FDA TVECA post table of contents for Deeming Final Rule

[Lessifer]

Matthew McConaughey taught me that the FDA is a bully, and then I bought a Lincoln.

 

[navigator2011]

My gosh how did Hitler & Stalin's love child get to be in charge of the FDA?

Well, Obama did promise change . . . and we did ask for it twice, right?

 

[tiburonfirst]

wrong - the country's been heading that way for a long time now

and let me assure you - i did note vote for obama

 

[Ca Ike]

Personally I think it should be up to the SFATA along with manufacturer, researcher and vaper input to set standards. They know the industry in ways no alphabet soup group will ever know it. TheFederal Dictators Association needs to be abolished as their conflict of interest level insures they can't be impartial and objective like they are supposed to.

 

[puffon]

and we did ask for it twice, right?

Hmmm...not me.........

 

[nicnik]

TheFederal Dictators Association needs to be abolished as their conflict of interest level insures they can't be impartial and objective like they are supposed to.

Instead of abolishing the FDA, the conflicts of interest need to be removed. The same goes for other regulatory angencies.

The President promised to fix the regulatory capture problem, and quickly retreated as soon as there was pushback from his first feeble attempts. The revolving doors between industry and regulators are still in full swing in both directions.

 

[squee]

Well, Obama did promise change . . . and we did ask for it twice, right?

I did! Twice!

 

[Katya]

One thing that Confuses me when I hear the expression "Self-Regulation" is can Regulation Exist without Enforcement of said Regulations?

If so, who Enforces things when Something or Someone is in Non-Compliance in this Self-Regulated Market? And what are the Actual Regulations that we are Self-Regulating ourselves to in the First Place?

The Congress has granted the FDA the power to deem e-cigarettes as tobacco product. Only Congress can take it away--not likely under this administration. So the regulations are going to happen, whether we like it or not. The only question remaining right now is how much regulation...

The entire discussion about self-regulating is, at this time, moot, albeit interesting. The OMB is holding hearings as we speak. They can reject the proposed deeming regulations as too draconian and send them back to FDA, which would be the best possible outcome for us and for the industry. Or the Congress could pass one of the grandfather bills that are still in limbo. which would severely limit the FDA's regulatory powers.

We have but a few weeks left to launch a massive effort on behalf of the industry and vapers to try to convince the OMB and/or our representatives to do something to save vaping.

I don't understand why CASAA is silent. I've been trying to get in touch with @JustJulie and @kristin. Time is running out...

@Robino1 @JustJulie @Vocalek @kristin

Speaking of calls to action, I know you guys must be very busy right now, but since the last one was so successful, shouldn't CASAA issue a new one?



There is another bill very similar to the HR 2058:

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?

Also, I listened very carefully to Dimitri's interview with Bill Godshall and Azim Chowdhury the other night. Shouldn't we be writing to OMB/OIRA also? They are not FDA and they are supposed to be on the side of small businesses. Wouldn't it be helpful if they could hear from us, vapers-customers, about what would happen to us and about the risks of creating a huge black market for e-cigarettes when/if the vaping industry is destroyed by the FDA draconian deeming regs?

VP Live - Vaping Podcasts



Thanks!

Yes, I can write to the OMB myself, but that won't do much, I'm afraid. I'm just a vaper who doesn't want to go back to smoking or NRT products...

I would also like to hear from @Bill Godshall.

It's now or never, folks.

My

 

[Kent C]

I now agree that we are in a "Self-Regulated" Market.

Ok - now we're getting somewhere. I just propose that we should stay that way because - as in my post above - we (including you I might add) we've done so good at it.

For anything else I'll just say to you "Oh Yeah, I'm Totally with you." :- )

 

[LouisLeBeau]

The Congress has granted the FDA the power to deem e-cigarettes as tobacco product. Only Congress can take it away--not likely under this administration. So the regulations are going to happen, whether we like it or not. The only question remaining right now is how much regulation...

The entire discussion about self-regulating is, at this time, moot, albeit interesting. The OMB is holding hearings as we speak. They can reject the proposed deeming regulations as too draconian and send them back to FDA, which would be the best possible outcome for us and for the industry. Or the Congress could pass one of the grandfather bills that are still in limbo. which would severely limit the FDA's regulatory powers.

