Still no timeline for final pho GRAS rule

by Jeff Gelski
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If the F.D.A. rules that phos are not GRAS, manufacturers may need to reformulate some products.

WASHINGTON -- The Food and Drug Administration has yet to make a final decision on its proposed rule to take away the Generally Recognized As Safe (GRAS) status of partially hydrogenated oils. The proposed rule first appeared in the Federal Register on Nov. 8, 2013.

“F.D.A. is nearing completion of its review but has no specific timeline at this point,” said Dani Schor, a spokesperson in the F.D.A.’s Office of Foods and Veterinary Medicine, when contacted by Food Business News.

An update may come this June 1. The F.D.A. in court documents from Nov. 26, 2014, estimated it will complete its review of public comments on the proposed rule and take any final action on its tentative determination, including necessary reviews and clearance from multiple offices, by June 1, 2015.

The documents come from a case initially filed Aug. 9, 2013, in the U.S. District Court, Central District of Illinois by Fred Kummerow, Ph.D., professor emeritus in the Department of Comparative Biosciences at the University of Illinois. He sought to obtain a court order compelling the F.D.A. to respond to his petition seeking a ban of phos and compelling the F.D.A. to ban phos unless a complete administrative review finds new evidence for their safety.

The F.D.A. issued its proposed rule about three months after Dr. Kummerow’s initial court filing. The F.D.A. on Nov. 8, 2013, said it tentatively had determined phos, the primary dietary source of industrially-produced trans fatty acids, are not GRAS for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat. If the proposed rule is finalized, food manufacturers no longer would be permitted to sell phos, either directly or as ingredients in another food product, without prior F.D.A. approval for use as a food additive.

A final rule possibly could come this year.

“The F.D.A. has not defined a date or deadline for issuing its final ruling regarding GRAS status of phos, but the industry expectation is that we will hear something from F.D.A. in the second quarter of this year,” said Bob Johnson, director of research and development for Bunge Oils and based in Bradley, Ill.

If the F.D.A. issues a final ruling that phos are not GRAS, the agency intends to provide a compliance date that would be adequate for producers to reformulate any products as necessary and that would minimize market disruption.

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