PHO Decision

The Food and Drug Administration on or before June 15 expects to make a final decision on the Generally Recognized As Safe (GRAS) status of partially hydrogenated oils (PHOs), according to a May 22 filing in the U.S. District Court, Central District of Illinois, Urbana Division.

The FDA in the Nov. 8, 2013, issue of the Federal Register tentatively determined PHOs, which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not GRAS for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives. If finalized, the rule would mean 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.

The tentative determination in 2013 came after Fred Kummerow, Ph.D., professor emeritus at the University of Illinois, filed suit against the FDA in the Illinois court on Aug. 9, 2013. He sought an order compelling the FDA to respond to his petition to ban trans fat and to ban partially hydrogenated oils unless a complete administrative review finds new evidence for their safety.

A stay in the case was set to expire on June 1 of this year. The May 22 court filing extends the stay until June 22, which should be after the FDA makes its final decision on the GRAS status of PHOs.