Swedish Match Offers Details on FDA 'Modified-Risk' Application
Seeks to demonstrate potential public health benefit of snus
Published in CSP Daily News
STOCKHOLM, Sweden -- Swedish Match officially announced that it has submitted a Modified Risk Tobacco Product (MRTP) application to the U.S. Food & Drug Administration (FDA) for eight sub-brands in the General snus product line.
Swedish snus now available in more than 20,000 stores in the United States, it said.
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," said Lars-Erik Rutqvist, senior vice president of scientific affairs at the company. "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.
Stockholm, Sweden-based Swedish Match develops, manufactures, and sells products snus and moist snuff, other tobacco products (cigars and chewing tobacco) and lights (matches and lighters). 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 company's North American headquarters is in Richmond, Va.