Wormerveer, The Netherlands, February 6, 2004 – Lipid Nutrition, a division of Loders Croklaan and a global leader in lipid-based health ingredients, announces that the U.S. Food and Drug Administration (FDA) has no questions at this time about the company's GRAS determination of BetapolTM.
The Department of Health and Human Services of the FDA informed the company that based on the information provided by Lipid Nutrition, as well as other information available to the FDA, the agency has no questions at this time regarding Lipid Nutrition’s conclusion that BetapolTM is GRAS under the intended conditions of use. BetapolTM is intended for use in infant formulas as a human milk fat substitute.
“This notice is a positive step in the direction to getting Betapol™ approved for use in infant formulas by the FDA,” said Katinka Abbenbroek, Global Marketing Manager, for Lipid Nutrition. “We expect the U.S. infant formula market to adopt Betapol’s use just as the European market has.”
The BetapolTM brand is a novel infant formula fat that closely mimics the structure of human milk fat. It has been shown in scientific studies to offer unique nutritional and health benefits to babies born prematurely and at term. Betapol™ improves energy supply to the infant as well as improving calcium uptake and preventing constipation.
Lipid Nutrition, a division of Loders Croklaan, is a global leader in the supply of lipid-based ingredients (nutritionally active components of oils and fats). The company offers a variety of branded products that have resulted from their intensive lipid research program, including ClarinolTM, CLA (for weight management), Marinol™ fish oil products (for heart health), Safflorin™ isomerized safflower oil (for immune health) and Membranol™ (for brain health).
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