FDA Issues Final Determination That Partially Hydrogenated Oils Are Not GRAS Due To Trans Fat Content

Today the Food and Drug Administration (FDA) published a Declaratory Order finalizing its determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for any use in food. FDA rejected the legal and scientific arguments submitted by the industry challenging the tentative determination and concluded there no longer is consensus among qualified individuals that PHOs are GRAS. Using a novel procedural approach under the Administrative Procedure Act, the agency issued the final determination as a “declaratory order,” and thus avoided many of the procedural safeguards that are mandated by notice and comment rulemaking. The agency established a three-year “compliance date” of June 18, 2018. FDA noted the time frame should be sufficient for the agency to complete its review of any food additive petition that is submitted and for industry to reformulate foods.

FDA’s determination is limited to PHOs because they are viewed as the primary dietary source of “industrially-produced trans fat” and does not extend to other foods or ingredients that contain trans fat such as meat and dairy, refined oils, fully hydrogenated oils, or ingredients derived from PHOs. In this memorandum, we explain the scientific and legal bases for FDA’s determination, the procedures FDA used to revoke the GRAS status of PHOs, and implications for industry.

Hogan Lovells Memo
FDA's Final Determination Regarding PHOs