FDA Godshall meets with White House OMB/OIRA again urging rejection of FDA deeming ban on vapor products

[Endor]

Bill, yet another thanks for your advocacy.

Also, thanks for posting the notes... although I've read the deeming regs several times, it is nice to see dots connected that shows that the FDA really has no clue the impact these regulations will have on the vapor industry (apparently a key piece of OIRA's review criteria).

It is also more evidence that the FDA deeming is really political rather than science based. "We know it will have an impact, but we can't really quantify it, and it doesn't matter anyway because we know it will save the children!"

 

[Kent C]

the FDA really has no clue the impact these regulations will have on the vapor industry

Here's a clue:

 

[Heybilox]

Thank you Bill for all your efforts. Even though I'm Canadian I realize what hapens in the U.S. will affect Canada.
I was a chain smoker for over 50 years and quit instantly when I started vaping and my intention was not to quit.
I was visiting my son for a few days in January and he said I could vape in his house, ( he is neither a smoker or vaper).
I've tried the patch, gum, cold turkey, even prayer sessions and vaping has been the only thing that freed me of my PAST bondage. What started as a whim one cold Canadian weekend last winter has given me a new freedom and an enhanced feeling of self-worth.
Thanks again Bill!!!

 

[Katya]

That's been my (our) goal, and that's what I urged them to do many times during our 30-40 minute meeting.

But even if OMB/OIRA sends it back to FDA, that doesn't mean the reg is dead (as OMB/OIRA sent the proposed reg back to FDA in Jan/Feb 2014, but it was subsequently proposed several months later in April).

Still, it's our best option and our last hope, ATM, at least.

Who knows what happens next year...

Thank you, Bill! Again.

 

[oplholik]

Well, if it gets sent back, at least it will give us a little more time for whatever, even if it's just to stock up.
If it does get sent back, will we know for what reason?

 

[Katya]

If it does get sent back, will we know for what reason?

For any/all of the reasons so elegantly outlined in Bill's OP.

 

[DC2]

Well, if it gets sent back, at least it will give us a little more time for whatever, even if it's just to stock up.
If it does get sent back, will we know for what reason?

No information was ever presented here the last time it was sent back...
So I'm going to guess that we will never know.

 

[Katya]

All we know, from Bill G., is that it was sent back because it was too restrictive.

WARNING: Old thread linked below. Do not start celebrating!

White House OMB rejects FDA's draft regs for e-cigs as too restrictive, tells agency to draft/submit a new proposal

And since this one isn't any less restrictive, well...

 

[sofarsogood]

All we know, from Bill G., is that it was sent back because it was too restrictive.

WARNING: Old thread linked below. Do not start celebrating!

White House OMB rejects FDA's draft regs for e-cigs as too restrictive, tells agency to draft/submit a new proposal

And since this one isn't any less restrictive, well...

This is the first I've heard that the last time around the OMB rejected the proposed regulations. Was that April 2014, 18 months ago? I wonder how many more vapers there are now than back then, double, triple, quadruple? The devices have been though several generation changes. One thing that hasn't changed much is the rhetoric. Google on ecig news dated 5 years ago and it sounds the same as today except today the anti folks are a lot nastier.

I read a post by someone who said there used to be 5 heavy smokers in her household and now there are none and one of them quit vaping too. That is ecig news. Then there is my story, 15 smokers at work down to 10 smokers and 5 vapers a year later. The anti crowd should be delighted to hear about such successes but they won't acknowledge them.

 

[Katya]

BTW, CASAA is meeting with the OMB on the 15th of the month. They need our help, so please, if you haven't done so yet, now is the time.

Please take this survey--it's short and sweet; they would like to have 20,000 responses, only got 13,000 so far:

CASAA E-cigarette Survey - November 2015

Join and tell your story--they would like to have at least 10,000 testimonials:

http://blog.casaa.org/2015/11/national-call-to-action-stop-fda-from.htmltestimonials.casaa.org

Thanks!

 

[FranC]

Thank you,Bill.

 

[Hulamoon]

Thanks so much Bill.

 

[Manycats]

I am from Canada. Can I take the survey too and also tell my story on the BLOG?

