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By EAS Senior Advisor for Food and Color Additive Safety Robert Martin, Ph.D.

Partially hydrogenated oils (PHOs) have been in the news a lot recently. Since the 1990s, a strong association of PHOs (which contain trans fat) with harmful effects on human health, especially on blood cholesterol levels and the risk of cardiovascular disease, has been established. This has caused food manufacturers to take steps to reduce the amounts of PHOs in foods. PHOs are the main source of added trans fat to the diet, which is the focus of all of the safety concerns. Since 2006, FDA has required that added trans fat be listed on the nutrition facts panel. While the amount of added trans fat has been reduced significantly – currently, the consumer consumes approximately 1 – 1.3 grams of added trans fat per day (See bit.ly/1cbakrT) as compared to 4.6 grams per day in 2003 (78 FR 67171; November 8, 2013). Notwithstanding this reduction, FDA believes that given the safety concerns associated with the use of added trans fats, the amounts should be significantly lower. Because of these concerns, in a November 8, 2013 Federal Register notice (78 FR 67169 – 67175), FDA announced that it has tentatively determined that partially hydrogenated oils, the primary dietary source of artificial trans fat, are no longer generally recognized as safe (GRAS) for any use in food and that PHOs are therefore food additives subject to section 409 of the Federal Food, Drug, and Cosmetic Act. If finalized, this finding will mean that food manufacturers could no longer add PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. To demonstrate that the use of trans fat under the food additive regulation is safe could prove to be a difficult hurdle.

The agency said it based its new determination on current scientific evidence including the opinions of expert panels and the 2005 recommendation of the Institute of Medicine (IOM) that consumers should limit their trans fat consumption as much as possible while consuming a nutritionally adequate diet. 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, we have tentatively determined that there is no longer a consensus among qualified scientific experts that PHOs, the primary dietary source of industrially-produced trans fatty acids, are safe for human consumption, either directly or as ingredients in other food products,” FDA said.

The agency’s latest move takes place in the context of a decline in the use of trans fats. In 2010, FDA prepared an estimate of the intake of industrially-produced trans fat using available food consumption data (2003–2006 National Health and Nutrition Examination Survey (NHANES)), market share information, and trans fat levels based on label declaration data and analytical data for products that were identified as containing PHOs. According to that estimate, the mean dietary intake of industrially-produced trans fat has decreased significantly since the previous estimated a decade ago.

The agency has invited comments on the tentative determination by January 7, 2014.

Many manufacturers have taken steps to reformulate their products to remove and/or eliminate added trans fats, but the process is incomplete. It appears likely that FDA will require labeling of any added trans fat and not the current labeling which requires the amount to be stated only if it exceeds 0.5 grams per serving [21 CFR 101.9(c)(2)(ii)]. It is possible that FDA will set a Daily Reference Value (DRV) for added trans fats.

Among the alternatives that manufacturers may consider would be the use of interesterified oils (where the structure of the oil is enzymatically or chemically modified to make them more solid or stable), or using blends of oils to achieve the desired effects, or using butter (which contains natural trans fat), or developing new products that could achieve the desired oil/fat properties, etc. All of these approaches have their pluses and minuses. For example, new oils may remove the trans fat issues, but could raise formulation, taste and regulatory issues that will need to be resolved.

A large number of products on the market still use PHOs, so reformulating these products will be an ongoing process. The EAS consulting network can provide expertise in nutrition, labeling, regulatory and related areas to help meet the challenges of product reformulation.

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