Swedish Match vs FDA

[elenamylove]

I hope the FDA decides on facts and not special interests (money) or failed (outdated) science. Do the right thing and grant SM MRTP!!!:distrust:

[codyg140]

We'll have an answer in hours, hopefully good news comes from this.

[Snusie]

Thursday, April 9, was the first day of hearings. Here are a few related articles:

• Swedish Match hoping to snuff out snus warnings - From The Local, Sweden's news in English
http://www.thelocal.se/20150410/swed...-snus-warnings
or
http://m.thelocal.se/20150410/swedis...-snus-warnings

• Meet the cancer doctor who wants the FDA to soften tobacco warnings - The Washington Post
http://www.washingtonpost.com/blogs/...acco-warnings/

• How a Big FDA Decision Could Change Tobacco Control | TIME
http://time.com/3815234/snus-fda/

• Swedish Company Asks F.D.A. to Remove Warnings From Smokeless Tobacco Product - NYTimes.com
http://www.nytimes.com/2015/04/09/he...o-product.html


Also:

• FDA Briefing Documents prepared for the hearings:
http://www.fda.gov/downloads/Advisor.../UCM441431.pdf

[Snusie]

Thank you.

I'm going to try to watch some of the testimony. This kind of thing is often dry, but Swedish Match has an excellent, and very interesting case.

[Snusdog]

Great find Snusie!

and if I have not done so already.....welcome to the forum.

I will be interested in how this progresses.........I will also be interested to see if it will have any real bearing on the outcome......kind of like when a company has to advertise a opening but they have already made the decision on who to hire.........the public part is merely an irrelevant hoop.

I hope not.....but we shall see.........regardless thanks for posting the heads up.

[Snusie]

From the FDA website:

April 9-10, 2015 TPSAC Meeting Notice

Tobacco Products Scientific Advisory Committee
Date: April 9-10, 2015
Time: The meeting will be held on April 9, 2015 from 8:30 a.m. to 5 p.m. and on April 10, 2015 from 8 a.m. to 5 p.m. The meeting will be closed to the public from 4 p.m. to 5 p.m. on April 9, 2015.

Location:
Food and Drug Administration
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

Webcast:
Seating for this meeting may be limited, so the public is encouraged to watch the free webcast instead of traveling to the meeting. The link for the webcast will be available approximately 15 minutes prior to the beginning of the meeting each day and can be accessed on the TPSAC page.

➡️ Agenda: On April 9-10, 2015, the Committee will discuss modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products:

MR0000020: General Loose, smokeless tobacco, loose snus, 1.59 oz (45g), cardboard can (SKU 4852);
MR0000021: General Dry Mint Portion Original Mini, smokeless tobacco, snus portions, 0.21 oz (6g), 20—0.3g portions, plastic can (SKU 4800);
MR0000022: General Portion Original Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4880);
MR0000023: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4877);
MR0000024: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4878);
MR0000025: General Mint Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4352);
MR0000026: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4876);
MR0000027: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4875);
MR0000028: General Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4881); and
MR0000029: General Wintergreen Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4882).
Meeting Materials: Links to meeting materials will be added as they become available. FDA intends to make the background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and will be posted on FDA’s website after the meeting.
Public Participation Information: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before March 20, 2015. Please send 20 paper copies, and one electronic copy, of your submission to:

Caryn Cohen, M.S.
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002


Copies must be received by 4 p.m. (Eastern) on March 20, 2015.

Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 p.m. on April 10, 2015. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 12, 2015.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 13, 2015.


Contact Information

Caryn Cohen Office of Science Center for Tobacco Products Food and Drug Administration Document Control Center, Bldg. 71, rm. G335 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 Phone: 1-877-287-1373 (choose Option 5) FAX: 240-276-3655 Email: TPSAC@fda.hhs.gov

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)

[elenamylove]

I posted on the FDA open comments about Snus - I really hope this goes in favor of Swedish Match !!! I will pass out bumper stickers!!! :afro:

[rickcharles606]

will certainly generate consumer interest and in turn provide incentive for other companies to be more agressive

"other companies" are watching optimistically, but have no plans to issue a request to the FDA for MRT status, until a decision is made on this one. This is a costly submission, so we'll wait and see :-) Honestly, I don't think the FDA will move on this until they've run their own studies. The problem with that is that they'll have the anti's do the studies, lol. So, we'll have to see.

[Skell18]

And as a Bonus

5) If the FDA grants the designation, how will this impact (give weight to) future snus issues in the EU

It can't hurt................and together with the recent snus scandals......it might just begin to swing the tide....it certainly will give snus producers some leverage

one would hope it's positive, but when they won't even listen to the country who makes it within it's own union,there isn't much hope of them listening to this.

[Snusdog]

And as a Bonus

5) If the FDA grants the designation, how will this impact (give weight to) future snus issues in the EU

It can't hurt................and together with the recent snus scandals......it might just begin to swing the tide....it certainly will give snus producers some leverage

[Snusdog]

4 things:

1) As others have said.......it will be interesting to see how the zealots respond. I don't think approval is a slam dunk by any means....but neither do I think it is a fool's errand........30/70 are the Dog odds for approval

2) It will be interesting to note the tax implications of this ruling (and thus the impact on price for the consumer). Things considered "vices" are taxed higher. If the harm of the product is determined to be significantly less......will this drop it into another tax bracket (say from that of cigarettes to something like coffee).........in the end hidden implications concerning tax revenue might be a large part of the final verdict.

3) How long until SM's subsidiary company Pinkerton Tobacco (Longhorn, Timber Wolf, Redman dip) whose products have a TNSA of 5 and do not elevate with shelf life (Snus is at 2)....how long until they file a similar suit

4) Will this have any impact on distribution/availability. Despite SM's commitment to a limited range......their motives are market driven........and a significant opening of the market (such as a harm reduction designation might provide).......will certainly generate consumer interest and in turn provide incentive for other companies to be more agressive

[Burnsey]

More on the subject, from 06/12/14.....
http://snuscentral.org/snus-news/mr-...d-risk-tobacco

[jtricer1973]

The FDA Nazis will never go for this. I don't care if they submit a million page report!! It's just like the global warming agenda!! They don't care about real science, only junk science. Too many of these US govt agencies and the employees of these agencies have their entire life and careers built around these agendas. Global warming has been shown time and time again to be nothing more than the normal warming and cooling cycles of the earth, and yet they move right along with their agenda and call people like me global warming deniers. LMAO!!! Morons!!! So I am sure they will just ignore all the science in that report and carry on with business as usual!!

[Burnsey]

^^^ You're probably right ssgt, but it is a huge step in the right direction, let's hope for the best.......

[ssgtdirt]

as much as I hope this ends well, I don't have much faith in the U.S. government. it seems that if it doesn't match their agenda, it doesn't work out.