WASHINGTON, June 16, 2015 -- The Food and Drug Administration today finalized a determination that partially hydrogenated oils (PHOs) – the primary dietary source of artificial trans fat in processed foods – are no longer “generally recognized as safe” (GRAS) and gave food manufacturers three years to remove  PHOs from their products.

The long-expected decision – FDA tentatively determined PHO’s were not GRAS in 2013 -- was praised by public health advocates who said it will cut back on heart disease and save thousands of lives each year from heart attacks.

“The eventual elimination of artificial trans fat from the food supply will mean a healthier food supply, fewer heart attacks and heart disease deaths, and a major victory for public health,” said Michael Jacobson, executive director of the Center for Science in the Public Interest, which petitioned FDA to ban trans fats nine years ago. “The final determination made today by FDA gives companies more than enough time to eliminate the last of the partially hydrogenated oil that is still used in foods like microwave popcorn, biscuits, baked goods, frostings, and margarines.”

Food makers have been cutting back on use of PHOs for years, especially since 2006 when manufacturers were required to include trans fat content information on the Nutrition Facts label of foods. The FDA estimates that trans fat use decreased about 80 percent since about 2003 and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods.

FDA said today that while trans fat consumption 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. 

“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. "This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

Under the final rule announced today, FDA is reclassifying partially hydrogenated oils as food additives. This means companies would need federal approval before including them in food products.

In a statement, The Grocery Manufacturers Association said it will work with FDA to further reduce PHOs in foods and that it was pleased that the agency is providing time for its members to complete their transition to suitable alternatives and to seek food additive approval for limited uses.

“GMA’s food additive petition to FDA will show that the presence of trans fat from the proposed low-level uses of partially hydrogenated oils (PHOs) is as safe as the naturally occurring trans fat present in the normal diet,” GMA said. “Food and beverage companies have already voluntarily lowered the amount of trans fat added to food products ….. and will continue lowering PHO use in foods.”

CSPI noted that the food additive petition process would require the industry to demonstrate that the uses would be safe at the levels intended. 

“The FDA should continue to minimize Americans’ exposure to artificial trans fat and subject the industry’s petition to a rigorous and skeptical test,” Jacobson said.  “If FDA approves it for use as a food additive, it must do so only in the tiniest of amounts.”


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