FDA Implements Final Rule to Remove Partially Hydrogenated Oils from Food Supply

The U.S. Food and Drug Administration (FDA) has issued a direct final rule to conclude administrative measures that align with the agency's prior decision in June 2015. This decision affirmed that the utilization of partially hydrogenated oils (PHOs) in foods is no longer considered Generally Recognized as Safe (GRAS).

The FDA's actions pertain to synthetic sources of trans fat, with an acknowledgment that trans fat will persist in the food supply due to its natural occurrence in meat and dairy products, as well as its minimal presence in other edible oils.

Hydrogenated oil exists in two variants: partially hydrogenated and fully hydrogenated. Partially hydrogenated oil contains trans fat, which can elevate cholesterol levels and lead to health complications. One of its functions is to extend the shelf life of food products.

The direct final rule involves the following modifications:

1. Amendments to the regulations to exclude PHOs as optional ingredients in the identity standards for peanut butter and canned tuna.
2. Revisions to FDA GRAS affirmation regulations, excluding partially hydrogenated forms of menhaden and rapeseed oils.
3. Revocation of the regulation that considers partially hydrogenated fish oil as an indirect food substance.
4. Withdrawal of the pre-1958 authorization for employing PHOs in margarine, shortening, bread, rolls, and buns. This authorization predates the enactment of the Food Additives Amendment of 1958 and thus cannot be regulated as food additives.

In its 2015 final determination, the FDA indicated its intent to address outdated references to PHOs in regulations separately. Regarding the removal of PHOs from the food supply, the FDA set January 1, 2021, as the ultimate compliance date. This timeline allowed manufacturers to reformulate foods and facilitate a smooth transition in the market.

The FDA is releasing these amendments as a direct final rule, anticipating negligible adverse comments. This is based on the fact that the FDA had already established in 2015 that PHOs are no longer GRAS for any human food. However, to account for the possibility of substantial adverse comments leading to the withdrawal of the direct final rule, the agency is concurrently issuing a companion proposed rule in the same edition of the Federal Register. This would enable the agency to proceed with implementing the changes through a proposed rule.

Both the direct final and proposed rules are open for public comments, which must be submitted within 75 days after the publication in the Federal Register. 

Comments can be submitted electronically at https://www.regulations.gov/ or in writing to the Dockets Management Staff at the FDA's address.

Dockets Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

The direct final rule is set to take effect 135 days after its publication date in the Federal Register.

For further details, please refer to the 

• 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)