SAFEGUARDS | Food NO. 187/16

SafeGuardS breakfast cereals

The US FDA, on November 22, 2016, issued draft guidance [1] on dietary fiber labeling because of the addition of seven isolated or non-digestible fibers than can be included in the dietary fiber amount. At the same time as producing this draft guidance the US FDA requested information on whether an additional 26 forms of fiber should also be included. The criteria for inclusion will be whether or not these sources of fiber provide a physiological effect that is beneficial to human health. 

US FDA New Dietary Fiber Definition – Inclusion of Seven Fibers [2]

In the original Nutrition Facts, published in the 1990s, the US FDA did not define dietary fiber. When the US FDA published changes to the Nutrition Facts on May 27, 2016 they defined that dietary fiber is “as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.” [3] In this final regulation they classified seven isolated or non-digestible fibers as having a physiological effect that is beneficial to human health, therefore the amounts of these ingredients can be included in the dietary fiber calculation. These are Beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose. Naturally occurring fibers are directly in the food such as cereal bran, flaked cereal, vegetables, fruits, whole grains and flours.

Request for Inclusion of Additional Forms of Fibers

The US FDA selected 26 of the most commonly used added isolated or synthetic non-digestible fibers and is asking if these fibers have information which proves beneficial physiological effects to human health. They are:

  • Gum Acacia

  • Alginate

  • Apple Fiber

  • Bamboo Fiber

  • Carboxymethylcellulose

  • Corn Hull Fiber

  • Cottonseed Fiber

  • Galactooligosaccharides

  • Inulin/Oligofructose/Synthetic Short Chain Fructooligosaccharides

  • Karaya Gum

  • Oat Hull Fiber

  • Pea Fiber

  • Polydextrose

  • Potato Fibers

  • Pullulan

  • Rice Bran Fiber

  • High Amylose Corn/Maize Starch (Resistant Starch 2)

  • Retrograded Corn Starch (Resistant Starch 3)

  • Resistant Wheat and Maize Starch (Resistant Starch 4)

  • Soluble Corn Fiber

  • Soy Fiber

  • Sugar Beet Fiber

  • Sugar Cane Fiber

  • Wheat Fiber

  • Xanthan Gum

  • Xylooligosaccharides

If scientific information proves at least one benefit, such as lower blood glucose and cholesterol level, lowering blood pressure, improved laxation and bowel function, increased mineral absorption in the intestinal tract, or reduced energy intake, then this ingredient would be included in the dietary fiber definition.

What does this Mean for the Food Industry?

For products with labels that have dietary fiber claims and where the level of fiber is supported by the addition of isolated or synthetic non-digestible fibers, then the inclusion of these compounds into the dietary fiber definition may be necessary for these claims to be continued. Additionally, as more compounds are added into the dietary fiber definition it provides the industry with a wider variety to use in order to manufacture products. Because analytical testing cannot distinguish between naturally occurring fibers and isolated or synthetic fibers, the industry will have to keep records to provide traceability. However, it will still need to perform analytical testing of dietary fiber in order to subtract those fibers not approved to be accounted for in the total amount. The analytical testing methods suggested are AOAC 2009.01, AOAC 2011.25 or equivalent. 

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Food Scientific and Regulatory Affairs Manager

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