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Formula Decisions
The most common sources of protein in infants’ formulas are either cow's milk or soybeans. If the mother cannot or chooses not to breast-feed, normal, full-term infants should get a conventional cow's-milk-based formula, according to John N. Udall Jr., M.D., chief of nutrition and gastroenterology at Children's Hospital of New Orleans.
For a healthy, full-term infant, "cow's milk formula would be the first choice," Schanler says. "The only indication that I see for soy is for babies with lactose intolerance."
However, in cases of adverse reactions to the protein in cow's milk formula or symptoms of lactose intolerance (lactose is also known as milk sugar, is the main carbohydrate in cow's milk) may require switching to another type of formula, he says.
"For full-term infants, soy formulas appear to be as nutritionally sound as milk-based formulas, and their use is unlikely to expose infants to nutritional risk," wrote pediatrician Samuel J. Foman in 1987 in the American Journal of Clinical Nutrition. Baylor's Schanler agrees, but says that there is some question about whether the minerals in soy-based formulas can be used by the infant's body as well as those from cow's milk formula.
Symptoms that may indicate an adverse reaction to cow's milk protein include vomiting, diarrhea, abdominal pain, and rash. With lactose intolerance, the most common symptoms are excessive gas, abdominal distension and pain, and diarrhea. Since some of the symptoms overlap, a stool test may be necessary to determine the culprit. Usually, lactose intolerance will produce acidic stools that contain glucose. If the protein is the problem, stools will be nonacid and have flecks of blood.
The main alternative to cow's milk formula is soy formula. About 20 percent of the formula sold in the United States is soy. "Lactose intolerance is probably the biggest reason to switch to soy formula," says William J. Klish, M.D., chairman of the American Academy of Pediatrics Committee on Nutrition.
The carbohydrates in most soy formulas are sucrose and corn syrup, which are easily digested and absorbed by infants. However, soy is not as good a protein source as cow's milk. Also, babies don't absorb some minerals, such as calcium, as efficiently from soy formulas. Therefore, according to the American Academy of Pediatrics, "Healthy full-term infants should be given soy formula only when medically necessary."
Schanler does not think soy formula is a good choice for infants with milk allergies, however. "If there is a real history of milk allergy in the family, the baby might be allergic to soy, too," he says. Instead of soy, Schanler recommends special cow's milk formula known as protein hydrolsates, which won't cause allergic reactions because the proteins are already broken down. "That way the chance of a cross reaction with the soy protein is eliminated," he explains.
For a child who can't tolerate cow's milk protein, William J. Klish, M.D., a Baylor College of Medicine pediatrician and former chairman of the American Academy of Pediatrics Committee on Nutrition also recommends the use of hydrolyzed-protein formula. Although hydrolyzed-protein formulas are made from cow's milk, the protein has been broken up into its component parts. Essentially, it's been predigested, which decreases the likelihood of an allergic reaction.
Homemade Formulas Aren’t a Good Choice
Homemade formulas should not be used, says Nick Duy a consumer safety officer in FDA's Office of Special Nutritional.
Homemade formulas based on whole cow's milk don't meet all of an infant's vitamin and mineral needs. In addition, the high protein and electrolyte (salt) content of cow's milk that has not been cooked or processed makes it difficult for an infant to digest and may put a strain on the baby's immature kidneys. Substituting evaporated milk for whole milk may make formula easier to digest, because of the effect of processing on the protein, but it is still nutritionally inadequate when compared to commercially prepared formula, and still may stress the kidneys. And the use of soy drinks as an infant formula can actually be life-threatening.
"Infant formulas are the most heavily regulated food that there is," says Wallingford.
FDA regulations specify minimum and, in some cases, maximum exact 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, thiamine (vitamin B1), riboflavin (vitamin B2), vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, vitamin C, calcium, phosphorous, magnesium, iron, zinc, manganese, copper, iodine, sodium, potassium, and chloride. In addition, formulas not made with cow's milk must include biotin, choline and inositol.
Today's infant formula is a very controlled, high-tech product that can't be duplicated at home, says Udall.
Soy Beverages Not Complete Formulas
This kind of soy beverage, sometimes improperly called "soy milk," should not be confused with soy based infant formulas. Unlike true infant formulas, which are nutritionally complete and appropriate for infants, soy beverages are lacking some of the nutrients infants need.
Analysis of Soy Moo by the Arkansas Children's Hospital revealed deficiencies in calcium, niacin, and vitamins D, E, and C. A severely malnourished 5-month old infant was admitted to Arkansas Children's Hospital, Little Rock, Arkansas, in February 1990 with symptoms including heart failure, rickets, vasculitis (blood vessel inflammation), and possible neurological damage. According to the hospital, the baby girl had been fed nothing but Soy Moo since she was 3 days old. Soy Moo is a soy beverage sold in health food stores.
Labels on Soy Moo cartons and literature about the drink do not suggest that Soy Moo be used as an infant formula. In addition, an FDA investigation found no evidence that infant's parents were explicitly told the Soy Moo could be used as a baby's sole nourishment. Nevertheless, Soy Moo's distributor, Health Valley Foods, Irwindale, California, has voluntarily stopped distribution until the new labels stating "Do Not Use as Infant Formula" can be printed.
