Infant Formula: the FDA Supervision

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, in the new article.

The FDA advises parents and caregivers to not make or feed homemade infant formula to infants. Homemade 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 the 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 formula is adulterated. The agency can take action to remove adulterated formula from the marketplace.

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 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.

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 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.

Storage: Manufacturers must include instructions on the 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.

Infant Formula 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 the 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.