Swedish Match vs FDA

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts
  • blotgode
    Member
    • Apr 2009
    • 338

    Swedish Match vs FDA

    This is translated with Google, so not perfect Article in Swedish newspaper: Aftonbladet

    Swedish snus to get Americans to quit smoking.
    The hope of snuff, Swedish Match now submitted a 100,000-page application to the U.S. Food and Drug Administration FDA.
    - America's scientific authority dares to ask the right questions about Swedish snus, instead of, as the EU, the effort to remain ignorant and spreading myths, says communications Hildingsson.


    Swedish Match has filed a 100,000-page application with over 800 scientific reference articles to the FDA, U.S. Food and Drug Administration. The hope of the Swedish snuff is snus should be classified as a "modified risk product", ie a product with reduced detrimental effects.
    - Then we get the opportunity to communicate to the public to snuff in a reduced risk, says Professor Lars-Erik Rutqvist, Scientific Director at Swedish Match, with a background as a medical oncologist and chairman of Karolinska Institute's Research Ethics Committee.
    Large potential market
    In the United States smokes today according to the American Cancer Society near one in five adults, around 42 million inhabitants, and the potential market for alternatives is large.
    In order to obtain this classification, the manufacturer must prove that the product means lower risks compared with smoking for the individual user, and also that it is beneficial to public health in the United States.
    Rutqvist take up to 30 years of research shows that Sweden has the West's lowest figures for tobacco-related mortality for Swedish men extensively use snus.
    Professor Hans Gilljam at Karolinska Institute have difficult to comment on how he makes himself available to the possible classification.
    - It is not in a physician's role to advocate toxic products. It's not a vitamin. There are risks associated with snus, but certainly they are far less than the neck puff, clearly, he says.
    Controversial risks
    Gilljam takes up to snuff according to the World Health Organization are expected to double the risk of pancreatic cancer, increased risk of type 2 diabetes and increased mortality from stroke and heart attack.
    But Rutqvist state that there are only a few studies that suggest that this is the case.
    - But there are other studies that show this, and upon a comprehensive analysis of all the studies is no convincing evidence for any connection. However, there are established and clear connection between smoking and they mentioned health outcomes. This is something that the FDA will analyze carefully when assessing our application.
    The FDA now has a year to go through the application. Lars-Erik Rutqvist is optimistic.
    - We have a very heavy and convincing scientific evidence in our application, and I have great confidence that the FDA will share our many international tobacco judgment of scientists.
    "The United States distinct from the European Union"
    Rutqvist also serves as business representative for tobacco products in an advisory committee to the FDA.
    - Yes, it is a conflict of interest, I'm employed by the company that comes with the application. But it is completely open and declared, and I have no vote in the Committee.
    Hildingsson, Communications Manager at Swedish Match, says it is calculated what classification would mean business.
    - In the first stage, it is not something we counted on the commercial, it is not possible to predict. But that would mean that the world's largest and leading consumer care authority has scrutinized everything there is to know about our Swedish snus, and it is clear that it means something to the consumer, and then it is of course something for us too.
    - The EU has not been ready to embrace the evidence-based science available on snus. It is completely different from the FDA on the contrary show an active interest.
  • trebli
    Member
    • Mar 2010
    • 797

    #2
    Sounds great. I hope the FDA will give it serious consideration.

    Comment

    • ssgtdirt
      Member
      • May 2014
      • 36

      #3
      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.

      Comment

      • Burnsey
        Member
        • Jan 2013
        • 2572

        #4
        ^^^ You're probably right ssgt, but it is a huge step in the right direction, let's hope for the best.......

        Comment

        • jtricer1973
          Member
          • Jul 2009
          • 63

          #5
          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!!

          Comment

          • Burnsey
            Member
            • Jan 2013
            • 2572

            #6
            More on the subject, from 06/12/14.....
            http://snuscentral.org/snus-news/mr-...d-risk-tobacco

            Comment

            • Snusdog
              Member
              • Jun 2008
              • 6752

              #7
              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
              When it's my time to go, I want to die peacefully in my sleep, like my uncle did....... Not screaming in terror like his passengers

              Comment

              • Snusdog
                Member
                • Jun 2008
                • 6752

                #8
                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
                When it's my time to go, I want to die peacefully in my sleep, like my uncle did....... Not screaming in terror like his passengers

                Comment

                • Skell18
                  Member
                  • May 2012
                  • 7067

                  #9
                  Originally posted by Snusdog View Post
                  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.

                  Comment

                  • rickcharles606
                    Member
                    • Mar 2009
                    • 2307

                    #10
                    Originally posted by Snusdog View Post
                    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.

                    Comment

                    • elenamylove
                      Member
                      • Nov 2014
                      • 58

                      #11
                      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:

                      Comment

                      • Snusie
                        Member
                        • Mar 2015
                        • 40

                        #12
                        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)

                        Comment

                        • Snusdog
                          Member
                          • Jun 2008
                          • 6752

                          #13
                          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.
                          When it's my time to go, I want to die peacefully in my sleep, like my uncle did....... Not screaming in terror like his passengers

                          Comment

                          • Snusie
                            Member
                            • Mar 2015
                            • 40

                            #14
                            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.

                            Comment

                            • Snusie
                              Member
                              • Mar 2015
                              • 40

                              #15
                              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
                              Last edited by Snusie; 10-04-15, 03:40 PM.

                              Comment

                              Working...
                              X