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Upper Limits of Vitamin A in Infant Formulas, With Some Comments on Vitamin K^1,2,

Department of Biochemistry and Biophysics, Iowa State University, Ames, IA 50011

Current Food and Drug Administration (FDA)—approved levels of adequacy and of upper limits in infant formulas for vitamin A are 250 and 750 KI per 100 kcal, repsectively. The level of adequacy is generous relative to need. Because vitamin A toxicity has been noted in infants at intakes of 2,100 KI per 100 kcal, an upper limit might well be selected in the range of 750–1,000 KI per 100 kcal for healthy infants. Some children and adults, however, are intolerant of relatively low intakes. The current FDA-approved adequacy level for vitamin K is 4 µg per 100 kcal, which also is generous relative to need. An upper limit has not previously been set. Neither single intramuscular doses of phylloquinone that are 100 times the RDA (RDI) for infants nor diets that contain 10–20 times the RDA (RDI) for adults show any adverse effects. Some allergic reactions to injected vitamin K have been reported, however, and menadione, even in low doses, shows significant toxicity in neonates. Thus, although toxicity to phylloquinone is unlikely, it has been suggested that the upper limit of phylloquinone in infant formulas be set at 20 µg per 100 kcal, primarily to discourage nutritionally unwarranted supplementation.

KEY WORDS: • vitamin A • retinol • adequate level • upper limit • infant formulas • toxicity • intolerance • vitamin K • phylloquinone • menadione

¹ This paper was presented at a symposium, "Upper Limits of Nutrients in Infant Formulas," November 7–8, 1988, in Iowa City, IA.

² Supported in part by NIH DK-32793 and USDA 87-CRCR-1-2320. Journal Paper No. J-13301 of the Iowa Agriculture and Home Economics Experiment Station, Ames, Iowa. Project No. 2534.