Albion Laboratories, Inc.

In order to produce a ferrous chelate four criteria must be met: 1) the ligand must contain two functional groups which are capable of entering into covalent and coordinate covalent bonds; 2) a ring structure with the ferrous ion being the closing member of the ring must be created; 3) the chelate must be sterically possible; and 4) the chelation reaction must be energetically possible. In addition to the above, a totally nutritionally functional ferrous chelate must meet three further criteria: 1) it must have low molecular weight; 2) its stability constant must be nutritionally functional; and 3) the ligand must be metabolizable by the body. When ferrous iron is reacted with glycine and forms a bis-glycinate chelate, it meets all of the requirements of being both a chelate and being a totally nutritionally functional chelate.

This paper summarizes several studies which describe significant increases in the intestinal absorption of iron from iron amino acid chelate compared to inorganic iron salts. While these increased uptakes of iron from the amino acid chelate into mucosal tissue are highly significant, this paper also demonstrates that there is a mechanism in the mucosal tissue which controls the quantity of iron from the amino acid chelate that is transferred to the plasma. For example, the higher the hemoglobin value, the less iron transferred. When considered together these studies demonstrate that iron amino acid chelate is both a safe and effective source of iron for treatment of iron deficiencies.

Iron is estimated to be deficient in the diets of one fifth of the world's population. Iron is commonly provided as a supplemental nutrient in industrialized countries for uses of choice. In other countries of the world, it may be required as an overt addition to the diet to prevent iron deficiency. This may be accomplished through fortification of a common food. As a micronutrient, iron has a relatively narrow range of safety--whether given as a supplement or fortificant, it must be in a high enough dose to be appreciably absorbed, but low enough to avoid toxicity. This concern can be ameliorated by careful choice of the form of iron administered. A source of iron which has proven to be highly bioavailable, yet regulated by dietary need, is iron chelated with amino acids. The structural integrity and longevity of these compounds have been proven by valid chemical and instrumental tests. Proofs of safety of iron amino acid chelate in the dietary administration of iron to swine in both multigenerational and longevity studies are reported. Formal tests of toxicity utilizing ferrous bisglycinate chelate (Ferrochel) carried out in accordance to US-FDA guidelines are also summarized. Ferrochel has been demonstrated to have a No Observable Adverse Effect Level (NOAEL) of at least 500 mg per kg rat body weight, the highest dose tested. This and other results of the detailed toxicity test, as well as other tests of safety and efficacy, have resulted in the US-FDA acknowledging that this product is Generally Recognized As Safe (GRAS) under its approved conditions of use as a source of iron for food enrichment and fortification purposes.