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Are PHOs GRAS? Decoding FDA's move to ban trans fat

Sysco Shape December 2013

Trans fats are in the news again.

In November, various news outlets announced that the U.S. Food and Drug Administration (FDA) would soon ban partially hydrogenated oils (PHOs), which are the primary source of industrially produced trans fatty acids, or trans fats. Removing trans fats from processed foods would reportedly prevent 3,000 to 7,000 deaths caused by heart disease each year.

While operators and their vendors figure out what they must do to comply, there are two things foodservice professionals should know, says Joe Higgs, vice president of technical services for Ventura Foods. “First, what the FDA is doing is not a ban on trans fats,” he says. “They are looking at revoking ‘generally recognized as safe,’ or GRAS, status for partially hydrogenated oils.”

PHOs are made by adding hydrogen to vegetable oil. The ingredient is used in some commercially baked foods such as cookies and crackers, and in margarine and some frying oils. Ingredients that have GRAS status do not have nutritional value, but are considered not to be harmful.

In 2006, the FDA implemented labeling changes, which required food manufacturers to indicate the amount of trans fat in packaged foods. Over the past few years, many food manufacturers not only have made the changes on labels, they have reduced the amount of PHOs in processed foods as well. Companies have reformulated many foods to enable consumers to avoid trans fats, but there are still some products that contain these unhealthy fats.

In its November 8th Federal Register notice, the FDA announced it was tentatively determining that PHOs were no longer GRAS, citing research indicating that consumption of trans fats can lead to elevated levels of LDL-C, or “bad cholesterol,” which contributes to heart disease. Also, the FDA noted, some studies indicate that increased levels of bad cholesterol may worsen insulin resistance. By determining that a substance is not GRAS, the FDA is indicating the substance is an additive.

The FDA launched a 60-day comment period, which ends January 7. If the FDA maintains that determination, food companies that still want to use PHOs could do so only if authorized by a new regulation that allows it. That is not likely to happen, Higgs says.

“The trans fats formed by the partial hydrogenation process create some health concerns, and there are enough clinical studies now that you can’t refute it,” he explains. “There has been enough medical research to say we need to change this. It is similar to what the FDA did years ago with Red Dye No. 2.” (In the 1970s, the dye was considered a possible carcinogen and was removed from the marketplace.)

Some trans fats occur naturally in meats and dairy products, and the FDA recognizes that those trans fats cannot be avoided in a non-vegan diet. Restaurants, foodservice and grocery product manufacturers would not have to do anything to avoid serving foods with naturally occurring trans fats. The foods involved in the FDA determination include, for example, certain cooking oils, although some chains changed their cooking oils a few years ago when trans fats first gained negative attention. PHOs also are used in pastries, ready-to-use frosting and some prepared foods that have a solid texture and are shelf-stable. It’s easy to see whether a packaged food contains PHOs because that information is on the ingredient statement.

So the second important fact, Higgs says, is that foodservice vendors are aware of the FDA proposal, and have been working on implementing changes in ingredients. “We will evolve through the marketplace,” he says. “We have done a lot of work over the last 10 years, and we have many trans-fats-free products with different ingredients.”

Manufacturers have been testing other oils, such as soybean oil, canola oil, corn oil and other ingredients. “Restaurants need to contact vendors and ask, ‘Do you have alternatives to products we are buying?’” Higgs says.

Vendors understand the challenges of changing ingredients and complying with everything from new regulations to consumer trends. Just look at how vendors have adapted to all the various allergen demands, Higgs says.

The FDA asked for comments on specific questions, including:

  • Should the FDA finalize its tentative determination that PHOs are no longer GRAS?
  • Are there data to support other possible approaches to PHOs in food, such as limiting the level of trans fats in foods?
  • How long will it take to reformulate food products?
  • What would be an adequate compliance date?

The agency estimated the cost of removing PHOs from the food supply to be about $8 billion, but that amount would be shared by multiple entities over several years.

Companies that supply ingredients and prepared foods are already working on alternative fats. “There are still a few categories out there that rely heavily on PHOs,” Higgs says. “Ventura Foods is not in those categories, but I’m sure there will be development in ingredients and processing conditions that look to provide alternatives.”

For more information, the notice in the Federal Register is here:


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