WASHINGTON — The Food and Drug Administration’s decision June 14 that eight additional carbohydrates meet its fiber definition pleased several suppliers of branded ingredients. The decision also should ease the anxiety of food and beverage manufacturers seeking to meet a compliance date for labeling updates.
“A.B.A. appreciates all of the efforts the agency has put forth to finalize decisions on fiber sources under the new definition,” said Lee Sanders, senior vice-president, government relations and public affairs for the Washington-based American Bakers Association. “Bakers and other food manufacturers can now begin to move forward with labeling updates as part of the Nutrition Facts Label (N.F.L.) revisions final rule compliance efforts.”
The eight additional non-digestible carbohydrates recognized as fiber are inulin and inulin-type fructans, high-amylose starch (resistant starch 2), mixed plant cell wall fibers (a category that includes fibers like sugar cane fiber and apple fiber), arabinoxylan, alginate, galactooligosaccharide and resistant maltodextrin/dextrin. The F.D.A. decision appeared in the June 15 issue of the Federal Register, which may be found here. The eight approvals give food manufacturers additional clarity in updating their labels as needed ahead of the compliance date for the F.D.A.’s new Nutrition Facts Label, which is Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales and Jan. 1, 2021, for smaller manufacturers.
Inulin and inulin-type fructans, often sourced from chicory root, were a major focus as food companies for years have promoted the ingredients as fiber in products, including Fiber One. The F.D.A. said inulin and inulin-type fructans met its fiber definition because they provide beneficial physiological effects in the form of bone mineral density and absorption of calcium. Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America, Inc., Lawrenceville, N.J.; Oliggo-Fiber from Cargill, Minneapolis; and Orafti from Beneo, Inc., Parsippany, N.J.
“Inulin/oligofructose has been clearly shown to support physiological health benefits as assessed by the F.D.A.’s strict criteria,” said Carl Volz, president of Sensus America. “The F.D.A.’s inclusion of chicory root fiber as dietary fiber in its new food labeling regulations allows our customers to continue marketing their products as sources of dietary fiber and to continue to use chicory root fiber as a tool to reduce calories and added sugar.”
Anke Sentko, vice-president of regulatory affairs and nutrition communication at Beneo, said, “Given the ever-growing body of research in favor of our fibers, we never doubted this outcome but are obviously delighted with the result of the latest ruling from the F.D.A.”
The F.D.A. said resistant maltodextrin met its fiber definition because it increases calcium absorption. Archer Daniels Midland Co., Chicago, submitted a citizen petition on July 22, 2016, stating why Fibersol resistant maltodextrin should qualify as fiber. ADM/Matsutani, L.L.C., a joint venture between ADM, Matsutani Chemical Industry Co., Ltd. and Matsutani America, Inc. offers Fibersol.
“Fibersol has a large body of clinical science behind it,” said Yutaka Miyamoto, executive vice-president for Matsutani America. “The citizen petition for Fibersol presented a multitude of scientific studies conducted on Fibersol, including post-prandial blood glucose response, post-prandial blood triglycerides response, and non-English language journals for the F.D.A.’s review and determination of Fibersol as a dietary fiber.”
Tate & Lyle, P.L.C. pointed to two ingredients that now meet the F.D.A. fiber definition: Promitor soluble fiber (a resistant maltodextrin) and Sta-Lite polydextrose.
“Due to extensive clinical research on our fibers of their proven physiological benefits, we were confident that our fibers would meet the new requirements and are delighted that this has now been confirmed by the F.D.A.,” said Andrew Taylor, president I.C.D. (Innovation and Commercial Development) for Tate & Lyle.
Other branded ingredients that now meet the F.D.A.’s fiber definition include Litesse polydextrose from DuPont Nutrition & Health, New Century, Kas., now part of DowDuPont, Inc., and Hi-Maize resistant starch from Ingredion, Inc., Westchester, Ill. The F.D.A. said polydextrose met its fiber definition because its intake leads to a statistically significant reduction in energy intake at a subsequent meal. The F.D.A. said resistant starch 2 met its fiber definition because of a reduced post-prandial insulin response in the absence of a rise on post-prandial glucose. While there are four types of resistant starch, resistant starch 2 is found in some starchy foods. Ingredion sources its resistant starch 2 from high-amylose corn.
The F.D.A. considered many of the 26 total non-digestible carbohydrates that it reviewed to be mixed plant cell wall fibers. Examples were sugar cane fiber, oat hull fiber, rice bran fiber and soy fiber.
The F.D.A. in the May 27, 2016, issue of the Federal Register defined dietary fiber for the first time 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 the F.D.A. to have physiological effects that are beneficial to human health.
Isolated or synthetic non-digestible carbohydrates not listed as dietary fiber by the F.D.A. at that time could provide citizen petitions to the F.D.A. explaining how the carbohydrates provided physiological effects beneficial to human health. The F.D.A. received citizen petitions for each of the eight non-digestible carbohydrates approved as fiber on June 14. The F.D.A. is evaluating other petitions.
“Our expectation is that we will continue to evaluate additional dietary fibers on a rolling basis, and we expect that additional fibers may be recognized in the future,” said Scott Gottlieb, M.D., commissioner of the F.D.A.
A clearer ruling on “intrinsic and intact” might be needed, Ms. Sanders of the A.B.A. said.
“It is still unclear whether F.D.A. has officially opined on intrinsic and intact fibers,” she said. “A.B.A. looks forward to additional insight from the agency on this issue and future decisions on the additional pending fiber petitions.”