UNITED STATES
FDA issues partial ruling on Swedish Match‘s MRTP request

The Food and Drug Administration (FDA) denied a request by Swedish Match to remove a warning about gum disease and tooth loss on snus sold in the US, but left the door open on the company’s modified risk application.

FDA said it has deferred action on requests to remove government imposed warnings that snus can cause mouth cancer and that Swedish Match be allowed to revise a third warning to say their product poses lower risk to health than cigarettes. Swedish Match was the first company to have an application accepted by FDA for acceptance of its snus as a Modified Risk Tobacco Product (MRTP). Applications for eight varieties of General brand snus were submitted in June, 2014.
Swedish Match said it interpreted the partial ruling as evidence FDA wants additional discussions, “on how to best communicate a modified risk message to the general public.” The snus maker noted it would be able to amend its application in the absence of a final ruling.
“We believe it's a sign that we're moving in the right direction,” said Fredrik Peyron, senior vice president for regulatory affairs. “We will adhere to the invitation by the agency to continue our constructive dialogue in order to understand the next steps necessary for issuance of a modified risk order.”

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