THE food and feed industries got blindsided Nov. 8 when the Food & Drug Administration published a notice saying it had made a preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fats in processed foods, would no longer be considered "generally recognized as safe" (GRAS) for use in food.
FDA said removal of PHOs from the food supply could prevent up to 7,000 deaths from heart disease each year. A final decision would mean that the use of these oils in the food supply would be phased out over a number of years.
It also could have implications that could go beyond trans fats in the way the process proceeded, said Thomas Hammer, president of the National Oilseed Processors Assn.
"They've never done something like this before," Hammer said. "What's next? Salt? Or even carcinogenics?"
Richard Sellers, American Feed Industry Assn. (AFIA) senior vice president, told Feedstuffs that nothing was in the FDA notice concerning non-human food; instead, it used the term "food." He noted that this often also includes food for animals, which put the feed industry on alert as to FDA's intent regarding the rule.
Leah Wilkinson, AFIA director of ingredients, pet food and state affairs, said in correspondence with FDA since publication of the notice, FDA stated that its intention was that the change would apply only to the human food side. She noted that she isn't sure when or how a clarification would be made, but AFIA anticipates that FDA will do that soon.
If so, the change would likely have a negligible impact on the feed industry. However, the food industry could be pushed to make significant changes in formulations.
FDA has required the industry to declare the amount of trans fats in food on the Nutrition Facts label since 2006. FDA data indicate that many processed foods have been reformulated to reduce their trans-fat content since the requirement was instituted, but a substantial number of products still contain PHOs.
The Grocery Manufacturers Assn. (GMA) said food manufacturers have voluntarily lowered the amounts of trans fats in their food products by more than 73% since 2005.
Currently, in order to preserve soybean oil for cooking, manufacturers use a process called hydrogenation, which is what creates the trans fats.
Hammer noted that, at one point, up to 8 million lb. of soybean oil were going into PHOs. Today, approximately 2-3 million lb. of partially hydrogenated soybean oil goes into products such as popcorn, frosting, pizza crusts and potentially goods from small bakeries, he explained.
American Soybean Assn. president Danny Murphy said, "Given that the food and vegetable oil industries have already moved to greatly reduce trans fats in food products and in American diets, we do have questions about the need for FDA to take this proposed action.
"We've replaced the functional characteristics that some baking and frying applications needed from partially hydrogenated oils through blending of various oils, the blending of fully hydrogenated soybean oil (which does not contain any trans fats) with liquid soybean and other oils, and other processes that reduce or eliminate trans fats," Murphy added.
Oils with high levels of oleic acid, like olive oil, are able to be preserved for much longer without having to add trans fats.
Hammer noted that acreage amounts for high-oleic soybeans have been small, and the industry's substitution ability isn't immediate. The processes that fully hydrogenate soybeans to eliminate the trans-fat characteristics also look promising but are not ready for the market. "It will take us time to get us where we need to go," he said.
New oils that can compete with other healthier oils such as canola oil are coming along, Hammer said, but food companies must be willing to pay a premium for the specialty beans, which will require being grown in an identity-preserved situation.
"Maybe food companies' willingness to pay a premium for those oils may have gotten a little stronger," Hammer said. Or, on the flip side, demand may drop because FDA told consumers that this product is unsafe at any level.
"Consumers can be confident that their food is safe, and we look forward to working with the FDA to better understand their concerns and how our industry can better serve consumers," GMA said in a statement.
In the notice, FDA asked the industry to comment on how long it would take producers to reformulate food products to eliminate PHOs.
Murphy said, "Since it will take a few years to ramp up high-oleic soybean production to provide an economical alternative to food processors, we believe any final FDA determination on the matter should reflect this time frame."
The 60-day comment period started Nov. 8. FDA said comments can also weigh in on whether FDA should finalize its tentative determination that PHOs are no longer GRAS.
If, after reviewing comments received, FDA determines that PHOs are not GRAS, then PHOs could not be used in foods unless authorized by a regulation.