The U.S. Food and Drug Administration 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” (GRAS) for use in food.
The move, based on “a thorough review of the scientific evidence,” essentially bans artificial trans fat from the food supply. Companies can still seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm from the proposed uses.
PHOs can no longer be added to foods after June 18, 2018, unless they are otherwise approved by FDA. The three-year compliance period is meant to allow food manufacturers to either reformulate products without PHOs or petition the FDA to permit specific uses.
“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.”
Consumption of trans fat can increase the risk of coronary heart disease by raising low-density lipoprotein cholesterol, commonly referred to as “bad cholesterol,” and the Institute of Medicine has concluded that there is no safe level of consumption of trans fat.
According to the Centers for Disease Control and Prevention, removing PHOs from processed foods could prevent up to 20,000 heart attacks and 7,000 coronary deaths each year.
“PHOs or partially hydrogenated oils have been used as ingredients since the 1950s to improve the shelf-life of processed foods,” wrote Susan Mayne, the director of FDA’s Center for Food Safety and Applied Nutrition, in an agency blog post. “In this case, it has become clear that what’s good for extending shelf-life is not equally good for extending human life.”
On Nov. 8, 2013, FDA announced a tentative determination that PHOs are no longer GRAS under any condition of use in human food and therefore are food additives. At the time, the agency requested additional data and scientific information and asked for comments on several questions.
The public was originally given until Jan. 7, 2014, to comment on the notice. However, in response to several requests, FDA extended the comment period to March 8, 2014.
The agency received more than 6,000 comments in response to the notice, including more than 4,500 form letters. The submissions came from individuals, industry and trade associations, consumer and advocacy groups, health professional groups, and state or local governments.
FDA encourages consumers seeking to reduce trans fat intake to check the Nutrition Facts label for trans fat. The most effective way to avoid PHOs is to check the ingredient list for partially hydrogenated oils because, even if trans fat is listed as having “0” grams, they could still contain less than 0.5 grams of trans fat per serving.
