FDA revokes GRAS status of partially hydrogenated oils; allows food industry to file petition to permit specific uses

By Elaine Watson

- Last updated on GMT

FDA revokes GRAS status of partially hydrogenated oils

Related tags Partially hydrogenated oils Trans fat

As widely expected, the FDA has finalized plans to revoke the GRAS (generally recognized as safe) status of partially hydrogenated oils (PHOs) in a bid to eradicate artificial trans fats from the US food supply. However, it says manufacturers may petition the agency to permit specific uses of PHOs.

Announcing the move this morning (click HERE​), the FDA said it has set a compliance period of three years, adding: “This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs.

It added: "Three years also provides time for the growing, harvesting, and processing of new varieties of edible oilseeds to meet the expected demands for alternative oil products and to address the supply chain issues associated with transition to new oils."

After June 18, 2018, it said: “No PHOs can be added to human food unless they are otherwise approved by the FDA.”

A historic victory for the nation’s health

The move was welcomed by the American Heart Association, which described it as a “historic victory for the nation’s health”,​ while the Center for Science in the Public Interest (CSPI) said it would mean a “healthier food supply, fewer heart attacks and heart disease deaths, and a major victory for public health”.

Executive director Michael F. Jacobson added that the FDA was also giving companies “more than enough time to eliminate the last of the partially hydrogenated oil that is still used in foods like microwave popcorn, biscuits, baked goods, frostings, and margarines.”

The Grocery Manufacturers Association (GMA), meanwhile, said it planned to file a food additive petition to the FDA “to show that the presence of trans fat from the proposed low-level uses of partially hydrogenated oils (PHOs) is as safe as the naturally occurring trans-fat present in the normal diet”.​  

Trans fats

"A 2002 report by the National Academy of Sciences’ Institute of Medicine found a direct correlation between intake of trans fat and increased levels of low density lipoprotein cholesterol. LDL cholesterol is commonly known as 'bad' cholesterol, because it contributes to clogged, damaged arteries. What this means is that there is an increased risk of heart disease."​ Susan Mayne, Ph.D. Director of FDA’s Center for Food Safety and Applied Nutrition

What applications might a food additive petition cover?

As for a food additive petition, many manufacturers would like to be able to use PHOs in ingredients that contribute negligible amounts of trans-fat to the diet such as spices, processing aids, emulsifiers, encapsulates for flavor agents and color additives, pan release agents, anti-caking agents, and gum bases.

Nestlé, for example, which has committed to “removing all PHOs as functional ingredients by the end of 2016​", said in comments filed with the FDA last year that it should “establish a reasonable specification or de minimis level for trans fat in PHOs in the food supply to account for minor uses of PHOs that have no technical or functional effect in the finished food."

It added: “These include minor quantities of PHOs created by the action of heat in conventional frying and oil deodorizing processing and uses such as carriers and coatings in flavors, or release agents on processing equipment– i.e., uses that readily qualify as ‘processing aids’ in finished foods and contribute only nominal levels of PHOs (and trans fat) to the these foods.”

The GMA also listed several examples of where PHOs are critical to recipes, but contribute only trace amounts of trans-fat to finished foods.

For example, PHOs are added to many chewing gum formulations as softeners or texturizers, but gum is not swallowed, and only microscopic amounts of fat are ‘chewed out’ and ingested, it noted.

The use of PHO-derived emulsifiers, particularly mono- and di-glycerides, is “ubiquitous​” in food applications

Meanwhile, the use of PHO-derived emulsifiers, particularly mono- and di-glycerides, is “ubiquitous​” in food applications from cakes to ice cream, toppings, peanut butter, margarine and coffee whiteners, it said.

Asked on a call with the media this morning how long it might take to review food additive petitions on PHOs, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said it should be able to complete reviews within the three year compliance period.

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Since 2006, manufacturers have had to label trans fats in the Nutrition Facts panel, but can state that products contain 0g if they contain less than 0.5g per serving

What are partially hydrogenated oils?

Partially hydrogenated oils are made by adding hydrogen to vegetable oil via a partial hydrogenation process, which can make liquid oils more solid at room temperature (enabling firms to use liquid vegetable oils in baking instead of butter where a more solid fat is required, for example), and also makes them stay fresher for longer/more stable.  

However, it also creates harmful trans fats, which have been shown to increase the risk of coronary heart disease.

'Fully' or 'completely' hydrogenated oil doesn't contain trans fat.


"Despite the declines in trans fat in foods, PHOs have continued to be found in some brands of popular food products, such as frostings, microwave popcorn, packaged pies, frozen pizzas, stick margarines and coffee creamers. And for consumers who consistently choose products with added PHOs, their daily intake of industrially-produced trans fat is approximately twice as high as the average consumer." Susan Mayne, Ph.D. Director of FDA’s Center for Food Safety and Applied Nutrition

For the purposes of this order, the FDA has defined partially hydrogenated oils (PHOs) as "Fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an IV greater than 4 as determined by a method that is suitable for this analysis (e.g., ISO 3961 or equivalent)."

It also clarified that its order does not apply to ingredients (eg. meat, dairy products) that contain only naturally occurring trans fat, and does not apply to the use of conjugated linoleic acid (CLA) as a food ingredient.

Similarly, it does not ban the use of PHOs as raw materials used to synthesize other ingredients, adding: "There is no requirement that materials used to make food ingredients be GRAS themselves; rather, the resultant food ingredient must be safe for the intended conditions of use."

Click HERE ​to read the FDA’s determination.  

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