In 2015, the Food and Drug Administration (F.D.A.) removed the GRAS status of a common and crucial ingredient to pastries and pies — partially hydrogenated oil. Despite the definitiveness of the ruling, it wasn’t a shocking decision. The writing had long been on the wall that phos were on the way out.
“It has been discussed for many years that phos were detrimental to health,” said Carol Culhane, president, International Food Focus, a regulatory compliance and commercialization consulting group. “Some manufacturers removed them voluntarily, and some were waiting for the hammer to come down, but it didn’t come as a surprise.”
This discussion was fueled by growing concern over trans fats and their contribution to cardiovascular disease. With phos being a major source of trans fat, it seemed only a matter of time that this or a similar ruling would come into play. When the GRAS determination came, however, in June 2015, the American Bakers Association (A.B.A.), though not surprised, did express disagreement with how the agency went about the ruling.
“A.B.A. is disappointed that F.D.A. chose a novel approach to address partially hydrogenated oils through a GRAS determination instead of a more appropriate formal rule-making that requires thorough economic, environmental and small business impact analyses,” the A.B.A. said in a statement issued shortly after the F.D.A.’s determination. “Short changing the regular rule-making process deprived F.D.A. of critically important stakeholder feedback and data collection. A.B.A. supports F.D.A.’s intent of further reducing exposure to trans fats and applauds its members for their tremendous efforts over the past decade to significantly reduce trans fats in bakery products.”
The F.D.A. defended its decision and jurisdiction to make it. After announcing a tentative determination in the Federal Register on Nov. 8, 2013, the public comments the F.D.A. received were mostly supportive, said Marianna Naum, Ph.D., strategic communications and public engagement, Office of Foods and Veterinary Medicine, F.D.A.
“A substance is GRAS if it is generally recognized among experts to be safe for its intended use, either through scientific procedures or for substances used in food prior to Jan. 1, 1958, through experience based on common use in food,” she said. “Scientific evidence supports F.D.A.’s determination that there is no longer a consensus among qualified experts that phos are safe for use in human food. This determination is based on the body of available scientific evidence regarding consumption of trans fat and increased risk of cardiovascular disease, which can lead to strokes and heart attacks, and the opinions of expert panels.”
While it may have been less democratic for the F.D.A. to make this determination outside of the rule-making process (which it can do under the Federal Food, Drug, and Cosmetic Act), Ms. Culhane believes it gives the food industry some certainty when it needed some.
“We can say ‘at least we know where they stand,’ instead of one of these consultations where you don’t know for years what is going to come out of it,” she said. “This way, the industry knows F.D.A.’s position. We had our marching orders. Let’s make it happen. There was no ambiguity from F.D.A. on this, and that, I think, is something we can be thankful for.”
As a part of its determination, though, the F.D.A. did give the industry a three-year compliance period that is almost up. On June 17, 2018, all phos must be removed from all formulations of human food.
“The compliance period was chosen after carefully weighing input from all stakeholders,” Dr. Naum said.
That compliance timeline definitely softened the news of the F.D.A.’s determination for the A.B.A. In a statement the association released after the GRAS determination, the A.B.A. noted the timeline would give the baking industry adequate time to reformulate.
“A.B.A. is pleased that the agency was responsive to its strong recommendations for an orderly transition by providing a three-year compliance period,” the A.B.A. said. “A.B.A. and its members are appreciative that F.D.A. recognizes the complexity of this issue.”
In the meantime, the House Appropriations Committee added an amendment to the fiscal 2016 agricultural spending bill that preserved the GRAS status of phos through the compliance deadline. This amendment resolved any confusion regarding the immediate revocation of phos’ GRAS status and the gradual phase-out of their use in formulations.
Since the announcement, Ms. Culhane observed that the food industry has mostly been quick to cooperate with the ruling.
“Many manufacturers got busy that first year to replace phos with another fat source but maintain the organoleptic properties that they would like their product to have,” she said. “The industry was prepared for this because the writing was on the wall.”
That writing led many in the industry to start researching and making the change before the GRAS determination was announced. Since an F.D.A. mandate in 2006 required trans fats to appear on the Nutrition Facts Panel, the food industry at large has made efforts to cut phos from products. Prior to the 2015 announcement, the A.B.A. estimated that pho usage already had been reduced by 70% in the baking industry. At this point, the Grocery Manufacturers Association (G.M.A.) estimates that the voluntary reduction of phos use has reduced pho-related trans fat intake by close to 98%.