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.
To paraphrase Mark Twain, the reports of the death of the General Snus Reduced Harm Tobacco Product (MRTP) application have been greatly exaggerated.
Friday afternoon, the anti-all-tobacco crowd and media immediately began reporting that the FDA Tobacco Products Scientific Advisory Committee (TPSAC) had "turned down" the General Snus application; that "approval was denied", that the MRTP application had been "voted down" and in the case of Matthew Myers of Tobacco Free Kids, the Swedish Match application was "poorly written" and "full of holes".
As more information about the TPSAC deliberations began to trickle out, a different picture began emerging.....
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!
FDA Tobacco Czar Mitch Zeller, Ruler of the FDA Center for Tobacco Products (CTP), has announced the first tobacco products to move through the long-awaited substantial equivalence (SE) process. Two new cigarettes from Lorillard, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, were found by FDA to be substantially equivalent to predicate products and blessed with approvals. Four other unknown tobacco products were denied and put to the sword.
Of the 4000 tobacco products submitted to FDA for SE approval, all but about 500 are currently on the market in a provisional awaiting review status. Understandably, the manufacturers of those provisional products are rather anxious how they will fare when under review.
It would be helpful if FDA could have at least released the types of tobacco products rejected if not their manufacturers as well. That's probably why Congress forbid FDA from publicly sharing any information on rejected SE applications.Swedish snus; particularly those introduced in the US after the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009, have pending substantial equivalence applications. Swedish Match does have an advantage as a number of their snuses were grandfathered since they were available prior to the Tobacco Control Act cut-off.If Lorillard's two new cigarettes were approved on the basis that they are equally (but not more) dangerous than their pre-Tobacco Control Act predecessors, logically the same would hold true for the extremely less harmful than cigarettes Swedish Match snuses created both before and after Tobacco Control Act took effect .By not being able to tell us even what category of tobacco products the four rejected products fell under, Swedish snus and other reduced risk tobacco products continue to circle in a rather frustrating FDA holding pattern in the US.
Appointed in March 2013 as Tobacco Czar after the rather hasty departure of Dr. Lawrence 'Bopper' Deyton, Zeller has kept the tobacco community walking on egg shells.
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