Last week, the U.S. Food and Drug Administration (FDA) published its Tentative Determination Regarding Hydrogenated Oils and requested comments and scientific data and information from industry. In the Notice, FDA tentatively determined that partially hydrogenated oils (PHOs)—the primary source of trans fat—are no longer generally recognized as safe (GRAS) for any use in food. Historically, PHOs have been considered GRAS by the food industry for use in foods based on the history of use prior to 1958, when the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act was passed. FDA stated, however, that there is no longer “consensus among qualified experts that the substance is safe” and that therefore, PHOs are food additives requiring approval by FDA prior to use in foods. If finalized, this would mean that food manufacturers currently marketing products containing PHOs will have to reformulate their products to remove PHOs, otherwise obtain food additive approval for their continued use (which approval may be unlikely given FDA’s preliminary safety findings). Although FDA has required labeling of trans fat on foods since 2006, this action marks the first time since 1969 that FDA has declared that a food additive is unsafe for consumption. This is certainly a major development, and one that food companies will need to quickly consider and determine their response. We note that this preliminary determination by FDA does not have any impact on foods that naturally contain trans fats, only those containing PHOs.
FDA is soliciting comments on its tentative determination until January 7, 2014. Companies should consider filing comments on FDA’s tentative conclusion explaining any disagreement with FDA’s determination. More importantly, companies should consider filing comments that reflect the time and resources necessary for food manufacturers to reformulate their food products (or whether they cannot be reformulated) in order to eliminate PHOs from their foods. Our attorneys at Alston & Bird are experienced in preparing regulatory comments for companies and helping guide them through the reformulation process to ensure any replacement ingredients are appropriate for use under FDA’s regulations and to ensure labels are updated accordingly.
Finally, in 2004, the Center for Science in the Public Interest (CSPI) filed a petition, which helped drive this preliminary determination by FDA, asking the agency to revoke the GRAS status of PHOs. Many other food petitions that would place limits on certain other food ingredients remain under review at FDA’s food center, including petitions on caffeine, sodium, and added sugars, so this action on PHOs could be the beginning of additional actions planned by FDA in the next year.