On November 7, 2013, the U.S. Food and Drug Administration (“FDA”) published an announcement, entitled “Tentative Determination Regarding Partially Hydrogenated Oils,” announcing its preliminary determination that Partially Hydrogenated Oils (“PHOs”), which are the primary source of trans fatty acids (trans fat) in processed foods, are not generally recognized as safe (GRAS) for any use in food. The FDA’s determination is based on evidence that the consumption of PHOs, which are commonly added to food to increase shelf life and flavor, are associated with serious health risks. Accordingly, the FDA’s action signals the first steps in a move to ban trans fat in foods. You can read the Federal Register notice here.
If the determination is finalized, PHOs, and in turn trans fat, would be considered a food additive subject to pre-market approval by the FDA. Specifically, pursuant to Sections 201(s) and 409 of the U.S. Food, Drug, and Cosmetic Act (“FDCA”) any substance that is intentionally added to food is a food additive that must be reviewed and approved by the FDA prior to its being added as an ingredient, unless the substance is GRAS. To be GRAS, there must be either a consensus among qualified experts, based on scientific evidence, that the substance is safe under conditions of its intended use or a common use of the substance in food prior to 1958. Pursuant to FDA regulations, the agency may determine that a substance is not GRAS and is thereby a food additive when it believes there is no longer a consensus about its safety.
Although PHOs have been commonly used as an ingredient in processed food since the 1950s and are considered GRAS by the food industry, the FDA has tentatively determined that PHOs should not have GRAS status because trans fat, an integral component of PHOs, is associated with serious health risks such as heart disease. According to the FDA, the common use of a food prior to 1958 is insufficient to support continued GRAS status if there is no longer a scientific consensus that the substance is safe for its intended use in food. Thus, common use of a substance in food prior to 1958, alone, is not enough for a substance to maintain GRAS status.
In conclusion, the notice is available for public comment for 60 days. The FDA has especially requested comments regarding the impact of the removal of PHOs on small businesses and the time it would take businesses to phase out the use of PHOs. For example, the removal of PHOs, and accompanying trans fat, may impact businesses by requiring companies to undertake product reformulations and relabel affected products in order to comply with the FDA’s determination, if finalized. If the FDA does make a final determination, the next step will be a notice in the Federal Register.
If you have any questions about this notice or compliance with food additive regulations or regulatory compliance generally, please contact us at firstname.lastname@example.org.