Trans Fats Now Subject to FDA’s Food Additive Regulations

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Trans Fats Now Subject to FDA’s Food Additive Regulations

On June 16, 2015, the U.S. Food and Drug Administration (FDA) announced that the use of PHOs in food is no longer generally recognized as safe (GRAS). Consequently, PHOs are now subject to FDA’s food additive regulations.

Trans fats have been a source of concern in the public health community for over 30 years. Formed through a manufacturing process in which hydrogen is added to vegetable oil in a reaction called hydrogenation, most trans fats in American diets are found in partially hydrogenated oils (PHOs), which are often used in commercial baked goods to improve shelf life.

On June 16, 2015, the U.S. Food and Drug Administration (FDA) announced that the use of PHOs in food is no longer generally recognized as safe (GRAS). Consequently, PHOs are now subject to FDA’s food additive regulations. In addition, FDA gave food manufacturers three years to either remove PHOs from their products or to submit a Food Additive Petition for the use of PHOs in food. If manufacturers’ Food Additive Petitions are successful, PHOs could still be used in foods after the three-year deadline.

One question unaddressed by FDA’s announcement is whether low levels of PHOs in food are safe. Metabolic and epidemiology studies provide strong support linking consumption of high levels of trans fats to increased risks of coronary heart disease; however, it is not clear whether low levels of trans fats in the diet are associated with cardiovascular risk. In a recent article titled “Trans fats: Current scientific update,” Gradient scientists addressed this question. The metabolism of trans fats and the multiple feedback loops involved in lipoprotein synthesis in the body support the idea that a minimum amount of PHOs must be consumed before adverse effects occur. Nonetheless, FDA and other regulatory agencies have implied that consuming any amount of trans fats is a health risk. In August, the Grocery Manufacturers Association (GMA) filed a Food Additive Petition asking FDA to allow low-level uses of PHOs. Given the biological uncertainty and legal considerations, there will likely be lawsuits involving food companies that have produced or continue to produce food items containing trans fats or PHOs.

Gradient’s scientists have the expertise to address issues in food safety, including issues related to PHOs. From assisting with Food Contact Notifications and GRAS evaluations for food or food additives, to providing input on harvest safety measures and assessing potential risks from contaminants and impurities in food, Gradient scientists deliver sound science and high quality analyses, affording clients the information and solutions they need to resolve the critical issues they face.

Click to see information on Gradient’s GRAS Panel Experts.

Recent Relevant Gradient Publication:
Peterson, MK; Zu, K. 2016. “Trans fats: Current scientific update.” Food Saf. 22 (1) :54-60.



For more information on Gradient’s services, please contact:

Leslie A. Beyer, M.S., DABT
Principal Scientist

lbeyer@gradientcorp.com

 

 


Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.

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