FDA This is what a MRTP application looks like

[Oliver]

Well here it is, the publicly viewable modified risk tobacco product (MRTP) application by Swedish Match for their Snus product.

There's 1.79gb worth of files altogether (reportedly over 100k pages) so no-one (apart from the FDA is going to read it), but it's very interesting to see the introductory documents and the overall content of what they submitted as contributing evidence.

 

[twgbonehead]

And best guess is that the application will be rejected for "Insufficient information provided"...... 5 years from now.

 

[DrMA]

Here's a link to the FDA docket regarding this MRTP submission. We shuold submit comments urging FDA to approve the application for all ten products, and extend the same Reduced Risk designation to all other non-combustible tobacco products.

 

[Krashman Von Stinkputin]

Wow.
I can't help but imagine the FDA receiving hundreds of thousands of these for all the ecig devices, components and eliquids that currently are out there.

 

[csardaz]

Might have been interesting - with less redacting. Book and study references all or mostly redacted because they are copyrighted or might be. Anything at all about ingredients and processing - redacted - proprietary.

FDA page on MRTP looks like 2 applications were rejected and 4 denied - any way to see what products they were or basis for denial?

 

[Moonbogg]

Well if that's not designed to keep products off the market then nothing is.

 

[Krashman Von Stinkputin]

Well if that's not designed to keep products off the market then nothing is.

Welcome to the world of the FDA.

And remember this is just the submittal part of the process.
It still needs to go through the approval process.

 

[aikanae1]

I need some guidence on this one for an intelligent comment since I'm unlikely to read or understand 1.8 GB of data - but I do think filing comments is important since this could lay the road map for how ecigs are treated and access to snus is just as important as ecigs. I'd like to see a sticky or banner requesting comments on this.

 

[Krashman Von Stinkputin]

I need some guidence on this one for an intelligent comment since I'm unlikely to read or understand 1.8 GB of data - but I do think filing comments is important since this could lay the road map for how ecigs are treated and access to snus is just as important as ecigs. I'd like to see a sticky or banner requesting comments on this.

I'll admit I'm confused by your question.

Are you looking for guidance on posting a comment to the FDA website on the SNUS MRTP application specifically?

From the FDA site:
FDA is required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (MRTP) applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request ]comments on the information contained in the application and on the label, labeling, and advertising accompanying the applications.

I've not seen much in the way of SNUS-specific discussions in these forums. You may start with a forum like:
SnusOn Snus Forum & Community - SnusOn Snus Forum

Or is your questionnot trying to put words in your mouth here)

"Given that the FDA is required to make public and take comments ON PRODUCT APPLICATIONS--which are composed of research findings,studies, hard data points, citations, administrative eye candy and redacted elements---how should we, the ecig common consumer, frame a relevant comment that has impact?

In that case, you may be on to something there.
We as a community need to be prepared to comment to the FDA on applications ranging from batteries, tanks, wire, wicking material, etc. in addition to things like eliquid and nicotine.
They may all be "deemed " tobacco products and be subject to this process.

 

[sonicdsl]

There is a smokeless tobacco forum here as well: Smokeless tobacco