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Innovation in the fiber market is alive and kicking again now that FDA has accepted citizen petitions to classify inulin and other non-digestible carbohydrates as legal dietary fibers.
Innovation in the fiber market is alive and kicking again now that FDA has accepted citizen petitions to classify inulin and other non-digestible carbohydrates as legal dietary fibers. In June, the agency said it will bring eight additional fibers, including inulin and polydextrose, within the legal definition of a dietary fiber, allowing these fibers to contribute to the total fiber listing on the Nutrition Facts label. Prior to that, companies selling or formulating with those fiber ingredients had waited over two years for FDA’s decision, debating whether or not they might eventually need to reformulate with other fibers in order to continue making a fiber claim. FDA’s mission to finally establish a legal definition for dietary fiber, and to determine which fibers meet that definition, is part of the agency’s overall revision of the Nutrition Facts label, which goes into full effect beginning in 2020.
Andrew Estal, director, customer technical service, Americas region, at Beneo (Manheim, Germany), said innovation around the fibers in question had ceased as companies waited for FDA’s verdict. This included a pause in innovation around improving scientific methods to test and quantify fiber content, he said. (More information to come on this in a subsequent Nutritional Outlook article.)
“Development of everything stopped dead for two-and-a-half years until the FDA decided what was going to be what,” Estal told Nutritional Outlook at the Institute of Food Technologists’ Annual Meeting and Food Expo in Chicago in July. “Our customers didn’t know what they were going to do, so a lot of them just kind of stopped new developments.”
He said progress on improving test methods also stopped “because if nothing was going to be fiber, there was no need for a method improvement.” (Beneo’s Orafti chicory root inulin and oligofructose were among the fibers whose petitions FDA recently approved.)
Mervyn L. de Souza, PhD, vice president, health and wellness, global R&D, innovation and commercial development, for Tate & Lyle (Hoffman Estates, IL), said that Tate & Lyle’s clients were relieved to hear FDA’s positive decision on the company’s Promitor soluble corn fiber (a resistant maltodextrin) and Sta-Lite polydextrose. (Tate & Lyle’s PromOat oat beta-glucan was already included in FDA’s initial fiber definition.)
“We’re obviously really, really excited about the FDA ruling, with our fiber portfolio-both our soluble corn fiber as well as our Sta-Lite polydextrose-both being included as dietary fibers,” said de Souza. “We weren’t surprised, but we were glad to have the ruling so that now that it’s out there, our customers can benefit from it. A lot of customers were on the fence because they wouldn’t have been able to make dietary fiber claims if the ingredients weren’t going to be included [in FDA’s fiber definition].”
FDA has so far not ruled positively on outstanding citizen petitions for two fibers: isomaltooligosaccharide (IMO) and xylooligosaccharide (XOS). Companies who had been using these two fibers, or any other fibers so far not on FDA’s official fiber list, may now be looking to reformulate, de Souza said. “A lot of customers are looking to reformulate as they’re looking to get IMO out and the dietary fibers in,” de Souza told Nutritional Outlook. In fact, Tate & Lyle is starting to get business requests from some of those customers, he said. “We’re actively engaged with a lot of customers who were using IMO,” he said.
The prospect of replacing certain fibers was often unwelcome, as some fibers are not easy to find comparable replacements for, Estal said. Of some Beneo customers, he said, “They looked at existing products, and none of the fibers that were approved would work because they were all highly viscous fibers. They would have turned the product into a viscous mess at the level you’d need to use them at in order to get a claim.”
So, these companies “were out in limbo land for the last two-and-a-half years,” he said, waiting to make the decision to reformulate.
Denisse Colindres, manager of nutrition communication, North America, Beneo, told Nutritional Outlook that Beneo had been fairly confident that FDA would ultimately include Beneo’s Orafti chicory root inulin and oligofructose in its definition, largely due to the body of scientific evidence Beneo has to support those ingredients. In setting the new fiber definition, FDA said that in order for a fiber to be approved as a dietary fiber, fiber manufacturers must be able to prove that the fiber provides a physiological benefit in humans.
“We were confident because of the science that we have and [because] we’ve been pioneering in the field of prebiotic and fiber research since the 1980s,” Colindres said. “We have so many clinical studies: 25 human intervention studies on prebiotics, all of the studies on aiding calcium absorption, and all of the studies on weight management.”
Now, Beneo’s Estal said, formulators can go back to business as usual, using the fibers as they originally had been. “They can continue to label it as dietary fiber as it was before. We are good to go. Customers are very happy now,” he said.