Infant Formula Basics



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What is an Infant Formula?

Infant formulas are liquids or reconstituted powders fed to infants and young children. They serve as substitutes for human milk. Infant formulas have a special role to play in the diets of infants because they are often the only source of nutrients for infants. For this reason, the composition of commercial formulas is carefully controlled and FDA requires that these products meet very strict standards.

How does FDA regulate Infant Formulas?

The safety and nutritional quality of infant formulas are ensured by requiring that manufacturers follow specific procedures in manufacturing infant formulas. In fact, there is a law -- known as the Infant Formula Act -- which gives FDA special authority to create and enforce standards for commercial infant formulas. Manufacturers must analyze each batch of formula to check nutrient levels and make safety checks. They must then test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas must also have codes on their containers to identify each batch and manufacturers must keep very detailed records of production and analysis.

Does FDA have nutrient specifications for infant formulas?

FDA regulations list specifications for minimum amounts of 29 nutrients and maximum amounts for 9 of those nutrients. All formulas marketed in the United States must meet these nutrient requirements. As more information becomes available about infants' nutrient needs, FDA's nutrient specifications for infant formulas may be modified to incorporate that information.

Does FDA approve infant formulas before they are marketed?

The law does not require that FDA approve infant formulas but instead requires companies to provide certain information to FDA before they market new infant formulas. Manufacturers must provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. If such assurances are not provided, FDA will object to the manufacturer's marketing of the formula; however, the manufacturer may market the new infant formula over FDA's objection.

How do parents know what formula to feed to their infant?

A wide selection of different types of infant formulas is available on the market. Parents should ask their infant's health care provider if they have questions about selecting a formula for their infant.

Do infants fed infant formulas need to take additional vitamins and minerals?

Infants fed infant formulas do not need additional nutrients unless a low-iron formula is fed. If infants are fed a low-iron formula, a health care professional may recommend a supplemental source of iron, particularly after 4 months of age.

FDA's nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, manufacturers set nutrient levels for their label claims that are generally above the FDA minimum specifications and they add nutrients at levels that will ensure that their formulas meet their label claims over the entire shelf-life of the product.

Do "house brand" or generic infant formulas differ nutritionally from name brand formulas?

All infant formulas marketed in the United States must meet the nutrient specifications listed in FDA regulations. Infant formula manufacturers may have their own proprietary formulations but they must contain at least the minimum levels of all nutrients specified in FDA regulations without going over the maximum levels, when maximum levels are specified.

Some ingredient statements on infant formula labels include ingredients in addition to nutrients and familiar components such as milk. Why are those ingredients added?

Ready-to-feed and concentrated liquid formulas often contain ingredients such as lecithin, carrageenan, and mono- and diglycerides added to ensure that the formula doesn't separate during shelf-life.

What does the "use by" date mean on infant formula product labels?

The "use by" date on infant formulas is a date, selected by the manufacturer based on tests and other information, to inform retailers and consumers about the quality of the infant formula. Until that declared date, the infant formula will contain no less than the amount of each nutrient declared on the product label and will otherwise be of acceptable quality. The "use by" date is required by FDA regulations on each container of infant formula.

What are counterfeit infant formulas? How can I avoid buying such products?

Counterfeit infant formulas are infant formula products that have been diverted from normal distribution channels and relabeled. Diverted products may be relabeled with counterfeit labels to misrepresent the quality or identity of a formula. For example, if an infant formula is past the "use by" date, a counterfeit label may bear a false "use by" date to obscure the fact that the product may no longer contain the amounts of nutrients listed on the label and may otherwise not be of acceptable quality. As a second example, an infant formula may be relabeled to disguise the true content of the product. Infants who are intolerant to certain ingredients and are fed such a counterfeit formula could experience serious adverse health consequences.

To protect infants, parents or other caregivers should always look for any changes in formula color, smell, or taste. Parents should make sure the lot numbers and "use by" dates on the containers and boxes are the same (if buying by the case), check containers for damage, and call the manufacturer's toll-free number with any concerns or questions.

I have seen bottled water marked for use in preparing infant formula. What does this mean?

The manufacturers of infant formula provide directions for mixing their products with water and usually do not specify the source of water other than to indicate that the water should be safe to drink. In most situations, it is safe to mix formula using ordinary cold tap water that is brought to a boil and boiled for one minute or as directed on the label of the infant formula. Some water companies wish to make available bottled waters which are marketed for infants and for use in mixing with infant formula. When manufacturers label their water as intended for infants, the water must meet the same standards established for tap water by the Environmental Protection Agency. The label must also indicate that the bottled water is not sterile. As with tap water, consumers should boil bottled water one minute before mixing with infant formula. Water that is sterilized by the manufacturer and intended for use with infants must meet certain strict FDA standards.

Are there approved recipes for homemade infant formulas?

FDA regulates commercially available infant formulas, which are marketed in liquid and powder forms, but does not regulate recipes for homemade formulas. Great care must be given to the decision to make infant formulas at home, and safety should be of prime concern. The potential problems associated with errors in selecting and combining the ingredients for the formula are very serious and range from severe nutritional imbalances to unsafe products that can harm infants. Because of these potentially very serious health concerns, FDA does not recommend that consumers make infant formulas at home.

How do I report a problem or illness caused by an infant formula?

If a consumer has a general complaint or concern about a food product including an infant formula, FDA is the appropriate agency to contact. These problems, complaints, or injuries can be reported in writing or by telephone, or by the Internet at http://www.fda.gov/opacom/backgrounders/problem.html

If you think your infant has suffered a serious harmful effect or illness from an infant formula, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or by using the website www.fda/report/hcp.htm. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods, dietary supplements, and infant formulas. The identity of the patient is kept confidential. In addition, health care providers should report infectious diseases in infants associated with use of infant formula to CDC's Division of Healthcare Quality Promotion (1-800-893-0485).

Consumers may also report an illness, injury or other problem they believe to be related to the use of an infant formula by calling FDA at 1-800-FDA-1088 or using the website www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when a product may have caused a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.

Infant formula manufacturers provide toll-free telephone numbers on the labels of their products and should be notified about problems, complaints, or injuries caused by their products.

Reproduced from FDA/CFSAN Infant Formula: Frequently Asked Questions