The ingredient has been available in the European Union for the last five years and is expected to enjoy similar success on the US market.
Lipid Nutrition, a division of IOI-owned lipids specialist Loders Croklaan, was informed by FDA that based on the information it provided, as well as other information available to the agency, the ingredient can be classified GRAS under the intended conditions of use.
"This notice is a positive step in the direction to getting Betapol approved for its intended use in infant formulas by the FDA," said Katinka Abbenbroek, global marketing manager for Lipid Nutrition. "We expect the US infant formula market to adopt Betapol's intended use just as the European market has."
The Betapol 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 nutritional and health benefits to babies born prematurely and at term, according to Lipid Nutrition.
The company says Betapol enhances energy and calcium absorption and improves stool consistency, reducing the incidence of constipation, increasing energy supply and supporting normal bone growth and development in formula-fed infants.
Lipid Nutrition also makes Clarinol brand CLA for weight management, Marinol fish oil products for heart health, Safflorin isomerized safflower oil for immune health and Membranol for brain health.