FDA Extends Comment Period on 'Deeming' Regs

New deadline is Aug. 8

Published in CSP Daily News

WASHINGTON -- In response to the request of interested parties, the U.S. Food & Drug Administration (FDA) has extended by 30-days the comment period on the agency's proposed options for regulation of cigars, regulatory approach to electronic cigarettes and other non-combustible tobacco products, pathways to market for proposed deemed tobacco products and other issues.

The new deadline is Aug. 8, 2014.

The FDA published the proposed rule on April 25, 2014, with a 75-day comment period ending July 9, 2014 to request comments on its proposed options for regulation of products deemed to be tobacco products, and compliance dates for certain provisions, among other issues.

The agency received multiple requests to extend the comment period for the proposed rule including more than 2,000 form letters as part of a write-in campaign to request additional time to comment. The requests conveyed concern that the current 75-day comment period did not allow sufficient time to develop a meaningful or thoughtful response to questions raised in the proposed rule.

The FDA also received comments opposing an extension of the current comment period on the grounds that ample time has been given to comment on the issues raised in the proposed rule.

FDA has considered the requests and decides to extend the comment period for the proposed rule for an additional 30 days. The agency said it believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.