Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration (FDA) has finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. In 2013, the FDA made a tentative determination that PHOs could no longer be considered GRAS and is finalizing that determination after considering public comments.
Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78% and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. While trans fat intake has significantly decreased, the current intake remains a public health concern. The Institute of Medicine (IOM) recommends that consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.
“Studies show that diet and nutrition play a key role in preventing chronic health problems, such as cardiovascular disease and today’s action goes hand-in-hand with other FDA initiatives to improve the health of Americans, including updating the Nutrition Facts label,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. “This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.”
The FDA has set a compliance period of three years. This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by the FDA.
In response to the ruling, the Grocery Manufacturers Association (GMA) released the following statement: “GMA is pleased that FDA has acted in a manner that both addresses FDA’s concerns and minimizes unnecessary disruptions to commerce. GMA will work in collaboration with FDA to further reduce PHOs in foods. The delayed effective date for FDA’s Notice of Final Determination regarding the Generally Recognized as Safe (GRAS) status of Partially Hydrogenated Oils (PHOs) provides time needed for food manufacturers to complete their transition to suitable alternatives and/or seek food additive approval.”
