For the past two years, suppliers of 26 isolated and synthetic non-digestible carbohydrates have been in a state of limbo, with food manufacturers permitted to use these ingredients in their formulations, but unsure whether they would be able to count them as grams of dietary fiber on the new-look Nutrition Facts label.
Thursday’s guidance spells outs which of these ingredients – which have been subject to industry petitions – have a green light from the FDA after a lengthy scientific review process to determine if they have physiological effects beneficial to human health.
According to the FDA: “To be clear, the FDA didn’t approve or reject anything. We granted and denied certain petitions and made determinations about whether the 26 non-digestible carbohydrates from the 2016 science review meet the criteria to be considered a dietary fiber as laid out in this guidance from earlier this year).
"We intend to exercise enforcement discretion for the declaration of dietary fiber, pending completion of a rulemaking regarding revising our regulations, if the declaration includes one or more of the following eight isolated or synthetic non-digestible carbohydrates:
- Mixed plant cell wall fibers: a broad category that includes barley fibers, cocoa fibers, sugar cane fiber, apple fiber, sugar beet fiber, corn hull fiber, potato fiber, oat hull fiber, pea fiber (hull and cotyledon), bamboo fiber, cottonseed fiber, rice bran and hull fiber, soy fiber (cotyledon and hull), citrus fiber, and wheat fiber. [The FDA defines it as: “Ingredients that contain two or more of the following plant cell wall fibers in varying proportions: cellulose; pectin; lignin; beta-glucan; and arabinoxylan" and says: "Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits, vegetables, grains, legumes, pulses, nuts, and other plants that undergo processing methods."
- Inulin and inulin-type fructans;
- High amylose starch (resistant starch 2);
- Polydextrose (which will be listed as having 1 kcal/g; vs the typical 2 kcal/gram for soluble non-digestible carbs)
- Resistant maltodextrin/dextrin.
"Several petitions are still pending with FDA and reviewing this information is a very high priority for the agency. Firms also can submit new citizen petitions, and we will review the petitions on a rolling basis. Firms whose non-digestible carbohydrates do not meet our regulatory definition of dietary fiber at this time can still use those non-digestible carbohydrates in foods and declare these as part of the amount of total carbohydrate on the food package."
Scott Gottlieb: We have received additional petitions
In a press release announcing the guidance, Gottlieb said additional fibers may still get the green light, adding: "We have received additional petitions asking for additional fibers to be recognized in a similar fashion to the eight dietary fibers we are identifying today. We are actively evaluating these additional requests, working through the petitions and, in some cases, supplementary information provided by the petitioners, in an efficient manner.
"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."
FoodNavigator-USA has contacted the FDA for clarification as to the status of the isolated and synthetic non-digestible carbohydrates that were on its original list of ingredients under scrutiny but were not explicitly mentioned in Thursday’s guidance and has had some feedback on gum acacia and xanthan gum.
Cathy Peterson, regulatory and commercialization manager at J. Rettenmaier USA – which supplies a range of fibers that have just been given the green light, told FoodNavigator-USA: “Although we have clarity on the majority of the fibers [in FDA’s original list of 26], there are still a few gray areas:
- Carboxymethylcellulose: According to Peterson: "This is not included in the definition. A manufacturer would need to submit a citizen petition with clinical trials demonstrating a health benefit for approval."
- Gum acacia: According to an FDA spokeswoman, gum acacia "didn’t meet the definition based on the evidence reviewed."
- Karaya gum: This is not explicitly mentioned by FDA in its guidance document.
- Pullulan (produced from starch by the fungus Aureobasidium pullulans): "A manufacturer would need to submit a Citizen Petition with clinical trials demonstrating a health benefit for approval," said Peterson.
- Retrograded cornstarch (Resistant Starch 3) "This is pending completion of a citizen petition review," said Peterson.
- Resistant wheat and maize starch (Resistant Starch 4) "This is pending completion of a citizen petition review," said Peterson [see citizen's petition HERE from MGP Ingredients].
- Xanthan gum (produced from sugars using a fermentation process): According to an FDA spokeswoman, xanthan gum "didn’t meet the definition based on the evidence reviewed."
- Xylooligosaccharides: According to Peterson: "They are structurally different than fructooligosaccharides and inulin and a manufacturer would need to submit a Citizen Petition demonstrating a health benefit for approval." According to the FDA citizen petition tracker, a petition was filed by AIDP in early 2017 [click HERE].
Mixed plant cell wall fibers: “Many of the 26 non-digestible carbohydrates we reviewed (e.g., sugar cane fiber and oat hull fiber) are considered to be ‘mixed plant cell wall fibers.’ While some isolated non-digestible carbohydrate ingredients are added to foods and listed as a specific non-digestible carbohydrate (e.g., cellulose), they may also be added and listed as part of a mixed plant cell wall fiber (e.g., sugar cane fiber).
