FDA TVECA post table of contents for Deeming Final Rule

[Kent C]

and in support of the Agriculture bill, as I suggested in my post linked above.

Bill G mentioned it (Ag bill - "H.R. 3049") in June this year.

US House Appropriations Cmte bill would prevent FDA from banning e-cigs now on the market

Earlier, and one time since, I've contacted the sponsor and committee for support.

Robert B. Aderholt
Email Robert

US House Appropriations Cmte bill would prevent FDA from banning e-cigs now on the market


The Section regarding the GF date is Sec. 747

747.

For each tobacco product which the Secretary of Health and Human Services, by regulation under section 901(b) of the Federal Food, Drug, and Cosmetic Act, deems to be subject to chapter IX of such Act, none of the funds made available in this Act or any other Act may be used to treat any reference in sections 905 and 910 of such Act to February 15, 2007, as other than a reference to the effective date of the regulation under which a tobacco product is deemed subject to the requirements of such Act pursuant to section 901(b)(1) of such Act, and any reference in such sections to 21 months after the date of enactment of the Family Smoking Prevention and tobacco Control Act as other than a reference to 21 months after the date of such final deeming regulation.

The bill is currently in committee:

H.R.3049 - 114th Congress (2015-2016): Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016

 

[Katya]

The bill is currently in committee:

And as I understand it, it is being fiercely opposed by the ANTZ...

Contacting our representatives on the Hill is necessary, IMO. We did it for HR 2058...

@Robino1 @JustJulie @Vocalek @kristin

Keller Heckman | The Grandfather Date – What are FDA's Alternatives?

"While it may be unlikely that this bill [HR 2058] ever becomes law given how difficult it is to get anything controversial through Congress, even more recently, Congressman Robert Aderholt introduced a rider to the 2016 Agricultural Spending Bill in the House Appropriations Committee that, similar to the Cole bill, would prohibit FDA from enforcing the February 15, 2007 Grandfather Date for newly deemed tobacco products and move the grandfather date to the effective date of Final Rule for Deeming Regulation. That bill was approved by the Committee on July 8, 2015, but is still unlikely to become law because of opposition in the Senate and the Obama Administration. A good discussion of this issue can be found in the Committee Report starting on page 71: http://appropriations.house.gov/uploadedfiles/hrpt-114-hr-fy2016-agriculture.pdf."

Wouldn't it be worthwhile to issue a new CTA in support of the 2016 Agricultural Spending Bill?

 

[zoiDman]

And a global CTA--IMHO. It's now or never.

"I have made the decision to publish the commentary now because by the time the deeming regulations are released, it will be too late to change them."

"According to the OIRA web site:

"Outside parties may provide written comments to the OIRA Administrator on a rule that is under review. If a rule is at OIRA for review, interested parties can provide comments by email at OIRA_submission@omb.eop.gov. In the email please specify the name of the rule and the regulatory identification number (RIN) as specified in the docket for the rule on www.reginfo.gov.
Outside parties may also request a meeting with the Administrator, or his/her designee. If you would like to request a meeting to provide views on a rule being reviewed at OIRA, email: Mabel_E._Echols@omb.eop.gov or call 202-395-6880 to schedule."

The regulatory identification number (RIN) for the deeming regulations is 0910-AG38."

When the FDA did their submission to the OMB/OIRA, I thought that there would be a Massive Drive to get Retail/Online owners to send in their comments.

With a Key Talking Point of the Hundreds of Thousands of Jobs that would be Lost. And the Thousands of Businesses that would go Under.

But there Doesn't seem to be any Traction for this. It's Almost like Most People have adopted the Pelosi attitude that we have to Let the OMB OK it to Know what we Fighting.

Which is Strange? Because there aren't going to be Too Many More Stops on the FDA Railroad after things leave the OMB.

 

[Katya]

But there Doesn't seem to be any Traction for this. It's Almost like Most People have adopted the Pelosi attitude that we have to Let the OMB OK it to Know what we Fighting.

It's absolutely baffling to me. Yes, calling the White House was fun, but the chances that the President will veto the FDA regs are pretty much nil--in my opinion.

However, contacting OIRA (and possibly our representatives wrt to the Agricultural Bill) might actually get some traction. Like we all said many times here, the OMB/OIRA is not FDA. They may (and should be) on our side. And they are the only ones who have the power to send this deeming crap back to the FDA as too costly, unworkable and overreaching. And that would end everything, once and for all.

So why aren't we writing to them?????

 

[Kent C]

And as I understand it, it is being fiercely opposed by the ANTZ...

Google searched - House Agriculture and Drug Administration, and Related Agencies "section 747"

And got almost all the 3 and 4 letter agencies and more in an uproar. Cigar/ecig groups are all in

 

[Kent C]

It's absolutely baffling to me. Yes, calling the White House was fun, but the chances that the President will veto the FDA regs are pretty much nil--in my opinion.

But he's vetoed the Defense Spending and may veto the Agriculture spending as well.

 

[zoiDman]

It's absolutely baffling to me. Yes, calling the White House was fun, but the chances that the President will veto the FDA regs are pretty much nil--in my opinion.

However, contacting OIRA (and possibly our representatives wrt to the Agricultural Bill) might actually get some traction. Like we all said many times here, the OMB/OIRA is not FDA. They may (and should be) on our side. And they are the only ones who have the power to send this deeming crap back to the FDA as too costly, unworkable and overreaching. And that would end everything, once and for all.

So why aren't we writing to them?????

I agree. I think a Veto is Very Unlikely. If not Zero.

And I have No Clue why there Isn't a Movement to contact the OMB? Seems like if something was coming down the line that Can/Will Destroy my Business, that I would be able to find 30 Minutes out of my Busy Day to Write a Letter.

