FDA finalizes rule to eliminate Partially Hydrogenated Oils from food products
Following several years of rigorous research and stringent regulatory efforts, the U.S. Food and Drug Administration (FDA) has issued a final rule, revoking the status of partially hydrogenated oils (PHOs) as Generally Recognized as Safe (GRAS) for use in food products.
This landmark ruling is a milestone in the FDA's ongoing commitment to enhance the nation's nutritional health. The decision builds on a previous determination made in June 2015, concluding that PHOs are not suitable for human consumption due to their potentially harmful effects.
In 2015, the FDA identified outdated references to PHOs in its regulations, which it has since addressed systematically. To facilitate a smooth transition for food manufacturers, the agency set a final compliance date of January 1, 2021, providing ample time for companies to modify their products and ensure a seamless market shift.
The FDA's measures to eliminate PHOs are primarily focused on their artificial origins. The goal is to eradicate harmful trans fats derived from these sources. However, it should be noted that natural trans fats found in meat and dairy products, and the low levels present in some other edible oils, will not be entirely eliminated from the food supply.
The final rule includes several significant amendments aimed at purging PHOs from food products. Regulations for peanut butter and canned tuna have been revised to no longer include PHOs as optional ingredients. Furthermore, partially hydrogenated forms of menhaden and rapeseed oils are no longer deemed GRAS under FDA regulations.
The authorization for using PHOs in a range of products including margarine, shortening, bread, rolls, and buns, which dates back to before the Food Additives Amendment of 1958, has been rescinded. The regulation for partially hydrogenated fish oil as an indirect food substance has also been revoked.
The FDA is confident in its decision and has chosen to issue this as a direct final rule, expecting no significant adverse comments. However, a companion proposed rule is also being introduced in the Federal Register to prepare for the possibility of withdrawal of the direct final rule due to substantial adverse comments.
The FDA welcomes public input on both the direct final rule and the proposed rule. The comment period extends for 75 days after publication in the Federal Register. The direct final rule is scheduled to take effect 135 days after its publication in the Federal Register.
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