FDA learned of a similar incident that occurred in April 1990 when a California couple questioned a physician about their 2-month old daughter's failure to gain weight. The physician discovered that the baby had been exclusively fed Edensoy, another brand of soy beverage. A midwife had recommended Edensoy to the parents, according to the FDA investigator assigned to the case.
In response to this incident, Edensoy's manufacturer, Eden Foods, Clinton, Michigan, wrote all its retailers in the United States and Canada to remind them that Edensoy is not an infant formula. In addition, the letter said, "Please make sure that no store personnel suggest or imply that Edensoy or other soy beverages are suitable for use as an infant formula."
In an effort to prevent this problem with similar soy beverage, FDA asked all 68 known manufacturers, importers, and private label distributors of these products to include a warning against using beverages as infant formula. The agency does not, however, have the regulatory authority to require this warning.
Vitamin Supplements - Yes or No?
The American Academy of Pediatrics says "the normal breast-fed infant of the well-nourished mother has not been shown conclusively to need any specific vitamin and mineral supplement. Similarly, there is no evidence that supplementation is necessary for the full-term, formula-fed infant and for the properly nourished normal child."
Many physicians recommend supplements, nevertheless - especially for breast-fed infants. "There is definitely some controversy here," says Wallingford. The controversy on supplements usually revolves around the following:
Iron - Although the amount of iron in breast milk is very low (0.3 milligrams of iron per liter), the infant absorbs almost half. In contrast, while iron-fortified formulas contain 10 to 12 mg per liter, babies absorb only 4 percent, amounting to 0.4 mg per liter to 0.5 mg per liter. In either case, those amounts of iron are adequate for the first 4 to 6 months, according to the American Academy of Pediatrics. 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, 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." Over the past 10 years, based on several studies, the American Academy of Pediatrics does not believe there is any evidence connecting these problems to iron and recommends that iron-fortified formula be used for all formula-fed infants.
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.
Vitamin D - Insufficient vitamin D can cause rickets, a disease that results in softening and bending of the bones. Although the amounts of vitamin D in breast milk are small, rickets is uncommon in the breast-fed term infant. This may be because, like iron in breast milk, the vitamin D in breast milk is easily absorbed by the baby. Sunlight is important for the formation of vitamin D, but probably as little as a few minutes exposure a day is all the baby needs, say Schanler, and exposure to the whole body isn't necessary - just the arms and face is enough.
Fluoride - No one knows for sure if giving fluoride during the first six months of life will result in fewer cavities. Reflecting the uncertainty surrounding fluoride supplements, the American Academy of Pediatrics recommends starting fluoride supplements shortly after birth in breast-fed infants, but also says that waiting up to six months is acceptable. Because there is no fluoride in infant formula, the twofold recommendation also applies when ready-to-feed formula is used or when the water used for powdered or concentrated formula has less than 0.3 parts per million of fluoride.
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.
Cooking Lessons
Either 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 amount 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.
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 them in a pan of boiling water for five minutes.
Bottles should not be heated in the microwave oven because the ovens do not heat evenly, MacLean warns. "The drop a mother tests on her wrist could be fine," he says. But, he explains, undetected "hot spots" in the formula could seriously burn the baby.
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, according to Christine Watson, a nurse who specializes in maternal and newborn care at Shady Grove Adventist Hospital in Gaithersburg, MD. "You can also run hot tap water over the bottle, but that isn't very quick.
Solid Evidence
Sometime between a baby's 4-month and 6-month birthdays solid food can be introduced. Exactly when depends on several factors.
One factor involves the disappearance of the involuntary action called the extrusion reflex. Before this reflex disappears, feeding solids usually involves putting a spoonful in the mouth and scraping most of it off the baby's face as he or she spits it back out.
Also, babies should be able to sit up and turn their heads away. That way, Schanler explains, they can communicate that they're not ready for the next spoonful or just not hungry anymore.
Usually, the first food recommended is a single-grain, iron-fortified infant cereal. Starting with single-grain cereals makes it easier to pinpoint any allergic reactions. (For more information on introducing solids see "Good Nutrition for the Highchair Set" article.)
The biggest concern with feeding solids too early is that the solids will replace breast milk or formula in the baby's diet. "Solids vary nutritionally depending on the food," says Schanler. "None of them is a complete as formula or breast milk. You don't want to rob the baby of milk."
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 American Academy of Pediatrics recommends that babies be breast-fed for at least 12 months and thereafter for as long as mutually desired. The only acceptable alternative to breast milk is infant formula iron fortified and solid foods can be introduced gradually when the baby is 6 months old, but a baby should drink breast milk or formula, not regular cow's milk, for a full year.
"There aren't any rules about when to stop breast-feeding," says Ruth Lawrence, M.D., professor of pediatrics and obstetrics at the University of Rochester School of Medicine in Rochester, N.Y., and spokeswoman for the academy. "As long as the baby is eating age-appropriate solid foods, a mother may nurse a couple of years if she wishes. A baby needs breast milk for the first year of life, and then as long as desired after that." Formula, however, should not be continued after the first birthday. That's the time to introduce milk.
For all babies 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, former 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.
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