Source - Food & Beverage Litigation and Regulatory Update | Issue 806

FDA Revokes GRAS Status from PHOs

The U.S. Food and Drug Administration (FDA) has amended regulations in light of its determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS). The 2015 determination “recognized that there were some uses of PHOs in foods that are expressly authorized by GRAS affirmation regulations, acknowledged that there could be some uses recognized by ‘prior sanction’ (and thus could not be regulated as a food additive), and stated that we would address such uses separate from the final determination,” according to the agency’s Federal Register announcement.

“[B]ased on our current review of scientific data and information, as well as previous safety reviews performed to support various FDA actions regarding trans fat, we are prohibiting all prior-sanctioned uses of PHOs,” the agency announced. “We have determined that the prior-sanctioned uses of PHOs may render food injurious to health.” PHOs were previously listed as an optional ingredient in peanut butter and canned tuna, were allowed in menhaden and rapeseed oils, and were sanctioned in margarine, shortening, bread, rolls and buns.

The rule will take effect December 22, 2023, and comments will be accepted until October 23, 2023.

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