FDA Takes Action to Reduce Trans Fats in Food

FDA based its determination on current scientific evidence establishing the health risks associated with the consumption of trans fat. Given the potential health risks, FDA has deemed PHOs to be “food additives” that require FDA approval prior to their use in food. Thus, if FDA’s tentative determination is finalized, food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. FDA estimates the initial cost of removing PHOs from the US food supply at $8 billion. As noted below, FDA is requesting comment, in part, on how long it would take the food industry to reformulate food products to eliminate PHOs.

Although all refined edible oils contain some trans fat as an unintentional byproduct of their manufacturing process, trans fats are an integral component of PHOs and are purposely produced in these oils to affect the properties of the oil and the characteristics of the food to which they are added.  According to FDA, PHOs have been used in food for many years based largely on self-determinations conducted by food manufacturers that trans fats are GRAS. However, FDA noted in its tentative determination that “current scientific evidence,” including the opinions of expert panels, and a 2005 recommendation from the Institute of Medicine (IOM) to limit dietary consumption of trans fat as much as possible, identifies significant health risks caused by the consumption of trans fat. In addition, according to the Centers for Disease Control and Prevention, elimination of PHOs from the food supply could prevent 10,000 to 20,000 coronary events and 3,000 to 7,000 coronary deaths annually, if the marginal benefits of continuing to remove trans fats from food items remain constant. Given this evidence, FDA is now taking the position that there is no longer a consensus among qualified scientific experts that PHOs are safe for human consumption, either directly or as ingredients in other food products.

Comments on FDA’s tentative determination involving PHOs should be submitted to the Agency by January 7, 2014. In addition to requesting general comments from interested parties, FDA is seeking specific comments on the following questions:

1. Should FDA finalize its tentative determination that PHOs are no longer GRAS?

2. Are there data to support other possible approaches to addressing the use of PHOs in food, such as by setting a specification for trans fat levels in food?

3. How long would it take producers to reformulate food products to eliminate PHOs from the food supply? Are there likely to be differences in reformulation time for certain foods or for certain types of businesses?

4. If FDA makes a final determination that PHOs are not GRAS and does not otherwise authorize their use in food, FDA intends to provide for a compliance date that would be adequate for producers to reformulate any products as necessary and that would minimize market disruption. We welcome comments on what would be an adequate time period for compliance.

5. Are there any special considerations that could be made to reduce the burden on small businesses that would result from removal of PHOs from foods, such as additional time for reformulation? Would those considerations be consistent with a final determination that PHOs are not GRAS?

6. Are there other challenges regarding the removal of PHOs from foods? Are there products that may not be able to be reformulated? If so, what sorts of products and what challenges are faced?

7. Is there any knowledge of an applicable prior sanction for the use of PHOs in food?