On August 8, FDA announced the release of its direct final rule amending the regulations that provide for the use of partially hydrogenated oils (PHOs) in food and revoking the uses of PHOs in food in light of the Agency’s determination that PHOs are no longer generally recognized as safe (GRAS) in 2015.

The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. Further, it revises FDA’s regulations affirming food substances as GRAS 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 GRAS as an indirect food substance. FDA is also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on its conclusion that these uses of PHOs may be injurious to health.

FDA issued these amendments directly as a final rule because the Agency views these changes as noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives.  However, the Agency also issued a companion proposed rule in the event the direct final rule is withdrawn because significant adverse comments are received. 

FDA is accepting public comments on both the direct final and proposed rules. Comments must be submitted by Monday, October 23, 2023, and may be submitted here.