October 19, 2018

New FDA Rules for Infant Formula

The FDA just published a new interim rule about infant formula. It sets standards for manufacturers to ensure that they produce safe formula that supports healthy growth. The rule, along with two draft guidance documents for industry, was published on February 6, 2014.

Powdered Infant FormulaSince 25% of all infants are never breast fed, and by three months, two-thirds are consuming some infant formula, this rule is crucial. Infants who do not have any medical or dietary problems should be able to grow and thrive on any infant formula marketed in the United States.

Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine said in a statement, “many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age. The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being.”

The rule covers quality control, notification, and record and reporting requirements for infant formula manufacturers, along with establishing good manufacturing practices (GMP). Manufacturers are required to test for Cronobacter and Salmonella contamination. Many manufacturers already follow GMP and quality control measures.

Some of the nutrient specifications include fortification with iron. Infants should not be given cow’s milk, since it contains little iron which is poorly absorbed when fed in this form. Cow’s milk given to babies under 6 months can cause bowel irritation and blood loss, which can lead to anemia.

If you are interested in more about this issue, the FDA’s page on Infant Formula 101 has lots of information, including how to safely prepare and store infant formula, and how to look out for counterfeit formula. You can report concerns or problems with infant formula to FDA Medwatch.

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