Several food and beverage companies promote inulin from chicory root as fiber, including General Mills, Inc., Minneapolis, in its Fiber One bars, but the F.D.A. officially has never recognized inulin as a source of fiber.
The F.D.A. in the May 27 issue of the Federal Register presented a fiber definition that includes naturally occurring fibers and only fibers added to food that show a physiological health benefit. The F.D.A. said it sought comment on available scientific data on non-digestible carbohydrates to assist in the review of the scientific evidence. The F.D.A. said it would identify and summarize available clinical trial data for non-digestible carbohydrates, including inulin, bamboo fiber, soy fiber, pea fiber, wheat fiber, cotton seed fiber, sugar cane fiber, sugar beet fiber and oat fiber.
While the F.D.A. said one physiological health benefit may qualify an ingredient for fiber status, the Sept. 12 petition said inulin-type fructans have a number of physiological health benefits, including improved laxation/bowel function, increased calcium absorption, reduced blood cholesterol levels and attenuated postprandial blood glucose levels.
The petition refers to several types of inulin-type fructans: inulin with degrees of polymerization (D.P.) ranging from 3 to 60; long-chain inulin with a D.P. of 10 or more; oligofructose (also known as fructooligosaccharides or FOS) with a D.P of 10 or less; and oligofructose-enriched inulin, which is a combination of long-chain and shorter-chain inulin.
“As a result of their common physiological fate and metabolism, I.T.F. (inulin-type fructans), irrespective of their D.P., exert the same beneficial physiological effects such as improved bowel function, increased calcium absorption, reduced blood cholesterol levels and attenuated postprandial glycemic response,” the petition said.
The petition does not address short-chain fructooligosaccharides, which chemically is a fructans compound with more than 85% of the molecules having a D.P. of three or four and only a negligible occurrence of D.P. greater than five.
The three companies in the petition have decades of experience with inulin.
Cosucra Groupe Warcoing S.A., a Belgian company, develops, produces and markets natural food ingredients from chicory roots and yellow peas. The company has produced inulin-type fructans since 1986. They are sold worldwide. Cargill, Minneapolis, distributes the ingredients in the United States.
Sensus B.V., based in The Netherlands, has been involved in the manufacture and sale of inulin-type fructans from chicory roots since 1995. The company has a customer base in Europe, North America and Asia. Sensus America, Inc. is based in Lawrenceville, N.J.
Beneo has been involved in chicory root fiber for more than 20 years. The company manufactures inulin-type fructans from chicory roots in production facilities in Belgium and Chile. The company has a U.S. office in Morris Plains, N.J.
The petition said 14 of 16 human intervention studies it cited on improved laxation/bowel function pointed in a favorable direction for inulin-type fructans. Among the 10 human intervention studies on calcium absorption, 7 showed that inulin-type fructans significantly increased calcium absorption compared to a placebo and 3 did not show an effect, which may have resulted from factors other than inulin-type fructan supplementation.
Among the 16 human intervention studies on blood cholesterol levels, 5 “well-designed and well-analyzed” studies found inulin-type fructans reduced blood cholesterol levels; 4 studies, “albeit with imperfect design or comparisons,” also pointed toward a favorable effect; and 7 studies did not observe an effect, which may have resulted from factors other than inulin-type fructan supplementation.
Among the 5 human intervention studies on postprandial blood glucose, all of them pointed in the favorable direction that replacing glycemic carbohydrates with inulin-type fructans reduces the postprandial blood glucose level.
The F.D.A. in the May 27 Federal Register said it already had determined scientific evidence supports a beneficial physiological effect from the following fibers: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose.
The F.D.A. on Aug. 19 confirmed Sunfiber, which is partially hydrolyzed guar gum, is included in the agency’s dietary fiber definition for guar gum. More than 100 clinical studies support Sunfiber, according to Taiyo International, which offers Sunfiber and has a U.S. office in Minneapolis.
The date for food and beverage companies to be in compliance with labeling on fiber is July 26, 2018, for manufacturers with $10 million or more in annual food sales and July 26, 2019, for manufacturers with less than $10 million in annual food sales.