FDA has made it official. The main source of artificial trans fat in processed foods, partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in human food. The agency is giving food manufacturers three years to comply. Companies can either reformulate products without PHOs and/or petition FDA to allow specific uses.
FDA is defining PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four”.
“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,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in an FDA press release. Manufacturers have been required to indicate the presence of trans fats on product labeling since 2006. The agency estimates that between 2003 and 2012, consumption of trans fat decreased by nearly 78%, and attributes this drop to labeling requirements and consumer awareness. For the past decade, the Institute of Medicine has recommended limiting trans fat consumption.
“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” stated Stephen Ostroff, M.D, acting commissioner of FDA. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
After issuing its notice in November 2013 that PHOs were not GRAS, FDA received more than 6000 comments in response to this tentative determination. According to the Federal Register notice, the majority of comments from industry, trade associations, advocacy groups, health professionals, and government stakeholders were in favor of FDA’s tentative determination. Those who expressed dissent cited the agency’s scientific analysis as well as its potential effect on trade, taxes, and the potential that it could lead to bans on other substances; some provided alternatives to dealing with the issue of trans fat in food.