Today, FDA issued a quite frankly poorly written press release entitled FDA issues first product marketing orders through premarket tobacco application pathway.
Since General Snus and the eight products Swedish Match sells over-the-counter (OTC) are involved, there has been understandable confusion. Up until now, the focus on US General Snus OTC products has revolved around the Modified Risk Tobacco Product Application (MRTPA) made by Swedish Match over a year ago.
In their General Snus MRTPA, Swedish Match is asking FDA to eliminate and/or change three of the four mandatory warning labels required on all cans of snus sold in the US. The most obvious are eliminating the cancer and tooth loss labels since they are so factually inaccurate.
Today's announcement concerns General Snus and the Premarket Tobacco Application (PMTA) pathway. Confused yet? I was after reading the FDA press release since they jumbled both PMTA and MRTP in a statement only a technocrat could love.
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.
Updated 18 August 2015 - NOTE: This story was originally published on 29 September 2014 during the first FDA Public Comment Period on the General Snus MRTPA. Fast forward almost 11 months and we are reaching the 31 August 2015 for the second and final Public Comment Period. If you haven't already acted, now is the time to do so.
This article contains my 2014 statement to FDA which was published in the Federal Register. It was just my snus story from the heart. This is what FDA needs see.
You can then review my 30 July 2015 General Snus MRTPA update for instructions on how to get your opinion on the record. This is our last chance!
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