FDA FDA issues Final Guidance for SE Reports, making it nearly impossible to obtain FDA SE approval for 2006 e-cigs

[Bill Godshall]

Today, FDA issues Final Guidance for “Demonstrating the Substantial Equivalence of a New tobacco Product: Responses to Frequently Asked Questions.” Agency now allows for some changes/differences (from 2007 SE predicate product) in “label” (but not brand name),
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM436468.pdf
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-05023.pdf

Looks like the FDA has decided that it won't be approving more than one or two SE Reports for e-cig products that that are SE to an e-cig on the market back in 2006 (although njoy might have saved one or two of their 2006 E-cigars, and may consider submitting an SE Report for it if it decides to put the product back on the market).


Please see 2013 thread explaining FDA SE guidance, SE Reports and SE approvals by FDA
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

 

[Kent C]

I would hope people would read the gov't's pdf on this, just to show the minutiae that regulators go to hamstring manufacturers, either for any whatsoever trumped up reason - environment, health, equality, political correctness, fairness OR to help protect their fascistic business partners who fund them and who rely on them to eliminate any competition. And that such minutiae occurs on any product that is produced or any service that is provided by the market. And that this is just a fraction of the regulations on any such product or service.

 

[TheRac25]

help protect their fascistic business partners who fund them and who rely on them to eliminate any competition.

as long as there is a state capable of doing this there will be those who seek to utilize it. in fact it is their fiduciary responsibility to do so

 

[Kent C]

as long as there is a state capable of doing this there will be those who seek to utilize it. in fact it is their fiduciary responsibility to do so

Doesn't make them less fascistic. But it does call into question their free market (and hence moral) credentials - something that stockholders should be aware of and choose wisely as to what to invest in.

 

[TheRac25]

Doesn't make the less fascistic. But it does call into question their free market (and hence moral) credentials - something that stockholders should be aware of and choose wisely as to what to invest in.

Right, since they can choose to do something else that makes them part of it. Its not a gun to the head situation like paying taxes, which would be in the category of concentration camp inmate.

 

[DEA7H INC]

So I take it by this that it means the deeming regulation is going to be completely unreasonable in every respect and ban pretty much everything? Because that's what it sounds like this means.

 

[Kent C]

So I take it by this that it means the deeming regulation is going to be completely unreasonable in every respect and ban pretty much everything? Because that's what it sounds like this means.

I pretty much came to the same conclusion - they're 'adjusting' for it already - they must think it's going to be. I'm sure there are some doubts but it looks like full steam ahead. If I were them, I'd take the same position. (well, if I were them, I'd kill myself )

 

[klynnn]

Did you really expect anything different?

 

[Luisa]

Today, FDA issues Final Guidance for “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.” Agency now allows for some changes/differences (from 2007 SE predicate product) in “label” (but not brand name),
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM436468.pdf
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-05023.pdf

Looks like the FDA has decided that it won't be approving more than one or two SE Reports for e-cig products that that are SE to an e-cig on the market back in 2006 (although NJOY might have saved one or two of their 2006 E-cigars, and may consider submitting an SE Report for it if it decides to put the product back on the market).


Please see 2013 thread explaining FDA SE guidance, SE Reports and SE approvals by FDA
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

Does this mean that only a lawsuit against the FDA can save e-cigs?

 

[Moonbogg]

I have no idea what this means. I guess I could hire a lawyer to decode it for me and rewrite it in English.

 

[caramel]

I have no idea what this means. I guess I could hire a lawyer to decode it for me and rewrite it in English.

It says "We'll do as we wish nah nah nah".

 

[Bill Godshall]

Kent wrote

I would hope people would read the gov't's pdf on this, just to show the minutiae that regulators go to hamstring manufacturers, either for any whatsoever trumped up reason - environment, health, equality, political correctness, fairness OR to help protect their fascistic business partners who fund them and who rely on them to eliminate any competition. And that such minutiae occurs on any product that is produced or any service that is provided by the market. And that this is just a fraction of the regulations on any such product or service

Please remember that the only reason FDA regulators are imposing dozens of nonsensical and dangerous (for public health and freedom) regulations is because the FSPTCA (enacted by Congress) requires the agency to do so.

The only reason the FSPTCA was enacted was because Philip Morris, GSK, RWJF, CTFK, ACS, AHA, ALA, AMA, AAP, Waxman, Kennedy aggressively lobbied for its enactment to protect their own selfish interests (by deceitfully repeating the lie that the bill was essential for protecting children from Big Tobacco).

And the only reason those entities spent hundreds of millions of dollars lobbying for the FSPTCA from 2003-2009 was because in 2003/04 Philip Morris lawyers, GSK's Mitch Zeller and CTFK's Matt Myers secretly negotiated (and hammered out details of) every provision in the FSPTCA.

