FDA Seeks Feedback on Marketing Snus as Modified Risk
SILVER SPRING, Md. -- The Food and Drug Administration (FDA) is looking for public input on Swedish Match's request to certify its General-branded tobacco products as less harmful than cigarettes.
It is the first time the FDA has filed for scientific review a "modified risk" tobacco product application, a move that's being closely watched by the public health community and tobacco companies, according to The Associated Press.
In June, Swedish Match submitted a Modified Risk Tobacco Product (MRTP) application to the 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, as CSNews Online previously reported.
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 cited 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.
The FDA on Tuesday said it will accept public comments on the company's application to market the snus products as modified risk for 180 days. The agency's scientific advisory panel also plans to review the application in approximately 90 days, according to the news outlet. The entire review process is expected to take about a year.
Swedish Match's corporate headquarters is in Stockholm and its U.S. division is based in Richmond, Va.