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Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)

In 2015, FDA released its final determination that Partially Hydrogenated Oils (PHOs) are not Generally Recognized as Safe (GRAS). The determination is based on extensive research into the effects of PHOs, as well as input from stakeholders during the public comment period.

PHOs are the primary dietary source of artificial trans fat in processed foods. Removing PHOs from processed foods could prevent thousands of heart attacks and deaths each year. To learn more about trans fat, see our Trans Fat page. It’s important to note that trans fat will not be completely gone from foods because it occurs naturally in small amounts in meat and dairy products, and is present at very low levels in other edible oils.

Implementation

FDA is extending the compliance date for certain uses of partially hydrogenated oils (PHOs). For the majority of uses of PHOs, June 18, 2018, remains the date after which manufacturers cannot add PHOs to foods. However, to allow for an orderly transition in the marketplace, FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. FDA is extending the compliance date for these foods to January 1, 2020. This action balances the health benefits of removing PHOs from the food supply with the need to provide an orderly transition in the marketplace.

At the same time, the FDA is denying a food additive petition from the Grocery Manufacturers Association (GMA) requesting approval for certain limited uses of PHOs. To allow for time for reformulation, the agency is extending until June 18, 2019 the compliance date to stop manufacturing foods with these specific, limited petitioned uses of PHOs, and until Jan. 1, 2021 for these products to work their way through distribution.

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs   June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021

Background

In January 2006, FDA required the food industry to declare the amount of trans fat in food on the Nutrition Facts label. One of FDA's core regulatory functions is ensuring that food, including all substances added to food, is safe. In November 2013, FDA made a preliminary determination that PHOs are not “generally recognized as safe” (GRAS) for use in food. The final determination was released June 16, 2015. This determination was based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.

Federal Register Notices

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