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.
What is the Premarket Tobacco Application (PMTA) pathway?
Under the Tobacco Control Act, if a company decides to make product and process improvements after March 22, 2011, it must first get the FDA’s permission under either a Substantial Equivalency (SE) or PMTA process.
Though the factories in Sweden that make General snus have made such improvements and have been implemented for General snus sold in Sweden and via internet shops, they have not been implemented for the products sold over the counter in the US.
Accordingly, Swedish Match asked the FDA, both through the substantial equivalency process and the PMTA pathway, if they would be permitted to do so. The PMTA orders reflect that FDA has given Swedish Match permission to do so.
What this means to US consumers who purchase the eight affected General Snus products OTC is that soon you will be using the 2015 versions of these snuses; not the 2011. That's a good thing for snusers.
For the record, the eight General snuses sold OTC in the USA are General Original Portion, General White Portion, General Loose, General Wintergreen, General Mint, General Mini Mint, General Nordic Mint, and General Classic Blend.
Meanwhile, the General Snus MRTPA is still officially "pending" at FDA. There is no other information on it's status or when/if it will be approved as of now.
Under the leadership of FDA Tobacco Czar Mitch Zeller, huge leaps forward have been made in implementing the ill-conceived Tobacco Control Act compared to his predecessor.
Unfortunately, even Zeller can't overcome the massive, wasteful, and inefficient Washington bureaucracy which invades all our lives in so many ways.
In the meantime, enjoy your REAL Swedish snus!
Best Regards/Bästa hälsningar/Med venlig hilsen,
LARRY WATERS
Swedish Snus Ambassador to the United States
Reporting for SnusCENTRAL.org