Infant Formula : Iron, Cooking Lessons

by Food and Drug Administration (FDA)

(Page 2 of 3)

Iron

The infant formulas currently available in the United States are either "iron-fortified" — with approximately 12 milligrams of iron per liter — or "low iron" — with approximately 2 milligrams of iron per liter.

"There should not be a low-iron formula on the market for the average child because a low-iron formula is a nutritionally deficient formula," says Klish. "It doesn't provide enough iron to maintain proper blood cell counts or proper hemoglobin." (Hemoglobin is a blood protein that carries oxygen from the lungs to the tissues, and carbon dioxide from the tissues to the lungs.)

In addition, studies have shown that school children who had good iron status as infants because they were fed iron-fortified formula performed better on standardized developmental tests than children with poor iron status. However, Wallingford says that "FDA has permitted marketing of low-iron formulas because some pediatricians prefer to use them, with the caveat that the physician would be monitoring iron status and prescribing iron supplements when appropriate."

Why is there low-iron formula on the market? "In the past there have been a lot of symptoms that have been attributed to iron, including abdominal discomfort, constipation, diarrhea, colic, and irritability," says Klish. "Also there was some concern about too much iron interfering with the immune system. All of those concerns and questions have been laid to rest with appropriate studies."

Another reason for originally producing low-iron formulas was that human milk contains low amounts of iron — less than a milligram per liter. However, it is now understood that an infant absorbs virtually 100 percent of the iron from human milk, but considerably less from infant formula.

Researchers continue to try to determine the best amount of iron for infant formula. While low-iron formulas don't supply enough iron, the best amount of iron for formulas has not been established. "We did not have much data at the time the regulations were written for different intake levels of iron," says Wallingford. He explains that the current amounts give good developmental results, "but, based on European experience, half [of the high level] is probably good enough to do the same thing." Currently, the Federation of American Societies for Experimental Biology is evaluating what the best levels may be and will make recommendations to FDA on what levels of iron to require in formulas. The study is also reviewing the level of all other nutrients in infant formula, as well as the need for nutrients not currently included.

Cooking Lessons

Both milk and soy formulas are available in powder, liquid concentrate, or ready-to-feed forms. The choice should depend on whatever the parents find convenient and can afford.

Whatever form is chosen, proper preparation and refrigeration are essential. Opened cans of ready-to-feed and liquid concentrate must be refrigerated and used within the time specified on the can. Once the powder is mixed with water, it should also be refrigerated if it is not used right away. The exact amounts of water recommended on the label must be used. Under-diluted formula can cause problems for the infant's organs and digestive system. Over-diluted formula will not provide adequate nutrition, and the baby may fail to thrive and grow.

Until recently, the American Academy of Pediatrics felt that municipal water supplies were safe enough without boiling the water before mixing with the formula. But because of the contamination of Milwaukee's water with the parasite Cryptosporidium in 1993, "the whole business of boiling water has come up again," says Klish. "The academy is now again recommending boiling water for infant formulas."

Klish advises heating the water until it reaches a rolling boil, continue to boil for one to two minutes, and then let it cool. "That should take care of all the bacteria and parasites that might be in the water," he explains.

The American Academy of Pediatrics does not have any recommendations about bottled water. Klish says bottled water is fine, but it still needs to be boiled. "There's no reason to think that bottled water is any safer than city water," he says.

Bottled water must meet specific FDA quality standards for contaminants. These are set in response to requirements that the Environmental Protection Agency has established for tap water.

A new regulation published in the Nov. 13, 1995, Federal Register sets standard definitions for different types of bottled waters, helping resolve possible confusion about what different terms mean.

The regulation also requires accurate labeling of bottled waters marketed for infants. If a product is labeled "sterile," it must be processed to meet FDA's requirements for commercial sterility. Otherwise, the labeling must indicate that it is not sterile and should be used as directed by a physician or according to infant formula preparation instructions.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.