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U.S. Department of Health and Human Services

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What should I know about infant formula?

FDA oversees manufacturers of infant formulas, and ensures that they comply with established nutritional requirements. However, it does not approve infant formulas before they can be marketed. 

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.

FDA monitors infant formula products as part of its responsibility and conducts yearly inspections of all facilities that manufacture infant formula, and collects and analyzes product samples. FDA also inspects new facilities. The agency is authorized to initiate a mandatory recall if it determines that an adulterated or misbranded infant formula presents a risk to human health.

Babies fed infant formulas do not need additional nutrients, unless they are being fed a low-iron formula.

FDA 101: Infant Formula

Questions & Answers for Consumers Concerning Infant Formula

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