On June 16, 2015, the FDA announced the upcoming publication of a declaratory order 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 human food. The announcement confirms FDA’s tentative determination made in 2013. FDA announced that its order is aimed at improving heart health and preventing health problems related to the consumption of trans fat.
The order, which is scheduled to be published in the Federal Register on Wednesday, June 17, 2015, provides a compliance period of three (3) years to allow industry time to reformulate products without PHOs or to petition the FDA for food additive approval to permit specific uses of PHOs. According to the advance copy of the order, effective June 18, 2018, no PHOs may be added to human food unless they are otherwise approved as a food additive by the FDA. The FDA stated in the notice that it expects the food industry to have sufficient time to identify suitable replacement ingredients for PHOs:
The compliance date will have the additional benefit of minimizing market disruptions by providing industry sufficient time to identify suitable replacement ingredients for PHOs, to exhaust existing product inventories, and to reformulate and modify labeling of affected products. Three years also provides time for the growing, harvesting, and processing of new varieties of edible oilseeds to meet the expected demands for alternative oil products and to address the supply chain issues associated with transition to new oils.
The declaratory order defines PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.” PHOs are distinct from fully hydrogenated oils (“FHOs”), which are defined as “fats and oils that have been hydrogenated to complete or near complete saturation, and with an IV of 4 or less, as determined by a method that is suitable for this analysis (e.g., ISO 3961 or equivalent).” The FDA has not changed the GRAS status of FHOs in this order. The order also does not change requirements for nutrition labeling of trans fat. Currently, foods are allowed to be labeled as having “0” grams of trans fat if they contain less than 0.5 grams of trans fat per serving.
Michael Best has a full-service FDA regulatory practice that can assist companies with the process of evaluating ingredients and food production changes to assess FDA regulatory compliance. Further, Michael Best’s Intellectual Property Practice Group has experience with protecting new food formulation technology.