Key FDA panel votes down warning label change for snus
The eight-member panel voted unanimously that there was insufficient evidence to demonstrate that use of snus – a smokeless-tobacco product contained in packets placed under the lip – didn’t increase the risk of tooth loss and gum disease. The New York Times reports members were split on other questions related to the relative risk of oral cancer:
Perhaps the most direct question, whether the research showed that health risks from Snus were “substantially lower” than those from cigarettes, divided the panel in half, with four members voting yes and four no.
“I voted no because I have a problem with the word ‘substantially’ lower as it relates to all health risks,” said Pebbles Fagan, an associate professor at the University of Hawaii Cancer Center. “There’s no evidence that pregnancy outcomes related to snus would be any different than with any other tobacco product.”
But other panel members were persuaded.
“You can still care about a wide array of health effects and still endorse the idea that there’s a substantial reduction in risk,” said Kurt M. Ribisl, a professor of health behavior at the University of North Carolina Gillings School of Global Public Health. “Cancer and heart disease are top killers of women in this country, and the risk for those are substantially lower in these products.”
The hearings followed up a 130,000-page application Swedish Match submitted last June, which included the results of dozens of studies – including two double-blind, randomized trials comparing snus to placebo for those trying to quit smoking – that the company said demonstrate that snus use is at least 90 percent safer than smoking cigarettes.
Much of the evidence is drawn from 50 years of data from snus users in Sweden, which has one of the highest rates of tobacco use in Europe, but one of the lowest-rates of smoking-related deaths. The reason, says Swedish Match, is that Swedes prefer snus to cigarettes, with roughly one-in-five Swedish men reporting they are regular snus users.
Indeed, snus accounts for roughly half of Swedish Match’s $15 billion in annual sales. But in the United States– where there are still 40 million regular smokers – its General Swedish brand has only about 4 percent of the smokeless tobacco market. Swedish Match also makes cigars and the chewing tobacco brand Redman.
The company sought clearance to replace on its U.S. snus packages such standard warnings as “This product can cause mouth cancer” and “This product is not a safe alternative to cigarettes” with one that reads: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”
R Street Associate Fellow Brad Rodu, who wrote about the hearings last week, told Reuters:
“The committee appears to have set an absolute standard of safety that ignores decades of evidence showing that snus is vastly safer than cigarettes,” said Dr. Brad Rodu, a professor of medicine at the University of Louisville.
Or, as another expert quoted by the Washington Post put it:
“Can you make the claim that a product is safer when it’s not perfectly safe? Yes, I think you can,” said Lynn Kozlowski, a University of Buffalo professor who studies tobacco use policy. “But there are some who think their job is satisfied only when they say nothing is safe.”
These were the first hearings conducted under provisions of the 2009 Tobacco Control Act, which granted the FDA authority to regulate tobacco, but permits companies to petition for the right to demonstrate one tobacco product is safer than another. The panel’s recommendations are considered advisory, though they likely will have significant weight with the FDA, which is expected to render a final decision this summer.