FDA: Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today 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” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.
“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 the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans
fat consumption decreased about 78 percent and that the labeling rule
and industry reformulation of foods were key factors in informing
healthier consumer choices and reducing trans fat in foods. While trans
fat intake has significantly decreased, the current intake remains a
public health concern. The Institute of Medicine recommends that
consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.
“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,” said
Susan Mayne, Ph.D., 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.”
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.
The FDA encourages consumers seeking to reduce trans fat
intake to check a food’s ingredient list for partially hydrogenated oils
to determine whether or not a product contains PHOs. Currently, foods
are allowed to be labeled as having “0” grams trans fat if they contain less than 0.5 grams of trans fat per serving, including PHOs, the primary dietary source of artificial trans fat in processed foods.
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.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.