The Infant Formula Task Force of the Food Advisory Committee of the Food and Drug Administration met on November 18 and 19 to discuss the scientific issues and principles involved in assessing and evaluating whether a “new” infant formula supports normal physical growth in infants when consumed as a sole source of nutrition. The Infant Formula Act of 1980 and the 1986 Amendments established quality factors, that is, factors necessary to demonstrate that the infant formula, as prepared for market, provides nutrients in a form that are bioavailable and safe and that support healthy growth when fed as a sole source of nutrition. In providing for quality factors, Congress recognized a need to ensure that each infant formula product contains an adequate amount of each nutrient in a form that can be digested, absorbed and utilized to meet the infant’s physiological needs.
The Infant Formula Task Force considered two issues: (1) criteria for the adequate evaluation of normal physical growth during the first six months as an indicator of the nutritional adequacy of new infant formulas; and (2) types of changes in infant formulas that should be accompanied by a clinical study in order to provide assurances of normal physical growth.
The Weston A. Price Foundation submitted written testimony by Sally Fallon delineating the high levels of isoflavones in soy infant formula and their detrimental health impact on infants. Her testimony urged the Task Force to remove soy-based formula from the market and develop a meat-based formula in its stead. All Task Force members, guest speakers and the audience received copies of our testimony, which included a list of over 100 studies showing adverse effects of isoflavones.
While the Task Force was not charged with reviewing the health impact of isoflavones and soy as a nutrient source for infants, there was indication throughout the proceedings that the FDA is concerned. In its Background Paper for these meetings, the FDA listed the “processing of soy to remove isoflavones” as an example of a change to a nutrient ingredient that might require a clinical growth study.
The Task Force asked a series of guest speakers to speak to the two questions posed for review. W. Cameron Chumlea, PhD, Department of Community Health and Pediatrics, Wright State University School of Medicine discussed the most useful measures of infant growth, namely weight, recumbent length and head circumference. Laurence M. Grummer-Strawn, PhD, Maternal and Child Nutrition Branch, Centers for Disease Control and Prevention (CDC) presented new revised CDC growth charts. Samuel J. Fomon, MD, Department of Pediatrics, College of Medicine, University of Iowa discussed some of the criteria and problems in clinical studies. (Dr. Fomon played a critical role in the development of soy infant formula.) Duane A. Benton, PhD, retired from Ross Products Division, Abbott Laboratories, also focused on measurements of growth.
The emphasis on using early growth as a measure of formula effectiveness actually works in the favor of soy formula, because growth is usually normal with soy. The adverse effects show up in other ways—from learning disabilities to endocrine disruption to thyroid problems—and often not until adolescence.
Industry representatives claimed that the US is coming closer to the Healthy People 2010 goals for breastfeeding rates (75 percent breast fed at birth, 50 percent continuation at six months, and 25 percent at one year). This fact was contradicted by Barbara Heiser, RN and executive director of the National Alliance for Breastfeeding Advocacy, who stated that infant formula manufacturers have engaged in actions that have driven down exclusive breastfeeding rates in the US to approximately 47 percent in hospitals and only 25 percent at six months. She was highly critical of the practice of giving out free formula in hospitals.
The Task Force plans to continue evaluating Federal infant formula regulations and manufacturer procedures with another meeting in the spring of 2003 and we will submit further testimony at that time. We also plan to testify before Congress in 2003 during the reauthorization of the Child Nutrition Act.
Other recent activities include participation as an exhibitor at the National Vaccine Information Center’s annual conference and attendance at a dinner given by the National Foundation for Alternative Medicine.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly magazine of the Weston A. Price Foundation, Winter 2002.