FAQs about Baby Formula, Bottle Feeding and Infant Nutrition

Breast milk provides an infant with the proper balance of nutrients required for growth and development without straining an infant's developing digestive and kidney systems. Breast milk also contains substances that help protect infants from certain infections. Nursing is convenient since breast milk is always available and does not require preparation or storage. Additionally, both mother and infant can benefit psychologically through this close and warm interaction. The American Academy of Pediatrics recommends breast feeding as the preferred mode of feeding. It states, "Exclusive breastfeeding is ideal nutrition and sufficient to support optimal growth and development for approximately the first 6 months after birth. Infants weaned before 12 months of age should not receive cow's milk feedings but should receive iron-fortified formula." *

*The AAP further states, "Gradual introduction of iron-enriched solid foods in the second half of the first year should complement the breast milk diet. It is recommended that breastfeeding continue for at least 12 months, and thereafter for as long as mutually desired."

What Are The Various Forms Of Infant Formula?

Baby formula is available in three forms: ready-to-feed, concentrated liquid and powder. Ready-to-feed is used "as is." Concentrated liquid (the only liquid that comes in a 13 ounce can) and powder must be diluted with water according to instructions on the label. Ready-to-feed and concentrated liquid baby formulas are commercially sterile. Powdered formulas are not sterile. Preparation of any form of infant formula (especially powdered products) requires careful handling to prevent contamination and minimize growth of microorganisms. Manufacturer's instructions should be followed in all cases.

A graphic depicting the addition of water and the statement "add water" are found on concentrated formula containers. Because ready-to-feed and concentrated formulas are both liquids, anyone caring for your child should be made fully aware of what form of formula you use, and whether or not water must be added. (Powdered infant formula containers also provide a graphic depicting the major preparation steps for that formula.)

What Is The Difference Between Milk-Based And Soy-Based Infant Formulas?

The protein in milk-based formulas comes from cow's milk which has been heat treated, making it easy for a baby to digest. The sugar in milk-based formulas is lactose, unless specifically manufactured as lactose-free. Soy-based formulas are milk-free and lactose-free; the protein in these formulas comes from a soybean source that also is easy for a baby to digest. If a baby exhibits signs of lactose intolerance or certain allergic reactions to milk protein, the physician may recommend a soy-based formula to help treat these conditions. A baby with confirmed milk protein-induced colitis could also be sensitive to soy protein so might be given an extensively hydrolyzedsate formula, one in which the protein has been predigested so it will decrease the likelihood of a reaction. Parents who seek a vegetarian-based diet for their healthy infant may want to discuss the use of soy-based formula with the pediatrician.

What Nutrients Are Present In Infant Formula And Why Are They Included?

Baby formulas contain energy-providing nutrients (protein, carbohydrate and fat) as well as water (an essential nutrient) and appropriate vitamins and minerals. The energy nutrients provide the calories necessary to maintain bodily functions, support activity, and promote growth. They also support desirable immune functions as an outcome of overall nutrition. Protein provides the building blocks necessary to form and repair tissue. Vitamins and minerals are essential in the metabolism of energy nutrients. Minerals play an important part in bone structure, regulate certain body functions and, together with water, help maintain the body's water balance.

Standard iron-fortified baby formulas are nutritionally complete foods for normal infants. When a physician recommends a formula not fortified with iron, another source of iron should also be recommended. A physician may recommend fluoride supplementation to infants at least 6 months of age only if the water supply is severely depleted of fluoride.

U.S. manufacturers of infant formula currently offer formulas containing docosahexanoic acid (DHA) and arachidonic acid (ARA), two nutritional fatty acids considered to be "building blocks" for the development of brain and eye tissue. Formulas containing DHA and ARA have been shown to provide visual and mental development similar to the breastfed infant.

Why Shouldn't I Feed Just Plain Cow's Milk To My Baby?

Cow's milk (e.g., whole, 2%, 1%, 1/2% or skim) is not appropriate for children under the age of one year, according to the Committee on Nutrition of the American Academy of Pediatrics. Cow's milk is a poor source of iron, and iron deficiency anemia is the most common nutritional problem in infants. Cow's milk that has not been specially heat processed (such as the heat processing used in infant formula) can cause intestinal blood loss in some babies. Iron is lost with the blood. Also, the levels of protein and sodium in cow's milk are higher than recommended for infants. Additionally, cow's milk is low in vitamin C, vitamin E and copper. Further, cow's milk contains butterfat that is difficult for a baby to digest. For these reasons, the Committee on Nutrition recommends that breastfeeding or iron-fortified infant formula be continued during the first year of life.

