FDA Issues Final Rule to Complete 2015 Decision that PHOs are No Longer GRAS

The U.S. Food and Drug Administration (FDA) has issued a final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS).

In the 2015 final determination, FDA indicated that there were outdated references to PHOs in regulations that FDA would address separately. With respect to removing PHOs from the food supply, FDA established January 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.   

FDA’s actions regarding PHOs address artificial sources of trans fats, but the agency acknowledges that trans fats cannot be completely removed from the food supply because they occur naturally in meat and dairy products and are present at very low levels in other edible oils.

The direct final rule:

• Revises regulations to no longer include PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna
• Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils   
• Revokes the regulation for partially hydrogenated fish oil as an indirect food substance  
• Revokes pre-1958 authorization for using PHOs in margarine; shortening; and bread, rolls and buns; the authorization occurred before the enactment of the Food Additives Amendment of 1958, so the aforementioned uses of PHOs could not be regulated as food additives.

FDA is issuing the amendments directly as a final rule because they agency anticipates no significant adverse comments after declaring PHOs no longer GRAS for any human food in 2015. However, the agency is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn due to significant adverse comments, in which case the agency would need to move forward with a proposed rule.

FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted by 75 days after publication in the Federal Register. Written comments can be submitted to Dockets Management Staff (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Room 1061 Rockville, MD 20852.

The direct final rule would be effective 135 days after the date of publication in the Federal Register.