The U.S. Food and Drug Administration has issued a direct 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).

The FDA’s actions regarding PHOs address artificial sources of trans fat. Still, trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.

Hydrogenated oil comes in two forms: partially or fully hydrogenated. One use of hydrogenated oil is to preserve the shelf life of food. Partially hydrogenated oil contains trans fat that can raise cholesterol and result in health complications.

The direct final rule: 

• Revises regulations to no longer include PHOs as an optional ingredient in the identity standards 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, bread, rolls, and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958, so these uses of PHOs could not be regulated as food additives. 

In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately.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

The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments. After all, FDA declared 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agency is issuing a companion proposed rule in the same issue of the Federal Register in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place. 

The 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.

Submit electronic comments at https://www.regulations.gov/. 

Submit written comments to:

Dockets Management Staff (HFA-305)
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.  

• Federal Register Notice: Direct Final Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023) 
• Federal Register Notice: Companion Proposed Rule on Revocation of Uses of Partially Hydrogenated Oils in Foods (August 2023)  
• Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)