Swedish Match vs FDA

[Snusdog]

Still hope. What a lousey way to run a Government...
http://www.snuscentral.org/snus-news...plication.html

Thanks for sharing the Article. Larry does a good job reporting on the issues.

It seems SM is still in the game.......I still give the odds at 30/70......

I also would be hesitant to read correlation into a mere series of events.........i.e. that releasing certain members from the FDA committee is somehow correlated (or reflects upon) how the FDA will think through SM's request.........there are too many other possible causal explanations (like there actually was a conflict of interest, that actually did hinder the FDA's operations in court, and that the nature of the conflict (pro or anti- tobacco) played no factor in the decision.......the conflict of interest not the content of interest was the grounds for their release)....Thus I would be hesitant to draw indication of sweeping changes in ideology from a mere temporal sequence of unrelated events.


Anyway...........it is good news........and even if the request is finally denied.......I think it has done its job.........It has weakened (or exposed the weakness) of the Anti-tobacco position.......and.....it has succeeded in making the topic of Harm Reduction Products a serious one

[grimsaviour]

What's with this debacle regarding Onyx not being able to be sold in the US because of some pigmentation ? Anyone have some intel to give ?

[Burnsey]

What's with this debacle regarding Onyx not being able to be sold in the US because of some pigmentation ? Anyone have some intel to give ?

Several online stores have it available to US.......

[codyg140]

They seem to go through periods where they stop selling onyx to the US then a week later they sell it again. Perfectly normal

[Burnsey]

What's with this debacle regarding Onyx not being able to be sold in the US because of some pigmentation ? Anyone have some intel to give ?

snuscentral has Onyx on sale atm........

[Daniel_snus24]

imho Onyx is not worth the price

[Burnsey]

http://www.snuscentral.org/snus-news/mr-unz-reports/item/670-general-snus-mrtp-application-moves-forward-fda-to-release-tomorrow.html

[Snusdog]

http://www.snuscentral.org/snus-news/mr-unz-reports/item/670-general-snus-mrtp-application-moves-forward-fda-to-release-tomorrow.html

Nice find Burnsey! Larry does a good job on reporting these matters.

Best line from the article

You don't have to be a scientist or tobacco expert to make a statement. Your personal story of how General Snus and Swedish snus helped you, a friend, or a loved one quit smoking is equally if not more valuable.

[Burnsey]

Nice find Burnsey! Larry does a good job on reporting these matters.

Best line from the article

Indeed dog, Larry is on the ball.....

Comments here, green box/link....https://www.federalregister.gov/arti...-swedish-match

[mattzq8sonoma]

What's with this debacle regarding Onyx not being able to be sold in the US because of some pigmentation ? Anyone have some intel to give ?

The pigment, used by at least 1 supplier, in the pouch material to make it black is not yet FDA approved as a food grade additive. It's approved pretty much everywhere else to my knowledge. So you can get it, but IMO it's not 100% "kosher" in the US.

[Burnsey]

“This application is important for us because we are hoping that, for the first time, we will actually be able to remove what we believe to be inaccurate, inappropriate warnings for snus products,” .......Gerry Roerty, vice president and general counsel of Swedish Match North America

http://www.richmond.com/business/loc...bcf7afb5a.html

[Snusdog]

“This application is important for us because we are hoping that, for the first time, we will actually be able to remove what we believe to be inaccurate, inappropriate warnings for snus products,” .......Gerry Roerty, vice president and general counsel of Swedish Match North America

http://www.richmond.com/business/loc...bcf7afb5a.html

That was a pretty balanced article. Not a lot of new or in depth info......but a good summery of where the lines divide....Thanks for posting it bro

[mattzq8sonoma]

http://www.fda.gov/NewsEvents/Newsro.../ucm472026.htm

Swedish Match given the OK for premarket tobacco application...PMTA...for 8 General Brands. This is not the same thing as MRTP, but my opinion and hope is that it's a necessary precursor to an MRTP order being approved....

we shall see

[Snusdog]

http://www.fda.gov/NewsEvents/Newsro.../ucm472026.htm

Swedish Match given the OK for premarket tobacco application...PMTA...for 8 General Brands. This is not the same thing as MRTP, but my opinion and hope is that it's a necessary precursor to an MRTP order being approved....

we shall see

That is good news on several fronts

1) it seems to indicate that SM is looking to release more variety into the American market

2) That the FDA has granted this prelim step is a good sign

3) More important than all of that, SM's apparent preparation to expand its American market, may reveal an optimism on how they think the FDA will rule on the Harm Reduction application.

Maybe not. But it does seem to indicate a fairly significant change in their prior "General only" policy

[mattzq8sonoma]

It is my understanding that the PMTA approval is for the 8 General brands that are currently sold in the US today. Mint, Mini Mint, Wintergreen, White, Original, Loose, Nordic Mint, Classic Blend. You have to get PMTA approval before making modifications to a product that was originally marketed and sold after Feb 15, 2007, but before March 22, 2011, which is where these General brands fit in on the timeline. See the link below, page 5. In order to have more variety, Snusdog, at this point, manufacturers are required to go down the SE (substantial equivalence) pathway to sell new products. So these unfortunately are NOT additional products. Sorry to burst that bubble. But it's still good news for the MRTP applications, as reduced risk, among other things, is part of what has to be proven in a PMTA application....which in turn would be good news for additional products.

http://www.fda.gov/downloads/tobacco.../ucm277665.pdf