October 22, 2012
MADISON, N.J.The self-affirmed GRAS (generally recognized as safe) determination submitted jointly by Pfizer and BENEO for its Orafti®p95 oligofructose fiber received no objection from FDA, clearing the way for its use in infant formula. The submission demonstrated the safe use of this chicory root fructan ingredient at a maximum level of 3g/L in milk-based term infant formula. The fructan offers digestive benefits as a prebiotic, feeding growth healthy gut microflora, and as a fiber, improving stool consistency.
"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," said Anke Sentko, VP of regulatory affairs & nutrition communication at BENEO, noting the GRA confirmation is a step forward for the sensitive infant population. "This will further contribute to the confidence in the safe use of this ingredient in infant formulas worldwide."
A panel of independent scientific experts in food and food ingredient safety evaluated the science and data on Orafti®p95 for safe use in the infant formula and affirmed the ingredient as GRAS for this application. Mike Russomano, chief commercial research & development officer for Pfizer Nutrition, said, "The independent review panels thorough assessment, coupled with several publications in peer-reviewed journals, further validates the importance of our pediatric nutrition research efforts."
For more information, including a comparison of GRAS and NDI (new dietary ingredient) notifications, check out the education session, GRAS or NDI Notification: Selecting a regulatory Pathway, scheduled for Nov. 7, 2 pm to 2:50 pm, at Supplyside West in Las Vegas. Speakers include Richard Kraska and Robert S. McQuate, Ph.D., from GRAS Associates, and Marc S. Ullman, Esq., from Ullman, Shapiro & Ullman LLP.
McQuate also offers his outlineon the roadmap for compliance with FDA's operating procedures for GRAS determinations in a Supplyside Store video.
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