FDA FDA announces E-Cigarette workshop (DEC 2014)

[zoiDman]

Yey! all of 16 people.

I am deeply saddened by the gross negligence a large proportion of vapers display thru their inaction. And I fear that, in absence of overwhelming support, the ANTZ, BT, BP, BG cabal will do away with vaping as they've planned all along. I'm tempted to some degree to drop all my advocacy efforts, withdraw into my well-stocked vape den, and marvel at the perverse massacre as Orwellian FDA regulation carpet-bombs vaping out of existence.

It does get Discouraging.

But what Keeps me going is Knowing that No Matter What Happens, I wasn't someone who Did Nothing. And Even it is Bad, Really Bad, I can Look in the Mirror and Smile. Knowing that I at least Did Something.

And Tried to Make a Difference.

 

[zoiDman]

I could be a reticence to 'liking'. Unfortunately wv2win is no longer around to 'like' the post.

The Ultimate Sacrifice. "Liking" one of My Posts in the Name of Advocacy.

 

[Kent C]

Down to 15 now....
Put that lol where your facepalm is.

 

[zoiDman]

Down to 15 now....
Put that lol where your facepalm is.

Grow Up Kent

 

[SeniorBoy]

Yey! all of 16 people.

I am deeply saddened by the gross negligence a large proportion of vapers display thru their inaction. And I fear that, in absence of overwhelming support, the ANTZ, BT, BP, BG cabal will do away with vaping as they've planned all along. I'm tempted to some degree to drop all my advocacy efforts, withdraw into my well-stocked vape den, and marvel at the perverse massacre as Orwellian FDA regulation carpet-bombs vaping out of existence.

Ditto! BTW, don't read a daily RSS SE scrape of current Vaping related News. THAT is equally depressing for me.

It does get Discouraging.

But what Keeps me going is Knowing that No Matter What Happens, I wasn't someone who Did Nothing. And Even it is Bad, Really Bad, I can Look in the Mirror and Smile. Knowing that I at least Did Something.

And Tried to Make a Difference.

Well said. Ditto! The other thing that sometimes keeps me going is what I affectionately term, "Misery Loves Company" /lol I'm surrounded by a small number of ECF members who share my passion. Not perfect given the "dynamics" /cough of a Forum but helpful for me.

 

[Krashman Von Stinkputin]

Before congratulating the FDA for holding this forthcoming workshop and for allowing THR supporters to present, please remember that on December 17, 2012, more than a dozen e-cig consumers and supporters testified at a FDA public hearing about the many benefits of e-cigs, and how FDA approved drugs didn’t help them quit smoking
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal

Then in January 2013, e-cig consumers submitted more than 5,200 comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public
Regulations.gov
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html

Smokefree Pennsylvania submitted to FDA’s docket for Section 918 vast quantities of scientific and empirical evidence documenting that e-cigs and other noncombustible tobacco/nicotine products are far less hazardous than cigarettes and have helped many smokers quit smoking and reduce cigarette consumption, and that FDA approved nicotine gums, lozenges and patches have very low success rates for smoking cessation.
http://www.e-cigarette-forum.com/fo...mments-sec-918-tobacco-act-6.html#post8403639 and
http://www.e-cigarette-forum.com/fo...t-written-comments-sec-918-tobacco-act-7.html

But in April 2013, FDA sent a Report to Congress per Section 918 of TCA that contradicted and misrepresented the evidence provided to the agency on the health benefits of smokers switching to e-cigarettes or smokefree tobacco products, and on NRT’s dismal success rate for smoking and nicotine cessation at the 12/17/12 Section 918 public hearing, in >5,200 public comments submitted to agency’s dockets, at a 2/3/11 IOM MRTP meeting, at a 8/25/11 FDA MRTP meeting, and at many FDA TPSAC meetings.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html

Also note this little nugget:
Participants should note that this workshop is not intended to inform the Agency's deeming rulemaking. All comments regarding the proposed deeming rule were to be submitted to the Agency by August 8, 2014 (Docket No. FDA-2014-N-0189). As such, the scope of this workshop is limited to the topics presented in Section II.

