Upper limit of vitamin E in infant formulas.

Reports of toxicity to enterally administered vitamin E are rare in infants. However, increased risks of sepsis and necrotizing enterocolitis have been reported after both enteral and parenteral vitamin E, primarily when plasma (or serum) vitamin E levels exceed 3.5 mg/dl. Levels this high are seldom seen with enteral vitamin E when intake is 25 mg d-alpha-tocopherol equivalent/(kg.d) or less. Intakes below this threshold will be provided by infant formulas with vitamin E to energy ratios of up to 20 mg/100 kcal (30 IU/100 kcal) so long as energy intake does not exceed 125 kcal/(kg.d). To allow a margin of safety, it would be reasonable to limit the amount of vitamin E added to the formula during its manufacture to half this amount, or 10 mg/100 kcal (15 IU/100 kcal). This level coincides with the highest levels of vitamin E found in human colostrum and is 20 times the recommended lower limit for vitamin E in infant formula of 0.5 mg/100 kcal.