The FDA said Tuesday that, following “a thorough review of the scientific evidence,” it has concluded that PHOs — the primary dietary source of artificial trans fat in processed foods — are not “generally recognized as safe” (GRAS) for use in human food. In 2013, the agency made a tentative determination that PHOs could no longer be considered GRAS and has now finalized that determination after considering public comments.
“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” Stephen Ostroff, acting commissioner of the FDA, said in a statement. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
During the three-year compliance period, food makers can reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. After the compliance periods, no PHOs can be added to human food unless they are otherwise approved by the FDA.
The FDA noted that many food manufacturers have already been working to remove PHOs from processed foods, and the agency expects that many of these companies may eliminate them before the end of the three-year compliance period.
Manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods since 2006. The FDA estimated that between 2003 and 2012 consumer trans fat consumption dropped 78%, and the agency said the labeling rule and industry reformulation of foods were key factors in helping consumers make healthier food choices as well as in reducing trans fat in foods.
Although trans fat intake has decreased significantly, the current intake remains a public health concern, according to the FDA. 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, including PHOs.
“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,” stated 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.”