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U.S. Department of Health and Human Services

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FDA 101: Infant Formula


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FDA's Center for Food Safety and Applied Nutrition (CFSAN) oversees manufacturers of infant formulas, and ensures that they comply with nutritional requirements. Divisions within CFSAN have program responsibility for infant formula products and their ingredients and packaging. In addition, FDA regulations for current good manufacturing practice requirements for foods apply to the production of infant formula. 

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula. 

FDA monitors infant formula products as part of its responsibility. The agency conducts yearly inspections of all facilities that manufacture infant formula, and collects and analyzes product samples. FDA also inspects new facilities. The agency is authorized to initiate a mandatory recall if it determines that an adulterated or misbranded infant formula presents a risk to human health.

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Products on the Market

Baby formula comes in three forms:

  • Powder—the least expensive of the infant formulas. It must be mixed with water before feeding.
  • Liquid concentrate—must be mixed with an equal amount of water.
  • Ready-to-feed—the most expensive form of formula that requires no mixing.

The protein source varies among different types of infant formula.

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Nutritional Specifications

FDA's nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, formula manufacturers set nutrient levels that are generally above the FDA minimum requirements. Thus, babies fed infant formulas do not need additional nutrients, unless they are being fed a low-iron formula.

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.

The American Academy of Pediatrics (AAP) recommends that formula-fed infants receive an iron-fortified formula as a way of reducing the prevalence of iron-deficiency anemia.

If infants are fed a low-iron formula, a health care professional may recommend a supplemental source of iron, particularly after 4 months old.

Whole cow's milk
Consult your pediatrician before feeding your baby anything except breast milk or infant formula. Whole cow's milk is considered an inappropriate option for infants, which FDA defines as babies not more than 12 months old.

According to AAP, cow's milk contains very little iron and the small amount present is poorly absorbed into the body. Starting an infant on cow's milk too early can result in iron-deficiency anemia, particularly if the baby is not given an iron supplement or foods with iron.

Also, cow's milk given to an infant under 6 months old can cause irritation of the bowel and small amounts of blood loss. This causes loss of red blood cells, and can result in anemia.

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Safety Issues

  • Formula preparation. In most cases, it's safe to mix formula using ordinary cold tap water that's brought to a boil and then boiled for one minute and cooled. According to the World Health Organization, recent studies suggest that mixing powdered formula with water at a temperature of at least 70 degree C—158 degrees F—creates a high probability that the formula will not contain the bacterium Enterobacter sakazakii—a rare cause of bloodstream and central nervous system infections. Remember that formula made with hot water needs to be cooled quickly to body temperature—about 98 degrees F—if it is being fed to the baby immediately. If the formula is not being fed immediately, refrigerate it right away and keep refrigerated until feeding.  
  • Bottles and nipples. The Mayo Clinic says you may want to consider sterilizing bottles and nipples before first use.  After that, you can clean them in the dishwasher or wash them by hand with soapy water.
  • Water. Use the exact amount of water recommended on the label. Under-diluted formula can cause problems related to dehydration.  Over-diluted formula will not provide adequate nutrition, and, if fed for an extended period of time, may result in slower growth.
  • Bottled water. If consumers use non-sterile bottled water for formula preparation, they should follow the same directions as described for tap water above. Some companies sell bottled water that is marketed for infants and for use in mixing with infant formula. This bottled water is required to meet general FDA quality requirements for bottled water. If the bottled water is not sterile, the label must also indicate this. Water that is marketed by the manufacturer as sterile and for infants must meet FDA's general requirements for commercial sterility.
  • Formula warming. This isn't necessary for proper nutrition. The best way to warm a bottle of formula is by placing the bottle in a pot of water and heating it on the stove until warm (at body temperature). Never use microwave ovens for heating infant formulas. Microwaving may cause the bottle to remain cool while hot spots develop in the formula. Overheated formula can cause serious burns to the baby.
  • "Use by" date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date on each container of infant formula.
  • Storage. Manufacturers must include instructions on infant formula packaging for before and after the container is opened. They must also include information on the storage and disposal of prepared formula.
  • Freezing formula. This is not recommended, as it may cause a separation of the product's components.
  • Homemade formula. FDA does not regulate or recommend recipes for these. Errors in selecting and combining ingredients for homemade formula can have serious consequences affecting the nutrition and overall well-being of the infant.
  • Counterfeit formula. These formulas have been diverted from normal distribution channels and relabeled to misrepresent quality or identity. An example is illegal labeling of the "use by" date. Infant formula may also be illegally relabeled to disguise its true content. This can lead to serious adverse health consequences for infants who cannot tolerate certain ingredients.
  • Formula changes. Always look for any changes in formula color, smell, or taste. If you buy formula by the case, make sure the lot numbers and "use by" dates on the containers and boxes match. Also, check containers for damage, and call the manufacturer's toll-free number with any concerns or questions. You may contact FDA (see below.)

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Reporting Infant Formula Problems and Concerns

  • For general complaints or concerns, contact FDA at 1-888-INFO-FDA (1-888-463-6332): or by the Internet at MedWatch
  • To report a serious harmful effect or illness, have your health care provider contact FDA's MedWatch hotline at 1-800-FDA-1088, or at MedWatch
  • Health care providers looking to report infectious diseases in infants associated with use of infant formula should call the Centers for Disease Control and Prevention's Division of Healthcare Quality Promotion at 1-800-893-0485.
  • Consumers may report an illness, injury or other problem believed to be related to infant formula by calling FDA at 1-800-FDA-1088 or visiting medwatch online voluntary reporting.
  • Notify manufacturers about problems, complaints, or injuries caused by their products by calling the toll-free telephone numbers listed on their product labels.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Reposted: December 2007

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