Is It Ok To Add Cereal To My Baby's Bottle?

According to the American Academy of Pediatrics, "Cereal should not be added to bottles except for medically-indicated reasons (e.g., gastroesophageal reflux) because this practice deprives children of the opportunity to learn to feed themselves." Note, "there is no nutritional indication to add complementary foods to the diet of the healthy term infant before age 4 months."

Should I Stop Using Infant Formula When My Baby Starts Eating Solid Foods?

No. The nutrient content of various baby foods, either commercially prepared or homemade, varies considerably. Additionally, during the period of transition when an infant is gradually increasing both the type and the amount of solids being eaten, the formula still contributes substantially toward meeting the infant's nutrient requirements. During this time, either breast milk or iron-fortified infant formula can most appropriately meet these requirements. The Committee on Nutrition of the American Academy of Pediatrics recommends that either breastfeeding or iron-fortified infant formula be continued during the first year of life, even after solids have been introduced.

Should I Sterilize Bottles And Use Boiled Water When Making Infant Formula?

Sterilization of all equipment and water used in preparing infant formula is commonly recommended until a health professional decides it is unnecessary. Check with your physician. When you are preparing infant formula, your own personal cleanliness, as well as that of any utensils that you use, is important.

The American Dietetic Association does not recommend preparing formula with boiling hot water due to problems with physical stability of the formula (e.g., clumping or separation) and nutrient degradation.

Should I Use An Infant Formula Product Beyond Its Expiration Date?

No. All infant formula containers carry "use by" or "use before" dates to ensure that the consumer receives a wholesome, high-quality product. Formula should not be bought or fed beyond the expiration date. After the expiration date, some vitamin levels decrease and changes in physical properties, such as discoloration and separation of fat, may occur. Infant formula companies have a reimbursement program covering outdated products and company policy encourages stores not to sell outdated products. Any formula that is out-of-date at the time of purchase should be returned to the store from which it was purchased for exchange or reimbursement.

How Long Can Infant Formula Be Kept After Opening?

An open can of liquid infant formula can be kept for up to 48 hours, if tightly covered and immediately placed in the refrigerator. Bottles of formula made from liquid should be refrigerated and used within 48 hours.

Formula that is prepared from powder and placed in bottles for feeding should be refrigerated and used within 24 hours. The remaining powder should be tightly covered and stored in a cool, dry place and used within a month after opening.

How Long Can A Bottle Of Infant Formula Remain Unrefrigerated?

Baby formula that is removed from refrigeration should be used within two hours or discarded. Because of possible bacterial contamination, formula remaining in a bottle one hour after the start of feeding should also be discarded.

Should I Reheat A Bottle After Feeding Part Of It To My Baby?

No. Once a baby has nursed from a bottle, microorganisms from the baby's mouth are introduced into the formula. If any unused portion of formula is refrigerated and reheated, these microorganisms will have the opportunity to multiply. Neither refrigeration nor reheating will prevent this growth. Therefore, you should fill each bottle with only the amount of formula needed for one feeding. After feeding, if any formula remains unused in the bottle, it should be discarded.

Should Infant Formula Be Frozen?

The use of infant formula after freezing is not recommended. Although freezing does not affect nutritional quality or sterility, physical separation of the product's components may occur.

Can Infant Formula Be Heated In A Microwave Oven?

Microwave ovens should NEVER be used for heating infant formulas since there is a danger of overheating the liquid. During the microwaving process, the bottle may remain cool while hot spots develop in the formula. Overheated formula can cause serious burns to the baby.

Are Infant Formulas Required To Meet Government Standards?

Yes. All infant formulas marketed in the U.S. must comply with the Infant Formula Act of 1980 and subsequent amendments passed in 1986. The nutrient levels specified by law are based on the recommendations of the Committee on Nutrition of the American Academy of Pediatrics and are periodically reviewed as new information arises.

What Testing Is Performed To Assure That Infant Formula Is Safe?

Infant formula is tested for 29 nutrients (as defined by the Infant Formula Act) to assure that each batch provides the appropriate nutrition for infants. In addition, IFC member companies carefully monitor the ingredients used in infant Formula to help assure that product quality is not compromised.

What is melamine?

Melamine is a nitrogen rich compound that is approved for a wide variety of industrial applications, including cleaning products and in pesticides and fertilizers. It is also approved for use in food packaging and tableware.

