Swedish Match Seeks Modified Risk Label for Snus
RICHMOND, Va. -- Swedish Match submitted a Modified Risk Tobacco Product (MRTP) application to the Food and Drug Administration (FDA) for eight sub-brands in its General snus product line.
Snus, which is a smokeless tobacco product traditionally found in Scandinavia, is currently available in more than 20,000 stores in the United States.
With this FDA application, Swedish Match is seeking 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 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," said Lars-Erik Rutqvist, senior vice president of scientific affairs at Swedish Match. "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 agency on its submission, meeting with FDA representatives on several occasions regarding the format and data requirements for the MRTP application. The move follows the company's 2013 formation of an MRTP Advisory Panel, which provides independent advice and guidance to Swedish Match as it moves forward with the application.
Swedish Match's corporate headquarters are located in Stockholm and its U.S. division is in Richmond.