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FDA Extends Comment Period for New Trans Fat Regulations

The U.S. Food and Drug Administration (FDA) issued an extension for the comment period for its tentative determination regarding Partially Hydrogenated Oils, i.e. the primary dietary source of industrially-produced trans fatty acids, or trans fat. Due to the public health risks associated with eating PHOs, FDA requested comments and scientific data and information on PHOs. The original deadline for comments was January 7, 2014. According to a new notice in the Federal Register, the FDA has given a 60-day extension of the comment period to March 8, 2014. This was due to several comments that people and companies wanting to do experiments didn’t have enough time to collect sufficient data.

On November 8, 2013, the FDA released a notice in the Federal Register announcing the tentative determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for any use in food. If this preliminary determination is finalized, PHOs would be considered food additives, which are subject to premarket approval by FDA. Foods found to contain unapproved food additives are adulterated by law, and cannot be legally marketed in the U.S. This means that the burden of proving that PHOs are safe to eat would fall on the manufacturers of products containing PHOs.

The most common and frequently used PHOs have long been considered GRAS food ingredients by the industry. If FDA finalizes its determination that PHOs are not GRAS, the agency and food industry would have to establish a way to gradually phase out the use of PHOs in the U.S. food supply.

Submit a comment on the Tentative Determination Regarding Partially Hydrogenated Oils.

Learn more about FDA’s Trans Fat Notice

Registrar Corp will be providing additional information on U.S. FDA Labeling and Ingredient regulations and will alert industry when the final decision is published. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.