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Letters to the Editor

Response to Comments on LSRO Report's Recommendations

Expert Panel Member, New Braunfels, TX 78132

As a member of the Expert Panel, but not attempting to speak on behalf of the Panel or Life Sciences Research Office (LSRO), I would like to respond to the letter of the International Formula Council. Nutrients for which the Expert Panel recommended upper limits where no such limits are currently specified in the Code of Federal Regulations can be assigned to three categories. The first category, pertaining to nutrients for which there is evidence of adverse effects from high intakes, consists of essential amino acids and 14 other nutrients. The upper limit for carbohydrate is constrained by the lower limits for protein and fat and, strictly speaking, would not need to be specifically identified. Based on available evidence, the rationale for setting upper limits for the essential amino acids is to avoid imbalance in the dietary amino acid pattern. For the other nutrients, the rationale is as follows: sodium, chloride, potassium and available phosphorus because they are components of potential renal solute load (and available phosphorus also because an excess may cause or predispose infants to neonatal hypocalcemia); linoleic acid because an excess may interfere with elongation and desaturation of the (n-3) series of fatty acids, and -linolenic acid because of a similar adverse effect on the (n-6) series of fatty acids; calcium because of adverse nutrient interactions associated with excess intakes of calcium (with iron, phosphorus, and magnesium); zinc (with copper); manganese (with iron); magnesium, copper, selenium and vitamin E because of toxicity from high intakes; and folic acid, because of the possibility of masking the effects of vitamin B-12 deficiency.

The second category includes substances that are present in human milk and are added to infant formulas because of demonstrated or suspected health advantages: carnitine, taurine, nucleotides, choline and inositol. There has been little study of possible adverse effects in infants from consumption of high amounts of these nutrients, and there is no evidence that intakes greater than those of breastfed infants are advantageous. The Expert Panel therefore concluded that the concentrations of these nutrients in infant formulas should not exceed the concentrations in human milk.

Upper limits have been applied to a third category of nutrients, the water-soluble vitamins other than folic acid, in an effort to forestall unwarranted advertising. Although I am impressed by the record of safety and nutritional adequacy of infant formulas, the excellent record of the past is not necessarily predictive of the future. Considerations in infant feeding practices are changing; parents rather than physicians are now choosing the brand of formula; formula advertising is directed at the general public, and one cannot exclude the possibility that future advertising of infant formulas will become analogous to advertising of breakfast cereals, where the public is lead to believe that the greater the intake of a nutrient the better. With the possibility that new infant formula companies will enter the market in the United States, such advertising may not be far off, and setting upper limits for most nutrients seems desirable. If the International Formula Council can present convincing evidence that for specific nutrients the proposed upper limits will present an unreasonable burden to the infant formula industry, those upper limits should be discussed.

Manuscript received February 19, 1999. Revision accepted March 8, 1999.

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