FDA Committee Was Right to Reject Swedish Match's Flawed Application

WASHINGTON, DC – FDA’s Tobacco Products Scientific Advisory Committee had no choice but to recommend rejection of Swedish Match's application because it did not answer the basic question of whether, if it were allowed to make the claim of lower risk, smokers would switch from cigarettes to snus or use both products at the same time. A properly prepared application could well have received a different result, but the flaws in the application were so blatant that they made it impossible for the advisory committee to rule in their favor.

The change Swedish Match requested also would have left consumers without critically important information about the known health risks of its products. Scientific studies have found that the snus product increases the risks of fatal heart attacks and stillbirths and may increase the risks of pancreatic and esophageal cancer.