Melamine is not allowed to be added to foods, but very low background levels may be present as a result of these other uses.

Do infant formulas contain melamine?

Trace amounts of melamine have been detected in very few U.S. infant formulas by the U.S. FDA and Health Canada. However, according to the FDA, the background levels detected were orders of magnitude less than the levels reported in 2008 in Chinese-manufactured milk products intentionally contaminated with melamine. The FDA issued a statement confirming that all infant formulas manufactured in the US are safe.

The FDA's results are consistent with similar findings from Health Canada, which recently surveyed infant formulas sold in Canada using an even more sensitive testing method than the FDA method. Health Canada detected very low background levels of melamine in several formulas it tested and clearly stated that none of the samples exceeded their revised standard of 0.5 parts per million (ppm) and that none would represent a risk to Canadian infants.

In both cases, the trace amounts of melamine found in infant formula were well within the margin of safety established by international authorities.

Is melamine in foods a health risk?

The World Health Organization (WHO) has noted that melamine is commonly found throughout the environment because it has many approved uses and has established a tolerable intake level representing the amount of melamine that a person can ingest on a daily basis without appreciable health risk. (Levels in food typically fall far below this level and do not pose a health risk.) According to the WHO and numerous other regulatory agencies, the very low levels of melamine in the environment and in some foods do not pose a health risk.

By contrast, the very high levels of melamine found in some milk ingredients and milk powders in China - which caused renal illnesses - were the result of intentional addition of melamine to foods, which is illegal.

What is cyanuric acid?

Cyanuric acid is an analogue of melamine. It is an FDA-approved component of some sanitizers commonly used in food manufacturing sites and in the household, and it may be found in chemically purified drinking water following the World Health Organization (WHO) guidance for safe drinking water.

Do infant formulas contain cyanuric acid?

Trace levels of cyanuric acid have been detected in very few U.S. infant formulas (three samples of one product tested positive). However, according to safety standards issued by the WHO and FDA, the trace amounts reported are much too low to be considered a safety concern.

Is cyanuric acid in food a health risk?

Due to the extremely large margin of safety and the recognized positive public health benefit for use of cyanuric acid salts, the U.S. FDA affirms there is no reason to question the safety of a trace amount of cyanuric acid in foods or formula products.

Is cyanuric acid present in other foods?

Yes. In the World Health Organization Guidelines for Drinking-Water, the typical concentration of cyanuric acid resulting from maintaining microbiological safety is approximately 40 mg/L of water. That, for comparison, is approximately 80 times greater than the minute levels of cyanuric acid reported to have been found by the FDA in infant formula.

Why would trace quantities of cyanuric acid be present in infant formula?

Minute quantities (parts per billion) of residual sanitizer used to clean formula-processing equipment, utensils and packaging may sometimes be detected with modern analytical technology that is capable of measuring ultra trace quantities of chemical substances. Sanitizing formula-processing equipment is a key step in making infant formula, as it protects the integrity of the formula. Concentrations at these extremely low levels, if they occur at all, are not a food safety concern and have no effect on the final product, similar to finding water spots on dishes.

Since melamine and cyanuric acid have a variety of industrial uses, low levels can be found within the environment and in foods.

Have safe limits for melamine and cyanuric acid in foods been established?

In November 2008, FDA concluded that "levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns." The FDA added their "ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas."

In December 2008, the World Health Organization established a tolerable daily intake (TDI) of 0.2 milligrams per kilogram of bodyweight per day for melamine. Health Canada has adopted the WHO recommendation, and has established a safe limit of 0.5 parts per million for melamine in infant formula.

Does the presence of cyanuric acid mean that melamine is present?

No. It does not mean that melamine is present. Melamine and cyanuric acid are compounds in the same chemical family. The FDA- approved uses of cyanuric acid can result in ultra-trace amounts of cyanuric acid in food products.

Do formula companies test for melamine? If so, has it been detected in the product?

Companies testing for melamine use a published U.S. FDA testing methodology. Given the many approved uses of melamine it is not unexpected to find background levels in infant formula. The extremely low trace levels that have been detected are below the limits deemed safe by the WHO.

What should parents do?

