Thursday, 30 July 2015 15:34

FDA moves General Snus MRTP Application forward!

Written by Larry Waters
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A notice on the Federal Register that indicates the Swedish Match General Snus Modified Risk Tobacco Product Application (MRTPA) will be published tomorrow.

Since accepting the General Snus application in August of last year, the FDA Center for Tobacco Products (CTP) has on several occasions asked for additional or clarifying information. These amendments will now be available for a second 30-day public comment period ending August 31.

After this comment period ends, FDA Tobacco Czar Mitch Zeller should be able to finally make a final decision on the fate of the General Snus MRTPA.

General Snus does NOT cause cancer or gum disease

My 2014 article Swedish Match, FDA, General Snus, and Modified Risk Tobacco Products: What does it mean? details and illustrates how Swedish Match's MRTP application for General Snus can significantly play a roll in cigarette smoking cessation and consumer education.

In a nutshell, cigarettes and all forms of smokeless tobacco currently carry the same four warning labels.  In the case of Swedish Snus; specifically the 10 General Snus products offered/were offered for over-the-counter sale in the US, 3 of the 4 warning labels are factually incorrect.

These inaccuracies would lead a smoker considering a switch to General snus to believe snus is just as harmful as cigarettes....so why bother switching?  This is important since Swedish snus overall is roughly 99% less harmful to a smoker than cigarettes.  Swedish snus and French roast coffee contain about the same risk profile.

Swedish snus also delivers significantly more nicotine than nicotine gum or patches.  Without sufficient free nicotine, smokers odds of quitting cigarettes are about as good as using Altoids to stop smoking....nil.

Both the nicotine patch and gum boast only an 8% success rate among smokers trying to quit cigarettes after one year.  That translates to a 92% failure rate which is unacceptable if the goal is to save the lives and health of current smokers and eliminate second-hand smoke dangers.

Why a second public comment period and what should I do?

During the course of FDA's hearings, testimony and previous public comments, FDA went back to Swedish Match for clarifications and more information which Swedish Match supplied in addition to the 123K+ pages already submitted in the original MRTPA.

Since the General Snus MRTPA has been amended, FDA is obligated to open a second 30-day public comment period which will begin at 08:45 EDT on 31 July 2015.

As during the first public comment period, it is essential for snus users and Tobacco Harm Reduction advocates to make themselves heard.  I have no doubt the Anti-All-Tobacco extremists will be lining up to do everything they can to paint General Snus in the most negative, non-factual way possible.

The official Public Inspection Notice, Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc. will give instructions starting Friday morning on how you can add your thoughts and comments to this important process.

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.

This is all about improving the public health and reducing the cost of healthcare caused by smoking-related illnesses. We are the American public.  It's our right to make your voice heard and encourage your snus using friends to join you.

Share this post with as many snusers you know.  The stakes are very high and we only have 30 days.

LARRY WATERSSeal of the Swedish Snus Ambassador to the United States

Swedish Snus Ambassador to the United States
Reporting for SnusCENTRAL.org

 

Read 4225 times Last modified on Tuesday, 18 August 2015 14:28

7 comments

  • Comment Link Larry Waters Monday, 28 September 2015 15:38 posted by Larry Waters

    The only update we've heard is "any time now". FDA is being pretty tight-lipped. Once the final decision is announced, trust me, you will hear about it.

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  • Comment Link Robert Wednesday, 23 September 2015 21:24 posted by Robert

    Does anyone know if the FDA has made a decision yet? I haven't been able to find any new updates about this.

    Report
  • Comment Link Lucio Johanek Friday, 04 September 2015 05:43 posted by Lucio Johanek

    The regular General is a good snus to start or the minis if those are to strong. Not offended -- though I am a bit exercised about someone in another thread who s spouting a lot of crap and insisting it s THE ONLY WAY TO VAPE CORRECTLY.

    Report
  • Comment Link Larry Waters Thursday, 06 August 2015 15:08 posted by Larry Waters

    Hi Bobby! The EU Snus Ban is just wrong on so many levels. Science, public health, and logic aside, Sweden's right of free trade within the EU has been impinged by the snus ban for the last 20+ years. EU Commission politics and an anti-Swedish bias play a very large roll in the Snus Ban.

    Meanwhile well over 150MM EU citizens continue to sicken and die before their time because unlike snus, cigarette smoking is not banned in the EU...and real, proven alternatives to cigarettes like Swedish snus are instead banned.

    Public health costs continue to explode as a % of each EU member country;s budget because of cigarette-related illness and disease.

    Sweden has continued to put up only a token fight to overturn the snus ban. I hope one day they will become aggressively serious and the EU Commission will come to it's senses.

    Report
  • Comment Link Larry Waters Thursday, 06 August 2015 14:57 posted by Larry Waters

    Hi Grady! The scenario you outline in your comment is not accurate. No doubt some anti-all-tobacco extremist group authored it.

    TPSAC, the tobacco advisory board to the FDA, was strongly packed with anti-tobacco types. Director Zeller removed 4 TPSAC members for conflicts of interest or bias a few weeks prior to TPSAC making its recommendation to FDA on the General Snus MRTP application.

    The final TPSAC recommendation was 3 voting for the MRTPA, 3 voting against, and 2 abstaining.

    FDA went back to Swedish Match and asked for more information and some clarifications which Swedish Match provided.

    FDA now has all the information it needs for Mr. Zeller to make a decision. On 31 July 2015, they opened the required 30 day public comment period to finalize the review process.

    You can read the details in my previous article; "FDA has NOT Killed the General Snus reduced harm application".

    http://www.snuscentral.org/snus-news/mr-unz-reports/item/658-fda-has-not-killed-the-general-snus-reduced-harm-application.html

    This is the final chance for tobacco harm reduction advocates to tell FDA directly why they feel the General Snus MRTP Application should be approved. I hope you will join us!

    Report
  • Comment Link Bobby Wednesday, 05 August 2015 20:43 posted by Bobby

    Thanks for letting us know about his. I just filled the comment as an individual consumer - I don't know if it carries weight - but it felt good to have a voice - snus users haven't had one in a long time. Maybe if the FDA looks into this, the EU will also start thinking.

    Report
  • Comment Link Grady Tuesday, 04 August 2015 13:24 posted by Grady

    I was of the opinion when I first saw these procedings posted and subsequently unfavorably passed along by the initial empanneled members at the FDA that General blew their chance at making a strong case because they came accross as condescending and out to bash the FDA instead of presenting a scientific case.

    What were the circumstances of the original application's review?

    Report

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