Talk about mid-season roster changes. That’s essentially what happened to “Team Total Dietary Fiber” when the Food and Drug Administration (FDA) published the final rules that updated the Nutrition Facts Panel, a mandatory part of food package labeling.
Many definitions of dietary fiber have circulated, written by AACC International, Codex Alimentarius and other industry and government groups. Some insisted that the only food components that qualify as dietary fiber must be those placed there solely by Mother Nature. Others asserted that any food ingredient that analyzes chemically as a non-digestible carbohydrate should be considered dietary fiber.
But until May 27, 2016, FDA had not weighed in, and when it did, the agency set the bar high. It established a brand new, three-part definition. First, it listed “non-digestible soluble and insoluble carbohydrates (with three or more monomeric units) and lignin that are intrinsic and intact in plants.” Second, it acknowledged “isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.” And third, total dietary fiber (TDF) was recognized as the sum of “intrinsic and intact” and “isolated or synthetic” present in the food.
That definition is quite literally a mouthful. But it means that the rules of the game have changed drastically for choosing fiber ingredients and making claims about the amount of dietary fiber contained in a food product.
The good news is that “intrinsic and intact” fiber is found in many bakery ingredients such as flour, cereal brans, whole grains, fruits and vegetables. The bad news is that FDA named only seven of the marketplace’s numerous fiber additive ingredients — now termed “isolated or synthetic non-digestible carbohydrates.” It left more than two dozen in limbo. Suppliers of such ingredients can get them onto FDA’s list through the citizen petition process, and several have filed already.
Still, the fact is that fiber and baked foods go together. “Fiber is a natural for baked foods,” said Cathy Dorko, regional product manager, DuPont Nutrition & Health.
Consumers do understand that dietary fiber is good for them, observed Douglas Raeder, product manager, DuPont Nutrition & Health. “We see a lot of positive feedback about fiber’s positive effect on health,” he said. “And many consumers feel they fall short on fiber intake. Fiber occupies a very important space.”
A compound annual growth rate (CAGR) of 13.4% through 2020 is projected for the dietary fiber market, noted Renee Beall, food marketing, Roquette America. “Consumers — looking to address health risks, weight management and simply to make better choices for themselves and their families — recognize that fiber is a critical part of a healthy eating pattern,” she said. “Adding fiber is an easy, cost-effective way to add a health-related claim and differentiate your product. It can also lower fat, calories and sugar content of your product.”
With FDA’s new definition, bakers and snack food producers — and their fiber ingredient suppliers who want to make fiber claims — have been put into a third-and-long situation. “Although this new rule poses some challenges to the food industry, the purpose is to update packaged foods labels to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease,” said Tom Carrington, senior regulatory scientist, Ardent Mills. “The intent is for the new label to make it easier for consumers to make better informed food choices.”
By the rules
The new definition is based on the physiological effects in humans conferred by consuming non-digestible carbohydrates, a.k.a. dietary fiber. This differs from past practice.
“Unfortunately, FDA retained the definition of dietary fiber based on a showing of a beneficial physiological effect, rather than a chemical definition, as is the case for most other nutrients,” said Lee Sanders, senior vice-president for governmental relations and public affairs for the American Bakers Association (ABA).
On Feb. 13, Ms. Sanders filed comments with FDA in which ABA urged the agency to rescind or stay “the unworkable and impractical definition of dietary fiber until it can thoroughly address the unintended consequences, costs and burdens for bakers under the current one.” Specifically, the group asked for additional fibers to be listed, provide examples about how the agency’s scientific evaluation process works, develop a public notification process for fibers it approves in the future, reclassify two fibers already approved and lengthen compliance timing.
Because most people don’t consume enough fiber, the 2015 Dietary Guidelines for Americans designated this food component a “nutrient of concern.” FDA took note and, for labeling purposes, increased fiber’s Daily Value (DV) from 25 g per day to 28. “Caloric contribution for an insoluble non-digestible carbohydrate is 0 Cal per g,” said Paula Trumbo, PhD, nutrition programs, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, FDA, speaking to AACC International’s 2016 annual meeting held in October. “For soluble, it will range from 2 to 4 Cal per g. We don’t see this as being any different than in the past.”
What is different, however, is that food processors making dietary fiber claims must track fiber usage. “Record keeping is now required for foods that contain both dietary fiber and added non-digestible carbohydrates that do not meet the definition of dietary fiber,” Dr. Trumbo said.
The nub of the problem for formulators is that no analytical test can ascertain which fibers have or have not been determined by FDA to have physiological effects, explained Amy Fratus, regulatory affairs, Roquette America. “Any product with an added fiber that has been isolated from a plant will have to be reviewed to determine the declarable dietary fiber amount.”
When a food makes a fiber content claim, its packaging must disclose the amount. “Fiber declarations have always been voluntary,” Dr. Trumbo added, “and they still are, even under the new regulations.”
