FDA Extends Comment Period on Proposal to Deem PHOs Unsafe
The U.S. Food and Drug Administration (FDA) has decided to extend the comment period by 60 days, to March 8, 2014, on its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. This extension is being provided in response to numerous stakeholder requests to provide additional time for comments. FDA is expediting publication of a notice in the Federal Register and will issue a Constituent Update when the exact publication date is known.
FDA published a notice in the Federal Register announcing its preliminary determination on November 8, 2013. The Agency initially provided 60 days, until January 7, 2014, for interested persons to provide comments and scientific data pertaining to the notice, including specific issues that FDA sought comments on such as possible alternative approaches, time needed for reformulation, burden on small businesses, and other technical challenges to removal of PHOs from the food supply.
Interested parties may submit comments electronically to the FDA docket on www.regulations.gov, using docket number FDA-2013-N-1317.
To submit comments by mail, send to FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All submissions must include the agency name and docket number.