We have but a few weeks left to launch a massive effort on behalf of the industry and vapers to try to convince the OMB and/or our representatives to do something to save vaping.

I don't understand why CASAA is silent. I've been trying to get in touch with @JustJulie and @kristin. Time is running out...



Yes, I can write to the OMB myself, but that won't do much, I'm afraid. I'm just a vaper who doesn't want to go back to smoking or NRT products...

I would also like to hear from @Bill Godshall.

It's now or never, folks.

My

Yeah, I replied to my Senators boilerplate response to my letter stating "he would keep my views in mind", and told him I didn't VOTE for him to "keep my views in mind", I voted for him to be PROACTIVE in REPRESENTING THE WILL OF HIS CONSTITUENTS instead of "keeping them in mind". Kerfluffle candypants junket junky mealymouths. Told him he better check the number of vapers, and their passion for an alternative to CANCER. Backlash is satisfying, but always too little too late.

 

[Kent C]

Personally I think it should be up to the SFATA along with manufacturer, researcher and vaper input to set standards.

I'm all for that - and for those who want that assurance. However, there are some vendors that want to do it their way or use their own testing - for that as well. Just so they don't use that as a stepping stone to get a job at the FDA in order to 'enforce' those standards on all, as so many other people in 'consumer groups' have done. Or use their positions to attend hearings to lobby for designated smoke/vape areas.

 

[Kent C]

The entire discussion about self-regulating is, at this time, moot, albeit interesting.

I agree (somewhat) - I'm a realist, BUT part of the reason for HR 2058 and HR 3049, is the innovation and self-regulatory efforts by the industry. Sen Burr pointed some of them out, so did Cole and Aderholt. The other part is to save jobs and save the THR aspect of ecigs - but even that has to do with how self-regulation has been beneficial and healthier and safer.

And all of my emails CTA's include this aspect to show how it can be and has been done, rather than all the handwringing and personal stories - which truly is moot to people who know what's best for you.

 

[haleysdadda]

I did! Twice!

BLASPHEEMER! LOL!

 

[sofarsogood]

After these rules are finalized our dear beloved so-called vape "industry" will propose that pre mix should be allowed but taxed. The moment the discussion turns to money for the government the health issues will disappear from the discussion. Our right honorable congress will throttle that nasty old FDA (in return for billions of dollars) and we poor poor vapers will be so relieved and grateful.

Nutts

 

[navigator2011]

I thought I heard that Obama vowed to veto HR 2058 and HR 3049 if they are passed by Congress.

 

[zoiDman]

The Congress has granted the FDA the power to deem e-cigarettes as tobacco product. Only Congress can take it away--not likely under this administration. So the regulations are going to happen, whether we like it or not. The only question remaining right now is how much regulation...

...

It is Refreshing to hear from Someone who has a Clear Grasp as to What is going to Happen.

And is Thinking More about the Future and what is Actually Possible.

 

[Kent C]

I thought I heard that Obama vowed to veto HR 2058 and HR 3049 if they are passed by Congress.

Bill G speculated about that earlier:

"While Obama almost certainly would veto HR 2058 if it is enacted this session of Congress"

And the Ag bill proposal is about a 1/2 a billion less than what the President wanted/proposed, so that's possible but likely not on the FDA issue.

 

[Kent C]

Still holding on eh?

It is Refreshing to hear from Someone who has a Clear Grasp

Which you clearly don't have. Any more snide comments??

 

[Katya]

I thought I heard that Obama vowed to veto HR 2058 and HR 3049 if they are passed by Congress.

That should not stop us from writing to our representatives and letting them know how we the people feel.

And all the more reason to write to the OMB. We need hundreds of thousands of emails and/or phone calls NOW! Even the president can't prevent the OMB from rejecting the deeming regulations.

 

[salemgold]

After these rules are finalized our dear beloved so-called vape "industry" will propose that pre mix should be allowed but taxed. The moment the discussion turns to money for the government the health issues will disappear from the discussion. Our right honorable congress will throttle that nasty old FDA (in return for billions of dollars) and we poor poor vapers will be so relieved and grateful.

Nutts

Health issues have only been a part of the discussion to keep up appearance. They have never truly been considered. It is and always has been all about the money IMHO