Is infant formula regulated?

The U.S. Food and Drug Administration (FDA) maintains a set of guidelines for infant formula manufacturers (detailed below) and sets minimum and maximum required nutrient levels “as resources permit.” Although the chief scientist Stephen Ostroff, MD, refers to them as “high quality standards” that ensure the “safety and nutritional quality” of infant formulas in the U.S., it’s important for consumers to be aware that these guidelines in no way suggest that the FDA tests and pre-approves formulas before they are marketed. Unlike prescription drugs, there is no review and submission process for infant formulas. Manufacturers must register with the FDA, must notify the FDA before marketing any new formula, and must adhere to established guidelines. But they do not have to provide any product samples or conduct any studies on their formulas prior to selling it to consumers. 

According to the “FDA 101: Infant Formula” consumer information guide, agency staff do “conduct yearly inspections” of infant formula manufacturing facilities, and “collect and analyze product samples.” They also inspect new facilities. In addition, the agency can initiate a mandatory recall “if it determines that an adulterated or misbranded infant formula presents a risk to human health.”

The infant formula guidelines address: 

  • Quality control—The FDA establishes rules for checking for microbiological contamination, which has been a high-profile problem for several infant formula makers in the past. Specifically, manufacturers will need to check for Salmonella and Cronobacter, which can threaten newborn health. 
  • Nutrient content—The FDA requires manufacturers to ensure that products contain the nutrients necessary for healthy growth. The new regulations also require a growth-monitoring study to measure physical growth of healthy babies who consume infant formula. 
  • Manufacturing processes—The FDA sets forth “good manufacturing standards” for infant formula makers in two documents totaling more than 550 pages of rules. 
  • Recordkeeping and reporting—The FDA aims to reduce redundancy for manufacturers.

The FDA chose not to provide direction about specific manufacturing processes, allowing manufacturers to determine which practices best meet these concerns. Acknowledging that powdered infant formula is not sterile, the FDA provides guidance for how to prepare infant formula in the safest way possible. (For powdered formula, boil and cool tap water before mixing. For powdered and concentrated formula, mix with the amount of water instructed on the packaging. For all formula, keep an eye on the “Use by” date, as the nutritional content is not guaranteed adequate by the manufacturer after this date.) 

The current regulations are silent on some of the major topics in nutrition circles, including the controversial additives docosahexaenoic acid (DHA) and arachidonic acid (ARA) and the use of genetically modified organisms (GMOs). Organizations such as the independent think tank Cornucopia Institute and the National Alliance for Breastfeeding Advocacy (NABA) have for several years been requesting that the FDA rule against the inclusion of DHA and ARA in infant formula, citing questionable research about the health claims and instances of diarrhea and gastrointestinal upset in newborns. (You can read more about the controversy here.) The rule also only applies to formula manufactured for use with healthy infants, leaving out those products marketed to infants with specific health conditions. 

Parents who choose to formula-feed, either exclusively or in conjunction with breastfeeding, are encouraged to select their babies’ infant formula carefully. See our guidance on soy and and organic formulas as well as iron-fortified formulas, learn the difference between ready-to-feed and powdered formulas, and check out the AAP’s “Choosing a Formula” website. Don’t take the FDA’s action on infant formula as an endorsement of any particular brand. If you will be feeding your baby formula, discuss your options with your child’s health care provider and do your own research to determine which brand is best for your baby.

Last updated June 15, 2017

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