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FDA Approves Ban on Partially Hydrogenated Oils in Processed Foods

The Food and Drug Administration has determined based on the available scientific evidence and the findings of expert scientific panels that partially hydrogenated oils, which are the primary dietary source of industrially-produced trans fatty acids, are not generally recognised as safe (GRAS) for any use in food and should therefore be categorised as food additives. The FDA believes that PHOs pose significant health risks and the fact that these substances were used prior to 1958 is not sufficient to support continued GRAS status if there is no longer a scientific consensus that they are safe for their intended use in food.

As a result of the FDA's determination, effective from 18 June 2018 food manufacturers will no longer be permitted to sell PHOs, either directly or as ingredients in other food products, unless they can prove to the FDA that one or more specific uses are safe under the "reasonable certainty of no harm" safety standard. Industry experts believe that the likelihood of the FDA approving such a food additive petition after declaring that PHOs are not GRAS is remote to non-existent. The FDA notes that many companies have already been working to remove PHOs from processed foods and many may eliminate them ahead of the compliance date. The agency estimates that over 20 years the net present value of the quantified costs of removing PHOs from the food supply will be about US$6.2 billion and the benefits will be about US$140 billion.

PHOs have a long history of use as food ingredients. The partial hydrogenation process was developed in the 1930s and has been in widespread commercial use since the 1940s. Two common PHOs currently used by the food industry are partially hydrogenated soybean oil and partially hydrogenated cottonseed oil, neither of which is listed as GRAS in the FDA regulations. However, these and other commonly used PHOs (e.g., partially hydrogenated coconut oil and palm oil) have been considered GRAS through a self-determination by the food industry for use in food at levels consistent with good manufacturing practice based on a history of use prior to 1958.

Section 409 of the Federal Food, Drug, and Cosmetic Act provides that a food additive is unsafe unless it is used in accordance with certain conditions set forth in that section. "Food additive" is defined by Section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result in its becoming a component or otherwise affecting the characteristics of any food, if such substance is not GRAS. A substance is GRAS if it is generally recognised, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to 1 January 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. However, history of use prior to 1958 is not sufficient to support continued GRAS status if new evidence demonstrates that there is no longer a consensus that an ingredient is safe.

The FDA notes that it is not aware that either it or the U.S. Department of Agriculture granted any explicit sanction or approval for any use of PHOs in food prior to the 1958 Food Additives Amendment to the FD&C Act. In contrast, the partially hydrogenated versions of low erucic acid rapeseed oil and menhaden oil are affirmed by regulation as GRAS for use in food. Partially hydrogenated LEAR oil was affirmed as GRAS for use in food through scientific procedures, whereas partially hydrogenated menhaden oil was affirmed as GRAS for use in food on the basis that the oil is chemically and biologically comparable to commonly used partially hydrogenated vegetable oils such as corn and soybean oils. These PHOs are not currently widely used by the food industry, however.

As an initial step to address the negative effect of trans fat, the FDA issued a final rule in July 2003 amending the U.S. nutrition labelling regulations to require declaration of the trans fatty acid content of food in the nutrition label of conventional foods and dietary supplements. This requirement entered into force on 1 January 2006. While the IOM/National Academy of Sciences report about trans fat did not make any quantitative recommendations for establishing a daily reference value for trans fat, it recommended that the intake be as low as possible while maintaining a nutritionally balanced diet.

The FDA estimated in the July 2003 rule that the mean adult intake of this substance was 4.6 grams per day from products containing PHOs and 5.8 grams per day from those products and animal products containing trans fat. This analysis showed that many food products, including frozen potato products and most frozen breaded products, have been reformulated to eliminate or substantially reduce the amount of industrially-produced trans fatty acids. However, the FDA notes that certain population groups still consume high levels of trans fatty acids, primarily through the consumption of food products containing PHOs. The mean trans fat intake for the U.S. population aged two years or more who consumed one or more of the processed foods identified as containing PHOs was estimated to be 1.0 grams per person per day in 2012, with the mean intake for high-level consumers estimated at 2.6 grams per day.

While the mean dietary intake of industrially-produced trans fat has decreased significantly over the past decade, there are still a number of foods made with PHOs that remain on the market. These products fall into one or two broad categories: (1) foods for which consumers have alternatives containing lower levels of trans fat (e.g., cookies, baked goods, microwave popcorn, frozen pizza, frozen pies and shortening) and (2) foods for which consumers have limited or no choice of an alternative containing a lower level of trans fat (e.g., ready-to-use frostings and stick margarine).

The National Resources Defense Council welcomed the FDA's decision on trans fat but urged the agency to perform safety reviews of 1,000 other chemicals in food that manufacturers have self-certified as safe. Erik Olson, director of the health and environmental programme at NRDC, said that the FDA "should do its own safety reviews of these chemicals and provide more transparency so the public can learn whether we are eating potentially harmful chemicals, and what actions the agency is taking to make sure that our food is safe."

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