DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Washington, DC 20204

February 26, 1997

William J. Klish, M.D.
Chairperson
Committee on Nutrition
American Academy of Pediatrics
Nutrition & GI #3-3391
Texas Children's Hospital
5621 Fannin
Houston, TX 77030

Dear Dr. Klish:

This letter is meant to inform you about our concerns regarding a recipe for homemade infant formula that was the subject of a recent consumer complaint. It is our hope that you will assist in disseminating this information to your members.

A pediatric nurse practitioner reported to FDA's New York District Office that a patient of hers brought to her attention a copy of a homemade infant formula recipe that had been received from a Down's Syndrome support group. The infant formula was purported to be for infants with Down's Syndrome. The homemade infant formula recipe is in the form of a letter from two doctors in Shippensburg, PA. The nurse practitioner was concerned about certain unconventional ingredients in the recipe, especially flaxseed oil, maple syrup, and beta-carotene.

As a result of this complaint, the Food and Drug Administration (FDA) interviewed the complainant and the people responsible for developing and distributing the recipe. It was claimed in the interviews that the recipe is not necessarily for infants with Down's Syndrome or any specific medical condition but is meant for use by any infant who is allergic to commercial infant formulas. It was also stated that the formula is to be used as the sole source of nutrition or as a supplement to an infant's diet as determined on a case-by-case basis by a health care professional. In the absence of labeling, the actual intended use of the formula, and the intended population for its use, are not clear.

The number of infants who have used the homemade infant formula recipe, and the scope of distribution of the recipe are unknown. It is our belief, however, that dissemination of the following information is important to reduce the likelihood of misinformed use of the recipe by parents.

We have listed our concerns (below) about the use of an infant formula made according to the enclosed recipe.

Concerns about use of the homemade infant formula:

1. The homemade infant formula is apparently recommended as the sole source of nutrition for infants who are allergic to other infant formulas. A full description of the ingredients and nutrient composition and analysis of the product is lacking.

2. An estimated value for caloric content (50 kcal/dL) is below well established nutritional requirements for healthy infants (63-71 kcal/dL).

3. Given the possibility that the infants fed the formula may already manifest symptoms of crying, irritability, etc., any nutritional deficiencies as a consequence of prolonged use of this formula, that could result in similar symptoms, may go undetected.

4. Sources of many of the nutrients in the homemade infant formula do not have any history of use in commercially prepared infant formulas and therefore the safety and nutritional adequacy of the formula are unknown. For example, the protein source contains hydrolyzed bovine lactalbumin which is not currently used by the infant formula industry. Many of the sources of minerals such as magnesium citrate, zinc picolinate, manganese picolinate, vanadium citrate, and boron citrate have no history of use in commercially prepared infant formulas. Other examples of ingredients in the recipe which have no history of use in infant formula include maple syrup and flaxseed oil.

5. The claimed level of potassium (62.4 mg/100 kcal), and the estimated sodium (10.4 mg/100 kcal) and chloride (32 mg/100 kcal) contents are below levels required in commercially prepared infant formulas (80 mg/100 kcal, 20.0 mg/100 kcal, and 55.0 mg/100 kcal, respectively). As you will recall, the Infant Formula Act was enacted in response to a formula which was deficient in chloride. Furthermore, the phosphorus content cannot be estimated as it is not claimed in the list of nutrients provided with the recipe for the homemade infant formula.

6. The claimed level of manganese is 960 g/100 kcal which is much greater than the minimum amount (5 g/100 kcal) required for commercially prepared infant formulas and is also much greater than amounts (7-10 g/100 kcal) found in standard milk-based infant formulas. The effect of high doses of manganese in humans is unknown; however, high doses are known to be neurotoxic if ingested by laboratory animals.

7. The estimated fatty acid composition (high in à-linolenic acid) and low fatty acid ratio (n-6/n-3) do not follow current scientific recommendations for infant formulas and may be unsafe. Flaxseed oil (an ingredient in the homemade recipe) has no history of use in infant formula, but is the sole fat source in the recipe, providing over 50% of calories.

8. The only source of vitamin A in the infant formula recipe is -carotene, in contrast to the predominance of the more bio-available preformed vitamin A in human milk and commercially prepared infant formulas.

9. The stability of vitamins in the prepared formula may be compromised by the very high content of linolenic acid.

10. Instructions for use of the recipe for the homemade infant formula are imprecise and susceptible to error. For example, the instructions say to "let your nose be your guide to the shelf life of the oil mix. If it starts to smell different or weird, throw it out and make a fresh batch."

    In conclusion, we believe there may be serious safety concerns regarding the use of this recipe for homemade infant formula. Prolonged use of the formula, particularly if the formula is used as the sole source of nutrition, could be hazardous to the health of an infant. Among our concerns are hypochloremia, hypokalemia, hypermanganesemia, metabolic acidosis, vitamin deficiencies, and failure to thrive. We would appreciate it if you could help us disseminate this information. Please share this information with other persons as you see appropriate.

    Sincerely,

    Elizabeth A. Yetley, Ph.D.
    Director
    Office of Special Nutritionals
    Center for Food Safety and Applied Nutrition

    Enclosure
    

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