Iron Study in Mice

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Iron Study in Mice

International Formula Council* (IFC) Statement Regarding the Iron Study in Mice Conducted by the Buck Institute for Age Research

Overall Comment:
The study by the Buck Institute is an iron study, not an infant formula study, and it is not relevant to infant feeding.  The extremely high doses of iron fed to the mice in this study are at least 60 times as much as that consumed in iron-fortified infant formulas on a weight-adjusted basis, and the form of iron is not the iron used in infant formula.  Iron-fortified infant formula is considered a major U.S. public health policy success, having virtually wiped out the lifelong consequences of iron-deficiency anemia.  The American Academy of Pediatrics (AAP) continues to recommend iron-fortified infant formula as the only safe and nutritious alternative to mother's milk.

Specific Points:

• The American Academy of Pediatrics states that breastfeeding is the best source of nutrition for infants, but that those infants who are not breastfed or are partially breastfed should receive an iron-fortified infant formula -- the only recommended safe alternative to mother's milk
• Extensive research in infants (as opposed to animals) has addressed the potential health effects of iron-containing formula, and has proven its safety
• The iron fortification of infant formulas is considered a huge public health policy success in terms of decreasing rates of iron-deficiency anemia (the most common nutritional deficiency in infants)
• The amounts of iron in infant formulas are closely regulated by the U.S. Food and Drug Administration and in accordance with recommendations of the AAP
• A healthy baby born after a normal, full-term pregnancy generally has enough iron stored in the body to meet iron requirements for the first 4 to 6 months of life. Before this iron is depleted, iron should be supplied in the diet as research suggests iron deficiency in early childhood may lead to long–term changes in behavior that may not be reversed even with iron supplementation sufficient to correct the anemia;
• Cow's milk (which is an inappropriate alternative to mother's milk but might be considered by mothers reading about this study) is a poor source of iron. The AAP emphatically states that ordinary cow's milk is not suitable for infants under one year of age.

Background on Iron and Iron-Fortified Infant Formulas:
Iron is important in an infant's diet because of its role in the formation of hemoglobin, which carries oxygen through the blood to the rapidly growing cells and tissues. Iron is also essential for proper mental and psychomotor development. An adequate source of iron is needed to prevent iron deficiency anemia, which may affect the behavioral and intellectual development of infants.

International Formula Council (IFC) members support the American Academy of Pediatrics' position:
"Exclusive breastfeeding is ideal nutrition and sufficient to support optimal growth and development for approximately the first 6 months after birth. Infants weaned before 12 months of age should not receive cow’s milk feedings but should receive iron-fortified infant formula."

The question of how much iron should be in infant formula has been a subject of research and discussion for more than 30 years. Various expert advisory groups have recommended different levels of iron. In the United States, all formulas are manufactured in strict compliance with established U.S. Food and Drug Administration regulations, which specify allowable levels for nutrients, including iron. These FDA regulations have set the allowable range for low iron formulas from 1 mg/L up to 6.7 mg/L of iron, and iron-fortified formulas from 6.7 mg/L up to 20 mg/L of iron.

On July 6, 1999, AAP's Committee on Nutrition issued a recommendation to raise the minimum level of iron in any infant formula to 4.0 mg/L. IFC members concurred with this new recommendation. Further, it is our understanding that U.S. infant formula manufacturers have independently determined all infant formulas in the U.S. are consistent with AAP's recommended minimum level of iron.

Finally, it is important to note that infants fed formulas within FDA's low iron range will still require additional sources of iron in their diet. All low iron formula labels will continue to carry this message, as required by FDA regulations.

*IFC is an international association of manufacturers and marketers of formulated nutrition products (e.g., infant formulas and adult nutritionals) whose members are predominantly based in North America. IFC members include all U.S. manufacturers: Mead Johnson Nutrition; Nestlé Infant Nutrition; PBM Products; Abbott Nutrition; Solus Products; and Wyeth Nutrition.