You could hear the collective sigh of relief among ingredient suppliers and food processors when the FDA in June approved a list of ingredients as dietary fibers. And the agency's decision came just in time for some marketing at the July IFT Food Expo.
Most of the ingredients had long been marketed as dietary fibers – and labeled as such by food processors. But all that existing work was called into question when the FDA in 2016 announced it would review the many ingredients that claimed to be dietary fiber, part of the agency's ramp-up to the new Nutrition Facts label final rule.
FDA’s initial ruling was that only certain naturally occurring dietary fibers such as those found in fruits, vegetables and whole grains, and isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health, could be declared “Dietary Fiber" on food labels. The latter group included beta-glucan, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropyl methylcelluose.
Suppliers of all other ingredients claiming to be fibers had to supply the FDA with scientific evidence showing the ingredient had "physiological effect that is beneficial to human health." There began a two-year process and a two-year wait.
FDA's June announcement said the eight new fibers 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; and resistant maltodextrin/dextrin.
"As part of those efforts [to update nutrition information overall], the FDA issued decisions on citizen petitions regarding additional dietary fibers," says FDA Commissioner Scott Gottlieb. "We also issued a guidance that will allow food manufacturers to count these fibers when calculating the total amount of fiber per serving to declare on the Nutrition Facts label. They can also be counted as fiber on the Supplement Facts label."
"We were 99 percent sure we would get approved, but still …" said a spokesperson for Sensus (www.inspiredbyinulin.com), which petitioned for chicory-based inulin. Speaking at July's IFT Food Expo, she said the small group of inulin producers collaborated on sending clinical studies to FDA.
"Inulin is the most-studied fiber and, it turns out, the second most-studied ingredient, behind only vitamins," the Sensus spokesperson said. Sensus' Frutafit and Frutalose chicory root fibers were confirmed.
Likewise, Cosucra Group (www.cosucra.com), another global producer of inulin, received certification for its Fibrulin fructans, sold in the U.S. under the name Oliggo-Fiber.
Tate & Lyle's (www.tateandlyle.com) Promitor Soluble Fiber (a resistant maltodextrin), and Sta-Lite Polydextrose also were certified. The company's PromOat Beta Glucan immediately qualified under the new definition because of a pre-existing FDA authorized health claim for oat beta glucan.
Oat hull fiber had to wait for the second round of certifications, and that's where Grain Millers’ (www.grainmillers.com) oat fiber fell, under the category “Mixed Plant Cell Wall Fiber."
"Food producers can continue to describe Nutriose as fiber in the nutritional information of their products and the level of fiber can be used as a basis to support the fiber nutrient content claims," was the message from Roquette (www.roquette.com). As for labeling, "The common or usual names recognized by the FDA for the resistant maltodextrin/dextrin listing include 'soluble corn fiber' and 'soluble wheat fiber.'" In addition to Nutriose, Roquette’s Pea Fiber I50M, produced from yellow peas, also was recognized as fiber under the category of “mixed plant cell wall fibers.”
Another resistant maltodextrin is Fibersol from the ADM/Matsutani joint venture (www.fibersol.com).
MGP (www.mgpingredients.com) "continues to work directly with FDA on the final approval of Fibersym and has two new human clinical studies near completion in 2018," the company says. "These new studies will confirm the consistency of results of two previous studies the FDA previously recognized for Fibersym as a dietary fiber.”
Solvaira Specialties (solvaira.com) formerly was known as International Fiber Corp., and as a result markets a wide variety of fibers. "With the recent FDA clarification on dietary fibers, all our fibers are now approved as dietary fibers in USA," says a spokesman.
So are all of the products from InterFiber (interfiber.com), most of which fall under the "mixed plant cell wall fibers" category.
Three Ingredion (www.ingredion.us/) fibers met the new definition: Nutraflora short-chain fructooligosaccharide (an inulin-type fructan), Hi-Maize 260 high-amylose maize (a resistant starch 2) and Bioligo GL 5700 GOS (a galactooligosaccharide).
As a specialist in hydrocolloids, especially marine-origin ones, Ingredients Solutions Inc. (www.isi.us.com) does not market its Nalgin products as a fiber. But Nalgin and all alginates are one of new fiber additions.
"The most important aspects of this approval are the obvious health claims as well as reduced caloric values of those approved products," says Kevin Johndro, Ingredients Solutions' R&D director. "For caloric determinations, grams of soluble non-digestible carbohydrate for these will be x2 instead of the x4 formula used for all other carbohydrate calculations. ISI will be making changes to nutritionals of affected products in our portfolio to reflect these updates."
"We're happy with the guidance, which was important to enable [food] products to remain on the market," Cathy Peterson, regulatory and commercialization manager for J. Rettenmaier USA (www.jrsusa.com), said at the IFT Expo. All of Rettenmaier's fibers also made the cut. "There remains a large fiber gap in the U.S., and we need more ways to solve it rather than fewer ways."