FDA TVECA post table of contents for Deeming Final Rule

[zoiDman]

True, but there is the existing framework of Modified Risk tobacco Product, and that one works so well...

Sorry, I'm not really trying to be a downer, just not feeling all that hopeful at the moment. Maybe I should go read some testimonials and get my spirits back up.

I did read today that the CDC estimates about 9 million vapers in the US, I just wish we could get at least half of them to participate.

Hey No Problem. I'm not Exactly Thrilled about How Much Sand is left in the Glass. Or the way I think things are going to come out.

But take a Small Amount of Positiveness out of Everything that has happened. Because I think that the Extremely Long Amount of Time that the FDA has Taken to get to where they are is More of a Good Sign that a Bad One.

And it has Allowed Meaningful Studies to be Published in the Interim that Can have Positive Effects at the State/Local Policy Levels.

 

[Kent C]

I know of No Requirement for the Office of the President to act on any OMB Submission.

then the OMB is not under any Time Requirements.

From the Dem "Senator Letter" to OMB director Shaun Donovan:

"As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer. "

Senators Press OMB to Quickly Review Rule Finally Regulating E-Cigarettes and Other Unregulated Tobacco Products | U.S. Senator Jeff Merkley of Oregon

 

[zoiDman]

From the Dem "Senator Letter" to OMB director Shaun Donovan:

"As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer. "

Senators Press OMB to Quickly Review Rule Finally Regulating E-Cigarettes and Other Unregulated Tobacco Products | U.S. Senator Jeff Merkley of Oregon

"Finalizing this rule cannot wait until 2016."

What I find somewhat Comical about statement like this is "Why does it have to be Done by the End of 2015?". Seems like the Importance would be placed on Doing a review Right. Not on doing a review Fast.

I wonder when the Last Time the OMB has Reviewed something this Meaningful to Public Health?

BTW - What happens if the OMB Can't or Doesn't get their Review process completed in the Allotted Timeframe?

Do they have to Forfeit their Game Checks on Sunday?
Censored in front of a Bi-Partisan committee on Government Employee Performance?
Have their Names Listed on the CNN Crawl 24-7?
Nothing?

 

[Katya]

From the Dem "Senator Letter" to OMB director Shaun Donovan:

"As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer. "

Senators Press OMB to Quickly Review Rule Finally Regulating E-Cigarettes and Other Unregulated Tobacco Products | U.S. Senator Jeff Merkley of Oregon

"Every day of further delay is compromising the health of America’s youth."

Wrong!

"According to the Centers for Disease Control and Prevention (CDC) 2014 National Youth tobacco Survey released in May, e-cigarette use among high school students tripled in the last year, from 4.5 percent in 2013 to 13.4 percent in 2014."

Lies!

E-cigarette regulations may increase teen smoking (and help Big Tobacco)

E-cigarettes are NOT a gateway and they DO help people quit

Yale study finds state youth e-cig bans lead to increased traditional cigarette smoking

Well, if the senators can write to the OMB, so can we!

Still hoping that CASAA will issue a CTA--before it's too late.

@JustJulie @kristin

 

[Kent C]

Exactly right on the links - only thing is that while it's the CDC's own study/data - they spin it the other way .... of course

Well, if the senators can write to the OMB, so can we!

I don't wait for them anymore.... just as easy, and less 'form lettery', for me to get the email and contact directly. Thanks to snork, Zoidman and others who posts links to these people too.

 

[Katya]

I don't wait for them anymore.... just as easy, and less 'form lettery', for me to get the email and contact directly.

Right. I agree. But 200K emails would be nice...

 

[Lessifer]

Just saw this, and it probably deserves its own thread if there isn't one already.
FDA issues first product marketing orders through premarket tobacco application pathway

So after almost two years, and probably millions spent, Swedish Match gets PMTA authorization for their General Snus. Not MRTP, so they can't say it's less harmful than smoking, but at least they can sell it, with the warning that it is not less harmful than smoking, of course.

 

[Katya]

Just saw this, and it probably deserves its own thread if there isn't one already.
FDA issues first product marketing orders through premarket tobacco application pathway

So after almost two years, and probably millions spent, Swedish Match gets PMTA authorization for their General Snus. Not MRTP, so they can't say it's less harmful than smoking, but at least they can sell it, with the warning that it is not less harmful than smoking, of course.

Good news! Congratulations to Swedish Match (the makers of my favorite snus)--and the FDA!

Keep up the good work. Tobacco harm reduction is a good thing, Mr. Zeller.

Too bad about the time and money wasted--snus has been already proven to be safe years ago, through hundreds of studies...

“The law is clear. Companies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”

Hmmm... The timing of this pronouncement is a bit suspect, methinks...

 

[zoiDman]

Just saw this, and it probably deserves its own thread if there isn't one already.
FDA issues first product marketing orders through premarket tobacco application pathway

So after almost two years, and probably millions spent, Swedish Match gets PMTA authorization for their General Snus. Not MRTP, so they can't say it's less harmful than smoking, but at least they can sell it, with the warning that it is not less harmful than smoking, of course.

