ImmunoLin, which contains at least 45 percent immunoglobulin, has been available to for use in supplements as an immune-enhancer for about nine years. Following Proliant’s self-affirmed GRAS declaration, the FDA has said it has no further questions regarding the ingredient’s safety.
The ingredient is described as “particularly rich in the immunoglobulins IgG, IgM and IgA” and containing “transferring, endotoxin-biding proteins and other phase proteins that can provide additional immune support benefits”.
Making it available for use in foods looks to be a good move, according to Eric Weaver, chief scientific officer, who said: “The market for food and nutrition products that support gut health and immunity are expanding rapidly.”
As well as functional foods and beverages, he expects the ingredient to be used in meal replacements and medical foods. It may also have a role in the market for foods to meet the needs of people who cannot tolerate lactose.
In terms of efficacy, the company has conducted more than 50 studies into its immune supporting properties. It is also investigated its benefits for sufferers of irritable bowel syndrome.
With its GRAS submission Proliant submitted details of clinical studies involving adults, and one involving 278 children who were fed a food supplement containing Immunolin for 6 months.
The lack of adverse effects in these studies, together with the history of safe use, “affirm that the product is safe for use in foods intended for all age groups,” said the company.
Stephen Welch, CEO, emphasised the high safety standards and said the product is made in a state-of-the-art manufacturing facility that makes protein fractions to bulk pharmaceutical ingredient standards.