• Application pertains to sub-brands for the General snus product line in the US
• Application seeks a risk modification order which would allow changes to warning label statements currently required for smokeless tobacco products
• Application includes extensive research findings on Swedish snus
• Swedish Match has been actively engaged in the FDA regulatory science process
Swedish Match today announced that it has submitted a Modified Risk Tobacco Product (MRTP) application to the US Food and Drug Administration (FDA) for eight sub-brands in the General snus product line, manufactured by the Company. Swedish snus is a unique smokeless product traditionally consumed in Scandinavia and is now available in more than 20,000 stores in the US.
The MRTP application seeks a risk modification order permitting the use of warning label statements on the Company’s snus tobacco products that differ from those carried by other commercially marketed smokeless tobacco products.
In its MRTP application, Swedish Match cites an abundance of Swedish and international evidence on the health effects of snus -- evidence that stretches over three decades and includes governmental cohort studies and clinical trial results.
“Swedish snus is very well scientifically documented and our application consists of more than 100,000 pages,” says Professor Lars-Erik Rutqvist, MD, PhD, Senior VP Scientific Affairs at the Company. Rutqvist added, “As an industry leader we must properly apply the evidence to demonstrate the potential public health benefit of our snus tobacco products.”
Consistent with FDA recommendations, the Company has actively engaged with the FDA on its submission, meeting with FDA representatives on several occasions regarding the format and data requirements for the MRTP application.
In 2013, the Company also established an MRTP Advisory Panel, which has and will continue to provide independent advice and guidance to Swedish Match as it moves forward with the MRTP application.
For media queries, please contact:
USA: Sandy Fowler-Jones
Office +1 804 7875 132, Mobile +1 804 3630 424
Sweden: Johan Wredberg
Office +46 8 658 0248, Mobile +46 73 027934
Norway: Nils Erlimo
Office +47 22 727 240, Mobile +47 920 85814
Global: Rupini Bergström
Office +46 8 658 0106, Mobile +46 70 5402892
Swedish Match develops, manufactures, and sells quality products with market-leading brands in the product areas Snus and moist snuff, Other tobacco products (cigars and chewing tobacco), and Lights (matches and lighters).Well known brands include General snus, Longhorn moist snuff, White Owl cigars, Red Man chewing tobacco, Fiat Lux matches, and Cricket lighters. The Group sells products across the globe, with production units in six countries. The Group’s global operations generated sales of 12,642 MSEK for the twelve month period ending March 31, 2014. The Swedish Match share is listed on NASDAQ OMX Stockholm (SWMA).
Swedish Match AB (publ), Box 7179, SE-103 88 Stockholm, Sweden
Visiting address: Västra Trädgårdsgatan 15. Telephone: +46 8 658 0200
Corporate Identity Number: 556015-0756
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