Thank you for Posting this Lessifer. I hadn't seen it.

"The marketing orders are for eight Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. The PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse. The FDA’s review also determined that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively. The marketing orders are product-specific and do not apply to other tobacco products."

I'm not very familiar with Snus. So here is a Question.

For How Long has Swedish Match North America been selling those 8 Products in the US Market?

 

[Kent C]

Just saw this, and it probably deserves its own thread if there isn't one already.
FDA issues first product marketing orders through premarket tobacco application pathway

Hmmm... The timing of this pronouncement is a bit suspect, methinks

Good. And this part looks more like an ad for a deeming that will destroy ecigs - UNLESS, you follow the law (and pay dearly for the opportunity):

“The law is clear. Companies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”

An attempt to show them as 'reasonable' - that is IF you have the $333,000 per product application

However, the 'studies' needed for ecigs, imo, should be even less because there is no actual tobacco involved - but that may just me being 'overly optimistic' :- )

And again, there should be no deeming at all, no applications, no fees, just vaping left alone.

 

[Katya]

An attempt to show them as 'reasonable' - that is IF you have the $333,000 per product application

That's exactly what I thought...

And as for reasonable, well, Swedish Match submitted a 100,000-page-long application. And they already had tons of studies from Sweden and Europe showing that snus is benign, including one published in The Lancet.

Swedish Match submitting 100,000 page MRTP application for General Snus to FDA

"Please note that Swedish Match has already filed at least 185 Substantial Equivalence applications with the FDA, and that FDA approved 8 of them so far. Although none of the eight SE approvals were for Swedish Match General snus, I strongly suspect that at least several of the 185 SE applications submitted by Swedish Match were for General snus.
http://www.snuscentral.org/snus-new...ight-swedish-match-smokeless-tobacco-products"

So there.

 

[Katya]

For How Long has Swedish Match North America been selling those 8 Products in the US Market?

IIRC, since 2009. Officially, at least.

 

[SeniorBoy]

FYI: TVECA has posted details about their public Q and A Meeting on their Twitter page.

I have no clue on exactly what topics they will cover or any other information to offer, other than what they have publicly disclosed on their Twitter page.

 

[zoiDman]

IIRC, since 2009. Officially, at least.

At that was for the 8 Products that just Received PMTA Approval. Right?

 

[Katya]

At that was for the 8 Products that just Received PMTA Approval. Right?

I'm really not sure, Z, and I don't want to spread misinformation...

All I do remember is that snus was included in the PACT Act, and that made our (Swedish snus users') lives absolutely miserable...

 

[zoiDman]

I'm really not sure, Z, and I don't want to spread misinformation...

All I do remember is that snus was included in the PACT Act, and that made our (Swedish snus users') lives absolutely miserable...

I completely Understand Kat.

I was just trying to get a Warm-n-Fuzzy feeling of how this might Apply to people Selling e-Liquids while they have a PMTA under Submission? Or to how long a person can keep Selling an e-Liquid without having Submitted a PMTA Submission?

BTW - Do you ever feel like you are Trying to figure out the Color of a Wallpaper by stumbling around in a Dark Room full of Furniture?

 

[zoiDman]

FYI: TVECA has posted details about their public Q and A Meeting on their Twitter page.

I have no clue on exactly what topics they will cover or any other information to offer, other than what they have publicly disclosed on their Twitter page.

Thanks for Posting this SB.

Nothing against Twitter. But with something as Important as the FDA Deeming, I sure wish someone would spend 20 Minutes to put a 3 or 4 Paragraph "News Flash" on their Web Site.

 

[DC2]

I don't know about owners and moderators, but I know for a fact that at least two prominent ECF members were involved with AEMSA from day 1.

All I know is that one of the founders of AEMSA was the leader of this project...
https://www.indiegogo.com/projects/we-are-vapers#/

Last update was two years ago.
And yes, I donated money, and yes, I hold a grudge.

 

[Katya]

I was just trying to get a Warm-n-Fuzzy feeling of how this might Apply to people Selling e-Liquids while they have a PMTA under Submission? Or to how long a person can keep Selling an e-Liquid without having Submitted a PMTA Submission?

Get in line, dear.

BTW - Do you ever feel like you are Trying to figure out the Color of a Wallpaper by stumbling around in a Dark Room full of Furniture?

Only for the past six years, Z. Before that, I was a smoker and I had no problems whatsoever. I just smoked and I knew that nobody would ever dare ban cigarettes--no matter what they said.

 

[Katya]

All I know is that one of the founders of AEMSA was the leader of this project...
https://www.indiegogo.com/projects/we-are-vapers#/

Last update was two years ago.
And yes, I donated money, and yes, I hold a grudge.

Right.

Whatcha gonna do...