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Infant formula FAQ

What is infant formula?

Infant formulas are liquids or reconstituted powders fed to infants and young children. They serve as substitutes for human milk. The composition of commercial formulas is carefully controlled and FDA requires that these products meet very strict standards. Breastfeeding is still the best way to feed you baby. But there may be mitigating factors that will make breastfeeding impossible, like breast removal from breast cancer, breast damage due to implant surgery and adoption.

How does the FDA regulate infant formula?

The safety and nutritional quality of infant formulas are ensured by requiring that manufacturers follow specific procedures in manufacturing infant formulas. In fact, there is a law known as the Infant Formula Act which gives FDA special authority to create and enforce standards for commercial infant formulas. Manufactures must analyze each batch of formula to check nutrient levels and make safety checks. They must then test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas must also have codes on their containers to identify each batch and manufacturers must keep very detailed records of production and analysis.

How do I report a problem or illness caused by an infant formula?

If a consumer has complaint or concern about an infant formula, the FDA is the appropriate agency to contact. If you think your infant has suffered a serious harmful effect or illness from an infant formula, you or your health care provider can report this by calling the FDA's MedWatch hotline at 1-800-FDA-1088.

The FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.

Source: U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Office of Special Nutritionals.

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