On August 9, 2023, the Food and Drug Administration (“FDA”) announced a direct final rule revoking certain uses of partially hydrogenated oils (“PHOs”) in food.  The rule will go into effect on December 22, 2023. Any comments to the rule must be submitted by October 23, 2023.

The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. It also revises FDA's regulations affirming food substances as generally recognized as safe pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as generally recognized as safe as an indirect food substance.

The 2023 direct final rule is a culmination of several years of agency activity on PHOs.  In 2015, FDA determined that as the major source of artificial trans fat in the food supply, PHOs would no longer be generally recognized as safe. However, manufacturers had until June 18, 2018 to stop adding PHOs to foods. The compliance date was then extended to January 1, 2020.

FDA stated: “[w]e are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer [generally recognized as safe] for any use in human food in 2015.”

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