In a recent document, FDA outlined its thinking on the subject of purified and isolated and/or synthetic carbohydrates marketed as dietary fibers. Much R&D development in the food and dietary supplement world has gone into these fibers, which in many cases can have the upside of extending the benefits of dietary fiber to new food and supplement matrices, where the addition of bran from various grains would be inappropriate, either from the standpoint of taste or from a functional property point of view. The addition of fiber to beverages is one example.
Five fibers mentioned
In the memorandum issued in early May, FDA singled out five types of isolated fibers that it believes have the clinical evidence for physiological benefit to back a dietary fiber type of claim. FDA said that cellulose, guar gum, locust bean gum, pectin and hydroxypropylmethylcellulose met this standard.
Scott Smith, vice president of sales and marketing at Taiyo International, said his company went the extra step to get a bit more assurance on its Sunfiber ingredient. Sunfiber is a highly purified, extensively researched derivative of the guar plant. Smith said dissolves easily and fully in water and is easy for consumers to use and for formulators to work with. It is sold as both a standalone dietary supplement and is present in various other finished products. Smith said Taiyo queried FDA to make sure that the agency agreed that Sunfiber fit inside of its definition of “guar gum.”
“Sunfiber is partially hydrolyzed guar gum. It was not clear to us that Sunfiber was within that definition. FDA confirmed that for us on August 19th,” Smith said.
The fact that FDA singled out the five purified fibers does not mean that others not yet mentioned, such as inulin, can’t clear the bar set by the agency. But Smith said the developers of those ingredients will have to submit their evidence for the physiological benefits of their products within the next two years to the agency via a process that has yet to be established. It could provide a market advantage for those fibers already on the list, he said.
“The five carbohydrates that FDA itself considers as fibers are grandfathered in. All the other fibers will have to submit clinical evidence. While many of the fibers will be able to do that there is a limited period of time and we think FDA will be swamped with applications during that period,” Smith said.
“We’re hoping that a lot of companies that are out there that might have considered SunFiber in the past but might have gone with a less expensive alternative might now reconsider,” he said.