Time to Replace PHOs? FDA Proposes to Remove Added Trans Fats from Processed Foods

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.

FDA Needs Input on Proposed Animal Food Rule

In last month’s FSMA Perspective, I focused on FDA’s release of its proposed rule on Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. I would like to follow up here with issues raised November 21 at a public meeting in College Park, MD — the first of three FDA meetings on the animal feed proposal. The agency held a second session in Chicago, IL, Nov. 25, and has scheduled a third for Sacramento, CA, on December 6.

These meetings are extremely helpful for two-way communication between the agency and stakeholders. The regulated industry learns the agency’s thinking about the proposed rule and FDA staff hears the specific concerns of the stakeholders. I know the agency values these “listening” sessions highly. The first meeting featured public comment and Q&A sessions with senior FDA officials, including: Linda Tollefson, Associate Commissioner in the Office of Foods and Veterinary Medicine; Dan McChesney, director of the Office of Surveillance and Compliance in the Center for Veterinary Medicine (CVM); Kim Young, deputy director of the Division of Compliance in CVM; Eric Nelson, director of the Division of Compliance in CVM; and Jenny Scott, senior advisor in the Office of Food Safety in FDA”s Center for Food safety and Applied Nutrition (CFSAN).

Representatives of the American Feed Industry Association (AFIA) turned out in strength for the first meeting and argued that FDA is proposing to apply tougher preventive controls to animal feed producers than are justified by a risk-based approach. The industry group believes the agency is being overzealous in applying the same rigorous controls to animal feed as it plans for pet foods and for human foods. Instead, the feed industry would like the agency to modify the proposed rule to recognize differences between animal feed and pet food production facilities. The group argues that lawmakers kept animal food separate from human food in FSMA and that the agency needs to do the same. In addition, it wants FDA to apply the same approach to the Federal Food Drug and Cosmetic Act and to separate animal food and human food.

As a former CVM director who is now a consultant to the industry, I can see both sides of this picture. Cleary, there are significant differences between feed mills and pet food processing facilities and these should be taken into account in a final rule. But that does not mean animal feed facilities should get a pass from compliance with FSMA’s preventive approach.

The preventive controls provisions of the proposed rule, would apply to domestic and imported animal food, including pet food, animal feed, and raw materials and ingredients. Facilities producing animal food would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions would be taken to correct problems that arise. The proposed rule would also establish CGMPs that specifically address animal food. This will be a burden for the feed industry, which will have to comply with CGMP requirements for the first time.

The clock is ticking down toward the court-ordered deadline of June 30, 2015 for publishing this and four other FSMA final rules. So this does not leave much room for additional rounds of comment beyond the current comment deadline of February 26, 2014. For this reason — as I have suggested here before — now is the time for the regulated industry to play an active role in this rulemaking process.