Removing GRAS status would mean that these oils – still commonly used in various processed foods for flavor and shelf-life-extension purposes – would be classified as food additives that could not be legally used in food unless authorized by the FDA.
PHOs are the primary dietary source of artificial trans fat in processed foods, according to the agency. Its determination covers only PHOs, not fully hydrogenated oils or the trans fat that occurs naturally in small amounts in some meat and dairy products.
The list of foods that would be affected is long. It would include some items within categories such as frozen entrees/meals, pizza and bakery products; cake, pancake and biscuit mixes; non-frozen bakery products; crackers; peanut butter; margarine; coffee creamers; hot chocolate; whipped toppings and certain desserts; microwave popcorn and fried foods such as French fries.
In addition, some brands of breakfast cereals, corn and potato chips, frozen snack foods, low-fat ice creams, breads, noodle soup cups, and pasta and sauce mixes contain PHOs, according to PureZing.com. Some dietary supplements also contain PHOs.
The FDA has opened a 60-day comment period to collect additional data and get input on the time potentially needed for food manufacturers to reformulate products to phase out PHOs. In its announcement, the agency stated that If it decides to finalize its determination, it would provide adequate time for reformulations "in order to minimize market disruption."
The FDA said it based its preliminary determination on available scientific evidence and the findings of expert scientific panels.
“While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern,” said FDA commissioner Margaret A. Hamburg. Citing Centers for Disease Control and Preventing findings, she said that 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.
Trans fats, including PHOs, raise low-density lipoprotein (LDL), or “bad” cholesterol, increasing the risk of coronary heart disease. The Institute of Medicine has concluded that trans fat provides no known health benefit, that its consumption should be as low as possible, and that there is no safe level of consumption of artificial trans fat, according to the FDA.
Mandatory listing trans fat content on the Nutrition Facts label became effective in 2006. (Foods containing 0.5 gram or less of trans fat currently do not have to list it on the label.)
Americans' trans fat intake declined to about 1 gram per day in 2012, from 4.6 grams per day in 2003, the FDA reported.
The labeling regulation spurred many food manufacturers to reformulate their products, and most major restaurant chains abandoned PHOs by the mid- to late 2000s. Some local and state regulations limit or ban use of PHOs by restaurants (for instance, New York City banned restaurants from using partially hydrogenated vegetable oils and spreads in 2007).
However, a "handful" of restaurant chains, such as Carl's Jr., Hardee's and Popeyes, have menu items that contain some PHO, "at least in localities where they're not required by law to use a healthier alternative," stated the Center for Science in the Public Interest.
CSPI, which petitioned the FDA to remove PHOs' GRAS status in 2004, lauded the FDA's announcement. "Not only is artificial trans fat not safe, it's not remotely necessary," said CSPI executive director Michael F. Jacobson. "Many companies, large and small, have switched to healthier oils over the past decade. I hope that those restaurants and food manufacturers that still use this harmful ingredient see the writing on the wall and promptly replace it."
In response to the FDA's announcement, the Grocery Manufacturers Association, which represents more than 300 food and beverage companies, released a statement stressing that, due to these companies' efforts to reformulate products and develop suitable alternatives, "trans fats that are not naturally occurring have been drastically reduced in the food supply. Since 2005, food manufacturers have voluntarily lowered the amounts of trans fats in their food products by over 73%."
GMA said its members "look forward to working with the FDA to better understand their concerns and how our industry can better serve consumers."