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Safety Update: The FDA Proposes New Infant Formula Rules

By Sandra Gordon

As you may know, all infant formula sold in the United States is regulated by the Food and Drug Administration (FDA) as mandated by the Infant Formula Act of 1980. The FDA sets standards for manufacturers to follow to produce safe infant formula that supports growth and development.

To ensure that the infant formula you feed your baby is the safest and healthiest in the world, the FDA recently took steps to mandate how infant formula used by healthy infants (not those with unusual dietary or medical problems) is manufactured.

As of July 2014, an interim final rule, which immediately implements a rule by Federal agencies, will go into effect and regulate certain procedures infant formula manufacturers must follow regarding production, packaging and labeling. These are steps the makers of store brand infant formula have already been taking voluntarily. Here’s a sampling:

  • Quality control procedures: Powdered infant formula will be required to be tested for contaminants, such as Salmonella and Cronobacter, before the formula is distributed.
  • Notification: Manufacturers will be required to notify the FDA about a new formula or changes to infant formula they make.
  • Nutrient content: Manufacturers will also be required to document that the infant formula they produce has the federally required nutrients, such as protein, carbohydrates, fat, vitamins and minerals, to ensure that it supports an infant’s normal physical growth. The new rule also establishes that the quality of the protein in formula must be in a form that infants can use.

As you can tell, a lot goes on behind the scenes to ensure that the infant formula you feed your baby is safe and supports healthy growth. Overall, store brand formula must be nutritionally equivalent to name brand infant formula and produced to the same safety and quality standards. Even though it costs as much as 50 percent less than name brands, store brand infant formula meets or exceeds all FDA requirements. In fact, during production of store brand infant formula, over 600 tests related to quality and safety are performed on every batch.

For more information about how infant formula is regulated in the U.S., visit

About the Author

Sandra Gordon

Sandra Gordon is a consumer products expert, a writer, and a mother of two. She has appeared on NBC's Today Show and as a baby safety expert on The Discovery Health Channel's "Make Room for Baby." A Consumer Reports author, her latest book is Save a Bundle: 50+ Ways to Save Big on Baby Gear.

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