FDA approves eight SE applications for smokeless tobacco products manufactured by Swedish Match

[Bill Godshall]

Today the FDA approved eight SE applications for smokeless tobacco products manufactured by Swedish Match North America, Inc.: Timber Wolf Long Cut Wintergreen, Renegade Long Cut Straight, Renegade Long Cut Wintergreen, Timber Wolf Long Cut Apple, Timber Wolf Long Cut Peach, Timber Wolf Long Cut Straight, Timber Wolf Long Cut Cool Wintergreen, and Timber Wolf Fine Cut Wintergreen.
Tobacco Product Marketing Orders

According to FDA

The Agency determined these products to be “substantially equivalent” to predicate tobacco products. FDA concluded that, while the new products have different characteristics than the predicate products, the new products do not raise different questions of public health. An SE Marketing Order is not a finding that the product is safe or safer than its predicate product, or less harmful in general. In addition, the law makes clear that companies cannot say their products are FDA approved.

This is a relief, as prior to this, the FDA had only approved nine SE applications, and all were for cigarettes (2 for manufactured cigarettes, and 7 for RYO papers and tobacco).

Unfortunately, this won't help e-cigs if they are deemed regulated as tobacco products, as none of today's e-cig products are substantially equivalent to those on 2007, and the deeming regulation would ban the sale of all e-cigs currently on the market (unless FDA specifically exempts e-cigs from Section 905 and 910 prohibition clauses.

 

[Orb Skewer]

A major step forward in THR-good news indeed

 

[AgentAnia]

If you have a few or several hundred minutes, take a gander at this FDA report on just one review and evaluation report on one of these products (which, btw, took from January 2012, when the application was submitted, to the present): http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM375196.pdf

Bureaucratic insanity. Positively, absolutely, un effing believable...

 

[Orb Skewer]

Sickening and surreal
DC2 (I think) pointed this out a while back-Nicotine-if it was classified as a dietary product (which it could easily be described as)
And a PV was re described as a "Fat person resizing device" the FDA would 'fast-track' its approval,,,Fot the wuk ??

 

[Elnroth]

What I want to know is what are the items they blanked out, and why did they blank them out.

 

[AgentAnia]

What I want to know is what are the items they blanked out, and why did they blank them out.

"Government in the sunshine"? Nope, it's cloudy with possibility of thunderstorms over at FDA...

 

[Bill Godshall]

AgentAnia wrote

Bureaucratic insanity. Positively, absolutely, un effing believable...

Swedish Match has employed many researchers in the past fifteen years to document that snus/smokeless is far less hazardous than cigarettes. Unfortunately, no e-cig manufacturers (except Altria, Reynolds and Lorillard) have that type of scientific expertise.

Now try to envision 500 e-cig companies submitting these types of reports. That's why FDA regulation of e-cigs will basically give the e-cig industry to Big Tobacco.

Elnroth inquired

What I want to know is what are the items they blanked out, and why did they blank them out.

Its called redacting (to remove proprietary or other information that FDA isn't allowed to make public).

 

[AgentAnia]

....Now try to envision 500 e-cig companies submitting these types of reports. That's why FDA regulation of e-cigs will basically give the e-cig industry to Big Tobacco.

I'm trying to envision the FDA "reviewers" reviewing the applications submitted by 500 e-cig companies, given that each individual product (each flavor of each strength, e.g.) requires a separate application. And we think that fewer than, what?, a dozen SE applications took so long!

:developing "envisioning" headache; going to order more nic base for the freezer:

 

[Elnroth]

Its called redacting (to remove proprietary or other information that FDA isn't allowed to make public).

I figured that was some of it. There is an awful lot of blanked out material for it to be solely proprietary information. But then again, the fda was evaluating whether the darkness of the product made it more attractive to users. So I could see them assessing every minute detail. Because it would not be substantially equivalent if a man named Stan packaged the chewing tobacco. But, if he was wearing nike's at the time, it's ok.

 

[WarHawk-AVG]

Ultimately...boils down to, Do you trust your government?

 

[k3vin]

ISnt our liquid "substantially equivalent to what was on the market in 2007??

 

[NorthOfAtlanta]

ISnt our liquid "substantially equivalent to what was on the market in 2007??

By any common sense rules yes, by the FDA rules: