More to Mull on Menthol

FDA extends comment period for advance notice of proposed rulemaking

Published in CSP Daily News

WASHINGTON -- The U.S. Food & Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) for menthol in cigarettes and other tobacco products that appeared in The Federal Register on July 24, 2013. The FDA is extending the comment period to Nov. 22, 2013.

The FDA requested comments, including comments on its preliminary evaluation, and data, research or other information that may inform regulatory actions that FDA might take with respect to menthol in cigarettes. The agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.

On July 24, the FDA established a 60-day comment period to request comments on its preliminary evaluation, and data, research or other information that may inform regulatory actions FDA might take with respect to menthol in cigarettes.

The agency has received comments requesting a 60-day extension of the comment period for the ANPRM. These comments convey concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to questions raised in the ANPRM (it has also received comments opposing an extension on the grounds that it has given ample time to comment).

FDA has considered the requests and is extending the comment period for the ANPRM for 60 days. It said that it believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying any potential regulatory action on these issues.

Keywords: 
cigarettes