An upcoming F.D.A. definition may require fiber suppliers to have scientific evidence.

The Food and Drug Administration in the Federal Register of March 3 proposed to define fiber. Grain-based foods manufacturers may wonder if ingredients promoted as fiber in their products will meet the upcoming definition

If the fiber is intact in plants, it should be okay, according to the F.D.A.’s proposed definition. If the fiber is extracted, scientific evidence on physiological health benefits may be needed. Thus, an upcoming final fiber definition should be of importance to suppliers and users of such ingredients as inulin, resistant starch, bran, soluble corn fiber and polydextrose.

The Institute of Medicine has defined “dietary fiber” as non-digestible carbohydrates and lignin that are intrinsic and intact in plants, and it has defined “added fiber” as isolated, non-digestible carbohydrates that have beneficial physiological effects in humans. Under the F.D.A.’s proposed rule in the Federal Register, manufacturers would be required to provide the F.D.A. with evidence that demonstrates the physiological effects beneficial to human health of isolated and synthetic non-digestible carbohydrates added to food.

Other fiber definitions in the world may give food manufacturers an idea as to how the F.D.A. will consider “physiological effects beneficial to human health.”

Health Canada issued a policy for the labeling and advertising of food products containing dietary fiber in February 2012. The policy lists physiological effects that are functions of dietary fiber and are acceptable as a physiological effect of novel fiber sources. They include: improves laxation or regularity by increasing stool bulk, reduces blood total and/or low-density lipoprotein cholesterol levels, reduces post-prandial blood glucose and/or insulin levels, and provides energy-yielding metabolites through colonic fermentation.

The Codex Alimentarius Commission, which develops harmonized international food standards, established a fiber definition in 2010. The standards mention health benefits “as demonstrated by generally accepted scientific evidence to competent authorities,” but they do not give examples.

To avoid trade difficulties, an F.D.A. fiber definition might need to harmonize with other definitions such as the ones from Health Canada and Codex, according to a June 27 webinar put on by AACC International. The webinar featured the two co-chairs of its Dietary Fiber and Other Carbohydrates Approved Methods Technical Committee. Jon DeVries, Ph.D., is senior technical manager of General Mills, Inc.’s Medallion Laboratories. Stuart Craig, Ph.D., is director of regulatory and scientific affairs at DuPont Nutrition & Health.

Dr. DeVries said Codex involves 186 countries, including the United States. Dr. Craig pointed out the list of physiological benefits from Health Canada is non-exclusive, meaning other physiological benefits may be recognized as science evolves. Dr. Craig said companies should look at the list of fibers approved in Canada.

“I think it would give you a good sense of what the F.D.A. is proposing,” he said.

The F.D.A. has proposed that fiber ingredients that already have a health claim would meet the definition of fiber. Beta-glucan soluble fiber and barley beta-fiber thus would meet the definition because they are subjects of authorized health claims.

AACC International is putting together comments on the proposed fiber definition that it will submit to the F.D.A., Dr. DeVries said. The F.D.A. will accept comments on the fiber definition, along with proposed changes to the Nutrition Facts Panel, until Aug. 1.


Health Canada has ruled favorably on inulin, which generally is sourced from chicory root for use in food products.

Health Canada in 2013 sent a letter of no-objection to Sensus relating to classifying its Frutalose line of products as a source of dietary fiber in non-standardized food. The letter complemented Health Canada approving Frutafit inulin from Sensus as dietary fiber in 2006.

Also in 2013, Beneo’s complete portfolio of inulin and oligofructose dietary fibers joined Health Canada’s list of acceptable dietary fibers. Beneo has a “volume of science” on inulin and its beneficial health effects, including satiety and blood sugar, said Joseph O’Neill, president and general manager of Beneo.

Health Canada in 2007 sent a no-objection letter to Cargill for classification of its Oliggo-Fiber inulin as dietary fiber for labeling purposes in Canada.

Resistant starch

Resistant starch draws its name from its ability to resist digestion. Different forms of resistant starch are used as food ingredients.

