FDA Opens Comment Period on GRAS Status of Trans Fats
The U.S. Food and Drug Administration (FDA) “has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives.” If the agency finalizes this determination, “food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.” It would not, however, affect the trans fat that occurs naturally in small amounts in meat and dairy products.
Announcing the initiative, FDA Commissioner Margaret Hamburg said, “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year—a critical step in the protection of Americans’ health.” According to FDA, trans fat, found in some processed foods, raises low-density lipoprotein, the “bad” cholesterol, thus purportedly increasing the risk of coronary heart disease. The Institute of Medicine has apparently concluded that no safe level of consumption of artificial trans fat exists. Comments, including scientific data and information, must be submitted by January 7, 2014.
Lawmakers, including Sen. Tom Harkin (D-Iowa) who called on FDA in February to remove PHOs’ GRAS status, applauded the agency’s decision. He said, “Eliminating artificial trans fats from our food supply will be an enormous step towards improving our public health and reducing our health care costs, as well as potentially helping to prevent thousands of premature, fatal heart attacks each year.” Rep. Rosa DeLauro (D-Conn.) responded to the announcement by calling the move “a great step in the battle against heart disease and an obesity epidemic that threatens Americans’ quality of life. Local efforts blazed a trail for this decision, but there is no substitute for a nationwide standard.”
The Grocery Manufacturers Association, which indicated that it planned to submit comments on the tentative determination, noted that food makers “have voluntarily lowered the amounts of trans fats in their food products by over 73 percent” since 2005. According to a news source, biotech companies are working to create and commercialize genetically engineered soybeans that can be used to replace PHOs. See FDA News Release and CQ News, November 7, 2013.
Issue 503