"We have evaluated the beneficial physiological effects of specific, isolated non-digestible carbohydrates that also may be part of a mixed plant cell wall fiber (e.g., cellulose and pectin). We have determined that each of these individual isolated non-digestible carbohydrates (e.g., cellulose and pectin) has a beneficial physiological effect. Therefore, we intend to consider “mixed plant cell wall fibers” as a general category of isolated non-digestible carbohydrates.”
For suppliers with ingredients on FDA’s latest list, Thursday’s news came as a welcome relief. Here is a selection of comments from stakeholders:
“This is an excellent piece of work by FDA in my opinion because it adds to the definition of dietary fiber a number of widely used food ingredients that impart real health benefits to the public at low cost.”
George Salmas, The Food Lawyers (boutique law firm specializing in food and beverage law).
“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."
Anke Sentko, VP regulatory affairs & nutrition communication, Beneo
“Inulin/oligofructose has been clearly shown to support physiological health benefits as assessed by the FDA’s strict criteria. 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.”
Carl Volz, president, Sensus America (manufacturer of Frutafit and Frutalose chicory root fibers).
“ABA appreciates all of the efforts the agency has put forth to finalize decisions on fiber sources under the new definition. Bakers and other food manufacturers can now begin to move forward with labeling updates as part of the Nutrition Facts Label (NFL) revisions final rule compliance efforts…It is still unclear whether FDA has officially opined on intrinsic and intact fibers.”
Lee Sanders, SVP government relations and public affairs, American Bakers Association
“We are pleased that the FDA has finally issued some additional dietary fiber Guidance, based on strong scientific evidence, needed for implementation of the revised Nutrition Facts Label. In the future, it is critical that FDA issue timely Guidance important for implementation of rule changes so that implementation periods are sufficient to avoid unnecessary costs that could be passed on to consumers in the form of higher food prices.”
Christina Martin, EVP, Corn Refiners Association
“Tate & Lyle’s full fiber portfolio is accepted under the FDA’s new fiber definition and is further proof that Tate & Lyle’s soluble fibers provide a number of different health benefits to consumers alongside functional benefits to manufacturers.”
Tate & Lyle (which makes PROMITOR soluble Fiber (a resistant maltodextrin), and STA-LITE polydextrose. The company’s PromOat beta glucan immediately qualified under this new definition because of a pre-existing FDA authorized health claim for oat beta glucan, noted the company.)
“We are pleased with the FDA’s decision to include Fibersol on the approved list of dietary fiber. We remained confident in Fibersol’s physiological benefit to human health and its classification as a dietary fiber. We look forward to helping more food and drink developers use Fibersol to boost the nutritional profile of their products.”
Brent Flickinger, Ph. D. VP regulatory and scientific affairs, ADM (which markets soluble corn fibers under the Fibersol brand in partnership with Matsutani)
“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."
Greg Dodson, VP, Fiber, ADM
“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 FDA’s review and determination of Fibersol as a dietary fiber. Once the FDA reviewed the petitions and supporting evidence, it made the decision to include digestion-resistant maltodextrin on its list of dietary fibers that have a physiological effect beneficial to human health.”
Yutaka Miyamoto, EVP, Matsutani America
“J. Rettenmaier USA LP is very pleased with the information released by the FDA today. In the guidance document, the FDA announced the addition of Mixed Plant Cell Wall Fibers (MPCWF) to the list of dietary fibers. MPCW fiber ingredients contain two or more plant cell wall fibers such as cellulose, arabinoxylan, pectin, beta glucan and lignin in varying proportions.
“Vitacel apple fiber, bamboo fiber, oat fiber (conventional and organic), orange fiber, pea (cotyledon) fiber, potato fiber, rice fiber, organic soy fiber, sugar cane fiber and wheat fiber; Canadian Harvest oat fiber; Justfiber cottonseed fiber and Vidofibres Bf sugar beet fiber are all plant cell wall fibers that are composed of two or more of the following individual fibers: cellulose, pectin, arabinoxylan and lignin.
“The inclusion of a broad range of dietary fibers ensures that consumers will continue to have access to existing fiber enriched products they have relied on for many years and will enable the development of additional fiber enriched products to help minimize the fiber deficiency that exists for more than 95% of consumers.”
Cathy Peterson, regulatory and commercialization manager, J. Rettenmaier USA (which supplies a range of ingredients included in the new mixed plant cell wall fibers category)
"The FDA review identifies the significance of the scientific data provided suggesting that "inulin and inulin-type fructans" have a statistically significant effect on calcium absorption and bone mineral density that is beneficial to human health."
“I’m really pleased to see the inclusion of inulin and inulin type fructans up there plus the decision to include mixed plant cell wall fibers, which makes sense to me.”
Taylor Wallace, food science consultant
The FDA classifies dietary fibers into three groups:
1 - Non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants [these don’t need FDA pre-approval and automatically meet the definition].
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 (the FDA initially approved six: Beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose], but required suppliers of many others to submit citizen's petitions.
3 - Isolated and synthetic non-digestible carbohydrates FDA has just given the green light to:
- Mixed plant cell wall fibers
- Inulin and inulin-type fructans;
- High amylose starch (resistant starch 2);
- Resistant maltodextrin/dextrin