 

[Bill Godshall]

It appears that the past month's deluge of press releases from DHHS agencies (CDC, NIDA, VA) lying about and further demonizing e-cigs are a coordinated campaign by DHHS agencies to lobby the White House to sign off on the FDA Deeming Reg were/are push back in response to our many meetings with the White House OMB/OIRA urging them to send the reg back to FDA.

So it appears our meetings with White House OMB have and continue to delay issuance of FDA's final deeming rule, which the e-cig prohibitionists wanted to be finalized before the end of 2015.

 

[Kent C]

It appears that the past month's deluge of press releases from DHHS agencies (CDC, NIDA, VA) lying about and further demonizing e-cigs are a coordinated campaign by DHHS agencies to lobby the White House to sign off on the FDA Deeming Reg were/are push back in response to our many meetings with the White House OMB/OIRA urging them to send the reg back to FDA.

Absolutely right. Not just agencies but some representatives/Senators calling on passing the final rule as well. Here's Debbie Dingell (D-Mi) (John's wife - John held that office for the longest Congressional tenure in U.S. history - 59years and succeeded his father, who held the office from 1933! lol.... some redistricting in there - mainly Detroit)


Dingell urges FDA to finalize e-cigarette rule after roadblock averted in funding bill

"U.S. Rep. Debbie Dingell (D-12th District) is thanking negotiators for preventing a “poison-pill” *** policy rider from being included in the 2016 government funding bill that would have exempted electronic cigarettes from being regulated by the Food and Drug Administration.

Following numerous reports of injuries caused by defective e-cigarettes, Dingell wrote a letter last August to FDA Acting Commissioner Stephen Ostroff urging him to finalize a proposed rule to regulate the products as soon as possible."

“poison-pill” *** - that was the amendment in the Ag bill HR 3049 that called for a new grandfather date of final rule rather than the Feb 15, 2007 date.

 

[Hulamoon]

Yes, they can get away with saying anything they please, just be first to say it, and that's what's sticks in uninformed minds. "injuries caused by defective e-cigarettes" ?? I can only assume that she included laptops, hover boards and the Dreamliner in her attempts to save us all?

Bill - as always - you are a pillar of strength in this whole lying mess. Thank you!

 

[Katya]

This is a community service announcement.

New CTA from CASAA--German steamers need our help!

CASAA: Help German Vapers oppose the TPD! Sign the petition to German Parliament.

Yeah, it's in German, but translation and a helpful guide are provided.

Carry on!

 

[sofarsogood]

It appears that the past month's deluge of press releases from DHHS agencies (CDC, NIDA, VA) lying about and further demonizing e-cigs are a coordinated campaign by DHHS agencies to lobby the White House to sign off on the FDA Deeming Reg were/are push back in response to our many meetings with the White House OMB/OIRA urging them to send the reg back to FDA.

So it appears our meetings with White House OMB have and continue to delay issuance of FDA's final deeming rule, which the e-cig prohibitionists wanted to be finalized before the end of 2015.

We are a noisey bunch. And we are talking about something important. And the pres is a smoker. AND if he has good people around him he is getting an honest presentation of the issues that is higher quality than what the pubic health nazis are spewing. To me the personal stories are the important ones, not missed business opportunities. I believe the president himself could make this call if he wanted to and may be he will.

 

[Endor]

I believe the president himself could make this call if he wanted to and may be he will.

Many of the anti-ecig crowd in government are influential Democrats. Obama is a Democrat in an election year. If he were to make the call, my fear would be that he'd follow the party line.... and that's probably not good for us.

I didn't look at every single calendar entry, but from what I did check out on the OIRA calendar, it appears that a lot more pro-ecig groups (like Bill and CAASA) met with OIRA than anti-ecig groups (at least the more recent ones).

Maybe some ANTZ groups are starting to worry?

 

[EBates]

We are a noisey bunch. And we are talking about something important. And the pres is a smoker. AND if he has good people around him he is getting an honest presentation of the issues that is higher quality than what the pubic health nazis are spewing. To me the personal stories are the important ones, not missed business opportunities. I believe the president himself could make this call if he wanted to and may be he will.

"...maybe he will." Hell will freeze over first. There is no MONEY in it! Vaping cannot match the BT/BP/BB money. So.....