Last fall the U.S. Food and Drug Administration (FDA) made an announcement that partially hydrogenated oils (PHOs), the major source of added trans fats in the diet, would no longer be Generally Recognized as Safe, or GRAS. The health effects related to consuming certain levels of trans fats have been known for several years, and manufacturers have taken great strides to minimize trans fats in the food supply. Therefore, to some, the announcement that the GRAS status of PHOs may be revoked seemed a bit out of left field. What was the motivation for FDA’s announcement at this particular time, and what does it mean for the food supply?
The International Food Information Council Foundation recently moderated a session at the 2014 Academy of Nutrition & Dietetics Annual Food & Nutrition Conference & Expo to examine this question, as well as to provide background on what GRAS ingredients are and the process for reviewing their safety, and how the food supply would change, should the proposed removal of the GRAS status for PHOs be passed.
Mitchell Cheeseman, PhD, a managing director at the law firm Steptoe & Johnson, formerly part of the leadership of the Center for Food Safety & Applied Nutrition (CFSAN) at FDA, explained the thorough safety review process that ingredients undergo before being permitted for use in foods and beverages.
Many common food ingredients that were in use before the Food Additive Amendment was passed in 1958 were deemed Generally Recognized as Safe (GRAS). Many of these ingredients include things like sodium, sugar, and caffeine.
Today, food producers may take one of two paths to begin using a new food ingredient, or adopt a new use of an existing food ingredient: 1) They can submit a food additive petition or 2) They can establish that the use of the ingredient as GRAS. Regardless of whether a food ingredient becomes part of the food supply via the food additive path or the GRAS path, the food producer must have deemed the ingredient to be safe for its intended use, and is responsible for upholding the safety of that ingredient as used in foods and beverages. (For more on this process, see the IFIC Foundation’s “Food Ingredient Journey” infographic.)
If PHOs were no longer GRAS, food producers could submit a Food Additive Petition to receive approval for specific uses of PHOs in foods; however, it is unclear whether such a petition would be approved, given the scientific evidence pointing to increased risk of coronary heart disease (CHD) at certain consumption levels. FDA’s role is to ensure the safety of the food supply, and if scientific evidence suggests a safety concern, FDA can and will remove a food or ingredient from the food supply until its safety for the amounts used for a particular purpose can be confirmed.
The second speaker, Janet Collins, PhD, RD, CFS, immediate past President of the Institute of Food Technologists, explained that since researchers learned about the potential negative health effects of trans fats in the diet, food producers have largely phased out their use, with the exception of very small amounts in cases where there is currently no good replacement that performs a similar functional role of PHOs fats in foods. This is the case particularly with baked goods.
However, the reductions across the food and beverage supply have been vast and comprehensive. An FDA review of Estimated Daily Intake of Trans Fat found that there has been a more than 70 percent reduction in trans fat consumption since 2003 (Doell, et al., 2012). Estimates of current daily intake of added trans fat is about 0.5 percent of total calories, with “natural” sources of trans fat in the diet representing an equal share of total calories, at about 0.5 percent.
Food scientists have been working for several years to find a replacement for the remaining PHOs in the food supply, although some alternatives, such as palm oil, may not be any better from a health perspective, contributing high levels of saturated fat, which the Dietary Guidelines for Americans recommends to minimize in the diet. (USDA, 2010)
If trans fat has been significantly reduced in the food supply, then why is FDA making this announcement now? And what will happen to foods that still require a minimal amount of PHOs in order to maintain the taste and texture of the product without compromising the foods’ quality?
As far as why FDA would make an announcement now, Cheeseman indicated that pressure from some individuals and consumer advocacy groups to completely remove trans fats from the food supply likely played a role, despite intake studies showing the efforts to date have significantly reduced trans fat levels. In addition, while PHOs in the food supply have been reduced, FDA says it issued the preliminary determination that PHOs are no longer GRAS due to the link between trans fat consumption and CHD, and its responsibility to ensure the safety of the food supply. (FDA, 2013)
Regarding what will happen if food producers are forced to abandon all use of PHOs before they have found a comparable replacement, it takes years for food scientists to conduct the proper research to have a new ingredient developed, and for that ingredient to be properly reviewed for safety before being added to foods on the market, so it could be a while before comparable replacements are available for some foods. Until then, alternatives that are high in saturated fat may be no better from a health perspective and may be subject to their GRAS status being revoked as well, if they are also deemed to be associated with adverse health outcomes.
Collins reviewed some additional alternatives to PHOs, including high oleic soybean and canola oils, which offer an improved nutritional profile and have been in use for several years in many reformulated products. However, in those products for which these alternatives do not function similarly to PHOs, there could be a noticeable change in the product’s attributes.
The FDA announcement of its final determination regarding whether PHOs would no longer have GRAS status is expected soon.
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