FDA Issues Declaratory Order Revoking GRAS Status of PHOs

By Ricardo Carvajal, Diane B. McColl & Jenifer R. Stach –

FDA issued a declaratory order revoking the GRAS status of partially hydrogenated oils (PHOs), thereby finalizing its November 2013 tentative determination that there is no longer consensus among qualified experts that PHOs are safe for use in human food (see our prior posting here).  The compliance date for the order is June 18, 2018, after which any uses of PHOs in human food that have not been approved by FDA pursuant to its food additive authority would be prohibited. 

For purposes of the order, FDA defines PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an IV [Iodine Value] greater than 4 as determined by a method that is suitable for this analysis (e.g., ISO 3961 or equivalent).”  Fully hydrogenated oils fall outside the scope of the order.

As noted in the order, “food additive” is defined by section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result in its becoming a component or otherwise affecting the characteristics of any food, if such substance is not GRAS or otherwise excepted from the definition. A substance is GRAS if it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. 

FDA has defined “safe” as “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”  To establish general recognition of safety, there must evidence of a consensus among qualified experts regarding the safety of the use of a substance.  In concluding that there is no longer consensus regarding the safety of PHOs, FDA is not making a determination regarding the safety of specific uses of PHOs.  Such a determination would be made in the context of the agency’s evaluation of a food additive petition describing in detail specified uses of PHOs, which the order encourages industry to submit.

The final determination responds in part to two pending citizen petitions regarding the safety of PHOs.  One petition was submitted in 2004 by the Center for Science in the Public Interest, and the second citizen petition was submitted in 2009 by Dr. Fred Kummerow, who subsequently sued FDA to compel a response to his petition. It is as yet unclear how FDA’s order will affect that lawsuit.