Processors, Groups React as FDA Closes Comments on PHOs

The agency recently closed the comment period on a possible ban on partially hydrogenated oils.

By Dave Fusaro, Editor in Chief

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While everyone seems to agree that a gradual phase-out of partially hydrogenated oils (PHOs) in foods is a good and perhaps inevitable thing, some high-profile food processors and their associations are encouraging the FDA to reconsider withdrawing generally recognized as safe (GRAS) status for the ingredient.

The FDA's November 7 "preliminary determination" that PHOs were no longer GRAS came as a surprise to some but not all. The agency followed that preliminary statement with the traditional comment period, which it extended to March 8 because of the ramifications of this issue.

Now the agency is reviewing the 1,587 comments and is expected soon to make a final determination, although there is no deadline. Most parties expect the FDA will stick with its preliminary determination, essentially meaning an eventual ban on PHOs. If that occurs, "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."

Sifting through the comments, some big and important food processors wrote in opposition to the agency's stance. All said they support a gradual phase-out and are working to remove PHOs and trans fats from their own product lines. But a sudden switch to alternatives "could have unintended consequences that could raise other public health concerns, such has increased intakes of saturated fat by Americans," as the representative for Schwan Food Co. wrote.

In a 29-page letter, General Mills said: "We recognize and support efforts made by the [FDA] to reduce trans fat consumption from PHOs. However, we do not support the agency’s tentative determination … as current low intakes of trans fat are safe. We urge the agency to use other effective regulatory alternatives to make continued progress and achieve FDA’s goal of significantly reducing consumption of industrial produced trans fat in a timely manner."

The General Mills letter suggested two options:

  • Consider revis[ing] nutrition labeling regulations to permit a declaration of 0g of trans fat only if the product contains less than 0.2g of trans fat and/or
  • Establish a threshold limit of [less than] 0.2g of industrial produced trans fat per serving in foods. "We believe a threshold is appropriate for trans fat to permit manufacturers to use small levels of highly functional PHOs in certain food products because these small levels of PHOs have an overall minimal impact on total daily trans fat consumption and are safe for use in food. Replacing these small levels of PHOs would be difficult, especially for products for which there are no functional alternative to PHOs yet."

Getting back to the Schwan letter, "Over the past 10 years, Schwan has removed PHOs from all manufacturing facilities. Nearly 90 percent of the entire product portfolio no longer contains PHOs. However, a number of suppliers of minor ingredients have not been successful in finding acceptable alternatives to PHOs. To formulate out PHOs requires significant time and investment. … It will take three or more years before the food industry can reasonably find suitable, new, alternative oils."

Mark Andon, vice president of research, quality, and innovation at ConAgra, agreed with the agency's goal, but "We disagree that revoking the GRAS status of PHOs is an appropriate approach. Such an action would in essence result in the prohibition of a production process, and otherwise would place potentially thousands of food products at risk of being deemed adulterated due to the presence of an ingredient that has been safely and commonly used in food for over 50 years. Rather, we urge the FDA to explore other, less disruptive approaches to further reduce the dietary intake of trans-fatty acids, such as setting a maximum permissible amount of non-animal derived trans-fatty acids in foods irrespective of the source." ADM said instead of banning PHOs because they are a source of trans fatty acids, FDA should focus its regulatory attention on trans fatty acids themselves.

Nestlé USA, while sounding noncommittal, noted it "is on target for removing all PHOs as functional ingredients by the end of 2016 – and it is likely we will meet this goal in 2015." And it is doing so "with little to no increase in saturated fat levels."

Private citizen comments appeared to be 100 percent in favor of a ban. As expected, so were comments directly from and forwarded by groups such as Center for Science in the Public Interest.

Public health groups, such as the National Assn. of County and City Health Officials (NACCHO), also supported the FDA's determination. "NACCHO applauds the FDA for its preliminary determination that PHOs are no longer generally recognized as safe. NACCHO urges the FDA to act expeditiously to eliminate them from the nation’s food supply."

Trade associations and individual vendors who supply alternatives to PHOs also support a ban. "The U.S. sunflower industry offers immediate solutions to partially hydrogenated (PH) oils," wrote the National Sunflower Assn. About the same came from the U.S. Canola Assn. And from IOI Loders Croklaan, a supplier of palm oils: "There is no reason to continue to use PHOs in food products, as there already exists in all cases alternative fats and oils which provide similar functionality at similar cost in bakery, snack food and confectionery applications."

But the American Soybean Assn. said removal of GRAS status would result in significant hardship to soybean farmers. It would "decrease U.S. soybean farmer incomes by approximately $1.6 billion per year."

"We are particularly concerned about this financial hardship on our member companies, including many who are small businesses, when the agency approach is not supported by the underlying science," wrote the Independent Bakers Assn.

Associations representing the broader food industry opposed the FDA. The Grocery Manufacturers Assn. painted a doomsday scenario:

"This sudden and dramatic change in regulatory status could lead to a significant disruption of the food supply, as thousands of food products could be deemed adulterated by FDA and unable to proceed in interstate commerce. The resulting adverse economic consequences would be severe, and would be felt at all points in the chain of food manufacture and distribution. Consumers would be unjustifiably denied access to products such as baked goods, pastries, confectionaries, some flavors, seasonings and many other products.

"We believe the agency should take great care as it considers final action and reexamine the agency’s legal and scientific rationale, analysis of costs and benefits, and the numerous issues on which the agency requested comment," GMA continued. "FDA’s analysis of available scientific data is inadequate and therefore does not support its conclusion and tentative determination."

FMI asked some questions. "PHOs have been in the food supply for decades and while we agree that consumption should be reduced to minimum levels … the current intake of all trans fat in the diet is one gram per day. How much of that one gram is from PHOs? Is that one gram physiological harmful? What will that one gram be replaced with if PHOs become food additives and disappear from the U.S. food supply?"

And FMI ended with, "We encourage FDA to obtain information on the fats and oils likely to replace PHOs in the food supply and evaluate the public health impact of those compounds." Probably a good idea.

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