FDA Boehner asks FDA to move Grandfathering date to April 2014 or time of final rule

[Oliver]

Action in congress! This is hopeful...

No confirmation as yet regards authenticity, but a letter has been sent to the FDA by John Boehner, Speaker of the House, Kevin McCarthy, Majority leader and Fred Upton, Chairman of the Energy & Commerce committee.

Download it here: https://dl.dropboxusercontent.com/u/18613027/Boehner Letter 24Nov2014.pdf

 

[Lessifer]

That would be a HUGE step in the right direction.

 

[B2L]

What appears to be common sense and rational thought from a politician

Now I've truly seen it all.

If this is indeed authentic, and is acted on, it would be game changing.

 

[440BB]

Definitely a step in the right direction!

 

[wv2win]

(if the letter is authentic): Note to CASAA or AVA or SAFTA or any vendor, let's send John Boehner an iStick with an Aspire Nautilus and a selection of tobacco (and non-tobacco) e-liquids to show our gratitude. (he's a smoker) And to those politicians who have been trying to kill vaping for 5+ years, lets send them another kind of "Stick-it".

 

[pamdis]

Would have preferred a letter that said "Please exempt nicotine only products from the proposed regulation. The phrase 'derived from tobacco' was never intended to be applied to products that don't actually contain any tobacco."

Maybe we can lobby Senate leaders to write this type of a letter instead come January when leadership of the Senate changes.

 

[Nate760]

Would have preferred a letter that said "Please exempt nicotine only products from the proposed regulation. The phrase 'derived from tobacco' was never intended to be applied to products that don't actually contain any tobacco."

Lots of nicotine-only products are already exempted. They just happen to all be made by Big Pharma.

 

[SeniorBoy]

Thanks SJ. I tried to reach Boehner by phone to verify the authenticity of the letter. No luck. I'm waiting for a call back from Chairman Upton's Press Secretary. I just love dropping URLs in the hopes that we all get a quick answer with respect to the authenticity. What politician doesn't love favorable "ink".

 

[pamdis]

Lots of nicotine-only products are already exempted. They just happen to all be made by Big Pharma.

Yeah, and all three of the signatories to this letter were in the top five recipients of pharma manufacturer campaign contributions for 2014.

Why did they simply write a letter making a suggestion? Why not actual legislation? Why not a letter to suggest exempting e-cigs?

I say, this is nothing but a sop to us.

sop (noun) something given to pacify or quiet

 

[Kent C]

Action in congress! This is hopeful...

No confirmation as yet regards authenticity, but a letter has been sent to the FDA by John Boehner, Speaker of the House, Kevin McCarthy, Majority leader and Fred Upton, Chairman of the Energy & Commerce committee.

Download it here: https://dl.dropboxusercontent.com/u/18613027/Boehner Letter 24Nov2014.pdf

And with a 'cc' to Zeller

It's a start. I'm still in favor of Azim Chowdhury's plan of setting up a “baseline” predicate product* rather than a grandfather date, but it's better than what we have now - by far, I might add. Thanks for posting SJ. Perhaps all the CTA's paid off - the idea of moving the grandfather date (and the reason why) was mentioned in many of the emails.

http://www.khlaw.com/webfiles/What_To_Expect.pdf

 

[Kent C]

Lots of nicotine-only products are already exempted. They just happen to all be made by Big Pharma.

Those products are under a different authority/classification. This addresses the deeming - of which we're concerned. I understand the 'larger' nic debate, but that isn't the point in this more specific request.

 

[Kent C]

Yeah, and all three of the signatories to this letter were in the top five recipients of pharma manufacturer campaign contributions for 2014.

Why did they simply write a letter making a suggestion? Why not actual legislation? Why not a letter to suggest exempting e-cigs?

I say, this is nothing but a sop to us.

sop (noun) something given to pacify or quiet

.............

 

[SeniorBoy]

You would not believe the amount of time, phone calls, and gentle probing it took me to verify the authenticity of this letter.

Your welcome /lol (thanks Kent C)

Subject letter as posted by SJ is authentic. Direct from "Josh" who is a staff assistant in Speaker Boehner's DC office. He retrieved the document which took forever and we had a nice chat. I took the liberty of thanking speaker Boehner for leading the charge and know I'm going to take a nap and then go to press.

 

[catlady60]

Boehner, a.k.a. "the Orange Man", is doing something right for a change. Do wonders ever cease?

 

[Kent C]

Boehner, a.k.a. "the Orange Man", is doing something right for a change. Do wonders ever cease?

And yet some never change....