 

[skoony]

"Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA." exert from : The Rest of the Story: Tobacco News Analysis and Commentary: FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

???!!!!,what in the is this?
If this was concerning cigarettes it would mean the tobacco company's were exempt and the local
gas station would have to do the filing.
I am understanding this wrong am I not?
I couldn't read anymore.
Regards
Mike

 

[DC2]

If this was concerning cigarettes it would mean the tobacco company's were exempt and the local
gas station would have to do the filing.
I am understanding this wrong am I not?

That's how I read it as well.

Just another example of how the deeming is intended to hand the whole vaping industry to Big Tobacco.
And perhaps how Big Tobacco has no plans to expand the vaping market, but rather destroy it.

It wouldn't be surprising if Big Tobacco helped "round out" the deeming regulations.
Much like they did when the FSPTCA was written.

 

[Kent C]

If this was concerning cigarettes it would mean the tobacco company's were exempt and the local
gas station would have to do the filing.
I am understanding this wrong am I not?

Not exactly a good analogy since the cigarette companies make cigarettes and the gas stations do not - therefore, no need to submit applications.

And the cigarette companies are just as liable for applications for ecigs and other ecig vendors/manufacturers:

To stay on the market, Marlboro cigarettes had to do nothing at all. But to stay on the market, much safer Vuse e-cigarettes, which have been shown to have very low emissions with non-detectable levels of all the major chemicals of concern, will have to conduct extensive research, both clinical and non-clinical studies, spending millions of dollars, in order to stay on the market for the long-term.

It really only favors tobacco companies by virtue of the fact that they can afford it and others can't - or not as easily depending on the size of the companies involved.

Calling it "The Cigarette Protection Act of 2015" is more of a PR move, but a good one, imo, to drive home the point. I think it's an unwanted but necessary 'unintended consequence' by the FDA.

If it were gun control, the NRA might call it the 'Arm All Criminals and Disarm All Victims ACT".

 

[Katya]

"Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA." exert from

Wait a sec... What???? How did I miss that?

So Kangertech, Njoy, Joyetech and all the big e-cig and e-juice makers don't have to submit PMTAs??????? The only ones who actually have the resources to do so are exempt? And mom and pop stores are going to do R&D for them and submit PMTAs?

Geez.................

 

[roxynoodle]

Wait a sec... What???? How did I miss that?

So Kangertech, Njoy, Joyetech and all the big e-cig and e-juice makers don't have to submit PMTAs??????? The only ones who actually have the resources to do so are exempt? And mom and pop stores are going to do R@D for them and submit PMTAs?

Geez.................

That's what I read.

 

[skoony]

Not exactly a good analogy since the cigarette companies make cigarettes and the gas stations do not - therefore, no need to submit applications.

"Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA." exert from : The Rest of the Story: Tobacco News Analysis and Commentary: FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

What part is not analogical ? If we were talking a new brand of cigarette those who sold
directly to end users bare the burden of regulation.
What am I getting wrong?
Regards
mike

 

[Katya]

That's what I read.

That can't be right... We must be missing something.

Please somebody tell me we're missing something. Please....

 

[skoony]

That can't be right... We must be missing something.

Please somebody tell me we're missing something. Please....

The only thing that makes sense to me is that those that said they couldn't
stop shipments from China are correct. Though I believe they could if they
choose i think there have been some behind the scenes trade negotiations
between Embassy's going on. Then again BT may have a whole line up of
shiny new vape gear to sell us.
The only other thing that comes to mind is the FDA is (insert colorful metaphor here)
messing this up so bad as to get Congress to step in to take the heat off.

Regards
Mike

 

[roxynoodle]

Its on the retailers, who obviously can't do it. Ergo, elimination of vaping in the US.

I know, many on ECF don't believe me, but that's exactly what the plan is.

And if they're smart it will be a done deal quickly so 2016 elections can't change the outcome.

 

[Ca Ike]

With all the uproar I hope along with the CTA stuff everyone a also signing our petition here www.vapingpetition.com. It's another angle of attack for us.

 

[roxynoodle]

And for those who might meet this nearly impossible, pre-approval process, and sell their own mods (Provape, Hana, VS), what will a mod cost? $5000? Yeah.

 

[zoiDman]

Wait a sec... What???? How did I miss that?

So Kangertech, Njoy, Joyetech and all the big e-cig and e-juice makers don't have to submit PMTAs??????? The only ones who actually have the resources to do so are exempt? And mom and pop stores are going to do R&D for them and submit PMTAs?

Geez.................

If I am a Wholesaler or Distributor, why would I have to Bare the Cost of doing a PMTA on every product I Broker?

All I do is take the Boxes off a Rail Car or a Truck, put them in my Warehouse, and the later put them back onto a Truck and send them to a Retailer. Or Another Wholesaler/Distributor.

Someone like Kanger doesn't have to do a PMTA for one of it's Products if Kanger Doesn't sell Directly to the End User. But Someone will have to.

So Usually Kanger will put up the Money/Paperwork for a PMTA. And then Defer an Amortized Cost to it's Distributors. That way, anyone can Sell the particular Kanger Product once the PMTA is Approved.

Of course, Small Cap Companies which make their Own Product, or make their own "House Blend" e-Liquids will have to Bare the Entire Cost of a PMTA if they are the Only Ones selling to the Public.

 

[DC2]

Its on the retailers, who obviously can't do it. Ergo, elimination of vaping in the US.

I know, many on ECF don't believe me, but that's exactly what the plan is.

Many of those in the know have resisted coming to that conclusion.
But it is becoming clearer by the day.