Infant Formula : Nutrient Requirements

by Food and Drug Administration (FDA)

(Page 3 of 3)

What about sterilizing the bottles and nipples? "Dishwashers tend to sterilize bottles and nipples fairly well," says Klish. They can also be sterilized by placing in a pan of boiling water for five minutes.

Warming the formula before feeding isn't necessary for proper nutrition, but most infants prefer the formula at least at room temperature. The best way to warm a bottle of formula is by placing the bottle in a pot of water and heating the pot on the stove.

Don't Try This at Home

Homemade formulas should not be used, says Nick Duy, a consumer safety officer in FDA's Office of Special Nutritionals. Homemade formulas based on cows' milk don't meet all of an infant's nutritional needs, and cow's milk protein that has not been cooked or processed is difficult for an infant to digest. In addition, the high protein and electrolyte (salt) content of cow's milk may put a strain on an infant's immature kidneys. Substituting evaporated milk for whole milk may make the homemade formula easier to digest because of the effect of processing on the protein, but the formula is still nutritionally inadequate and still may stress the kidneys.

Today's infant formula is a very controlled, high-tech product that can't be duplicated at home, says Udall.

Nutrient Requirements

FDA regulations specify minimum and, in some cases, maximum nutrient level requirements for infant formulas, based on recommendations by the American Academy of Pediatrics Committee on Nutrition. The following must be included in all formulas:

• protein
• fat
• linoleic acid
• vitamin A
• vitamin D
• vitamin E
• vitamin K
• thiamin (vitamin B1)
• riboflavin (vitamin B2)
• vitamin B6
• vitamin B12
• niacin
• folic acid
• pantothenic acid
• vitamin C
• calcium
• phosphorus
• magnesium
• iron
• zinc
• manganese
• copper
• iodine
• sodium
• potassium
• chloride

In addition, formulas not made with cow's milk must include biotin, choline and inositol.

Whole Milk for First Birthday

There's nothing like a cold glass of milk with a slice of birthday cake. That works out great for babies because, in general, parents should stop the formula and introduce milk around the time of a baby's first birthday.

The milk, however, should be whole milk. Low-fat and skim milk do not have enough fat and calories to supply the nutritional needs of a 1-year-old, explains John Udall, chief of nutrition and gastroenterology at Children's Hospital of New Orleans. At that age, "the child is growing so quickly, and the fat is so important for brain and central nervous system development," he says. "The recommendation that our daily intake of fat should compose less than 30 percent of our caloric intake does not apply to children under 2 years of age."

New on the market are special toddler formulas that claim to be better than milk. The formulas are good nutritionally, says Udall, but they're not necessary. "A well-balanced diet with milk and juices would be just as good in a healthy, normally active, normally growing child," says Udall.

William Klish, chairman of the American Academy of Pediatrics Committee on Nutrition, says that if a child needs to take a vitamin supplement, the toddler formula, fortified with a full range of vitamins and minerals, including iron, can serve that purpose. In addition, the toddler formulas don't need refrigeration, making them a convenient choice for snacks away from home.

Counterfeit Formulas

In February 1995, FDA special agents arrested a suspect in Southern California in a scheme to distribute infant formula in counterfeit packaging. The agency also seized 17,236 kilograms (38,000 pounds) of powdered formula at the suspect's counterfeit manufacturing operations in Southern California and 6,366 0.45-kilogram (1-pound) cans from retail and wholesale outlets.

The scheme involved the purchase of bulk infant formula labeled "for export only" from a legitimate manufacturer. The bulk formula was then packaged in the 1-pound cans that looked like Similac, an authentic formula made by Ross Products Division of Abbott Laboratories, Columbus, Ohio.

The agency did not receive any reports of illness attributable to the counterfeit formula.

The California counterfeit scheme has been completely suppressed, but it is just part of a diversion market in numerous products. One of FDA's concerns is the conditions the formula is subjected to during the illegal manufacturing operations.

Production records like those normally kept by legitimate manufacturers don't exist, explains Jim Dahl, assistant director of FDA's Office of Criminal Investigations. "How it was transported, what temperature conditions, what sanitary conditions, how cans were treated, how long they were held in those conditions, all of that is unknown," he says.

To protect their babies, parents need to be on the lookout for any changes in formula color, smell or taste, Dahl says. He also advises parents and retailers to:

• make sure lot numbers and expiration dates on both the can and the cardboard case are the same
• check containers for damage
• call the manufacturer's toll-free number with any concerns or questions.

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.