On Tuesday, June 16, 2015, the Food and Drug Administration (”FDA”) announced its Final Determination Regarding Partially Hydrogenated Oils. According to the determination, by June 18, 2018, food sold in the United States may not contain partially hydrogenated oils, which are generally known as trans fats.
Specifically, the FDA banned the use of “those fats and oil that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.” The FDA’s decision does not apply to naturally-occurring trans fats.
The FDA’s decision is based upon its finding that “there is no longer a consensus among qualified experts that [trans fats] are generally recognized as safe (GRAS) for any use in human food.” Without reaching GRAS standards, trans fats are now considered food additives subject to the Federal Food, Drug, and Cosmetic Act. As such, any manufacturer still wishing to use trans fats in its products must seek approval from the FDA through “data demonstrating a reasonably certainty of no harm to the proposed user(s).”
The FDA has been openly contemplating banning trans fats since at least November 2013, when it issued a notice regarding whether trans fats should still be classified as GRAS. The ensuing comment period generated thousands of comments. Nearly two years later, the FDA’s final determination is likely to spur similar discussion.