How are we to read this then?

Having read the Deeming Proposals the FDA seemed fairly clear about their definition of an ecig being a 2007 era non-refillable tobacco/menthol flavored cigalike
If this workshop is not to INFORM (or guide) them, on what basis can a APV or mech mod even be discussed--when they don't fit that definition.
Why have the damn thing?

Does Section II tell more?

"Topics to be addressed include, for example: (1) Product science (including design, chemistry, and toxicology); packaging, labeling, and environmental impact assessments; (2) potential risks and benefits of product characteristics; (3) strategies to mitigate risk to users; (4) methods for evaluating product performance, constituents, stability, etc.; and (5) potential risks to the environment. "

So if APVs/Mods--and e-liquids for that matter--- can be discussed is that only in the context of the FDA approval process methodology?

The execution outcome of this "workshop" will be VERY ENLIGHTENING about the future of vaping
Will be following this one closely.

Thanks for posting this!

 

[VBdev]

3hour ride to DC for me. I may try to get up there for this.

 

[pamdis]

Also note this little nugget:
Participants should note that this workshop is not intended to inform the Agency's deeming rulemaking. All comments regarding the proposed deeming rule were to be submitted to the Agency by August 8, 2014 (Docket No. FDA-2014-N-0189). As such, the scope of this workshop is limited to the topics presented in Section II.

How are we to read this then?

Having read the Deeming Proposals the FDA seemed fairly clear about their definition of an ecig being a 2007 era non-refillable tobacco/menthol flavored cigalike
If this workshop is not to INFORM (or guide) them, on what basis can a APV or mech mod even be discussed--when they don't fit that definition.
Why have the damn thing?

Does Section II tell more?

"Topics to be addressed include, for example: (1) Product science (including design, chemistry, and toxicology); packaging, labeling, and environmental impact assessments; (2) potential risks and benefits of product characteristics; (3) strategies to mitigate risk to users; (4) methods for evaluating product performance, constituents, stability, etc.; and (5) potential risks to the environment. "

So if APVs/Mods--and e-liquids for that matter--- can be discussed is that only in the context of the FDA approval process methodology?

The execution outcome of this "workshop" will be VERY ENLIGHTENING about the future of vaping
Will be following this one closely.

Thanks for posting this!

My interpretation of the workshop purpose:

1. The deeming rule is a forgone conclusion.
2. After the deeming rule is finalized, we will need the ammunition to back our denials of product applications.
3. We need your help through these workshops to gather this ammunition.

I would also submit that the deeming rule will be finalized, not after it has been reworked based on comments, but after they have gathered all the information they need to bolster their application denials. Based on science gathered from these workshops, of course.

 

[DrMA]

Except that there would only be 3 applications: Vuse, Blu, Njoy. And all 3 will be accepted. The other companies out there cannot afford putting together a PMTA.

 

[Nate760]

"Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony."

-- Sherman Antitrust Act of 1890

 

[ronnbert]

"Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony."

-- Sherman Antitrust Act of 1890

Someone needs to tell this to Walmart -_-

Anyways, I will be following this newest development closely, and have subscribed to this post. Thanks for the great info from all!

 

[Kent C]

"Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony."

-- Sherman Antitrust Act of 1890

Like any union? or the Federal Reserve? Fannie Mae, Freddie Mac?

 

[Krashman Von Stinkputin]

Except that there would only be 3 applications: Vuse, Blu, Njoy. And all 3 will be accepted. The other companies out there cannot afford putting together a PMTA.

and for those that possibly could afford the price of submission (perhaps the "big boys" like Innokin, ProVape, Evolv, KangerTech,Johnson Creek, Halo--who MAY have little additional production compliance costs) could they afford the disruption in sales while "approval pending"?