Listed first in the FDA definition of dietary fiber are those considered intrinsic and intact. “Intact means having no relevant component removed or destroyed; intrinsic means originating and included wholly within a food,” Dr. Trumbo explained. Examples are vegetables, whole grains, fruits, cereal brans, flaked cereal and flours.When developing the final rule, FDA did a scientific review of additive dietary fiber ingredients touting physiological effects beneficial to human health. Only the seven listed presented enough accessible and supportive scientific data, according to the agency. The draft guidance FDA published on Nov. 22 described how it plans to evaluate the science supporting the dietary role claimed by isolated or synthetic non-digestible carbohydrates. That same day, the agency also released “Science Review of Isolated and Synthetic Non-Digestible Carbohydrates.” This summarized the background and scientific evidence involving various health benefits and physiological effects for 26 ingredients touting dietary fiber status. But the review did not take the next step: approval. That awaits the petition process.
“However, this evaluation is currently without conclusion,” said Jon Peters, president, Beneo, Inc. “FDA is now requesting additional scientific data and information, including unpublished studies. They are also asking for comments that would help them to finish the evaluation of the beneficial physiological effects of isolated or synthetic, non-digested carbohydrates that are added to foods.”
Dr. Trumbo confirmed this need. “If the fiber is not considered to be intrinsic and intact in a food, then it needs to demonstrate a physiological benefit to human health,” she said. “The final rule provides examples of physiological effects, such as lowering of blood glucose and cholesterol levels, lowering of blood pressure, improved laxation and bowel function, increased mineral absorption, reduced energy intake. This is not an exclusive list.”
Mr. Carrington noted, “Ardent Mills’ ingredients are only milled, rolled, chopped or crushed. Because of this, the fiber remains intrinsic and intact.” Among these high-fiber ingredients is the company’s Sustagrain barley, a whole grain that delivers 34 g total dietary fiber and 12 g beta-glucan soluble fiber per 100 g.
Traditional processing methods also characterize Grain Millers’ oat fibers and oat bran. “They are intrinsic and intact and naturally processed, made from the oat,”
explained Rajen Mehta, PhD, senior director, specialty ingredients, Grain Millers, Inc. The company also processes oat hull fiber with oat bran blends offering a broader spectrum of functional absorptive ingredients. “These, too, are considered intrinsic and intact fibers because they contain all the material from the anatomical layers from both the bran and the hulls. We have thoroughly studied the content of these ingredients, and the oat hull components are in the same proportion at the end of the process as at the beginning. We don’t throw anything away.”
Beans and pulses, typically supplied in cooked, dried and powdered formats, qualify for this category, too. “ADM offers a variety of plant-based bean and pulse ingredients that offer high fiber and protein in a whole-food ingredient,” said Doris Dougherty, Fibersol technical service representative at ADM.
BI Nutraceuticals specializes in fiber ingredients and offers a portfolio of fruit and vegetable powders. These satisfy the intrinsic-and-intact provision, said Alison Raban, certified food scientist. “Compliance will not be an issue for our customers using those ingredients.”
The situation with isolated or synthetic fiber additives is far more complex. FDA’s May 27, 2016, final rule listed seven that met its definition: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, locust bean gum, pectin and hydroxypropyl methylcellulose (HPMC). Beta-glucans and psyllium husk qualified because they can make FDA-approved health claims for reducing the risk of coronary heart disease. Cellulose is listed because it supports improved bowel function. The other four are hydrocolloids known to attenuate blood cholesterol.
In its Feb. 13 comments, ABA questioned placement of beta-glucans and psyllium husk in the “isolated or synthetic” category. “All sources of beta-glucan soluble fiber … are clearly intrinsic and intact, including oat bran, rolled oats, whole oat flour, oatrim, whole grain barley and dry milled barley,” Ms. Sanders wrote to FDA. “Similarly, psyllium husk … is clearly intrinsic and intact and should not be included in FDA’s list of ‘isolated or synthetic non-digestible carbohydrates.’ ” She cited existing descriptions of the materials as dietary fiber in 21 CFR 101.81 and 21 CFR 101.9.
It’s common for suppliers of fibers qualifying as intrinsic and intact to also offer isolated or synthetic choices.
At BI Nutraceuticals, Ms. Raban termed the situation “complicated.” She said, “Formulators may be scrambling to find a fiber ingredient that will meet the new definition.” The company is primary in psyllium, and offers Psyberloid psyllium fiber. “It is one of the seven isolated sources of fiber FDA has already determined to fit the new definition, so any finished products using it are already in compliance.”
Citing the approved health claims, Don Trouba, director of marketing, Ardent Mills, said that they “can be used on packaging, helping consumers understand the fiber benefits of certain products. Beyond the approved claims, other benefits of fiber in intact forms include adding flavor, textural or culinary appeal.” He described the company’s colored barleys — purple, blue and black — that provide a burst of color in beige-colored baked foods and snacks.
All of the fiber products from Solvaira Specialties qualify as insoluble, “so the body does not absorb them and, instead, assist in digestion by adding bulk,” said Jit Ang, executive vice-president, specialty ingredients. “Under current food regulations, our cellulose fiber qualifies to be labeled and counted as dietary fiber on the food label.”