Breastfeeding is ideal, but for a mother who cannot or chooses not to breastfeed, infant formula remains the only safe alternative to nourish her baby. FDA has stated that "there's no basis for concern because we're talking about trace levels that are so low ... that there's absolutely no risk." No changes in feeding practices are recommended. Infant formula is safe and nutritious. FDA also stated: "Parents using infant formula should continue using U.S. manufactured infant formula. Switching away from using one of these infant formulas to alternate diets or home-made formulas could result in infants not receiving the complete nutrition required for proper growth and development."

What is perchlorate?

Perchlorate is a colorless, odorless substance that is prevalent throughout the environment and the food supply. Perchlorate occurs naturally in both potash ore and in arid states of the Southwest United States, and in nitrate fertilizer deposits in Chile; it can also form naturally in the atmosphere. It is also manufactured and used as a component (oxidizer) of rocket fuels, explosives and fireworks. Perchlorate is not an ingredient in infant formula. However, because perchlorate is present in the environment, including in the drinking water supply and the food supply chain, trace levels may be found in infant formula and in breast milk and do not pose a health risk.

Does perchlorate affect the thyroid gland?

High levels of perchlorate (above 245 parts per billion [ppb]) can temporarily affect the thyroid's ability to absorb iodide from the bloodstream. However, these effects are thought to be reversible upon removal of perchlorate with no cumulative effects. According to the Perchlorate Information Bureau, a human would have to consume 14,000 ppb of perchlorate in drinking water daily to result in adverse effects.

What impact does iodine have on perchlorate?

Iodine has been shown to counteract the potential effects associated with perchlorate. Additionally, the National Academy of Sciences found that perchlorate is not metabolized, is not stored in the body, and any effects of perchlorate on the thyroid are reversible once exposure stops.

Do infant formulas contain iodine?

All infant formulas manufactured in the U.S. contain iodine, as required by law, to aid in the development of the baby's brain and thyroid.

Are there safe limits for perchlorate?

Yes; in 2003 the National Research Council of the National Academy of Sciences recommended a Reference Dose (RfD) of 0.7 micrograms per kilogram body weight per day (mcg/kg bw/d) for perchlorate. The U.S. Environmental Protection Agency (EPA) defines RfD as "an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects over a lifetime." In 2005, the EPA adopted the RfD, which includes a 10-fold safety factor. This means if the RfD were 10-times larger there would likely be no appreciable risk of deleterious effects over a lifetime.

Are the trace quantities of perchlorate in food a health risk?

No. Due to the large safety factor associated with the EPA RfD, the trace levels of perchlorate that have been detected in food do not pose a health risk. FDA has stated they do not recommend that people alter their diet or eating habits because of perchlorate. Additionally, neither the World Health Organization, nor U.S. or European health agencies, have issued health warnings regarding perchlorate.

Which companies' products were tested by CDC for the presence of perchlorate?

We do not know which companies' products were tested. CDC did not identify brand names.

Do infant formula manufacturers test product for the presence of perchlorate?

Since the FDA has determined the trace amounts of perchlorate that may be present in food products do not pose a health concern to humans, including infants, and because perchlorate is not an added ingredient to infant formula, manufacturers do not test finished products for the presence of perchlorate.

How are infant formula manufacturers limiting the amount of perchlorate that could be in their products?

As an industry, members of the IFC take all safety issues very seriously. Our research and development programs are targeted to produce the highest quality of infant formula products available. And our quality assurance process starts at the farm level and continues throughout the manufacturing process. The water used to manufacture infant formula is filtered to ensure its safety and quality.

What kind of water should I use to reconstitute my baby's formula?

In January 2009, the EPA released an interim drinking water health advisory of 15 parts per billion (ppb) for perchlorate, which is based on the NRC RfD of 0.7 mcg/kg bw/d. According to the FDA, most municipal water supplies do not contain levels of perchlorate that exceed 15 ppb. However, if you are concerned with the perchlorate levels in your drinking water supply, the FDA advises that you should use bottled water or water that has been filtered from a home treatment system that has been certified to remove perchlorate. If you are unsure about your municipal water supply, we recommend that you contact your baby's doctor, or your local water utility, or go to this web site www.epa.gov/safewater/dwinfo/index.html.

What levels of perchlorate were detected in infant formula and how do they compare to the RfD?

According to the CDC study, the average perchlorate concentration of milk-based powder infant formula studied was 1.72 ppb. To put this into perspective, this level is more than eight times lower than the level determined by the EPA to be safe in drinking water. Using the estimates for exposure described in the CDC study, infants who consume formula containing these average levels and prepared with perchlorate-free water would not exceed the RfD.