SM makes modified risk filing in U.S.

Swedish Match said today that it had submitted a modified-risk tobacco product (MRTP) application to the U.S. Food and Drug Administration (FDA) for eight sub-brands of its General snus product line.

“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,” the company said in a statement posted on its website.

The company went on to say that it had cited “an abundance” of Swedish and international evidence on the health effects of snus—evidence that stretched over three decades and included governmental cohort studies and clinical trial results.

“Swedish snus is very well scientifically documented, and our application consists of more than 100,000 pages,” professor Lars-Erik Rutqvist, M.D., Ph.D., the company’s senior vice president scientific affairs, was quoted as saying. “As an industry leader, we must properly apply the evidence to demonstrate the potential public health benefit of our snus tobacco products.”

Swedish Match said it had 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,” the statement said.

Swedish snus is said to be available in more than 20,000 stores in the U.S.