January 19, 2018

FDA Published Final Rule on Infant Formula Protections

The FDA has published its final rule setting standards for manufacturing infant formulas. Those standards include current good manufacturing practices, including required testing for Salmonella and Cronobacter.

Infant FormulaThe manufacturers must also demonstrate that the formula they product supports normal physical growth. And finally, infant formulas must be feted for nutrient content three times: in the final product stage, before entering the marketplace, and at the end of the products’ shelf life. Dr. Stephen Ostroff, FDA’s acting chief scientist said in a statement, “FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development.”

The rule applies to formulas intended for use by healthy babies without any “unusual medical or dietary problems.” The rule will make these requirements enforceable by government officials. The government doesn’t approve infant formulas before they are marketed, but all formulas marketed in this country must meet federal nutrition requirements. And the FDA inspects infant formula facilities yearly, collecting and analyzing product samples.

Infant formula comes in three forms: powder, liquid concentrate, and ready-to-feed. The source of protein in these products varies depending on the type.

When preparing infant food, parents must follow food safety rules. When preparing formula, mix it with tap water that has been boiled for one minute and cooled. If you are feeding a baby with formula made with hot water, cool it quickly to room temperature, about 98°F, and feed immediately. If the formula isn’t use immediately, it must be refrigerated.

Sterilize bottles and nipples before the first use; then clean them in the dishwasher or with soapy water. Always use the exact amount of water recommended on the package label; never dilute the product to extend use. Warming formula isn’t necessary, but if you want to do this, place the bottle in a pot of water and heat it on the stove until it’s at body temperature. Never use a microwave to heat formula, since the product math develop hot spots that can cause serious burns.

Always follow the “use by” date, and store formula properly. And do not freeze formula, since it can cause separation of the ingredients.

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