FDA Reopens Public Comment Period on Modified Risk

SILVER SPRING, Md. — The public is getting a second chance to have their say on Swedish Match's bid to have its General snus labeled as a modified risk tobacco product (MRTP).

The Food and Drug Administration (FDA) has reopened the public comment period for the MRTP applications submitted last year by Swedish Match North America Inc. for 10 snus smokeless tobacco products.

The second round of comments specifically applies to amendments to the originally filed applications, according to the agency. After filing the applications for scientific review — the first MRTP applications to reach this milestone — the FDA requested clarifying and other information from the company and received several amendments in response.

The amendments, redacted for trade secrets and confidential commercial information, can be read on the FDA's Center for Tobacco Products' website and at docket FDA-2014-N-1051 on regulations.gov.

Comments on the amendments should be submitted to the docket by Aug. 31.

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