FDA Has Concerns With Swedish Match's Modified-Risk Request

SILVER SPRING, Md. — The Food and Drug Administration (FDA) will raise a few questions during this week's review of Swedish Match's request to classify its General snus products as less harmful than cigarettes.

According to The Associated Press, FDA scientists say they have "concerns" about how the company studied its snus tobacco product and its proposal to modify cancer warning language on the packaging. The agency's Tobacco Products Scientific Advisory Committee is set to meet with the tobacco company over two days beginning Thursday.

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. The company proposed a new warning emphasizing that snus is less risky than smoking: "No tobacco product is safe but this product presents substantially lower risks to health than cigarettes."

But in a scientific review posted Tuesday, FDA staff members questioned whether that language "adequately reflects the health risks of using snus," according to the news outlet.

Swedish Match also wants FDA clearance to remove a warning about mouth cancer from its product. Agency staffers, however, noted that the studies submitted by the company may have underestimated cases of mouth cancer as users quit using snus.

Among other changes, Swedish Match wants the FDA to permit dropping another warning that smokeless tobacco products can cause gum disease and tooth loss. However, according to the AP, regulators noted a number of shortcomings with the company studies of that issue, including small populations that were often made up of adolescents and young adults.

In addition, regulators said the company "does not provide an argument as to why it is biologically plausible that effects of snus on gum disease and tooth loss would be significantly different from other smokeless tobacco products."

Swedish Match's corporate headquarters are located in Stockholm and its U.S. division is in Richmond, Va.