The case for inulin
Omission of inulin from the May 2016 lists surprised most food ingredient industry observers. It is probably the most studied of all isolated dietary fibers and has well-acknowledged prebiotic properties, an important function of dietary fiber. The inulin that plays such an important role in supplementing a food’s TDF content is extracted from the roots of chicory plants.
Several inulin producers submitted comments in a joint petition to FDA.
“The review [of the joint petition] is still ongoing,” said Scott Turowski, technical sales, Sensus America, Inc., “but we fully anticipate chicory root fiber to gain approval and maintain its status as a dietary fiber.
“A great deal of clinical research has been conducted with chicory root fiber in the area of digestive health, establishing its position as a proven, prebiotic fiber,” he continued. “There is also emerging research that has shown positive indications linking chicory root fiber to improved immune function, an area that will continue to be researched. In addition, research has shown that chicory root fiber consumption can lead to a decrease in daily caloric intake, making it a potential tool in the area of weight management.”
Mr. Peters of Beneo noted another move. “Along with other European inulin producers, we have also submitted a citizen petition on inulin-type fructans.” He expected that FDA analysis would take place over the next few months.
Oliggo-Fiber chicory root fiber (inulin) made by Cosucra in Belgium is distributed by Cargill in the US and Canada. Cosucra is also a participant in the joint petition. “Given the wealth of data on chicory root inulin’s beneficial physiological effects, the major inulin producers and Cargill are confident that the additional information supplied through the citizen petition will aid in the review and approval of inulin as a dietary fiber,” said Pam Stauffer, global marketing programs manager.
Cereal grains and vegetables qualify as “intrinsic and intact” fiber when used in their whole food form and as flakes, cracked grains, flours and powders. But when further processed to extract their soluble and insoluble carbohydrates, they move into the category of “isolated or synthetic.” Many such fiber additives are offered for their ability to contribute healthy qualities to processed foods.
MGP Ingredients derives its RS4-type resistant starches Fibersym RW and FiberRite RW from wheat. The patented ingredients are based on technology developed at Kansas State University. They fit within the new definition’s requirements for isolated or synthetic non-digestible carbohydrate fiber sources having at least three monomeric units, according to Ody Maningat, PhD, vice-president of R&D and chief science officer. The company submitted a citizen petition for both. “The petition includes supporting evidence demonstrating three beneficial physiological effects in humans. First is lowering total blood cholesterol levels; second, reducing waist circumference and body fat percentage, which can reduce the risk of being overweight or obese; and third, lowering post-prandial glucose levels,” Dr. Maningat said.
Corn, another cereal grain, figures into other fiber additive choices. Soluble corn fiber did not make FDA’s initial cut. Roquette wants to change this and plans to submit for listing. “Only 3% of Americans get the minimum recommended adequate intake of fiber,” Ms. Fratus said. “Given the breadth of scientific evidence supporting the health benefits of soluble corn fiber, we anticipate FDA approval.”
Roquette turns to a variety of plants to create its food ingredients. “Peas, corn and wheat are three main crops we work with to bring ingredients like plant protein, fiber and starch to the food industry,” Ms. Beall said. “Within baking and snacks, Nutriose soluble fiber is used to impart the health benefits of dietary fiber; for sugar, calorie and fat reduction; and to provide excellent taste and texture. All Nutriose soluble fibers are made in France and are non-GMO.”
Citrus fruit — specifically its pulp and peel — are the source for Fiberstar’s portfolio of Citri-Fi fiber additives, noted Kurt Villwock, PhD, director of R&D. “The Citri-Fi 100 series qualifies as dietary fiber according to the new rules,” he said, describing them as meeting intrinsic and intact qualifications. “This product line has been derived solely from a citrus source, with citrus fiber being its only ingredient.”
He described the manufacturing process. “The orange juice pulp raw material (also known as pulp cells, juice vesicles, segment membranes and rag/core) are washed with water, heated, dewatered, sheared, dried, ground and screened to make the finished product,” Dr. Villwock said. “That is, the patented process to manufacture the dry ingredient does not use chemicals to modify or purify it, leaving the fibers essentially in their natural form.”
At Taiyo International, sunflower seed yields Sunfiber, a tasteless, colorless and odorless dietary fiber. Scott Smith, vice-president, noted that this is one of the truly low-calorie fibers, accounting for less than 2 Cal per g. “Sunfiber does fit within FDA’s recently updated definition for dietary fibers,” he said, crediting the large volume of human clinical research that has been performed with it.
There’s no doubt that consumers have a complex relationship with dietary fiber. Currently, they don’t get enough in their daily eating patterns, but it’s a food component that continues to appeal to them. The changes wrought by FDA in the wording and content of the Nutrition Facts Panel may help remedy this under-consumption.
So, even though “Team Total Dietary Fiber” faces a third-and-long situation, the players are taking the right steps through FDA’s petition and comment process to maintain the diverse supply of fiber additive ingredients.