Proliant Health and Biologicals is pleased to announce self-affirmed GRAS (Generally Recognized as Safe) status for the company’s proprietary, trademarked ingredient ImmunoLin® (bovine globulin concentrate). ImmunoLin is the first immunoglobulin concentrate ingredient available to the nutrition industry with GRAS status. After due consideration of the application, the FDA has no further questions regarding the safety of ImmunoLin® as an ingredient in food products. The response to the self-affirmation application for ImmunoLin is available at U.S. FDA/CFSAN: Agency Response Letter: GRAS Notice No. GRN 000255
The FDA issues a no-objection statement as confirmation of self-affirmed GRAS status when qualified experts agree that a substance has been adequately shown to be safe under the conditions of its intended use. “The market for food and nutrition products that support gut health and immunity are expanding rapidly. The formal approval allows the use of ImmunoLin in products requiring GRAS such as functional foods and beverages, meal replacement, and medical foods” commented Eric Weaver, Chief Scientific Officer. Mel Vandenberg, VP, Regulatory and Quality Assurance, notes the significance of the self-affirmation “Achieving GRAS status for the use of ImmunoLin in foods supports our
commitment to meeting the highest standards for ingredient safety.”
Included in the documentation of safety were published clinical studies in healthy adults and an extensive study involving 278 children 6 to 9 months of age fed a food supplement containing the important globulin proteins contained in ImmunoLin for 6 months. Together with the history of use, the lack of adverse effects in these studies affirms that the product is safe for use in foods intended for all age groups.
“ImmunoLin is a unique, functional protein source unlike any other ingredient in the nutrition industry. In the development of ImmunoLin, we strived to create a new ingredient category with high safety standards. Unlike colostrum products, which contain globulin proteins but typically do not have GRAS status, this product is manufactured in a state-of-the-art manufacturing facility that produces protein fractions to bulk pharmaceutical ingredient standards” explains Stephen Welch, CEO of Proliant Health and Biologicals.
About Proliant Health and Biologicals Proliant Health and Biologicals (http://www.proliantinc.com) is part of the Lauridsen Group Incorporated Group of companies, leading manufacturers of protein and dairy ingredients. With over $600 million in sales and 36 manufacturing locations worldwide, LGI serves the food, feed, life science, pharmaceutical, and veterinary industries with functional proteins and dairy ingredients.