FDA's final guidance on SE reaffirmed the agency's previous draft guidance on SE, but threw a tiny little bone to cigarette and smokeless tobacco companies (who have made, or who want to make, negligible changes in their 2007 cigarettes or smokeless tobacco products), as the draft guidance didn't allow for any changes to the 2007 product.


Luisa wrote

Does this mean that only a lawsuit against the FDA can save e-cigs?

The FDA could still change the SE grandfather date for newly deemed products (e.g. from 2007 to 2014/15), as the letter to DHHS Secretary Burwell from US House leaders requested.

But if the FDA issues a Final Rule for the "deeming reg/ban" without changing the 2007 SE date, a lawsuit could be filed by an e-cig manufacturer challenging that date (by arguing that Congress never intended FDA to retroactively apply the 2007 SE date to newly deemed tobacco products, and that the FDA has never taken any action on SE Reports submitted for 98% of cigarette brands and smokeless tobacco brands (most of which were submitted back in 2011)).

Also, Congress can further reign in the FDA (if we can convince the House E&C Cmte and/or Senate HELP Cmte to hold hearings and take action).

But we need to focus on exposing and stopping the deeming regulation from moving forward (not trying to get the SE date moved forward, although that's Plan B).

If FDA moves the SE date forward for newly deemed tobacco products in the Final Rule, it would still halt virtually all technological changes to vapor products beyond the new SE date, which could keep some PVs and e-liquid products on the market (but would still ban most PVs and e-liquid products due to high costs and barriers to attain SE approval by FDA).

 

[skoony]

Does this mean that only a lawsuit against the FDA can save e-cigs?

they were given authority by congress to do this.
can't sue them for that.
mike
p.s. or what Bill just said in the above post.

 

[Kent C]

Did you really expect anything different?

No. What, in what I said, would make you think I didn't? There's no hint of 'surprise' or 'shock'.....

 

[Kent C]

Kent wrote

"I would hope people would read the gov't's pdf on this, just to show the minutiae that regulators go to hamstring manufacturers..."

Please remember that the only reason FDA regulators are imposing dozens of nonsensical and dangerous (for public health and freedom) regulations is because the FSPTCA (enacted by Congress) requires the agency to do so.

Bill, I agree with all you say here. My point was to those, unlike you, who haven't read how 'refined' regulations can get - how deeply intrusive the rules are, and to make the point that there is no part of manufacturers' business OR people's lives that the gov't thinks is none of their business. Many here know this well, some don't - those that don't, should know, and reading just this should help this understanding.

 

[work_permit]

Does this mean that only a lawsuit against the FDA can save e-cigs?

That or an act of congress. Boehner is a smoker and seems favorible to our cause. Maybe someone should send him and evod.

 

[DC2]

That or an act of congress. Boehner is a smoker and seems favorible to our cause. Maybe someone should send him and evod.

Here are some interesting things to look at...
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News
EverSmoke offers Boehner e-cigarettes | TheHill
09 – Even President Obama owns an electronic cigarette! | mHerbal.com
House Leader Boehner Opposes E-Cigarette Ban - Record


The second link indicates that Boehner has been offered an electronic cigarette by EverSmoke.
The third link indicates that Boehner has been sent an electronic cigarette by Congressman Cliff Stearns.
The last link claims that Boehner does in fact use an electronic cigarette.

 

[Kent C]

Here are some interesting things to look at...
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News
EverSmoke offers Boehner e-cigarettes | TheHill
09 – Even President Obama owns an electronic cigarette! | mHerbal.com
House Leader Boehner Opposes E-Cigarette Ban - Record


The second link indicates that Boehner has been offered an electronic cigarette by EverSmoke.
The third link indicates that Boehner has been sent an electronic cigarette by Congressman Cliff Stearns.
The last link claims that Boehner does in fact use an electronic cigarette.

There was a picture of Boehner and Rep. Duncan Hunter Jr. both vaping outside near the Capitol Building. I can no longer bring up that pic.

 

[work_permit]

Here are some interesting things to look at...
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News
EverSmoke offers Boehner e-cigarettes | TheHill
09 – Even President Obama owns an electronic cigarette! | mHerbal.com
House Leader Boehner Opposes E-Cigarette Ban - Record


The second link indicates that Boehner has been offered an electronic cigarette by EverSmoke.
The third link indicates that Boehner has been sent an electronic cigarette by Congressman Cliff Stearns.
The last link claims that Boehner does in fact use an electronic cigarette.

If he's willing to sends a letter to the FDA just from getting an eversmoke, imagine the possibilities if he tried a subtank. But whats really intriguing is the possibility that Obama is a closet vaper. That would be just too good to be true.