The U.S. FDA on Tuesday revoked a generally recognized as safe determination for partially hydrogenated oils, a decision that ultimately will affect the soy industry's production of high-oleic soybeans but will not impact animal feed, FDA clarified.
PHOs are the main dietary source of artificial trans fat in human foods, the FDA said, and the change is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year, according to FDA Acting Commissioner Dr. Stephen Ostroff.
FDA first indicated its intention to eliminate the GRAS determination for PHOs in 2013. Under the now-finalized decision, manufacturers will have three years to eliminate PHOs from processed food products.
According to the American Soybean Association, that's enough time to allow the soy industry to increase production of high-oleic soybeans. ASA says high-oleic soybean oil can replace PHOs and other highly saturated fats in food production.
"High oleic soybeans represent a key evolution in soybean farmers' ability to meet the needs of our customers," ASA President Wade Cowan said in a statement Tuesday. "But we've emphasized to FDA all along that we need the time to get the high oleic trait integrated into soybean varieties and approved in overseas markets so we can produce what the industry demands."
Cowan said the industry was concerned at first that without sufficient "ramp-up" time, the food industry would turn to other oils – like palm oil – that aren't as well-suited as soybeans to decrease trans fat without creating a negative environmental impact.
"Soybean oil contains no trans fat, is low in saturated fat, is sustainable, and is a broadly available, domestic option for the food industry here in the United States," Cowan said.
FDA said companies will now either reformulate products containing PHOs or submit specific petitions to the FDA for certain exemptions. Many companies have already been working to remove PHOs from processed foods, FDA said. It anticipates that many may eliminate them ahead of the three-year compliance date.
Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, said the decision was ultimately the result of "extensive research" into the effects of PHOs and input from stakeholders since 2013.
Only 'human' food clarification
Following up on an inquiry from the American Feed Industry Association, the FDA also clarified that the GRAS decision for PHOs is limited to food for humans, not animals.
FDA's definition of "food," said AFIA director of ingredients, pet food and state affairs Leah Wilkinson, represents both food for human consumption and food for consumption by animals. That worried the group, because vegetable oils and partially hydrogenated oils have been deemed as safe ingredients in the animal food industry for decades, she said.
The clarification ensures PHOs can continue to be used in animal feed rations, AFIA said.