FDA Advisory Committee hesitates to endorse message of safe smokeless tobacco
Source: www.medpagetoday.com Author: Shannon Firth An FDA advisory panel were reluctant to recommend a gentler warning label for one brand of smokeless tobacco products at a committee hearing on Friday. Swedish Match North America (SMNA), the first company to be considered for a modified risk tobacco designation by the FDA, is asking to replace a current label warning, "This product is not a safe alternative to cigarettes," with this: "Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes." It also wants to drop warnings required for other smokeless tobacco products about oral cancers, tooth loss, and gum disease. In a key vote, the eight-member FDA's Tobacco Products Scientific Advisory Committee split 4-4 on whether the claim that snus offer a "substantially lower risk" claim relative to cigarettes is justified. Many members said the health risks were lower for certain tobacco-related illnesses, but not for all health concerns. Those who disputed the claim argued that it could not be taken as a "global statement" -- as there are known risks to pregnant women and uncertain risks for adolescents. As for the proposed label change, the whole committee agreed that the sponsor's statements would not suffice. Gary Giovino, PhD, chair of the department of Community Health and Health Behavior at the State University of New York at Buffalo, felt the statement was "dismissive of the health risks." The word "but" in any sentence seems to negate the first half, he said. Snus is a [...]