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.
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