The Food and Drug Administration has finalized its determination that partially hydrogenated oils (phos), the primary dietary source of industrially produced trans fat, are not Generally Recognized As Safe (GRAS) for use in human food, the agency announced June 16.
The F.D.A. said there is no longer a consensus among qualified experts that phos are GRAS for use in any human food. Food manufacturers have until June 18, 2018, to remove phos from their products. Any interested party may seek food additive approval for one or more specific uses of phos by providing data demonstrating a reasonable certainty of no harm of the proposed use or uses, according to the F.D.A.
“The F.D.A.’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” said Stephen Ostroff, M.D., acting commissioner of the F.D.A. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
Susan Mayne, Ph.D., director of the F.D.A.’s Center for Food Safety and Applied Nutrition, said, “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 F.D.A. defines phos as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, with an iodine value (IV) greater than 4.
The F.D.A. encouraged consumers to check a food ingredient’s list for partially hydrogenated oils. Currently, foods are allowed to be labeled as having 0 grams of trans fat if they contain less than 0.5 grams of trans fat per serving, even if they included phos.
The Grocery Manufacturers Association, Washington, said it had no problems with the three-year compliance period.
“G.M.A. is pleased that F.D.A. has acted in a manner that both addresses F.D.A.'s concerns and minimizes unnecessary disruptions to commerce,” the G.M.A. said in a June 16 statement. “G.M.A. will work in collaboration with F.D.A. to further reduce phos in foods. The delayed effective date for F.D.A.’s Notice of Final Determination regarding the Generally Recognized as Safe (GRAS) status of partially hydrogenated oils (phos) provides time needed for food manufacturers to complete their transition to suitable alternatives and/or seek food additive approval.”
The G.M.A. still plans to file a food additive petition with the F.D.A.
“G.M.A.’s food additive petition to F.D.A. 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,” the G.M.A. said.
The F.D.A. in the Federal Register of Nov. 8, 2013, said it tentatively determined that phos are 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. The F.D.A. said it received more than 6,000 comments, including 4,500 form letters, in response to the 2013 Federal Register notice.
Commonly used phos have been considered GRAS by the food industry based on a history of use prior to 1958, according to the F.D.A. Beginning in 2006, the F.D.A. required food manufacturers to include trans fat content information on the Nutrition Facts Panel of food.
“If you walk down any grocery store aisle, you can look at packages, whether it’s baked goods packages, crackers, or dairy items, margarine, pastries, etc., you will find some products with added phos and you’ll find other products without added phos,” said Dennis M. Keefe, Ph.D., director of the F.D.A.’s Office of Food Additive Safety, in a June 16 media briefing. “This reflects different industries’, different companies’ reformulations to remove phos. Really phos have been used over the years in a variety of shelf stable processed foods.”
The F.D.A. estimated consumption of trans fat in the United States decreased about 78% between 2003 and 2012.
“That’s good progress, but there is more to be done, and we estimated that today’s action will prevent thousands of coronary heart attacks and deaths each year,” Dr. Mayne said in the media briefing. “We know that trans fat increases the levels of low-density lipoprotein, or L.D.L. cholesterol, which contributes to coronary heart disease.”
The F.D.A.’s 2013 posting in the Federal Register recognized how the amount of trans fat consumption has fallen in the United States. The F.D.A. estimated that in July 2003 the mean adult (aged 20 years or more) intake of trans fat from products containing phos was 4.6 grams per day. The F.D.A. estimated that in 2010 the mean trans fat intake for the U.S. population aged 2 years or more who consumed one or more of the processed foods identified as containing phos to be 1.3 grams per person per day.