FDA committee meeting set

A committee that advises the US Food and Drug Administration is to meet to discuss an amendment to Swedish Match North America’s (SMNA) modified risk tobacco product (MRTP) applications for eight General Snus products, and an MRTP application submitted by US Smokeless Tobacco Company (USSTC) for its Copenhagen Snuff Fine Cut tobacco product.
In a note issued through its Center for Tobacco Products, the FDA said it had issued a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for February 6-7 at the FDA White Oak campus.
The committee is due to discuss scientific issues related to SMNA’s amendment – made public in October – to its MRTP applications for eight General Snus products. It is due to discuss also the MRTP application submitted by USSTC for its Copenhagen Snuff Fine Cut tobacco product, which is currently under scientific review by FDA.
‘The Tobacco Control Act defines an MRTP as any tobacco product sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products,’ the FDA said in its note. ‘MRTP information may communicate to consumers that the product is less harmful or presents a lower risk of tobacco-related disease than other commercially marketed tobacco products, reduces exposure to a substance, or does not contain or is free of a substance.
‘During this upcoming meeting, representatives from Altria (parent company to USSTC) and FDA’s Center for Tobacco Products’ Office of Science will present information about the company’s MRTP application currently under FDA scientific review.
‘In addition, TPSAC members will hear presentations from SMNA and FDA about that company’s recent amendment to their MRTP applications for eight General Snus smokeless tobacco products, which FDA previously acted on in December 2016.
‘TPSAC members may then discuss available scientific evidence related to issues and questions posed by FDA about the USSTC application and SMNA amendment. During this discussion, TPSAC voting members may vote on specific issues and questions or other topics arising during the committee’s discussion.’