FDA Reopens Comments for R.J. Reynolds’ MRTP Application

Tobacco company submitted several amendments to application in response to FDA request
FDA website
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) reopened the comment period for R.J. Reynolds Tobacco Co.’s modified risk tobacco product (MRTP) application for six Camel Snus smokeless tobacco products.

This comes after the Winston-Salem, N.C.-based tobacco company submitted several amendments to its MRTP in response to a request from the FDA, the agency said. The comment period will close on Dec. 30.

Application materials can be read on the FDA’s website.

The FDA takes into consideration all information available, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee, before making a final decision on an MRTP application, the agency said.  

The FDA filed for substantive scientific review for six MRTP applications from R.J. Reynolds Tobacco Co. on Dec. 18, 2017, for Camel Snus Frost, Camel Snus Frost Large, Camel Snus Mellow, Camel Snus Mint, Camel Snus Robust and Camel Snus Winterchill.

Any person can submit a MRTP application seeking an FDA modified risk order. Under the Family Smoking Prevention and Tobacco Control Act, manufacturers are prohibited from making health claims about products and are only allowed to do so through modified risk orders issued by the FDA.

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