Swedish Match vs FDA

[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 ?

[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

[Burnsey]

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

"It is deeply troubling that the FDA today removed several extraordinarily qualified members of its Tobacco Products Scientific Advisory Committee (TPSAC) based on a misguided and overreaching court ruling that is under appeal."

For the record, I don't find this particularly troubling....

[Andy105]

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

[Snusie]

From The New York Times:

"At one point Mitch Zeller, head of the F.D.A.’s Center for Tobacco Products, which will ultimately decide on the application... Mr. Zeller congratulated the company as the meeting ended, calling it a “trailblazer.”

At least there's that.

📌 Full article:
http://www.nytimes.com/2015/04/11/sc...acco-item.html

[Snusie]

Smart interpretation, Snusdog. The panel left the door open for future label changes on snus.

With this appliclation, Swedish Match actually has an excellent PR opportunity. Using the kind of information presented at the hearing and using the fact that most members agreed that their pasturized snus are a harm reduction product, they have the basis to engage with US media to create awareness of what snus are and why they're far better.

I hope they do exactly that and, by extension, take their case to the public.

[Snusdog]

First, though disappointed, I don't think anyone here is really surprised by this.

However, I actually found the report to be very good news. Notice that they did not reject the basis of SM's proposal (Snus is safer than cigarettes and ought to be treated as a harm reduction product). In fact the report said most of the members of the panel agreed. Instead they weezeled out of it on a technicality

Still, committee members said Swedish Match did not provide enough evidence to show Sweden's experience could be replicated in the United States, or that the company had properly tested its proposed warning to ensure consumers would understand or be able to interpret it.

What does the first issue even mean (that the Swedish experience could be replicated in the US) and why is it even a factor. Either snus is safer or it is not. Either the current anti tobacco narrative is false or it is not.

As to the second complaint (SM had not tested its labels to see how people would interpret them)....how about all those adds that steer people to the patch or gum in hopes of quitting when there is a 95% failure rate using those products.........why is it ok for me to interpret those ads as suggesting their product offer true hope when the numbers starkly say otherwise.

Anyway.......the good news is that the science seems to have won the day........the bad news is that (at least for today) that victory seems to matter little.

I interpret the FDA's responses as simply political ......tucked under the guise of thin excuses

[resnor]

I like your style, Andy!

[Andy105]

If they don't, we should march on Washington! We could call it the "27 Man March", if we got enough of us together
That would show 'em that we mean business!

[resnor]

Does anyone really think the FDA will go against the recommendations of the panel?

[Skell18]

I thought it was 4 votes in favour and 4 against? So all the reporting that they knocked it back is really, wrong. The FDA can still go against the committiees descision from what I have read.

[Burnsey]

I'll admit to being a bit sad that SM's bid was a failure, but not at all surprised.......imagine how many smokers might have given snus a try if the labeling had become less offensive..... (sighs using much healthier lungs)

[Andy105]

...as the President lights up a Monte Cristo in the Rose Garden.

[resnor]

http://www.reuters.com/article/2015/...0N11VP20150410

Middle finger, indeed. I hate the FDA. I want to buy Jaks melon in my local shop. They just screw everything up.

[codyg140]

From what I read the FDA gave Swedish match the middle finger

Hopefully they were just talking outa there arse