Dietary fiber helps maintain moisture levels in gluten-free baked foods.
From intrinsic to synthetic

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 The draft guidance FDA published on Nov. 22 described how it plans to evaluate the science supporting the dietary role claimed by isolated or synthetic non-digestible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said Jon Peters, president, Beneo, Inc. “FDA is now requesting additional scientific data and information, including unpublished studies.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.”

Read on for more information on inulin.