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Safe Baby Formula Rules

If you feed your baby using infant formula, it’s important to know the facts.

All manufacturers of infant formula sold in the U.S. must register with FDA which sets standards to ensure the nutritional quality and safety of infant formula.

Formula — whether powder, liquid concentrate, or ready-to-feed — can become contaminated during preparation and handling.

Safe Preparation

Handwashing is the first step — don’t spread bacteria on your hands to your baby. Wash your hands often with warm water and soap for at least 20 seconds, especially before and after preparing formula.

Prepare formula in a clean area to prevent cross-contamination when bacteria are spread from one food product to another.

Sterilize bottles in boiling water before first use — after that they can be safely washed and dried in a dishwasher.

Don’t sterilize nipples in boiling water or wash them in a dishwasher. Heat breaks down the latex in nipples, so wash them by hand with hot soapy water, rinse thoroughly, and air dry.
It’s usually safe to mix formula using cold tap water that’s been boiled for one minute and cooled to body temperature just before feeding. Water that is not cooled can cause serious burns. Keep the water covered while cooling to prevent contamination with bacteria.
If you use bottled water for formula preparation, remember that most bottled water is not sterile so follow the same boiling and cooling procedure.
Use the exact amount of formula and water as directed on the label, mix only enough for one feeding, and prepare it immediately before feeding. Follow label instructions carefully. If a lot of formula is prepared and not properly refrigerated, bacteria can multiply to very large numbers. The more bacteria there are, the greater the chance for foodborne illness. Preparing formula in smaller quantities on an as-needed basis greatly reduces the possibility of contamination.

Safe Use

Don’t leave formula out at room temperature for more than two hours. Discard formula that’s been left out longer.
If you need to warm formula, the best way is to put the bottle in a small pan of water and heat it on the stove until body temperature. Shake the bottle before feeding. Never use microwave ovens because microwaving can heat the formula unevenly and cause hot spots to develop, even though the bottle and the rest of the formula remain cool.
Don’t feed infant formula after the “Use By” date on the label. Manufacturers guarantee the nutrient content and the quality of the formula only up to the use by date. If you buy formula by the case, make sure the lot numbers and use by dates on the containers and boxes match.
Follow the storage instructions on the container.
Don’t save unfinished formula. Bacteria from a baby’s mouth can be introduced into the bottle during feeding and they can grow even if leftover formula is refrigerated.
Freezing is not recommended because it may cause the formula’s components to separate.

Homemade and Counterfeit Formula

FDA does not regulate recipes for homemade formula and does not recommend making formula at home. Errors in selecting and combining ingredients for homemade formula can have serious consequences for the health of infants.
Counterfeit Formula products are sometimes diverted from normal distribution channels and relabeled to misrepresent quality or identity–altering the “Use By” date for example, or relabeling to disguise the true content. Always purchase infant formula from a licensed, reputable retailer.