Executive Summary

This rule will remove references to partially hydrogenated oils (PHOs) from our regulations for peanut butter, canned tuna, menhaden oil, fish oil, and rapeseed oil. FDA is also revoking all prior sanctions for the use of PHOs in margarine, shortening, and bread, buns, and rolls. This action is being taken because PHOs are associated with increased risk of coronary heart disease (CHD). This action aligns with the FDA’s 2015 declaratory order that revoked the “generally recognized as safe” (GRAS) status of PHOs.

We estimate that the quantifiable benefits of this rule will accrue from potential reduction of number of coronary heart disease cases resulting from less use of PHO-containing ingredients. The estimated benefits discounted at seven percent over a 20-year period yields the mean present value of $652 million, or annualized total of $61.54 million. We quantify the costs to industry and consumers resulting from removal of PHO-containing foods from the market. These include the costs of product reformulation, relabeling, changing recipes for some foods, finding substitute ingredients and costs associated with changes in functional and sensory product properties, such as taste, texture, and product shelf life. The cost of this rule relative to gradual voluntary removal of PHOs was estimated at annualized primary value of $24.5 million with a lower bound estimate of $20.8 million and an upper bound estimate of $29.7 million. These estimates are discounted at seven percent over a 20-year period.

Regulatory Impact Analysis

Direct Final Rule for Revocation of Uses of Partially Hydrogenated Oils in Foods (PDF - 624KB)

Federal Register: 88 FR 53764

Publication Date: 08/08/2023

Docket Number: FDA-2019-N-4750