On June 17, 2015, FDA revoked the GRAS status of artificial trans fats, specifically partially hydrogenated oils (PHOs), dictating removal of the ingredients from foods no later than June 18, 2018 (see “Final Determination Regarding Partially Hydrogenated Oils”). This comes in the wake of FDA’s preliminary determination in November 2013 that PHOs are no longer GRAS for any use in human food.
Per FDA, GRAS ingredients are permitted in foods without FDA review or approval. FDA has noted that fully hydrogenated oils (FHOs) remain outside the scope of this ruling. FHOs typically contain levels of trans fat similar to non-hydrogenated, refined fats and oils (less than 2 percent).
By definition, PHOs feature mixtures of triglycerides, produced by partial hydrogenation, and include at least one nonconjugated double bond in a trans configuration.
“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 Dr. Stephen Ostroff, acting commissioner, FDA, in a release. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”
This ruling follows FDA’s directive in 2003 to begin including trans fat on Nutrition Facts labeling, a ruling that went into full effect at the beginning of 2006. Foods can note “0 grams” trans fat if levels are below 0.5 grams per serving.
Between 2003 and 2012, FDA estimates that trans fat consumption in the U.S. decreased by about 78 percent. Despite this significant reduction, FDA has determined that “current intake remains a public health concern.” FDA suggests that this move to completely remove PHOs from foods could prevent thousands of heart attacks and deaths each year.
In FDA’s notice, Susan Mayne, Ph.D., director, Center for Food Safety and Applied Nutrition, FDA, 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.”
Following the compliance period concluding in June 2018, FDA has dictated that manufacturers cannot add PHOs to food without FDA approval. This includes processing aids and food-contact substances, like pan-release agents, that contain PHOs.
Although some members of the industry have suggested that adequate supplies of PHO replacements might pose challenges to reformulation, FDA believes that the three-year compliance period will prove adequate, noting, “Based on our experience and on the changes we have already seen in the market, we believe that three years is sufficient time for submission and review and, if applicable requirements are met, approval of food-additive petitions for uses of PHOs for which industry or other interested individuals believe that safe conditions of use may be prescribed.” (For more information on available ingredients to replace PHOs and tactics for their use, see “Replacing trans fats in snack and bakery products.”)
FDA acknowledges that removal of GRAS status for trans fat won’t completely remove it from our foods. Some trans fat occurs naturally in meat and dairy products, and is also present at very low levels in select edible oils. This FDA order does not apply to ingredients that only contain naturally occurring trans fat, such as ingredients derived from ruminant sources. The order also does not impact the GRAS status of conjugated linoleic acid (CLA).
In a release following the FDA decision, the American Bakers Association (ABA) noted that: “ABA is disappointed that FDA chose a novel approach to address partially hydrogenated oils through a GRAS determination instead of a more-appropriate formal rulemaking that requires thorough economic, environmental and small-business impact analyses. Short-changing the regular rulemaking process deprived FDA of critically important stakeholder feedback and data collection.”
That said, ABA noted that it was pleased that FDA was responsive to its “strong recommendations for an orderly transition by providing a three-year compliance period. This action provides bakers and other food makers adequate time to further formulate to other, healthier alternatives, as well as address a number of practical challenges, including packaging changes and availability. ABA and its members are appreciative that FDA recognizes the complexity of this issue.”