The Final Steps for the FDA ‘Deeming’ Regulations
From: CSPnet.com
Only OMB review, publication in the Federal Register remain
Published in Tobacco E-News
By Thomas A. Briant, NATO Executive Director
MINNEAPOLIS — On October 19th of this year, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products submitted to the Office of Management and Budget (OMB) the final deeming regulations on cigars, pipe tobacco, and e-cigarettes.
The submission of the final deeming regulations by the FDA to the OMB is the eighth step in the federal government’s nine-step regulatory process to deem whether certain tobacco products are under the FDA’s jurisdiction. Step Eight involves the OMB reviewing the financial impact of the FDA’s final regulations. If the OMB approves the final deeming regulations, then Step Nine requires that the final regulations be published in the Federal Register. Generally, the OMB has 90 days to review the regulations and then the regulations would be effective 30 days after the date of publication in the Federal Register.
