The Food and Drug Administration (FDA) authorized marketing of Swedish Match snus in what the agency said were its first approvals via the pre-market tobacco application (PMTA) process, however the rulings do not allow modified-risk claims.
Swedish Match in June, 2014, asked FDA for Modified Risk Tobacco Product (MRTP) approvals for eight variations of its General snus brand sold in the US. An MRTP ruling is expected this autumn.
In addition to the MRTP applications, a company spokesperson said FDA marketing approval had been sought, and obtained with the PMTA rulings, for changes made to the product since 22 March, 2011, a statutory cutoff date in US tobacco product regulation.
FDA regulators in their PMTA rulings concluded the eight snus variants “would likely provide less toxic options if current adult smokeless users used them exclusively,” the agency said. The tobacco regulator warned product claims of reduced exposure or risk cannot be made without an MRTP authorization.