FDA Seeks Snus Comments
Will consider Swedish Match’s modified risk application
Published in Tobacco E-News
RICHMOND, Va. -- Back in June, smokeless tobacco maker Swedish Match announced its intentions to file an application with the U.S. Food and Drug Administration (FDA) to market its General Snus products as “modified risk," with Swedish Match North America’s director of federal government affairs Jim Solyst describing snus pouches as “substantially less risky than smoking.” While the FDA has a year to evaluate the company’s application, The Associated Press reported that the agency announced on Tuesday that it is seeking public comments on the issue.
This public commenting period, which will last 180 days, marks the first time the FDA has asked for input on a modified risk tobacco product application (MRTP). Additionally, the agency announced that its scientific advisory panel intends to review Swedish Match’s 100,000 page application the next time it meets – though that meeting has not yet been scheduled.
According to the 2009 Family Smoking Prevention and Tobacco Control Act (which granted the FDA authority to regulate tobacco products and evaluate which products might qualify as modified risk), the entire review process could take up to a year. Since 2009, the agency has not approved any MRTP applications, though the director of the FDA’s Center for Tobacco Products (CTP) Mitch Zeller has acknowledged many times that some tobacco products may pose less health risks than others.
"Nicotine is the very same compound FDA has approved for over 30 years as a safe and effective medication," Zeller said during a recent Legacy Foundation Warner Series webinar. "People are dying from the tobacco-related diseases from the smoke particles, not the nicotine. It's a challenge to all of us. Can we start to take a different look at this?"
"Let's not lose sight of the bigger picture here," he continued. "Tobacco use remains the leading cause of preventable death and disease primarily because of the use of combustible tobacco products. If there's some kind of emerging technology in a regulated environment, I think we have to have an open mind on the potential of these (products) to benefit public health."