How does the US Food and Drug Administration (FDA) investigate the safety of a food additive to allow it to have the very valuable and reassuring designation, Generally Recognized As Safe (GRAS)?

The agency doesn’t investigate. It looks at documents presented by manufacturers who wish to self-affirm their products as GRAS. The harried FDA personnel then say “OK” if nothing seems obviously hazardous.

The FDA this month, for example, gave the “OK” to Proliant Health and Biologicals, a company founded in 1998 to develop bioactive proteins and peptides for the nutraceutical and pharmaceutical markets to declare its Immunolin GRAS.

What is Immunolin? It is a highly concentrated protein fraction derived from spray dried cow’s blood collected at slaughterhouses. It is filtered; the plasma is removed, and then dried to a powder. Immunolin contains immunoglobulins IgA, IgG and IgM. The basic functions of immunoglobulins are to shore up the immune system. I searched back several years and found the immunolin was first suggested for irritable bowel disease. Then it was promoted for lowering cholesterol. Now it is being touted as protecting us against viruses, bacteria and other immunity suppressing ills and is being offered as a dietary supplement. Because it is a health supplement, proof that it is effective and has no harmful properties, is less exacting than for a medication.

Now immunolin is probably perfectly harmless. Whether is worth $12 for a five-day supply of the drink or $16 for 60 tablets, is up the consumer. I checked and I found a few reports of its beneficial use in alternative and nutrition magazines. There was nothing I could find in the scientific literature. The only double blind study I did find in which soy was used as the control was conducted by the company, itself.

According to some traditional physicians, giving proteins by mouth is not very effective since antibody proteins quickly disintegrate by chemical action in the stomach.

You may be interested in determining for yourself the worth of immunolin. Check: http://www.proliantinc.com

In the meantime, I am interested and will continue checking  the increasing number of new self-affirmed GRAS food additives for my book, A Consumer’s Dictionary of Food Additives (Three Rivers/Crown). Keep tuned.