FDA Adds Inulin and Seven Other Fibers to Legal Dietary Fiber Definition

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Suppliers of inulin and certain other non-digestible carbohydrates can breathe a sigh of relief. After waiting two years to hear whether or not FDA would include these ingredients in the agency’s new legal definition of a dietary fiber, these companies learned today from FDA Commissioner Scott Gottlieb, MD, that the agency will in fact consider these ingredients dietary fibers, meaning the ingredients can be listed as dietary fibers on the Nutrition Facts label and be included when calculating the total amount of fiber per serving declared on the Nutrition Facts label.

When FDA announced in 2014 that it was revising the Nutrition Facts label, the agency made numerous changes, including adding a requirement to list “total sugar” content; requiring dual-column labeling for larger serving sizes; and updating Daily Values. Another change the agency made was establishing, for the first time, an official definition for dietary fiber. In May 2016, the agency published a final rule for the Nutrition Facts label, which defined a dietary fiber as either: 1) a non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants (such as whole grains and fibers naturally present in fruits and vegetables), and 2) isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health-with emphasis on the fact that companies had to prove to FDA that their ingredients have benefits for human health. As Gottlieb said today, “Before the FDA established this definition, manufacturers could declare synthetic or isolated fibers as fiber on the label without evidence that these fibers had beneficial physiological effects on the body.”

When FDA released the final definition for dietary fiber in May 2016 as part of its Nutrition Facts label final rule, at the time the agency authorized a list of seven non-digestible carbohydrates that the agency said were included in the list of dietary fibers. Those seven were: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.

Suppliers of other non-digestible carbohydrates not on the shortlist, like the increasingly popular insoluble and prebiotic fiber inulin, have been left to worry for years that FDA would bar their ingredients from being classified as dietary fibers. During the past two years, many of these fiber suppliers have been submitting citizen petitions to FDA, imploring the agency to include their fibers in the dietary fiber list and submitting evidence to demonstrate that their ingredients meet FDA’s requirement for “physiological effects that are beneficial to human health.”

Today, Commissioner Gottlieb announced the agency has approved eight new, additional fibers that can be counted as fiber on the Nutrition Facts label and the Supplements Facts label. These eight are:

• Mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others)
• Arabinoxylan
• Alginate
• Inulin and inulin-type fructans
• High-amylose starch (resistant starch 2)
• Galactooligosaccharide
• Polydextrose
• Resistant maltodextrin/dextrin

Gottlieb said the agency has already responded positively to citizen petitions from companies requesting approval for these eight fibers. Gottlieb said these eight approvals “are based on a careful review of the scientific evidence suggesting that each of these additional fibers has a physiological effect.”

A new FDA guidance document on dietary fiber FDA released today¹ states likewise: “Based on our review of the citizen petitions, comments that we have received, and our independent evaluation of the available scientific data, we intend to propose to add eight new isolated or synthetic non-digestible carbohydrates because we have tentatively determined that they have physiological effects that are beneficial to human health.”

The agency also said it would be looking to amend its existing regulations to include the new fibers: “We intend to exercise enforcement discretion for the declaration of dietary fiber, pending completion of rulemaking regarding revising our regulations.”

The agency did not approve all of the petitions it received. Commissioner Gottlieb said, for instance, “The FDA also issued two denials to petitioners because we did not agree that the evidence submitted met the scientific standards as described in our March scientific guidance.” (In February of this year, the agency published industry guidance describing the agency’s thinking in terms of what kind of scientific evidence that agency is looking for when companies, via citizen petitions, try to show that their fibers are beneficial to human health.) Gottlieb said that FDA is still in the process of reviewing more citizen petitions and that “we’re also working expeditiously to complete our review and responses for the other petitions that we haven’t yet responded to.”

He added, “We recognize the importance of providing timely responses so that food makers have certainty around their manufacturing decisions. We also welcome the submission of additional petitions in the future as science emerges and as new ingredients are identified. 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.”

These changes come on the heels of FDA’s official announcement in May that it has extended the compliance deadline for the new Nutrition Facts label regulation. Manufacturers with $10 million or more in annual food sales have until January 1, 2020, to comply with the new law, while smaller manufacturers have until January 1, 2021 to comply.

