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 co
nsume 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 e
valuated by the FDA and may lack nutrients vital to an infant’s growth. It is im
portant 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 co
ntain 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 co
ntamination and absence of, or inadequate amounts of, critical nutrients. These problems are serious, and the co
nsequences may range from severe nutritio
nal imbalances to foodborne illnesses, both of which can be life-threatening. Because of these severe health concerns, the FDA stro
ngly 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, co
ntact your local health department or use bottled water. If your baby is very young (younger than 3 mo
nths old), was born prematurely, or has a weakened immune system, co
ntact 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 a
bout how to properly clean your baby’s bottles and other feeding supplies, visit the Centers for Disease Co
ntrol (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 co
ntent and the quality of the formula. After this date, a package or co
ntainer of infant formula should not be fed to infants. FDA regulations require this date to be specified on each co
ntainer of infant formula.
Storage: Manufacturers must include instructions on infant formula packaging for its handling before and after the co
ntainer 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 compo
nents to separate.
Products on the Market
The American Academy of Pediatrics recommends exclusive breastfeeding for a
bout 6 months, followed by co
ntinued breastfeeding as other foods and drinks are introduced with co
ntinuation of breastfeeding for one year or lo
nger as mutually desired by mother and infant. While breastfeeding is stro
ngly 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 nutritio
nal 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 additio
nal 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 “Additio
nal 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.
Article source: FDA
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