What Are The Regulations For Infant Formula

Many parents rely on formula for their infants.

Many parents, at one time or another, rely on formula to feed their infants. In order to make sure all formulas made in the United States are safe and contain certain necessary nutrients, the U.S. Food and Drug Administration (FDA) regulates the manufacturing of all infant formulas. The FDA defines infant formula as a food that is made exclusively for use by babies 12 months old or younger as a total or partial substitute for breast milk.

Vitamin Requirements

Infant formulas must contain numerous vitamins and minerals, according to the FDA. Some of these include niacin, folic acid, vitamin A, vitamin B1, vitamin C, vitamin E, iron, calcium and potassium. The FDA requires a minimum for every nutrient listed, but the FDA also lists maximums for certain nutrients. The nutrients that have maximums include vitamin A, vitamin D and sodium.

Testing

The FDA requires that formula manufacturers test each batch of formula at the very end of the manufacturing process for vitamins A, B1, C and E to make sure they are at the required levels. Manufacturers must also test the mixes used to add the nutrients to the formula before they are used to make sure they contain the correct amount of nutrients. If the FDA decides to add additional nutrients to the list of requirements for infant formula, manufacturers must test for these as well.

New Formulas

Although the FDA does not approve each new formula before it is marketed, the manufacturer must notify the FDA before advertising any new formula. New infant formulas must also meet the nutrient standards set by the FDA. If the manufacturer does not notify the FDA when they are creating a new or reformulated formula, the FDA can take action against the company.

Exemptions

All regular infant formula, whether name brand or generic, must meet the guidelines set by the FDA. A formula may be classified as exempt from these regulations if it is made for infants who have problems with metabolism, were born underweight or who have other dietary or medical issues. These formulas must be clearly labeled to show they are not for normal, healthy infants.

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