Inulin supplier Sensus (Lawrenceville, NJ) celebrated today’s news in an official statement: “Sensus, manufacturer of Frutafit and Frutalose chicory root fibers, welcomes the announcement that the U.S. Food and Drug Administration recognizes inulin-type fructans derived from chicory root as dietary fiber for the new Nutrition Facts label.” Sensus had submitted a joint citizen petition to FDA together with inulin suppliers Beneo (Manheim, Germany) and Cosucra-Groupe Warcoing (Belgium).

Sensus America president Carl Volz added, “The FDA’s inclusion of chicory root fiber as a 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.”

Other fiber suppliers celebrated the good news in public statements:

Anke Sentko, vice president of regulatory affairs and nutrition communication at Beneo, supplier of Orafti chicory root inulin and oligofructose, 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 FDA. This decision means that consumers can continue to access great tasting fiber naturally sourced from chicory roots, without any labeling confusion. The FDA ruling has further reinforced that Beneo’s chicory root fibers, including Orafti inulin and oligofructose, are a beneficial way for customers to improve the nutritional quality of their products and to help consumers bridge the fiber gap.”

Greg Dodson, vice president, fiber, for ADM/Matsutani LLC (Chicago; the joint venture between ADM, Matsutani Chemical Industry Company, Ltd., and Matsutani America Inc.), said of the company's soluble dietary fiber Fibersol digestion-resistant maltodextrin: “ADM supports the FDA’s efforts to provide consumers with nutritional labeling information that is honest, clear and relevant. We remained confident in the totality of scientific evidence that shows Fibersol’s physiological benefit to human health and its classification as a dietary fiber. With the FDA’s decision, food and drink companies can be reassured that their products using Fibersol can continue to be labeled as containing dietary fiber and will meet the compliance date for the nutrition facts labeling final rule.”

Yutaka Miyamoto, executive vice president, Matsutani America, added: “Fibersol has a large body of clinical science behind it. The citizen petition for Fibersol presented a multitude of scientific studies conducted on Fibersol, including: postprandial blood glucose response, postprandial blood triglycerides response, and non-English language journals for the FDA’s review and determination of Fibersol as a dietary fiber.”

Andrew Taylor, president ICD, Tate & Lyle (Chicago), supplier of Promitor soluble fiber (a resistant maltodextrin) and Sta-Lite polydextrose, both now on the approved list, said: “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 FDA.” The company's PromOat beta-glucan was already on FDA's original list of approved non-digestible carbohydrates. The company says that, following the new approvals for Promitor and Sta-Lite, "Tate & Lyle’s full fiber portfolio is accepted under the FDA’s new fiber definition."

Grain Millers (Eden Prairie, MN) says its oat fiber ingredients are now recognized as a dietary fiber, under the “mixed plant cell wall fibers” category. The company says it utilizes a proprietary, chemical-free, environmentally friendly processing technique for all of its oat fiber ingredients, including what it says is the market’s first chemical-free and organically certified oat fiber. “In today’s era of demand for transparency and traceability, our oat fiber has always checked all the boxes for discerning consumers,” said Chris Kongsore, executive vice president of Grain Millers, in a press release. “The recent change in FDA regulations further strengthens our position as a market leader in the supply of organic, chemical-free, clean label dietary oat fiber.”

Ingredion (Westchester, IL) confirmed that three of its fibers meet FDA's new definition: 1) inulin-type fructan NutraFlora short-chain fructooligosaccharide (scFOS), 2) Hi-Maize 260 high-amylose maize resistant starch 2, and 3) BioLigo GL 5700 galactooligosaccharide (GOS). “Ingredion’s fibers help to enable diverse benefits and are suitable for applications ranging from beverages to dairy to bakery to snacks,” said Maria Stewart, PhD, director of global nutrition R&D, Ingredion Inc., in a press release. “NutraFlora short-chain fructooligosaccharide, Hi-Maize 260 resistant starch, and BioLigo LG 5700 GOS can now continue to bring consumers the benefits of fiber in convenient, everyday foods.”

Updated 6/15/2018 9 AM PST, 6/20/2018 8 AM PST, and 6/28/18 2 PM PST to include comments from other fiber suppliers:

Also read:

FDA Extends Deadline for Nutrition Facts Label Changes to January 2020 and January 2021

At IFT, Fiber Suppliers “Confident” FDA Will Define Their Ingredients as Dietary Fibers

FDA’s Rules for Dietary Fiber Are “Unreasonably Restrictive,” Associations Say

References:

1. FDA Guidance. “The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry.” June 2018. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM610144.pdf