RS2 is natural granular starch with no chemical modification, according to Ingredion, Inc., Westchester, Ill. Examples include green banana starch, raw potatoes and maize.

Ingredion offers Hi-maize resistant starch from corn. Studies have shown it provides health benefits in weight management, glycemic management, energy management and digestive health. Hi-maize resistant starches qualify as dietary fiber for labeling purposes by AOAC methods 985.29 and 991.43, according to Ingredion.

MGP Ingredients, Atchison, Kas., offers an RS4 form, or a chemically modified form, of resistant starch in Fibersym RW sourced from wheat. A study published this year in Molecular Nutrition & Food Research gave credence to the health benefits of Fibersym RW.

Researchers at South Dakota State University in Brookings, S.D., led a 26-week, double-blind, placebo-controlled, cluster cross-over intervention involving 86 people. One group ate food products containing flour enriched with Fibersym RW. A control group ate food products with flour.

People who consumed Fibersym RW had 7.2% lower mean total cholesterol. The researchers concluded incorporating resistant starch of the RS4 form could offer an effective strategy for public cardio-metabolic health promotion.

MGP Ingredients supported the study as did the National Institutes of Health, an S.D.-Agriculture Experiment Station grant and the EA Martin Endowment at South Dakota State University.

“Functional food ingredients incorporating resistant starch in daily meals can potentially contribute to a long-term healthier dietary lifestyle,” said Moul Dey, Ph.D., of the Department of Health and Nutritional Sciences at South Dakota State University.

Previously compiled data have demonstrated Fibersym RW’s effectiveness in blood glucose and insulin control, caloric reduction and the production of beneficial and energy-yielding metabolites through colonic fermentation, according to MGP Ingredients.


Health Canada already has approved all corn bran as fiber, Dr. DeVries said. He said he expects the F.D.A. will rule corn bran, along with oat bran, wheat bran and barley bran, to be dietary fiber.

“Even though they fit that isolated definition, there shouldn’t be any reason to object to them being labeled as fiber,” he said.

Grain Processing Corp., Muscatine, Iowa, offers TruBran corn bran that is made from yellow dent corn at 85% dietary fiber. The company used the ingredient in offering artisan pita with Cajun-seasoned chicken and a cucumber-yogurt sauce during the Institute of Food Technologists’ annual meeting and food exposition in June in New Orleans.

Didion Milling, Cambria, Wis., offers HarvestGold corn bran. Corn fiber is about 75% insoluble fiber and 25% soluble fiber, making it a good balance of the two forms of fiber, said Todd Giesfeldt, mill R.&D. senior manager for Didion Milling.

“Corn fiber is unique in the fact that it is made from the corn kernel hull, which brings along other beneficial materials such as corn hull oil,” he said.

Phytosterols in corn fiber oil have been shown to block the absorption of dietary cholesterol in the body, Mr. Giesfeldt said. Corn fiber oil contains about 10 times more phytosterols than regular corn oil, he said.

Soluble corn fiber

Suppliers showcased soluble corn fiber and its benefits at the I.F.T. event.

Fibersol, a joint venture between Archer Daniels Midland Co., Matsutani Chemical Industry Co. Ltd. and Matsutani America, Inc., offers a family of soluble corn fiber ingredients. Clinical studies have indicated Fibersol helps support or maintain intestinal regularity. At the I.F.T. event, Fibersol was used in Cajun-spiced whole wheat crackers that had 6 grams of fiber per 28-gram serving.

Multiple clinical trials have shown Promitor soluble corn fiber to have digestive tolerance, according to London-based Tate & Lyle. The company at the I.F.T. event used Promitor to create corn bread with 3 grams of fiber per serving.


DuPont Nutrition & Health offers a Litesse brand of polydextrose that it says is low-calorie, low-sugar, low-glycemic and prebiotic.

Tate & Lyle in March agreed to buy the business and assets of Winway Biotechnology Nantong Co. Ltd., a producer of polydextrose in China. Polydextrose has prebiotic properties, helps support gastrointestinal health and has a low glycemic/blood glucose response, according to Tate & Lyle, which has other polydextrose facilities in The Netherlands and the United States.