Do infants fed infant formulas need to take additional vitamins and minerals?
The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk” (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old (Title 21, Code of Federal Regulations 21 CFR 105.3(e)). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula March 1, 2006
How does FDA regulate Infant Formulas?Because infant formula is a food, the laws and regulations governing foods apply to infant formula. Additional statutory and regulatory requirements apply to infant formula, which is often used as the sole source of nutrition by a vulnerable population during a critical period of growth and development. These additional requirements are found in section 412 of the FFDCA and FDA’s implementing regulations in 21 CFR 106 and 107. To view the FFDCA and regulations in 21 CFR, see FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula March 1, 2006.
Does FDA have nutrient specifications for infant formulas?Yes, FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. If an infant formula does not contain these nutrients at or above the minimum level or within the specified range, it is an adulterated product unless the formula is “exempt” from certain nutrient requirements. An “exempt infant formula” is “any infant formula which is represented and labeled for use by an infant who has an inborn error of metabolism or low birth weight, or who otherwise has an unusual medical or dietary problem” (FFDCA 412(h)(1). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula March 1, 2006.
Does FDA approve infant formulas before they are marketed?No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated under Section 412(a)(1) of the FFDCA and FDA has the authority to take compliance action if the new infant formula is marketed. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula March 1, 2006.
How do parents know what formula to feed to their infant?A wide selection of different types of infant formulas is available on the market. Parents should ask their infant’s health care provider if they have questions about selecting a formula for their infant. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.
Do infants fed infant formulas need to take additional vitamins and minerals?Infants fed infant formulas do not need additional nutrients unless a low-iron formula is fed. If infants are fed a low-iron formula, a health care professional may recommend a supplemental source of iron, particularly after 4 months of age. FDA’s nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, manufacturers set nutrient levels for their label claims that are generally above the FDA minimum specifications and they add nutrients at levels that will ensure that their formulas meet their label claims over the entire shelf-life of the product. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.
