s leading preventable cause of death."
Look, there are Democrat allies in this fight and there has been a growing and successful effort by businesses and consumers to expand the coalition of Congressional supporters. That being said, it's silly to ignore the fact that GOP House and Senate leadership and GOP caucus would have made this happen if Democrats weren't empowered to derail the effort. The anti-vaping tobacco control extremists (leaders) in the Democrat party are the reason we've yet to succeed on a legislative front.
The Time for Administrative Action is Now
One day after GOP and Democrat leaders rolled out the FY17 budget that did not include the Cole-Bishop language to rein in part of the FDA's overreach, the FDA (essentially) delayed all future filing deadlines by 90 days. The extension pertains to major deadlines such as manufacturer submission of future warning label plans, registration and listing, health documents, Substantial Equivalence (SE) exemption requests and applications, Premarket Tobacco Product Applications (PMTAs), and Harmful and Potentially Harmful Constituent reports. Check out this article from Cigar Aficionado for a more thorough explanation.
"This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court,” stated Lindsay R. Tobias, an FDA policy analyst.
This is a temporary stay of execution but my hope is that it's a sign of what's to come. Once Dr. Scott Gottlieb is confirmed as the next Commissioner of the FDA, it will be of the upmost importance that HHS/FDA immediately delay all future deadlines even further, by at least two years. His confirmation may come as soon as mid-May and this isn't an issue he or Secretary Price are unfamiliar with. There's no learning curve on this issue, as numerous organizations and businesses have already put in that effort. This is plain and simple. As the FDA devises more appropriate guidelines for the industry, it must give Congress more time to figure out a short and longer term solution to the unworkable nature of the Tobacco Control Act's regulatory requirements for the vapor industry.
The Future isn't Filled with Binary Choices
There's been a lot of chatter recently about a number of alternative approaches to preventing Prohibition Day from hitting the vapor industry and its millions of U.S. consumers. Cole-Bishop, as part of the FY17 budget, obviously was the first and most important element of this fight. So let's examine other and future options:
- Cole-Bishop 2.0: An effort to get the CB language in the FY18 budget is important because budgets are "must-pass" pieces of legislation. Budgets have to pass, compared to stand-alone bills that Congressional committees don't have any obligation to consider. The consequences of not passing a budget is a government shutdown; the consequence of not passing a policy bill is less significant (politically).
- House Resolution 1136: Obtaining more co-sponsors for H.R. 1136, which is essentially the '17 CB appropriations language in stand-alone bill form, helps us make the case that there is growing and broad support in Democrat and Republican circles to make a predicate date change happen. As of today, this bill has 57 co-sponsors, including 6 Democrats (Bishop, Clay, Peterson, Costa, Cuellar, Peters). The focus from businesses, consumers, and interested organizations should be urging support for this bill.
- The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act: Congressman Duncan Hunter's H.R. 2194 is an important marker of where this fight could go in the future. The legislation essentially removes the requirement that manufacturers of vapor products obtain permission from the FDA to introduce new products while at the same time establishing a pathway for manufacturing standards for liquids and devices over the coming years. It's been assigned to the Energy and Commerce Committee.
In order of priorities, given the political reality associated with how Congress currently functions, the path forward is relatively clear but not entirely binary. CB language needs to get into the FY18 budget, simply because it's must-pass legislation. H.R. 1136 helps with that effort because it gets folks on the record early. The Hunter bill is a good start for the ongoing conversation about where the regulatory discussion heads next. It forces questions such as, "Is the Tobacco Control Act's current regulatory structure most appropriate for the regulation of vapor products?" and "Can hesitant activists at the Center for Tobacco Products be trusted to ever approve innovative 'tobacco' products in a timely and non-burdensome way?" As of now, the answer to both questions is no.
But our legislative options going forward aren't limited; they're open-ended. I remain optimistic that we'll achieve success.
If you think this email was informative please do forward to friends or colleagues who might be interested in Vapor News and Views! They can subscribe by clicking here.
And if you can't get enough... If you crave even more exclusive information... If want to know more about what's going on in Washington and around the country, get your premium content even quicker with a subscription to Vapor News and Views Pro by emailing me at pblair@atr.org
Paul Blair | Americans for Tax Reform | 202-785-0266 | pblair@atr.org | www.atr.org
I'd rather see a continuing resolution every few months for the rest of my life than another minibus or omnibus for any purpose whether it suits me or not.
And the Cole-Bishop is a slow death to the industry in the U.S. as I see it.
Personally, I agree, the Hunter bill is a conversation starter for a new direction.
That pleases me to no end.
Let them keep facing lawsuits and pushing back the date until they accept something reasonable.
The Hunter bill is close, but not quite there.
Honestly, I'm not disturbed in the least that it's not projected to pass.
Just happy it's a sign of potential forward, just movement.
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I like your reasoning here. I hope you are right and I am inclined to agree. I read a great piece that Oliver wrote that drew some of the same conclusions. Even though Cole/Bishop wouldn't have been the whole solution for vaping and that things could still turn out to be alright, I'd much prefer a win on it. More concrete reassurance would be very nice right now.
Someone needs to explain to me what is progressive about upholding Deeming regulations.
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It puts control in the hands of the government and out of the hands of individuals. Which is a good definition of 'progressivism', and one you won't find in any dictionary - which is part of the progressive mindset - they couldn't tell the truth or no one would follow them.
Nothing.
What need to be focused on and the FDA challenged on is for them to prove Vaping is Tobacco. They and we perfectly well know it's not. Supporting Bills like this and the Hunter Bill establishes a regulatory committee within the FDA to regulate Vaping thus handing control to them on a Silver Platter.
The Deeming Regulations are built on a house of cards, remove the Tobacco card and it all collapses.
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And global warming is now climate change.
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