FDA to eliminate the use of trans-fats by 2018, after determining they are not “generally recognized as safe” for use in human food
The U.S. Food and Drug Administration (FDA) announced 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. Food manufacturers will have three years to remove PHOs from products.
The major provisions of FDA’s order, printed in the Federal Register, are:
- PHOs are not GRAS for any use in human food.
- Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s).
- For the purposes of this declaratory order, FDA is defining PHOs as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four.
- FDA is establishing a compliance date of June 18, 2018.
“The FDA’s action on this major source of artificial trans-fat demonstrates the agency’s commitment to the heart health of all Americans,” said FDA’s Acting Commissioner Stephen Ostroff, M.D. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
This determination will significantly reduce the use of PHOs, the major source of artificial trans fats, in the food supply. 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 food Nutrition Facts labels. Between 2003 and 2012, the FDA estimates that consumer trans-fat consumption decreased about 78% and credits its labeling rule and industry food reformulation as key factors in reducing trans-fat in foods. While trans-fat intake has significantly decreased, FDA says the current intake remains a public health concern.
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. Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.