Selenium concentration upper limit in infant formulas urged by IFC.

INFANT FORMULA SELENIUM CONCENTRATION UPPER LIMIT URGED by the Infant Formula Council at a public meeting held by the Life Sciences Research Office of the Federation of American Societies for Experimental Biology on May 31. The Infant Formula Council, which consists of three formula manufacturers -- Wyeth-Ayerst, Nestle and Abbott Labs -- advocated a maximum level of added selenium of 6 mcg/100 kcal in infant formulas.

Despite the fact that the Infant Formula Act does not require fortification with selenium, most U.S. infant formulas include the nutrient, making a minimum content requirement unnecessary, in IFC's opinion. Even without fortification, IFC noted, infant formulas have inherent selenium levels of about 2-15 mcg/L. "The minimum intake required to prevent selenium deficiency is probably about 3 mcg/day, a figure calculated from data obtained in low-selenium areas of China," the industry group said.

FASEB, at FDA's request, is investigating the current infant formula specifications and plans to make specific recommendations to the agency by next March ("The Tan Sheet" March 11, p. 10). The formula specs were last modified in 1985; since that time the National Academy of Sciences has published the tenth edition of the Recommended Dietary Allowances, which set an RDA for selenium of 10 mcg, and estimated safe and adequate daily intakes for three nutrients -- molybdenum, chromium and fluoride.

A specific level was not set for molybdenum intake for children; the recommended amount is based on the 75-250 mcg/day intake recommended for adults, extrapolated for a child's body weight. For chromium, the RDAs state that a varied diet will meet the needs of children for the nutrient, and tentatively recommended 50-200 mcg/day intake for adults. For fluoride, the RDAs recommend .1-1 mg/day in the first year of life .5-1.5 mg/day and in the second and third years. The guidelines set a maximum level of 2.5 mg/day for children.

IFC recommended against establishing minimum and maximum levels for molybdenum, chromium and fluoride in infant formulas. Molybdenum and chromium both appear to be essential nutrients for infants, IFC said, but "there are limited data on which to base precise requirements." IFC noted that there are no reported incidences of deficiency of either nutrient in infants.

IFC noted that "the inherent...content of most infant formulas appears to provide sufficient molybdenum to result in...intakes in the current Estimated Safe and Adequate Daily Dietary Intake [ESADDI] ranges (15 to 30 mcg/100 kcal). IFC therefore "strongly recommends" that "no minimum or maximum be established." The group stipulated that if a maximum should become necessary, the recommended level would be 6 mcg/100 kcal and would apply to added molybdenum only. Infant formulas currently are not fortified with the nutrient.

The formula manufacturers suggested that no action be taken on chromium. They pointed out that breast-fed infants do not meet the ESADDI of 10 mcg/day and there is no data on its bioavailability from human milk or formulas. Commercial infant formulas contain between 5.2-23.4 mcg/L. If the establishment of a maximum is considered to be necessary, IFC recommended a level of 100 mcg/100 kcal of added chromium.

Levels of fluoride in infant formulas "should remain consistent and as low as possible," IFC cautioned, because fluorosis may occur if a child ingests as little as 40 mcg/kg/day. The source of most of the fluoride found in infant formulas is the water used in manufacturing, the fluoride levels of which are regulated by the Environmental Protection Agency and typically range from nearly 0 ppm to 4 ppm with few areas exceeding 2 ppm.

"There would appear to be little reason to regulate the level of fluoride in infant formula if the water used to reconstitute concentrated liquid and powdered formula is not similarly regulated," IFC stated. "Manufacturers accept the responsibility to provide information on fluoride content of infant formulas to health care professionals," the industry group noted.

The infant formula makers did not recommend minimum or maximum levels for taurine, which is included in infant formulas at levels approximating human milk. If a maximum level were to be set, IFC recommended that it be 20 mg/100 kcal added taurine, the upper level found in human milk. A minimum level should be at the low end of breastmilk levels, i.e., 4 mg/100 kcal, IFC said.

Because oral carnitine intake, "even at relatively high levels, is considered relatively safe," IFC said, no upper or minimum levels are needed. If a minimum level must be set, however, the group believes that a lower limit similar to that of human milk of about 1 mg/100 kcal "seems reasonable."