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The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them.

Don’t Make Homemade Formula

The FDA advises parents and caregivers to not make or feed homemade infant formula to infants. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth. It is important for parents and caregivers to remember that infant formula can be the sole source of nutrition for infants and is strictly regulated by the FDA.

The agency has requirements for certain nutrients in infant formulas sold in interstate commerce, and if the formula does not contain these nutrients at or above the minimum level or within its specified range, the infant formula is adulterated. The agency can take action to remove adulterated formula from the marketplace.

The agency has received reports of hospitalized babies who had been fed homemade infant formula and then suffered from hypocalcemia (low calcium). Other potential problems with homemade formulas include contamination and absence of, or inadequate amounts of, critical nutrients. These problems are serious, and the consequences may range from severe nutritional imbalances to foodborne illnesses, both of which can be life-threatening. Because of these severe health concerns, the FDA strongly advises parents and caregivers not to make and feed their infants homemade formulas.

Other Safety Issues to Keep in Mind

Formula Preparation: Use water from a safe source to mix with powdered infant formula. If you are not sure if your tap water is safe to use for preparing infant formula, contact your local health department or use bottled water. If your baby is very young (younger than 3 months old), was born prematurely, or has a weakened immune system, contact your infant’s pediatrician to find out if you need to take extra precautions in preparing your infant’s formula. Use the amount of water and number of powder scoops listed on the instructions of the infant formula label. Be sure to use the scoop provided by the manufacturer. Always measure the water first and then add the powder. If the formula is not being fed immediately, refrigerate it right away, keep refrigerated until feeding, and use within 24 hours. Discard any formula left in the bottle after your infant has finished a feeding.

Bottles & Nipples: Bottles, rings, caps, and nipples need to be clean and sanitized. To learn more about how to properly clean your baby’s bottles and other feeding supplies, visit the Centers for Disease Control (CDC) webpage “How to Clean, Sanitize, and Store Infant Feeding Items.”

Formula Warming: This isn’t necessary. If you prefer to feed your infant warmed formula, place the bottle under running warm water, taking care to keep the water from getting into the bottle or on the nipple. Put a couple drops of the infant formula on the back of your hand to make sure it is lukewarm and not too hot. Never use a microwave oven 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 your baby.

“Use By” Date: This is the date up to which the manufacturer guarantees the nutrient content and the quality of the formula. After this date, a package or container of infant formula should not be fed to infants. FDA regulations require this date to be specified on each container of infant formula.

Storage: Manufacturers must include instructions on infant formula packaging for its handling 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 the product’s components to separate.

Products on the Market

The American Academy of Pediatrics recommends exclusive breastfeeding for about 6 months, followed by continued breastfeeding as other foods and drinks are introduced with continuation of breastfeeding for one year or longer as mutually desired by mother and infant. While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, many infants in the U.S. rely on infant formula for some portion of their nutrition.

Infant formula comes in three forms:

  • Powder — Must be mixed with water before feeding.
  • Liquid concentrate — Must be mixed with an equal amount of water before feeding.
  • Ready-to-feed — Requires no mixing.

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

The infant formulas currently available in the U.S. are labeled as either “Infant Formula with Iron” or “Additional Iron May Be Necessary.” The American Academy of Pediatrics recommends that formula-fed infants receive an “Infant Formula with Iron” as a way of preventing iron-deficiency anemia.

If you have concerns about infant formula, contact your health care provider and FDA at 1-888-INFO-FDA (1-888-463-6332), or you can file a report online at MedWatch.

See this page for more questions and answers on infant formula, and click here to read the FDA’s safety alert for homemade infant formula.