 

[JustJulie]

I also called Speaker Boehner's office to confirm the letter's authenticity. It's legit.

CASAA will be issuing a Call to Action in the next few days.

A definite step in the right direction and solves the worst of the short-term problems, but it's still not the long-term solution we should be looking for. But, like I said, a step in the right direction,

 

[DC2]

Interesting that this comes after the elections.

It appears to signal that a change for the better with respect to electronic cigarettes can now be hoped for.
It's not the BEST thing we can hope for, but it's certainly ONE of the best things we can hope for.

I agree with the the idea of exempting electronic cigarettes.
But that is a LOT to hope for.

 

[Bill Godshall]

This letter is huge, as the three signatures on the letter are the two most powerful members of the US House of Representatives (Speaker John Boehner and Majority Leader Kevin McCarthy), and Chairman of the House Energy and Commerce Committee Fred Upton (which has oversight of FDA and CDC).

While the FDA's proposed deeming regulation correctly points out that 2007 is the grandfather date in the FSPTCA, US Congress has the legal authority to enact legislation to change that grandfather date to 2014 (or whenever it desires).

This letter indicates that House Republican leaders are willing to support legislation that would change the FSPTCA (and may be able to generate the necessary votes in the House) to set a new grandfather date to 2014 or later for newly deemed tobacco products (including all vapor products). I suspect the new Republican Senate Leadership might also be amenable to support changing the grandfather date.

Don't know who was behind this letter, but I think all tobacco and vapor product companies support moving the grandfather date to 2014 (as then they'd only have to submit SE reports instead of submitting a far more expensive new tobacco product application).

The letter was also posted at:
https://mlsvc01-prod.s3.amazonaws.com/cbd370f8401/1cfb48c5-3621-40b7-9fad-ea36083870e5.pdf

Siegel blogged about it today at
http://tobaccoanalysis.blogspot.com/

 

[Nate760]

Don't know who was behind this letter, but I think all tobacco and vapor product companies support moving the grandfather date to 2014 (as then they'd only have to submit SE reports instead of submitting a far more expensive new tobacco product application).

If nothing else, it signals a recognition by some people on Capitol Hill that the previous "grandfather" date was nothing more than an attempt to summarily ban (without actually saying so) nearly every vapor product currently on the market.

 

[Kent C]

This letter is huge, as the three signatures on the letter are the two most powerful members of the US House of Representatives (Speaker John Boehner and Majority Leader Kevin McCarthy), and Chairman of the House Energy and Commerce Committee Fred Upton (which has oversight of FDA and CDC).

While the FDA's proposed deeming regulation correctly points out that 2007 is the grandfather date in the FSPTCA, US Congress has the legal authority to enact legislation to change that grandfather date to 2014 (or whenever it desires).

This letter indicates that House Republican leaders may be willing to change the FSPTCA (and may be able to generate the necessary votes in the House) to set a new grandfather date to 2014 for newly deemed tobacco products (including all vapor products). I suspect the new Republican Senate Leadership also would be amenable to support changing the date.

Don't know who was behind this letter, but I think all tobacco and vapor product companies support moving the grandfather date to 2014 (as then they'd only have to submit SE reports instead of submitting a far more expensive new tobacco product application).

The letter was also posted at:
https://mlsvc01-prod.s3.amazonaws.com/cbd370f8401/1cfb48c5-3621-40b7-9fad-ea36083870e5.pdf

Siegel blogged about it today at
http://tobaccoanalysis.blogspot.com/

And....

Senate Health, Education, Labor and Pensions:

Senator Lamar Alexander (TN) could become the new chairman of the HELP Committee. Two Democrats are leaving – Tom Harkin (IA) who is currently chairman, and Kay Hagan (NC).
Anticipating Committee Changes in the 114th Congress « Ag/FDA Blog

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Commerce, Science & Transportation John Thune of South Dakota will almost certainly assume the chair of the Commerce Committee from the retiring Democratic chair, Jay Rockefeller of West Virginia. - See more at: The New Senate Power Grid: Here

Thune, who serves as the panel’s top Republican, did not remain at that hearing long enough to hear that verbal thumping of the CEOs by the chairman.

But while he used his opening statement to state his opposition to smoking in general and his support for keeping e-cigarettes away from children, he also spoke of their potential for reducing harm to current smokers.

“As with most issues that we face in Congress, I believe that more scientific investigation and thoughtful discussion is needed,” Thune said.

“Many e-cigarette companies argue that their product is still an emerging technology and warn that restrictions on e-cigarettes that do not follow the science may inhibit future innovation to create safer production for existing smokers.”

Could Republicans