To help clear up possible questions about the recent Food and Drug Administration (FDA) approved soy health claim as it may relate to adult nutritional formulas and infant formulas, the International Formula Council issued the following statement:
“As the association representing the manufacturers and marketers of formulated nutrition products including adult nutritional formulas and infant formulas, the International Formula Council supports the recent FDA approval of a health claim for soy protein and reduced risk of coronary heart disease (CHD). Because some adult nutritional formulas and some infant formulas contain soy protein, questions have been raised whether these products are permitted to carry a soy health claim. To state the claim, a product must contain at least 6.25 grams of soy protein per serving. It must also be low in saturated fat, cholesterol and (in most cases) total fat. If an adult nutritional formula meets these requirements, it is permitted to carry the following health claim on its label: ’25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.’
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“Although some infant formulas contain significant amounts of soy protein, the amount contained in an 8-fl-oz bottle is less than the amount required for the soy health claim. Additionally, because of differences in the nutritional needs of infants and adults, the Nutrition Labeling and Education Act regulations do not authorize health claims on foods intended for infants and toddlers less than 2 years of age, unless the regulation for a particular claim specifies its applicability to these age groups. To date, none of the FDA-authorized health claims regulations, including the soy health claim, has specified applicability to infant formulas.
“Soy infant formulas have been fed to millions of infants for over 60 years. The American Academy of Pediatrics Committee on Nutrition recommends that ‘in term infants whose nutritional needs are not being met from maternal breast milk or cow milk-based formulas, isolated soy protein- based formulas are safe and effective alternatives to provide appropriate nutrition for normal growth and development.’
“For further information on adult nutritional formulas and infant formulas, or for referral to appropriate experts in adult or pediatric nutrition, contact the International Formula Council at 404-252-3663.”
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