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FDA clears Pfizer, BENEO to use Orafti P95 in infant formula

FDA clears Pfizer, BENEO to use Orafti P95 in infant formula

FDA raised no questions regarding the safety of BENEO's oligofructose in milk-based infant formula at a maximum level of 3 grams per liter.

A communication from the U.S. Food and Drug Administration (FDA) to Pfizer Nutrition and BENEO acknowledges that Orafti®P95 is safe for addition to milk-based term infant formula powder.

The FDA agreed with the Generally Recognized as Safe (GRAS) determination jointly submitted by Pfizer Nutrition and BENEO. Orafti®P95, manufactured by BENEO, is a soluble dietary fiber. It is commonly referred to as oligofructose, a fructan derived from the chicory root plant. Fructans are well-known for both prebiotic and fiber effects. Ingestion of oligofructose can provide a prebiotic effect by selectively stimulating the growth of natural beneficial gut microflora. It can also act as fiber, resulting in softer stool consistency.

“Pfizer Nutrition’s research efforts are focused on providing nutrients that provide functional benefits,” stated Mike Russomano, chief commercial, research and development officer, Pfizer Nutrition. “The independent review panel’s thorough assessment, coupled with several publications in peer-reviewed journals, further validates the importance of our pediatric nutrition research efforts.”

The GRAS determination jointly submitted by Pfizer Nutrition and BENEO was based on the evaluation by a panel of independent scientific experts qualified to review the safety of food and food ingredients. The panel evaluated all information pertinent to its application and concluded that the intended use of Orafti®P95 is GRAS based on scientific procedures. The FDA raised no questions regarding the safe use of Orafti®P95 in milk-based term infant formula at a maximum level of 3 grams per liter (g/L) as consumed.

BENEO’s prebiotic fibers are of 100 percent natural plant origin and are used widely in the food, beverage and nutritional industries worldwide for their prebiotic effect, for their contribution to digestive health and for great tasting fiber enrichment.

“This FDA letter of no questions for the use of Orafti® P95 in the sensitive population group, infants, is an important step forward,” says Anke Sentko, vice president of regulatory affairs and nutrition communication at BENEO. “The FDA response goes hand-in-hand with evaluations conducted previously by other authorities in Australia/New Zealand, China and Russia for the use of Orafti® P95 in infant formulas. This will further contribute to the confidence in the safe use of this ingredient in infant formulas worldwide.”

Pfizer Nutrition and BENEO jointly submitted GRAS Notice No. GRN 000392 to the FDA in July 2011.

About Pfizer Nutrition
Pfizer Nutrition, formerly Wyeth Nutrition, is part of Pfizer Inc. Pfizer Nutrition supports the company’s mission to improve health and well-being at every stage of life, bringing breadth and depth of consumer and scientific insight to new populations and new markets around the world. Pfizer Nutrition brings together nearly a century of experience in which the company has leveraged clinical rigor, scientific research, world class manufacturing and product safety standards to drive scientifically sound solutions that offer parents confidence, help nourish children and support their healthy futures. We develop premium-quality nutritional products that are scientifically-designed to meet the needs of infants and young children, as well as pregnant and lactating mothers.

BENEO offers functional ingredients derived from chicory roots, beet sugar, rice and wheat. BENEO is the ideal partner to help improve a product in its nutritional and technological characteristics. Key nutritional benefits include ‘less fat’, ‘less sugar’, ‘less calories’, ‘added fiber’, ‘gluten-free’ and dairy alternatives as well as energy management, digestive, bone and dental health. Key technological benefits focus on taste and texture improvements. Through a unique chain of expertise, including the BENEO-Institute that provides decisive insights into nutrition science and legislation, and the BENEO-Technology Center that consults in application technology, BENEO actively supports customers in the development of more balanced and healthy food products.

BENEO is a division of the Südzucker Group, employs almost 900 people and has production units in Belgium, Chile, Germany and Italy.

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