Prebiotic wheat bran extract gets FDA GRAS no objection

By Stephen Daniells

- Last updated on GMT

The Food and Drug Administration (FDA) has issued a letter of no objection for the wheat bran extract Brana Vita, giving manufacturers a new prebiotic for a range of food and beverage products.

The wheat bran extract is a rich source of arabinoxylan oligosaccharides, compounds with the potential to stimulate the growth of beneficial intestinal bacteria such as bifidobacteria. The ingredient also contains ferulic acid, a polyphenol with antioxidant effect which is bound to the fibre fraction.

“With this approval, the regulatory path for commercialisation of our ingredient in the U.S.A. is cleared,” ​said Willem Broekaert, chief technology officer for Fugeia, the Belgian company behind the ingredient. “It is an important step in our overall strategy towards achieving regulatory clearance in all major global markets, as authorities in several countries carefully consider the GRAS status”​ added Broekaert.

Specifically, Dirk Hoegaerts, PhD, director of business development, Fugeia, told that the wheat bran extract can be “applied in a broad category of food and beverage products: Bakery, breakfast cereals, bars, yoghurts, dairy drinks, fruit juices, and cookies”​.

The ingredient

Fugeia began life as a spin-off from the Katholieke Universiteit Leuven (K.U. Leuven), and the University College Sint-Lieven (KaHo Sint-Lieven). In 2008 UK-based ingredients giant Tate & Lyle dipped into its independent €30+m venture capital fund to the tune of €3.5m to partner with Fugeia to research the gut health and antioxidant properties of bran fibres.

Fugeia has been pursuing a similar strategy to other prebiotic powerhouses like Beneo-Orafti, with the development of robust science an integral part of the business strategy.

The FDA no objection was heralded as an important milestone for the development of products for the US market by Herman Van Mellaert, the company’s CEO. “Food companies want to differentiate their products by delivering great taste and specific health benefits to consumers. With Brana Vita we offer them a natural ingredient from a trusted origin to achieve these goals. The results achieved across a wide range of food categories have been very exciting. Our partners also value the body of scientific evidence that we have created to back up a high-impact commercial launch. ”

The appliance of science

In addition to the potential gut health and antioxidant properties, Dr Hoegaerts added that the ingredient has excellent technical properties, including acid and heat stability, making it readily applicable in a broad range of food applications. “Acid stability is a main problem with the popular fructo-oligosaccharides,”​ he added.

Dr Hoegaerts said that prebiotic dose of the ingredient is in the same range as established prebiotics like inulin and fructo-oligosaccharides (FOS), with modern recommendations for these ingredients currently between five and eight grams per day.

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